Document gbJ65boKRD631mGqrYjyovx7G

Annual Report 2023 Ref. Ares(2024)3624628433526 - 034/059/2024 Disclaimer The European Chemicals Agency is not responsible for the use that may be made of the information contained in this document. Europe Direct is a service to help you find answers to your questions about the European Union. Freephone number (*): 00 800 6 7 8 9 10 11 (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed. More information on the European Union is available on the Internet (http://europa.eu). Annual Report 2023 Reference: ECHA-24-R-03-EN ISBN: 978-92-9468-355-7 ISSN: 2600-0849 Cat. Number: ED-BF-24-001-EN-N DOI: 10.2823/25240 Publ.date: April 2024 Language: EN European Chemicals Agency, 2024 Cover page European Chemicals Agency If you have questions or comments in relation to this document, please send them (quote the reference and issue date) using the information request form. 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Box 400, FI-00121 Helsinki, Finland 3 Annual Report 2023 Table of Contents TABLE OF CONTENTS .................................................................................................. 3 LIST OF ACRONYMS .................................................................................................... 5 MANAGEMENT BOARD ANALYSIS AND ASSESSMENT .................................................. 8 Achievements of the year ........................................................................................................... 8 Management ............................................................................................................................ 9 Budgetary and financial management .......................................................................................... 9 Human resources management ................................................................................................... 9 Audit and retrospective evaluation results and follow-up on recommendations ................................... 9 Internal control framework and Integrated Management System...................................................... 9 Organisational risk management ............................................................................................... 10 Management Assurance ........................................................................................................... 10 Recommendations for the secretariat for 2024 ............................................................................ 10 Acknowledgments ................................................................................................................... 11 Conclusion ............................................................................................................................. 11 FOREWORD............................................................................................................... 12 EXECUTIVE SUMMARY .............................................................................................. 14 PART I. ACHIEVEMENTS OF THE YEAR ...................................................................... 19 Dossier preparation ................................................................................................................. 19 Dossier submission and processing ............................................................................................ 20 Identification and prioritisation.................................................................................................. 22 Evaluation ............................................................................................................................. 23 Authorisation.......................................................................................................................... 25 Restrictions ............................................................................................................................ 26 Classification and labelling........................................................................................................ 28 Safe and sustainable use of chemicals........................................................................................ 30 Data management and dissemination ........................................................................................ 31 Promotion of alternatives to animal testing ................................................................................. 32 Biocides................................................................................................................................. 33 Prior informed consent............................................................................................................. 36 Persistent organic pollutants ..................................................................................................... 37 Waste Framework Directive ...................................................................................................... 38 Drinking Water Directive .......................................................................................................... 39 Support to the 8th Environmental Action Programme of the EU....................................................... 40 EU Observatory for Nanomaterials ............................................................................................. 40 EU Chemicals Legislation Finder ................................................................................................ 41 Support to occupational health legislation ................................................................................... 41 Instrument for Pre-Accession Assistance (IPA) ............................................................................ 42 Support to other legislation ...................................................................................................... 43 IUCLID for EFSA ..................................................................................................................... 43 Partnership for the Assessment of Risk from Chemicals (PARC)...................................................... 44 Support to Forum ................................................................................................................... 45 Board of Appeal ...................................................................................................................... 46 Management .......................................................................................................................... 47 ICT 50 Financial Resources ................................................................................................................. 51 Human Resources ................................................................................................................... 52 Corporate Services .................................................................................................................. 53 PART II. MANAGEMENT ............................................................................................ 55 Management Board ................................................................................................................. 55 Major developments ................................................................................................................ 55 Budgetary and financial management ........................................................................................ 56 Delegation and sub-delegation of the powers of budget implementation to agency's Staff .................. 56 Human Resources (HR) management ......................................................................................... 56 4 Annual Report 2023 Strategy for efficiency gains ..................................................................................................... 57 Assessment of audit and retrospective evaluation results during the reporting year .......................... 57 Follow up of recommendations and action plans for audits and evaluations ...................................... 59 Follow up of observations from the Discharge authority ................................................................ 59 Environment management ....................................................................................................... 60 Assessment by management .................................................................................................... 61 PART III. ASSESSMENT OF THE EFFECTIVENESS OF THE INTERNAL CONTROL SYSTEMS ........................................................................................................................... 62 Effectiveness of internal control system...................................................................................... 62 Conclusions of assessment internal control systems ..................................................................... 67 Statement of the manager in charge of risk management and internal control ................................. 69 PART IV. MANAGEMENT ASSURANCE ........................................................................ 70 Review of the elements supporting assurance ............................................................................. 70 Reservations .......................................................................................................................... 70 PART V. DECLARATION OF ASSURANCE .................................................................... 71 Declaration of assurance by the Authorising Officer ...................................................................... 71 APPENDICES............................................................................................................. 72 Appendix I - Key indicators ...................................................................................................... 73 Appendix II - Budget implementation reports and statistics on financial management ....................... 74 Appendix III - Organisational chart ........................................................................................... 84 Appendix IV - Establishment plan and additional information on human resources management ......... 85 Appendix V - Human and financial resources by activity ............................................................... 90 Appendix VI - Contribution, grant and service-level agreements .................................................... 91 Annex VII - Environment management....................................................................................... 92 Annual Report 2023 List of acronyms Acronym AD APCRA ARN ASO AST BEF BPC BPR BPRS BREF C&L CA CCH CCS CEFIC CEOS Chesar CLH CLP CMD CMR CoIAC COM CoRAP CSA CSR CSS DEC Description Administrator Accelerating the Pace of Chemical Risk Assessment Assessment of regulatory needs Accredited Stakeholder Organisation Assistant BPR-EN-FORCE (Forumcoordinated BPR enforcement project) Biocidal Products Committee Biocidal Products Regulation BPR Subgroup of the Forum Best Available Techniques Reference documents Classification and labelling Contract agent Compliance check Chemicals Strategy for Sustainability of the Commission Conseil Europen des Fdrations de l'Industrie Chimique Conditions of Employment of Other Servants of the European Union Chemical Safety Assessment and Reporting tool Harmonised classification and labelling Classification, labelling and packaging (and the respective Regulation) Carcinogens and Mutagens Directive 2004/37/EC Carcinogenic, mutagenic or toxic to reproduction Conflict of Interest Advisory Committee European Commission Community rolling action plan Chemical safety assessment Chemical safety report Chemicals Strategy for Sustainability of the Commission Discharge procedure 5 Acronym DG DIGIT DG EMPL DG GROW DG NEAR DG RTD DNA DNEL DPP DU DWD EAP EC ECA ECETOC TRA ECHA eChemPortal ED EEA EFSA EFTA EMA EMAS EMCDDA EMS US EPA ERR Description 2021/2157(DEC) Directorate General for Informatics Directorate General for Employment, Social Affairs and Inclusion Directorate General for Internal Market, Industry, Entrepreneurship and SMEs Directorate General for Neighbourhood and Enlargement Negotiations Directorate General for Research and Innovation Designated national authorities Derived no-effect level Digital Product Passports Downstream user Drinking Water Directive Environmental Action Programme European Commission European Court of Auditors European Centre for Ecotoxicology and Toxicology of Chemicals Targeted Risk Assessment European Chemicals Agency OECD Global Portal to Information on Chemical Substances Endocrine disruptor European Economic Area European Food Safety Authority European Free Trade Association European Medicines Agency EU Eco-Management and Audit Scheme European Monitoring Centre for Drugs and Drug Addiction Environmental management system United States Environmental Protection Agency Exposure-risk relationship Annual Report 2023 Acronym ES EU EUCLEF EUON EUSES Forum FRA FTE FWC GIME GPP HelpNet HR IAC IAS ICT IED IMS IPA IR IRS ISO IT IUCLID JEAP JRC KPI MB MCCP MFF MISA Description Exposure scenario European Union European Chemicals Legislation Finder European Union Observatory for Nanomaterials European Union System for Evaluation of Substances Forum for Exchange of Information on Enforcement Final regulatory action Full-time equivalent Framework contract Groupe Interinstitutionnel de Management Environnemental (Interinstitutional Group for Environmental Management) Green Public Procurement Network of national BPR, CLP and REACH helpdesks Human resources Internal Audit Capability of ECHA Internal Audit Service of the Commission Information communications technology Industrial Emissions Directive 2010/75/EU Integrated Management System Instrument for Pre-Accession Assistance Information requirements Integrated Regulatory Strategy International Organisation for Standardisation Information technology International Uniform Chemical Information Database Joint Evaluation Action Plan Joint Research Centre Key Performance Indicators Management Board Medium-chain chlorinated paraffins Multiannual Financial Framework Metals and Inorganics Sectoral Approach 6 Acronym MS MSC MSCA NAM NGO NEA NeRSAP NONS Odyssey OECD OEL OSH PACT PAH PARC PBT PCN PFAS PFCA PFOS PIC PMT POP POPRC POPs PPORD PPP PVC QSAR R4BP RAC REACH Description Member State Member State Committee Member State competent authority New approach methodologies Non-governmental organization National enforcement authority Network of REACH SEA and Analysis of Alternatives practitioners Notification of New Substances ECHA's tool to support evaluation tasks Organisation for Economic Cooperation and Development Occupational exposure limit Occupational safety and health Public activities coordination tool Polycyclic aromatic hydrocarbons Partnership for the Assessment of Risks of Chemicals Persistent, bioaccumulative and toxic Poison Centre Notifications Per- and polyfluoroalkyl substances Perfluorocarboxylic acids Perfluorooctanesulfonic acid Rotterdam Convention on the prior informed consent procedure (and the respective Regulation) Persistent, mobile and toxic Persistent organic pollutants Persistent Organic Pollutants Review Committee Persistent organic pollutants (and the respective Regulation) Product and Process Oriented Research and Development Plant protection products Polyvinyl chloride Quantitative Structure-Activity Relationship Register for Biocidal Products Committee for Risk Assessment Registration, evaluation, authorisation and restriction of 7 Annual Report 2023 Acronym REACH-IT REF DG RTD SCBTH SCIP SEAC SLA SME SNE SON SPC SVHC TA TP Description chemicals (and the respective Regulation) Central IT system providing support for REACH REACH-EN-FORCE (Forumcoordinated REACH enforcement project) Directorate-General for Research and Innovation Serious Cross-Borders Threats to Health Database for information on Substances of Concern In articles as such or in complex objects (Products) Committee Socio-economic Analysis Committee Service Level Agreement Small and medium-sized enterprises Seconded national expert Security Officers Network Summary of product characteristics Substance of very high concern Temporary agent Testing proposal Acronym UNEP UNGHS UVCB vPvB WFD WP 1S1A Description United Nations Environment Programme United Nations Globally Harmonised System of classification and labelling of chemicals Substance of Unknown or Variable composition, Complex reaction products or Biological materials Very persistent and very bioaccumulative Waste Framework Directive Work programme One substance one assessment 8 Annual Report 2023 Management Board analysis and assessment The Management Board welcomes the Annual Report 2023, combining the reports prepared according to the requirements of the REACH Regulation (General Report)1 and those of the ECHA Financial Regulation (Consolidated Annual Activity Report)2. We consider that this report provides a comprehensive account of the activities carried out by ECHA during 2023, the performance of the Agency against the expected inputs, outputs, outcomes, and the impacts defined in the Programming Document 2023-20263. It also represents a fair overview of the evolution of ECHA's budget, staffing, management, and its internal management system strategy and framework. This assessment is based on our analysis of all parts of the report, including the activities carried out, achievements, financial information, results of audits, retrospective evaluations, and the assessment of the internal control system, as well as the risks related to ECHA's activities together with the corresponding mitigating measures. Achievements of the year We consider that the performance and quality of the outputs in 2023 were high, as shown in Part I of the Annual Report. In assessing4 the Consolidated Annual Activity Report of the Authorising Officer for 2023, we: Emphasize the importance of the ECHA Strategy adopted in December 2023, in providing direction and priorities for ECHA in implementing its evolving mandate. Commend the secretariat and all ECHA bodies for being prepared for and having started to implement new or expanded legal mandates. Welcome that ECHA made progress with the Integrated Regulatory Strategy, including identification of (groups of) substances that are candidates for regulatory risk management measures, addressed the key actions from the Joint Evaluation Action Plan and started the review of its outcomes. Acknowledge the significant support provided to the European Commission in the implementation of the Chemicals Strategy for Sustainability (CSS). Express concern regarding the membership of the ECHA scientific Committees, which poses a risk of not meeting legal deadlines and targets in operational areas that are dependent on the Committees outputs. Acknowledge and support the efforts of all contributors in facilitating the preparation of the RAC/SEAC opinion on the Annex XV report for the UPFAS restriction, given its unique complexity and size. Acknowledge that the number of opinions that the Biocidal Products Committee (BPC) was in a position to deliver in 2023 was well below estimated numbers due to significantly less submissions by the Member States of evaluation dossiers both for active substances and Union authorisations. 1 Article 78(a) of the REACH Regulation. 2 Article 48 of ECHA's Financial Regulation. 3 https://echa.europa.eu/documents/10162/17623970/final_mb_41_2022_echa_pd_2023-2026_en.pdf 4 Assessment pursuant to Article 48(1) of the Agency's Financial Regulation. 9 Annual Report 2023 Acknowledge the efforts in promoting alternatives to animal testing, and in clarifying the opportunities and challenges in moving away from animal testing for the regulatory assessment of chemicals. Welcome the increased clarity in the way the secretariat reports to the Management Board. Note that ECHA defined 179 specific outputs for 2023 and accomplished 154 out of these during the year. In addition, 23 actions are in progress and 2 not done. Based on the periodical reporting and the Annual Report 2023 prepared by the secretariat, the Board makes the following observations: Management The 10 recommendations the Management Board provided for 2023 as part of the assessment of the 2022 Annual Report have been implemented or are in progress. Budgetary and financial management We welcome the outstanding performance of ECHA in implementing its budget with 99% of commitment rate and 1% of cancelled payment appropriation rate, while keeping the strict segregation between its funding sources and operating in an environment of fluctuating and challenging to predict fee income. Human resources management We commend ECHA for having maintained a high rate of filling its establishment plan posts and the strong focus on staff wellbeing, diversity and inclusion. Audit and retrospective evaluation results and follow-up on recommendations We received adequate information from, and assurance provided by the Internal Audit Capability (IAC) on audits, follow-up audits and the implementation of the recommendations, as well as appropriate information from the secretariat on the retrospective evaluations. The European Court of Auditors adopted a positive opinion regarding the 2022 annual accounts, with no reservation or observation. We welcome that there are no pending observations or recommendations. The European Parliament, as the Discharge Authority, granted discharge to the Executive Director with respect to ECHA's 2021 budget, including the decision on the closure of the 2021 accounts. The secretariat duly provided replies to the Discharge Authority's observations and the implementation of the recommendations is on track. The Internal Audit Service (IAS) of the Commission conducted an audit on `Budget preparation, monitoring and reporting'. The audit did not result in any critical or very important recommendations. The audit identified two improvement areas, classified as important, on resource allocation and the exceptions register. Internal control framework and Integrated Management System The internal control framework remains effective and functioning as intended. Areas identified for improvement are not considered major or critical and relate to areas such as performance management and stakeholder engagement. We welcome that the Integrated Management System Strategy and Framework was revised in 2023, to align it with the new ECHA Strategy 2024-2028. 10 Annual Report 2023 ECHA's ISO 9001:2015 and 14001:2015 quality certificates were renewed with no nonconformities found in the re-certification audit, and EMAS (Eco-Management and Audit Scheme) registration maintained. Organisational risk management We welcome the development of the new organisational Risk Management Policy, which includes a dedicated role for a Chief Risk Officer. We found the regular updates on the risk register, including the continued specific reporting on the IT-security related risks, pertinent. We note that appropriate measures are in place to identify, monitor and manage risks threatening the achievement of ECHA's objectives. The secretariat regularly signalled significant risks and control issues to the Management Board, including as part of the Executive Director reporting, as well as the updates to the Agency Risk Register. We welcome that no high impact IT/cyber security incidents took place in 2023 and that ECHA is ready to implement the new EU regulation on cybersecurity for Union Institutions, Bodies, Offices and Agencies. Management Assurance The Board takes note of the systems in place to support the Executive Director's declaration of assurance and takes note of the declaration of assurance of the Executive Director. The Board takes note of the fact that no reservations were made. Recommendations for the secretariat for 2024 Based on our assessment, the Management Board requests particular emphasis in 2024 on the following actions, without prejudice to the implementation of the Single Programming Document 2024-2026: 1. Actively continue engaging with Member State partners and stakeholders. 2. Take appropriate actions to maintain the ECHA Committees' ability to deliver transparent, independent and high-quality outputs, including attention on ensuring the necessary level of competence, expertise and working structures. 3. Follow up on the results of the Integrated Regulatory Strategy (IRS), including promoting and facilitating the uptake of regulatory measures by Member States and further refining the performance indicators and targets for grouping. 4. Maintain efforts to bring to the Management Board timely and sufficient information on the implementation of current and potential new tasks, including impacts, synergies, efficiency gains, challenges and risks, including the sustainability of ECHA's Committees. 5. Support the preparation of the RAC/SEAC opinion on the UPFAS dossier to ensure the delivery of a transparent, independent and high-quality opinion in an appropriate timeframe. 6. Support the implementation of the new hazard classes in the CLP regulation. 7. Improve and facilitate cooperation with other Agencies and Commission Directorates General to promote issues of common interest. 8. Maintain efforts in providing fit-for-purpose support to Member State Competent Authorities for biocidal products, with a view to achieving progress with the Review Programme for existing active substances. 9. Review the costing of ECHA activities and assess whether the services delivered to duty 11 Annual Report 2023 holders are fully charged. 10. Maintain strong focus on staff wellbeing, diversity and inclusion. Acknowledgments The members of the Management Board express their appreciation to ECHA staff, members of ECHA bodies and the Agency's partners, in particular Member States, for their commitment and achievements in 2023. Conclusion In assessing the Annual Report 2023, the Management Board concludes that the overall performance of ECHA is in line with the objectives included in the Agency's Programming Document 2023-2026. Based on the above observations, the Management Board requests that the Annual Report 2023 be forwarded to the Member States, the Court of Auditors, the Commission, the European Parliament, the European Economic and Social Committee and the Council. Annual Report 2023 Foreword Dr Sharon McGuinness Executive Director 12 I am pleased to present the Agency's annual report for 2023. This is the final report under ECHA's Strategic Plan 2019-2023, and it shows that we have delivered the actions and performance metrics set out in our Work Programme for 2023. We continued to deliver our legal mandate across the wide range of chemical legislation under our remit. With respect to the REACH and CLP Regulations, our two scientific committees (Risk Assessment Committee and SocioEconomic Analysis Committee) delivered six opinions on restriction dossiers, 58 opinions on uses of substances in authorisation applications and 42 opinions on proposals for harmonised classification and labelling. The Biocidal Products Committee (BPC) adopted 13 opinions for active substance approvals and renewals as well as 10 opinions on Union authorisations. We continued the prioritisation of efforts on promoting alternatives to animal testing and held a collaborative workshop with all stakeholders to discuss how collectively we can work to promote and move to using alternatives to animal testing. Support and input to the Commission on the Chemicals Strategy for Sustainability (CSS) was high on our agenda for 2023. We actively supported the decision-making process for the revised CLP Regulation and have already commenced work in preparation for its implementation. We also worked closely with the Commission to assist them in their considerations for the revision of the REACH Regulation and the Basic Regulation. While the anticipated publication of the REACH revision did not materialise as expected in 2023, we remain ready to support the Commission's proposal for a future revision. We also continue to support the Commission in relation to their work on the various legislative packages under One Substance, One Assessment as well as the Basic Regulation. This year also saw us commence work on implementation of the new regulatory tasks given to the Agency under the Drinking Water Directive, the Batteries Regulation, and the Serious Cross-Border Threats to Health Regulation. While we have delivered on our mandate and Work Programme obligations, we also recognise that some issues continue to challenge. For instance, a recurring challenge was the low number of draft assessment reports for biocidal active substances and this year also a lower number of Union authorisation applications for biocidal products evaluated and submitted by Member States. Another area of challenge is the ability to fully resource and sustain membership in our scientific committees. This poses a risk of not meeting legal deadlines and targets in operational areas that are dependent on input by Committee members. We recognise that Member States Annual Report 2023 13 are finding it increasingly difficult to find experts with the right competencies and who can commit to the everincreasing workload. Together with the Commission and the Management Board, we have looked at ways to encourage and increase membership and participation. One first step was to review the current payments for member's rapporteur work together with the Management Board. Over the course of 2023, we emphasised the importance of a Basic Regulation for ECHA to enable us, and our committees deliver on existing and future tasks, and we hope that such a regulation will be forthcoming in the near term. As this was my first full year as Executive Director, I spent time getting to meet ECHA's staff, partners and stakeholders. These included colleagues in the Commission, the EU Agencies, Member States, industry stakeholder groups and civil society organisations. As an Agency, we rely on close engagement and collaboration with these groups in our delivery of our legal mandate. I look forward to continuing my visits to the remaining Member States in 2024 as their current and future collaboration with ECHA is key for successful delivery of existing and future tasks. While 2023 was the final year of our Strategic Plan 20192023, it was also the year that our Management Board adopted our new Strategy Statement 2024-2028. I would like to thank the members of the Management Board and all ECHA's staff for their support and active participation in the development of this new strategy. I look forward to working with them and our stakeholders in the coming period to implement our vision of chemical safety through science, collaboration, and knowledge. Finally, I would like to express my thanks to the Management Board for their support and collaboration as I settled into my first year. A particular note of thanks and appreciation also to ECHA's management team and all the staff for their dedication and commitment in delivering our 2023 Work Programme. 14 Annual Report 2023 Executive summary With 2023 the last year of our strategic plan 2019-2023, we concluded the delivery of our strategic objectives and performed the planned activities specified in our Work Programme. This year also saw us commence work on implementation of the new regulatory tasks assigned to the Agency under the Drinking Water Directive, the Batteries Regulation and the Serious CrossBorder Threats to Health Regulation. We also continued to deliver our legal mandate across the wide range of chemical legislation under our remit. Two key deliverables under our strategic plan were the Integrated Regulatory Strategy (IRS) and the Joint Evaluation Action Plan (JEAP) and these are relevant to both the REACH and CLP regulations. Identification and prioritisation of substances and groups of substances for risk management actions is central to our Integrated Regulatory Strategy. In 2023, we made further strides in understanding the data on substances in our database with some 92% of substances registered above 100 tonnes now assessed. Another important aspect of the IRS is to identify substances or groups of substances for which generation of data under dossier or substance evaluation may be needed. These substances are considered under the JEAP, which sets targets for checking the compliance of registration dossiers. In 2023, we performed 301 compliance checks under dossier evaluation. With the conclusion of our strategic plan in 2023, reviews of both the IRS and JEAP took place, the outcomes of which will be used to determine the next steps for implementation of our new strategic goals and priorities. In substance evaluation, the Community rolling action plan (CoRAP) update for 2023-2025 was agreed by the Member State Committee (MSC) and published with 24 substances for evaluation by 12 Member States. Conclusions were also reached for 26 substances while 6 substance evaluation decisions were issued requesting data to address concerns regarding endocrine disruption, PBT/vPvB, and mutagenicity. Risk management actions under REACH and CLP in 2023 included the delivery of six opinions on restrictions dossiers as well as 42 opinions on proposals for harmonised classification and labelling. These opinions were delivered by the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC). One of the restriction opinions covered the use of PFAS in firefighting foams. Early in 2023, we also received the restriction dossier on per- and polyfluoroalkyl substances (PFAS) by the five Member States (Germany, the Netherlands, Sweden, Denmark and Norway), and by year end had concluded the initial public consultation and screening of the more than 5600 comments received. We will continue to progress this dossier through the RAC and SEAC in the course of 2024. We also received a mandate from the European Commission to prepare a restriction dossier by 2024 for chromium (VI) substances, which are covered in the growing number of authorisation applications currently being received. ECHA also completed several investigative and screening reports, including reports on Polyvinyl chloride (PVC) and additives and on substances that are carcinogenic, mutagenic or toxic to reproduction (CMRs) in childcare articles. Other risk management actions taken in 2023 were the addition of a further 11 substances to the Candidate List for Authorisation, bringing the total number of substances of very high concern entries to 235. We also submitted eight substances under the 11th Recommendation for inclusion of substances to the Authorisation List to the European Commission. We saw an increase in the number of authorisation applications mainly for the use of chromium (VI) substances. The total numbers of applications and review reports received was 100 and our scientific committees RAC and SEAC delivered opinions on applications for authorisation of 58 uses of substances. 15 Annual Report 2023 In 2023, we processed 13 749 registration dossiers and completed 416 SME company size verifications. Our Helpdesk answered 9200 questions, while the combined total of queries answered by Member State and European Economic Area country helpdesks was approximately 45000. While we continued to receive many questions on registration, we also saw queries on PFAS, authorisation of chromates and were seeing queries on the new legislative tasks that the Agency has been assigned. In furtherance of public availability of data, we devoted significant time to the development of our new data dissemination platform, ECHA Chem, which is scheduled to be launched in 2024. This work is the start of efforts in transforming the way we provide and make data available. The Biocidal Products Committee (BPC) adopted 13 opinions for active substance approval and renewal, while for Union authorisations, 10 opinions were adopted in 2023. We continue to observe that estimates from Member States on submission of active substance dossiers are not met and nor are estimates of applications for Union authorisation. This is a worrying trend and requires renewed efforts by Member States to meet their ongoing regulatory obligations. We were pleased to have delivered the pollinators guidance and make progress in the move to use IUCLID for biocides dossiers. We continued the prioritisation of efforts on promoting alternatives to animal testing in the year. We held a collaborative workshop with all stakeholders to discuss how collectively we can work to promote and move to using alternatives to animal testing. We published our fifth report on the use of alternatives to testing on animals for the REACH Regulation and highlighted the opportunities and challenges in moving away from animal testing for the regulatory assessment of chemicals. We processed 10857 notifications under the Prior Informed Consent Regulation (PIC) with many of these related to the inclusion of benzene as the first substance in substance entry. In 2023, we published the three-years report on the operation of the PIC Regulation (Article 22 report) and provided the recommendations made in the report to the Commission's evaluation of the PIC Regulation. A key recommendation was the need to review the extent of which information is made publicly available in any future legislation as access to document (ATD) requests are increasing in relation to PIC. In addition to the above regulatory areas, we continued to deliver on specific tasks in relation to environmental legislation or service level agreements with the Commission. For instance, we prepared a draft scientific dossier (Annex D proposal) for three substances in support of the Commission implementation of the Stockholm Convention. We continued to provide support under the Industrial Emissions Directive (IED) and followed closely the decision making for the revision of this legislation as it will formalise ECHA's role in this support work. We also delivered five opinions from the RAC on Occupational Exposure Limits (OELs) in fulfilment of our support to the Commission's Directorate General for Employment, Social Affairs and Inclusion (DG EMPL). We concluded a new contribution agreement for the period 2023-2026 with the Commission to continue providing support and training to pre-accessing countries. Support and input to the Commission on the Chemicals Strategy for Sustainability (CSS) remained a high priority for us in 2023. We supported the Commission before and during the decision making on the revised CLP Regulation and have already commenced work in preparation for its implementation. We worked together with the European Environment Agency (EEA) under the 8th Environmental Action Programme (EAP), in establishing a new framework of indicators aimed at monitoring the drivers and impacts of chemical pollution and assessing the effectiveness of the chemical legislation. This framework will be published in 2024. As noted already, we commenced work on the implementation of the new legislative tasks related to Drinking Water, Batteries and Serious Cross-Border Threats to Health. We supported the Commission in developing the implementing and delegated acts necessary for the operation of the Drinking Water Directive (DWD). As tasks under the DWD will eventually come under the RAC work area, we have already established a Working Group under RAC to commence 16 Annual Report 2023 preparations for this new task by the committee. Our implementation planning for the tasks under the Batteries Regulation got underway with the publication of the legislation in August 2023. First tasks are expected to be delivered in 2025. Significant levels of support and advice were provided to the Commission services to assist them in their considerations for the revision of the REACH Regulation and the ECHA Basic Regulation. While the anticipated publication of the REACH revision did not materialise as expected in 2023, we are ready to continue to support the Commission on a future revision. The Commission's one substance, one assessment (1S1A) approach under the CSS was also an area where ECHA provided significant levels of input and advice. We were pleased to see that the legislative package to support 1S1A was published by year end. This package covered not only reattribution of tasks to ECHA but also a data regulation establishing a common EU data platform. We look forward to working with the Commission and decision makers in 2024 to progress this legislation. As an agency that relies on science to develop our opinions and decisions, we worked closely with the research community to ensure that regulatory science needs are communicated and understood. In this regard, we continued to engage with the Partnership for the Assessment of Risks from Chemicals (PARC), an EU-wide research and innovation programme focused on developing next-generation chemical risk assessment to protect health and the environment. A key achievement for ECHA in 2023 was the publication of a report, Key Areas of Regulatory Challenge, which clearly set out areas where the research community could direct future research efforts. Engagement and collaboration with stakeholders are fundamental to how we work. We continued to collaborate closely with EU agencies, particularly those with an environmental and health focus. Our close collaboration with the European Food Safety Authority (EFSA), to assess the safety of substances and develop consistent views across regulatory frameworks, including for areas such as biocides and pesticides, remained a focus in 2023. We have, as mentioned, worked closely with the European Environment Agency (EEA) to build a joint framework of indicators that will help to track the progress and impact of the CSS implementation and chemicals legislation. We received increased requests in 2023 to join our Accredited Stakeholder Organisation (ASO) list. We expect increased stakeholder requests to the ASO list to continue especially with our wider our legal mandate, which will bring in many new stakeholders who may not have previously worked with us. We developed a new stakeholder engagement approach, which together with our new communications strategy for 2024-2028 will enable us to continue to build strong engagement and communication channels and networks. One of the key stakeholder groups for ECHA is our Member State colleagues, whom we work closely with daily in many different fora, for example, through our Management Board, our scientific committees, our Forum on Enforcement, Member State Communications Network, HelpNet and expert working groups. In 2023, we renewed our engagements directly with the Member States through visits to Member States so that we heard first-hand the views and requests of national authorities. Member States' full and active participation in all our committees is essential for delivery of opinions and decisions. Throughout the year, we kept a focus on facilitating sufficient nominations to the RAC and SEAC as well as ensuring that we can keep the members already involved. In these efforts, our Management Board and Commission colleagues engaged closely with us. We are pleased to report that our legal, governance and management obligations for 2023 were all met. Our financial and HR key performance indicators were met and exceeded in many instances. We had no significant findings in any financial or other audits completed. We maintained our International Organisation for Standardisation (ISO) 9001:2015; 14001:2015 and EU Eco-Management and Audit Scheme (EMAS) certifications. We also successfully 17 Annual Report 2023 organised meeting services for 640 events and official meetings, hosted 5000 visitors in person and 32,800 online. We continued to work to reduce CO2 emissions and in 2023 remained in line with our targets. Our Management Board led the successful development of our new Strategy Statement for 20242028. This Statement was developed in close collaboration with our staff as well as Member States, Commission and stakeholders and we look forward to implementing it over the coming years. While the year saw many deliverables and achievements, we also wish to note a number of areas that continue to challenge. A major challenge again this year was the low number of draft assessment reports for biocidal active substances submitted by Member States. This is detrimental to completing the evaluation of all existing active substances in the Review Programme by the end of 2024 as required by the Biocidal Products Regulation. While ECHA has and will continue to make efforts to support the Member States to make further progress, the reality is that Member States are not prioritising this work and many lack the capacity or resources to deliver in the near future. Our scientific committees are a key component in delivering transparent, independent and highquality opinions, and decisions. These committees rely heavily on the participation, commitment, and expertise of members from the Member States. Keeping current members in the RAC and SEAC active and engaged was an ongoing effort in 2023. One aspect to ensure committee sustainability was to review the current payments for member's rapporteur work together with the Management Board. We hope these measures will encourage uptake across the members in the future. Notwithstanding these efforts, the number of members in the RAC and SEAC is falling as Member States find it harder to find nominees with the relevant experience and competence. This poses a risk of not meeting legal deadlines and targets in operational areas that are dependent on input by Committee members. In 2023, we worked closely with the Commission on how we can ensure a sustainable future for the committees, especially considering new tasks that have already been assigned or could be assigned because of published legislative proposals. The future ECHA Basic Regulation is an important means to achieve long term sustainability and competence for our scientific committees and ECHA has and will continue to emphasise that this Regulation is needed as soon as possible. Another challenge is posed by the high number of authorisation applications significantly exceeding our capacity to deliver opinions. ECHA is closely monitoring the incoming applications and planning and phasing the opinion making. The European Commission has requested ECHA to prepare a restriction on chromium VI substances that may in time lead to a more efficient and timely management of the risks of these substances, while maintaining a level playing field for the operations in the industrial sectors involved. In 2023, we commenced implementation of new legislation and new tasks. These efforts will continue over the coming years and will increase as proposals coming through the co-decision process will be finalised. Balancing implementation of new requirements while continuing to deliver a full regulatory programme will be a key area of focus in the coming period. ECHA's staff are fully committed to implementing these new tasks and we will be looking to work in close collaboration with our EU institutional partners, the Member States and other stakeholders to support us in delivering what is required. With the publication of the `one substance one assessment' legislative package at the end of 2023, we now can see the extent of the work required by all agencies to align their opinions and decisions across different scientific committees. We also welcome the introduction of new hazard classifications in the CLP Regulation, which will help further alignment. However, the achievement of full alignment may continue to be a challenge in the absence of changes in other legislation. 18 Annual Report 2023 As our Strategic Plan 2019-2023 is concluded, we are reviewing some of the initiatives that supported its delivery, for example, the IRS and JEAP. These reviews have commenced in 2023. We need to determine how best to use the data in our databases to ensure that the appropriate risk management action is taken by the relevant parties, be that harmonised classification, authorisation or restriction. However, we also need to consider how we integrate additional risk management actions coming from new legislation into our thinking. Furthermore, while ECHA can analyse and provide information to the Commission and Member States, we do not have the legal basis to take action directly ourselves. Therefore, we need to have closer cooperation and engagement with the Commission and Member States to align on identification and prioritisation on appropriate risk management actions. The new Strategy Statement 2024-2028 identifies this as a priority, and we look forward to collaborating with all parties in this regard. Further details on achievements and metrics are available in the following sections. 19 Annual Report 2023 Part I. Achievements of the year Dossier preparation Highlights In 2023, we continued to provide companies with the tools and support they need to successfully register and update their registration information. We successfully managed the inquiry process and took decisions on the data sharing requests. We updated the International Uniform Chemical Information Database (IUCLID) to incorporate new regulatory requirements at EU or international level. We contributed to development of the Organisation for Economic Cooperation and Development (OECD) test guideline programmes in key areas by actively participating in the expert group meetings and consultations. We continued development of the Chemical Safety Assessment and Reporting tool (Chesar) to support both REACH and Biocides. The platform will fully integrate the European Union System for Evaluation of Substances (EUSES) models for environmental assessment, as well as the European Centre for Ecotoxicology and Toxicology of Chemicals' Targeted Risk Assessment (ECETOC TRA) models for workers and consumers. It will help companies to perform their chemical safety assessments and generate chemical safety reports under REACH. For biocides, it will enable users to carry out environmental risks assessments for active substances and biocidal products. Integration of models for risk assessment in the platform brought a few technical challenges which lead to delays and prevented from launching in 2023 as originally planned. The ECHA helpdesk answered 9200 questions in 2023. Intensive cooperation with the national helpdesks continued and they replied to 45000 questions, with a growing number of questions outside the original regulations in scope REACH, CLP and BPR. Most questions were on dossier preparation, the per- and polyfluoroalkyl substances (PFAS) restriction and chromates authorisation. The network of national helpdesks (HelpNet) held 26 meetings including dedicated workshops on REACH and CLP, approving four new or revised FAQs. Two campaigns to address companies that were not in compliance with the update obligations for their registration dossiers were concluded during the year: one on compliance with harmonised classifications and one on compliance with authorisation obligations for substances in Annex XIV. Main outputs O1 Companies are supported in inquiries and in sharing their data across the EU, helping to reduce registration costs and to avoid unnecessary testing. Inquiries and disputes on data sharing are handled. Yes O2 Harmonised IT tools and advice ensure consistency of risk management and safety information, thus promoting exchange across and between industry and regulatory authorities. ECHA continues to lead the development of IUCLID and its promotion as the Yes international harmonised format for chemical data. 20 Annual Report 2023 IUCLID is progressively maintained to incorporate regulatory requirements, Yes such as changes resulting from the amendment of REACH Annexes, other technical and scientific progress under REACH and CLP, or requirements from our OECD international partners. ECHA contributes to the development of the OECD harmonised test guidelines Yes relevant for the EU information requirements. The unified CHESAR-EUSES platform is released, facilitating improved exposure assessments for both REACH and BPR. On-going Questions are timely and effectively answered; a number of topics are Yes discussed and agreed among all national helpdesks for harmonised advice. In support of the Commission implementing regulation on registration updates, Yes a second campaign in collaboration with the national enforcement authorities is organised on cases of potential breach of the update obligation. Indicators O1 Effective working time for processing inquiries Inquiries received and concluded Estimate 0.3 person day 4 200 Actual 0.3 person day 4 835 Dossier submission and processing Highlights In 2023, ECHA processed 13 749 registration dossiers with 5 883 invoices generated. Completeness check was performed on all dossiers, with around 30 % of these checks completed with the manual verification, a similar number compared to 2022. The completeness check rules were updated to address the revised REACH Annex VI-XI information requirements under the Commission-ECHA Joint Action Plan. ECHA put in place support actions and no major deviations were found in terms of incomplete submissions. Over 400 companies submitted as SMEs went through the company size verification process to ensure that they were rightly benefitting from reduced fees. We provided advice to the Commission to support a review of this process into an ex-ante approach. The time between submission and SME verification continued to reduce this year. The invalidation of registrations continued tackling non-existing companies, or companies subject to restrictive measures due to the war in Ukraine. ECHA's submission systems' vision for the future was developed and the work towards a single Industry portal was kicked off including the setup of a user group for discussions with companies and information sessions for authorities. 21 Annual Report 2023 Main outputs O1 Access to market for duty holders continues to be fast and predictable and data comes in a way that supports subsequent regulatory work. The flow of registration dossiers (initial and updates) is processed; completeness Yes checks are performed, including manual verifications, invoices are issued, and confidentiality requests are assessed. Clear and timely feedback is provided to companies on how to successfully complete their submissions. ECHA verifies the size of companies that registered in 2018 and previous Yes deadlines and continues the initiation and verification of the size of SME companies which registered after the last registration deadline; the time gap of ca. 4.5 years between submission and beginning of the verification continues to be reduced. Tools and processes for invalidation of registrations are further developed for Yes different circumstances, such as the implementation of EU sanctions. PPORD notifications are processed and indications for innovation and new Yes kind of substances are monitored. As part of the development of a registration obligation for certain polymers, Yes ECHA supports the Commission in the development of a registration process, including a notification step, and the following regulatory activities, and starts preparations for the necessary changes in relevant IT tools. O2 Submission activities are built in a streamlined way to facilitate their long-term functioning. Develop a vision paper for the future of ECHA's submission systems and Yes commence implementation. Indicators O1 Number of PPORD notifications received Number of C&L notifications received Number of Registration dossiers received (incl. updates) Number of SME companies verified for their status Effective working time for processing a registration dossier (first submission) Registrations stopped for manual verification at technical completeness check Number of registrations failing first technical completeness check Estimate 340 33 000 16 000 Actual 235 43 933 13 749 400 0.50 - 0.60 person days 5 900 416 0.45 person days 4 721 1 600 1 035 22 Annual Report 2023 Identification and prioritisation Highlights In 2023, we continued screening structurally similar substances individually or in groups. We screened 61 groups rather than the initially estimated 70 groups. However, the actual number of substances screened is higher than initially planned. Overall, we screened around 1380 substances and identified that 320 may eventually be or are already considered for risk management actions; around 280 require data generation to confirm the suspected hazard; and about 540 substances do not need further regulatory risk management as they are considered low hazard, have low exposure potential or there are already sufficient risk management measures in place. By the end of 2023, we assessed 92 % of substances registered above 100 tonnes; less than 400 high-tonnage substances remained to be assessed. We continued to publish the reports on the assessment of regulatory needs (ARN) for groups of substances, providing transparency to our work and supporting the work of our stakeholders. We liaised with our industry stakeholders to provide further clarity on the content and scope of the ARN reports, including holding a well-attended webinar. To improve clarity, we updated the template and format of the reports based on the feedback received. An internal review of our integrated regulatory strategy was initiated which will feed into a workshop with our stakeholders in spring 2024. Main outputs O1 ECHA, Member States and Commission services can perform risk management processes and evaluation activities related to hazardous chemicals more effectively and efficiently, based on grouping of chemicals and their assessments and supported by ECHA's expertise and tools. Complete the assessment for 70 new groups of chemicals to support the Yes needs of the main regulatory processes (evaluation, restrictions, authorisations and harmonised classification). Support the annual update of the restriction roadmap based on the outcomes Yes of the group assessments results. Publish the annual report on the implementation of the Integrated Regulatory Yes Strategy. Prepare the publication of the assessments of regulatory needs for groups of Yes substances. Update information through Chemical Universe engine to show the progress Yes with assessing groups of substances. Indicators O1 Number of substances registered above 100 t/y in the unassigned region of the chemical universe for which a conclusion on potential regulatory follow up was drawn Estimate 250 Actual 156 Annual Report 2023 Number of groups of substances for which the 70 assessment of regulatory needs is carried out 23 61 Evaluation Highlights The REACH Evaluation Action Plan sets targets for checking the compliance of registration dossiers submitted to ECHA. A minimum of 20% of registrations for substances registered in quantities of 100 tonnes or more per year need to be checked for compliance, with a similar percentage for substances in tonnage bands less than 100 tonnes per year. In 2023, ECHA carried out 301 full compliance checks and 104 testing proposal examinations, covering 367 unique substances. With these outputs we addressed the key actions from the Joint Evaluation Action Plan (JEAP). ECHA has started a review of the outcomes of the JEAP, and the review will continue together with the Commission and stakeholders at the beginning of 2024 (originally planned for 2023). Collaboration with the Member State competent authorities was effective and showed good alignment as only 9% of the draft decisions were discussed by the Member State Committee (following proposals for amendment). Follow-up actions were conducted to verify that any updated information provided in response to evaluation decisions addressed what was requested. An analysis revealed that around 19 % of completed dossier evaluation cases were considered for further regulatory action (harmonised classification and labelling (CLH), endocrine disruptor (ED), and persistent, bioaccumulative and toxic (PBT) assessment or substance evaluation). The most frequent outcome by far was the consideration of a CLH process, particularly for reproductive toxicity concerns. We also put greater focus on those decisions where there is a backlog in follow up and testing proposal evaluations. The increased focus on clearing this backlog will continue in the coming years. In substance evaluation, the Community rolling action plan (CoRAP) update for 2023-2025 was published in March. The list was updated with 24 substances for evaluation by 12 Member States. A conclusion was reached for 26 substances. Some of the regulatory follow-up actions at EU level included harmonised classification and labelling (20), identification as a substance of very high concern (10) and restriction (12). In 2023, 6 substance evaluation decisions were issued requesting data to address concerns regarding endocrine disruption, PBT/vPvB, and mutagenicity. Main outputs O1 Dossier evaluation is efficient, transparent and scientifically and legally robust. Deliver the outputs in line with the objectives from the Joint Evaluation Action Yes Plan, including 300 compliance checks concluded as draft decision or no action. Organise - jointly with the Commission - a mid-term review of the achievements of the Joint Evaluation Action Plan (including screening, grouping and evaluation of chemicals), considering the impact of changes arising from the REACH and CLP reviews. On-going 24 Annual Report 2023 Examine testing proposals within the legal deadlines striving for zero proposals that are not handled in time. The information submitted in response to ECHA evaluation decisions is examined without delay and conclusions communicated to the Commission and Member State competent authorities. The national enforcement authorities are informed in case of non-compliance with the decision and follow-up decisions are drafted where appropriate Report on the progress made in (both dossier and substance) evaluation as part of the annual report on the Integrated Regulatory Strategy and publish annually the updated recommendations to registrants stemming from evaluation. Contribute to the Caracal sub-groups and other fora in support of the Commission in their policy activities, in accordance with the REACH Evaluation Joint Action Plan. Support the Commission in CSS relevant activities. It includes the review of the Evaluation title in REACH and the annexes on information requirements. Request targeted study audits in case a concern about compliance with principles of good laboratory practice is identified by ECHA or a Member State. Publish the report on the scientific and technical review of the received extended one-generation reproductive toxicity studies in collaboration with the Member State Competent Authorities. Provide regulatory advice to registrants and other interested parties on information requirements and on dossier and substance evaluation processes. On-going On-going Yes Yes Yes Yes Yes Yes Yes O2 For Substance Evaluation Member States are supported to conclude as fast as possible, in a scientifically and legally robust manner, enabling the initiation of appropriate regulatory risk management measures. Propose updates of the CoRAP to the MSC with substances for which Yes substance evaluation is the most appropriate tool to generate further hazard information. Support Member States in achieving substance evaluation conclusions as fast Yes as possible. Encourage that appropriate regulatory risk management measures and initiatives are taken up by Member states. Keep reducing the number of substance evaluation cases currently opened. Yes Indicators O1 Compliance checks concluded: draft decisions or no action Estimate 300 Actual 301 Annual Report 2023 Final decisions on dossier evaluation (testing proposals and compliance checks) Number of substances for which a conclusion was reached in the follow-up to dossier evaluation 25 300 367 200 202 O2 Substance evaluation final decisions issued Number of substances for which a conclusion was reached in substance evaluation 10 6 25 26 Authorisation Highlights In 2023 eleven substances were added to the Candidate List, bringing the total to 235 entries. These substances were found to have either very persistent and very bio accumulative properties, or were shown to be persistent, mobile and toxic, or displayed negative effects on reproduction. Other reasons for inclusion were the carcinogenic properties or endocrine disrupting potential of these substances. In 2023, we submitted to the European Commission the 11th recommendation for inclusion of substances to the Authorisation List. It recommended to add eight substances, including lead. The inclusion of lead generated many comments from the stakeholders, related to the best timing, its combination with other ongoing or planned regulatory activities as well as the expected workload for industry and authorities at the next stage. This recommendation brought lead metal to the same regulatory stage as other lead compounds with similar uses already recommended for inclusion to the Authorisation List. The number of applications for authorisation increased, mainly for the use of hexavalent chromium substances. In total we received just over one hundred applications and review reports for authorisation. The scientific committees, RAC and SEAC, delivered opinions on applications for authorisation of 58 uses of substances. To manage the gap between applications received and opinions delivered, we monitored closely the incoming applications and planned and phased the opinion making process. The European Commission requested ECHA to prepare a restriction dossier for chromium (VI) substances, to be delivered in 2024. In view of the widespread use of these substances, this may lead to a more efficient and timely management of the risks of these substances, while maintaining a level playing field for the operations in the industrial sectors involved. We contributed to the Authorisation Taskforce that was set up in 2023 by the European Commission to discuss the operation and streamlining of the authorisation process under REACH, also in view of the judgement of the European Court of Justice on the `Chemservice' case. Main outputs O1 Substances of very high concern are properly controlled and progressively replaced by suitable alternatives. Identification of substances of very high concern and inclusion in the Candidate Yes List 26 Annual Report 2023 Prioritise the chemicals on the Candidate List and propose to the MSC the ones Yes to be included in the 11th Annex XIV recommendation to the Commission for inclusion in the Authorisation List. Provide web-based training to stakeholders on analysis of alternatives and Yes informed substitution of substances subject to regulatory risk management. O2 Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) on applications for authorisations are timely and fit-for purpose. Develop and implement - jointly with the Commission - an agreed approach to Yes deal with the anticipated significant increase in the number of authorisation applications. Hold workshops and network meetings to develop methodologies and to Yes enhance the capacity of Member States and companies to carry out analysis of alternatives and socio-economic analysis with view of finding viable alternatives. Indicators O1 Number of new entries in the Candidate List Recommendation for inclusion of substances in the authorisation list Applications and review reports for authorisation received (number of uses) Number of downstream user notifications of authorised uses of SVHCs Estimate 15 1 100-140 3 000 Actual 11 1 102 2 742 O2 Number of RAC and SEAC opinions adopted on applications for authorisation (number of uses) Effective working time of ECHA staff per opinion 60 38-46 person days 58 39 person days Restrictions Highlights We continued to deliver high impact restrictions dossiers and investigation reports. In 2023, we produced three restriction investigation reports and five screening reports (art.69.2) including reports on Polyvinyl chloride (PVC) and additives as well as on substances that are carcinogenic, mutagenic or toxic to reproduction (CMRs) in childcare articles. Our scientific committees (RAC and SEAC) delivered six opinions on restrictions dossiers for regulatory decision making, including opinions on medium-chained chlorinated paraffins (MCCPs) and on per- and polyfluoroalkyl substances (PFAS) in fire-fighting foams. Furthermore, we received the restriction 27 Annual Report 2023 dossier on universal PFAS from five dossier submitter countries and handled the publication, consultation and screened the 5,642 comments received in a record two months' time to facilitate the further process. There were no Commission mandates received requiring delivery of Annex XV reports in 2023. Furthermore, we continued to contribute to the development of scientific methodologies for regulatory assessments on the valuation of various health and environmental endpoints for socio-economic analysis together with OECD countries. The implementation plan for the new tasks allocated to the Agency by the EU Batteries Regulation was developed this year and initial steps were taken to prepare for the first phase of the study on relevant substances and the recruitment of staff. Main outputs O1 Support the Commission in the implementation of the Restrictions Roadmap by developing timely fit-for-purpose restrictions dossiers. Annex XV reports proposing restrictions developed for 2-3 substances from the No restriction roadmap at the request of the Commission per year (e.g., flame retardants, ortho-phthalates). The investigative reports requested by the Commission related to risks of PVC Yes and substances in PVC, CMR substances in childcare articles, and PAHs in rubber granules used on children's playgrounds prepared according to the deadlines agreed with the Commission. Screening reports for 2-3 substances under Article 69(2) prepared per year. Yes O2 Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) on restrictions are timely and fit for purpose. Deliver restriction opinions, including for the use of lead in outdoor shooting Yes and fishing, BPA+ in articles, chloroalkanes (C14-C17) and PFASs in firefighting foams. Develop methodologies related to socio-economic analysis to create a fit-for- Yes purpose toolbox, including i.a., the valuation of various health and environmental endpoints in OECD. The Commission's Better Regulation guidelines are taken into account. O3 Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) on restrictions are timely and fit for purpose. Batteries restrictions implementation plan Yes Indicators O1 Restriction proposals or investigation/screening reports developed Estimate 5 Actual 8 28 Annual Report 2023 O2 Number of RAC and SEAC opinions on restriction proposals Effective working time of ECHA staff per opinion (ECHA dossier) Effective working time of ECHA staff per opinion (Member State dossier) 6 220 - 330 person days 200 - 300 person days 5 227 person days 193 person days Classification and labelling Highlights We supported the Commission in the review of the CLP Regulation. After its adoption, we started the update of the tools and CLP guidance. Proposals for harmonised classification of 45 substances were brought to the Risk Assessment Committee. We started to support the Member States to develop the dossier for proposed Harmonised Classification for two groups of substances originated from the chemical universe screening. As part of our new public chemicals database (see activity Data management and dissemination), we worked on a redesign of the Classification and labelling inventory that is expected to be launched in autumn 2024. Our preparatory work in 2023 took into account the proposed changes in the CLP regulation. We received 4,748,401 Poison Centre Notifications (more than in 2022). The compliance deadline of 1 January 2024 for mixtures with industrial uses was met without major problems for submitters with the appropriate support in place. We supported the European Commission in the context of the United Nations Globally Harmonised System of classification and labelling of chemicals (UN GHS) and in the implementation of the United Nations Environment Programme (UNEP) project to pilot the implementation of GHS in four African countries. Main outputs O1 Opinions of the Committee for Risk Assessment (RAC) are timely and fit-for purpose Process incoming CLH dossiers, including industrial chemicals from the Yes outcome of identification and prioritisation (based on the grouping approach) while continuing to process a high number of PPP and Biocides dossiers resulting from the joint Commission, EFSA and ECHA efforts to encourage timely submission of dossiers. Undertake pilot projects with the relevant RAC subgroup for a number of Yes identified groups of substances to improve the usability of grouping information for the purpose of CLH proposals. O2 Up-to-date information on the classifications for chemicals is publicly available in a userfriendly format, also for those substances for which no harmonisation at EU level has taken place yet 29 Annual Report 2023 As part of the creation of ECHA's new public data availability system, design and develop the new C&L Inventory, taking into account the changes in the revised CLP regulation. On-going O3 Member States, Commission services and duty holders have the support they need to fulfil their obligations, with a specific focus to ensure the readiness for the implementation of the planned CLP 2.0 Closely monitor the progress of the legislative process and, according to the Yes expected entry in force, deliver an internal roadmap for the implementation of the planned legislative changes to the CLP Regulation including ECHA's role in the CLH process. Start implementation of guidance updates, teams and systems for the entry in Yes force of the revised CLP processes. Provide scientific and technical support to the Commission in the context of the further development of the United Nations Globally Harmonised System of classification and labelling of chemicals (UNGHS), including: On-going o related to new hazard classes and criteria to fully address environmental toxicity, persistency, mobility and bioaccumulation; and to introduce endocrine disruptors, persistent, mobile, toxic, very persistent and very mobile substances as categories of substances of very high concern. o for the implementation of revisions 8, 9 and 10 of UNGHS. This implementation should start in spring 2023 at the very latest. o to the work of selected GHS working groups, notably the working group on the use of non-animal testing methods for classification. Provide scientific and technical support to the Commission in its Yes implementation of the Chemicals Strategy for Sustainability in the context of the revisions of the CLP regulation and to the UNEP-GHS project in African countries. O4 Structured, high quality and consistent information for the EU poison centre scheme is timely available across Europe Maintain the notification portal and system-to-system submission channel and Yes keep it aligned with IUCLID. Conclude the development of the searchable central database, to be used by Yes the national appointed bodies and Poison Centres, based on the Commission's mandate and the feedback from national authorities on the use of the database. Continue the promotion of the PCN activities, in preparation for the next Yes compliance date of 1 January 2024 for mixtures with industrial uses. 30 Annual Report 2023 Indicators O1 Proposals for harmonised classification and labelling Number of RAC opinions on proposals for harmonised classification and labelling Effective working time for processing RAC opinions Estimate 60 50 Approx. 40-55 person days Actual 45 42 37.4 person days O3 Decisions made on requests to use an alternative chemical name (Art 24 CLP) 40 26 O4 Poison centre notifications received and made available to Appointed Bodies and Poison Centres Poison centre notifications viewed by national authorities in the PCN central database 2 million 10 000 4.4 million 23 804 Safe and sustainable use of chemicals Highlights Our work on safe and sustainable use of chemicals focused on providing technical and scientific support and guidance to companies. We also continued developing tools to support chemical safety assessment at company level (e.g., CHESAR) and ensured basic maintenance of industrydeveloped use maps. We also continued to support the European Commission in testing its framework for safe and sustainable by design, by providing a priority list of substances of very high concern which could be considered as candidates for testing the framework. Main outputs O1 Registrants perform an effective chemical safety assessment, demonstrating (i) safe use to the authorities via the registration and (ii) delivering safe use advice for inclusion in the safety data sheets Provide maintenance and ensure dissemination of tools developed to support Yes industry work. Support the Commission in developing case studies and testing the framework Yes and criteria for Safe and Sustainable by design. Indicators O1 N/A Estimate Actual 31 Annual Report 2023 Data management and dissemination Highlights During 2023, ECHA data services supported the Commission work on preparing several legislative packages including REACH and CLP review or the Directive 2004/37/EC on the protection of workers from the risks related to exposure to CMR substances at work. We also supported the Member States with data relevant for preparing their restrictions proposals. Tools that allow users to search, convert and manage their chemicals data in IUCLID format were further developed and we supported our key stakeholders such as EFSA and Member States in their use. Data management has a central role in improving the consistency and integration of the EU regulatory system on chemicals. In 2023, we initiated a review of our data management approach and established a Data Governance Office responsible for managing our regulatory data. This work will further support regulatory data consistency, coherence and transparency. During 2023, the first version of ECHA's new public chemicals database, ECHA CHEM, was developed, leaving it ready for launch in January 2024. The development of this new public database involved extensive engagement with our stakeholders to ensure it would meet the user needs. The new database has IUCLID as a central building block and is designed on a modular platform to ensure a stable and high-performing system that will enable efficient onboarding of new datasets in the future, as well as a starting point for a future EU common data platform on chemicals. The OECD eChem portal was maintained and developed with new datasets coming from REACH Registrations. Main outputs O1 The regulatory processes performed by ECHA, Member States and Commission are efficiently supported and monitored. Deliver a plan to consolidate data management and guarantee regulatory data consistency, coherence, transparency and reporting. On-going Deliver the necessary features to optimise the Interact Portal with due Yes consideration of process and users' requirements. Data analysis services upon request from EU institutions or Member States. Yes Tools to search, extract and analyse data in registration dossiers made Yes available to other authorities and industry. Develop tools and methodologies to convert legacy toxicity data to IUCLID Yes harmonised templates in collaboration with other Authorities and industry. O2 Data submitted to ECHA under different regulations is publicly available in user friendly ways and progress of ECHA's regulatory activities is transparent. Deliver the first prototype of ECHA's new public data availability system based Yes on IUCLID, including hazard and classification and labelling data, and supporting the preparedness for the EU Common Data Platform. 32 Annual Report 2023 Deliver a plan to develop the new solution for dissemination of regulatory data Yes and proceed with its integration into ECHA's new data availability system. Further develop IUCLID as a key building block, considering the future EU Yes common data platform on chemicals and bearing in mind the OECD intentions for a Global Chemicals Knowledge Base. OECD Global Portal to Information on Chemical Substances (eChemPortal) is Yes maintained and synchronised with ECHA's dissemination website. Indicators O1 Description and number of data requests O2 Number of user page views for published information on chemicals Estimate Internal: 50 External: 20 48 million Actual Internal:77 External:13 50 million Promotion of alternatives to animal testing Highlights In 2023, we intensified our activities to promote alternatives to animal testing. We invested in many international activities, particularly APCRA (Accelerating the Pace of Chemical Risk Assessment), PARC (Partnership for the Assessment of Risks from Chemicals) and OECD (Organisation for Economic Co-operation and Development) to enhance regulatory knowledge on how we can protect health and the environment and reduce our reliance on animal testing. We also increased the access to toxicity data, aiming to support research and development within the wider regulatory and scientific community. We published the fifth report on the use of alternatives to testing on animals for the REACH Regulation. The report shed light on opportunities and challenges associated with moving away from animal testing in the regulatory assessment of chemicals. We strengthened our interactions with stakeholders and worked closely with the European Commission and international partners to support the development and uptake of alternatives that are suitable for regulatory purposes. We organised a workshop to further explore new approach methodologies and work towards an animal testing-free regulatory system for industrial chemicals. The event brought together regulators, policy makers, scientists and stakeholders (industry, animal welfare NGOs, environmental NGOs) to discuss the state of the art and research needs for phasing out animal testing. The workshop supported the efforts at EU level to work towards development of a EU roadmap for fully replacing animal testing in the risk assessment of industrial chemicals. 33 Annual Report 2023 Main outputs O1 Industry generates hazard data using non-animal testing methods and new approaches, wherever appropriate, to fulfil the REACH information requirements. Invest in further development of the QSAR toolbox to integrate new Yes information (for example, metabolites, biocides or data from pharmaceuticals) and models. Expand data available for download (REACH studies results and pharmaceutical Yes industry data contribution) that can be used for NAMs development and/or avoiding unnecessary animal testing. Further implement predictive models to support substance grouping, Yes prioritisation and scientific decision making. O2 ECHA plays a proactive role towards the public and policy makers to provide clear, timely and sufficient information on alternatives to animal testing in a regulatory context, within ECHA's role and mandate. Organise an external workshop on new approach methodologies (NAMs) to Yes contribute to EU efforts towards building an EU roadmap for replacement of animal testing. Publish the fifth report on the use of alternatives to testing on animals for the Yes REACH Regulation (117.3). Contribute to OECD activities related to further development of alternatives Yes and integration of regulatory relevant alternatives in the OECD test guidelines. Further develop high throughput NAMs in cooperation with ECHA's international Yes partners. Collaborate at international level towards the identification and acceptance of Yes alternatives in regulatory frameworks (e.g., with US and Canada within the APCRA initiative (Accelerating the Pace of Chemical Risk Assessment). Indicators O1 N/A Estimate Actual Biocides Highlights The number of opinions that the Biocidal Products Committee (BPC) was in a position to deliver in 2023 was well below the estimated numbers due to significantly less submissions by the Member States of evaluation dossiers both for active substances and Union authorisations (UA). While we observed a decrease in numbers of UA applications this year, we also noted that these cover product families and therefore dossiers tend to be larger and more complex. In response to technical scientific questions from the Commission, the BPC developed opinions on alternatives to active substances and the comparative assessment of anticoagulant substances 34 Annual Report 2023 used to control infestations of rodents, as well as on technical aspects of disagreements arising in the mutual recognition of biocidal products authorisations. On request of the Commission, we also reviewed the work of the BPC with respect to analysis of available alternatives and socioeconomic aspects related to potential non-approval of certain active substances. We continued providing support to Member States under the Active Substance Action Plan. This included the organisation of two information sessions with Member States to discuss and share their best practices on active substance approval and renewal. Furthermore, we provided regulatory and scientific advice and allowed Member States to increase competence in areas such as genotoxicity and endocrine disruptors. We also continued to provide the secretariat of the Coordination Group, assisting Member States in the resolution of disagreements arising during mutual recognition of biocidal products authorisations and in reaching agreements on horizontal topics which may help preventing certain future disagreements. This allowed for a reduction in the number of Art. 38 requests compared to what was initially foreseen. In the regular and ad-hoc meetings (19 in total), an increasing number of disagreements were discussed together with the endorsement of key specific procedures. Regarding Union authorisations, we established a working procedure for processing applications for minor changes, which allows the swift evaluation of the first such cases. Additionally, several critical working procedures were improved and streamlined, including the procedure for processing application for major changes and for the linguistic review of the SPC translations. Within the scope of one-substance-one-assessment, ECHA continued to collaborate with EFSA on common guidance documents, such as on the impact of water treatment processes on residues of active substances in drinking water. Furthermore, we introduced alignment mechanisms, such as identifying common substances early in advance and connecting and supporting the evaluating Member States across regulations. We also established an engagement procedure on inviting experts to meetings of working groups and of the BPC. The experience gained helped in defining collaboration practices with other EU agencies, in particular EFSA. In close collaboration with EFSA, we finalised the guidance for the assessment of risk to bees from the use of biocides as our contribution to maintain biodiversity. We have established an IT vision for biocides that sets the direction towards further integration of the tools, ensuring structured data and increased data availability as well as efficiency gains for all stakeholders. The first implementation steps in the transfer of biocides information to IUCLID format, based on a roadmap agreed with Member States, were a major advancement in this regard. Main outputs O1 Provide timely fit-for-purpose opinions, including means for improved consideration of cross-regulations consistency, on active substance and Union authorisation applications. Prepare ECHA's opinions on the approval of active substances and on Union Yes authorisation of biocidal products. Prepare ECHA's opinions on Union authorisation of same biocidal products and Yes on administrative and minor changes to Union authorisations. Cooperate with EFSA and within ECHA to interlink guidance documents and put Yes in place means to improve synergies and alignment, with focus on the evaluation of common substances. Update of the list of frequently used sentences in the SPCs translated in all the Yes EU official languages. 35 Annual Report 2023 Perform assessments of applications for technical equivalence, inclusion in the Yes Article 95 BPR list and classification for changes. O2 Provide support to Member States and Commission to facilitate biocides processes and accelerate the Review Programme. Providing regulatory, procedural and technical support to the MSCAs in the Yes evaluation and BPC opinion forming on the approval of active substances, with specific effort to progress with the Review Programme, and on Union authorisation of biocidal products. Contribute to the MSCAs capacity building by providing training and scientific- Yes technical advice. Support the MSCAs in their work on potential endocrine-disrupting substances. Yes Prepare the BPC opinions requested by the Commission pursuant to Article 38 Yes of the BPR on scientific and technical questions. Providing technical and scientific support to the Commission under Article Yes 15(2) and 75(1)(g) of the BPR on general and case specific issues relevant for the implementation of the BPR. Provide training to stakeholders on analysis of alternatives and informed Yes substitution of substances. Develop and maintain guidance and provide support to the development of an Yes easily accessible, structured overview of ECHA guidance documents and relevant policy documents. Engage with stakeholders in different fora such as the BPC and its Working Yes Groups, organisation of biocides stakeholders' day, etc. Dossiers submitted by industry to ECHA are timely processed and feedback Yes given as appropriate. O3 Continuing the integration of the biocides IT tools with the ECHA IT systems Integrate, where feasible, specialised Biocides IT tools with ECHA IT systems. Yes Continue developing the Register for Biocidal Products (R4BP 3). Yes Continue developing the IT support tools (ECHA Act and Interact). Yes Finalise the introduction of the biocides' environmental exposure scenarios in the CHESAR platform (see REACH activity Dossier preparation). On-going Move the SPC Editor into a IUCLID based solution. On-going 36 Annual Report 2023 Promote and initiate the enhancement of structured data availability in IUCLID Yes for Annex II and III BPR information requirements. Propose and support a campaign on the IUCLID dossier filling for active Yes substances and Union authorisation cases. Indicators O1 Number of opinions on active substances [approval & renewal] Number of opinions on Union authorisation of biocidal products Number of opinions on Union authorisations subprocesses: same biocidal products, administrative and minor changes Number of technical equivalence application assessments Estimate 28 31 52 30 Actual 13 10 21 32 O2 Satisfaction of authority actors Establishment of baseline Number of opinions on Article 15, Article 38 and 20 Article 75(1)(g) requests 84 % 7 O3 User satisfaction of ECHA IT tools (e.g., R4BP, SPC editor, Interact) Establishing baseline with BPR user group 90% Prior informed consent Highlights The reception and processing of PIC notifications experienced an increase in volumes compared with previous years. A total of 10 857 notifications were processed in 2023 which represents 97% of the annual forecast (11 200) and is +8% compared to the number of notifications processed in 2022 (10 072)). This increase was mainly due to the addition of benzene, being the first `substance in substance' entry in the list of substances subject to PIC notification obligations. ECHA continued to devote significant efforts to support all involved parties with these obligations. In terms of reporting, the usual annual report on exports and imports subject to Rotterdam convention was published. In addition, we published the three-years report on the operation of the PIC Regulation (`article 22 report'). Its conclusions input to the Commission's ongoing evaluation of the PIC Regulation, as some changes in legal provisions could facilitate the implementation, in particular the extent of the information that is made publicly available. This was important as the increasing number of Access to documents requests showed public interest 37 Annual Report 2023 in this information. In this context, we hosted an information session to exchange experiences among Member States with the access to documents under PIC. We continued to support the Commission in the implementation of the Rotterdam Convention including participation in the 11th Conference of the Parties. Main outputs O1 Companies and Authorities in the EU and third countries can effectively manage the international trade of chemicals listed under the Rotterdam Convention and the PIC regulation. Process effectively the received number of notifications allowing companies to Yes export these chemicals in accordance with the EU's international commitments; execute related tasks such as stakeholder support. Prepare the tri-annual report on the operation of the PIC Regulation (2020- Yes 2022). O2 The Commission and other Authorities receive fit-for-purpose support in the context of PIC implementation and UN Rotterdam Convention. Produce and publish the annual report on PIC exports and imports. Yes Support the Commission with the EU contribution to the Rotterdam convention Yes implementation. Indicators O1 Export notifications processed Share of notifications validated/accepted by ECHA Support provided to PIC duty holders (importers and exporters) Estimate 11 200 90 % 250 Actual 10 857 96 % 245 O2 Scientific and technical support provided to the Commission, EU and non-EU DNAs 3 600 3 570 Persistent organic pollutants Highlights At the European Commission's request and linked to ECHA's scientific support to the Commission in identifying new POP substances, we prepared in 2023 a draft scientific dossier (Annex D proposal) for Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5) and Dodecamethylcyclohexasiloxane (D6). We provided technical and scientific support to the Commission for discussions at the 19th meeting of the POPs Review Committee (POPRC-19). At this meeting in October 2023, the risk 38 Annual Report 2023 profile for chlorpyrifos, an organophosphate pesticide, was adopted as was the risk management evaluations for Medium-chain chlorinated paraffins (MCCPs) and long-chain perfluorocarboxylic acids and related compounds (LC-PFCAs). Both substances were recommended for listing under Annex A (elimination) of the Stockholm Convention, with specific exemptions. Nevertheless, the POPRC agreed that further information on the scope of the chemical identity of MCCPs for the purpose of its listing under the Convention is required, which would be subject to further discussion at POPRC-20. In addition, ECHA reviewed and commented on the POPRC document on long-range environmental transport which had been finalised in October 2023. This document is equivalent to a guidance on how to assess the long-range environmental properties of substances. The Union Overview report detailing the implementation of the POPs Regulation in the EU was updated in May and December 2023. The report provides information on various aspects of POPs, such as manufacturing, market placement, stockpiling, enforcement actions and releases of POPs into the environment. Finally, ECHA supported the European Commission in the following activities linked to the POPs: revising the document for the notification of articles use for submission to the Stockholm Convention, gathering UV-328 information to support the specific exemptions in the EU POPs Regulation (investigation report under Article 69(2)) and contributing to the amendment of the PFOS entry of the POPs Regulation. Main outputs O1 Prepare and support processing of the technical dossiers that the European Commission uses when proposing to list a substance as a POP in the Stockholm Convention, review the technical dossiers submitted by other parties and support the implementation of POP Regulation. Draft scientific dossiers for a new EU proposal to list a potential POP substance Yes under the Stockholm Convention on Persistent Organic Pollutants and provide further support to the Commission for the listing process. Maintain and develop where possible within the resource constraints the Yes reporting system for the implementation of the POP Regulation and update the Union Overview report based on the Member States reports regularly. Indicators O1 Number of scientific dossiers drafted for the identification of new substances as Persistent Organic Pollutants Support provided to various stakeholders Scientific and technical support provided to the Commission, EU and non-EU Cas Estimate 1 50 10 Actual 1 55 14 Waste Framework Directive Highlights The reception of notifications of SVHCs present in articles on the EU market continued in 2023 39 Annual Report 2023 including corresponding support to duty holders. The total number of notifications received in 2023 is 10 653 336. The resulting Database for information on Substances of Concern In articles (SCIP database), making this information public, was maintained. Main outputs O1 Maintain a database on the presence of Candidate List substances in articles. Maintain the notification portal and disseminate the SCIP database information. Yes Provide support to duty holders to allow EU suppliers of articles to submit the Yes required information to ECHA. Indicators O1 Successful SCIP notifications received (incl. updates) Estimate 8-12 million Actual 10.6 million Drinking Water Directive Highlights With the revision of the Drinking Water Directive, ECHA assumed new responsibilities related to setting up and maintaining European positive lists of substances that are authorised to be used for the manufacturing of materials coming into contact with drinking water. We provided support to the European Commission for drafting and smooth adoption of the implementing and delegated acts related to the adoption of the EU positive list, information requirements for materials in contact with drinking water and the process for submission and inclusion of substances on the EU positive list. The acts were successfully agreed through Comitology by the end of 2023. We also worked to develop guidance and tools necessary to support applicants and set up a RAC working group to ensure overall readiness for entry into operation in 2025. Main outputs O1 Ensure the readiness for the implementation of Article 11 of DWD (2025) (including development of the delegated acts, delivery of the tools and processes for submission, accordance check and opinion forming, including setting up of a working group attached to RAC). Provide technical and scientific support to the Commission in drafting and Yes adopting the Implementing and Delegated acts. Clarify the likely number of applications to be expected in period 2025-2028 Yes through engagement with stakeholders. Setup internal operational procedures and working instructions for handling the applications to be submitted from 2025 onwards. On-going 40 Annual Report 2023 Set up a Working Group associated to RAC and start developing procedures for opinion forming. On-going Finalise the DWD IT solution, including the adaptation of IUCLID to the specific needs of the DWD process. On-going Develop guidance documents for the applicants. On-going Indicators O1 N/A Estimate Actual Support to the 8th Environmental Action Programme of the EU Highlights In 2023, we worked further with EEA towards creating the first version of the framework and prepared to publish the relevant indicator dashboard. We also worked to develop a common report with joint messages on the EU progress towards the policy objectives of the CSS. The report accompanies the CSS indicator dashboard and is expected to be published in early 2024. Main outputs O1 Ensure a sound, accessible and transparent evidence base to support the monitoring, measuring and reporting on chemicals Implement indicators based on ECHA's data in ECHA's data platforms, Yes according to the plan agreed with the Commission and EEA. Develop the public version of the indicator framework jointly with EEA and the Yes Commission. Together with EEA develop a joint synthesis report, offering policy-relevant Yes messaging on the trends observed in the chemicals indicators Indicators Estimate Actual O1 N/A EU Observatory for Nanomaterials Highlights During 2023, EUON continued to produce and publish new and updated content regarding the markets and safety of nanomaterials. In the beginning of the year, the NanoData knowledgebase was refreshed with updated information about nanomaterials on the EU market. The EUON also commissioned new studies on topics of general interest and published regular `Nanopinions' on 41 Annual Report 2023 current matters related to nanomaterials. Main outputs O1 Provide better access to information on nanomaterials on the EU market, their uses and safety aspects, and related research activities. Continue to fulfil specific data gaps in the public knowledge about Yes nanomaterials via the commissioning of external studies. Continue to promote the EUON via different channels to increase its outreach Yes to a wide variety of audiences. Indicators O1 All traffic to EUON websites Estimate 125 000 Actual 186 084 EU Chemicals Legislation Finder Highlights EUCLEF continued to provide up-to-date information on EU chemicals legislation throughout the year. A new framework contract for the data provision feeding EUCLEF was put in place ensuring its continuation. Main outputs O1 Improve transparency for the public and the business environment for EU companies and SMEs in particular, with regard to access to information on legislation applicable to a given substance. Continue to operate EUCLEF and maintain updated the pieces of legislation in Yes the scope of the service. Continue to promote EUCLEF via different channels to increase the utility of the Yes service for its target audiences. Run the corresponding helpdesk. Yes Indicators O1 Number of data updates on EUCLEF pieces of legislation All traffic to EUCLEF pages Estimate 4-6 350 000 Actual 5 395 000 Support to occupational health legislation Highlights In 2023 ECHA continued supporting the Directorate General for Employment, Social Affairs and 42 Annual Report 2023 Inclusion (DG EMPL), through Service Level Agreements, in providing five opinions from the RAC on Occupational Exposure Limits (OELs). These OELs were values set by authorities at EU and national levels that help employers protect their workers' health from possible risks when using chemicals at work and limit exposure to harmful chemicals in the air of a workplace. All RAC opinions were made in advance to the contractual deadlines set and covered the following substances: 1,2-dichloropropane, 1,2,3-trichloropropane, 2-chloro-1,3-butadiene (chloroprene), 2,3-epoxypropyl methacrylate (glycidyl methacrylate) and Nitrosamines. ECHA's website was updated in 2023 to host a repository of substances, for which the recommendations and opinions relating to the toxicological evaluations of substances affecting the health of workers were adopted by the Scientific Committee on Occupational Exposure Limits (SCOEL) - Recommendations of the SCOEL - ECHA (europa.eu). Five new requests for setting occupational exposure limits were received under the 2023 contribution agreement with the Commission: 1,3-butadiene, Boron and its compounds, Bisphenol A, Silicon carbide fibres, Pyrocatechol. RAC opinions for these substances will be adopted by 23 February 2025. Main outputs O1 Opinions of the Risk Assessment Committee (RAC) on OELs to the Commission are timely and fit-for purpose. 6 RAC opinions per year Yes Indicators O1 Number of OEL requests received under SLA Number of RAC opinions on OELs completed Number of scoping documents Estimate 5 6 0 Actual 5 5 0 Instrument for Pre-Accession Assistance (IPA) Highlights We continued supporting the pre-accessing countries to the EU under a new contribution agreement with the Commission for 2023-2026. The focus of this support remained on training on the EU chemicals legislation and related IT tools. Quarterly bilateral meetings were held with beneficiaries to make sure topics and mechanisms to provide information and support are in line with their priorities. Main outputs O1 Enhance the readiness of EU (pre)candidate countries to assume their role in their path towards EU membership in the area of EU legislation for chemical management. Implement support actions as agreed in the IPA grant agreement for 2023-25 Yes 43 Annual Report 2023 Indicators O1 N/A Estimate Actual Support to other legislation Highlights In 2023, we provided input to the review of some Best Available Techniques Reference documents (BREF) under the Industrial Emissions Directive and prepared for the formal onboarding of tasks under the upcoming revision of the Industrial Emissions Directive foreseen to be adopted in spring 2024. We contributed to the workshop organised by the European Integrated Pollution Prevention and Control Bureau (EIPPCB), whose aim was to clarify with stakeholders the main priorities and approaches for further development of the Chemical Management System. We worked with the Commission to determine the appropriate structure for ECHA to deliver on the new tasks received under the Serious Cross-Borders Threats to Health (SCBTH) Regulation. We also participated in the discussions with the other Agencies involved in the SCBTH regulation to share experiences and align approaches. Main outputs O1 Promote and support the use of the REACH/CLP data and expertise under other EU regulatory schemes Sustaining active input to the review of the Best Available Techniques Yes Reference documents (BREF) under the Industrial Emissions Directive. At Commission's request, prepare for the onboarding of additional tasks under the upcoming revision of the Industrial Emissions Directive in relation to risk assessment methodology in the Chemical Management System framework. On-going O2 Establish a readiness structure within ECHA for delivering rapid risk assessments in case of cross-border threats to health Agree on a process for delivering the risk assessments with the Commission. On-going Indicators O1 N/A Estimate Actual IUCLID for EFSA Highlights In 2023, we continued to provide support for the integration of IUCLID into the EFSA IT infrastructure by facilitating the publication of IUCLID data and assessing the implementation of 44 Annual Report 2023 data analysis tools. Data Uploader was successfully used by EFSA to upload OpenFoodTox to IUCLID format. Assessment on the use of Text analytics and Data extractor will be completed in 2024. Main outputs O1 Maintain cooperation between EFSA and ECHA and effective operation of the IUCLID platform. Assess applicability of IUCLID to other food regulated products (e.g., Food Yes Contact Materials and synergies with Drinking Water Directive). Submission portal is enhanced to automate the handling of large PPP Yes submissions. Assess the implementation of data analysis tools. On-going Continue support to EFSA to perform its regulatory work. Estimate resources Yes and compensation mechanisms. Execution of the Service Level Agreement for implementation of agreed scope and regular service accordingly. Indicators O1 N/A Estimate Actual Partnership for the Assessment of Risk from Chemicals (PARC) Highlights As a co-leader of Task 2.1 `Priority setting' under PARC, ECHA's experts reviewed 34 projects, mainly related to hazard, exposure and risk assessment methodologies. We also developed with the partners of Task 2.1 the process for a Rapid Response Mechanism (RRM) to submit project requests for specific information (e.g., urgent needs on hazardous chemicals). Furthermore, we actively participated in PARC projects addressing data gaps, for example, on bisphenol alternatives and development of innovative methods on different hazard endpoints (e.g., developmental neurotoxicity) To better communicate ECHA's research needs to the scientific community, we started to map key areas of regulatory challenge. The identified key areas of regulatory challenge were formulated as an `evolving research and development agenda' aiming to support and inspire researchers. The report was published during a joint webinar together with the European Environmental Agency and the European Food Safety Authority in June. These research needs will be updated and refined as the scientific areas evolve and key regulatory challenges develop. ECHA presented its research needs in various scientific fora (e.g., Joint Policy Session organised by DG RTD, at Eurotox 2023) and via relevant communication channels (e.g., ECHA Safer Chemicals podcast). 45 Annual Report 2023 Main outputs O1 Ensure, together with EFSA and EEA, that the research activities will support current regulatory challenges and new areas identified in the Commission's Chemicals Strategy for Sustainability. Steer the development and implementation of a prioritisation strategy Yes (including surveys, interviews and workshops on regulatory needs with EU and national regulatory bodies) based on the initial work done during the PARC proposal development phase. Contribute to the development of a framework with clear decision criteria to Yes enable transparent decision making for the prioritisation of activities within PARC. Support the development of annual work plans by steering the process of Yes review of the projects submitted, ensuring identified EU priorities and knowledge gaps in the area of chemical risk assessment are appropriately considered in the process. Steer for the development and implement a rapid response mechanism to Yes allow national and European policy makers to submit requests for specific information to the PARC Consortium outside of the formal timeframes. Indicators O1 N/A Estimate Actual Support to Forum Highlights We continued supporting the Forum of enforcement authorities, with a focus on the preparation, execution and reporting for the Forum-coordinated REACH and BPR enforcement projects. Three projects were under preparation (imports, online sales and SPCs for biocides), two under execution (safety data sheets and PFCAs in cosmetics) and four under reporting (authorisation, restrictions in products, biocides and classification of mixtures). We provided advice on enforceability aspects of seven restrictions proposals to enhance their regulatory process and future implementation including the restriction on the universal PFAS and on CMR on childcare articles. 210 REACH and 630 BPR inspectors were trained via the train the trainers approach that supports the harmonisation of EU enforcement of chemicals regulations. We provided support to the Commission as input to the preparation of legislative proposals in the context of the CSS ambition towards zero tolerance for non-compliance. Henrik Hedlund (SE) was appointed as the new Forum chair and Helmut de Vos (BE) as the new BPRS chair. 46 Annual Report 2023 Main outputs O1 An equal level playing field for economic operators is promoted in the EU through harmonised enforcement Prepare, execute, report and follow up on five Forum-coordinated REACH and Yes BPR enforcement projects on: REACH authorisation (REF-9), REACH and POP Restrictions (REF-10), REACH safety data sheets (REF-11), control of REACH for imports (REF-12), BPR approved substances in biocidal products (BEF-2) and select the subjects of next REACH and BPR coordinated projects (REF-13 and BEF-3). Establish best practice in enforcement by maintaining the Forum and BPRS Manuals of Conclusions on practical enforcement issues and running four Forum pilot projects on exemption from registration for recovered substances, classification of mixtures and poison centre notifications. On-going Deliver timely advice on enforceability on all submitted proposals for Yes restrictions and revise the process for delivering the Forum advice. Develop and deliver four trainings for national trainers and inspectors. Yes Contribute and facilitate Forum's input on the Commission's ideas on enhanced enforcement of chemicals legislation on imports, on European Audit Capacity for enforcement and other enforcement topics under the CSS/REACH revision. On-going Indicators O1 Number of enforcement trainers trained by the Forum Estimate 200 Actual 840 Board of Appeal Highlights In 2023, the Board of Appeal adopted 15 final decisions, all under REACH. In those decisions it addressed important aspects such as the interpretation of REACH information requirements and the possibility for ECHA to revoke registrations. 10 cases (two under BPR) remained pending at the end of the reporting period. The General Court confirmed three decisions of the Board of Appeal which were adopted in previous years. Most notably, the Court confirmed the decisions in which the Board of Appeal examined the relationship between REACH and the Cosmetics Regulation. Main outputs O1 Increase the efficiency of the Board of Appeal procedures, while continuing to ensure their quality. Process and decide on appeals brought against decisions of the Agency, Yes according to procedural requirements. Annual Report 2023 Communicate to parties and the general public about appeal decisions. Defend appeal decisions when challenged before the EU Courts, together with the Secretariat. Contribute to ECHA's input for the review of the REACH Regulation. Prepare and adopt a code of conduct applicable to members of the Board of Appeal who are Agency staff members. 47 Yes Yes Yes Yes Indicators O1 Appeals submitted REACH Appeals submitted BPR Appeals concluded REACH Appeals concluded BPR Estimate 12 2 12 2 Actual 10 2 14 1 Management Highlights ECHA continued to meet its governance and management obligations during 2023. All deliverables regarding annual reports, planning and budget requirements were done within the required timelines. With our new Executive Director, several governance and management changes and initiatives were completed. Our new Strategy Statement for the period 2024-2028 was developed and finalised. The development process involved significant staff and Management Board engagement and consultation. We also developed a new risk management policy, risk register and procedure. To ensure even greater levels of transparency to the Management Board, the Executive Director introduced a new ED report that is presented at each meeting. Discussions continued with the Management Board on ensuring our planning and other documents are clear, concise, and accessible to our stakeholders and partners. Further efforts on transparency included a new quarterly report to the Management Board as well as a review and update of our Conflicts of Interest policy. We supported Commission colleagues in their policy development work under the Chemicals Strategy for Sustainability including our joint efforts on alternatives to animal testing. This facilitated the establishment of structured contacts around specific files. Due to this focus, drafting a Memorandum of Understanding with Commission services was de-prioritised. Although the REACH revision and ECHA Basic Regulation were not published in 2023, we provided significant support to these. We aim to continue the dialogue with the Commission on the Basic Regulation in 2024 given it is a priority us. We also paid particular attention to increasing our engagement with the Member States and institutional partners. This involved meetings with the European Parliament and EU agencies as well as several Member States visits initiated by the Executive Director, which will continue in 2024. Following a successful audit, ECHA maintained its ISO 9001:2015 certification. We also completed several successful audits and evaluations and ensured the necessary follow-up was completed on their main recommendations. Outside of the day-to-day legal activities, ECHA defended its own decisions at the European Court of Justice and the Board of Appeal. We also supported the Commission at the European Court of Justice in risk management and biocides 48 Annual Report 2023 related cases. Altogether more than 50 cases were pending at different stages during the year, and the judgments received were predominantly very positive, confirming the position of ECHA. We expect the level of litigation to continue similar or higher in the next years. Our key focus was in communicating and engaging with our stakeholders and partners and will continue under the new strategy. As our legal mandate is widened, we will also be increasing our stakeholder and partner contacts in the EU, Member States, industry, and civil society organisations. We have resumed the organisation of regular NGO dialogues. We received increased requests for our Accredited Stakeholder Organisation (ASO) list in 2023 and we expect this to continue into 2024 and beyond. To help us prepare for the increased levels of engagement envisaged in our new strategy and new tasks, we completed our new stakeholder engagement approach and drafted our new communications strategy for the period 2024-2028. Both will be finalised and rolled out in 2024. ECHA's communications activities in 2023 focused on supporting the organisation in presenting its work clearly and transparently, across the range of its activities to its different internal and external stakeholder audiences. Key initiatives included the introduction of the Executive Director, the promotion of ECHA's work on new alternative methodologies and key areas of regulatory challenge, the proposed universal restriction on PFAS amongst many others. We continued to broaden our use of digital communications channels focusing, in addition to the website, on the development of our social media channels which are reaching a growing community, podcasts, audiovisual products and supporting stakeholder interaction through information and training webinars. Main outputs O1 ECHA's (multi-)annual planning provides clear direction that is aligned with its mandate and developing EU policies, while facilitating the efficient integration of new tasks Adopt a multi-annual work programme (Strategic Plan) and associated Yes objectives for integration in the Programming Document Develop and implement a project portfolio management mechanism to Yes provide continued effective support to the implementation of the Commission's Chemicals Strategy for Sustainability. Develop and implement a project portfolio management mechanism to Yes facilitate the integration of new regulatory tasks and changes to ECHA's governance structures. O2 The management bodies are in the position to drive performance and ensure compliance of ECHA. Adopt and publish the Programming Document, including (multi-)annual work Yes programme and budget in line with the Commission guidelines. Prepare and take the decisions statutorily required from the management Yes bodies, including the Management Board, within the applicable deadlines. Monitor performance through monthly and quarterly reporting to the Yes Management Board and address issues through mitigating actions; and report the overall status and achievements through the annual report published by end of April each year. Annual Report 2023 Timely reporting on measures taken in the light of the observations accompanying the annual discharge from the EU budget authority. Prepare and implement the corporate audit and evaluation plan, in consultation with the Management Board, with regular status reports and appropriate follow-up actions. Maintain the ISO 9001:2015 certification. Review ECHA's Policy for the Prevention and Management of Conflicts of Interest. Defend ECHA's interests in legal proceedings and ensure legal advice to its operations and on issues relating to financial interests, human resources, procurement, intellectual property and access to documents. 49 Yes Yes Yes Yes Yes O3 ECHA addresses the individual circumstances and needs of its institutional partners and is aligned with EU priorities. The Executive Director has a regular exchange of views with the European Yes Parliament's Committee for Environment, Public Health and Food Safety and maintains regular contacts with its liaison MEP and other MEPs. Organise regular bilateral interactions with Member States authorities. Yes Propose a draft Memorandum of Understanding on mutual expectations with No the Commission services. O4 Stakeholders and general audiences are aware of ECHA's activities and impact and easily obtain the information they need from the Agency. Implementation of 2023 Communications Action Plan to support the Work Yes Programme. Organise the biennial ECHA Conference. On-going Maintain and further develop the ECHA websites as key communication channels to provide accurate, relevant and up to date information to stakeholders. On-going Adopt a revised, cooperative approach for stakeholder engagement to support the implementation of the new multi-annual work programme (Strategic Plan) and clarify ECHA's work to key audiences in view the Agency's evolving role under the Chemicals Strategy for Sustainability and implement related actions. On-going 50 Annual Report 2023 Indicators O2 Areas where audits and evaluations results (including prevention of conflicts of interest and fraud) have been considered in future strategic decisions. O4 Combined neutral and positive feedback monitored in media publications Website unique visitors/traffic to the web content Estimate 5 Actual 5 >90 % 4.2 million 96 % 5.8 million ICT Highlights During the year 2023 ECHA embarked on the transformative ECHA IT 3.0 Journey, which has a primary focus on IT resilience, scalability and delivery capabilities. ECHA systems maintained an availability rate of 99%, surpassing the target of 98%, ensuring good level of service delivery internally and towards all stakeholders. By keeping the focus on IT security and business continuity, and implementing the agency's cybersecurity policy, the Agency avoided major cybersecurity incidents, and maintained the high standards of defences against evolving threats. In 2023, we made progress in implementing a modular and reusable IT architecture, aligning with the Target Enterprise Architecture vision established in 2022. Our modular approach ensures flexibility and adaptability, laying the groundwork for improved tooling support for regulatory processes. Following the same architecture prescriptions, a new version of ECHA's dissemination platform was designed and implemented. This revamp enhanced accessibility and scalability, ensuring seamless access to critical information for all stakeholders. Our ongoing refresh of administrative tooling ensured optimal performance, allowing us to keep pace with technological advancements and streamline workflows. The potential of artificial intelligence (AI) was also recognised, and a horizontal working group was established to identifying opportunities and setting guidelines for AI-related initiatives. Main outputs O1 Improve the resilience and scalability of the IT product and services portfolio in order to improve the efficiency and cost effectiveness in absorbing a growing mandate (CSS, 1S1A, new tasks etc). The target enterprise architecture is adopted, and implementation is started to improve tooling for regulatory processes for internal and authority users. On-going O2 Further develop the capability of the IT function to deliver through more effective organisational processes, refined architecture and leverage of new technologies. Implement the cybersecurity policy adopted in 2022. Yes 51 Annual Report 2023 The refresh of end-of-life administrative tooling is continued. The implementation of the roadmap for the future of the ICT infrastructure towards the public cloud begins. Services continue to be run at the required level of quality, in an efficient and cost-effective manner, by continuously investing in evolving the tools and practices. The preparation and establishment of replacement framework contracts for Management Information Systems, Enterprise Content Management and for Managed IT Workplace Services. Indicators Estimate O1 Average availability of key systems >98 % O2 High impact security incidents <3 Yes On-going Yes Yes Actual 99 % 0 Financial Resources Highlights We effectively managed our financing in 2023 through close monitoring of uncertain fee income development. On the final budget size of EUR 123.3 million, the Agency reached a 99% commitment rate and 87% payment rate, exceeding the targets set. The European Court of Auditors gave a clean audit opinion on ECHA's annual accounts for 2022 and their first audit mission on the financial year 2023 concluded without any preliminary findings. We continued supporting the Commission in its design of a sustainable and more predictable financing model and a simpler budget structure. Details on ECHA's budget information and management in 2023 can be found in Part II and Appendix II of this report. Main outputs O1 ECHA's budget is implemented in line with the objectives set in the Programming Document, with a high degree of implementation and in line with the Financial Regulation. Prepare and implement ECHA's budget in line with the objectives set in the Yes Programming Document and the rules and deadlines set in the Financial Regulation. The refresh of end-of-life administrative tooling is continued. Yes Prepare and present the annual accounts to the Management Board and Yes Institutions in line with the rules and deadlines set in the Financial Regulation. Prepare and implement procurement and contracting activities in line with Yes the objectives set in the Programming Document and the rules and deadlines set in the Financial Regulation. Provide data and analysis to the Commission to support achieving a stable Yes and predictable financing model for ECHA, with a more flexible budget Annual Report 2023 allocation. Provide regular reports to the Commission partner services and the Management Board's Sub-group on Finance, Audit and Risk, on the evolution of fee income, actual budget implementation, including revenue and expenditure estimates for the future. Maintain regular contacts with the Commission's partner DGs' financial services to discuss ways of handling any shortfall or surplus during the budget year. Monitor and report annually on the evolution of the transfer of a proportion of fees to Member States, propose improvements thereto, as necessary, and prepare updates to the related transfer amounts per country when the Commission country coefficients are updated. Implement further efficiency measures, including the automation of electronic signature to contracts, further digitalisation of the financial workflows, streamlining the procurement process by onboarding PPMT (that provides a single platform access to all eProcurement tools) and further promotion of electronic invoicing. 52 Yes Yes Yes Yes Indicators O1 Level of budget implementation: commitment rate and cancelled payment appropriation rate (including carry-forward) Processing of payments within legal deadlines Estimate Min. 95 % and max. 5 % respectively No less than 99 % Actual 99 % and 1 % 99 % Human Resources Highlights During 2023, we continued to build our organisational capability to support the delivery of ECHA's Work Programme. The annual staff turnover rate was within target, while vacancies were promptly filled leading to a high 96.8 % of establishment plan posts filled. Our biennial staff engagement survey showed high levels of commitment and engagement and confirmed ECHA's recognition as one of Finland's most inspiring workplaces. 2023 was the final year of the existing HR Strategy and actions on priority areas were all delivered. Technical competencies were successfully reviewed and updated with a view to preparing for new tasks. Learning and development priorities were actively addressed and delivered to build and maintain critical competence in key areas, including management and leadership capabilities. ECHA continued to provide its staff with career development opportunities through regular career enhancement calls, an internal mentorship programme and career coaching addressing individual needs. The attractiveness of ECHA as an employer was promoted with our strategic partners, at both international and at host country level. We also revamped the organisation's presence in social media to further enhance our attractiveness as an employer. Finally, we consulted all our staff and the Staff Committee in the development of the new People and Organisational Strategy for the period 2024-2028. This key document will support the 53 Annual Report 2023 organisation in achieving its purpose, vision and goals as contained in ECHA's new Strategy Statement 2024-2028. Main outputs O1 ECHA attracts, develops and retains competent and committed staff to implement its current and future mandate. Develop a new human resources framework, in line with the new ECHA multi- Yes annual work programme (Strategic Plan), addressing core topics such as competence development, recruitment, inclusiveness, gender balance and career development. Implement ECHA's Wellbeing Action Plan 2023-2024 with the support of Yes ECHA's Corporate Services Unit and the Agency's Joint Committee for Health and Wellbeing. Provide competence development activities to ensure continuous capacity Yes building of staff, including exploring joint training initiatives with peer Agencies. Ensure regular communication with ECHA's Staff Committee to maintain a Yes healthy working culture and positive relations and dialogue. Implement ECHA's Diversity and Inclusion Action Plan 2023-2024 to advance Yes diversity (including gender balance) in the management team and at organisational level. Indicators O1 Turnover of Temporary Agents Turnover of Contract Agents Percentage of Establishment Plan posts filled Estimate <5 % <10 % 95 % Actual 1.1 % 4.6 % 96.8 % Corporate Services Highlights During 2023, we continued to adapt to the hybrid working environment and an external consultant conducted an analysis on optimising the use of our office building and Conference centre. In 2023, ECHA maintained its International Organisation for Standardisation (ISO) 14001:2015 and EU Eco-Management and Audit Scheme (EMAS) certifications, as well as business continuity and security while closely monitoring the geopolitical situation with local authorities. Our new environmental work programme 2023-2025 was coordinated and monitored effectively (more information can be found in Part II and Appendix VII). We successfully organised meeting services for 640 events and official meetings, with 32 800 participants joining online through Webex, and hosted approximately 5 000 visitors to our premises. We also continued to work towards our aim to reduce CO2 emissions from both staff travel and building operations. A feasibility study of ISO 20121:2012 standard on event 54 Annual Report 2023 sustainability management systems was concluded and based on this study, we will aim to implement this standard during 2024. We launched and concluded a significant number of procurement procedures in 2023, including several new 4-year service contracts (for example, cleaning, security and reception services contracts). We also provided the facilities, support in safety and access management for two European Agencies who organised an official event at ECHA. ECHA's Wellbeing Action Plan 20232024 was progressed, by the Agency's Joint Committee for Health and Wellbeing and numerous implementation measures were undertaken throughout the year. Main outputs O1 ECHA provides a safe and healthy physical work environment for staff and guests that facilitates optimal Agency-wide performance. Conduct an analysis on optimising the use of ECHA's office building and Yes Conference Centre, including related service delivery options. Implement ECHA's Wellbeing Action Plan 2023-2024 with the support of Yes ECHA's Human Resources Unit and the Agency's Joint Committee for Health and Wellbeing. Coordinate and monitor implementation of ECHA's Environmental Work Yes Programme 2023-2025. Conduct staff awareness-raising activities in carbon neutrality. Yes Indicators O1 Examine the feasibility of obtaining a relevant certification to confirm, and improve, the sustainability of ECHA's event-related activities. Estimate Completed Actual Completed 55 Annual Report 2023 Part II. Management Management Board The Management Board (MB) provides strategic direction and governance to ECHA to enable the Agency to deliver on its purpose and vision and meet the expectations of its stakeholders. In 2023, eight new Board members were appointed. A number of significant decisions were taken by the MB including the development of ECHA's strategy for 2024-2028, approving the new policy for managing corporate risks and revising ECHA's conflict of interest policy. The MB led the strategy development process via its dedicated subgroup, in close collaboration with the Executive Director. The MB assessed the evolution of ECHA's external environment, took stock of the achievements of the previous strategy period and gathered input from ECHA staff and the Agency's key stakeholder groups. The final Strategy Statement 2024-2028 was adopted in December 2023. In June 2023, the MB adopted ECHA's revised conflict of interest policy to strengthen the monitoring of compliance with post-employment duties by former staff members. The policy also provides guidelines for Member States to ensure the independence of their services provided to ECHA and clarifies the duties applicable to staff and to external contributors. In September 2023, the MB adopted the Agency's new framework for identifying, assessing, and managing risks to reduce the likelihood of negative impacts on ECHA's objectives and ensure that risk management is integrated into the decision-making process. Regular reports on risks related to IT security were provided to the MB as well as risks arising from legal obligations not being met due to committee capacity constraints or the size and complexity of dossiers. With a view to resources and work programming, the MB was regularly updated on pending and upcoming Commission initiatives with an impact on ECHA's mandate and/or resourcing, as well as on ECHA's technical input to the Commission's preparatory work. The MB adopted all statutorily required documents in line with the applicable rules and regulations. In its capacity of Appointing Authority, the MB took the necessary decisions in all staff matters for the functions reporting directly to it (Executive Director, members of the Board of Appeal), including probationary period and annual performance appraisal, as well as renewal of mandates. Major developments In 2023, the MB led ECHA's strategy development process via its dedicated subgroup, in close collaboration with the new Executive Director. The Strategy Statement 2024-2028 was adopted in December 2023, and it provides the framework for ECHA to deliver on its existing wide legal mandate, build on its expertise and experience, collaborate with its stakeholders and partners, implement new tasks and support the ambition of the EU policy goals on chemicals. During 2023, ECHA continued to support the implementation of the Chemicals Strategy for Sustainability (CSS) as requested by the Commission. For instance, we provided scientific and technical input to the Commission during the trilogues with the European Parliament and the Council on the CLP Regulation revision, until a provisional agreement was reached at the end of 2023. In addition, ECHA provided technical input to the Commission during the preparation of the legal proposals for the revision of the Groundwater, Water Framework and Environmental Quality Standards Directives, the revision of the End-of-Life Vehicles (ELV) and Restriction of Hazardous Substances in electrical and electronic equipment (RoHS) Directives, as well as the 56 Annual Report 2023 revision of the Toys Safety, Persistent Organic Pollutants (POPs) and Medical Devices Regulations, among others. For all these the Commission put forward legal proposals, reattributing scientific and technical tasks to the Agency. In addition, the Commission published a legal proposal to establish a Common Data Platform, which includes a number of "data-related" new tasks for ECHA, such as the development of an EU Common Data Platform for Chemicals, a new repository of reference values, the extension of the Public Activities Coordination Tool (PACT), the hosting of the Information Platform for Chemical Monitoring (IPCHEM), a new database of study notification, a new Early Warning Framework and the establishment of an EU data generation mechanism. For two newly adopted legislations, the Batteries Regulation and the Regulation on Serious Cross-Border Threats to Health, ECHA commenced our implementation plans with a view to become operational in 2024. ECHA supported the Commission in its conceptual work on the future ECHA Basic Regulation. In this context, ECHA delivered five retrospective evaluations on ECHA's financial model, Committees (RAC, SEAC and MSC) and the Board of Appeal. Main recommendations on ECHA's financial model referred to ex-ante verifications for SMEs and a potential reserve fund, which are expected to further enhance the flexibility and agility of ECHA's management system, if implemented. Among the main recommendations of the evaluation of the committees were increasing the number of coopted members, reconsidering the payment schemes for rapporteurs, considering alternative legislative structures for ECHA to get the needed expertise and assigning a more active regulatory role for ECHA for some processes. These recommendations are expected to increase the flexibility for ECHA in attracting and keeping the right expertise for rapporteurs, relieve the Committees' workload and ultimately speed up the opinion making process. Budgetary and financial management Financial management ECHA effectively managed its financing in 2023, closely monitoring fee income development and reaching a 99 % commitment rate and 87 % payment rate, exceeding the targets set. The European Court of Auditors gave a clean audit opinion on ECHA's annual accounts for 2022 and their first audit mission on the financial year 2023 concluded without any preliminary findings. Details on ECHA's budget information and management in 2023 can be found in Appendix II. Delegation and sub-delegation of the powers of budget implementation to agency's Staff ECHA has a system of operational and financial delegations as part of its Integrated Management System, which allows to effectively manage delegations and sub-delegations, taking into account the risk level of the particular process. Human Resources (HR) management Human resources management ECHA continued to implement its 2019-2023 Human Resources (HR) Strategy and had a high rate of filled establishment plan posts (96.8 %) with a low Temporary Agent turnover (1.1 %) rate. We maintained a strong focus on staff wellbeing through delivery on our respective action plan, in close cooperation with ECHA's Joint Committee on Health and Wellbeing. Finally, the Diversity and Inclusion Action Plan was further implemented, and our efforts were recognised through the award of a Certificate of Excellence from the Network of EU Agencies. ECHA's biennial staff engagement survey was conducted by ECHA's independent service partner in the spring of 2023. The results are above benchmark levels and show high employee 57 Annual Report 2023 engagement level. The service provider characterised ECHA as an inspiring workplace where business is developed together with employees. The results of the staff survey, together with the rest data sources, are analysed in the internal controls assessment (see Section III). Strategy for efficiency gains In the recently released draft discharge report for the financial year 20225, the European Parliament commends ECHA for its strategy for efficiency gains, stating that the Agency's strategy focuses on achieving added value through performance-based governance, alongside the development of new tools that enhance Planning and Reporting processes. These tools, designed to be more user-friendly, offer better reporting capabilities, and save time for the entire staff. In terms of efficiency gains, the discharge report also observes that the Agency also started an infrastructure capacity optimisation exercise to minimise any excess capacity in the IT infrastructure and the Agency was able to reduce the usage by roughly 25 %. With regard to ECHA's efficiency efforts in the area of IT management, in 2023 the Agency continued the process of organising its IT portfolio in modules, which allows a composable architecture and further enables synergies between activities and legislations. According to the 2023 staff survey, 42 % of respondents fully agree and 44 % tend to agree that their units operate efficiently, pointing to a perception of ECHA as an efficient organisation. As part of its efficiency initiatives, in 2023 the Agency prioritised the adoption of the PEPPOL platform for invoice exchange. This initiative ensures secure and timely transactions, benefitting both public and private sector entities within and outside the EU. The use of this platform has streamlined the recording of debit notes in the Agency's accounting system, handling an average of 2000 commercial invoices annually. Furthermore, to expedite financial transactions, the Finance unit now possesses the authority to approve payments below EUR 8,000. Approximately 75 % of invoice-based payments and 100 % of cost-claims, such as meeting participant reimbursements, are processed within the Finance unit, freeing up time for middle and senior management to focus on strategic priorities. Another significant change occurred with the implementation of the new hybrid working arrangement as of 1 September 2023. This approach replaced the previous structural teleworking request system, resulting in around 82 % decrease in teleworking requests during Q4 2023 compared to Q4 2022. The adoption of hybrid teleworking arrangement brought several tangible benefits. It has reduced the administrative burden for both staff and managers (two approval workflows per year instead of weekly or monthly) and reinforced flexibility and trust between staff and managers. This new approach is expected to lead to increased staff engagement and commitment. Assessment of audit and retrospective evaluation results during the reporting year Retrospective (ex-post) evaluations In 2023, ECHA performed the following retrospective evaluations following the criteria and methodology as stipulated in the Better Regulation Guidelines6 : Retrospective evaluation of ECHA's Committees, and namely: the Committee for Risk Assessment (RAC), the Committee for Socio-economic Analysis (SEAC) and the Member 5 https://www.europarl.europa.eu/doceo/document/CONT-PR-753516_EN.pdf 6 http://ec.europa.eu/smart-regulation/guidelines/tool_42_en.htm 58 Annual Report 2023 State Committee (MSC)7. Upon request of the services of the European Commission, this ex-post evaluation analysed the degree of effectiveness, relevance, efficiency, proportionality, coherence, added value and sustainability of the Committees established by the REACH Regulation. The results will be used to support the Commission's work on improving the governance of ECHA, for which the Chemicals Strategy for Sustainability (CSS) foresees the establishment of a self-standing basic regulation. Some process results may be used by the Commission in a possible future REACH revision. Retrospective evaluation of ECHA's Board of Appeal8. The objective of this evaluation was to analyse the degree of effectiveness, efficiency, proportionality, coherence, added value, relevance, and sustainability of the Board of Appeal (BoA), with the results supporting the European Commission's work on the Basic Regulation for ECHA. Retrospective evaluation of ECHA's financial model, including its REACH/CLP and Biocides fee income trends, and their predictability and stability throughout the years. A comparison with other agencies' models was covered to allow for conclusions on the proportionality of ECHA's model. The costs, risks and benefits associated with the model for ECHA, and its main stakeholders were also captured in the analysis. The results of the retrospective evaluation can be used to support the Commission's announced proposal for an ECHA Basic Regulation. Internal Audit Service (IAS) The Internal Audit Service (IAS) of the Commission conducted an audit on `Budget preparation, monitoring and reporting'. The audit did not result in any critical or very important recommendations. The audit identified two improvement areas, classified as important, on resource allocation and the exceptions register. Internal Audit Capability (IAC) The Internal Audit Capacity (IAC) conducted one assurance audit with the objective of assessing and providing reasonable assurance on the regularity and the quality of internal control systems applied as well as efficiency and effectiveness of the Follow-up to Dossier Evaluation process. The audit resulted in one very important recommendation: Provide a holistic overview and monitor dossier evaluation process (compliance checks and testing proposals) from start to end by e.g., preparing analysis on annual trends on status of Final decisions (closed, in follow-up evaluation, in enforcement). and three important recommendations: To support efficient and effective enforcement of the Failure to respond cases: o Inform National enforcement authorities of the priority cases according to the ECHA's strategy and Integrated Regulatory Strategy o Continue cooperation with the National enforcement authorities. Complete the existing calculations on resource needs to deal with the accumulated backlog and the scenarios for the future. Agree on the need to allocate resources to additional tasks such as restructuring and simplifying the Follow-up to Dossier Evaluation process, IT development. To reinforce assessment of the regulatory risk management measures as a Follow-up to Dossier evaluation outcome clarify if Follow-up to Dossier evaluation team needs 7 https://echa.europa.eu/documents/10162/17086/retrospective_evaluation_of_committees_report_en.pdf/e491f3531e6e-8616-8990-48db2fed0056?t=1695807929141 8 file://echa/data/users/u09175/Roaming%20Profile/Downloads/ex_post_evaluation_board_appeal_en%20(6).pdf 59 Annual Report 2023 additional support. The Agency follows up these recommendations with corresponding actions. For earlier audits, the Internal Audit Capability conducted two follow-up audits (one finalised in February 2024) to verify the implementation of the action plans, concluding that two very important and four important actions are still being implemented. European Court of Auditors (ECA) In their statement of assurance9, the European Court of Auditors (ECA) concluded that the accounts of the Agency for the financial year 2022 present fairly, in all material respects the financial position of the Agency at 31 December 2022, the results of its operations, its cash flows, and the changes in net assets for the year then ended, in accordance with its Financial Regulation and with accounting rules adopted by the Commission's accounting officer. The revenue and payments underlying the accounts for the year were also legal in all material aspects. The Court did not make any observations regarding the financial year 2022 and there are no observations open from previous years either. Follow up of recommendations and action plans for audits and evaluations Follow up of recommendations and action plans for audits and evaluations The follow-up of the evaluations performed in previous years showed that most of the recommendations on the retrospective evaluations, such as those concerning the SCIP database (Substances of Concern In articles as such or in complex objects (Products) established under the Waste Framework Directive (WFD))10, EU Chemicals Legislation Finder (EUCLEF), the EU Observatory for Nanomaterials (EUON), Cloud services and Portal Dashboard for national enforcement authorities (PD-NEA) and Portal Dashboard for Member State competent authorities (PD-MSCA) have been implemented. The follow up of the retrospective evaluation on the functioning of ECHA's Integrated Management System (performed in 2019) showed progress in areas such as further integration of internal control and quality, simplification of IMS processes, aiming to ensure proportionality between costs, risks and benefits at process level and promotion of staff empowerment. Follow up of recommendations issued following investigations by the European Anti-Fraud Office (OLAF) N/A Follow up of observations from the Discharge authority For the discharge 2022, the Secretariat of the European Parliament Committee on Budgetary Control asked all EU Decentralised Agencies for a follow-up report to the 2021 budgetary discharge to be submitted by 15 September 2023. 9 https://www.eca.europa.eu/en/publications/SAR-AGENCIES-2022 10 https://echa.europa.eu/documents/10162/6205986/scip_evaluation_report_en.pdf/2c677149-e876-f2b1-0ba73daca0a419ef?t=1665556373094 60 Annual Report 2023 The report11 provides an overview of the relevant observations and recommendations from the European Parliament Resolution12 of 10 May 2023 on discharge in respect of the implementation of the budget of ECHA for the financial year 2021, together with the measures ECHA has taken in light of these. On 10 May 2023, the European Parliament also adopted the resolution on discharge in respect of the implementation of the budget of the EU agencies for the financial year 2021: performance, financial management and control (2022/2134(DEC)). This resolution is a horizontal report containing recommendations and observations that accompanied the individual 2021 discharge reports for each of the Agencies and Joint Undertakings. The follow-up actions to these recommendations, where a collective response was prepared by the EU Agencies Network, will be presented in a separate report being prepared by the Agency holding the Chairing role of the EU Agencies' Network. ECHA has contributed to this report by providing information in relation to its own actions. In summary, there were nine recommendations from the European Parliament, out of which six have been implemented. Environment management Environmental and sustainability management To sustainably use resources and maintain sound environmental practices, ECHA has integrated environmental management into its systems. In 2023, the Agency was recertified under both the EU Eco-Management and Audit Scheme (EMAS) and International Organisation for Standardisation (ISO) 14001, which both confirm that ECHA evaluates, reports and improves its environmental performance. These certifications are central to realising our vision of becoming an Agency with net-zero greenhouse gas emissions by 2030, as stated in our climate neutrality pledge. ECHA's Environmental Work Programme (EWP) 2023-2025 outlines our goals, actions, and objectives for reducing the consumption of natural resources, cutting down waste, and minimising our carbon footprint. Overall, ECHA's total CO2 consumption was within the annual target of the 2023-2025 environmental work programme. This was made possible with the collective effort of all ECHA staff, who limited their work travel by respecting the limits set for total CO2 through the mission quota system introduced in 2023. Environmental Objectives 2023-25 (Benchmark year: 2019) Building CO2 emissions reduction of 20% Travel (meeting participants) CO2 emissions reduction of 75% Travel (staff missions) CO2 emissions reduction of 50% Result in 2023 61 %* decrease 73 % decrease 70 % decrease *Adjusted to 2022 CO2 emission factors Actions of the EWP implemented in 2023 included the strengthening sustainability criteria and monitoring for Green Public Procurement (GPP), the development and implementation of an 11 ECHA_2021_Discharge_report_follow-up.docx (europa.eu) 12 TA (europa.eu) 61 Annual Report 2023 Internal Audit methodology of the ECHA Environmental Management system (EMS) and the review of the scope of CO2 related to ECHA's activities. Finally, to promote and implement ECHA's environmental objectives, over 30 communications activities were undertaken during 2023 to promote international, EU, national and ECHA climate awareness actions such as Earth Day, EU Green week and the Baltic Sea Day. ECHA was also active in inter-institutional activities and participates in the Groupe Interinstitutionnel de Management Environnemental (GIME) and European Union Agency Network (EUAN) Greening Network to exchange best practice on environmental management among the EU institutions and Agencies. Assessment by management Based on the information in the Section II, no significant weaknesses or gaps that may threaten the achievement of ECHA's objectives were identified. An overall conclusion taking into account the findings from the internal control assessment is available in Section IV. 62 Annual Report 2023 Part III. Assessment of the effectiveness of the internal control systems Effectiveness of internal control system Compliance and performance of ECHA under the Integrated Management System Strategy and Framework The purpose of the annual internal controls assessment is to give reasonable assurance that ECHA's management system is functioning, continuously improved, and that the objectives set out in Article 30 of the ECHA Financial regulation are met, namely: (I) effectiveness, efficiency and economy of operations; (ii) reliability of reporting; (iii) safeguarding of assets and information; (iv) prevention, detection, correction and follow-up of fraud and irregularities; and (v) adequate management of risks relating to the legality and regularity of the underlying transactions. The reference for the assessment is ECHA's Integrated Management System Strategy and Framework, (POL-0001) which supplements the financial regulation and aligns with the principles and guidelines set out by the European Commission (in the areas of internal control and programming) and with the ISO 9001:2015 and ISO 14001:2015 standards. The assessment is based on a wide range of sources, such as internal and external audits, retrospective evaluations, risks, non-conformities, complaints, appeals, financial, operational, IT, environmental and HR reports. Following the recommendations from the IAS audit on `Budget preparation, monitoring and reporting', ECHA also sampled and analysed the whole exceptions register. The detailed conclusions from the sampling and analysis of all those sources are available in the internal controls assessment for the year 2023. Internal control surveys were conducted to capture the self-assessment of Directors, Heads of Units and Management board members with regard to the functioning of the ECHA's management system. Staff members' perception was also analysed as part of the annual staff survey 2023 and stakeholders' input was captured in the media report and various retrospective evaluations. Interviews were also conducted to deepen the analysis in the areas with low scores. The data on perception together with the other sources mentioned above were analysed and triangulated to derive conclusions. For 2023, the assessment confirms that the IMS is effective and functioning as intended. All directors and most middle managers agree that management commits to the core principles. Also, most of the detailed components are fully present and functioning (9 out of 12), while areas identified for improvement are not considered major, or critical, deficiencies of the whole IMS or about the objectives of Article 30 of the ECHA Financial Regulation. Performance management, and stakeholder engagement are the main areas of attention as a result of the internal controls assessment 2023 (details are available in the next section). Improvement work is either ongoing or planned for 2024. In terms of costing the controls, the Agency follows the definition in the General Financial Regulation13 of the EU, according to which `control' means `any measure taken to provide reasonable assurance regarding the effectiveness, efficiency and economy of operations, the reliability of reporting, the safeguarding of assets and information, the prevention and detection 13 Financial Regulation applicable to the general budget of the Union: https://op.europa.eu/en/publicationdetail/-/publication/e9488da5-d66f-11e8-9424-01aa75ed71a1 63 Annual Report 2023 and correction of fraud and irregularities and their follow-up, and the adequate management of the risks relating to the legality and regularity of the underlying transactions, taking into account the multiannual character of programmes as well as the nature of the payments concerned'. Controls may involve various checks, as well as the implementation of any policies and procedures to achieve the objectives. Based on an approximation of the resources deployed in the units responsible for governance, human resources and financial management, as well as the average salary costs, the cost of controls as a percentage of the total budget are estimated to be around 3.4 % which is lower than the previous year, when the percentage was 3.7%. The summary from the internal controls assessment as per the principles and characteristics of each component is covered in the next section below. Risk management Risk management is an integral part of ECHA's Integrated Management System. The risks, that were identified as possibly jeopardising the achievement of the objectives defined in the Programming Document, were followed up regularly and a more detailed assessment was carried out every four months during the year. In 2023, ECHA appointed a Chief Risk Officer and ECHA's Management Board adopted a new organisational Risk Management Policy. ECHA also developed a new Risk Management Procedure, together with implementing a revised internal framework for addressing risk management in ECHA. Regular updates were given to the Management Board and specific reporting continued on the IT-security related risks. Transparency, accountability and integrity Throughout 2023, the Agency lived up to its values of transparency and independence, ensuring continued public and stakeholder trust in the impartiality and objectivity of ECHA's work. The decision-making processes of the Agency are designed to be clear, open and to ensure a balanced outcome based on a reasoned scientific approach. Information on the intentions of ECHA and the Member States - for example, to look into substances or create dossiers - is available online, so companies have access to the data they need to make informed business decisions. Accredited stakeholder organisations may participate in scientific meetings as observers, except where confidential business information requires sessions to be closed. This gives them a chance to witness the debate and decision-making process and, where appropriate, express their views. Where consultations take place, the comments received are discussed and addressed. The reflections, minority opinions and conclusions of ECHA's scientific committees are recorded in opinions and minutes, and these are published online. ECHA maintains the world's largest regulatory database on chemicals. The database provides transparent information on the chemicals used in Europe today in three layers: a simple Infocard aimed at consumers, a more detailed Brief Profile for professionals and the non-confidential source data submitted by industry to ECHA. During 2023, ECHA published a IUCLID dataset for 528 approved pharmaceuticals, including results from animal studies and human data. The availability of this new data supports the development of alternatives to animal testing. In addition, a pilot project led by the European Federation of Pharmaceutical Industries and Associations (EFPIA), and supported by ECHA, has made an updated set of archived data from unpublished chemical tests available on the IUCLID website. The database contains now altogether information about the hazard properties of 94 substances from 517 tests. 64 Annual Report 2023 Prevention of conflicts of interest Based on a thorough risk assessment of its activities, the Agency has identified the processes and sub-processes that require conflicts of interest to be managed. Conflict of interest checks are performed for more than 30 processes, sub-processes or process steps, including the main operational processes of the Agency. In all of these processes, a review of the annual declarations of interest is performed by the process owner each time a task is assigned to a staff member, while for some sensitive processes this is complemented with a case-specific declaration of no interest by the staff member. If there is a potential conflict, the case is assigned to a different staff member. The approach is documented in detailed work instructions and guidance is available for those managing the interests to help them deal with individual cases. As a result, no cases of actual conflicts of interest among ECHA staff, affecting the output of the Agency were identified in 2023. However, one issue was identified within a process where an external service provider contributed to the Agency's outputs. The provider had failed to declare that one of its experts was at the same time and on the same topic also advising a private entity potentially affected by ECHA's work. Immediately after detecting this potential for a conflict of interest, ECHA took the necessary mitigating measures, including terminating the contract in question and re-evaluating all of the outputs produced by the external service provider in this file, to fully exclude any undue influencing. Improvements were also made to the procurement process to avoid any similar situations in the future. For the ECHA bodies, all members are assessed against the generic exclusion criteria agreed upon by the Management Board, at the time of their appointment. Once they take up their function, their annual declarations of interest are reviewed by the respective Chair and published on ECHA's website. Before each meeting of an ECHA body, specific declarations for items on the agenda are collected and documented in publicly available minutes together with the mitigating measures imposed. As most of the members of ECHA's bodies are Member State public officials, the majority of the conflicts of interest declared by the members concerned involvement in preparing dossiers submitted by their Member State competent authority. In all such cases, the members concerned were considered to not be in a position to participate in the voting on such dossiers. Policy update ECHA's Management Board adopted in June 2023 changes to ECHA's procedures for prevention and management of potential conflicts of interest. Based on recommendations issued by the European Parliament as discharge authority, the European Ombudsman and the European Court of Auditors, ECHA introduced additional measures to strengthen the monitoring of compliance with post-employment duties by former ECHA staff members. It also converted the existing individual Memoranda of Understanding between ECHA and Member State Competent Authorities (for ensuring the independence of Member State services to be provided to ECHA) into the format of a single document with guidelines for Member States, in order to streamline the process. Finally, it separated the duties applicable to ECHA staff from those applicable to members of ECHA bodies into two self-standing procedures under an overarching policy document. Post-employment Members of staff must notify new occupational activities for the first two years after leaving the service of the Agency. ECHA can forbid the new activity or impose conditions. In 2023, twenty-five (25) staff members left ECHA: six (6) of them went to work for another EU institution, body or Agency. Four (4) staff members moved to a national public administration or international organisation. Eight (8) staff members moved to the private sector or started 65 Annual Report 2023 self-employment and, in seven (7) of these cases, the Agency deemed it necessary to impose specific conditions due to the nature of the occupational activity or the role of the individual within their new occupation. In the remaining seven (7) cases, ECHA has not (yet) been informed about a new occupational activity, as the departure was due to retirement, permanent invalidity or death of a staff member. None of these cases concerned a member of senior management. An overview of the post-employment decisions of all former senior managers is published on ECHA's website, including their names, date of departure, positions, their foreseen new occupational activities, and the outcomes of ECHA's assessments14. No breaches of trust or disciplinary procedure were initiated for conflict-of-interest management. Conflict of Interest Advisory Committee The Conflict of Interest Advisory Committee (CoIAC) is an advisory body in the context of ECHA's Procedure on Prevention and Management of potential conflicts of interest. The Committee is available to the Management Board, the Committees, the Forum and the Executive Director for advice on matters related to potential conflicts of interest of ECHA staff or members of the Agency's bodies. The Committee comprises three members: Mr Per ngquist, appointed by the Management Board of ECHA (he has succeeded Ms Judite Dipane whose mandate in Management Board and CoIAC expired end of May), Mr Julio Bacio Terracino from the OECD ethics department, appointed as an external expert, and Ms Minna Heikkil, Head of ECHA's Legal Affairs Unit as Chairperson. On 31 May 2023, the CoIAC convened for its annual meeting where it took the opportunity of the change in its composition but also of the presence of the ECHA's new Executive Director to recapitulate and discuss the past ten years of advice given by the CoIAC. The CoIAC further received a request for advice from the Executive Director concerning analysis of ECHA's CoI prevention policy and implementing rules with a view to the expanding role and mandates of the ECHA Committees and the actors involved around the Committee work. The CoIAC agreed to base its advice on an analysis of the new and amended policy to be adopted in June 2023, and it held a number of interviews with Chairs of ECHA's Committees as well as Working Groups. The final advice will be delivered in 2024. Ex-post controls In line with the Procedure on Prevention and Management of potential Conflicts of Interest, ECHA may undertake ex-post controls to guarantee the effectiveness of the procedure. A sample check on 12 annual declarations submitted by the members of the ECHA Board of Appeal revealed that all of them were in place, publicly available and sufficiently complete to allow for effective conflict of interest prevention and management. However, while there is a duty for an annual update, for 1 declaration more than 21 months had expired since the latest update. While the Board of Appeal confirmed that the annual renewal process was ongoing also for this alternate member, they were reminded of the importance of the prescribed 12-month time limits to allow accurate assessments of potential conflict of interest situations. 14 https://echa.europa.eu/documents/10162/13559/postemployment_senior_managers_en.pdf/8567fc1f-1631-05fe-eceb-8817a0e110d1 66 Annual Report 2023 Fraud prevention By design, the Agency's internal control systems contain fraud prevention, with an emphasis on critical areas such as financial transactions, procurement and selections. ECHA's Code of Good Administrative Behaviour15 is well communicated to all staff members. Management Board decision 30/2009 of 23 April 2009 stipulates the terms and conditions for internal investigations in relation to the prevention of fraud, corruption, and any illegal activity detrimental to the Communities' interests. Guidelines for whistleblowers were first adopted in 2015 and updated in September 2018. Through these guidelines, ECHA ensures that its employees can always highlight any action which goes against the public interest. The ECHA Anti-Fraud Strategy16 was revised by the ECHA Management Board in December 2022 and includes a focus on maintaining and further developing the anti-fraud culture in the Agency and regularly reviewing key policies and procedures. In autumn 2023 a mandatory all-staff ethics training was organised, with a focus on dealing appropriately and effectively with lobbyists. Data protection The Data Protection Officer is an independent function within the Agency, who advises the units on compliance with privacy laws and regulations. He keeps the required records of processing operations centrally and acts as the liaison with the European Data Protection Supervisor. In 2023, the focus areas of support concerned contractual arrangements for IT solutions procured by the Agency, as well as an in-depth assessment of the privacy risks associated with ECHA's project of migrating its data to the public cloud. Actions have also been taken in the context of two data protection related complaints and three personal data breaches that occurred in ECHA and involving ECHA staff and/or stakeholders. As required, these cases were recorded and reported, and appropriate mitigating measures were agreed with process owners to avoid repeats in the future. Security and business continuity During 2023, separate training sessions on security for service providers in ECHA's premises as well as numerous unit/directorate fire-safety and evacuation walk throughs were organised. Based on a scheduled fire safety inspection the agency's Emergency Rescue Plan was updated and communicated to the Helsinki Rescue Authorities. ECHA's emergency procedures were audited as part of the ISO-audit and as part of the EMAS verification of ECHA's environmental statement. Radiation safety training was organised for ECHA's Radiation Safety Officer by the STUK organisation. ECHA's business continuity organisation was reviewed and updated in 2023 to better reflect the needs of the organisation. The agency has maintained and updated its physical security and safety equipment, in accordance with legal requirements and with due consideration to best practice throughout the year and continuously monitors its geopolitical operating environment. 15 https://echa.europa.eu/documents/10162/13559/code_of_good_administrative_behaviour_en.pdf/a4aa9 4f7-f631-43d6-8c28-77a10a0d0720 16 https://echa.europa.eu/documents/10162/10709201/final_mb_47_2022_annex1_anti-fraudstrategy_2023-2026_en.pdf/c42eb6f4-1d61-5be9-83a4-3f4af5ee6b4e 67 Annual Report 2023 Co-operation and security briefings with Commissions Representation in Helsinki, the Helsinki police and other local authorities on security and safety matters continued during year 2023. Finally, the Agency received one request for support from the EU Agencies Security Network related to security management. Regarding cybersecurity the new EU regulation on cybersecurity for Union Institutions, Bodies, Offices and Agencies was adopted in December 2023. Preparations for the new legal obligations were made and implementation will follow in 2024 and beyond. This includes cybersecurity riskmanagement, governance and control framework, maturity assessment, risk-management measures and cybersecurity plan. Public cloud services were being put in place the cybersecurity and resilience and continuity arrangements were put in place. In addition, regarding data protection various impact assessments were performed. Cybersecurity awareness campaign was continued with two more mandatory courses for ECHA staff as well as phishing simulation exercises and European Cybersecurity Month "Be Smarter than a Hacker" in October 2023. Although the Cybersecurity service of the Union Institutions, Bodies, Offices and Agencies (CERT-EU) reported unprecedented rise of cybersecurity incidents in the second half of 2023, cybersecurity of ECHA infrastructure and data, including hybrid working practice, was maintained and no high impact security incidents were encountered in ECHA. Conclusions of assessment internal control systems Component Conclusion Governance 1.1 Mission and vision ECHA's purpose, vision and values were reviewed in the context of the new ECHA strategy in 2023 building on input from staff, MB members and via them stakeholders. 1.2 Ethical and organisational values The principle is present and functioning. ECHA is perceived as a transparent organisation. Values have been updated in 2023 in consultation with staff and MB and reflect ECHA's new tone at the top and strategy 2024 -2028. Awareness raising efforts on dealing with sensitive topics need to remain high. 1.3 Management responsibility The Integrated management system is functioning, and management committed to its continual improvement and flexibility. The overall management perception of ECHA's ability to support effective decision-making at the right level is neutral towards positive for senior management. The overall perception of the efficiency of decision-making is positive among staff. The decreasing allocation of resources in the area of quality, internal control, internal audits and process improvements at ECHA is impacting the support to the work of the QAO network. 1.4 Human Resources ECHA has competent and highly qualified staff, and there is Management commitment to enhance staff and competence development. There is a need for improvement in the areas of identifying competence gaps and assessing staff performance in an objective, equal and transparent way. 1.5 Stakeholders and partners engagement ECHA is well committed to its stakeholders and their needs. In 2023 there was a new Communications' strategy and a stakeholder methodology developed and efforts were made towards identification, classification and prioritisation of stakeholders. However, it cannot yet be concluded that the actions taken have been effective in handling the deficiencies as identified in the IAC audit in 2022 since the strategy has not yet been implemented and there is work ongoing under the new stakeholders' approach. It will be beneficial to ensure stakeholder contacts are transparently 68 Annual Report 2023 shared in the organisation and tailor made to the Agency's strategic and operational goals. Strategy, planning and risk management 2.1 Priorities planning and resource allocation In 2023, Management Board adopted ECHA's new strategy and the SPD for 20242026 where it defined ECHA's strategic and operational priorities and their implementation. ECHA demonstrates commitment to stakeholders, priorities and objectives, which is demonstrated in the new strategic statement. The resources allocation based on strategic goals, including in horizontal services, is an area for improvement. 2.2 Risk management The corporate level risk exercise is well established. MB involvement and establishment of clear roles and responsibilities with the new risk policy in 2023 is a positive development. Process-level risk management is less structured, and controls are partly perceived as disproportionate or as removed without prior risk assessment. Different indications exist for the cost-benefit ratio of horizontal functions. No overall analysis is available. Operations and operational structure 3.1 Activity management The activity and process management enables synergies. Efforts were made in 2023 to define the outcomes, expected performance, efficiency, and impact of activities, however, biggest part of this work will take place in 2024 in alignment with the implementation of ECHA's new strategy. There are control mechanisms in place to manage suppliers and contracts at ECHA. The Agency may benefit from an overall systematic analysis of how and if the risk of overdependence has materialised in the different activities of ECHA, together with a consideration of the costs, risks and benefits of the dependency versus the transition to new potential contractors. Awareness raising around management of contractual risks and strengthening ECHA's negotiating power may target contract managers and process owners in the operational units. 3.2 Information and data management 3.3 Change management ECHA aims at effective, efficient, integrated information, communication, and data solutions. The level of IT has remained adequate, despite the increased number of security threats. There is ongoing work with regard to improving the overall efficiency of the IT systems and the systematic involvement of stakeholders in the development of IT products and services. Measuring the efficiency and economy of ECHA's IT initiatives, i.e. around re-using existing IT platforms and tools will be beneficial. ECHA overall responds to changes flexibly whilst ensuring continuity of operations. Changes to ECHA's financial model are expected to further enhance the flexibility and agility of the system. Specific consideration should be paid to the prerequisites (including the legislative ones) for maintaining a flexible and agile management system in the future in view of the changing stakeholders' requirements and the onboarding of new tasks. Evaluation and improvement 4.1 Performance management The structures ensure overall reliability of reporting, accuracy, completeness, and timeliness of data. No critical gaps were found from the analysis of non-conformities, complaints and exceptions register. Attention is required in the area of data management with the need to build more consistent reports and avoid manual interventions. The adequacy of corporate metrics will need to be addressed, taking into account the balance between quantitative and qualitative indicators, such as stories, and the data needs of the different stakeholder groups. 69 Annual Report 2023 4.2 Assessments, audits, and evaluations ECHA has adequate tools in their disposal to oversee the effectiveness, adequacy, and suitability of the Agency's Integrated Management System through assessments, audits, and evaluations. There is a need to improve the communication around the Management Review topics and to ensure that cost-risk-benefit analysis is performed when new initiatives are started. Statement of the manager in charge of risk management and internal control We, the undersigned, Shay O'MALLEY Director of Resources And Frank BCHLER Head of Unit Governance, Strategy and Relations In our capacities as manager in charge of risk management and internal control, we declare that in accordance with ECHA's Internal Control Framework, we have reported our advice and recommendations on the overall state of internal control in the Agency to the Executive Director. We hereby certify that the information provided in the present Annual Report and in its annexes is, to the best of our knowledge, accurate, reliable and complete. Done at Helsinki, on 12 March 2024 signed signed Shay O'MALLEY And Frank BCHLER Director of Resources Head of Unit Governance, Strategy and Relations 70 Annual Report 2023 Part IV. Management assurance Review of the elements supporting assurance The Authorising Officer performed an assessment of the effectiveness and efficiency of the internal control system, acknowledging that the system, based on ECHA's Integrated Management Strategy and Framework, is functioning well. The assessment considered a broad range of input and will feed into the Management Review 2024, where senior management of the Agency gets together to reflect on the strengths, weaknesses, risks and opportunities of the management system. Based on this retrospective assessment, the Senior Management agrees on the priorities and actions to take in 2024. No significant weaknesses that may have a potential impact on the declaration of assurance of the Authorising Officer were identified and reported in any of the relevant parts as set out in the present report. Reservations Not applicable 71 Annual Report 2023 Part V. Declaration of assurance Declaration of assurance by the Authorising Officer I, the undersigned, Dr Sharon McGuinness Executive Director of the European Chemicals Agency In my capacity as Authorising Officer, Declare that the information contained in this report gives a true and fair view, State that I have reasonable assurance that the resources assigned to the activities described in this report have been used for their intended purpose and in accordance with the principles of sound financial management, and that the control procedures put in place give the necessary guarantees concerning the legality and regularity of the underlying transactions, This reasonable assurance is based on my own judgement and on the information at my disposal, such as the results of the self-assessment, ex post controls, the work of the Internal Audit Capability, the recommendations of the Internal Audit Service and the lessons learnt from the reports of the Court of Auditors17 for years prior to the year of this declaration, Confirm that I am not aware of anything not reported here which could harm the interests of the Agency. Done at Helsinki, on 22 March 2024 signed Dr Sharon McGuinness Executive Director 17 With regard to the implementation of EU legislation and the fee regulations under the Agency's remit, this assurance has to be limited to the field of competences of the Agency. Since ECHA's mandate does not include controls or inspections at national level, it cannot be confirmed that only registered or authorised substances and products, for which a fee has been paid to the Agency, are circulating on the EU market. 72 Annual Report 2023 Appendices Annual Report 2023 Appendix I - Key indicators WP Activity Indicator 1.1 Dossier preparation Inquiries received and concluded 1.2 Dossier submission and processing 1.3 Identification and prioritisation 1.3 Identification and prioritisation Number of SME companies verified for their status Number of substances registered above 100 t/y in the unassigned region of the chemical universe for which a conclusion on potential regulatory follow-up was drawn Number of groups of substances for which the assessment of regulatory needs is carried out 1.4 Evaluation Compliance checks concluded: draft decisions or no action 1.4 Evaluation 1.4 Evaluation 1.4 Evaluation Final decisions on dossier evaluation (testing proposals and compliance checks) Number of substances for which a conclusion was reached in the follow-up to dossier evaluation Substance evaluation final decisions issued 1.4 Evaluation Number of substances for which a conclusion was reached in substance evaluation 1.5 Authorisation Number of new entries in the Candidate List 1.5 Authorisation Number of RAC & SEAC opinions adopted on applications for authorisation (number of uses) 1.6 Restrictions Number of RAC & SEAC opinions on restriction proposals 1.6 Restrictions Restriction proposals or investigation/screening reports developed 1.7 Classification and Labelling Number of RAC opinions on proposals for harmonised classification and labelling 1.7 Classification and Labelling 1.7 Classification and Labelling 2. Biocides Decisions made on requests to use an alternative chemical name (CLP Article 24) Poison centre notifications (millions) received and made available to Appointed Bodies and Poison Centres Number of opinions on active substances [approval & renewal] 2. Biocides Number of opinions on Article 15, Article 38 and Article 75(1)(g) requests 2. Biocides 2. Biocides 2. Biocides Number of opinions on Union authorisation of biocidal products Number of opinions on Union authorisations subprocesses (same biocidal products, administrative and minor changes) Number of technical equivalence application assessments 3.1 PIC - prior informed consent Export notifications processed 4.2 EU Chemicals Legislation Finder Number of data updates on EUCLEF pieces of legislation 4.3 Support to occupational health legislatNiounmber of RAC opinions on OELs completed 5.2 Board of Appeal Appeals concluded under REACH 5.2 Board of Appeal Appeals concluded under BPR 5.4 ICT Average availability of key Systems 5.5 Financial resources Commitment rate 5.6 Human resources Percentage of Establishment Plan posts filled Estimate 2023 (PD) 4200 400 250 70 300 300 200 10 25 15 60 6 5 50 40 2 28 20 31 52 30 11200 4 6 12 2 >98% 95% 95% Actual 4835 416 156 61 301 367 202 6 26 8 58 5 8 42 26 4.4 13 7 10 21 32 10857 5 6 14 1 99.96% 99.20% 96.80% Progress 115% 104% 62% 87% 100% 122% 101% 60% 104% 53% 97% 83% 160% 84% 65% 220% 46% 35% 32% 40% 107% 97% 125% 100% 117% 50% 99.96% 99.20% 96.80% 73 74 Annual Report 2023 Appendix II - Budget implementation reports and statistics on financial management Budget overview The initially budgeted total payment appropriations for the Agency's expenditure in 2023, as concluded by the Management Board in December 2022, amounted to EUR 117.7 million. In addition the budget included c. EUR 0.8 million for the separately budgeted Other tasks ("Contribution Agreements and SLAs" in the table below), and the final total expenditure, concluded in the amending budget in September 2023, amounted to EUR 118.0 million. The budget for the Other tasks was increased by EUR 4.5 million. Revenue Total revenue Expenditure Commitment appropriations Payment appropriations Initial voted budget 117 724 442 Initial voted budget 117 756 974 117 724 442 Amending budgets 249 258 Amending budgets 265 505 249 258 Final voted budget 117 973 700 Final voted budget 118 022 479 117 973 700 Revenue The budget funding of ECHA in 2023 consisted of the following (amounts in EUR): Description Fees and charges from Registrations & Updates Initial voted Budget 2023 23 413 785 Budget Amendment s 2023 2 744 690 Final voted Budget 2023 26 158 475 Entitlements established 2023 26 680 580 Fees and charges from Authorisations 2 932 200 200 000 3 132 200 3 297 666 Fees SME Administration 814 500 (114 500) 700 000 817 549 Fees and charges from CLP 90 500 - 90 500 100 600 Fees and charges from Appeals - 26 309 26 309 33 484 Total REACH Fees & Charges Income Fees relating to Biocidal Active Substances 27 250 985 705 712 2 856 499 (452 579) 30 107 484 253 133 30 929 879 236 500 Fees for Union Authorisation of Biocidal products 1 430 884 (442 982) 987 902 922 200 Miscellaneous fees 2 494 878 (735 913) 1 758 965 1 631 700 Fees and charges from Appeals - - - 2 500 Total BPR Fee & Charges Income REACH EU Contribution 4 631 474 (1 631 474) 70 711 023 (3 900 000) 3 000 000 66 811 023 2 792 900 66 811 023 BPR EU Contribution 7 556 055 2 000 000 9 556 055 9 556 055 ENV EU Contribution 4 907 490 - 4 907 490 4 907 490 EFTA Contribution - REACH 2 003 016 - 2 003 016 2 003 016 EFTA Contribution - BPR 190 924 - 190 924 190 924 Confederation of Switzerland Contribution - BPR 333 222 49 233 382 455 382 455 EFTA Contribution - ENV 140 253 - 140 253 140 253 Total EU and other Contributions Contribution Agreement EUON 85 841 983 (1 850 767) 83 991 216 - 609 000 609 000 83 991 216 614 000 Contribution Agreement EUCLEF - 1 519 000 1 519 000 1 053 400 Contribution Agreement IPA - 641 348 641 348 641 348 Contribution Agreement OELs - 975 000 975 000 975 000 SLA with EFSA 784 712 777 380 1 562 092 1 562 092 Total Contribution Agreements and SLAs 784 712 4 521 728 5 306 440 4 845 840 Revenue received 2023 26 680 580 3 297 666 817 549 100 600 33 484 30 929 879 236 500 922 200 1 631 700 2 500 2 792 900 66 811 023 9 556 055 4 907 490 2 003 016 190 924.00 382 455.00 140 253 83 991 216 614 000 1 053 400 641 348 975 000 1 562 092 4 845 840 75 Annual Report 2023 Description Bank Interest Income Other income - miscellaneous Total Administrative Operations Income Total REACH/CLP Revenue Initial voted Budget 2023 - Budget Amendment s 2023 875 000 Final voted Budget 2023 875 000 - - - Entitlements established 2023 930 573 96 067 - 875 000 118 509 154 4 770 986 875 000 123 280 140 1 026 640 123 586 475 Revenue received 2023 930 573 128 475 1 059 048 123 618 883 A) REACH/CLP Fees and Charges ECHA is financed through fees paid by industry and by an EU balancing contribution, in accordance with the REACH Regulation (No 1907/2006). The fees and charges collected by ECHA are determined by the REACH Fee Regulation and by the decisions of the Management Board. Due to the one-off nature of REACH fees and their dependence on strategic decisions of the chemical industry players, there is high uncertainty as to their amount and timing. The budgetary revenue from REACH fees and charges in 2023, in terms of cash received, amounted to EUR 30.90 million (EUR 33.36 million in 2022). In addition, EUR 0.03 million (EUR 0.03 million in 2022) was recorded in relation to REACH appeal fees18 giving a total of fees and charges of EUR 30.93 million (EUR 33.40 million in 2022). Broken down by fee category, ECHA collected a total of EUR 26.68 million from REACH Registrations and Updates fees (EUR 29.72 million in 2022). Furthermore, the Agency collected in 2023 EUR 3.30 million from Applications for Authorisation (EUR 2.78 million in 2022) and EUR 0.10 million from CLP fees (EUR 0.07 million in 2022). The additional registration fee income that was generated through the SME company size verification process (which is included in the REACH registrations and updates income) amounted to EUR 0.52 million in 2023 (EUR 0.52 million in 2022). On top of the additional registration fees, the Agency generated EUR 0.82 million in administrative charges (EUR 0.79 million in 2022) levied on companies who were deemed non-eligible for the granted SME fee rebates. B) REACH/CLP Contributions from the General Budget of the EU During 2023, the Agency received an EU balancing contribution for REACH/CLP of EUR 66.81 million (EUR 64.22 million in 2022) and a European Free Trade Association (EFTA) contribution of EUR 2.00 million (EUR 1.61 million in 2022). BPR Revenue A) BPR Fees and Charges In accordance with the Biocidal Products Regulation (BPR, No 528/2012), ECHA is financed through fees paid by industry and a balancing EU contribution. The biocide fees and charges collected by ECHA are determined by the Biocidal Products Regulation, the Fees and Charges Regulation and by the decisions of the Management Board. The budgetary revenue from biocidal product fees and charges for 2023, in terms of cash received, amounted to EUR 2.79 million (EUR 6.76 million in 2022). The significant decrease in the collected BPR fee income relates primarily to the significantly reduced number of Union Authorisation applications, for single products and for product family, received in 2023 compared to 2022 (6 applications in 2023 vs. 42 applications in 2022). 18 Income from appeal fees is recognised by ECHA only when a case has been decided and the Board of Appeal rules that the fee should not be refunded to the applicant. 76 Annual Report 2023 B) BPR Contributions from the General Budget of the EU During 2023, the Agency received an EU balancing contribution of EUR 9.56 million (EUR 7.10 million in 2022) and an EFTA contribution of EUR 0.19 million (EUR 0.20 million in 2022). In addition, the Agency received a contribution from the Confederation of Switzerland of EUR 0.38 million (EUR 0.31 million in 2022). Environmental directives and international conventions Revenue In accordance with the Prior Informed Consent (PIC) Regulation (EU) No 649/2012, Persistent Organic Pollutants (POPs) Regulation (EU)2019/2021, Waste Framework Directive (SCIP) (EU) 2018/851 amending Directive 2008/98/EC, the revised Drinking Water Directive (DWD) Directive (EU) 2020/2184, and the 8th Environmental Action Programme (8th EAP), ECHA is fully financed through an EU contribution for these activities. In 2023, the EU contribution amounted to EUR 1.22 million for PIC (EUR 1.16 million in 2022), EUR 0.29 million for POPs (EUR 0.20 million in 2022), EUR 1.34 million for SCIP (EUR 1.49 million in 2022), EUR 1.72 million for DWD (EUR 1.52 million in 2022), and EUR 0.33 million for 8th EAP (EUR 0.33 million in 2022), totalling EUR 4.91 million (EUR 4.73 million in 2022). Furthermore, in 2023, the Agency received an EFTA contribution of EUR 0.14 million (EUR 0.12 million in 2022) in total for the above tasks. Contribution Agreements and Service Level Agreements The Agency has signed contribution agreements with the European Commission to implement the European Union Observatory for Nanomaterials (EUON) and the European Union Chemicals Legislation Finder (EUCLEF), as well as for work with respect to the Instrument for Pre-Accession Assistance (IPA). ECHA has also signed a Service Level Agreement with the European Commission to provide opinions for occupational exposure limits (OELs). Additionally, the Agency has signed a Service Level Agreement with the European Food Safety Authority (EFSA) for developing and implementing IUCLID software solutions for plant protection products. In 2023, ECHA received an amount of EUR 4.85 million in aggregate for implementing these tasks (EUR 4.54 million in 2022). Other miscellaneous income from Administrative operations The table below shows the other miscellaneous income received by the Agency in 2023 (amounts in EUR). Description Bank Interest income Legal recoveries Late interest income Recoveries from other EU agencies Other recoveries Other income - miscellaneous Total Administrative Operations Income Entitlements established 2023 930 573 65 918 11 299 28 728 1 662 96 067 1 026 640 Revenue received 2023 930 573 32 489 11 299 28 728 1 662 128 475 1 059 048 Fee Invoicing (other information in accordance with Article 71 of FR) In accordance with Article 71 of the Agency's Financial Regulation, the number of debit notes issued and their global amount shall be provided in the Agency's report on budgetary and 77 Annual Report 2023 financial management. In addition, where fees and charges are entirely determined by legislation or decisions of the Management Board, the Authorising Officer may abstain from issuing recovery orders and directly draw up debit notes, after having established the amount receivable. Where the Agency uses a separate invoicing system, the Accounting Officer shall regularly, and at least on a monthly basis, enter the accumulated sum of fees and charges received into the accounts. The Agency uses a separate invoicing and debtors' system for daily transactions related to fee income, namely the REACH IT (REACH/CLP fees and charges) and REACH-NG (Biocidal Products fees and charges) invoicing modules. The invoices raised and the payments received are recorded in the central accounting system on a monthly basis. A) REACH Fees and Charges The total net invoiced by the Agency in 2023 amounted to EUR 31.01 million (EUR 33.02 million in 2022 and EUR 26.63 million in 2021). The table below depicts the breakdown of the net invoiced REACH fees during the years 2021-2023. REACH Description Invoices issued Credit Notes Unpaid Considered paid Net Invoiced Write offs 2023 No of Invoices 5 743 131 136 14 EUR 33 510 775 (1 790 613) (710 941) (259) 31 008 962 5 (87 682) 2022 No of Invoices 6 579 494 111 17 EUR 35 011 416 (1 628 744) (364 332) (842) 33 017 498 13 (238 488) 2021 No of Invoices 6 588 215 118 29 EUR 28 295 673 (1 161 459) (505 526) (488) 26 628 200 29 (458 573) On 31 December 2023, the amount to be recovered for REACH fees and charges, before any year-end accounting adjustments, stood at EUR 2.05 million relating to 266 open invoices (on 31 December 2022, the amount to be recovered for REACH fees and charges, before any year end accounting adjustment, stood at EUR 1.95 million relating to 290 open invoices). B) Biocidal Products Fees and Charges The total net invoiced by the Agency in 2023 amounted to EUR 2.88 million (EUR 6.80 million in 2022 and EUR 3.00 million in 2021). The table below depicts the breakdown of the net invoiced BPR fees during the year. BPR Description Invoices issued Credit Notes Unpaid Considered paid Net Invoiced 2023 No of Invoices 608 51 14 - EUR 3 618 500 (589 500) (149 500) - 2 879 500 2022 No of Invoices 1 201 103 37 3 EUR 8 232 100 (1 347 000) (81 400) (95) 6 803 605 2021 No of Invoices 730 39 14 2 EUR 3 383 700 (363 700) (13 700) (110) 3 006 190 On 31 December 2023, the amount to be recovered for Biocidal product fees and charges before any year end accounting adjustments, stood at EUR 0.18 million relating to 24 open invoices (on 31 December 2022, the amount to be recovered for BPR fees and charges, before any year end accounting adjustment, stood at EUR 0.10 million relating to 18 open invoices). Expenditure ECHA's expenditure budget consists of commitment appropriations (CA) and payment appropriations (PA). The initial CAs totalled EUR 117.8 million and the initial PAs totalled EUR 78 Annual Report 2023 117.7 million, while the figure concluded in the final budget is EUR 118.0 million for CAs and EUR 118.0 million for PAs. These commitment and payment appropriations consist of C1 funds. Budget expenditure includes payments made during the year and the carry-over of budgetary appropriations. The following paragraphs and the tables provided in the Statistics on Financial Management and Budget (Expenditure) summarise the execution of appropriations per title while a more detailed breakdown is provided in Appendix I. Changes and implementation of the commitment appropriations for the current year (C1) The initially adopted budget for the Agency in 2023 was EUR 117.7 million and the overall net increase during the year, including 22 transfers and three amending budgets, was EUR 0.3 million, to arrive at EUR 118.0 million as the final budget. The main reason for the increase in the budget was the positive fee income development, which allowed, for instance, accelerating some IT investments. The final executed amount totalled EUR 117.2 million corresponding to an execution rate of 99.3 % for the appropriations. Carry over of appropriations to 2024 The commitment and payment appropriations carried over to 2024 totals EUR 14.4 million, corresponding to 12.0 % of the committed amount. The carry-over of staff related expenditure, budgeted in Title 1, was insignificant and mainly relates to the commitments for training and interim services. In Title 2, covering the Agency's infrastructure, the carry-over totalled EUR 2.6 million, stemming mainly from commitments related to ECHA's IT services. The operational expenditure required to implement the Work Programme for the different regulations is budgeted in Title 3 for REACH and CLP, in Title 4 for Biocides, and in Title 5 for the Environmental Directives and International Conventions (PIC, POPs, Waste Framework Directive (SCIP), Drinking Water Directive and the 8th Environmental Action Programme). The carry-over in operational titles totalled EUR 11.5 million and is mostly related to IT development projects. The relatively high level of carry-overs stems from the contracting cycle caused largely by the uncertainty in the fee income. In the past years, ECHA has had to wait late in the year before signing the contracts to make sure sufficient funds will be available, and at the same time, has had to sometimes frontload certain projects when the income has exceeded the estimates. This had led to a situation where, during the first part of the year, the focus has been on implementing the projects carried over and new projects are only commenced during the second half and sometimes even during the last quarter of the year. Implementation of the appropriations carried over from 2022 (C8) The amount carried over from 2022 totalled EUR 15.6 million and the finally executed amount was EUR 15.4 million, corresponding to 99 %. The cancelled 1 % relates mostly to IT projects in Title 2 and lower than anticipated costs for legal services related to debt collection of administrative charges. Late interest payments During the year 2023, ECHA did not pay late interest for commercial invoices. 79 Annual Report 2023 Procurement procedures During 2023 budget implementation, ECHA signed 337 contracts and purchase orders19. Out of the 337 signed contracts, 276 were specific contracts and orders under framework contracts (FWC) and 61 were contracts resulting from tendering procedures. Out of the 61 contracts resulting from procurement, ECHA concluded four new FWCs: for managed IT workplace services, for consultancy on IT User Experience, for New Approach Methodologies (NAMS), and for the EU Chemicals Legislation Finder (EUCLEF) and led the procurement to establish two interagency FWCs for standard management certification services and for interim services to be signed in early 2024. ECHA also signed three multiannual contracts: for security and reception services, for cleaning services, and for the Cloudia e-procurement platform. ECHA also joined seven inter-institutional FWCs: for event management and related communication services (DG RTD), for audits and controls (DG BUDG), for leadership and management skills (EPSO), for learning and development (DG HR), for attracting and sourcing of candidates (EMA), for HR consultancy services (DG HR) and for Microsoft high-level services (DIGIT), and two DPS of DIGIT for Software (SIDE III) and Telecommunication Services. A total of 11 contracts were signed following negotiated procedures without prior publication based on the relevant rules of the Financial Regulation (Annex 1-11.1), eight of which refer to legal services; and three for technical reasons for subscriptions to a scientific database and professional journals, as well as for specialised software. Furthermore, there were two IT FWC ceiling increases that had been foreseen in the specifications of the original procurement procedure. In 2023, the performance of the suppliers of the Agency was satisfactory overall and in accordance with the terms of the contracts, with very few exceptions, which were successfully addressed by ECHA. Preliminary market consultation in the form of questionnaires to be filled in by potential tenderers continues being an established practice in ECHA before launching procurement. Green Public Procurement (GPP) remains a priority and an integral part of the Agency's management system. ECHA continued relying on and adopting suitable IT tools (e.g., Cloudia, PPMT) in its procurement and contract processes, and undertook the revision work of its overall and sectoral procurement strategy, which included participating in a 4-month specialised training delivered by the KEINO Academy of the central purchasing body (Hansel) in Finland. The annual list of contractors is published by ECHA by 30 June of each year for the previous year on ECHA's website 20. Acts of delegation and sub delegation For the purposes of the budget implementation, and in line with Article 41(1) of ECHA's Financial Regulation, the Executive Director as the Authorising Officer of the Agency has delegated financial powers to the directors for the budget lines which they are responsible for, in line with their activities. In accordance with Article 41(2) of ECHA's Financial Regulation, the directors have further subdelegated financial powers to the heads of unit of their directorates. For efficiency reasons, the Executive Director has also delegated financial powers to authorise payments below EUR 8 000 to staff in the Finance Unit. 19 This number also includes amendments with budgetary commitment. 20 https://echa.europa.eu/view-article/-/journal_content/title/annual-list-of-awarded-contracts 80 Annual Report 2023 Statistics on Financial Management and Budget (Expenditure) Budget 2023: Breakdown and changes in commitment appropriations and implementation of the appropriations for the current year (C1) per Title21 (EUR) Title Description Budget 2023 (1) Transfers / amendments (2) Final Available Commitment Appropriations (3) Executed Commitment Amount (4) % Committed (4)/(3) Final Available Payment Appropriations (5) Executed Payment Amount (6) % Paid (6)/(5) Carried over RAL (C8) (7) Carried over % (7)/(4) Cancelled (3)-(4) A-1 A-2 B0-3 STAFF 79 708 220 BUILDING. EQUIPMENT AND MISCELL OPER 17 067 482 EXPEND OPERATIONAL EXPENDITURE - REACH/CLP 16 645 769 145 217 -62 455 -264 219 79 853 437 17 005 027 16 381 550 79 574 605 16 970 489 15 964 264 99.7% 99.8% 97.5% 79 853 437 17 005 027 16 332 771 79 278 523 14 363 906 7 308 895 99.3% 84.5% 44.7% 296 082 2 606 583 8 607 206 0.4% 15.4% 53.9% 278 832 34 538 417 286 B0-4 B0-5 OPERATIONAL EXPENDITURE - BIOCIDES 1 898 690 OPERATIONAL EXPENDITURE ENVIRONMENTAL DIRECTIVES INTERNATIONAL CONVENTIONS AND 2 436 813 117 756 974 440 346 6 616 265 505 2 339 036 2 443 429 118 022 479 2 245 984 2 420 319 117 175 661 96.0% 99.1% 99.3% 2 339 036 2 443 429 117 973 700 976 720 41.8% 831 865 34.0% 102 759 909 87.1% 1 269 264 1 588 454 14 367 589 56.5% 65.6% 12.3% 93 052 23 110 846 818 21 Note: As ECHA operates with both differentiated (multi-annual) and non-differentiated (annual) budget lines, the funds reserved for commitments (commitment appropriations) do not equal the funds reserved for payments (payment appropriations). The results for the administrative titles 1 and 2 are combined for all three regulations. 81 Annual Report 2023 Budget 2023: Breakdown and changes in commitment appropriations and implementation of the appropriations for the current year (C1) per Regulation and Title (EUR) REACH/CLP Title A-1 A-2 B0-3 Description STAFF BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND OPERATIONAL EXPENDITURE REACH/CLP Budget 2023 (1) Transfers / amendments (2) Final Available Commitment Appropriations (3) Executed Commitment Amount (4) % Committed (4)/(3) Final Available Payment Appropriations (5) 68 878 569 -28 350 68 850 219 68 656 483 99.7% 68 850 219 14 473 218 -54 685 14 418 533 14 389 257 99.8% 14 418 533 16 645 769 -264 219 16 381 550 15 964 264 97.5% 16 332 771 99 997 556 -347 254 99 650 302 99 010 004 99.4% 99 601 523 Executed Payment Amount (6) % Paid (6)/(5) 68 405 623 99.4% 12 178 875 84.5% 7 308 895 44.7% 87 893 392 88.2% Carried over RAL (C8) (7) 250 860 2 210 382 8 607 206 11 068 448 Carried over % (7)/(4) Cancelled (3)-(4) 0.4% 193 736 15.4% 29 276 53.9% 417 286 11.2% 640 298 BIOCIDES Title Description A-1 A-2 B0-4 STAFF BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND OPERATIONAL EXPENDITURE BIOCIDES Budget 2023 (1) 8 833 154 Transfers / amendments (2) 93 345 Final Available Commitment Appropriations (3) 8 926 499 Executed Commitment Amount (4) 8 868 065 % Committed (4)/(3) 99.3% 1 979 831 -5 932 1 973 899 1 969 887 99.8% 1 898 690 12 711 675 440 346 527 759 2 339 036 13 239 434 2 245 984 13 083 937 96.0% 98.8% Final Available Payment Appropriations (5) 8 926 499 1 973 899 2 339 036 13 239 434 Executed Payment Amount (6) % Paid (6)/(5) 8 837 326 99.0% 1 667 524 84.5% 976 720 41.8% 11 481 570 86.7% Carried over RAL (C8) (7) Carried over % (7)/(4) 30 739 0.3% 302 364 15.3% 1 269 264 1 602 367 56.5% 12.2% Cancelled (3)-(4) 58 434 4 012 93 052 155 497 ENVIRONMENTAL DIRECTIVES AND INTERNATIONAL CONVENTIONS Final Budget Transfers / Available Title Description 2023 amendments Commitment (1) (2) Appropriations (3) A-1 STAFF 1 996 497 80 222 2 076 719 A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND 614 433 -1 838 612 595 Executed Commitment Amount (4) 2 050 056 611 344 % Committed (4)/(3) 98.7% 99.8% Final Available Payment Appropriations (5) 2 076 719 612 595 Executed Payment Amount (6) % Paid (6)/(5) 2 035 573 98.0% 517 507 84.5% Carried over RAL (C8) (7) Carried over % (7)/(4) 14 483 0.7% 93 837 15.3% Cancelled (3)-(4) 26 663 1 251 82 Annual Report 2023 B0-5 OPERATIONAL EXPENDITURE ENVIRONMENTAL DIRECTIVES AND INTERNATIONAL CONVENTIONS 2 436 813 6 616 2 443 429 2 420 319 99.1% 2 443 429 831 865 34.0% 5 047 743 85 000 5 132 743 5 081 720 99.0% 5 132 743 3 384 946 65.9% Budget 2023: Implementation of differentiated appropriations (EUR) 1 588 454 65.6% 1 696 774 33.4% 23 110 51 023 B3-111 B3-801 Total Budget line Substance evaluation and Rapporteurs (Multiannual) Cooperation with international organisations for IT programs Available commitment appropriations 910 363 610 000 1 520 363 Commitments made 909 694 609 982 1 519 676 % 99.93% c.100% c.100% Available payment appropriations 771 664 699 920 1 471 584 Payments made 771 618 699 894 1 471 512 % 99.99% c.100% c.100% Out of the total available commitment appropriations of EUR 2 672 838, the amount of EUR 1 152 475 is stemming from commitments made in earlier financial years. The available commitment appropriations for 2023 totalled EUR 1 520 363 out of which EUR 1 519 676 (c.100%) were committed. Budget 2023: Implementation of assigned revenue (C4, C5, R0) (EUR) Title Description A-1 A-2 B0-3 B0-4 B0-5 STAFF BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND OPERATIONAL EXPENDITURE - REACH/CLP OPERATIONAL EXPENDITURE - BIOCIDES OPERATIONAL EXPENDITURE - ENV Title Description FS Commitments Commitments Com % Payments Appropriations Established Appropriations C4 59 171 38 827 66% C4 6 176 0 0% C4 32 839 3 362 10% C4 606 453 75% C4 159 159 100% C4 98 951 42 801 43% 59 171 6 176 32 839 606 159 98 951 FS Commitments Commitments Com Appropriations Established % Payments Appropriations Payments Executed 38 827 Pay% 66% Carried over commitment appropriations 20 345 0 0% 6 176 1 939 6% 29 477 261 43% 153 92 41 119 58% 42% 0 56 150 Payments Executed Pay% Carried over commitment appropriations Carried over payment appropriations 20 345 6 176 30 900 345 67 57 832 Carried over payment appropriations 83 Annual Report 2023 A-1 A-2 B0-3 B0-4 BL B6-000 B6-010 B6-011 B6-020 B6-021 STAFF C5 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND C5 OPERATIONAL EXPENDITURE - REACH/CLP C5 OPERATIONAL EXPENDITURE - BIOCIDES C5 C5 28 728 11 299 33 043 852 73 922 28 728 100% 11 299 100% 21 384 65% 852 100% 62 263 84% 28 728 11 299 33 043 852 73 922 Description IPA programme EUON EUCLEF Occupational exposure limits Further development of IUCLID (w/ third parties) FS Commitments Commitments Com Appropriations Established % Payments Appropriations R0 644 465 189 377 29% R0 1 544 900 855 341 55% R0 3 338 602 1 532 088 46% R0 1 591 105 1 030 206 65% R0 2 517 055 2 114 362 84% R0 9 636 128 5 721 375 59% 644 465 1 544 900 3 338 602 1 591 105 2 517 055 9 636 128 28 728 100% 0 0 11 299 100% 0 0 19 769 60% 0 1 615 852 100% 60 648 82% 0 0 0 1 615 Payments Executed Pay% 171 977 27% Carried over commitment appropriations 455 088 Carried over payment appropriations 472 488 648 055 42% 689 559 896 844 1 012 758 30% 1 806 514 2 325 845 889 623 56% 560 899 701 483 1 748 316 69% 402 693 768 739 4 470 729 46% 3 914 753 5 165 399 Budget 2023: Implementation of the appropriations carried forward from previous year (C8) Per Title (EUR) Title A-1 A-2 B0-3 B0-4 B0-5 Description STAFF BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND OPERATIONAL EXPENDITURE - REACH/CLP OPERATIONAL EXPENDITURE - BIOCIDES OPERATIONAL EXPENDITURE - ENVIRONMENTAL DIRECTIVES AND INTERNATIONAL CONVENTIONS Carried Forward from 2022 196 707 1 761 736 10 147 612 1 929 864 1 519 288 15 555 208 Paid 192 366 1 723 707 10 040 092 1 922 169 1 513 877 15 392 209 Cancelled 4 342 38 029 107 521 7 696 5 411 162 999 % Cancelled 2% 2% 1% 0% 0% 1% 84 Annual Report 2023 Appendix III - Organisational chart 85 Annual Report 2023 Appendix IV - Establishment plan and additional information on human resources management Last establishment plan adopted Category and grade AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5 Total AD AST 11 AST 10 AST 9 AST 8 AST 7 AST 6 AST 5 AST 4 AST 3 AST 2 AST 1 Total AST AST/SC 6 AST/SC 5 AST/SC 4 AST/SC 3 AST/SC 2 AST/SC 1 TOTAL AD+AST Establishment plan in voted EU Budget 2023 REACH/ CLP 6 13 12 30 41 60 52 53 27 16 TA Biocides 1 2 1 5 10 9 9 5 1 ENV 1 1 3 TOTAL 0 6 14 14 31 46 71 61 63 35 17 310 43 5 358 0 0 3 3 8 8 10 1 2 13 18 1 19 26 3 2 31 16 3 2 21 10 1 11 3 3 0 94 9 6 109 0 0 0 0 0 0 404 52 11 467 Posts filled 31 December 2023* REACH/ CLP 2 4 9 18 42 41 64 44 47 27 TA Biocides ENV 1 5 7 1 7 7 1 9 6 3 TOTAL 0 2 4 10 18 47 49 71 52 56 36 298 42 5 345 0 0 0 5 5 12 12 16 1 17 22 2 1 25 8 2 3 13 11 3 14 18 1 2 21 0 92 9 6 107 0 0 0 0 0 0 390 51 11 452 CA FG IV CA FG III CA FG II CA FG I CA estimated need of FTEs 2023 REACH/ CLP Biocides ENV Other tasks 27 7 8 13 53 6 2 1 17 2 0 0.5 TOTAL 55 62 19.5 0 CA posts filled 31 December 202322 REACH/ CLP Biocides ENV Other tasks TOTAL 20 5 6 10 41 59 6 4 4 73 16 2 18 0 22 Under external recruitment (included in figures): REACH: 2 TAs and 2 CAs; BIOCIDES: 1CA Annual Report 2023 TOTAL 97 15 10 14.5 136.5 95 86 13 10 14 132 TA posts CA posts Percentage of posts filled on 31 December 2023 REACH/ CLP 96.53% 97.94% Biocides 98.08% 86.67% ENV 100.00% 100.00% Geographical and gender balance (as per 31 December 2023)23 Nationality Male TA Female Total Male CA Female Total 1 AT Austrian 2 2 BE Belgian 12 3 BG Bulgarian 1 4 CY Cypriot 0 5 CZ Czech 0 6 DE German 16 7 DK Danish 1 8 EE Estonian 0 9 ES Spanish 16 10 FI Finnish 59 11 FR French 20 12 GR Greek 14 13 HR Croatian 0 14 HU Hungarian 2 15 IE Irish 10 16 IS Iceland 0 17 IT Italian 25 18 LI Liechtenstein 1 19 LT Lithuanian 1 20 LU Luxembourger 0 21 LV Latvian 1 22 MT Maltese 0 23 NL Dutch 9 24 NO Norwegian 0 25 PL Polish 8 26 PT Portuguese 5 27 RO Romanian 2 28 SE Swedish 3 29 SI Slovenian 3 30 SK Slovakian 1 31 Other Other 0 TOTAL 212 4 10 9 0 3 9 1 6 12 85 15 6 0 6 7 0 18 0 6 0 5 3 5 1 9 7 5 1 3 2 0 238 6 0 22 2 10 3 0 1 3 1 25 1 2 0 6 1 28 6 144 15 35 2 20 6 0 0 8 0 17 0 0 0 43 5 1 0 7 0 0 0 6 1 3 0 14 2 1 0 17 1 12 0 7 3 4 1 6 1 3 0 0 0 450 52 0 0 1 3 4 7 0 1 0 1 0 1 0 0 0 1 5 11 30 45 6 8 6 12 1 1 4 4 1 1 0 0 2 7 0 0 0 0 0 0 1 2 0 0 1 3 0 0 3 4 2 2 7 10 0 1 1 2 2 2 0 0 77 129 OVERALL Sum 6 25 17 1 4 26 2 7 39 189 43 32 1 12 18 0 50 1 7 0 8 3 17 1 21 14 17 5 8 5 0 579 % 1.0% 4.3% 2.9% 0.2% 0.8% 4.5% 0.4% 1.2% 6.7% 32.6% 7.4% 5.5% 0.2% 2.1% 3.1% 0.0% 8.6% 0.2% 1.2% 0.0% 1.4% 0.5% 2.9% 0.2% 3.6% 2.4% 2.9% 0.9% 1.4% 0.9% 0.0% 100.0% 23 Data in the table includes statutory staff in place on the indicated date. Posts under recruitment are not included. 87 Annual Report 2023 Middle and senior management - gender and nationality overview24 BE DE ES FI FR GR IE IT NL MT PT RO SE SI Total NATIONALITY Belgian German Spanish Finnish French Greek Irish Italian Dutch Maltese Portuguese Romanian Swedish Slovenian OVERALL MALE 2 2 2 3 3 1 4 2 2 0 1 0 1 1 24 FEMALE 0 0 1 4 0 0 2 0 0 1 0 1 0 0 9 TOTAL 2 2 3 7 3 1 6 2 2 1 1 1 1 1 33 % 6.1% 6.1% 9.1% 21.2% 9.1% 3.0% 18.2% 6.1% 6.1% 3.0% 3.0% 3.0% 3.0% 3.0% 100% Results of the screening / benchmarking exercise Key functions Core functions Executive Director Deputy Executive Director Type of contract (official, TA or CA) Function group, grade of recruitment (or bottom of grade bracket if published with such bracket) TA - 5+5 years TA - 5+5 years + indefinite AD 14 AD 14 Indication whether the function is dedicated to administrative support or operations subject to definitions used in screening methodology Management-Operations Management-Operations Director (Head of Directorate) (Level 2) TA - 5+5 years + indefinite AD 12 Management-Operations Head of Unit (Level 3) TA - 5+5 years + indefinite AD 9 Operations/Administration Administrator TA - 5+5 years + indefinite AD 5 and higher depending on Operations/Administration 24 Data in the table includes statutory staff in place on the indicated date. Posts under recruitment are not included. 88 Annual Report 2023 Key functions Administration Head of Administration (Head of Directorate) (Level 2) Type of contract (official, TA or CA) Function group, grade of recruitment (or bottom of grade bracket if published with such bprarocfkileet) Indication whether the function is dedicated to administrative support or operations subject to definitions used in screening methodology TA - 5+5 years + indefinite AD 12 ManagementAdministration Head of Human Resources (Level 3) TA - 5+5 years + indefinite AD 9 Administration Head of Finance (Level 3) TA - 5+5 years + indefinite AD 9 Administration Head of Communications (Level 3) Head of IT (Level 3) TA - 5+5 years + indefinite TA - 5+5 years + indefinite AD 9 AD 9 Administration Administration Assistant Special functions ECHA Committee or Board of Appeal Chair TA - 5+5 years + indefinite TA - 5+5 years + indefinite AST 1 and higher depending on profile, up to AST 4 AD 10 Operations/Administration Operations Data Protection Officer TA - 5+5 years + indefinite AD 6 Administration Accounting Officer TA - 5+5 years + indefinite AD 8 Administration Internal Auditor TA - 5+5 AD 10 Administration Annual Report 2023 Key functions 89 Type of contract (official, TA or CA) years + indefinite Function group, grade of recruitment (or bottom of grade bracket if published with such bracket) Indication whether the function is dedicated to administrative support or operations subject to definitions used in screening methodology Benchmarking against previous results ECHA undertook the benchmarking (job screening) exercise in 2023, in accordance with the Commission's requirements. The 2023 results indicate an increase of 0.3% in the percentage of administrative support and coordination staff, an increase of 0.2% in the percentage of the operational staff and a decrease of 0.5% in the percentage of neutral staff in comparison to 2022. Job Type (sub) category Administrative support and Coordination Administrative Support Coordination Operational Top level Operational Coordination Programme management and Implementation Evaluation & Impact assessment General operational Neutral Finance/ Control Linguistics 2022 14.5 11.7 2.8 81.4 2.6 57 3.4 18.6 4.1 4.0 0.1 2023 14.8 12.1 2.8 81.6 2.5 56.1 3.2 19.8 3.6 3.6 0.0 90 Annual Report 2023 Appendix V - Human and financial resources by activity WP activity 1.1 Dossier preparation 1.2 Dossier submission and processing 1.3 Identification and prioritisation 1.4 Evaluation 1.5 Authorisation 1.6 Restrictions 1.7 Classification and labelling 1.8 Safe and sustainable use of chemicals 1.9 Data management and dissemination 1.10 Promotion of alternatives to animal testing 2. Biocides 3.1 Prior Informed Consent 3.2 Persistent organic pollutants 3.3 Waste Framework Directive 3.4 Drinking Water Directive 3.5 8th Environmental Action Programme 4.1 EU Observatory for Nanomaterials 4.2 EU Chemicals Legislation Finder 4.3 Support to Occupational health legislation 4.4 Instrument for Pre-Accession assistance (IPA) 4.5 Support to other legislation 4.6 IUCLID for EFSA 4.7 Partnership for the Assessment of Risk from Chemicals Governance and enablers Overall TOTAL Actual consumption of the human resources 29 34 55 91 26 29 33 1 23 6 56 7 1 4 7 1 3 1 6 1 1 4 2 169 590 Executed budget 2023 7 595 644 8 375 567 12 739 439 16 617 743 5 549 010 6 137 817 6 399 609 202 710 6 800 546 2 454 907 10 213 821 1 598 449 218 104 968 043 1 263 755 313 731 855 341 1 532 088 1 030 206 189 377 2 114 362 29 726 767 122 897 036 91 Annual Report 2023 Appendix VI - Contribution, grant and service-level agreements Actual or expected date of signature Grant agreements 1. IPA 20.12.2022 General information Total amount Duration Counterpart 675 103 42 months Commission DG NEAR Contribution agreements 1. EUCLEF 10.12.2021 5 829 200 5 years (20212025) Commission DG GROW 2. EUON 09.12.2021 3 066 000 5 years (20212025) Commission DG GROW Service-level agreements 1. IUCLID Annual fee of for 26.03.2021 784 712 plus N/A EFSA project cost EFSA 2. OEL 23.02.2022 195 000 per opinion 18-24 months per case Commission DG EMPL Total service-level agreements TOTAL (contribution agreements and SLAs) Short description Financial and HR impacts 2022 2023 Amount Number of 1 1.5 CA Number of - - SNEs Amount Number of CA 1 1.5 Number - - of SNEs Amount Number of 0 0 CA Number of - - SNEs Amount Number of 3 3 CA Number of - - SNEs Amount Number 3 3 of CA Number - - of SNEs Amount Number of 4 4 CA Number of - - SNEs Amount Number of 4 4 CA Number of - - SNEs Amount Number 8 8 of CA Number - - of SNEs Amount Number of CA 12 12.5 Number - - of SNEs 92 Annual Report 2023 Annex VII - Environment management Context of the Agency and its environmental management strategy ECHA implements the EU's chemicals legislation to protect health and the environment. Our work also contributes to a well-functioning internal market, innovation and the competitiveness of Europe's chemicals industry. Through ECHA's work, better knowledge and regulation of harmful chemicals helps to protect workers, consumers and the environment, makes recycling easier, and encourages industry to develop safer alternatives. ECHA has an environmental policy which commits ECHA to continually improve its environmental performance, and ECHA has pledged to be climate-neutral by 2030. Overview of the Agency's environmental management system ECHA has put in place a quality and environmental management system, aligned to its strategy, which commits to incorporating sustainability measures within the internal follow-up of actions and reporting. To achieve climate neutrality, ECHA has set objectives, targets and actions which are described its environmental work programme which was renewed in 2023 to cover the period up to 2025. In 2023, ECHA was recertified under ISO 14001:2015 standard (Environmental Management System) and ECHA's 2022 Environmental Statement was successfully registered under EMAS. Environmental aspects, indicators and targets 93 Annual Report 2023 94 Annual Report 2023 Actions to improve and communicate environmental performance In support of the ISO 14001:2015 environmental re-certification and EMAS registration, which includes additional planning and reporting on ECHA's environmental performance, the Agency has established a dedicated team for Environmental Compliance and Sustainability whose role is to facilitate the implementation the actions identified in ECHA's Environmental Work Programme. 2023 was the first year of ECHA's updated multi-annual Environmental Work Programme (20232025) which maintained the previous objectives and introduced new actions and targets. In 2023 ECHA: - reduced CO2 emissions from travel (staff missions) - strengthened environmental and sustainability standards into ECHA procurement (including the canteen services). - adapted the programming in building management systems and improving automation of technology. - promoted over 30 staff information campaigns and environmental initiatives at local, national, EU and international levels of interest. - reduced waste volume and the amount of landfill waste by leasing ICT equipment with sustainability requirements in the contract and recycling used equipment (mobile phones for Ukraine). - reviewed the scope of ECHA's CO2 footprint to ensure a comprehensive overview and to avoid gaps and reputational damage which will be included in future environmental reports. - took preparatory actions to implement a pilot project on carbon capture to begin CO2 offsetting under the forthcoming EU carbon certification Regulation. - developed and implemented an Internal Audit Methodology for its Environmental Management System in cooperation with the European Environment Agency. EUROPEAN CHEMICALS AGENCY P.O. BOX 400, FI-00121 HELSINKI, FINLAND ECHA.EUROPA.EU