Document om9Y3n8Qkkk22nZrZyJZkRvJo

GUIDE FOR REPLYING TO THE PUBLIC CONSULTATION -- Restriction on the manufacture, placing on the market and use of PFAS -- There is a legislative proposal in the EU to restrict the whole group of PFAS in all, but a few derogated uses. The final regulation will be shaped by the input given by stakeholders in a public consultation with the deadline 25 September 2023. In this document, you will find the information you need to provide your input to the consultation. This is an important opportunity to influence the details on the restriction. It is especially important to provide input on the availability of alternatives, as this will determine the specificity and timeline of the derogations. It is also important for the decision makers to understand that there is a support for the regulation amongst companies that have already, or have the ambition to move away from PFAS. HOW TO PROVIDE INPUT Important links Restriction proposal with annexes Q&A on the proposal ECHA guidance on how to respond to the consultation The public consultation The different parts of the consultation 1. Personal information. 2. Organisational information. 3. Non-confidential comments on the proposal. Your responses can be entered directly into the form or through section 4 as an attachment. General comments can be on any aspect of the Annex XV restriction report, including issues related to socio-economic analysis. 4. Non-confidential attachments can be added here. 5. Confidential attachments can be added here. Confidential information will only be available to the ECHA Secretariat, the Committees and Member State Competent Authorities. General requirements The information must be provided through the web-based form and on time Any information needs to be supported by evidence Specify the sectors and uses to which your comment applies When providing information on the availability of alternatives, also provide information on how long it would take to transition to the alternatives, with clear steps and timelines. When providing information on viability of alternatives, for example, alternatives employed within your organization, include information on which uses and functions that the alternatives could replace, and also information on cost, performance and time period that the alternative has been used. WHAT INFORMATION TO PROVIDE In order to provide information to the consultation and also to prepare for the upcoming restriction, you will need to find out: Have you substituted PFAS already? Can you provide information on alternatives?  Are any of the proposed derogations relevant to you? Do you have information on alternatives for these? Which of your products contain PFAS and will be affected by the restriction? Examples of information of interest that companies may have Process and timeline for substitution of PFAS - what has been done and what is needed to comply with the restriction Technical performance and quality management requirements for the use/products Availability of alternatives for the use/sector Customers' feedback on alternatives Cost aspects of switching to alternatives Uses covered by the restriction The consultation seeks to bring more information on the less investigated uses but also assuring all information is covered for the more investigated ones. The uses that have been investigated for the proposal and to what level they have been investigated is illustrated in the below table, which can be found in Annex A. What information is requested Further information on alternatives for the researched uses (blue and green in the table) For "missing uses"- some uses have not been covered in detail and some might be missing from the report (orange or missing). For these, information is asked for regarding: Functionality of the PFAS Availability of alternatives, costs, functionality and time aspects on substituting PFAS Tonnages and emissions Proposed derogations The derogations are described first in the table from page 4 and forwards in the main restriction report, and also at the end of this document as Annex A. For these, information is asked for regarding: Further information on alternatives Used tonnages and emissions of PFAS from this use Details on questions in the consultation For a list of the questions included in the consultation, as well as a short description of what information that can be submitted to each question, see Annex B of this document. Stakeholders guidance to relevant questions and important information to submit Below is a list of different stakeholders and the questions in the consultation that are most relevant to submit information to. 1. For all stakeholders - necessary information to provide a. Section I and II - general information, personal and organizational 2. Alternative providers a. Most relevant questions i. Section III part I - for providing general comment - indicate in the check boxes which sectors/uses are covered in the submitted comment ii. Section III - Questions 1, 6, 7, and 8 b. Most important pieces of information to submit i. Information on alternatives including functionality, performance, cost, and viability (examples of use cases etc) 3. Users of alternatives - such as brands and retailers a. Most relevant questions i. 1 ii. 2 b. Most important pieces of information to submit i. Information on viability of alternatives 4. Supporters of a strict regulation a. Most relevant questions i. Section III part I - for providing general comment - indicate in the check boxes which sectors/uses are covered in the submitted comment 5. Test/analysis professionals a. Most relevant questions i. Section III - Question 10 b. Most important pieces of information to submit i. Information on methods of analysis of PFAS 6. Recyclers a. Most relevant questions i. Section III - Question 4 b. Most important pieces of information to submit i. Information on impacts on recycling industry and recycling possibilities concerning the proposed concentration limits Other information of interest Information related to end-of-life: emissions, waste management options, impacts from the ban on the recycling industry Additional information on analytical methods CHEMSEC RESOURCES THAT MAY BE USEFUL IN THE PROCESS The PFAS guide assists in understanding where PFAS is used and is a good starting point The Marketplace is a database of potential alternatives On the ChemSec website there are a number of articles and recorded webinars related to PFAS ANNEX A Proposed derogations in detail a. polymerisation aids in the production of polymeric PFASs until 6.5 years after EIF. This derogation does not apply to the production of PTFE, PVDF and FKM. b. Textiles used in personal protective equipment (PPE) intended to protect users against risks as specified in Regulation (EU) 2016/425, Annex I, Risk Category III (a) and (c), until 13.5 years after EiF; c. textiles used in personal protective equipment (PPE) in professional firefighting activities intended to protect users against risks as specified in Regulation (EU) 2016/425, Annex I, Risk Category III (a) - (m), until 13.5 years after EiF; d. impregnation agents for re-impregnation of articles referred to in paragraph 5b and 5c until 13.5 years after EiF; e. textiles for the use of infiltration and separation media used in high performance air and liquid applications in industrial or professional settings that require a combination of water- and oil repellence until 6.5 years after EiF; f. refrigerants in low-temperature refrigeration below -50 C until 6.5 years after EiF; g. refrigerants in laboratory test and measurement equipment until 13.5 years after EiF; h. refrigerants in refrigerated centrifuges until 13.5 years after EiF; i. maintenance and refilling of existing HVACR equipment put on the market before [18 months after EiF] and for which no drop-in alternative exist until 13.5 years after EiF; j. refrigerants in HVACR-equipment in buildings where national safety standards and building codes prohibit the use of alternatives; k. industrial precision cleaning fluids until 13.5 years after EiF; l. cleaning fluids for use in oxygen-enriched environments until 13.5 years after EiF; m. clean fire suppressing agents where current alternatives damage the assets to be protected or pose a risk to human health until 13.5 years after EiF; n. diagnostic laboratory testing until 13.5 years after EiF; o. additives to hydraulic fluids for anti-erosion/anti-corrosion in hydraulic systems (incl. control valves) in aircraft and aerospace industry until 13.5 years after EiF; p. refrigerants in mobile airconditioning-systems in combustion engine vehicles with mechanical compressors until 6.5 years after EiF; q. refrigerants in transport refrigeration other than in marine applications until 6.5 years after EiF; r. insulating gases in high-voltage switchgear (above 145 kV) until 6.5 years after EIF s. lubricants where the use takes place under harsh conditions or the use is needed for safe functioning and safety of equipment until 13.5 years after EIF; t. calibration of measurement instruments and as analytical reference materials. The following potential derogations are marked for reconsideration after the Annex XV report consultation u. [textiles for the use in engine bays for noise and vibration insulation used in the automotive industry until 13.5 years after EiF]; v.[hardchromeplatinguntil6.5yearsafterEiF]; w. [foam blowing agents in expanded foam sprayed on site for building insulation until 6.5 years after EiF]; x. [industrial and professional use of solvent-based debinding systems in 3D printing until 13.5 years after EiF]; y. [industrial and professional use of smoothing agents for polymer 3D printing applications until 13.5 years after EiF]; z. [propellants for technical aerosols for applications where non-flammability and high technical performance of spray quality are required until 13.5 years after EiF]; aa. [preservation of cultural paper-based materials until 13.5 years after EiF]; bb. [cleaning and heat transfer: engineered fluids for medical devices until 13.5 years after EiF]; cc. [membranes used for venting of medical devices until 13.5 years after EiF]; dd. [use as refrigerants and for mobile air conditioning in vehicles in military applications until 13.5 years after EiF]; ee. [the semiconductor manufacturing process until 13.5 years after EiF]. 6. By way of derogation, paragraphs 1 and 2 shall not apply to fluoropolymers and perfluoropolyethers for the use in: a. food contact materials for the purpose of industrial and professional food and feed production until 6.5 years after EiF; b. implantable medical devices (not including meshes, wound treatment products, tubes and catheters) until 13.5 years after EiF; c. tubes and catheters in medical devices until 13.5 years after EiF; d. coatings of Metered Dose Inhalers (MDIs)until 13.5 years after EiF; e. proton-exchange membrane (PEM) fuel cells until 6.5 years after EiF; f. fluoropolymer applications in the petroleum and mining industry until 13.5 years after EiF. The following potential derogations are marked for reconsideration after the Annex XV report consultation: g. [non-stick coatings in industrial and professional bakeware until 6.5 years after EiF]; h. [hernia meshes until 13.5 years after EiF]; i. [wound treatment products until 13.5 years after EiF]; j. [coating applications for medical devices other than Metered Dose Inhalers until 13.5 years after EIF]; k. [Rigid gas permeable contact lenses and ophthalmic lenses until 13.5 years after EiF]; l. [PCTFE-based packaging for medicinal preparations, medical devices and medical molecular diagnostics until 13.5 after EIF]; m. [PTFE in ophthalmic solutions packaging until 13.5 years after EIF]; n. [packaging of terminally sterilised medical devices until 13.5 years after EIF]; o. [applications affecting the proper functioning related to the safety of transport vehicles, and affecting the safety of operators, passengers or goods until 13.5 years after EiF]. years ANNEX B Details on the questions in the consultation. SECTION I. Personal information SECTION II. Organizational information Note that there is an option to make this information publicly disclosed or not. SECTION III. Non-confidential information Important to indicate (by ticking the boxes) all the content that the reply covers. Contains two different ways of submitting information 1. A free text comment Submitted in the form of a free text comment in the box. 9 000 characters available for comment. Can cover several areas and include topics not included in the specific requests 2. A set of specific information requests - individually commented below SECTION III. Specific information request 1 - Sectors and (sub-)uses List the sectors and (sub-)uses that the information submitted covers. An overview of the identified sectors and (sub-)uses can be found in the restriction report SECTION III. Specific information request 2 - Emissions in the end-of-life phase Information regarding emissions, on a (sub-)use level Data on incineration, landfilling and recycling, shares of the different end-of-life pathways SECTION III. Specific information request 3 - Emissions in the end-of-life phase Specific information on incineration effectiveness with respect to the destruction of PFAS SECTION III. Specific information request 4 - Impacts on the recycling industry Impacts on the recycling industry with respect to: a. Concentration limits impact on technical and economic feasibility b. How to reach the concentrations limits c. Costs SECTION III. Specific information request 5 - Proposed derogations - Tonnage and emissions Information on the proposed derogations concerning tonnage and emissions per use SECTION III. Specific information request 6 - Missing uses - Analysis of alternatives and socioeconomic analysis Detailed information on alternatives for uses not covered in the dossier All details on such alternatives are interesting, see picture for complete list SECTION III. Specific information request 7 - Potential derogations marked for reconsideration - Analysis of alternatives and socio-economic analysis Detailed information on the [proposed derogations] in the proposal Information that warrants or justifies the proposed derogations Information regarding available information especially interesting SECTION III. Specific information request 8 - Other identified uses - Analysis of alternatives and socio-economic analysis Detailed information on alternatives and socio-economic impacts for other uses SECTION III. Specific information request 9 - Degradation potential of specific PFAS sub-groups Detailed information on the degradation potential of PFAS SECTION III. Specific information request 10 - Analytical methods Detailed information on analytical methods SECTION IV. Non-confidential attachment Possibility to add additional information and data as attached documents SECTION V. Confidential attachment Possibility to add additional information and data as attached documents