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EUROPEAN COMMISSION DIRECTORATE-GENERAL ENVIRONMENT Directorate B - Circular Economy ENV.B.2 - Safe and Sustainable Chemicals Brussels, 25.05.2023 DRAFT AGENDA 28th Meeting of the Competent Authorities for Regulation (EU) 2019/1021 on Persistent Organic Pollutants 14 June 2023 Time: 11:15 - 18:00 Venue: Centre Borschette, Bruxelles. WEDNESDAY 14 JUNE REGISTRATION 9:30-11:15 AGENDA ITEM 1. Adoption of the Agenda 2. Adoption of the Summary Record of the 27th meeting Minutes are adopted as amended by DOC CA 06/2023/01 CA 06/2023/02 ACTION Approval Approval TIME 11:15 - 11:20 11:20 - 11:25 POP-CA_06-23_02-D raft Record 27th CA meeting.docx 3. Amendment of the Annex I entry on HBCDD: revision of the UTC CA 06/2023/03 CA 06/2023/03-A CA 06/2023/03-B Discussion 11:25 - 11:35 Taking into account the comments received at and following several POP CA meetings, the Commission proposes the same approach as in the previous POP CA meeting (i.e. 75 ppm limit value for all uses, except for recycled EPS and XPS, for which there would be a limit of 100 ppm) and review clause on review by 2026. With regard to the scope of use of recycled EPS and XPS, considering the potential difficulties to trace whether an end product goes to building or construction, the fact that it is difficult to justify a higher UTC limit value in buildings which typically house or hold consumers (houses, museums, train stations, ...) than in civil engineering works which house or hold less consumers or for a shorter period of time (bridges, tunnels, ...) and Commission europenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGI - Tel. +32 22991111 consistency with the terminology defined in Regulation (EU) 305/2011 , the Commission has made a proposal to use the scope and wording `in buildings or civil engineering works' in its current draft delegated act compared to the wording `in building applications' in the previous version. The change in wording in the draft delegated act posted on circa-bc has been marked in track changes. This approach is supported by (annex XIV) asks COM to delete this entry from REACH 4. Amendment of the Annex I entry on PBDEs: revision of the UTC Information 11:35 - 11:45 Presentation is made by the Plastics recycling industry. Alignment of limits btw annex I and V is requested. Lowering the limit to 350 ppm is premature, a limit of 500 ppm for 3 years followed by a reduction to 350 ppm (unless limit on product is higher) is needed to prevent materials containing PBDEs above the UTC limit but below the LPCL to be directed to landfill. asks if, within the EU, articles containing PBDEs are removed before being shredded. Sectors confirms there is no manual disimanteling (difficulties in identifying articles containing POP-BDEs). asks whether the new listing of DP and UV-328 would have an an impact on plastic recycling. Sectors confirms that these new chemicals will be hard to detect but a separation by soaking works very well. asks if measurability methods are available. Sectors confirms that a method has been developed by combining XRF and analytical method (GCMS) EuRIC stresses that the revision of the ROHS directive has been delayed and that the current limit of 1000 ppm would still apply. 5. Amendment of the Annex I entry on PCBs: specification of a UTC CA 06/2023/05 CA 06/2023/05-A CA 06/2023/05-B Discussion 11:45 - 11:55 Based on the information previously collected and the comments received at the various POP CA meetings, the Commission is of the view that a UTC limit value of 10 ppm is still an appropriate value, since it ensures a high level of protection whilst not restricting all products where PCB are unintentionally present. It allows continuing with the production of most of the organic pigments (the main source of unintentional PCB) while restricting the ones with the highest concentrations. A review clause as proposed by one of the Member States is not considered necessary as a UTC limit value can be reviewed at any time. With regard to the explicit references to determination methods, considering the fact that technology evolves constantly and determination methods may therefore change in time, the Commission is of the view that they should not be specified in the delegated act. Such methods may however be specified in an FAQ or in a compendium of analytical methods under development by the Forum. The resulting proposal is therefore as follows: - UTC limit value: 10 ppm, - Identification: CAS = 1336-36-3 and others; EC = 215-648-1 and others, as is currently the case in Annex I and Annex IV to the POPs Regulation, - Concentration determination methods: no specification, but can be covered in FAQ if considered necessary. Approach supported by 2 PCBs are also listed in annex 3 and we are required to reduce emissions. The proposal is not in line with that requirement. To answer 's question, all oils containing waste might be concerned while currently limit of detection is applied. reiterates the position defended since the 25th POP CA meeting. PCBs are identified as EDC and they should therefore be considered as non-threshold substances. Currently, there is no limit value in annex I (UTC). This means that the limit of detection is in practice the limit value applied for control and enforcement purposes. Setting a limit at 10 ppm to allow placing on the market of product in which PCB are unintentionally present is a step backwards from the protection afforded by the current entry in the POP regulation. supports setting a limit but believes that 10 ppm is too high (a lower limit is applied nationaly). will submit written comments. COM lauches a call for comments until the end of July focusing : on enforcement activities in particular regarding paints, ink and food packaging and an alternative option which is to set a lower limit with some exemptions for very specific uses. 6. Annex 1 entry on PFOA: review of the UTC for transported intermediates CA 06/2023/06 Discussion 11:55 - 12:05 Considering that there is no new information on which basis it may be possible to lower the current UTC limit value, and that Member States do not support a higher limit value for a specific intermediate, the Commission sees no need to modify the current UTC limit value at this moment in time. The review clause of the Annex I entry on PFOA is no longer relevant but could be deleted in the next revision of the PFOA entry, as the Commission can initiate a review of the limits at any moment, on the basis of new information available. Therefore, the Commission proposes not modifying the entry on PFOA in Annex I to the POPs Regulation at this moment. No objection raised. 7. Amendment of the Annex I entry on PFOS: revision of the UTC and deletion of a specific exemption CA 06/2023/07 CA 06/2023/07-A CA 06/2023/07-B Discussion 12:05 - 12:20 Concerning the specific exemption granted under point 4 of Annex I, an inquiry made in 2021 among the CAs reported only one company in the EU still using PFOS in hardchromium plating. Therefore, the Commission proposes to delete this specific exemption. The CAs raised no objection during or after the 26th and 27th meeting. The COM proposes therefore to delete point 4 of Annex I. Following the discussion during the 27th POP CAs meeting, a MS commented that a full alignment with PFOA and PFHxS entry would be needed, proposing to add a UTC limit value also for PFOS, equivalent to the one for PFOA and PFHxS. The Commission agrees on the need for an alignment, and proposes two additional changes to the PFOS related entry to bring all the entries concerning PFAS groups fully in line: in the substance identification, change the wording from "PFOS and its derivatives" to "PFOS, its salts and PFOS related compounds" 3 delete point 5, as no other entry in the POPs Regulation specifies details on analytical methods and because analytical methods can change over time because of technical and scientific progress. In conclusion, the Commission proposes to align the wording of the substance identification for the entry of PFOS with the one for PFOA and PFHxS; to introduce a UTC limit value for PFOS and its salts of 0,025 mg/kg in substances, mixtures and articles (in line with the one for PFOA and PFHxS); to reduce the UTC limit value for PFOS related compounds in substances, mixtures and articles to 1 mg/kg, in line with the value for PFOA and PFHxS related compounds; to delete point 5 regarding CEN standards and point 4 regarding the specific exemption for non-decorative hard chromium (VI) plating in closed loop systems. Written comments are welcome by 7th July and then, a PC will be launched. express their support. asks which substances falls within "PFOS related compounds" as the term "derivatives" is used in the current POP reg. COM answers that the aim is not to change the scope of the entry, a feedback from stakeholders will be useful on this aspect. 8. Listing of methoxychlor in Annex I CA 06/2023/08 CA 06/2023/08-A CA 06/2023/08-B Discussion 12:20 - 12:30 At COP 11 to the Stockholm Convention, it was decided to include methoxychlor in Annex A to the Convention without specific exemption. There is no manufacture or use of methoxychlor in the EU. Methoxychlor is not approved for use as an active substance in plant protection products (PPP) in the EU under Regulation (EC) No 1107/2009. The authorisations of PPP containing methoxychlor had to be withdrawn by 25 July 2003 (Commission Regulation (EC) No 2076/2002). Methoxychlor is no longer approved for use in veterinary (Regulation (EC) No 726/2004) and biocidal applications (Regulation (EU) No 528/2012 and Commission Regulation (EC) No 2032/2003). Concerning the Unintentional Trace Contaminant limit value, as no information is available, the Commission proposes the value of 10 ppb (0,01 mg/kg). This value corresponds to the EU MRL (Maximum Residue Level) for methoxychlor and is based on the default lowest limit of analytical determination. Written comments are welcome by the end of July. Discussion will continue at the next meeting. 9. Listing of UV-328 in Annex I CA 06/2023/09 CA 06/2023/09-A CA 06/2023/09-B Discussion 12:30 - 12:45 UV-328 is included in Annex XIV to REACH, with a latest application date on 27 May 2022 and a sunset date on 27 November 2023. As no application for authorisation was submitted by the latest application date, no use of UV-328 will be allowed in the EU after 27 November 2023. Therefore, no exemption is needed in the EU for production and use. However, UV- 4 328 could still be imported in articles, such as the spare parts for which a specific exemption has been agreed at the COP. No information is currently available on the exemptions needed in the EU for spare parts containing UV-328 or for presence in other articles as there was no restriction dossier developed for UV-328. From the information available from submissions during the Risk Management Evaluation discussion, it seems that an exemption would be needed in the EU at least for motor vehicles. According to Article 69(2) of REACH, after the sunset date has passed for a substance included on the Annex XIV, ECHA should consider if risks from the use of the substance in articles are adequately controlled. ECHA's assessment on available information on UV-328 is captured in a Draft Screening report . ECHA has launched a call for evidence on the draft Screening report. This includes questions related to the specific exemptions agreed at the COP for UV-328 and their need in the EU. The draft Act and Annex currently include all the specific exemptions agreed at the COP. The Annex will be modified following the outcome of ECHA's call for evidence and, at a later stage, the public consultation on the Have your Say website. POP CAs will be consulted on the new draft at the next meeting. Concerning the Unintentional Trace Contaminant limit value, as no information is available, the Commission proposes the value of 10 ppb (0,01 mg/kg). This value will be revised on the basis of the outcome of ECHA's call for evidence and the public consultation on the Have you say website. stresses that we need to be prepared for the management of waste consisting/containing/contaminated and suggests the development of CEN methods for all newly listed POPs. asks whether the proposed UTC limit, which is quite low, is technically manageable- COM answers that availability of analytical methods has not been considered yet. This will be done soon and the proposed limit may be revised. Written comments are welcome by the end of July. Discussion will continue at the next meeting. 10. Listing of dechlorane plus in Annex I CA 06/2023/10 CA 06/2023/10-A CA 06/2023/10-B Discussion 12:45 - 13:00 Norway prepared a restriction dossier for dechlorane plus and ECHA's opinion was finalised in September 20221. The opinion supports a broad restriction of manufacture and placing on the market of dechlorane plus, with the following exemptions: - manufacture, use and placing on the market for o aerospace and defence applications (for 5 years) o medical imaging applications (for 7 years) o radiotherapy devices/installations (for 10 years) - manufacture, use and placing on the market of spare parts for o aerospace and defence applications o medical imaging applications 1 d4e88790-cfe2-c934-7ea4-489e1602d6c2 (europa.eu) 5 o radiotherapy devices/installations o motor vehicles (land-based) (already placed on the market at the entry into force) o marine, garden and forestry machinery applications (already placed on the market at the entry into force) The draft Act is attached POP-CA_06-23_10-D echlorane plus listing_Annex B (1).docx The Annex includes all the exemptions recommended in ECHA's opinion, including the relevant transitional periods. For the spare parts, where transitional periods were not recommended in ECHA's opinion, those in the COP decision are used. Concerning the Unintentional Trace Contaminant limit value, the ECHA's opinion proposes a limit of 0.1% (1000 mg/kg) to ensure that no dechlorane plus is intentionally used. This is considerably higher than the UTC limit values normally established in the POPs Regulation. As no information is available on the actual unintentional presence of dechlorane plus in substances, mixtures and articles, the Commission proposes the value of 10 ppb (0,01 mg/kg). This value will be revised on the basis of the outcome of the public consultation on the Have you say website. stresses that transitional periods are longer in REACH than in the SC - COM recognises that extension will be necessary for at least 2 specific exemptions. Written comments are welcome by the end of July. Discussion will continue at the next meeting. Lunch break 11. Listing of PFHxS in Annex I CA 06/2023/11-A CA 06/2023/11-B Information 13:00 - 14:00 14:00 - 14:10 POP-CA_06-23_11-B -PFHxS annex.pdf Publication will take place at the end of August/beginning of Septembre with an entry into force few days later. 12. ECHA - proposal for a nomination for D4-D5-D6 CA 06/2023/12 Discussion 14:10 - 15:00 D4, D5 and D6 have been identified in the EU under REACH as Substances of Very High Concern (SVHC) and included in the Candidate List for Authorisation in June 2018 due to their Persistent, Bioaccumulative and Toxic (PBT) and/or very Persistent, very Bioaccumulative (vPvB) properties. Furthermore, the use of D4 and D5 in wash-off cosmetic products has been restricted in the EU under the REACH Regulation since 31 January 2020 and another REACH restriction for D4, D5 and D6 in consumer and professional products is under decision making by the European Commission. COM stresses that the purpose is to ensure a global ban of D4, D5 and D6 uses in mixtures as in the REACH restrictions. A listing in annex B is proposed and the intention is to add an acceptable purpose for the transport of these 3 monomers for intermediate uses in the production of polymers. The on-site intermediate uses will be allowed according to note iii 6 of annex B which allow the production and use of the chemicals listed as a closed-system site-limited intermediate upon notification to the Secretariat. The draft Annex D screening dossier (Annex A) summarising relevant evidence relating to the screening criteria for persistence, bioaccumulation, long-range environmental transport and adverse effects was presented by ECHA. The proposal is based on the PBT/vPvB assessments performed at the EU level under the REACH Regulation, information from peer-reviewed scientific journals as well as grey literature. MS are encouraged to provide their comments on the draft proposal during the stakeholder consultation that will be launched from 15/06 to 10/08 in accordance with Article 8.1.(d) of the POPs Regulation. The dossier will be updated to address the comments received and the Commission will start the process for the Council decision on the nomination proposal. If comments are not appropriate for the public consultation, they can be submitted by the end of July to the COM. POP-CA_06-23_12-D 4 D5 D6 nomination_AnnexA_rev.docx , on the LRT criteria section, suggests to make a distinction when data are coming from remote areas even if this term is not defined. EU silicone industry disagrees with the nomination proposal as scientif discussions on LRT criteria are ongoing as well as monitoring projects in artic. IND stresses that several recent scientific studies have not been considered in the HH section of the annex D dossier. Implications on waste management have not been considered. More than 90% of emissions are coming from "direct uses" and this could be globalized in another way than through the SC. ECHA answers that all studies available in the registration dossier were considered but they will take into account any other publications that might be provided. asks if impact assessments were done. COM answers that impact assessments have been provided and are available in the restriction dossiers. As an acceptable purpose will be proposed for their uses as intermediates, additional impact assessment is not foreeen. asks if other monomers (e.g D3) have been also considered for the nomination. ECHA answers there are no SVHC identification for other monomers. DG Growth challenge the study on LRT through air. ECHA will further investigate this study and will contact the authors but stresses there are also LRT via water, migratory species and oceans. 13. ECHA - Union overview report and Member States reports CA 06/2023/13 Discussion 15:00 - 15:15 The Member States that wish to update their national (Art. 13) report this year need to provide their updated excel files to ECHA by the end of September 2023 for their data to be incorporated in the next Union Overview update. ECHA will generate an update of the Union Overview report using the latest version of the national reports available in S-CIRCA BC. ECHA will also generate the pdf versions of the updated national reports for their publication in ECHA webpage. ECHA will contact the MSCAs for their approval before publishing the updated national reports in its webpage. 7 stresses that getting info on production and manufacturing is really struggling and asks whether info available on ECHA databases is sufficient. reiterates the call launched at the last POP CA meeting and asks again the COM to assess whether the current requirements under REACH (i.e registration, SiA/SCIP/C&L notifications) and PIC (i.e art 10 reporting) are sufficient to get the required information. We could then identify whether any additional regulatory actions are needed at the EU or national level in order to properly implement art 13.1 f. Coffee / tea break 15:15 - 15:30 14. Report COP-11 CA 06/2023/14 Information 15:30 - 15:45 A milestone decision was the adoption of a compliance mechanism. The mechanism establishes a compliance committee to facilitate compliance with the requirements of the Convention. The work programme and the composition of the Committee shall be decided at the next COP. A compliance mechanism has been lacking since the entry into force of the Convention in 2004, since the Parties have not been able to agree on it at previous meetings. Furthermore, COP-11 adopted the listing of the flame retardant dechlorane plus, the pesticide methoxychlor and the plastics additive UV-328 in Annex A (elimination) of the Convention. Methoxychlor was listed without any exemption, whereas UV-328 was listed with the exemptions proposed by the POPs Review Committee of the Convention, and dechlorane plus without the production exemption since China announced that the only remaining manufacturer will stop production in 2024. A number of important decisions to advance the work towards elimination of listed POPs were adopted, such as on the work plan for further development of the Best Available Techniques (BAT) and Best Environment Practices (BEP) to reduce or eliminate releases from unintentional production, on the work to eliminate polychlorinated biphenyls and on the measures to reduce or eliminate releases from wastes. Decisions were also adopted on the management of existing exemptions, reporting obligations, national implementation plans and for effectiveness evaluation of the Convention, including the global monitoring plan. Regarding the continued use of DDT (insecticide), further measures were agreed to make progress as regards the phase-out by the 18 countries currently registered for the exemption to use DDT to eliminate malaria-spreading mosquitoes, which are invited to review their needs by 31 December 2023, and to transmit an update of their status in the register. The COP welcomed the report on effectiveness evaluation and acknowledged with appreciation the findings that the Convention provides an effective and dynamic framework for regulating POPs, as demonstrated by decreasing presence of such chemicals in the environment. 15. Notification of articles in use containing POPs CA 06/2023/15 Discussion CA 06/2023/15-A 15:45 - 16:00 COM introduces a draft of notifications of articles in use pursuant to note (ii) of Annex A and note (ii) of Annex B of the Stockholm Convention - these notifications are related to HBCDD, PCB, PFOA, deca BDE, SCCP and PFOS. asks whether exemptions for defence applications must be notified. COM stressed that notifications should be more specific. asks also whether the 6 months period apply also to exempted articles. COM answers that art 4.2 only apply as from the chemical is listed in the regulation but the intention could be challenged (do we really want to ban the use of 8 what we have allowed to be placed on the market? ) - further consideration and legal advices are needed. highlights the link with the task given by the last COP to the POPRC on identification of articles containing POPs. Written comments are welcome by the end of August. Notifications will then be sent to the SC SEC. 16. Implementation of the Convention CA 06/2023/16 Discussion 16:00 - 16:15 A summary is presented by the COM. POP-CA_06-23_16-S C implementation.docx 17. Union Synthesis Report on the CA 06/2023/17 application of the POPs Regulation Information 16:15 - 16:20 18. POPs waste issues: latest developments Information 16:20 - 16:40 Developments under the Basel Convention are presented by the COM : - Adoption of the general technical guidelines on the environmentally sound management of wastes consisting of, containing or contaminated with POPs, and of the technical guidelines on the ESM of wastes consisting of, containing or contaminated with PFOS, PFOA and PFHxS, its salts and related compounds. - Intersessional work agreed reagrding the update or development of guidelines on newly listed POPs : DP, UV-328 and methoxychlor Nothing new at the EU level since the publication of the legislative act amending Annex IV and V in Nov 2023. 19. AOB Information 16:40 - 16:50 on art 7.4 b : "A Member State may, in exceptional cases, allow wastes listed in Part 2 of Annex V containing or contaminated by a substance listed in Annex IV up to concentration limits specified in Part 2 of Annex V to be otherwise dealt with in accordance with a method listed in Part 2 of Annex V, provided that certains conditions are fulfilled" including condition iv "the Member State concerned has informed the other Member States, the Agency and the Commission of its authorisation and the justification for it" asks whether we should provide this info via the reporting according to art 13 or whether another communication method should be use. COM points out that, so far, notifications were sent to the COM by email before being published on CIRCA BC. 20. Closure and next meeting Information 16:50 - 17:00 COM proposes to have one fully in person + one fully virtual meeting every year (support expressed by ). The next meeting will be fully virtual in November 2023 and the next one could be held in June 2024 (fully in person). 9 10