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Saatja: Tiiu Noobel <[email protected]> Saaja: SM Info, [email protected], [email protected], Elen Ohov, Ramon Nahkur, Agne Nettan-Sepp Brüsselis, Margus Korsjukov (KeM) Teema: FW: REMINDER: for feedback - Nominations to RAC Drinking Water WG - deadline 28 February 2023 Tere! Edastan Euroopa Kemikaaliameti meeldetuletuse (algne kiri saadetud teile 09.12.2022, nr 14-4/1267). Vastamise tähtaeg on 28.02.2023. Palun saatke info määratud ekspertide kohta kolm tööpäeva enne tähtaega EV AEEL juures üldaadressile [email protected]<mailto:[email protected]> või mulle, et jõuaksime kirja siit õigel ajal välja saata. Heade soovidega Tiiu Noobel Sekretär Eesti Vabariigi alaline esindus Euroopa Liidu juures Rue Guimard 11/13, 1040 Brüssel Tel: + 32 2227 4337, [email protected]<mailto:[email protected]> https://eu.mfa.ee/et/ From: Esindus EL juures üldaadress <[email protected]> Sent: Tuesday, February 14, 2023 9:26 AM To: Tiiu Noobel <[email protected]> Subject: FW: REMINDER: for feedback - Nominations to RAC Drinking Water WG - deadline 28 February 2023 Importance: High From: ECHA Committees secretariat <[email protected]<mailto:[email protected]>> Sent: Monday, February 13, 2023 4:07 PM Cc: ECHA Committees secretariat <[email protected]<mailto:[email protected]>> Subject: REMINDER: for feedback - Nominations to RAC Drinking Water WG - deadline 28 February 2023 Importance: High Dear Member States Competent Authorities, RAC members, National contact points, national permanent representations in Brussels, Following our initial email of December 2022, may we remind you of the deadline of 28 February for nominating a representative a new Working Group of ECHA’s Committee for Risk Assessment (RAC) dedicated to the evaluation of drinking water applications for the EU Positive List. You will find in the attached letter the details of the expertise needed and other background information to inform your nomination. Should you have a suitable candidate(s) to propose, you are kindly invited to contact the RAC Chair, Dr Tim Bowmer, as soon as possible to discuss further: [email protected]<mailto:[email protected]> If you need any further clarification on the steps of the nomination procedure, please do not hesitate to contact us at [email protected]<mailto:[email protected]> Thank you in advance for your valuable collaboration, Yours sincerely, On behalf of the Committees Secretariat, Regina O’Rourke – RAC Secretariat European Chemicals Agency P.O. Box 400, FI-00121 Helsinki, Finland Email: [email protected]<mailto:[email protected]> http://echa.europa.eu/ [cid:[email protected]]<http://www.twitter.com/EU_ECHA> [cid:[email protected]] <https://www.facebook.com/EUECHA> [cid:[email protected]] <https://www.youtube.com/user/EUchemicals> [cid:[email protected]] <https://www.linkedin.com/company/european-chemicals-agency> The above represents the opinion of the author and is not an official position of the European Chemicals Agency. This email, including any files attached to it, is intended for the use of the individual to whom it is addressed. If you have received this message in error, please notify the author as soon as possible and delete the message. From: ECHA Committees secretariat [email protected]<mailto:[email protected]> Sent: Tuesday, December 13, 2022 4:37 PM To: [email protected]<mailto:[email protected]> Cc: ECHA Committees secretariat [email protected]<mailto:[email protected]>; ECHA Committee Risk Assessment [email protected]<mailto:[email protected]> Subject: FW: Nominations to RAC Drinking Water WG - by 28 February 2023 Dear Member States Competent Authorities, RAC members, National contact points, Please find attached the invitation that has been sent to your national Permanent Representations in Brussels with a request for the nomination of experts as members of a new Working Group of ECHA’s Committee for Risk Assessment (RAC). We would appreciate your support towards the co-ordination of your national Competent Authorities for the DWD, REACH and CLP Regulations in identifying and nominating scientific experts to support this new task for RAC. If you need any further clarification, please do not hesitate to contact us. Kind regards, Tim Bowmer Chair of RAC Email: [email protected]<mailto:[email protected]> On behalf of the Committees Secretariat, Pirjo Vainio-Hätönen, Assistant Risk Management European Chemicals Agency P.O. Box 400, FI-00121 Helsinki, Finland Tel.: +358 9 686180, Email: [email protected]<mailto:[email protected]> http://echa.europa.eu/ [cid:[email protected]]<http://www.twitter.com/EU_ECHA> [cid:[email protected]] <https://www.facebook.com/EUECHA> [cid:[email protected]] <https://www.youtube.com/user/EUchemicals> [cid:[email protected]] <https://www.linkedin.com/company/european-chemicals-agency> The above represents the opinion of the author and is not an official position of the European Chemicals Agency. This email, including any files attached to it, is intended for the use of the individual to whom it is addressed. If you have received this message in error, please notify the author as soon as possible and delete the message. Saatja: Webdesktop <[email protected]> Saadetud: 09.12.2022 19:20 Adressaat: SM Info <[email protected]>; <[email protected]>; <[email protected]>; Elen Ohov <[email protected]>; Ramon Nahkur <[email protected]> Koopia: Agne Nettan-Sepp Brüsselis <[email protected]>; <[email protected]> Teema: Webdesktop: KIri nr 14-4/1267 / Nominations to RAC Drinking Water WG Tere!Edastan Euroopa Kemikaaliameti kirja. Reg. number: 14-4/1267Reg. kuupäev: 09.12.2022Sisu: Invitation to nominate experts to contribute to a standing working group of ECHA Committee for Risk Assessment (RAC) dedicated to the evaluation of drinking water applications for the EU Positive List. Tähtaeg 28.02.2023.Heade soovidegaTiiu [email protected]är, EV alaline esindus EL juures 1 (9) D(2022)1329 Helsinki 9 December 2022 TB/MB/pv Permanent Representations of the EU Member States and EEA-EFTA Countries Sent by email only Subject: Invitation to nominate experts to contribute to a standing working group of ECHA Committee for Risk Assessment (RAC) dedicated to the evaluation of drinking water applications for the EU Positive List Dear Sir/Madam, This invitation concerns the most recent task of the ECHA Committee for Risk Assessment (RAC), the setting up of an expert working group to support RAC in evaluating applications for the inclusion of starting substances, compositions and constituents into the European positive lists, under Directive (EU) 2020/2184 on the quality of water intended for human consumption Directive (the recast Drinking Water Directive). Through this invitation we aim to inform EU/EEA Member States on the setup, mandate and work programme of this working group. Please see Annexes I and II for further details. Therefore, the competent authorities responsible for drinking water in all EU/EEA Member States, are cordially invited to nominate experts who can contribute to this working group. An expertise grid is contained in Annex III. Noting that the Directive has been in force since 12 January 2021, we envisage a preparatory phase in 2023/24 and an operational phase beginning in 2025 as the first European positive lists are adopted, and the 15-year review programme prescribed under Article 11(4) of the Directive begins. When nominating an expert, we respectfully recommend that you coordinate with the REACH and CLP competent authorities in your country who may already contribute to the activities of ECHA and RAC (See Annexes IV and V, linked below). The deadline for nominations to the working group is 28 February 2023. Yours faithfully, [e-signed] 1 Dr Sharon McGuinness Executive Director Annexes: I. Background II. Draft mandate of the working group III. Expertise grid IV. List of current RAC members V. List of REACH and CLP Competent Authorities Cc: REACH/CLP Competent Authorities (email 09.12.2022) Committee for Risk Assessment (email 09.12.2022) 1 As this is an electronic document, it is not physically signed. This communication has been approved according to ECHA’s internal decision approval process. P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu  2 (9) D(2022)1329 Helsinki 9 December 2022 TB/MB/pv ANNEX I - Background RAC Working Group 1. Legal basis The duties of RAC as set out in Art 76(1) of REACH are to service the needs of authorisations and restrictions as well as Classification and Labelling (CLP). RAC is also responsible under a Service Level Agreement between ECHA and DG Employment for evaluating occupational exposure limits (OELs). Under Art. 11 2(6) of the recast Drinking Water Directive (EU) 2020/2184, RAC will be additionally responsible for issuing an opinion3 on proposed inclusions or removals to and from the EU positive lists (EUPL) of starting substances, compositions or constituents. 2. Manner of appointment A two-tier system of appointment is anticipated: to RAC and its working group, or just to the working group (see further below). Members of RAC are currently nominated by the EU/EEA Member States under Art 85(1) of REACH and appointed by the Management Board of ECHA in their personal capacity as scientists and must not be instructed by their Member State Competent Authorities. Two members may be appointed per Member State. Currently, 44 of the 60 EU/EEA seats on RAC are filled, while 16 seats are vacant. RAC will continue to deliver on the current four processes with which it is tasked (Restrictions, Authorisations, Harmonised Classification and Labelling, and OELs). The Management Board of ECHA has been informed4 that the number of RAC members has declined in the last four years. It is therefore important for the current duties that Member States support a return to at least 50 regular members. Participation in RAC and its Drinking Water Working Group can be arranged in the following ways: Directly to the Drinking Water Working Group a) The simplest approach may be for Member States to nominate experts directly to the RAC Drinking Water Working Group, at the same time placing them in the role of advisor to their current RAC member(s) where the RAC plenary is concerned. Appropriate communication could then be arranged through the already appointed RAC members under REACH Art. 85(6 5). Art. 6.2 of the RAC Rules of Procedure provides for advisors to be appointed by members. 2 Minimum hygiene requirements for materials that come into contact with water intended for human consumption 3 Further procedural provisions on the application process and on the issuing of DWD EUPL opinions by RAC will be included in a Commission Decision which is currently in drafting and is expected to be adopted by 12 January 2024. 4 https://echa.europa.eu/documents/10162/10709189/mb_09_2022_annual_report_committees_mb65_en.pdf/84ba21 22-8623-1f16-b125-9e271c577475?t=1649413762200 5 i.e. “ensure that there is appropriate coordination between the tasks of the Agency and the work of their member State competent authority” (see also Art 6.2 of RoP). P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu  3 (9) D(2022)1329 Helsinki 9 December 2022 TB/MB/pv Through RAC Membership b) EU/EEA Member States with empty seats on RAC (approximately 10 above current REACH and CLP needs) may wish to nominate new members with expertise relevant to drinking water (see Annex III) to the Committee. The member could then join the Drinking Water Working Group; Or c) As has been the practice in RAC from its inception, interested Member States may also make arrangements to have a member nominated through a different Member State with a vacant seat on RAC6. The member could then join the Drinking Water Working Group. ECHA would like to highlight the importance of retaining sufficient capacity in RAC for its current duties, while catering for the needs of the new activity. - We would kindly suggest that you approach the Chair of RAC7 to discuss your plans. - We also recommend that you make prior contact with the REACH and CLP Competent Authorities in your country, i.e. those normally responsible for nominating RAC members. 3. Meeting format: - Meetings of the RAC Drinking Water Working Group will generally be held remotely, i.e., organised by ECHA using Webex as a meeting platform; - An exception for initial face-to face meetings will be made; - In principle, meetings of RAC and its working groups are open to accredited stakeholders as observers; - However, it is not envisaged that case-owners (applicants) will be present at meetings of RAC or its Drinking Water Working Group. 4. Resources: - Experts nominated to the Working Group should expect to spend about 25-30% of their working time on the activities of the working group in 2023 and 2024, i.e., during the start-up phase; - Members of RAC are expected to spend at least 50% of their time on the activities of the Committee, guaranteed by the Competent Authority in signing the nomination papers. Please note the independent status as described above; - ECHA will provide experts with travel and overnight expenses in case of physical meetings; - There is no provision for the remuneration of these activities to members of the Working Group, nor transfer of fees to the Member States to compensate for (part of) the costs incurred. 5. Work programme: - See draft mandate Annex II section 3. 6 While originally implemented to build capacity, this need has continued to the present day and remains open to all EU/EEA Member States. 7 The current Chair is of RAC is Tim Bowmer. Contact: [email protected], cc [email protected]; P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu  4 (9) D(2022)1329 Helsinki 9 December 2022 TB/MB/pv Helsinki, xx yyyy 2023 Agreed at RAC-64 ANNEX II Draft Mandate for a standing Working Group of the ECHA Committee for Risk Assessment on: the EU Positive Lists of starting substances, compositions and constituents for use in manufacture of materials or products in contact with water intended for human consumption as provided for in Directive (EU) 2020/2184 of the European Parliament and of the Council 1. Introduction and objectives The Committee for Risk Assessment agreed to set up a standing working group under Art 85(9) of REACH, ‘creation of ….and delegation of tasks to working groups’ and Art. 18 of the RAC Rules of Procedure On the EU Positive Lists of starting substances, compositions and constituents for use in manufacture of materials or products in contact with water intended for human consumption as provided for in Directive (EU) 2020/2184 of the European Parliament and of the Council called the “Committee for Risk Assessment Working Group on Drinking Water Directive (RAC DWD WG). The Rules of Procedure of the Committee apply to the working group, covering: independence, confidentiality, transparency, eligibility and participation. As subsidiary bodies, a quorum is not applied to the meetings of RAC working groups. The objective of this working group is to support the work of RAC and the future RAC rapporteurs in evaluating applications for EUPL inclusions and removals. The RAC Drinking Water Working Group shall operate in an efficient and timely manner, within the scope as defined in section 2 and shall deliver the required output in line with Committee deadlines. 2. Organisation a) In line with the procedures of ECHA Committees and their working groups, the RAC Drinking Water Working Group chair shall be an employee of the Agency; b) The RAC Drinking Water Working Group shall be supported by a Committee Co- ordinator from the Secretariat; c) Following each meeting, the RAC Drinking Water Working Group will prepare with the support of the Secretariat a brief report (summary record) to RAC containing its recommendations in the form of: i. a statement of the case or a topic for discussion/agreement; ii. conclusions; iii. action points and; iv. a reflection of stakeholder interventions by topic. d) The working group shall be open to accredited stakeholder observers to attend at the invitation of the Secretariat. P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu  5 (9) D(2022)1329 Helsinki 9 December 2022 TB/MB/pv 3. Scope of the RAC Drinking Water Working Group The RAC Drinking Water Working Group’s activities under this mandate are related to the evaluation (risk assessment) of Industry or Member State applications proposing inclusions or removals to and from the EU positive lists of starting substances, compositions and constituents for use in manufacture of materials or products in contact with water intended for human consumption. The RAC Drinking Water Working Group is tasked with evaluating submissions and preparing an opinion, or evaluating opinions on simpler cases prepared by the secretariat, so providing RAC with recommendations. The RAC Drinking Water Working Group shall, in advance of the subsequent RAC-plenary meeting, carry out the following tasks: 2023-2024 - Execute pilot projects related to the setting up of the drinking water applications; - The working group shall maintain a list of relevant horizontal issues which the Committee and the Secretariat can request them to discuss and report on from time to time; - Develop Committee procedures for the evaluations of applications; - Comment on proposed guidance for the drinking water process. 2025 onwards - Evaluate individual EUPL submissions (the risk assessments of applicants) on request and provide a recommendation in the form of an opinion; - Indicate which opinions require: o plenary debate, highlighting which specific aspects need to be discussed and any unresolved items for agreement by RAC; o Opinions (or groups thereof) which may be A-listed8 for agreement without plenary debate. - Evaluate groups of very similar submissions (presented in tabular form); 4. Validity This mandate is valid for one year, renewable in writing by the Chairman of RAC following consultation with the Agency and the Committee. 8 ‘A-listing’ is a formal Committee process for the scrutiny of applications, usually through written comment or following a Working Group recommendation but without plenary debate. The A-list is then read into the record at the plenary and members have the opportunity to agree or to object. P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu  6 (9) D(2022)1329 Helsinki 9 December 2022 TB/MB/pv Annex III - Expertise grid Nominated members or experts should be skilled in following area(s): Area Competence required Notes on organics Notes on cementitious Notes on metallics Notes on inorganic materials Substance Understanding of Assessing submitted As for organics. Metallic materials on the Inorganic materials on the identity substance identity information in relation to EUPL will be compositions EUPL will be compositions requirements in a substance identity, verifying with metallic constituents with inorganic constituents. regulatory context. spectra, other suitable and impurities. Understanding of relevant analytical data to confirm physico-chemical unambiguous compositional properties. information, including manufacturing process, checking consistency of identifiers (name, EC No., CAS No., etc.) with composition. Use Understanding of chemical Assessing the release potential As for organics. Understanding of the Less relevant. description behaviour (e.g. formation of starting substances from the characteristics and of by-products) and combination of technical influence on migration migration implications of function and type of matrix at assumptions of different different technical the level of different material product types for which the functions in different type (rubber vs plastics). metallic composition may matrices. Understanding of potential be used. formation of by-products when substance delivering his function (for example, for antioxidants). P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu  7 (9) D(2022)1329 Helsinki 9 December 2022 TB/MB/pv Area Competence required Notes on organics Notes on cementitious Notes on metallics Notes on inorganic materials Human Understanding of The data requirements for Human health hazards For several elements As for metallics, but likely health toxicological studies and investigating the human health from organic applied-for relevant to migration water, a higher number of hazard ability to analyse hazards for organics and substances and Non- parametric values in DWD elements would require assessment the available scientific data related Non-intentionally Added intentionally Added Annex I exist and can be toxicological assessment by in terms of relevance and Substances (NIAS), depend on Substances (NIAS) used to generate ‘safety the applicants and reliability for risk migration their levels in the depending on migration thresholds’; for some validation by RAC, if assessment. drinking water. In general, the level. relevant elements (e.g., relevant to the migration higher the migration the Bi), toxicological water. greater the amount of data is information is to be required. presented by the applicant and ‘safety threshold’ need to be proposed by the applicant and be validated by RAC. Migration Understanding of release Familiarity with relevant EN Familiarity with relevant Familiarity with relevant EN Familiarity with relevant EN assessment estimation from material standards on the migration of EN standards on the standards on the migration standards on the migration and matrices through physical substances from organic migration of substances of elements from metallic of elements from inorganic modelling testing and modelling. materials (EN 12873) and from cementitious materials (EN 15664) and materials (EN 12873). measurements of materials (EN 14944) and electrochemical tests to NB. modelling is not concentrations in the migration measurements of determine passivity and suitable for inorganic water leading to the estimation concentrations in the passive film stability (e.g., materials. of the concentration at the tap migration water leading to EN 16056 for steels). (Ctap). the estimation of the Good understanding of the Assessing migration via concentration at the tap main mechanisms qualitative argumentation (i.e., (Ctap). underlining migration from understanding the potential for NB. modelling is not metallic alloys (corrosion, release from physico-chemical suitable for cement-based etc.). properties, technical function materials. and type of matrix), via modelling estimation with recognised models based on diffusion and partitioning principles. Understanding of role of Not relevant. Not relevant. Relevant to certain metallic Not relevant. water characteristics alloys. (temperature, softness, alkalinity, chloride) on P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu  8 (9) D(2022)1329 Helsinki 9 December 2022 TB/MB/pv Area Competence required Notes on organics Notes on cementitious Notes on metallics Notes on inorganic materials substance release. Experience in analytical Relevant. Relevant. Less relevant, as the Less relevant, as relying on method assessment. assessment relies on existing parametric values existing parametric values for several elements of for several elements of relevance. relevance. Microbio- Understanding of the Testing for antimicrobial Testing for antimicrobial Not relevant. Not relevant. logical assessment of activity on the surface of the activity on the surface of properties microbiological activity of final material will be required the final material will be biocidal active substances. for the limited number of in- required for the limited can preservatives (BPR Product number of in-can Type 6) that may be relevant preservatives (BPR Product to the organics EUPL. Type 6) that may be relevant to the cementitious EUPL. Risk Good knowledge of how to Understanding of the scope of As for organics. A comparison of Ctap to As for metallics. assessment perform the risk risk assessment which is MTCtap for each relevant assessment process for intended to cover not only the element will be required. threshold and non- starting substance but also any For several elements, a threshold effects, in relevant NIAS (impurities, and toxicological assessment relation to human health. potential reaction and/or by- will not be required for products). MTCtap generation, as Based on its assessment, parametric values under For threshold effects, the Risk RAC will issue an opinion Annex I of the DWD can be Assessment consists of (a) for a substance or used for generating a generating a Derived No Effect composition to be MTCtap value. level (DNEL) from which the approved/or not approved MTCtap can be estimated and for inclusion into the EUPL (b) risk characterisation by with an appropriate MTCtap comparison of the Ctap to the (maximum tolerable MTCtap. concentration at the tap) value. A hazard-based approach will be considered for CMR/ED/PBT/vPvB substances (for which a migration limit and a residual concentration limit P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu  9 (9) D(2022)1329 Helsinki 9 December 2022 TB/MB/pv Area Competence required Notes on organics Notes on cementitious Notes on metallics Notes on inorganic materials will apply). Draft Experience in RAC procedures, Working Group arrangements, preparation of written arguments in support of an independent scientific opinion opinion generation General Experience in cross-disciplinary, cross-national/multi-cultural collaboration approach P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu Saatja: Esindus EL juures üldaadress </O=ESTONIAN MINISTRY OF FOREIGN AFFAIRS/OU=EVM/CN=RECIPIENTS/CN=ESINDUSELJUURESYLDAADR> Saaja: Tiiu Noobel Teema: FW: Nominations to RAC Drinking Water WG - by 28 February 2023 From: ECHA Committees secretariat <[email protected]> Sent: Friday, December 9, 2022 12:57 PM To: [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; Esindus EL juures üldaadress <[email protected]>; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected] Cc: ECHA Committees secretariat <[email protected]> Subject: Nominations to RAC Drinking Water WG - by 28 February 2023 Dear Sir/Madam, With the attached letter ECHA invites the Member States to nominate experts to contribute to a standing working group of ECHA Committee for Risk Assessment (RAC) dedicated to the evaluation of drinking water applications for the EU Positive List. The attached letter and annexes explain the setup, mandate and work programme, including information on the type of expertise sought for this working group. On behalf of ECHA, I would like to express my encouragement to the Member States to continue to support the work of RAC and its working groups. Yours faithfully, Tim Bowmer Chair of RAC p.p. Committees Secretariat Pirjo Vainio-Hätönen (Ms) European Chemicals Agency P.O. Box 400, FI-00121 Helsinki, Finland Tel.: +358 9 686180, Email: [email protected] <mailto:[email protected]> http://echa.europa.eu/ <http://echa.europa.eu/> <http://www.twitter.com/EU_ECHA> <https://www.facebook.com/EUECHA> <https://www.youtube.com/user/EUchemicals> <https://www.linkedin.com/company/european-chemicals-agency> The above represents the opinion of the author and is not an official position of the European Chemicals Agency. This email, including any files attached to it, is intended for the use of the individual to whom it is addressed. If you have received this message in error, please notify the author as soon as possible and delete the message.