Committee for Risk Assessment (RAC) Committee for Socio-economic Analysis (SEAC) Opinion on an Annex XV dossier proposing restrictions on substances used in tattoo inks and permanent make-up ECHA/RAC/RES-O-0000001412-86-240/F ECHA/SEAC/[reference code to be added after the adoption of the SEAC opinion] Adopted 20 November 2018 20 November 2018 ECHA/RAC/RES-O-0000001412-86-240/F 29 November 2018 ECHA/SEAC/[reference code to be added after the adoption of the SEAC opinion] Opinion of the Committee for Risk Assessment and Opinion of the Committee for Socio-economic Analysis on an Annex XV dossier proposing restrictions of the manufacture, placing on the market or use of a substance within the EU Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (the REACH Regulation), and in particular the definition of a restriction in Article 3(31) and Title VIII thereof, the Committee for Risk Assessment (RAC) has adopted an opinion in accordance with Article 70 of the REACH Regulation and the Committee for Socio-economic Analysis (SEAC) has adopted an opinion in accordance with Article 71 of the REACH Regulation on the proposal for restriction of Chemical name: Substances used in tattoo inks and permanent make-up EC No.: - CAS No.: - This document presents the opinion adopted by RAC and the Committee’s justification for its opinion. The Background Document, as a supportive document to both RAC and SEAC opinions and their justification, gives the details of the Dossier Submitters proposal amended for further information obtained during the public consultation and other relevant informat ion resulting from the opinion making process. PROCESS FOR ADOPTION OF THE OPINIONS ECHA has submitted a proposal for a restriction together with the justification and background information documented in an Annex XV dossier. The Annex XV report conforming to the requirements of Annex XV of the REACH Regulation was made publicly available at https://echa.europa.eu/restrictions-under-consideration/-/substance-rev/18114/term on 20/12/2017. Interested parties were invited to submit comments and contributions by 20/06/2018. ADOPTIO N OF THE OPINIO N ADOPTION OF THE OPINION OF RAC: Rapporteur, appointed by RAC: Veda Varnai Co-rapporteur, appointed by RAC: Boguslaw Baranski The opinion of RAC as to whether the suggested restriction is appropriate in reducing the risk to human health and/or the environment was adopted in accordance with Article 70 of the REACH Regulation on 20 November 2018. The opinion takes into account the comments of interested parties provided in accordance with Artic le 69(6) of the REACH Regulation. The opinion of RAC was adopted by consensus. ADOPTION OF THE OPINION OF SEAC Rapporteur, appointed by SEAC: Richard Luit Co-rapporteur, appointed by SEAC: Jean-Marc Brignon The draft opinion of SEAC The draft opinion of SEAC on the proposed restriction and on its related soc io-ec o nomic impac t has been agreed in accordance with Article 71(1) of the REACH Regulation on 29 November 2018. The draft opinion takes into account the comments from the interested parties provided in accordance with Article 69(6)(a) of the REACH Regulation. The draft opinion takes into account the socio-economic analysis, or information which can contribute to one, received from the interested parties provided in accordanc e with Artic le 69(6)(b) of the REACH Regulation. The draft opinion was published at http://echa.europa.eu/restrictions-under-consideration/- /substance-rev/18114/term on 12 December 2018. Interested parties were invited to submit comments on the draft opinion by 11 February 2019. The opinion of SEAC The opinion of SEAC on the proposed restriction and on its related soc io-ec ono mic impa c t was adopted in accordance with Article 71(1) and (2) of the REACH Regulation on [date of adoption of the opinion]. [The deadline for the opinion of SEAC was in accordance with Article 71(3) of the REACH Regulation extended by [number of days] by the ECHA decision [number and date]]1 . [The opinion takes into account the comments of interested parties provided in accordance with Artic le[s 69(6) and]5 71(1) of the REACH Regulation.] [No comments were received from interested parties during the public consultation in accordance with Article[s 69(6) and]3 71(1)]6 . The opinion of SEAC was adopted by [consensus.][a simple majority] of all membe rs having the right to vote. [The minority position[s], including their grounds, are made available in a separate document which has been published at the same time as the opinion.]6 . 1 Delete the unnecessary part(s) Contents A. OPINION OF RAC AND SEAC.............................................................................4 A.1. THE OPINION OF RAC ...............................................................................8 A.2. THE OPINION OF SEAC ........................................................................... 10 B. J USTIFICATION FOR THE OPINION OF RAC AND SEAC ........................................ 11 B.1. IDENTIFIED HAZARD, EXPOSURE/EMISSIONS AND RISK .............................. 11 Justific ation for the opinion of RAC .............................................................. 11 B.1.1. Description of and justification for targeting of the information on hazard(s) and exposure/emissions) (scope) ................................................................ 11 B.1.1.1. Summary of proposal: ............................................................... 11 B.1.1.2. RAC conclusion(s): .................................................................... 12 B.1.1.3. Key elements underpinning the RAC conclusion:............................. 13 B.1.2. Description of the risk(s) addressed by the proposed restriction............... 14 B.1.2.1. Information on hazard(s) ........................................................... 14 B.1.2.1.1. Summary of proposal: ......................................................... 14 B.1.2.1.2. RAC conclusion(s): ............................................................. 17 B.1.2.1.3. Key elements underpinning the RAC conclusion(s): .................. 17 B.1.2.2. Information on emissions and exposures....................................... 26 B.1.2.2.1. Summary of proposal: ......................................................... 26 B.1.2.2.2. RAC conclusion(s): ............................................................. 27 B.1.2.2.3. Key elements underpinning the RAC conclusion(s): .................. 27 B.1. 2.3. Cha rac terisation of risk(s) .......................................................... 30 B.1.2.3.1. Summary of proposal: ......................................................... 30 B.1.2.3.2. RAC conclusion(s): ............................................................. 30 B.1.2.3.3. Key elements underpinning the RAC conclusion(s): .................. 31 B.1. 2.4. Unc ertainties in the ris k c harac terisation ....................................... 36 B.1.3. Evidence if the risk management measures and operational conditions implemented and recommended by the manufactures and/or importers are not suffic ient to control the ris k ........................................................................ 39 B.1.3.1. Summary of proposal: ............................................................... 39 B.1.3.2. RAC conclusion(s): .................................................................... 39 B.1.3.3. Key elements underpinning the RAC conclusion(s): ......................... 39 B.1.4. Evidence if the existing regulatory risk management instruments are not suffic ient................................................................................................. 39 B.1.4.1. Summary of proposal: ............................................................... 39 B.1.4.2. RAC conclusion(s): .................................................................... 40 1 B.1.4.3. Key elements underpinning the RAC conclusion(s): ......................... 40 B.2. JUSTIFICATION IF ACTION IS REQUIRED ON AN UNION WIDE BASIS ............. 42 Justific ation for the opinion of SEAC and RAC ................................................ 42 B.2.1. Summary of proposal:...................................................................... 42 B.2.2. SEAC and RAC conclusion(s): ............................................................ 42 B.2.3. Key elements underpinning the SEAC and RAC conclusion(s): ................. 42 B.3. JUSTIFICATION WHETHER THE SUGGESTED RESTRICTION IS THE MOST APPROPRIATE EU WIDE MEASURE ................................................................... 42 Justific ation for the opinion of SEAC and RAC............................................. 42 B.3. 1. Sc ope inc luding de rogations .............................................................. 42 Justific ation for the opinion of RAC........................................................... 42 B.3.1.1. Summary of proposal: ............................................................... 42 B.3.1.2. RAC conclusion(s): .................................................................... 45 B.3.1.3. Key elements underpinning the RAC conclusion(s): ......................... 46 Justific ation for the opinion of SEAC ......................................................... 55 B.3.1.4. Summary of proposal: ............................................................... 55 B.3.1.5. SEAC conclusion(s): .................................................................