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Date: 25-Jan-2024 Category: Not Applicable State: Union Government Country: Europe

Decision of the EEA Joint Committee No 137/2021 of 23 April 2021 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/142]

Issued by EEA Joint Committee · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The Decision of the EEA Joint Committee No 137/2021 incorporates Commission Regulation (EU) 2020/2081 regarding substances in tattoo inks or permanent make-up and Commission Regulation (EU) 2020/2096 regarding carcinogenic, mutagenic or reproductive toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and testing methods for azocolourants into the EEA Agreement.

Key Changes

  • Annex II to the EEA Agreement is amended to include Commission Regulation (EU) 2020/2081 of 14 December 2020 concerning restrictions on substances in tattoo inks or permanent make-up.
  • Annex II to the EEA Agreement is also amended to include Commission Regulation (EU) 2020/2096 of 15 December 2020 concerning restrictions on carcinogenic, mutagenic or reproductive toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and testing methods for azocolourants.
  • The regulations are incorporated by adding indents in point 12zc of Chapter XV of Annex II to the EEA Agreement.
  • The Decision entered into force on 24 April 2021, provided that all notifications under Article 103(1) of the EEA Agreement were made.

Impact Analysis

Manufacturers and Suppliers of Tattoo Inks and Permanent Make-up

  • Action Items: Review product formulations, supply chains, and labeling to ensure compliance. Implement necessary changes to product composition and documentation. Monitor future regulatory updates.

Manufacturers and Suppliers of Chemicals and Products Containing CMR Substances, Persistent Organic Pollutants, etc.

  • Action Items: Review product formulations, supply chains, and labeling to ensure compliance. Implement necessary changes to product composition and documentation. Monitor future regulatory updates.

Tattoo Artists and Permanent Make-up Technicians

  • Action Items: Verify that the inks and products they use comply with Regulation (EU) 2020/2081. Obtain documentation from suppliers confirming compliance. Monitor future regulatory updates.

Consumers

  • Action Items: Be aware of the regulations and ask tattoo artists and suppliers about the compliance of their products.

EEA Member States

  • Action Items: Incorporate the regulations into national law and ensure effective enforcement.

Key Entities Referenced

EEA Joint Committee: The decision-making body responsible for amending the EEA Agreement. Commission Regulation (EU) 2020/2081: Regulation amending Annex XVII to Regulation (EC) No 1907/2006 (REACH) as regards substances in tattoo inks or permanent make-up. Commission Regulation (EU) 2020/2096: Regulation amending Annex XVII to Regulation (EC) No 1907/2006 (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and testing methods for azocolourants. Regulation (EC) No 1907/2006 (REACH): Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Regulation (EU) 2017/745: Regulation of the European Parliament and of the Council on medical devices. EEA Agreement: Agreement on the European Economic Area.
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Official Journal EN of the European Union L series 2024/142 25.1.2024 DECISION OF THE EEA JOINT COMMITTEE No 137/2021 of 23 April 2021 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/142] THE EEA JOINT COMMITTEE, Having regard to the Agreement on the European Economic Area (“the EEA Agreement”), and in particular Article 98 thereof, Whereas: (1) Commission Regulation (EU) 2020/2081 of 14 December 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent make-up(1) is to be incorporated into the EEA Agreement. (2) Commission Regulation (EU) 2020/2096 of 15 December 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and testing methods for azocolourants(2)is to be incorporated into the EEA Agreement. (3) Annex II to the EEA Agreement should therefore be amended accordingly, HAS ADOPTED THIS DECISION: Article 1 The following indents are added in point 12zc (Regulation (EC) No 1907/2006 of the European Parliament and of the Council) of Chapter XV of Annex II to the EEA Agreement: ‘- 32020 R 2081: Commission Regulation (EU) 2020/2081 of 14 December 2020(OJ L 423, 15.12.2020, p. 6), - 32020 R 2096: Commission Regulation (EU) 2020/2096 of 15 December 2020(OJ L 425, 16.12.2020, p. 3).’ Article 2 The texts of Regulations (EU) 2020/2081 and (EU) 2020/2096 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic. Article 3 This Decision shall enter into force on 24 April 2021, provided that all the notifications under Article 103(1) of the EEA Agreement have been made*. (1) OJ L 423, 15.12.2020, p. 6. (2) OJ L 425, 16.12.2020, p. 3. * No constitutional requirements indicated. ELI: http://data.europa.eu/eli/dec/2024/142/oj 1/2EN OJ L, 25.1.2024 Article 4 This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union. Done at Brussels, 23 April 2021. For the EEA Joint Committee The President Clara GANSLANDT 2/2 ELI: http://data.europa.eu/eli/dec/2024/142/oj

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