Date: 2022-09-22Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 122/2022 of 29 April 2022 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/1566]
**Executive Summary:**
This EEA Joint Committee Decision No. 122/2022, dated April 29, 2022, amends Annex II to the EEA Agreement to incorporate several EU regulations and directives. These include updates related to REACH (Regulation EC No 1907/2006), classification, labeling and packaging of substances and mixtures (Regulation EC No 1272/2008), and exemptions regarding the use of DEHP in certain medical devices (Directive 2011/65/EU). The decision entered into force on April 30, 2022.
**Key Points / Main Content:**
* **Amendment of Annex II:** Chapter XV of Annex II to the EEA Agreement is amended.
* **Directive 2011/65/EU:** Point 12q is updated to include:
* Commission Delegated Directive (EU) 2021/1979 regarding DEHP in MRI detector coils.
* Commission Delegated Directive (EU) 2021/1980 regarding DEHP in ion-selective electrodes.
* **Regulation EC No 1907/2006 (REACH):** Point 12zc is updated to include:
* Commission Regulation (EU) 2021/2045 amending Annex XIV.
* **Regulation EC No 1272/2008:** Point 12zze is updated to include:
* Commission Delegated Regulation (EU) 2021/1962 correcting Annex VI.
* **Authentic Texts:** The Icelandic and Norwegian language versions of Regulation EU 2021/2045, Delegated Regulation EU 2021/1962, and Delegated Directives EU 2021/1979 and EU 2021/1980 are authentic.
* **Entry into Force:** The Decision entered into force on April 30, 2022, following notifications under Article 103(1) of the EEA Agreement.
* **Publication:** The Decision will be published in the EEA Section of, and the EEA Supplement to, the Official Journal of the European Union.
**Impact Analysis:**
**EEA Member States:**
* *Impact:* EEA Member States are required to incorporate the updated EU regulations and directives into their national legislation to ensure alignment with the EEA Agreement.
* *Action Required:* Review and update national laws and regulations to reflect the changes introduced by the incorporated EU legislation.
**Businesses operating within the EEA:**
* *Impact:* Businesses manufacturing, importing, or using chemicals and products covered by REACH, the classification, labeling and packaging regulation, and the DEHP exemptions for medical devices must comply with the updated requirements.
* *Action Required:* Assess the impact of the new regulations and directives on their products and processes, and implement necessary changes to ensure compliance.
**European Commission:**
* *Impact:* The European Commission is responsible for ensuring that the incorporated EU regulations and directives are correctly implemented and enforced by EEA member states.
* *Action Required:* Monitor the implementation of the updated regulations and directives in EEA member states and provide guidance and support as needed.
Key Entities Referenced
EEA Joint Committee: The governing body responsible for decisions related to the European Economic Area (EEA) Agreement.
EEA Agreement: The Agreement on the European Economic Area, which extends the EU's single market to Iceland, Liechtenstein and Norway.
Commission Regulation EU 2021/2045: A regulation of the European Commission amending Annex XIV to Regulation EC No 1907/2006 (REACH) to be incorporated into the EEA Agreement.
Regulation EC No 1907/2006: Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
Commission Delegated Regulation EU 2021/1962: A delegated regulation of the European Commission correcting Annex VI to Regulation EC No 1272/2008 to be incorporated into the EEA Agreement.
Regulation EC No 1272/2008: Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures.
Commission Delegated Directive EU 2021/1979: A delegated directive of the European Commission amending Annex IV to Directive 2011/65/EU regarding an exemption for DEHP in MRI detector coils, to be incorporated into the EEA Agreement.
Directive 2011/65/EU: Directive of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS Directive).
L 246/64 EN Official Journal of the European Union 22.9.2022
DECISION OF THE EEA JOINT COMMITTEE No 122/2022
of 29 April 2022
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2022/1566]
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) 2021/2045 of 23 November 2021 amending Annex XIV to Regulation (EC)
No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH)(1)is to be incorporated into the EEA Agreement.
(2) Commission Delegated Regulation (EU) 2021/1962 of 12 August 2021 correcting Annex VI to Regulation (EC)
No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of
substances and mixtures(2)is to be incorporated into the EEA Agreement.
(3) Commission Delegated Directive (EU) 2021/1979 of 11 August 2021 amending, for the purposes of adapting to
scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council
as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in plastic components in magnetic
resonance imaging (MRI) detector coils(3)is to be incorporated into the EEA Agreement.
(4) Commission Delegated Directive (EU) 2021/1980 of 11 August 2021 amending, for the purposes of adapting to
scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council
as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes for analysing
human body fluids and/or dialysate fluids(4)is to be incorporated into the EEA Agreement.
(5) Annex II to the EEA Agreement should therefore be amended accordingly,
HAS ADOPTED THIS DECISION:
Article 1
Chapter XV of Annex II to the EEA Agreement shall be amended as follows:
(1) The following indents are added in point 12q (Directive 2011/65/EU of the European Parliament and of the Council):
‘— 32021 L 1979: Commission Delegated Directive (EU) 2021/1979 of 11 August 2021(OJ L 402, 15.11.2021,
p. 69),
— 32021 L 1980: Commission Delegated Directive (EU) 2021/1980 of 11 August 2021(OJ L 402, 15.11.2021,
p. 73).’
(2) The following indent is added in point 12zc (Regulation (EC) No 1907/2006 of the European Parliament and of the
Council):
‘— 32021 R 2045: Commission Regulation (EU) 2021/2045 of 23 November 2021(OJ L 418, 24.11.2021, p. 6).’
(1) OJ L 418, 24.11.2021, p. 6.
(2) OJ L 400, 12.11.2021, p. 16.
(3) OJ L 402, 15.11.2021, p. 69.
(4) OJ L 402, 15.11.2021, p. 73.22.9.2022 EN Official Journal of the European Union L 246/65
(3) The following indent is added in point 12zze (Regulation (EC) No 1272/2008 of the European Parliament and of the
Council):
‘— 32021 R 1962: Commission Delegated Regulation (EU) 2021/1962 of 12 August 2021(OJ L 400, 12.11.2021,
p. 16).’
Article 2
The texts of Regulation (EU) 2021/2045, Delegated Regulation (EU) 2021/1962 and Delegated Directives (EU) 2021/1979
and (EU) 2021/1980 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 30 April 2022, provided that all the notifications under Article 103(1) of the EEA
Agreement have been made*.
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, 29 April 2022.
For the EEA Joint Committee
The President
Nicolas VON LINGEN
(*) No constitutional requirements indicated.