Date: 2022-09-22Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 121/2022 of 29 April 2022 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/1565]
**Summary:**
EEA Joint Committee Decision No. 121/2022, adopted on April 29, 2022, amends Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement. The amendment incorporates Commission Delegated Directive (EU) 2021/1978 into the EEA Agreement. Directive (EU) 2021/1978 adapts Annex IV to Directive 2011/65/EU concerning restrictions on the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices, to scientific and technical progress. This decision adds reference "32021 L 1978: Commission Delegated Directive (EU) 2021/1978 of 11 August 2021 (OJ L 402, 15.11.2021, p. 65)" to point 12q (Directive 2011/65/EU) of Chapter XV of Annex II of the EEA Agreement. The Icelandic and Norwegian language versions of Delegated Directive (EU) 2021/1978 will be published in the EEA Supplement to the Official Journal of the European Union and are considered authentic. The decision entered into force on April 30, 2022, pending all notifications under Article 103(1) of the EEA Agreement. The decision will be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union. The President of the EEA Joint Committee is Nicolas VON LINGEN.
Key Entities Referenced
EEA Joint Committee: The decision-making body responsible for amending the EEA Agreement.
EEA Agreement: Agreement on the European Economic Area.
Commission Delegated Directive (EU) 2021/1978: A directive amending Annex IV to Directive 2011/65/EU regarding exemptions for phthalates in medical devices.
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).
Annex II: Annex II to the EEA Agreement which lists technical regulations, standards, testing and certification.
Annex IV: Annex IV to Directive 2011/65/EU which lists exemptions for the use of restricted substances.
Brussels: The location where the Decision was signed.
Nicolas VON LINGEN: The President of the EEA Joint Committee.
22.9.2022 EN Official Journal of the European Union L 246/63
DECISION OF THE EEA JOINT COMMITTEE No 121/2022
of 29 April 2022
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2022/1565]
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 Delegated Directive (EU) 2021/1978 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), butyl benzyl phthalate (BBP), dibutyl
phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or
refurbishment of medical devices(1)is to be incorporated into the EEA Agreement.
(2) Annex II to the EEA Agreement should therefore be amended accordingly,
HAS ADOPTED THIS DECISION:
Article 1
The following indent is added in point 12q (Directive 2011/65/EU of the European Parliament and of the Council) of
Chapter XV of Annex II to the EEA Agreement:
‘— 32021 L 1978: Commission Delegated Directive (EU) 2021/1978 of 11 August 2021(OJ L 402, 15.11.2021, p. 65).’
Article 2
The text of Delegated Directive (EU) 2021/1978 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
(1) OJ L 402, 15.11.2021, p. 65.
(*) No constitutional requirements indicated.