Date: 2018-03-15Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 143/2016 of 8 July 2016 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2018/365]
Executive Summary:
EEA Joint Committee Decision No. 143/2016 amends Annex II to the EEA Agreement to incorporate Commission Delegated Regulation (EU) 2016/128 regarding food for special medical purposes. This decision also repeals Commission Directive 1999/21/EC with effect from February 22, 2019. The Decision does not apply to Liechtenstein under specific conditions.
Key Points / Main Content:
* **Incorporation of Regulation (EU) 2016/128:**
* Commission Delegated Regulation (EU) 2016/128 is inserted into Chapter XII of Annex II to the EEA Agreement after point 77 (Regulation (EU) No 609/2013) as point 77a.
* Annex IV is updated with Icelandic and Norwegian translations.
* **Repeal of Directive 1999/21/EC:**
* Point 54w (Commission Directive 1999/21/EC) is deleted from Annex II to the EEA Agreement, effective February 22, 2019.
* **Liechtenstein Exemption:**
* The Decision does not apply to Liechtenstein as long as the Agreement between the European Community and the Swiss Confederation on trade in agricultural products is extended to Liechtenstein.
* **Authentic Languages:**
* The Icelandic and Norwegian language texts of Delegated Regulation (EU) 2016/128 are authentic and will be published in the EEA Supplement to the Official Journal of the European Union.
* **Entry into Force and Publication:**
* The Decision entered into force on July 9, 2016, following 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.
Impact Analysis:
**EEA Member States (excluding Liechtenstein under specific conditions):**
* Impact: Must comply with the updated regulations regarding food for special medical purposes as outlined in Regulation (EU) 2016/128.
* Action Required: Incorporate the provisions of Regulation (EU) 2016/128 into national legislation and ensure compliance.
**Food Producers and Manufacturers:**
* Impact: Must adhere to the specific compositional and informational requirements for food for special medical purposes as detailed in Regulation (EU) 2016/128.
* Action Required: Review and update product formulations, labeling, and marketing materials to comply with Regulation (EU) 2016/128.
**European Commission:**
* Impact: Responsible for overseeing the implementation and enforcement of Regulation (EU) 2016/128 within the EEA.
* Action Required: Monitor compliance and provide guidance to EEA Member States and stakeholders as needed. Ensure publication of the decision in the Official Journal.
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 Regulation EU 2016/128: A regulation supplementing Regulation EU No 609/2013 regarding food for special medical purposes.
Regulation EU No 609/2013: Regulation of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes
Commission Directive 1999/21/EC: A directive incorporated into the EEA Agreement concerning foodstuffs, repealed by Delegated Regulation EU 2016/128.
Liechtenstein: A country to which legislation regarding foodstuffs shall not apply under certain conditions as specified in the introduction to Chapter XII of Annex II to the EEA Agreement
European Community: Former name of European Union
Swiss Confederation: A country that has an agreement with the European Community on trade in agricultural products.
L 73/14 EN Official Journal of the European Union 15.3.2018
DECISION OF THE EEA JOINT COMMITTEE
No 143/2016
of 8 July 2016
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2018/365]
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 Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/
2013 of the European Parliament and of the Council as regards the specific compositional and information
requirements for food for special medical purposes (1) is to be incorporated into the EEA Agreement.
(2) Delegated Regulation (EU) 2016/128 repeals, with effect from 22 February 2019, Commission Directive 1999/21/
EC (2), which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA
Agreement with effect from 22 February 2019.
(3) This Decision concerns legislation regarding foodstuffs. Legislation regarding foodstuffs shall not apply to
Liechtenstein as long as the application of the Agreement between the European Community and the Swiss
Confederation on trade in agricultural products is extended to Liechtenstein, as specified in the introduction to
Chapter XII of Annex II to the EEA Agreement. This Decision is therefore not to apply to Liechtenstein.
(4) Annex II to the EEA Agreement should therefore be amended accordingly,
HAS ADOPTED THIS DECISION:
Article 1
1. The following is inserted after point 77 (Regulation (EU) No 609/2013 of the European Parliament and of the
Council) of Chapter XII of Annex II to the EEA Agreement:
‘77a. 32016 R 0128: Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing
Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific
compositional and information requirements for food for special medical purposes (OJ L 25, 2.2.2016, p. 30).
The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following
adaptations:
In Annex IV, the following shall be added:
— in Icelandic: “Matvæli til nota í sérstökum læknisfræðilegum tilgangi”
— in Norwegian: “Næringsmiddel til spesielle medisinske formål”.’
2. The text of point 54w (Commission Directive 1999/21/EC) shall be deleted with effect from 22 February 2019.
Article 2
The text of Delegated Regulation (EU) 2016/128 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 9 July 2016, provided that all the notifications under Article 103(1) of the EEA
Agreement have been made (*).
(1) OJ L 25, 2.2.2016, p. 30.
(2) OJ L 91, 7.4.1999, p. 29.
(*) No constitutional requirements indicated.15.3.2018 EN Official Journal of the European Union L 73/15
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, 8 July 2016.
For the EEA Joint Committee
The President
Bergdís ELLERTSDÓTTIR