Date: 2022-09-22Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 98/2022 of 29 April 2022 amending Annex I (Veterinary and phytosanitary matters) to the EEA Agreement [2022/1542]
Executive Summary:
This EEA Joint Committee Decision No. 98/2022 amends Annex I to the EEA Agreement to incorporate Commission Implementing Regulations (EU) 2021/1411 and (EU) 2021/1426 regarding feed additives. It also repeals Implementing Regulations (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014. The decision does not apply to Liechtenstein and came into force on April 30, 2022.
Key Points / Main Content:
* **Amendments to Annex I:**
* Commission Implementing Regulation (EU) 2021/1411 concerning Clostridium butyricum FERM BP2789 as a feed additive is added to Annex I.
* Commission Implementing Regulation (EU) 2021/1426 concerning serine protease produced by Bacillus licheniformis DSM 19670 as a feed additive is added to Annex I.
* Implementing Regulations (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014 are deleted from Annex I.
* **Liechtenstein Exclusion:**
* This Decision does not apply to Liechtenstein.
* **Authentic Texts:**
* The Icelandic and Norwegian language texts of Implementing Regulations (EU) 2021/1411 and (EU) 2021/1426 are authentic.
* **Entry into Force:**
* The Decision entered into force on April 30, 2022, after all notifications under Article 103(1) of the EEA Agreement were made.
Impact Analysis:
* **EEA Member States (excluding Liechtenstein):**
* *Impact:* Must align national regulations with the updated Annex I of the EEA Agreement, incorporating the new regulations on feed additives and removing the repealed ones.
* *Action Required:* Update national legislation to reflect the changes introduced by Implementing Regulations (EU) 2021/1411 and (EU) 2021/1426, and ensure compliance with the repeal of Implementing Regulations (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014.
* **Feed Additive Manufacturers/Suppliers:**
* *Impact:* Companies producing or supplying Clostridium butyricum FERM BP2789 and serine protease produced by Bacillus licheniformis DSM 19670 must comply with the specifications and conditions outlined in Implementing Regulations (EU) 2021/1411 and (EU) 2021/1426, respectively, for sales within the EEA (excluding Liechtenstein).
* *Action Required:* Ensure that their products meet the requirements of the new regulations and that any previously authorized products under the repealed regulations comply with current standards or are removed from the market.
Key Entities Referenced
EEA Joint Committee: The governing body responsible for decisions related to the Agreement on the European Economic Area (EEA).
EEA Agreement: Agreement on the European Economic Area
Commission Implementing Regulation EU 2021/1411: A European Union regulation concerning the renewal of the authorisation of Clostridium butyricum FERM BP2789 as a feed additive.
Clostridium butyricum FERM BP2789: Feed additive for chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species excluding laying birds, weaned piglets and weaned minor porcine species
Commission Implementing Regulation EU 2021/1426: A European Union regulation concerning the authorisation of serine protease produced by Bacillus licheniformis DSM 19670 as a feed additive for chickens for fattening
Bacillus licheniformis DSM 19670: A feed additive that produces serine protease.
Liechtenstein: A country in Europe to which specific aspects of the EEA Agreement may not apply regarding feedingstuffs legislation.
Brussels: The location where the decision was made by the EEA Joint Committee.
22.9.2022 EN Official Journal of the European Union L 246/19
DECISION OF THE EEA JOINT COMMITTEE No 98/2022
of 29 April 2022
amending Annex I (Veterinary and phytosanitary matters) to the EEA Agreement [2022/1542]
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 Implementing Regulation (EU) 2021/1411 of 27 August 2021 concerning the renewal of the
authorisation of Clostridium butyricum FERM BP-2789 as a feed additive for chickens reared for laying, turkeys for
fattening, turkeys reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned
minor porcine species, its authorisation for chickens for fattening, suckling piglets and suckling minor porcine
species, and repealing Implementing Regulations (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014
(holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium)(1) is to be
incorporated into the EEA Agreement.
(2) Commission Implementing Regulation (EU) 2021/1426 of 31 August 2021concerning the authorisation of serine
protease produced by Bacillus licheniformis DSM 19670 as a feed additive for chickens for fattening (holder of the
authorisation: DSM Nutritional Products Ltd., represented in the Union by DSM Nutritional Products Sp. z o.o.)(2)
is to be incorporated into the EEA Agreement.
(3) Implementing Regulation (EU) 2021/1411 repeals Commission Implementing Regulations (EU) No 373/2011(3),
(EU) No 374/2013(4)and (EU) No 1108/2014(5)which are incorporated into the EEA Agreement and which are
consequently to be repealed under the EEA Agreement.
(4) This Decision concerns legislation regarding feedingstuffs. Legislation regarding feedingstuffs 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 sectoral adaptations
to Annex I to the EEA Agreement. This Decision is therefore not to apply to Liechtenstein.
(5) Annex I to the EEA Agreement should therefore be amended accordingly,
HAS ADOPTED THIS DECISION:
Article 1
Chapter II of Annex I to the EEA Agreement shall be amended as follows:
1. The following points are inserted after point 424 (Commission Implementing Regulation (EU) 2021/1431):
‘425. 32021 R 1411: Commission Implementing Regulation (EU) 2021/1411 of 27 August 2021 concerning the
renewal of the authorisation of Clostridium butyricum FERM BP-2789 as a feed additive for chickens reared for
laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), weaned
piglets and weaned minor porcine species, its authorisation for chickens for fattening, suckling piglets and
(1) OJ L 304, 30.8.2021, p. 11.
(2) OJ L 307, 1.9.2021, p. 17.
(3) OJ L 102, 16.4.2011, p. 10.
(4) OJ L 112, 24.4.2013, p. 13.
(5) OJ L 301, 21.10.2014, p. 16.L 246/20 EN Official Journal of the European Union 22.9.2022
suckling minor porcine species, and repealing Implementing Regulations (EU) No 373/2011, (EU) No 374/2013
and (EU) No 1108/2014 (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma
NV Belgium) (OJ L 304, 30.8.2021, p. 11).
426. 32021 R 1426: Commission Implementing Regulation (EU) 2021/1426 of 31 August 2021 concerning the
authorisation of serine protease produced by Bacillus licheniformis DSM 19670 as a feed additive for chickens for
fattening (holder of the authorisation: DSM Nutritional Products Ltd., represented in the Union by DSM
Nutritional Products Sp. z o.o.) (OJ L 307, 1.9.2021, p. 17).’
2. The texts of points 2zb (Commission Implementing Regulation (EU) No 373/2011), 95 (Commission Implementing
Regulation (EU) No 374/2013) and 116 (Commission Implementing Regulation (EU) No 1108/2014) are deleted.
Article 2
The texts of Implementing Regulations (EU) 2021/1411 and (EU) 2021/1426 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.