Date: 2022-09-22Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 97/2022 of 29 April 2022 amending Annex I (Veterinary and phytosanitary matters) to the EEA Agreement [2022/1541]
Executive Summary:
This EEA Joint Committee Decision No. 97/2022 amends Annex I to the EEA Agreement to incorporate several Commission Implementing Regulations regarding feed additives. The decision incorporates regulations concerning phytomenadione, Bacillus licheniformis DSM 28710, Iron(III) citrate chelate, endo-1,4-beta-xylanase, Enterococcus faecium DSM 7134, manganese chelate of lysine and glutamic acid, and muramidase produced by Trichoderma reesei DSM 32338. This decision entered into force on April 30, 2022. The decision does not apply to Liechtenstein.
Key Points / Main Content:
* **Amendment of Annex I to the EEA Agreement:**
* Chapter II of Annex I is amended to include the following Commission Implementing Regulations:
* EU 2021/1409: Phytomenadione as a feed additive for horses.
* EU 2021/1410: Bacillus licheniformis DSM 28710 as a feed additive for poultry and ornamental birds.
* EU 2021/1412: Iron(III) citrate chelate as a feed additive for piglets and minor porcine species.
* EU 2021/1413: Endo-1,4-beta-xylanase produced by Bacillus subtilis LMGS 15136 as a feed additive for lactating sows.
* EU 2021/1414: Corrects Implementing Regulation EU 2021/422 concerning Enterococcus faecium DSM 7134 as a feed additive for laying hens.
* EU 2021/1424: Renewal of authorisation of Enterococcus faecium DSM 7134 as a feed additive for chickens for fattening and repeals Regulation EU No 998/2010.
* EU 2021/1425: Manganese chelate of lysine and glutamic acid as a feed additive for all animal species.
* EU 2021/1431: Muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for weaned piglets.
* Commission Regulation EU No 998/2010 is repealed.
* **Application:**
* The decision does not apply to Liechtenstein.
* **Authentic Texts:**
* The texts of the Implementing Regulations in Icelandic and Norwegian languages are authentic.
* **Entry into Force:**
* The Decision entered into force on 30 April 2022, following notifications under Article 103(1) of the EEA Agreement.
Impact Analysis:
* **Feed Additive Manufacturers and Suppliers:**
* *Impact:* Must comply with the updated regulations for feed additives, including new authorisations and the repealed regulation.
* *Action Required:* Ensure products meet the requirements of the incorporated regulations and discontinue use/production under the repealed regulation (EU No 998/2010).
* **Farmers and Animal Feed Users:**
* *Impact:* Need to be aware of the authorized feed additives and any changes in regulations.
* *Action Required:* Adjust feeding practices to comply with the updated list of authorized feed additives.
* **EEA Member States:**
* *Impact:* Required to implement and enforce the updated regulations.
* *Action Required:* Incorporate the changes into national legislation and ensure compliance.
* **Liechtenstein:**
* *Impact:* This Decision does not apply.
* *Action Required:* No action required.
Key Entities Referenced
EEA Joint Committee: The governing body responsible for decisions related to the Agreement on the European Economic Area (EEA).
EEA Agreement: The Agreement on the European Economic Area, an international agreement that extends the European Union's single market to non-EU member countries.
Commission Implementing Regulation EU 2021/1409: A European Union regulation concerning the authorisation of phytomenadione as a feed additive for horses.
Commission Implementing Regulation EU 2021/1410: A European Union regulation concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds.
Commission Implementing Regulation EU 2021/1412: A European Union regulation concerning the authorisation of Iron(III) citrate chelate as a feed additive for piglets and minor porcine species.
Commission Implementing Regulation EU 2021/1413: A European Union regulation concerning the authorisation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMGS 15136 as a feed additive for lactating sows.
Commission Implementing Regulation EU 2021/1424: A European Union regulation concerning the renewal of the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for chickens for fattening, and repealing Regulation EU No 998/2010.
Commission Implementing Regulation EU 2021/1431: A European Union regulation concerning the authorisation of muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for weaned piglets.
L 246/16 EN Official Journal of the European Union 22.9.2022
DECISION OF THE EEA JOINT COMMITTEE No 97/2022
of 29 April 2022
amending Annex I (Veterinary and phytosanitary matters) to the EEA Agreement [2022/1541]
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) 2021/1409 of 27 August 2021 concerning the authorisation of
phytomenadione as a feed additive for horses(1)is to be incorporated into the EEA Agreement.
(2) Commission Implementing Regulation (EU) 2021/1410 of 27 August 2021 concerning the authorisation of a
preparation of Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor poultry species for laying,
poultry species for breeding and ornamental birds (holder of authorisation Huvepharma NV)(2) is to be
incorporated into the EEA Agreement.
(3) Commission Implementing Regulation (EU) 2021/1412 of 27 August 2021concerning the authorisation of Iron(III)
citrate chelate as a feed additive for piglets and minor porcine species (holder of the authorisation: Akeso Biomedical,
Inc. USA, represented in the Union by Pen & Tec Consulting SLU)(3)is to be incorporated into the EEA Agreement.
(4) Commission Implementing Regulation (EU) 2021/1413 of 27 August 2021 concerning the authorisation of
endo-1,4-beta-xylanase produced by Bacillus subtilis LMG-S 15136 as a feed additive for lactating sows (holder of
the authorisation Beldem, division of Puratos NV)(4)is to be incorporated into the EEA Agreement.
(5) Commission Implementing Regulation (EU) 2021/1414 of 27 August 2021 correcting Implementing Regulation
(EU) 2021/422 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive
for laying hens (holder of authorisation: Lactosan GmbH & Co KG)(5)is to be incorporated into the EEA Agreement.
(6) Commission Implementing Regulation (EU) 2021/1424 of 31 August 2021 concerning the renewal of the
authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for chickens for fattening, and
repealing Regulation (EU) No 998/2010 (holder of authorisation Lactosan GmbH & Co KG)(6)is to be incorporated
into the EEA Agreement.
(7) Commission Implementing Regulation (EU) 2021/1425 of 31 August 2021 concerning the authorisation of
manganese chelate of lysine and glutamic acid as feed additive for all animal species(7)is to be incorporated into the
EEA Agreement.
(8) Commission Implementing Regulation (EU) 2021/1431 of 1 September 2021 concerning the authorisation of
muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for weaned piglets (holder of the
authorisation DSM Nutritional Products Ltd, represented in the Union by DSM Nutritional Products Sp. z o.o.)(8)is
to be incorporated into the EEA Agreement.
(1) OJ L 304, 30.8.2021, p. 5.
(2) OJ L 304, 30.8.2021, p. 8.
(3) OJ L 304, 30.8.2021, p. 14.
(4) OJ L 304, 30.8.2021, p. 18.
(5) OJ L 304, 30.8.2021, p. 21.
(6) OJ L 307, 1.9.2021, p. 9.
(7) OJ L 307, 1.9.2021, p. 12.
(8) OJ L 309, 2.9.2021, p. 5.22.9.2022 EN Official Journal of the European Union L 246/17
(9) Implementing Regulation (EU) 2021/1424 repeals Commission Regulation (EU) No 998/2010(9), which is
incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement.
(10) 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.
(11) 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 is added in point 400 (Commission Implementing Regulation (EU) 2021/422):
‘, as amended by:
— 32021 R 1414: Commission Implementing Regulation (EU) 2021/1414 of 27 August 2021(OJ L 304, 30.8.2021,
p. 21).’
2. The following points are inserted after point 417 (Commission Implementing Regulation (EU) 2021/982):
‘418. 32021 R 1409: Commission Implementing Regulation (EU) 2021/1409 of 27 August 2021 concerning the
authorisation of phytomenadione as a feed additive for horses (OJ L 304, 30.8.2021, p. 5).
419. 32021 R 1410: Commission Implementing Regulation (EU) 2021/1410 of 27 August 2021 concerning the
authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor
poultry species for laying, poultry species for breeding and ornamental birds (holder of authorisation
Huvepharma NV) (OJ L 304, 30.8.2021, p. 8).
420. 32021 R 1412: Commission Implementing Regulation (EU) 2021/1412 of 27 August 2021 concerning the
authorisation of Iron(III) citrate chelate as a feed additive for piglets and minor porcine species (holder of the
authorisation: Akeso Biomedical, Inc. USA, represented in the Union by Pen & Tec Consulting SLU) (OJ L 304,
30.8.2021, p. 14).
421. 32021 R 1413: Commission Implementing Regulation (EU) 2021/1413 of 27 August 2021 concerning the
authorisation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG-S 15136 as a feed additive for
lactating sows (holder of the authorisation Beldem, division of Puratos NV) (OJ L 304, 30.8.2021, p. 18).
422. 32021 R 1424: Commission Implementing Regulation (EU) 2021/1424 of 31 August 2021 concerning the
renewal of the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for chickens for
fattening, and repealing Regulation (EU) No 998/2010 (holder of authorisation Lactosan GmbH & Co KG)
(OJ L 307, 1.9.2021, p. 9).
423. 32021 R 1425: Commission Implementing Regulation (EU) 2021/1425 of 31 August 2021 concerning the
authorisation of manganese chelate of lysine and glutamic acid as feed additive for all animal species (OJ L 307,
1.9.2021, p. 12).
424. 32021 R 1431: Commission Implementing Regulation (EU) 2021/1431 of 1 September 2021 concerning the
authorisation of muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for weaned piglets
(holder of the authorisation DSM Nutritional Products Ltd, represented in the Union by DSM Nutritional
Products Sp. z o.o.) (OJ L 309, 2.9.2021, p. 5).’
(9) OJ L 290, 6.11.2010, p. 22.L 246/18 EN Official Journal of the European Union 22.9.2022
3. The text of point 2n (Commission Regulation (EU) No 998/2010) is deleted.
Article 2
The texts of Implementing Regulations (EU) 2021/1409, (EU) 2021/1410, (EU) 2021/1412, (EU) 2021/1413, (EU)
2021/1414, (EU) 2021/1424, (EU) 2021/1425 and (EU) 2021/1431 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.