Commission Implementing Regulation (EU) 2017/2325 of 14 December 2017 concerning the authorisation of preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for all animal species and amending Implementing Regulation (EU) 2017/1007 (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2017/2325@2017-12-14/en
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC.
(2) Lecithins were authorised without a time limit in accordance with Directive 70/524/EEC as feed additive for all animal species. These additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 an application was submitted for the re-evaluation of preparations of lecithins as feed additives for all animal species. The applicant requested those additives to be classified in the additive category technological additives and in the functional group emulsifiers. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (the Authority) concluded in its opinion of 13 July 2016 that, under the proposed conditions of use, the preparations of lecithins, lecithins hydrolysed and lecithins de-oiled do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparations are considered efficacious for use in feed as emulsifiers. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of lecithins liquid, lecithins hydrolysed and lecithins de-oiled shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annex I to this Regulation.
(6) It is considered appropriate to harmonise the characteristics of the lecithins, lecithins liquid, lecithins hydrolysed and lecithins de-oiled and the conditions of use to avoid the distortion of the market, Commission Implementing Regulation (EU) 2017/1007 should be amended accordingly.
(7) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1 Authorisation
The additives specified in Annex I belonging to the additive category technological additives and to the functional group emulsifiers, are authorised as additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2 Amendment to Implementing Regulation (EU) 2017/1007
The Annex to Implementing Regulation (EU) 2017/1007 is replaced by the text in Annex II to this Regulation.
Article 3 Transitional measures
1. The additives specified in Annex I and premixtures containing those additives which are produced and labelled before 4 July 2018 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Compound feed and feed materials containing the additives as specified in Annex I which are produced and labelled before 4 January 2019 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Compound feed and feed materials containing the additives as specified in Annex I which are produced and labelled before 4 January 2020 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 4 Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 14 December 2017. For the Commission The President Jean-Claude Juncker
ANNEX
ANNEX I
Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of lecithins/kg of complete feedingstuff with a moisture content of 12 % Category of technological additives. Functional group: emulsifiers 1c322i — lecithins liquid All animal species — — — 4 January 2028 1c322ii hydrolysed lecithins All animal species 4 January 2028 1c322iii — Lecithins de-oiled All animal species — — — 4 January 2028
Additive composition
Preparation of lecithins: phospholipids ≥ 48 %, Moisture ≤ 1 % Liquid form
Characterisation of the active substance
Liquid lecithins (CAS No 8002-43-5) extracted from rapeseeds, sunflower and/or soybean
Analytical method
For the characterisation of feed additive: Commission Regulation (EU) No 231/2012 and the corresponding tests in the FAO JECFA monograph Lecithin
Additive composition
preparation of hydrolysed lecithins: phospholipids ≥ 44 %, Moisture ≤ 1 % Liquid form
Characterisation of the active substance
Liquid hydrolysed lecithins (CAS No 8002-43-5) extracted from sunflowers and/or soybeans
Analytical method
For the characterisation of feed additive: Commission Regulation (EU) No 231/2012 and the corresponding tests in the FAO JECFA monograph Lecithin
Additive composition
Preparation of de-oiled lecithins having a minimum of: phospholipids ≥ 75 %, Moisture ≤ 2 % Solid form
Characterisation of the active substance
Solid de-oiled lecithins (CAS No 8002-43-5) extracted from sunflowers and/or soybeans and defatted by solvent extraction
Analytical method
For the characterisation of feed additive: Commission Regulation (EU) No 231/2012 and the corresponding tests in the FAO JECFA monograph Lecithin
ANNEX II
ANNEX
Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of lecithins/kg of complete feedingstuff with a moisture content of 12 % Category of technological additives. Functional group: emulsifiers 1c322 — Lecithins All animal species — — — = 6 July 2027
Additive composition
Preparation of lecithins having a minimum of: Moisture ≤ 1 %
phospholipids ≥ 18 %,
lysophospholipids ≥ 11 %,
Characterisation of the active substance
Lecithins (CAS No 8002-43-5) extracted from soybeans
Analytical method
For the characterisation of feed additive: Commission Regulation (EU) No 231/2012 and the corresponding tests in the FAO JECFA monograph Lecithin
Versions
Cited by
- Commission Implementing Regulation (EU) 2018/1980 of 13 December 2018 amending Implementing Regulation (EU) 2017/2325 as regards the terms of authorisation of preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for all animal species (Text with EEA relevance) Regulation · Grade B
The uses of the preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives were authorised as feed additives for all animal species by Commission Implementing Regulation (EU) 2017/2325.
- Commission Implementing Regulation (EU) 2018/1980 of 13 December 2018 amending Implementing Regulation (EU) 2017/2325 as regards the terms of authorisation of preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for all animal species (Text with EEA relevance) Regulation · Grade B
Implementing Regulation (EU) 2017/2325 should therefore be amended accordingly.
- Commission Implementing Regulation (EU) 2018/1980 of 13 December 2018 amending Implementing Regulation (EU) 2017/2325 as regards the terms of authorisation of preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for all animal species (Text with EEA relevance) Regulation · Grade B
Annex I to Implementing Regulation (EU) 2017/2325 is replaced by the Annex to this Regulation.