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. )
Date: 2017-12-14
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, food emulsifier, market approval




L_2017333EN.01001701.xml










15.12.2017   


EN


Official Journal of the European Union


L 333/17








            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)


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 (1), 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).












(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 (3) 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 (4) 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
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)  EFSA Journal 2016;14(8):4561.

(4)  Commission Implementing Regulation (EU) 2017/1007 of 15 June 2017 concerning the authorisation of a preparation of lecithins as feed additive for all animal species (OJ L 153, 16.6.2017, p. 13).




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



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
 (1)

For the characterisation of feed additive:
Commission Regulation (EU) No 231/2012 (2) and the corresponding tests in the FAO JECFA monograph ‘Lecithin’ (3)
 (4)



All animal species


—


—


—


 


4 January 2028




1c322ii


 


hydrolysed lecithins



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
 (1)

For the characterisation of feed additive:
Commission Regulation (EU) No 231/2012 (2) and the corresponding tests in the FAO JECFA monograph ‘Lecithin’ (3)
 (4)



All animal species


 


 


 


 


4 January 2028




1c322iii


—


Lecithins de-oiled



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
 (1)

For the characterisation of feed additive:
Commission Regulation (EU) No 231/2012 (2) and the corresponding tests in the FAO JECFA monograph ‘Lecithin’ (3)
 (4)



All animal species


—


—


—


 


4 January 2028






(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

(2)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

(3)  FAO JECFA Combined Compendium of Food Additive Specifications, ‘Lecithin’, Monograph No 4 (2007), http://www.fao.org/ag/agn/jecfa-additives/specs/monograph4/additive-250-m4.pdf

(4)  FAO JECFA Combined Compendium for Food Additive Specifications — Analytical methods, test procedures and laboratory solutions used by and referenced in the food additive specifications, Vol. 4, http://www.fao.org/docrep/009/a0691e/a0691e00.htm





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



Additive composition

Preparation of lecithins having a minimum of:






—


phospholipids ≥ 18 %,










—


lysophospholipids ≥ 11 %,




Moisture ≤ 1 %

Characterisation of the active substance

Lecithins (CAS No 8002-43-5) extracted from soybeans

Analytical method
 (1)

For the characterisation of feed additive:
Commission Regulation (EU) No 231/2012 (2) and the corresponding tests in the FAO JECFA monograph “Lecithin” (3)
 (4)



All animal species


—


—


—


=


6 July 2027






               ’
            


(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

(2)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

(3)  FAO JECFA Combined Compendium of Food Additive Specifications, “Lecithin”, Monograph No 4 (2007), http://www.fao.org/ag/agn/jecfa-additives/specs/monograph4/additive-250-m4.pdf

(4)  FAO JECFA Combined Compendium for Food Additive Specifications — Analytical methods, test procedures and laboratory solutions used by and referenced in the food additive specifications, Vol. 4, http://www.fao.org/docrep/009/a0691e/a0691e00.htm