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. )
Modified by
  • Commission Implementing Regulation (EU) 2018/1980of 13 December 2018amending 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), 32018R1980, December 14, 2018
Commission Implementing Regulation (EU) 2017/2325of 14 December 2017concerning 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)
Article 1AuthorisationThe 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 2Amendment to Implementing Regulation (EU) 2017/1007The Annex to Implementing Regulation (EU) 2017/1007 is replaced by the text in Annex II to this Regulation.
Article 3Transitional measures1.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 4Entry into forceThis 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.ANNEX I
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-reportsCommission 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).FAO JECFA Combined Compendium of Food Additive Specifications, "Lecithin", Monograph No 4 (2007), http://www.fao.org/fileadmin/user_upload/jecfa_additives/docs/monograph4/additive-250-m4.pdfFAO 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.htmCategory of technological additives. Functional group: emulsifiers
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg of lecithins/kg of complete feedingstuff with a moisture content of 12 %
1c322i—LecithinsAdditive compositionPreparations of:lecithins and hydrolysed lecithins in liquid (plastic to fluid) form;de-oiled lecithins and de-oiled hydrolysed lecithins in solid form.Characterisation of the active substanceLecithins, hydrolysed lecithins, de-oiled lecithins and de-oiled hydrolysed lecithins derived from soybean, sunflower or rapeseed:CAS no. 8002-43-5;Assay:Lecithins, de-oiled lecithins: not less than 60,0 % of substances insoluble in acetone;hydrolysed lecithins and de-oiled hydrolysed lecithins: not less than 56,0 % substances insoluble in acetone.Loss on drying: not more than 2 % (105 °C, 1 hour)Toluene-insoluble matter: not more than 0,3 %Acid value:Lecithins, de-oiled lecithins not more than 35 mg of potassium hydroxide per gram;hydrolysed lecithins and de-oiled hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gramPeroxide value: equal to or less than 10Analytical methodFor the characterisation of feed additive:Commission Regulation (EU) No 231/2012 and the corresponding tests in the FAO JECFA monograph "Lecithin"All animal species———In the label of feed additive and premixures the form(s) used shall be indicated6 July 2027
ANNEX II"ANNEX
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-reportsCommission 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).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.pdfFAO 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.htmCategory of technological additives. Functional group: emulsifiers
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg of lecithins/kg of complete feedingstuff with a moisture content of 12 %
1c322—LecithinsAdditive compositionPreparation of lecithins having a minimum of:phospholipids ≥ 18 %,lysophospholipids ≥ 11 %,Moisture ≤ 1 %Characterisation of the active substanceLecithins (CAS No 8002-43-5) extracted from soybeansAnalytical methodFor the characterisation of feed additive:Commission Regulation (EU) No 231/2012 and the corresponding tests in the FAO JECFA monograph "Lecithin"All animal species———=6 July 2027"
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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-reportsCommission 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).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.pdfFAO 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
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