Document ID: 02017R2325-20190103
Language: ENG

02017R2325 — EN — 03.01.2019 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>COMMISSION IMPLEMENTING REGULATION (EU) 2017/2325</p><p>of 14 December 2017</p><p>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</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 333 15.12.2017, p. 17)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2018/1980&#160;of 13&#160;December 2018</a></p></td><td><p>&#160;&#160;L&#160;317</p></td><td><p>12</p></td><td><p>14.12.2018</p></td></tr></table>
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)
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.
ANNEX I
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Identification number of the additive</p></td><td><p>Name of the holder of authorisation</p></td><td><p>Additive</p></td><td><p>Composition, chemical formula, description, analytical method</p></td><td><p>Species or category of animal</p></td><td><p>Maximum age</p></td><td><p>Minimum content</p></td><td><p>Maximum content</p></td><td><p>Other provisions</p></td><td><p>End of period of&#160;authorisation</p></td></tr><tr><td><p>mg of lecithins/kg of complete feedingstuff with a moisture content of 12 %</p></td></tr><tr><td><p><span>Category of technological additives. Functional group: emulsifiers</span></p></td></tr><tr><td><p>1c322i</p></td><td><p>&#8212;</p></td><td><p>Lecithins</p></td><td><p><span>Additive composition</span></p><p>Preparations of:</p><div><p>&#8212;&#160;lecithins and hydrolysed lecithins in liquid (plastic to fluid) form;</p></div><div><p>&#8212;&#160;de-oiled lecithins and de-oiled hydrolysed lecithins in solid form.</p></div><p><span>Characterisation of the active substance</span></p><p>Lecithins, hydrolysed lecithins, de-oiled lecithins and de-oiled hydrolysed lecithins derived from soybean, sunflower or rapeseed:</p><p>CAS no. 8002-43-5;</p><p><span>Assay:</span></p><div><p>&#8212;&#160;Lecithins, de-oiled lecithins: not less than 60,0 % of substances insoluble in acetone;</p></div><div><p>&#8212;&#160;hydrolysed lecithins and de-oiled hydrolysed lecithins: not less than 56,0&#160;% substances insoluble in acetone.</p></div><p>Loss on drying: not more than 2 % (105&#160;&#176;C, 1&#160;hour)</p><p>Toluene-insoluble matter: not more than 0,3&#160;%</p><p><span>Acid value:</span></p><div><p>&#8212;&#160;Lecithins, de-oiled lecithins not more than 35 mg of potassium hydroxide per gram;</p></div><div><p>&#8212;&#160;hydrolysed lecithins and de-oiled hydrolysed lecithins: not more than 45&#160;mg of potassium hydroxide per gram</p></div><p>Peroxide value: equal to or less than 10</p><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>For the characterisation of feed additive:</p><p>Commission Regulation (EU) No 231/2012&#160;<a>(<span>2</span>)</a> and the corresponding tests in the FAO JECFA monograph &#8216;Lecithin&#8217;&#160;<a>(<span>3</span>)</a>&#160;<a>(<span>4</span>)</a></p></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>In the label of feed additive and premixures the form(s) used shall be indicated</p></td><td><p>6 July 2027</p></td></tr><tr><td><p><a>(<span>1</span>)&#160;&#160;&#160;</a>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</p><p><a>(<span>2</span>)&#160;&#160;&#160;</a>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&#160;83, 22.3.2012, p.&#160;1).</p><p><a>(<span>3</span>)&#160;&#160;&#160;</a>FAO JECFA Combined Compendium of Food Additive Specifications, &#8216;Lecithin&#8217;, Monograph No 4 (2007), http://www.fao.org/fileadmin/user_upload/jecfa_additives/docs/monograph4/additive-250-m4.pdf</p><p><a>(<span>4</span>)&#160;&#160;&#160;</a>FAO JECFA Combined Compendium for Food Additive Specifications &#8212; 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</p></td></tr></tbody></table>
ANNEX II
‘ANNEX
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Identification number of the additive</p></td><td><p>Name of the holder of authorisation</p></td><td><p>Additive</p></td><td><p>Composition, chemical formula, description, analytical method</p></td><td><p>Species or category of animal</p></td><td><p>Maximum age</p></td><td><p>Minimum content</p></td><td><p>Maximum content</p></td><td><p>Other provisions</p></td><td><p>End of period of authorisation</p></td></tr><tr><td><p>mg of lecithins/kg of complete feedingstuff with a moisture content of 12 %</p></td></tr><tr><td><p><span>Category of technological additives. Functional group: emulsifiers</span></p></td></tr><tr><td><p>1c322</p></td><td><p>&#8212;</p></td><td><p>Lecithins</p></td><td><p><span>Additive composition</span></p><p>Preparation of lecithins having a minimum of:</p><div><p>&#8212;&#160;phospholipids &#8805; 18 %,</p></div><div><p>&#8212;&#160;lysophospholipids &#8805; 11 %,</p></div><p>Moisture &#8804; 1 %</p><p><span>Characterisation of the active substance</span></p><p>Lecithins (CAS No 8002-43-5) extracted from soybeans</p><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>For the characterisation of feed additive:</p><p>Commission Regulation (EU) No 231/2012&#160;<a>(<span>2</span>)</a> and the corresponding tests in the FAO JECFA monograph &#8220;Lecithin&#8221;&#160;<a>(<span>3</span>)</a>&#160;<a>(<span>4</span>)</a></p></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>=</p></td><td><p>6 July 2027&#8217;</p></td></tr><tr><td><p><a>(<span>1</span>)&#160;&#160;&#160;</a>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</p><p><a>(<span>2</span>)&#160;&#160;&#160;</a>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).</p><p><a>(<span>3</span>)&#160;&#160;&#160;</a>FAO JECFA Combined Compendium of Food Additive Specifications, &#8220;Lecithin&#8221;, Monograph No 4 (2007), http://www.fao.org/ag/agn/jecfa-additives/specs/monograph4/additive-250-m4.pdf</p><p><a>(<span>4</span>)&#160;&#160;&#160;</a>FAO JECFA Combined Compendium for Food Additive Specifications &#8212; 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</p></td></tr></tbody></table>