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.)

• CELEX: Implementing Regulation (EU) 2018/1980
• Articles: 4

Article 1

Annex I to Implementing Regulation (EU) 2017/2325 is replaced by the Annex to this Regulation.

Article 2 Transitional measures

1.   The additives 1c322i, 1c322ii and 1c322iii and premixtures containing those additives which are produced and labelled before 2 July 2019 in accordance with the rules applicable before 2 January 2019 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 2 January 2020 in accordance with the rules applicable before 2 January 2019 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 2 January 2021 in accordance with the rules applicable before 2 January 2019 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 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

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

Additive composition

Preparations 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 substance

Lecithins, 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 gram

Peroxide value: equal to or less than 10

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

—

—

—

In the label of feed additive and premixures the form(s) used shall be indicated

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/fileadmin/user_upload/jecfa_additives/docs/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