EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX  
10113/2016 CIS 
(POOL/2016/10113/10113-EN 
CIS.docx) 
[…](2020) XXX draft 
 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX 
concerning the authorisation of conjugated linoleic acid (t10, c12)-methylester as a feed 
additive for pigs for fattening and dairy cows 
(Text with EEA relevance) 
 EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX 
concerning the authorisation of conjugated linoleic acid (t10, c12)-methylester as a feed 
additive for pigs for fattening and dairy cows 
(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 nutrition1, 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(2) of Regulation (EC) No 1831/2003 provides for the re-evaluation of 
additives authorised pursuant to Council Directive 70/524/EEC2. 
(2) The substance conjugated linoleic acid (t10, c12)-methylester was authorised without 
a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal 
species under the category ‘nutritional additives’, functional group ‘vitamins, pro-
vitamins and chemically well-defined substances having similar effect’. Conjugated 
linoleic acid (t10, c12)-methylester was authorised implicitly under the mentioned 
functional group under the generic entry ‘3. All substances in the group except 
vitamins A and D’ without any specification. That substance was 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, in conjunction 
with Article 7 thereof, an application was submitted for the authorisation of 
conjugated linoleic acid (t10, c12)-methylester as feed additive for pigs for fattening, 
sows for reproduction, sows in order to have benefits in piglets, dairy cows and cows 
for reproduction. The applicant withdrew the application for sows for reproduction, for 
sows in order to have benefits in piglets and for cows for reproduction. The applicant 
requested the additive to be classified in the additive category ‘nutritional additives’ 
and in the functional group ‘vitamins, pro-vitamins and chemically well-defined 
substances having similar effect’. The application was accompanied by the particulars 
and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 
(4) The application of conjugated linoleic acid (t10, c12)-methylester in the functional 
group ‘vitamins, pro-vitamins and chemically well-defined substances having similar 
effect’ was based on the Report of the Scientific Committee for Animal Nutrition on 
                                                
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). EN 2  EN the classification of vitamins in the Annex to Directive 70/524/EEC concerning 
additives in animal feedingstuffs of 18 March 1994. This report considered that this 
substance had a similar effect to a vitamin.  
(5) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 3 
December 20153 and 24 January 20194 that, under the proposed conditions of use, 
linoleic acid (t10, c12)-methylester, does not have adverse effects on animal health, 
consumer safety or the environment for dairy cows and pigs for fattening. For pigs for 
fattening the Authority concluded that conjugated linoleic acid (t10, c12)-methylester, 
might have a potential for an improvement of feed to gain ratio. It effectively increases 
fat firmness due to an increased amount of saturated fatty acids in subcutaneous fat. 
There is also an increase in intramuscular fat, its degree of saturation and in marbling 
score. Conjugated linoleic acid (t10, c12)-methylester might also have a potential to 
improve the proportion of lean meat to subcutaneous fat in the carcass. For dairy cows, 
the Authority concluded that conjugated linoleic acid (t10, c12)-methylester reduces 
milk fat content and has the potential to reduce milk fat yield and milk energy output. 
The Authority stated that the allocation of this additive to the category ‘nutritional 
additives’ does not seem to be justified. The Commission, taking into account the 
considerations from the Authority and the effects of the additive on the zootechnical 
performance of dairy cows and pigs for fattening, has decided to classify this additive 
under the category ‘zootechnical additives’ and under the functional group ’other 
zootechnical additives’ 
(6) The Authority concluded that the exposure of users by inhalation of the solid product 
is likely to be minimal; no data on potential mist formation from the liquid product 
were provided. A beadlet formulation of the liquid product elicited mild but persistent 
dermal irritation, whereas it was not an eye irritant. The skin sensitisation potential 
was masked by the effect of the placebo. Neither of the products under application, the 
liquid or the solid product, was tested as such for skin and eye irritation and skin 
sensitisation. Therefore, the Commission considers that appropriate protective 
measures should be taken to prevent adverse effects on human heath, in particular, as 
regards the users of the additive, including the use of the additives in the form of a 
preparation. The Authority further concluded that the additive is effective. The 
Authority does not consider that there is a need for specific requirements of post-
market monitoring. It also verified the report on the method of analysis of the feed 
additive in feed submitted by the European Union Reference Laboratory set up by 
Regulation (EC) No 1831/2003. 
(7) The assessment of the additive shows that the conditions for authorisation, as provided 
for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use 
of conjugated linoleic acid (t10, c12)-methylester should be authorised as specified in 
the Annex to this Regulation. 
(8) Since safety reasons do not require the immediate application of the modifications to 
the conditions of authorisation of conjugated linoleic acid (t10, c12)-methylester, it is 
appropriate to allow a transitional period for interested parties to prepare themselves to 
meet the new requirements resulting from the authorisation.   
(9) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
                                                
3 EFSA Journal 2016;14(1):4348. 
4 EFSA Journal 2019;17(3):5614. EN 3  EN  
HAS ADOPTED THIS REGULATION: 
Article 1 
The substance specified in the Annex, belonging to the additive category ‘zootechnical 
additives’ and to the functional group ‘other zootechnical additives’, is authorised as an 
additive in animal nutrition, subject to the conditions laid down in that Annex.  
Article 2 
1. The substance specified in the Annex and premixtures containing this substance, 
which are produced and labelled before [ 6 months after the date of entry into force of this 
Regulation – Date to be inserted by the Service responsible for the publication] in accordance 
with the rules applicable before  [the date of entry into force of this Regulation – Date to be 
inserted by the Service responsible for the publication ] may continue to be placed on the 
market and used until the existing stocks are exhausted. 
2. Compound feed and feed materials containing the substance as specified in the Annex 
which are produced and labelled before [1 2 months after the date of entry into force of this 
Regulation – Date to be inserted by the Service responsible for the publication ] in accordance 
with the rules applicable before [ the date of entry into force of this Regulation – Date to be 
inserted by the Service responsible for the publication ] may continue to be placed on the 
market and used until the existing stocks are exhausted if they are intended for pigs for 
fattening, sows for reproduction, sows in order to have benefit in piglets, cows for 
reproduction and dairy cows. 
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 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President 
 Ursula VON DER LEYEN