EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/11231/2014 
(POOL/G1/2014/11231/11231-EN.doc) 
[…](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EC) No 1831/2003 of the European Parliament and of the Council 
as regards requirements for the placing on th e market and conditions of use of additives 
consisting of preparations 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EC) No 1831/2003 of the European Parliament and of the Council 
as regards requirements for the placing on th e market and conditions of use of additives 
consisting of preparations 
(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 additi ves for use in animal nutrition
1, and in particular 
Articles 3(5) and 16(6) thereof, 
Whereas: (1) In some preparations, authorised as additi ves in accordance with Regulation (EC) No 
1831/2003, technological additives and other substances or products are incorporated 
to exert a function on the act ive substance contained in the preparation, such as 
stabilising or standardising it,  facilitating its handling or its incorporation into feed. 
For example, those technological additive s or other substances or products may 
increase flowability or homogeneity or  reduce the dusting potential of the active 
substance. The specific composition of author ised additives consisting of preparations 
will therefore vary according to the rationale  for the use of those preparations. The 
technological additives or other substances or  products added to ma intain the integrity 
of an active substance are however not inte nded to perform a function in the feed in 
which the preparation is  to be incorporated. 
(2) Taking into account that technol ogical progress cont ributes to the development of new 
preparations, it is appropriate to better consid er the specificities of additives consisting 
of preparations and to bring more transpar ency and clarity when placing them on the 
market, without affecting intellectual prope rty rights relating to the composition of 
premixtures containing such additives. 
(3) In particular, it is appropriate to intr oduce into Annex III of Regulation (EC) No 
1831/2003 additional labelling requirements for this type of additives and for premixtures containing them, so as to allow a verification that te chnological additives 
used in a preparation are authorised for the intended purpose and that those additives exert a function only on the active substa nce contained in the preparation.  
                                                
 
1 OJ L 268 18.10.2003, p. 29.  EN 3   EN (4) While the most relevant information should be kept on the packaging or container of 
the additive or the premixture, techno logical progress also allows providing 
information about the composition of the pr eparations in a more flexible and less 
costly way via other written means. This is in compliance with the definition of labelling provided for in Regulation (EC)  No 767/2009 of the European Parliament 
and of the Council
2. 
(5) Operators should be able to provide in formation about the composition of the 
preparations which are placed on the market  since such information enables the end-
user or the purchaser to make an informed  choice, allows appropriate risk assessment 
and contributes to fairness of transactions. 
(6) Those additional labelling and informa tion requirements should apply only to 
additives belonging to the categories referred to in Article 6(1)(a ), (b) and (c) of 
Regulation (EC) No 1831/2003. Wh ere such additives are authorised as preparations, 
only the active substance is indeed the subj ect of the authorisati on, and not the other 
components of the preparations, which may vary. 
(7) In order to prevent any undesirable effect s on human health, animal health or the 
environment, operators should ensure that  there is physico-chemical and biological 
compatibility between the components of  the preparation which is placed on the 
market and used. 
(8) Annex III to Regulation (EC) No 1831/2003, on specific labelling requirements for 
certain additives and for premixtures, and Annex IV thereto, on general conditions of use, should therefore be amended in order to  take into account technological progress 
and scientific development concerning additives consisting of preparations. 
(9) A transitional period is needed  to avoid disruptions in th e placing on the market and 
use of existing additives consisting of preparations, and of feed containing them, so that they may be used until stocks are exhausted. 
(10) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Amendment to Annexes III and IV 
Annexes III and IV to Regul ation (EC) No 1831/2003 are ame nded in accordance with the 
Annex to this Regulation. 
                                                
 
2 Regulation (EC) No 767/2009 of 13 July 2009 of the European Parliament and of the Council on the 
placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council 
Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 
2004/217/EC. OJ L 229, 1.9.2009, p. 1. EN 4   EN Article 2 
Transitional provision 
Additives consisting of preparations and premixtures containing such additives, which are 
produced and labelled before [24 months after the date of entry into force of this Regulation – 
Date to be inserted by the Service respons ible for the publication] in accordance with 
Regulation No 1831/2003 as it stood before [the date of entry in to force of this Regulation – 
Date to be inserted by the Serv ice responsible for the publication]  may continue to be placed 
on the market and used until the existing stocks are exhausted. 
Article 3 
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, 
 For the Commission 
 The President  […]