COMMISSION REGUL ATION (EU) 2015/327 
of 2 March 2015 
amending Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards 
requirements for the placing on the market and conditions of use of additiv es consisting of 
preparations 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Articles 3(5) and 16(6) thereof, 
Whereas: 
(1)  In some preparations, author ised as additives in accordance with Regulation (EC) No 1831/2003, technological 
additives and other substances or products are incor porated to exert a function on the active substance contained 
in the preparation, such as stabilising or standardising it, facilitating its handling or its incor poration into feed. 
For examp le, those technological additives or other substances or products may increase flowability or 
homog eneity or reduce the dusting potential of the active substance. The specif ic compo sition of author ised 
additives consisting of preparations will theref ore vary according to the rationale for the use of those 
preparations. The technological additives or other substances or products added to maintain the integr ity of an 
active substance are however not intended to perform a function in the feed in which the preparation is to be 
incor porate d. 
(2)  Taking into account that technological progress contr ibutes to the development of new preparations, it is 
appropr iate to better consider the specific ities of additives consisting of preparations and to bring more 
transparency and clarity when placing them on the mark et, without affecting intellectual proper ty rights relating 
to the compo sition of premixtures containing such additives. 
(3)  In particular , it is appropr iate to introduce into Annex III to 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 
technological additives used in a preparation are author ised for the intended purpose and that those additives 
exer t a function only on the active substance contained in the preparation. 
(4)  While the most relevant information should be kept on the packag ing or container of the additive or the 
premixture, technological progress also allows providing information about the compo sition of the preparations 
in a more flexible and less costly way via other written means. This is in compl iance with the definition of 
labelling provided for in Regulation (EC) No 767/2009 of the European Parliament and of the Council (2). 
(5)  Operato rs should be able to provide information about the compo sition of the preparations which are placed on 
the market since such information enables the end-user or the purch aser to make an informed choice, allows 
appropr iate risk assessment and contr ibutes to fairness of transactions. 
(6)  Those additional labelling and information requirements should apply only to additives belonging to the 
catego ries refer red to in Article 6(1)(a), (b) and (c) of Regulation (EC) No 1831/2003. Where such additives are 
author ised as preparations, only the active substance is indeed the subject of the author isation, and not the other 
compo nents of the preparations, whic h may vary. 
(7)  In order to prevent any undesirable effects on human health, animal health or the environment, operat ors should 
ensure that there is physico-c hemical and biological compatibility between the compo nents of the preparation 
whic h is placed on the mark et and used. 3.3.2015 L 58/46 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(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). (8)  Annex III to Regulation (EC) No 1831/2003, on specific labelling requirements for certain additives and for 
premixtures, and Annex IV theret o, on general conditions of use, should theref ore be amended in order to take 
into account technological progress and scientific development concer ning additives consisting of preparations. 
(9)  A transitional period is needed to avoid disrupti ons in the placing on the market and use of existing additives 
consisting of preparations, and of feed containing them, so that they may be used until stoc ks are exhausted. 
(10)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Amendment to Annex es III and IV 
Annex es III and IV to Regulation (EC) No 1831/2003 are amended in accordance with the Annex to this Regulation. 
Article 2 
Transitional provision 
Additives consisting of preparations and premixtures containing such additives, which are produced and labelled before 
23 March 2017 in accordance with Regulation (EC) No 1831/2003 as it stood before 23 March 2015 may continue to 
be placed on the mark et and used until the existing stoc ks are exhaust ed. 
Article 3 
Entr y 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 State s. 
Done at Brussels, 2 March 2015. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  3.3.2015 L 58/47 Official Jour nal of the European Union EN     ANNEX 
Annex es III and IV to Regulation (EC) No 1831/2003 are amended as follows:  
(1) Annex III is replaced by the following text: 
‘ANNEX III 
1.  SPECIFIC LABELLING REQUIREMENTS FOR CER TAIN ADDITIVES AND FOR PREMIXTURES. 
(a)  Zootec hnical additives, coccidiostats and histo monostats: 
—  the expir y date of the guarant ee or the storag e life from the date of manuf acture, 
—  the directions for use, and 
—  the concentration. 
(b)  Enzymes, in addition to the abovementioned indications: 
—  the specific name of the active compo nent or compo nents in accordance with their enzyme activities, in 
conf ormity with the author isation given, 
—  the Internati onal Union of Bioch emistr y identif ication number , and 
—  instead of concentration: units of activity (units of activity per gram or units of activity per millilitre). 
(c)  Micro-organisms: 
—  the expir y date of the guarant ee or the storag e life from the date of manuf acture, 
—  the directions for use, 
—  the strain identif ication number , and 
—  the number of colony -forming units per gram. 
(d)  Nutr itional additives: 
—  the active-substance level, and 
—  the expir y date of the guarant ee of that level or storage life from the date of manuf acture. 
(e)  Techn ological and sensor y additives with the excep tion of flavouri ng compo unds: 
—  the active substance level. 
(f)  Flav ouring compo unds: 
—  the incor poration rate in premixtures. 
2.  ADDITIONAL LABELLING AND INFORMA TION REQUIREMENTS FOR CERT AIN ADDITIVES CON SISTING OF 
PREP ARA TIONS AND PREMIXTURES CONT AINING SUCH PREP ARA TIONS. 
(a)  Additives belonging to the catego ries refer red to in Article 6(1)(a), (b) and (c) and consisting of preparations: 
(i)  the indication on the packag ing or container of the specific name, the identification number and the level 
of any technological additive contained in the preparation for whic h maximum levels are set in the 
corresponding author isation; 
(ii)  the following information via any written medium or accompan ying the preparation: 
—  the specific name and the identif ication number of any technological additive contained in the 
preparation, and 
—  the name of any other substance or product contained in the preparation, indicated in descending 
order by weight. 3.3.2015 L 58/48 Official Jour nal of the European Union EN     (b)  Premixtures containing additives belonging to the catego ries refer red to in Article 6(1)(a), (b) and (c) and 
consisting of preparations: 
(i)  if appropr iate, the indication on the packag ing or container that the premixture contains technological 
additives included in additive preparations, for whic h maximum levels are set in the corresponding 
author isation; 
(ii)  upon request from the purch aser or the user , information on the specifi c name, the identification number 
and an indication of the level of technological additives refer red to in point (i) of this paragraph included 
in the additive preparations.’;  
(2) in Annex IV, the following point 5 is added: 
‘5.  Technological additives or other substances or products contained in additives consisting of preparations shall 
only modify the physico-chemical charact eristics of the active substance of the preparation and shall be used in 
accordance with their conditions of author isation where such provisions are provided for. 
Physico-chem ical and biological compat ibility between the compo nents of the preparation shall be ensured in 
relation to the effects desired.’.  3.3.2015 L 58/49 Official Jour nal of the European Union EN