EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11845/2015  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
establishing a list of intended uses of feed intended for particular nutritional purposes 
and repealing Directive 2008/38/EC  
(Text with EEA relevance)   
Ref. Ares(2019)3967445 - 21/06/2019EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
establishing a list of intended uses of feed intended for particular nutritional purposes 
and repealing Directive 2008/38/EC  
(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 767/2009 of the European Parliament and of the 
Council of 13 July 2009 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/EC1, 
and in particular Article 10  thereof , 
Whereas:  
(1) The placing on the market and use of feed is regulated by Regulation (EC) No 
767/200 9. In accordance with Article 9 of that Regulation feed intended for particular 
nutritional purposes  may only be marketed if its intended use is included in a list of 
intended uses .  
(2) Commission Directive 2008/38/EC2 establish ed a list of intended uses of animal 
feedingstuffs for particular nutritional purposes .  
(3) Part A of Annex I to Directive 2008/38/EC establish ed the general provisions for feed 
intended for particular nutritional purposes . Considering  scientific and technological 
developments and the labelling requirements established by Regulation (EC) No 
767/2 009, those general provisions were  to be  reviewed .   
(4) Articles  11 to 17 of Regulation (EC) No 767/2009 established new principles and rules 
for the placing on t he market  of feed , including labelling . As a consequence,  several  
entries in the list of intended uses of feed intended for particular  nutritional purposes 
contained in Part B of Annex I to Directive 2008/38/EC became  outdated , partially  
because of poor and overly general descriptions in the column "Essential nutritiona l 
characteristics". For such entries, it has been very difficult for the control authorities to 
verify compliance with the provisions of  Regulation (EC) No 767/2009, including 
whether the specific composition of the feed concerned fulfils the respective pa rticular 
intended nutritional purpose.  
(5) In accordance with Article 10 of Regulation (EC) No 767/2009, the Commission 
received a number of applications to amend and change the conditions of several 
particular nutritional purposes, which had become outdated.  Outdated entries for 
                                                 
1 OJ L 229, 1.9.2009, p. 1.  
2 Commission Directive 2008/38/EC of 5 March 2008 establishing a list of intended uses of  animal 
feedingstuffs for particular nutritional purposes  (OJ L 62, 6.3.2008, p. 9 ). EN 2  EN which no application has been submitted or for which the application was withdrawn 
should be deleted . 
(6) As regards  other intended uses of feed intended for particular nutritional purposes in 
Part B of Annex I to Directive 2008/38/EC , amendments  were  necessary  for the 
essential nutritional characteristics  and the l abelling declarations to adapt them to the  
scientific and technological developments .  
(7) Furthermore, the Commission received , in accordance with Article 10 of Regulation 
(EC) N o 767/2009  application s to add  the particular nutritional purpose s ‘support of 
energy metabolism and of the muscle function in the case of rhabdomyolosis ’ and 
‘support in stressful situations, which will lead to the reduction of associated 
behaviour ’ to th e list of intended uses of feed intended for particular  nutritional 
purposes.  
(8) The Commission made all applications, including the dossiers, available to the 
Member States.  
(9) Following the assessment of  the dossiers included in those applications, the Standing 
Committee on Plants, Animals, Food and Feed (‘ the Committee ’) acknowledged that 
the specific composition of the feed concerned fulfils the respective particular intended 
nutritional purpose and that it has no adverse effects on animal health, huma n health, 
the environment or animal welfare.  
(10) Based on the above considerations , the list of intended uses should be  reviewed . 
(11) Since safety reasons do not require the immediate application of the new general 
provisions and the list for the intended uses of  feed intended for particular  nutritional 
purposes , it is appropriate to provide for transitional measures in order to avoid 
unnecessary disruption of commercial practices  and to not create unnecessary 
administrative burden on the operators .  
(12) In the intere sts of clarity and rationality, Directive 2008/38/EC  should be repealed and 
replaced by a Regulation, which does not contain elements that would require 
transpositions by the Member  States into national law . 
(13) The measures provided for in this Regulation are  in accordance with the opinion of the 
Committee,  
HAS ADOPTED THIS REGULATION:  
Article 1 
Feed intended for particular  nutritional purposes within the meaning of Regulation (EC) No 
767/2009 shall be marketed only if :  
a) the general provisions for  feed inte nded for particular  nutritional purposes  of Part A 
of the Annex to this Regulation are complied with , and  
b) its intended use is included in Part B of the Annex and the provisions of the 
respective entry are complied with.  
Article 2 
By way of derogation from Article 1, feed intended for particular  nutritional purposes which 
compli es with the provisions of Directive 2008/38/EC may be placed on the market , provided  
that an application for the respective intended use has been submitted  to the Commission in 
accordance with Article 10 of Regulation (EC) No 767/2009  before [12 months after the date EN 3  EN of entry into force of this Regulation – Date to be inserted by the Service responsible for the 
publication ]. 
Article 3 
Feed intended for particular nutritional purposes which ha s been labelled before [24 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 b efore [ 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 th e existing stocks are 
exhausted.  
Article 4 
Directive 2008/38/EC is repeale d. 
Article 5 
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  
 … 