EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10027/2015 
(POOL/G1/2015/10027/10027 -EN.doc) 
D039828/03  
[…](2015) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 183/2005 of the European Parliament and of 
the Council as regards the dioxin testing of oils, fats and products derived thereof  
(Text with EEA relevance)    
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 183/2005 of the European Parliament and of 
the Council as regards the dioxin testing of oils, fats and products derived thereof  
(Text with EEA relevance)  
THE EUROPEAN COMMISSI ON, 
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 183/2005 of the European Parliament and the Council 
of 12 January 2005 laying down requirements for feed hygiene1, and in particular 
Article  27 thereof,  
Whereas:  
(1) Regulation (EC) No 183/2005 lays down general rules on feed hygiene, as well as 
conditions and arrangements to ensure that processing conditions to minimise and 
control potential hazards are respected. It also provides that feed business 
establishments are to be registered with or approved by the competent authority. In 
addition, feed business operators lower down the feed chain are required to source 
feed only from registered or approved establishments.  
(2) Annex II to Regulation (EC) No 183/2 005 sets out requirements for feed businesses 
other than at the level of primary production. In particular, it requires that the dioxin 
testing requirements set out in that Annex are to be reviewed by 16 March 2014.  
(3) The definition of products derived from vegetable oils set out in Annex II to 
Regulation (EC) No 183/2005 should be amended in order to clarify that products 
derived from refined oil and feed additives authorised in accordance with Regulation 
(EC) No 1831/2003 are not covered by that definition.  
(4) The definition of fat blending set out in Annex II to Regulation (EC) No 183/2005 
should also be amended in order to clarify the difference between fat blending and the 
solely storage  of consecutive batches of fats and oils  without mixing them . 
Furthermor e, it should be clarified when blended fats are considered a compound feed  
and when they are feed materials . 
(5) As it is prudent to detect products that are clearly contaminated with dioxin at the 
point of entry in the feed chain, it should be clarified that the requirements concerning 
dioxin monitoring set out in Annex II to Regulation (EC) No 183/2005 apply to all 
feed business operators placing feed on the market, including importers.  
(6) In order to ensure traceability of and proper information about the feed,  compliance 
with the labelling requirements established in Regulation (EC) No 767/2009 of the 
European Parliament and of the Council2 and in particular the denominations, 
                                                 
1 OJ L 35, 8.2.2005, p. 1.  
2 Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the 
placi ng on the market and use of feed  (OJ L  229, 1.9.2009, p. 1 ).  
EN 3   EN specifications and numbers in Commission Regulation (EU) No 68/20133 should be 
highli ghted. 
(7) It is necessary that the requirement of a representative analysis per large quantity is  
performed on the basis of a representative sample. Therefore it is appropriate that 
incremental samples to form the aggregate sample are taken at regular interva ls, e.g. at 
least one incremental sample every 50 tonnes, which is in line with the provisions on 
sampling as provided for in Commission Regulation (EC) No 152/20094. 
(8) The results of the dioxin testing established by Regulation (E C) No 183/2005, the 
reports5 of the audits  of the Commission`s Food and Veterinary Office and the fact 
that no non -compliant sample of products derived from vegetable oils, except fatty 
acid distillates from physical refining and deodistillates , were notifi ed to the Rapid 
Alert Syst em for Food and Feed6 show that those  products do not have a high risk for 
dioxin contamination. As a result, it is appropriate to alleviate the requirements as 
regards the 100% dioxin testing for these products  set out in Annex II to Regulation 
(EC) No 18 3/2005 . 
(9) In order to clarify the responsibility for the dioxin testing of imported products, a 
specific provision should be set out in Annex II  to Regulation (EC) No 183/2005 . This 
should also  assure that imported products have the same safety level of those produced 
in the Union . 
(10) The system established by Annex II to Regulation (EC) No 183/2005 in order to prove 
by means of a certificate that the mandatory analysis of a specific batch has been 
undertaken should be amended by several specifications concernin g the tasks for the 
different feed business operators  in order to clarify the responsibilities of the various 
actors in the feed chain . 
(11) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Ani mals, Food and Feed ,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex II to Regulation (EC) No 183/2005 is amended in accordance with the Annex to this 
Regulation.  
Article 2  
This Regulation shall enter into force on the twentieth day following that of its pub lication in 
the Official Journal of the European Union . 
Point 2(h)  in paragraph (3)(b) of the Annex to this Regulation  shall apply from [ Office of 
Publications please insert date six months after publication ].  
                                                 
3 Regulation (EC) No 68/2013 of 16 January 2013 on the Catalogue of feed materials ( OJ L 29, 
30.1.2013, p. 1 ). 
4 Commis sion Regulation (EC) 152/2009 of 27 January 2009 laying down the methods of sampling and 
analysis for the off icial control of feed (OJ L 54, 26.2.2009, p . 1)  
5 http://ec.europa.eu/food/fvo/audit_reports/index.cfm : Audit number s 2013 -6748 , 2013 -6749 , 2013 -
6750 , 2013 -6751 , 2013 -6752 , 2013 -6753 , 2014 -7036 , 2014 -7037 and 2014 -7038 . 
6 http://ec.europa.eu/food/safety/rasff/portal/index_en.htm   
EN 4   EN This Regulation shall be binding in its entir ety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER