EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10027/2015 ANNEX 
(POOL/G5/2015/10027/10027 -EN 
ANNEX.doc) D039828/03  
[…](2015) XXX  draft  
ANNEX 1  
  
ANNEX  
to the  
COMMISSION REGULATION (EU) …/…  
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    
EN 2   EN ANNEX  
Annex II to Regulation (EC) No 183/2005 is amended as follows:  
(1) In the Section headed ‘DEFINITIONS’,  points (b) and (c) are replaced by the 
following points (b) and (c) and the following point (d) is added : 
‘(b) “products derived from oils  and fats” means any product derived directly or 
indirectly from crude or recovered oils and fats  by oleochemical or biodiesel 
processing or distillation, chemical or physical refining, other than  
– the refined oil ,  
– products derived from refined oil  and  
– feed additives ; 
(c) “fat blending” means manufacturing of compound feed or , in case of all 
components belonging to  the same entry in PART C of the Annex to 
Regulation (E U) 68/2013* which  are derived from the same plant or animal 
species, of feed materials by mixing crude oils, refined oils, animal fats, oils 
recovered from food  business operators falling within  the scope of Regulation 
(EC) No 852/2004  or products derived thereof to produce a blended oil or fat, 
with the exception  of the 
– sole storage of consecuti ve batches  and 
– exclusive mixing of refined oils ;  
(d) “refined oil or fat” means oil or fat that has undergone the process of refining 
as referred to in No 53 of the glossary of processes listed in Part of the Annex 
to Regulation (EU ) 68/2013 .‘ 
(2) In Section headed  ‘PRODUCTION ’ point 8 is replaced by the following  and the 
following point 9 is added : 
‘8. The labelling of the products shall clearly indicate whether they are intended 
for feed or other purposes. If a certain batch of a product is declared not 
intended for feed use, this declaration shall not be subsequently altered by an 
operator at a later stage of the chain.  
9. The labelling of f eed materials according to Article 16 of  Regulation (EC) No 
767/2009 ** should  use, where available , the  denominatio ns as laid in 
Commission Regulation (EU) 68/2013 .‘ 
(3) The S ection  headed ‘DIOXIN MONITORING’  is amended as follows:  
(a) The heading of that Section is replaced by the following:  
‘DIOXIN MONITORING  FOR OILS, FATS AND DERIV ED PRODUCTS ’  
(b) Point 2 is repla ced by the  following:  
‘2. To supplement the feed business operator's HACCP system, the analyses 
referred to in point 1 shall be carried out with at least the following 
frequencies  (if not further specified, a  batch of products to be analysed 
shall not exce ed 1000 t onnes ): 
(a) Feed business operators process ing crude vegetable fats and oils: 
(i) 100 % of the batches of the products derived from oils and 
fats of vegetable origin , except  for the following:   
EN 3   EN  ‒ glycer ine,  
 ‒ lecithin,  
 ‒ gums,  
 ‒ products referred to in (ii) ;  
(ii) acid oils from chemical refining, soap stocks , used filter aids , 
used bleaching earth  and incoming batches of crude coconut 
oils shall be analysed and documented as part of  the HA CCP 
system .  
(b) Feed business operators produc ing animal fat  including animal fat 
processor s: 
(i) one representative analysis per 5 000 tonnes with a minimum 
of one  representative analys is per year  of animal fat and 
products derived thereof belonging to c ategory 3 material, as 
referred to in Article 10 of Regulation (EC) No 
1069/2009** * or from  an establishment approved in 
accordance with Article 4 of Regulation (EC) No 
853/2004 ****. 
(c) Feed business operators produc ing fish oil:  
(i) 100% of the batches o f fish oil if it is produced from:  
 ‒ products derived from fish oil other than refined fish 
oil; 
 ‒ fisheries with no monitoring history, of unspecified 
origin or from the Baltic Sea;  
 ‒ fish by -products from establishments manufacturing 
fish for human c onsumption that are not EU approved;  
 ‒ from blue whiting or menhaden;   
(ii) 100% of the outgoing batches of products derived from fish 
oil other than refined fish oil ; 
(iii) one representative analysis per 2000 tonnes as regards fish oil 
not referred to i n (i);  
(iv) fish oil decontaminated by an officially approved treatment 
as referred to in A nnex VIII o f Regulation (EC) 767/2009  
and in  Regulation (E U) No 2015/786 **** * shall be analysed  
and documented as part of the HACCP system . 
(d) Oleochemical industry  placing feed on the market : 
(i) 100 % of incoming batches of animal fats not covered by 
point (b) or (h) , fish oil not covered by point (c) or (h) , oils 
and fats recovered from food business operators falling 
within  the scope of Regulation (EC) No 852/200 4 and of 
blended fats and oils;  
(ii) 100 % of the batches of products derived from oils and fats 
placed as feed on the market , except  for the following:   
EN 4   EN  ‒ glycerine,  
 ‒ pure distilled fatty acids from splitting ,  
 ‒ products referred to in (iii) ; 
(iii) crude fatty acids from splitting, fatty acids esterified with 
glycerol , mono and diglycerides of fatty acids , salts of fatty 
acids  and incoming batches of crude coconut oils  shall be 
analysed  and documented as part of the HACCP system .  
(e) Biodiesel indus try placing feed on the market : 
(i) 100 % of incoming batches of animal  fats not covered by 
point (b) or (h) , fish oil not covered by point (c) or (h) , oils 
and fats recovered from food business operators falling 
within  the scope of Regulation (EC) No 852/ 2004  and of 
blended fats and oils ;  
(ii) 100 % of the batches of  products derived from oils and fats  
placed as feed on the market , except  for the following : 
 ‒ glycer ine,  
 ‒ lecithin,  
 ‒ gums,  
 ‒ products referred to in (i ii); 
(iii) acid oils from chemic al refining , soap stocks  and crude 
coconut oils  shall be analysed  and documented as part of the 
HACCP system . 
(f) Fat blending establishments:  
(i) 100 % of incoming batches of crude coconut oil , animal  fats 
not covered by point (b) or (h) , fish oil not cov ered by point 
(c) or (h), oils and fats recovered from food business 
operators falling within  the scope of Regulation (EC) No 
852/2004 , blended fats and oils  and products derived from 
oils and fats , except  for the following:  
 ‒ glycer ine,  
 ‒ lecithin,  
 ‒ gums ,  
 ‒ products referred to in ( ii);  
(ii) acid oils from chemical refining , crude fatty acids from 
splitting, pure disti lled fatty acids from splitting and soap 
stocks  shall be analysed and documented as part of the 
HACC P system  
or 
(iii) 100% of the batches of blended fats and oils intended for 
feed.  
  
EN 5   EN The feed business operator shall declare to the competent 
authority which alternative he choses.  
(g) Producers of compound feed for food producing animals  other than 
those c overed by point (f):  
(i) 100 % of incoming batches of crude coconut oil , animal  fats 
not covered by point (b) or (h) , fish oil not covered by point 
(c) or (h) , oils and fats recovered from food business 
operators falling within  the scope of Regulation (EC ) No 
852/2004 , blended fats and oils  and products derived from 
oils and fats , except  for the following : 
 ‒ glycer ine,  
 ‒ lecithin,  
 ‒ gums,   
 ‒ products referred to in (ii ); 
(ii) acid oils from chemical refining , crude fatty acids from 
splitting, pure dis tilled fatty acids from splitting ; filter aids, 
bleaching earth  and soap stocks  shall be analysed  and 
documented as part of the HACCP system ; 
(iii) 1% of the batches as regards manufactured compound feed 
containing products referred to in (i)  and (ii) .  
(h) Importers placing the following feed on the market:  
(i) 100 % of imported batches of crude coconut oil , animal  fats, 
fish oils , oils and fats recovered from food business 
operators , blended fats and oils , tocopherols extracted from 
vegetable oil and toc opheryl acetate made thereof and 
products derived from oils and fats , except  for the following : 
 ‒ glycer ine,  
 ‒ lecithin,  
 ‒ gums,  
 ‒ products referred to in ( ii);  
(ii) acid oils from chemical refining , crude fatty acids from 
splitting, pure disti lled fatty acids from splitting and soap 
stocks  shall be analysed  and documented as part of the 
HACCP system .‘ 
(c) Points 4, 5 and 6 are replaced by the following:  
‘4. Where a feed business operator has documentary proof  that a batch of a 
product or all compone nts of a batch of a product as referred to under 
point 2 entering his establishment has already been analysed at an earlier 
stage of production, processing or distribution, the feed business operator 
shall be released from the obligation to analyse this ba tch. 
5. Any batch of products analysed in accord ance with  point 2  shall be 
accompanied by docume ntary proof that these products, or all of its 
constituent components, have been analysed  or have been submitted for  
EN 6   EN analys is to an accredited laboratory  referr ed to in point 1 , except for the 
batches of products referred to in point 2 (a)(ii), (b)(i), (c)(iii) , (c)(iv), 
(d)(iii), (e)(iii), (f)(ii), (g)(ii) and (h)(ii) .  
The proof of analysis shall unambiguously link the delivery and the batch 
or batches tested. This link shall be described in the documented 
traceability system in place at the premises of the supplier. In particular, 
when the delivery is obtained from more than one batch  or component , 
the documentary proof to be provided shall be a proof for each of the 
components of the delivery . In the case where the testing is performed on 
the outgoing product, the proof that the product has been analysed shall 
be the analy tical report .  
Any delivery of products as referred to under point 2 (b) (i) or c (iii) shall 
be accompanied by a proof that these products are in compliance with the 
requirements of points 2(b)(i) or (c)(iii). If required, the proof of analysis 
that include the batch or  batches delivered must be consigned to the 
consignee when the operator receive s the analysis from the authori sed 
laboratories.  
6. If all incoming batches of products referred to  in point 2(g)(i) entering a 
production process have been analysed in accordan ce with the 
requirements of this Regulation and if it can be assured that the 
production process, handling and storage does not increase the dioxin 
contamination, the feed business operator shall be released from the 
obligation to analyse the outgoing product and analyse it according to the 
HACCP system . 
________________________  
* Commission Regulation (EU) No 68/2013 of 16 January 2013 on 
the Catalogue of feed materials (OJ L 29, 30.1.2013, p. 1).  
** 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 (OJ L 229, 1.9.2009, p. 1).  
*** Regulation (EC) No 1069/2009 of the European Parliament and of 
the Council of 21 October 2009 laying down health rules as 
regards animal by -products and derived products not intended for 
human consumption and repealing Regulation (EC) No 1774/2002 
(Animal by -products Regulation) (OJ L 300, 14.11.2009, p. 1).  
****  Regulation  (EC) No 853/2004 of the European Parliament and of 
the Council of 29 Apr il 2004  laying down specific hygiene rules 
for food of animal origin  (OJ L 139, 30.4.2004, p. 55 ). 
*****  Commission Regulation (EU) 2015/786 of 19 May 2015 defining 
acceptability criteria for detoxification processes applied to 
products intended for anima l feed as provided for in Directive 
2002/32/EC of the European Parliament and of the Council (OJ L 
125, 21.5.2015, p. 10) ‘