EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10719/2018 Rev. 2 
(POOL/E5/2018/10719/10719R2 -
EN.docx) D057573/04  
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending and correcting Annex I to Directive 2002/32/EC of the European Parliament 
and of the Council as regards maximum levels for certain undesirable substances in 
animal feed  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending and correcting Annex I to Directive 2002/32/EC of the European Parliament 
and of the Council as regards maximum levels for certain undesirable substances in 
animal feed  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treat y on the Functioning of the European Union,  
Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 
7 May 2002 on undesirable substances in animal feed1, and in particular Article  8(1) thereof,  
Whereas:  
(1) Directive 2002/32/EC provides that the use of products intended for animal feed which 
contain levels of undesirable substances exceeding the maximum levels laid down in 
Annex I to that Directive is prohibited.  
(2) Data have been received  from competent authorities and concerned fe ed business 
operators indicating that the general maximum level of 2 mg/kg for arsenic in feed 
materials of plant origin, is not achievable  in the specific feed materials leonardite and 
peat. It is therefore appropriate to increase the maximum level for total arsenic in these 
feed materials to ensure the supply . The increase does not adversely affect the animal 
or public health as the maximum level  laid down  for arsenic in complementary feed 
and complete feed remains unchanged.  
(3) Data have been received from concerned feed business operators indicating that the 
general maximum level of 30 mg/kg for arsenic in feed additives belonging to the 
functional group of compounds of trace elements is not achievable  for the trace 
element dimanganese chloride trihydr oxide. It is therefore appropriate to increase the 
maximum level for arsenic in dimanganese chloride trihydroxide , , based on the data 
obtained by the analytical method Inductively Coupled Plasma Mass Spectrometry 
(ICP -MS). The European Reference Laborator y for metals and nitrogenous 
compounds has confirmed that this method provides the correct results as regards  the 
presence of arsenic in trace elements. This increase does not adversely affect the 
animal or public health as the maximum level laid down for arsenic in complementary 
feed and complete feed remains unchanged.  
(4) The Joint Research Centre of the European Commission has examined in co -operation 
with the concerned parties certain findings concerning fluorine in calcareous marine 
algae. Th at examinati on has established that the background presence of fluorine in 
calcareous marine algae in some instances exceeds  the maximum level laid down  for 
fluorine in calcareous marine algae. It is therefore appropriate to increase the 
maximum level for fluorine in calcareous marine algae  from 1000 mg/kg to 1250 
mg/kg . This increase does not adversely affect the animal  or public health as the 
                                                 
1 OJ L 140, 30.5.2002, p. 10.  EN 2  EN maximum level established for fluorine  in complementary feed and complete feed 
remains unchanged.  
(5) Commission Regulation (EU) 2 017/22292 amended Annex I to Directive 2002/32/EC 
as regards, inter alia , lead. For reasons of clarity the whole entry for lead  was 
replaced. In this replacement, in the list of feed materials for which the maximum level 
of 15 mg/kg is applicable, the feed  material calcareous marine shells  was erroneously 
omitted. Regulation (EU) 2017/2229 established also a new maximum level for lead in 
dicopper oxide. However, the International Union of Pure and Applied Chemistry 
(IUPAC) name of the additive is copper(I) oxide. In line with the European Food 
Safety Authority’s ( ‘EFSA ’) recommendation in its opinion on cupric oxide3 the 
additive should be named copper(I) oxide , which was not done  in the English, Italian 
and Slovak language version s of the Regulation . Those errors should be corrected .  
(6) Certain feed materials belonging to the category of ‘fish, other aquatic animals and 
products derived thereof’ are placed on the market as canned wet feed material for 
direct feeding of dogs and cats. As t his canned wet feed ma terial replaces  the 
compound feed, it is therefore appropriate to apply the same maximum level of 
mercury to this canned wet feed material as the maximum level applicable to 
compound feed  as this change does not adversely affect the animal health.  
(7) EFSA ad opted a scientific statement on the presence of free gossypol in whole 
cottonseed4. It concluded that an update to the Scientific opinion as regards the animal 
health risks of the presence of gossypol as an undesirable substance in animal feed was 
not nece ssary , . Taking into account the occurrence data referred to in that  statement, it 
is appropriate to establish  a higher maximum level for free gossypol in the feed 
material cottonseed . This increase does not adversely affect the animal health as the 
maximu m level laid down for free gossypol in complete feed remains unchanged.  
(8) Directive 2002/32/EC establishes a maximum level for dioxins , sum of dioxins and 
dioxin -like PCBs and non -dioxin -like PCBs only in certain feed additives belonging to 
the functional group s of binders and anti -caking agents. However, recent findings 
notified through  the Rapid Alert System for Food and Feed  show high levels of 
dioxins and dioxin -like PCBs, in other feed additives belonging to that functional 
group . It is therefore appro priate to establish the maximum level for dioxins and PCBs 
to all feed additives belonging to the functional group s of binders and anti -caking 
agents . Furthermore, those maximum levels should also apply where the same feed 
additives are authorised in the f unctional groups “Substances for the control of 
radionuclide contamination” and “Substances for reduction of the contamination of 
feed by mycotoxins”  
(9) Directive 2002/32/EC should therefore be amended accordingly.  
(10) The measures provided for in this Regulatio n are in accordance with the opinion of 
the Standing Committee  on Plants, Animals Food and Feed , 
                                                 
2 Commission Regulation (EU) 2017/2229 of 4 December 2017 amending Annex I to Directive 
2002/32/EC of the European Parliament and of the  Council as regards maximum levels for lead, 
mercury, melamine and decoquinate  (OJ L  319, 5.12.2017, p. 6) . 
3 EFSA Journal 2015;13(4):4057.  
4 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4850  EN 3  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annex I to Directive 2002/32/EC is amended and corrected in accordance with the Annex to 
this Regulation.  
Article 2 
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  
 Jean -Claude JUNCKER