EN    EN EN 
SANCO/5166/2009 (POOL/D2/ 2009/5166/5166-EN.doc)  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
C(2009) final 
Draft 
COMMISSION DIRECTIVE 
of 
amending Annex I to Directive 2002/32/EC of the European Parliament and of the 
Council as regards maximum levels  for arsenic, theobromine, Datura sp., Ricinus 
communis L., Croton tiglium L. and Abrus precatorius L. 
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION DIRECTIVE 
of 
amending Annex I to Directive 2002/32/EC of the European Parliament and of the 
Council as regards maximum levels  for arsenic, theobromine, Datura sp., Ricinus 
communis L., Croton tiglium L. and Abrus precatorius L. 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
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 ma ximum levels laid down in 
Annex I to that Directive is prohibited. 
(2) As regards feedingstuffs obtained from the pro cessing of fish or other marine animals, 
recent information provided by competent authorities of the Member States on the presence of total arsenic (sum of organic a nd inorganic arsenic) i ndicates that it is 
necessary to increase certain maximum levels for total arsenic. By-products of the fish 
filleting industry are valuable raw materials for the production of fish meal and fish oil 
for use in compound feed, in particular fish feed. 
(3) The increase of the maximum levels for tota l arsenic in feedingstuffs obtained from 
the processing of fish or other marine an imals and feedingstuffs for fish entails no 
change in the maximum levels for inorga nic arsenic. Since the potential adverse 
effects of arsenic to animal and human hea lth are determined by the inorganic fraction 
in a given feed or food product and the or ganic arsenic compounds exhibit a very low 
toxic potential
2, the increased levels for total arse nic do not affect the protection of 
animal and public health. 
(4) In Annex I to Directive 2002/32/EC, arsenic re fers to total arsenic for the purpose of 
setting maximum levels, since there is no st andardised routine method for the analysis 
of inorganic arsenic. But for cases in wh ich the competent authorities request an 
                                                 
1 OJ L 140, 30.5.2002, p. 10. 
2 Scientific Opinion of the Panel on contaminants in the Food Chain of the European Food Safety 
Authority (EFSA) on a request from the European Commission related to arsenic as undesirable 
substances in animal feed, The EFSA Journal (2005) 180, 1-35.  
EN 3   EN analysis of the content of i norganic arsenic, that Annex sets out a maximum level for 
inorganic arsenic.  
(5) As the extraction method has in some cases a significant influence on the analytical 
result on total arsenic, it is appropriate to specify an extraction procedure for reference to be used for official control. 
(6) Information provided by competent authorities  and stakeholder organisations indicate 
significant levels of arsenic in additives belonging to the functional group of compounds of trace elements, authorised in application of Regulation (EC) No 1831/2003
3. It is appropriate to es tablish maximum levels for arsenic in these additives 
to protect animal and public health.  
(7) As regards theobromine, the European Food Safety Authority (EFSA) concluded in its 
opinion of 10 June 20084 that the current maximum levels for theobromine may not 
fully protect some animal species. It point ed out possible advers e effects on pigs, dogs 
and horses and on milk production in dairy cows. It is theref ore appropriate to 
establish lower maximum levels. 
(8) As regards alkaloids in Datura sp , EFSA concluded in its opinion of 9 April 20085 
that, since tropane alkaloids are present in all Datura sp., it is appropriate for the 
protection of animal health, in particular for pigs, to extend the maximum levels for 
Datura stramonium  L., as set out in Annex I to  Directive 2002/32/EC, to all Datura  
sp. 
(9) As regards ricin (from Ricinus communis L.), EFSA  concluded in its opinion of 
10 June 20086 that, given the similar toxic effects of the toxins from Ricinus communis 
L. (ricin) , Croton tiglium L. (crotin) and  Abrus precatorius L. (abrin) , it is appropriate 
to apply the maximum levels for Ricinus communis L., as set out in Annex I to 
Directive 2002/32/EC, also to Croton tiglium L. and Abrus precatorius L., separately 
or in combination. 
(10) Directive 2002/32/EC should therefore be amended accordingly. 
(11) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council has opposed them. 
                                                 
3 OJ L 268, 18.10.2003, p. 29. 
4 Scientific Opinion of the Panel on Contaminants in the Food Chain on a request from the European 
Commission on theobromine as undesirable substances in animal feed. The EFSA Journal (2008) 725, 
1-66.  
5 Scientific Opinion of the Panel on Contaminants in the Food Chain on a request from the European 
Commission on Tropane alkaloids (from Datura sp.) as undesirable substances in animal feed. The 
EFSA Journal (2008) 691, 1-55. 
6 Scientific Opinion of the Panel on Contaminants in the Food Chain on a request from the European 
Commission on ricin (from Ricinus communis ) as undesirable substances in animal feed. The EFSA 
Journal (2008) 726, 1-38.  
EN 4   EN HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex I to Directive 2002/32/EC is amended in accordance with the Annex to this Directive. 
Article 2 
Member States shall bring into force the la ws, regulations and ad ministrative provisions 
necessary to comply with this  Directive by 1 July 2010 at the latest. They shall forthwith 
communicate to the Commission the text of thos e provisions and a corr elation table between 
those provisions and this Directive.  
When Member States adopt those provisions, they  shall contain a refere nce to this Directive 
or be accompanied by such a reference on the o ccasion of their offici al publication. Member 
States shall determine how such  reference is to be made. 
Article 3 
This Directive shall enter into force on the tw entieth day following that  of its publication in 
the Official Journal of  the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla VASSILIOU  Member of the Commission  
EN 5   EN ANNEX  
Annex I to Directive 2002/32/EC  is amended as follows:  
(1) Row 1, Arsenic, is replaced by the following: 
Undesirable substances Products intended for animal feed Maximum content 
in mg/kg (ppm) 
relative to a 
feedingstuff with a 
moisture content 
of 12% 
(1) (2) (3) 
"1. Arsenic(*)(**) Feed materials with the exception of: 
- meal made from grass, from dried lucerne and 
from dried clover, and dried sugar beet pulp and 
dried molasses sugar beet pulp 
- palm kernel expeller - phosphates and calcareous marine algae 
- calcium carbonate - magnesium oxide - feedingstuffs obtained from the processing of 
fish or other marine animals, including fish 
- seaweed meal and feed materials derived from 
seaweed 
 Iron particles used as tracer. 2 
 
 
4 
4
(***) 
10 
15 20 
 
25
(***) 
 
40(***) 
50 
 Additives belonging to the functional group of 
compounds of trace elements except: 
- copper sulphate pentahydrate and copper 
carbonate 
- zinc oxide, manganese oxide and copper oxide.  
30 
 
50 
100 
 Complete feedingstuffs with the exception of: 
- complete feedingstuffs for fish and complete 
feedingstuffs for fur animals. 2 
 
10(***) 
 Complementary feedingstuffs with the exception of: 
- mineral feedingstuffs. 4 
12 
(*) The maximum levels refer to total arsenic. 
(**) Maximum levels refer to an analytical determination of  arsenic, whereby extraction is performed in nitric acid 
(5 % w/w) for 30 minutes at boiling temperature. Equi valent extraction procedures can be applied for which it 
can be demonstrated that the used extraction procedure has an equal extraction efficiency. 
(***) Upon request of the competent authorities, the responsible operator must perform an anal ysis to demonstrate that 
the content of inorganic arsenic is lo wer than 2 ppm. This analysis is of particular importance for the seaweed 
species Hizikia fusiforme "  
EN 6   EN (2) Row 10, theobromine, is replaced by the following: 
Undesirable substances Products intended for animal feed Maximum content 
in mg/kg (ppm) 
relative to a 
feedingstuff with 
a moisture 
content of 12% 
(1) (2) (3) 
"10. Theobromine Complete feedi ngstuffs with the exception of: 
- complete feedingstuffs for pigs 
- complete feedingstuffs for dogs, rabbits, horses 
and fur animals. 300 
200 
 
50" 
(3) Row 14, Weed seeds and unground and uncru shed fruits containing alkaloids, 
glucosides or other toxic substanc es, is replaced by the following: 
Undesirable substances Products intended for animal feed Maximum content 
in mg/kg (ppm) 
relative to a 
feedingstuff with 
a moisture 
content of 12% 
(1) (2) (3) 
"14. Weed seeds and unground and 
uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or 
in combination including. 
 Datura sp. All feedingstuffs  3000 
   
 
 
1000" 
(4) Row 15, Castor oil plant – Ricinus communis L., is replaced by the following: 
Undesirable substances Products intended for animal feed Maximum content 
in mg/kg (ppm) 
relative to a 
feedingstuff with 
a moisture 
content of 12% 
(1) (2) (3) 
"15. Seeds and husks from Ricinus 
communis L., Croton tiglium 
L. and Abrus precatorius  L. as 
well as their processed derivatives
(****), separately or 
in combination. All feedingstuffs 10 
(****) Insofar determinable by analytical microscopy." 
(5) Row 34, Croton – Croton tiglium L, is deleted.