EN    EN EN 
SANCO/6127/2009 (POOL/D2/2009/6127-EN.doc) – revision 1  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, SANCO/6127/2009 revision 1 
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 fo r mercury, gossypol, nitrites and  Madhuca 
longifolia 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 fo r mercury, gossypol, nitrites and  Madhuca 
longifolia 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 mercury, the Eur opean Food Safety Authorit y (EFSA) concluded in its 
opinion 20 February 2008
2, that following assessment of the current occurrence data 
the current maximum levels for compound  feedingstuffs for fish are not in 
correspondence with the maximum levels for f eed materials produced from fish or by 
the processing of fish or other marine anim als. In order to ad dress this, a slight 
increase of the maximum level for fish feed is appropriate and this increase would not 
endanger the compliance of farmed fish with the established maximum levels for mercury. Furthermore as EFSA concludes that the current maximum levels for compete feed for cats and dogs appear not to  be sufficiently protective against adverse 
animal health effects, a lowering of the maximum level is appropriate.   
(3) EFSA adopted on 25 March 2009 a scien tific opinion on nitrite as undesirable 
substance in feed
3. Total nitrite intake for pigs and cattle from feed as representative 
sensitive food producing species was estimate d using the maximum exposure level in 
complete feed and sufficient margins of safety with respect to the respective No Observed Adverse Effect Level (NOAEL) could be observed. It was furthermore 
concluded that the presence of nitrite in an imal products does not raise any concern for 
                                                
 
1 OJ L 140, 30.5.2002, p. 10. 
2  Opinion of the Scientific Panel on Contaminants in the Food chain on a request from the European 
Commission on mercury as undesirable substance in feed, The EFSA Journal (2008) 654, 1-76. 
3  Scientific Opinion of the Panel on Contaminants in the Food Chain on a request from the European 
Commission on nitrite as undesirable substances in animal feed. The EFSA Journal (2009) 1017, 1-47.  
EN 3   EN human health. Nitrite is aut horised for use as preservativ e in dog and cat feed with a 
moisture content exceeding 20 %.  Furthermore nitrite might also be used as 
preservative in silages. It is appropriate to exclude dog and cat feed and silage from 
the application of the maximum level of  nitrite as undesirable substance.  
(4) EFSA adopted on 4 December 2008 a scient ific opinion on gossypol as undesirable 
substance in feed4.  From the opinion it can be de rived that the current maximum 
levels for sheep, including lamb and goats, incl uding kids, is not sufficiently protective 
against adverse animal health effects, a nd therefore a significant lowering of the 
maximum level of gossypol in feed for thes e animal species is appropriate. The EFSA 
furthermore concluded that the human e xposure to gossypol through the consumption 
of food products from animal fed cottonseed  derived products is  probably low and 
would not result in adverse effects.  
(5) EFSA adopted on 29 January 2009 a scientific opinion on saponins in Madhuca 
longifolia  L. as undesirable substance in feed5. The EFSA concluded that no adverse 
animal health effects are expected because of  the negligible exposur e to target animals 
in the EU and that human dietary exposure to Madhuca  saponins in the EU can be 
considered as negligible. Therefore it is appropriate to delete Madhuca longifolia L. as 
undesirable substance from the Annex.  
(6) Directive 2002/32/EC should therefore be amended accordingly. 
(7) 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. 
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 September 2010 at the latest. They shall 
forthwith communicate to the Com mission the text of those provi sions and a correlation 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. 
                                                 
4  Scientific Opinion of the Panel on Contaminants in the Food Chain on a request from the European 
Commission on gossypol as undesirable substance in animal feed. The EFSA Journal (2008) 908, 1-56. 
5  Scientific Opinion of the Panel on Contaminants in  the Food Chain on a request from the European 
Commission on Saponins in Madhuca Longifolia L. as undesirable substances in animal feed. The EFSA Journal 
(2009) 979, 1-36.  
EN 4   EN 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 4, Mercury, 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) 
"4. Mercury(*)(**) Feed materials with the exception of: 
- feed materials produced from fish or by the 
processing of fish or other marine animals  
-      calcium carbonate  
 Compound feed  with the exception of  
-       compound feed for fish 
-       compound feed for dog, cat and fur animals 
. 0.1 
 
0.5  
0.3 
 
 
0.1 
0.2 
0.3 
(*) The maximum levels refer to total mercury. 
(**) Maximum levels refer to an analytical determination of mercury, 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." 
(2) Row 5, Nitrites, 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) 
"5. Nitrites  Feed materials with the exception of  
 -    silage 
 
Complete feedingstuffs with the exception of   -    feedingstuffs for dogs and cats with a moisture 
content exceeding 20 %. 15 (expressed as 
sodium nitrite) 
 
 
15 (expressed as 
sodium nitrite)" 
   
EN 6   EN (3) Row 9, Free gossypol 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) 
"9. Free gossypol Feed materials with the exception of: 
- cottonseed  -      cottonseed cakes and cottonseed meal   
Complete feedingstuffs with the exception of  
-       complete feedingstuffs for adult cattle 
-       complete feedingstuffs for poultry (except             
laying hens), goats (except kids) and calves 
-       complete feedingstuffs for rabbits, sheep (except 
lambs) and pigs (except piglets)  
. 20 
5000 
1200 
 
20 
500 
100 
 
60" 
 
 (4) Row 32, Mowrah, Bassia, Madhuca – Madhuca longifolia (= Bassuia longifolia = 
Illiped malabrorum, Madhuca indica (= Bassia latifolia = Illipe latifolia" is deleted.