EN    EN EN 
SANCO/10581/2010 EN    EN  EUROPEAN COMMISSION 
Brussels,  
C(2010)  final 
  
Draft 
COMMISSION DIRECTIVE 
of […] 
amending Directive 2009/32/EC of the European Parliament and of the Council on the 
approximation of the laws of the Member Stat es on extraction solvents used in the 
production of foodstuffs and food ingredients 
(Text with EEA relevance) EN 2   EN Draft 
COMMISSION DIRECTIVE 
of […] 
amending Directive 2009/32/EC of the European Parliament and of the Council on the 
approximation of the laws of the Member Stat es on extraction solvents used in the 
production of foodstuffs and food ingredients 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, ,  Having regard to  Directive 2009/32/EC of the Eu ropean Parliament and of the Council of 23 
April 2009 on the approximation of the laws of th e Member States on ex traction solvents used 
in the production of foodstuffs and food ingredients
1 and in particular Article 4 thereof,   
Whereas:  (1) Directive 2009/32/EC applies to  extraction solvents used or  intended for use in the 
production of foodstuffs or food ingredient s.  That Directive does not apply to 
extraction solvents used in the production of food additives, vitamins and other 
nutritional additives, unless such food additives, vitamins or nutritional additives are listed in its Annex I.  The European Food Sa fety Authority (the Authority) evaluated 
the safety of dimethyl ether as an extracti on solvent to remove fat from animal protein 
raw materials and expressed its opinion of 29 January 2009
2. The Authority concluded 
that there is no safety concern provided th at the maximum residual limit of dimethyl 
ether is 9 µg/kg of extracted animal proteins.  Therefore the use of dimethyl ether as an 
extraction solvent to remove fat from animal protein raw materials should be 
authorized under the condition of a maximum residual limit of dimethyl ether of 9 
µg/kg in the defatted protein product  
(2) Part III of Annex I to Dir ective 2009/32/CE does not estab lish specific residue limits 
in foodstuffs for methanol and propan-2- ol resulting from the preparation of 
flavourings. Member States a nd the Commission pointed out  that the general residue 
limit of 10 mg/kg for methanol a nd propane-2-ol, as  set  out in Part II of Annex I to 
Directive  2009/32/EC,  is too strict if applied directly to flavourings. 
                                                 
1 OJ L 141, 6.6.2009, p. 3. 
 
2 Scientific opinion of the panel on Food Contact Materials, Enzymes, Flavourings and Processing aids (CEF) on  
request from European Commission on the safety in use of dimethyl ether as an extraction solvent. The 
EFSA Journal (2009) 983, 1-13. 
 EN 3   EN (3) Therefore specific limits should be set in foodstuffs for methanol and propan-2-ol 
resulting from their use for the preparati on of flavourings from natural flavouring 
materials.  Those limits should be lower than  the limit of 10 mg/kg assessed as safe by 
the Scientific Committee for Food3,in order to be considered as safe. 
(4) 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 2009/32/EC is amended in accordance with the Annex to this Directive. 
Article 2 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with this Directive by 15.09.2011  at the latest. They 
shall forthwith communicate to the Commi ssion the text of those provisions.  
 When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 3 
This Directive shall enter into force on the 20th 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, 
 The President 
 José Manuel BARROSO 
                                                
 
3Scientific Committee for Food. Second opinion on extrac tion solvents expressed on 21 June 1999.  Food 
Science and Techniques Reports of the Scientific Committee for Food (29th series), p. 1-11 EN 4   EN ANNEX  
Annex I to Directive 2009/32/EC  is amended as follows: 
 
(1). In Part II the following row is added:  
Dimethyl ether Preparation of defatted animal 
protein products  0,009 mg/kg in the defatted 
protein product 
  
(2). Part III the following rows  are  added: 
  
Methanol 1,5 mg/kg  
 
Propan-2-ol   1 mg/kg