COMMISSION DIRECTIVE 2010/59/EU  
of 26 August 2010  
amending Directive 2009/32/EC of the European Parliament and of the Council on the 
approximation of the laws of the Member States 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 European 
Parliament and of the Council of 23 April 2009 on the 
approximation of the laws of the Member States on extraction 
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 ingredients. 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 
Safety Authority (the Authority) evaluated the safety of 
dimethyl ether as an extraction 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 that 
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 authorised 
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 Directive 2009/32/EC does not 
establish specific residue limits in foodstuffs for 
methanol and propan-2-ol resulting from the preparation 
of flavourings. Member States and the Commission 
pointed out that the general residue limit of 10 mg/kg 
for methanol and 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.  (3) Therefore specific limits should be set in foodstuffs for 
methanol and propan-2-ol resulting from their use for 
the preparation 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 Food (  3 ), in order to be considered as safe.  
(4) The measures provided for in this Directive are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal 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 September 2011 at the latest. They shall 
forthwith communicate to the Commission 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 determine 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 
its publication in the  Official Journal of the European Union .EN L 225/10 Official Journal of the European Union 27.8.2010  
( 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.  ( 3 ) Scientific Committee for Food. Second opinion on extraction 
solvents expressed on 21 June 1991. Food Science and Techniques 
Reports of the Scientific Committee for Food (29th series), p. 1-11.Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 26 August 2010.  
For the Commission  
The President  
José Manuel BARROSOEN 27.8.2010 Official Journal of the European Union L 225/11ANNEX  
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. in Part III the following rows are added: 
‘Methanol  1,5 mg/kg  
Propan-2-ol  1 mg/kg’EN L 225/12 Official Journal of the European Union 27.8.2010