Extraction Solvents in Food 

This Directive, which was published in the EU’s Official Journal (OJ) and entered into force on 26 June 2009, recasts Council Directive 88/344/EEC. This means that it incorporates the original legislative measure and its amendments into one text, and also introduces new measures.

Background

Extraction solvents are used in food production for extracting flavourings. Although these solvents are removed during the production process, unavoidable residues in foodstuffs may remain. The list of solvents that Member States may authorise for use in the production of foodstuffs was laid down in Council Directive 88/344/EEC. This Directive also established purity criteria.

This Directive has been amended several times. The Commission, in the interests of clarity, felt it necessary to propose a recast, which would repeal and replace the original text and its amendments with one text. The second reason for proposing a recast was that the Commission also wanted to recommend further amendments. The difference between a recast Directive and a codified Directive is that a recast also introduces new elements of substance.

Aims of the Directive

This Directive has two main aims:

· To clarify which extraction solvents Member States may authorise for use by bringing the original Directive and its corresponding amendments together into one text

· To take into account scientific and technical progress made in food production by enabling the Commission to make further amendments

Achieving Clarity

The Directive incorporates Council Directive 88/344/EEC on extraction solvents along with its successive amendments (as listed in Annex II):

·  Council Directive 92/115/EEC

·  Directive 94/52/EC

·  Directive 97/60/EC

·  Regulation (EC) No 1882/2003 (Point 9 of Annex III only)

The recast Directive establishes a single list of extraction solvents approved for use in food production (Annex I). Annex I also lists approved extraction solvents for which specific conditions of use are specified. These are Hexane, Methyl acetate, Ethylmethylketone, Dichloromethane, Methanol, and Proan-2-ol.

Finally, Annex I lists maximum residue limits in the foodstuff due to the use of extraction solvents in the preparation of flavourings from natural flavouring materials for: Diethyl ether, Hexane, Cyclohexane, Methyl acetate, Butan-1-ol, Butan-2-ol, Ethylmethylketone, Dichloromethane, Propan-1-ol, and 1,1,1,2-tetrafluoroethane.

Member States

The Directive also clarifies the responsibilities of Member States. When a Member State has detailed grounds for not authorising a substance on the grounds of health risk, it may temporarily suspend or restrict the use of this product within its territory. It must however inform other Member States and the Commission of its decision. The Commission will then examine the case and issue an opinion.

Member States must also ensure that the packaging, containers or labels of substances listed in Annex I and intended for use as extraction solvents in foodstuffs contain the following:

·  The commercial name as indicated in Annex I

·   A clear indication that the material is of a quality suitable for use for the extraction of food or food ingredients

·  A reference by which the batch may be identified

·  The name or business name and address of the manufacturer or packer or seller

·  The net quantity given as units of volume

·  If necessary, special storage conditions or conditions of use

Further Measures

The Directive also obliges the Commission to adopt measures in order to improve the implementation of the Directive. These cover:

·  Any necessary amendments to Annex I, the list of approved substances, that take into account scientific and technical progress made in food production

·  Establishing methods of analysis necessary to verify compliance with the purity criteria

·  Establishing procedures for taking samples and the methods for qualitative and quantitative analysis of the extraction solvents

·  Setting specific purity criteria for the extraction solvents listed in Annex I, in particular maximum permitted levels of mercury and cadmium in extraction solvents

These measures will be adopted through the comitology procedure with scrutiny, provided for in Article 5a of Decision 1999/468/EC. However, the Commission will be able to apply the urgency procedure provided for in Article 5a (6) of Decision 1999/468/EC for the adoption of amendments of the list of extraction solvents, if human health is thought to be at risk.

Scope of the Directive

This Directive defines ‘solvent’ as any substance used for dissolving a foodstuff or ingredient. ‘Extraction solvent’ is defined as a solvent used in an extraction procedure that is removed but may result in residue. The Directive applies to extraction solvents used or intended for use in the production of foodstuffs and food ingredients in the EU, but not to extraction solvents for export outside the EU. In addition, the Directive does not apply to extraction solvents used in the production of food additives, vitamins and other nutritional additives, vitamins or nutritional additives as listed in Annex I. The new elements introduced into this Directive only concern the committee procedures (comitology measures) and do not need to be transposed by Member States.

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 (recast) was published in the EU’s Official Journal (OJ) on the 6 June 2009 and entered into force 26 June 2009.