Legal provisions of COM(2008)154 - Approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (Recast)

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dossier COM(2008)154 - Approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ...
document COM(2008)154 EN
date June 26, 2009

Contents

Article 1

1. This Directive applies to extraction solvents used or intended for use in the production of foodstuffs or food ingredients.

This Directive shall 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 Annex I.

However, the Member States shall ensure that the use of food additives, vitamins and other nutritional additives does not result in foodstuffs containing extraction solvent residue levels dangerous to human health.

This Directive shall apply without prejudice to the provisions adopted under more specific Community rules.

2. For the purposes of this Directive:

(a)‘solvent’ means any substance for dissolving a foodstuff or any component thereof, including any contaminant present in or on that foodstuff;

(b)‘extraction solvent’ means a solvent which is used in an extraction procedure during the processing of raw materials, of foodstuffs, or of components or ingredients of these products and which is removed but which may result in the unintentional, but technically unavoidable, presence of residues or derivatives in the foodstuff or food ingredient.

Article 2

1. Member States shall authorise the use as extraction solvents in the manufacture of foodstuffs or food ingredients of those substances and materials listed in Annex I, under the conditions of use and where appropriate within the maximum residue limits specified in that Annex.

Member States may not prohibit, restrict or obstruct the marketing of foodstuffs or food ingredients on grounds relating to the extraction solvents used or their residues if these comply with the provisions of this Directive.

2. Member States shall not authorise the use of other substances and materials as extraction solvents, nor extend the conditions of use or permitted residues of the extraction solvents listed in Annex I beyond those specified therein.

3. Water to which substances regulating acidity or alkalinity may have been added and other food substances which possess solvent properties are authorised as extraction solvents in the manufacture of foodstuffs or food ingredients.

Article 3

Member States shall take all necessary measures to ensure that the substances and materials listed as extraction solvents in Annex I comply with the following general and specific purity criteria:

(a)they shall not contain a toxicologically dangerous amount of any element or substance;

(b)subject to any exceptions deriving from the specific purity criteria adopted in accordance with point (d) of Article 4, they shall not contain more than 1 mg/kg of arsenic or more than 1 mg/kg of lead;

(c)they shall satisfy the specific purity criteria adopted in accordance with point (d) of Article 4.

Article 4

The Commission shall adopt the following:

(a)the necessary amendments to Annex I in the light of scientific and technical progress in the field of the use of solvents, their conditions of use and maximum residue limits;

(b)the methods of analysis necessary to verify compliance with the general and specific purity criteria provided for in Article 3;

(c)the procedure for taking samples and the methods for qualitative and quantitative analysis of the extraction solvents listed in Annex I and used in foodstuffs or food ingredients;

(d)if necessary, the specific purity criteria for the extraction solvents listed in Annex I, and in particular maximum permitted limits of mercury and cadmium in the extraction solvents.

The measures referred to in points (b) and (c) of the first subparagraph, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(2).

The measures referred to in points (a) and (d) of the first subparagraph, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(3).

Where necessary, the measures referred to in points (a) and (d) of the first subparagraph shall be adopted in accordance with the urgency procedure referred to in Article 6(4).

Article 5

1. Where a Member State, as a result of new information or of a reassessment of existing information made since this Directive was adopted, has detailed grounds for establishing that the use in foodstuffs of any substance listed in Annex I or the level of one or more of the components referred to in Article 3 contained in such substances might endanger human health although it complies with the conditions laid down in this Directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision.

2. The Commission shall examine as soon as possible the evidence given by the Member State concerned and consult the Committee referred to in Article 6(1), and shall then deliver its opinion forthwith and take the appropriate measures, which may replace the measures referred to in paragraph 1 of this Article.

3. If the Commission considers that amendments to this Directive are necessary in order to resolve the difficulties mentioned in paragraph 1 and to ensure the protection of human health, it shall adopt those amendments.

Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the urgency procedure referred to in Article 6(4).

Any Member State which has adopted safeguard measures may in that event retain them until the amendments enter into force in its territory.

Article 6

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (6).

2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The periods laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at two months, one month and two months respectively.

4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 7

1. Member States shall take all necessary measures to ensure that the substances listed in Annex I and intended for use as extraction solvents in foodstuffs may not be marketed unless their packaging, containers or labels carry the following particulars in such a way as to be easily visible, clearly legible and indelible:

(a)the commercial name as indicated in Annex I;

(b)a clear indication that the material is of a quality suitable for use for the extraction of food or food ingredients;

(c)a reference by which the batch or lot may be identified;

(d)the name or business name and address of the manufacturer or packer or of a seller established within the Community;

(e)the net quantity given as units of volume;

(f)if necessary, the special storage conditions or conditions of use.

2. By way of derogation from paragraph 1, the particulars specified in points (c), (d), (e) and (f) of that paragraph may appear only on the trade documents relating to the batch or lot which are to be supplied with or prior to the delivery.

3. This Article shall be without prejudice to more precise or more extensive Community provisions regarding weights and measures or provisions applying to the classification, packaging and labelling of dangerous substances and mixtures.

4. Member States shall refrain from laying down requirements more detailed than those already contained in this Article concerning the manner in which the particulars provided are to be shown.

Each Member State shall, however, ensure that the sale of extraction solvents within its territory is prohibited if the particulars provided for in this Article do not appear in a language easily understood by purchasers, unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such particulars from being indicated in various languages.

Article 8

1. This Directive shall also apply to extraction solvents used or intended for use in the production of foodstuffs or food ingredients imported into the Community.

2. This Directive shall not apply to extraction solvents or foodstuffs intended for export outside the Community.

Article 9

Directive 88/344/EEC, as amended by the acts listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Article 10

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 11

This Directive is addressed to the Member States.