S.I. No. 334/1991 - European Communities (Extraction Solvents in Foodstuffs) Regulations, 1991.

S.I. No. 334 of 1991.

EUROPEAN COMMUNITIES (EXTRACTION SOLVENTS IN FOODSTUFFS) REGULATIONS, 1991.

The Minister for Health, in exercise of the powers conferred on her by Section 3 of the European Communities Act, 1972 (No. 27 of 1972), hereby makes the following Regulations:—

1. These Regulations may be cited as the European Communities (Extraction Solvents in Foodstuffs) Regulations, 1991.

2. These Regulations shall come into force on the 31st day of December, 1991.

3. (1) In these Regulations "The Council Directive" means Council Directive 88/344/EEC.

(2) In these Regulations words and phrases shall have the same meaning as in the Council Directive.⁽¹⁾

⁽¹⁾Official Journal of the European Communities

O.J. No. L157, 24-6-88, pages 28-33.

(3) In these Regulations any reference to an article or Schedule shall, except where otherwise indicated be construed as a reference to an article contained in these Regulations or, as the case may be, to a Schedule thereto; any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article.

4. (1) Subject to sub-article (2) these Regulations shall apply to extraction solvents used or intended for use in the production of foodstuffs or food ingredients.

(2) These Regulations shall not apply:

(i) 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 the Schedule;

(ii) to methanol, propan-1-ol, propan-2-ol and tricholoroethylene when used as extraction solvents in the production of foodstuffs or food ingredients.

(3) Notwithstanding the provisions of paragraph (i) of sub-article (2) the use of food additives, vitamins and other nutritional additives shall not result in foodstuffs containing extraction solvent residue levels dangerous to human health.

5. (1) The use of an extraction solvent other than one listed in the Schedule (hereinafter referred to as a "permitted extraction solvent") in the manufacture of foodstuffs or food ingredients is prohibited.

(2) Notwithstanding the provisions of sub-article (1):

(i) the use of water to which substances regulating acidity or alkalinity may have been added, other food substances which possess solvent properties and ethanol as extraction solvents for the manufacture of foodstuffs or food ingredients is permissible;

(ii) the use of substances for diluting or dissolving flavourings as solvents for the extraction of flavourings from natural flavourings materials is permissible;

(3) The use of a permitted extraction solvent in the manufacture of foodstuffs or food ingredients shall be subject to the following conditions of use:

(i) in the case of an extraction solvent listed in Part I of the Schedule, in accordance with good manufacturing practice for all uses.

For the purposes of this paragraph, an extraction solvent is considered as being used in accordance with good manufacturing practice if its use results only in the presence of residues or derivatives in technically unavoidable quantities presenting no danger to human health.

(ii) in the case of an extraction solvent listed in the first column of Part II of the Schedule in accordance with the conditions specified in the second column and subject to the maximum residue limits in the extracted foodstuff or food ingredients specified in the third column pertaining to such extraction solvent.

For the purposes of this paragraph, Hexane shall mean a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64°C and 70°C.

(iii) in the case of an extraction solvent listed in the first column of Part III of the Schedule in accordance with the maximum residue limits in the foodstuff due to its use in the preparation of flavourings from natural flavouring materials specified in the second column opposite such extraction solvent.

However, the limit, specified in the second column in respect of Dichloromethane insofar as confectionery and pastry products containing flavourings which are characteristic of the foodstuff and are obtained from extracts of alcoholic beverages of an alcoholic strength of over 35° are concerned, shall be 1mg/kg.

6. Substances and materials permitted for use as extraction solvents in accordance with these Regulations:

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

(b) shall not contain more than 1mg/kg of arsenic or more than 1mg/kg of lead.

7. (1) Substances intended for use as extraction solvents in foodstuffs shall not be marketed unless there is easily visible and legibly and indelibly written in a conspicuous position on the packaging, containers or labels, the following information:

(a) the commercial name as given in the Schedule;

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

(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 sub-article (1), the information specified in paragraphs (c), (d), (e) and (f) of that sub-article may appear merely on the trade documents relating to the batch or lot which are to be supplied with or prior to the delivery.

(3) The particulars required in this article shall be given in the Irish or English language unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such particulars from also being indicated in various other languages.

(4) This article is 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 preparations.

8. (1) A person shall not import, manufacture, prepare, distribute, market, or sell a foodstuff which breaches any of the provisions of these Regulations on extraction solvents used in the production of foodstuffs and food ingredients.

(2) A person shall not import, manufacture, prepare, distribute, market or sell an extraction solvent which breaches any of the provisions of these Regulations on extraction solvents used in the production of foodstuffs and food ingredients.

9. Where the Minister for Health is of the view that the use or intended use in foodstuffs of any extraction solvent listed in the Schedule or the level of one or more of the components referred to in article 6 of these Regulations, although complying with these Regulations, endangers human health she may take appropriate measures including the temporary suspension or restriction of trade in that extraction solvent or foodstuff containing that extraction solvent in order to protect public health.

10. (1) In any proceedings for an offence under these Regulations it shall be a defence for the person charged to show that the food in respect of which the offence is alleged to have been committed was intended for export and complied with the importing country's domestic food legislation relevant to the alleged offence.

(2) For the purpose of ensuring compliance with these Regulations the control system established under the provisions of the Health (Official Control of Food) Regulations, 1991 shall apply.

11. A person who contravenes these Regulations shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000 and, in the case of a continuing offence, to a further fine not exceeding £100 for each day on which the offence is continued.

12. (1) Where a sample of any foodstuff or extraction solvent has been certified under the provisions of the Health (Official Control of Food) Regulations, 1991 not to comply with these Regulations, an authorised officer may seize, remove and detain such foodstuffs as being a foodstuff which is unfit for human consumption.

(2) With the consent in writing of the owner or person responsible for such foodstuff, an authorised officer may destroy or otherwise dispose of it so as to prevent its use for human consumption.

(3) An authorised officer who has seized any foodstuff in pursuance of the provisions of this article may, on giving notice in writing to the owner or person responsible for such foodstuff of his intention to do so, apply to a Justice of the District Court for an order directing that such food be destroyed or otherwise disposed of as being a foodstuff which is unfit for human consumption.

(4) A Justice of the District Court to whom the application is made for an order under sub-article (3) shall, if satisfied that such foodstuff does not comply with these Regulations, order that it be destroyed or otherwise disposed of after such period, not exceeding fourteen days, as may be specified in such order, as being a foodstuff which is unfit for human consumption and an authorised officer shall destroy or dispose of it accordingly.

13. A person shall give to any authorised officer all reasonable assistance that the officer may require in the performance of his duties under these Regulations and such assistance shall include the giving of information relating to the composition and use of any foodstuff and the identity of the person from whom or the place from which any such foodstuff has been obtained and the person to whom and the place to which it has been consigned or the manner in which it has otherwise been disposed of.

SCHEDULE

Extraction solvents which may be used during the processing of raw materials, of foodstuffs, of food components or of food ingredients.

PART I

Extraction solvents to be used in compliance with good manufacturing practice for all uses

Propane	Ethanol
Butane	Carbon Dioxide
Butyl acetate	Acetone
Ethyl acetate	Nitrous oxide

PART II

Extraction solvents for which conditions of use are specified

Name	Conditions of Use (summary description of extraction)	Maximum residue limits in the extracted foodstuff of food ingredient
Hexane	Production or fractionation of fats and oils and production of cocoa butter.	5 mg/kg in the fat or oil or cocoa butter.
	Preparation of protein products and defatted flours.	10 mg/kg in the food containing the protein products and defatted flours.
	Preparation of defatted cereal germs.	5 mg/kg in the defatted cereal germ.
	Defatted soya products.	30 mg/kg in the soya product is sold to the final consumer.
Methyl acetate	Decaffeination of, or removal of irritants and bitterings from coffee and tea.	20 mg/kg in the coffee or tea.
	Production of sugar from molasses.	1 mg/kg in the sugar.
Ethylmethylketone	Fractionation of fats and oils.	5 mg/kg in the fat or oil.
Decaffeination of, or removal of irritants and bitterings from coffee and tea.	20 mg/kg in the coffee or tea.
Dichloromethane	Decaffeination of, or removal of irritants and bitterings from coffee and tea.	5 mg/kg in the roasted coffee and 5 mg/kg in the tea.

PART III

Extraction solvents for which conditions of use are specified

Name	Maximum residue limits in the foodstuff due to the use of extraction solvents in the preparation of flavourings from natural flavouring materials.
Diethyl ether	2 mg/kg
Isobutane	1 mg/kg
Hexane	1 mg/kg
Cyclohexane	1 mg/kg
Methyl acetate	1 mg/kg
Butan-1-ol	1 mg/kg
Butan-2-ol	1 mg/kg
Ethylmethylketone	1 mg/kg
Dichloromethane	0.1 mg/kg
Methyl-propan-1-ol	1 mg/kg

GIVEN under the Official Seal of the Minister for Health, this 16th

day of December, 1991.

MARY O'ROURKE,

Minister for Health.

EXPLANATORY NOTE.

The Regulations specify by name all the substances which may be used as extraction solvents and under conditions of good manufacturing practice (Part II) and to take account of protection of public health the conditions of use of other extraction solvents (Part III) and the residues permitted (Part IV) in food and food ingredients.

The Regulations implement EEC Directive No. 88/344/EEC relating to approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients.

The Regulation comes into effect on 31st December 1991.