European Communities (Certain Contaminants in Foodstuffs) Regulations, 2001
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the European Communities (Certain Contaminants in Foodstuffs) Regulations, 2001.
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paragraphs: (1) In these Regulations -
“Act of 1998” means the Food Safety Authority of Ireland Act, 1998 (No. 29 of 1998);
“the Annexes” means :-
(a) before 5 April 2002 :
the Annex to Commission Regulation 194/97 (and Corrigendum of 29 May 1997), as amended by Commission Regulation 1525/98, and Commission Regulation 864/1999, and Commission Regulation (EC) No. 1566/1999;
(b) on or after 5 April 2002 :
Annex I of Commission Regulation (EC) No. 466/2001 of 8 March 2001;
“approved examiner” has the meaning assigned to it by the European Communities (Official Control of Foodstuffs) Regulations 1998 ( S.I. No. 85 of 1998 ) and, for the purposes of these Regulations, includes the State Chemist in the State Laboratory;
“authorised officer” means -
(a) an authorised officer appointed under Section 49 of the Act of 1998;
(b) in relation to the functional area of a health board, a person or a person belonging to a class of persons, authorised by the chief executive officer of the health board concerned to perform the functions of an authorised officer under these Regulations, or
(c) in relation to the functional area of the Eastern Regional Health Authority, a person or a person belonging to a class of persons, authorised by the Regional Chief Executive of the Eastern Regional Health Authority to perform the functions of an authorised officer under these Regulations, or
(d) a person designated by the Minister for Agriculture, Food and Rural Development who is authorised in writing by the Minister for Agriculture, Food and Rural Development to be an authorised officer for the purposes of these Regulations;
“Certificate of an approved examiner” means a certificate given by an approved examiner of any test, examination or analysis made under these Regulations;
“contaminant” means any substance not intentionally added to food which is present in such food as a result of the production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport, holding and/or storage of such foodstuffs, or as a result of environmental contamination. (This definition does not cover extraneous matter such as insect fragments, animal hair, etc.);
“the Council and Commission Regulations” means Council Regulation (EEC) No. 315/93 of 8 February 1993 laying down Community procedures for contaminants in foodstuffs, and Commission Regulation (EC) No. 194/97 of 31 January 1997 setting maximum levels for certain contaminants in foodstuffs together with the Corrigendum to Commission Regulation (EC) No. 194/97, as amended by Commission Regulation (EC) No. 1525/98 of 16 July 1998 and Commission Regulation (EC) No. 864/1999 of 26 April 1999 and Commission Regulation (EC) No. 1566/1999 of 16 July 1999 and, with effect from 5 April 2002, Commission Regulation (EC) No. 466/2001 of 8 March 2001;
“EEA Agreement” means the Agreement on the European Economic Area signed in Oporto on 2 May 1992 as adjusted by the Protocol to that Agreement done at Brussels on 17 March 19938 ;
“Food Safety Authority” means the Food Safety Authority of Ireland established under section 9 of the Food Safety Authority of Ireland Act, 1998 (No. 29 of 1998);
“Foodstuff” means any substance used for food or drink by man, and
(a) any substance which enters into or is used in the composition or preparation of human food,
(b) any substance which enters into or is used in the composition or preparation of any such substance aforesaid, and
(c) chewing gum and products of a similar composition and use
and references to foodstuff include, as the context may require, references to a particular food, particular foods or a class or classes of food;
“functional area” means :-
(a) in relation to a health board the functional area of the health board as specified in the Health Board Regulations, 1970 ( S.I. No. 170 of 1970 );
(b) in relation to the Eastern Regional Health Authority, means its functional area as specified in section 7 (4) of the Health (Eastern Regional Health Authority) Act, 1999 (No. 13 of 1999);
(c) in relation to the Department of Agriculture, Food and Rural Development, means its functional area in all of the territory of the State;
“functions” includes powers and duties and references to the performance of functions include references to the exercise of powers and the performance of duties;
“import” means importation from a country other than a Member State;
“Member State” means a Member State of the European Community and shall be construed as including reference to those States which are Contracting Parties to the EEA Agreement;
“Minister” means the Minister for Health and Children;
“Official Control of Foodstuffs” hereinafter called “control of foodstuffs” means an inspection by an authorised officer of the compliance of :-
- foodstuffs,
- food additives, vitamins, mineral salts, trace elements and other additives intended to be sold as such, or
- materials and articles intended to come into contact with food,
with provisions aimed at preventing risks to public health, guaranteeing fair commercial transactions or protecting consumer interests, including provisions on consumer information;
“Official laboratory” means
(a) a laboratory approved in writing by the Minister to analyse any samples of a controlled item taken by an authorised officer for the purposes of these Regulations, or
(b) a laboratory approved in writing by the Chief Executive Officer of a health board with the consent of the Minister to analyse any samples of a controlled item taken by an authorised officer for the purposes of these Regulations, or
(c) a laboratory approved in writing by the Regional Chief Executive of the Eastern Regional Health Authority with the consent of the Minister to analyse any samples of a controlled item taken by an authorised officer for the purposes of these Regulations, or
(d) the State Laboratory;
“place on the market” means -
(a) import,
(b) sell,
(c) offer or expose for sale,
(d) invite the making by a person of an offer to purchase,
(e) distribute free of charge, or
(f) supply for any of those purposes,
and cognate words shall be construed accordingly;
“Public Analyst” means an analyst appointed by a health board and/or the Eastern Regional Health Authority to carry out the duties of a public analyst for the area of the board and/or Authority or an analyst designated by a health board and/or Authority to be a public analyst for its area.
“State Chemist” means the head of the State Laboratory or a person authorised by him or her in writing to perform the functions performed by the State Chemist in these Regulations;
(2) A word or expression that is used in these Regulations and which is also used in the Council and Commission Regulations has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Council and Commission Regulations;
(3) (a) A reference in these Regulations to a Regulation is to a Regulation of these Regulations, unless it is indicated that reference to some other Regulation is intended;
(b) A reference in these Regulations to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended.
PART II
General Provisions
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paragraphs: A person shall not place on the market foodstuffs unless they comply with the provisions laid down in these Regulations and in the Council and Commission Regulations.
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paragraphs: (1) A person shall not manufacture, produce, process, prepare, import, distribute, market, sell or offer for sale any of the products indicated in the Annexes which contains contaminants at a level higher than that specified therein;
(2) A person shall not place on the market foodstuffs containing a contaminant in an amount which is unacceptable from the public health viewpoint and, in particular, at a toxicological level;
(3) The maximum limits applicable to the products, as laid down in the Annexes shall also be applicable to processed products thereof in so far as no specific maximum limits are fixed for such processed products;
(4) Contaminant levels shall be kept as low as can reasonably be achieved by following good practices at all the stages referred to in paragraph (1).
(5) With effect from 5 April 2002 the maximum levels specified in Annex I of Commission Regulation (EC) No. 466/2001 shall apply to the edible part of the foodstuffs mentioned.
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paragraphs: Without prejudice to Regulation 4(4), and for the purposes of these Regulations, Regulations 3 and 4 shall not apply in the case of fresh spinach (Spinacia oleracea L) and fresh lettuce (Lactuca sativa L) grown in Ireland in accordance with the Irish Code of Good Agricultural Practice for Production of Protected Lettuce and Spinach with Respect to Nitrate Content, and intended for sale in Ireland, for as long as the derogation provided for in the Council and Commission Regulations continues in operation.
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paragraphs: (1) With regard to the products mentioned in point 1.2.1 of the Annex of Commission Regulation (EC) No. 194/97, and subject to the provisions of these Regulations it is prohibited :-
(a) to mix products complying with the maximum limits laid down in the Annexes with products exceeding the specified maximum limits, or to mix products to be subjected to a sorting technique or physical treatment with products intended for direct human consumption or as an ingredient in foodstuffs;
(c) comply with the maximum admissible levels laid down, before 5 April 2002 in point 1.2.1.1.3. of the Annex, and on or after that date in point 2.1.1.3. of the Annex, for nuts and dried fruit, and/or
(d) are subjected to a secondary treatment involving sorting or other physical treatments and that after this treatment the maximum levels laid down, before 5 April 2002 in points 1.2.1.1.1. and 1.2.1.2.1. of the Annex and after that date in points 2.1.1.1. and 2.1.2.1. of the Annex, are not exceeded, and this treatment does not result in other harmful residues;
(2) the destination of these products is demonstrated by labelling, which must be conspicuous, clearly legible and indelible, and comprising the indication “product must be subjected to sorting or other physical treatment to reduce aflatoxin contamination before human consumption or use as an ingredient in foodstuffs”.
(3) With effect from 5 April 2002, the maximum limits of aflatoxins applicable to the products, as provided for in Article 4(1) of Commission Regulation (EC) No. 466/2001 shall also be applicable to processed products thereof in so far as no specific maximum limits are fixed for such processed products.
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paragraphs: With effect from 5 April 2002, in the case of products, other than those mentioned under Article 4(1) of Commission Regulation (EC) No. 466/2001, which are dried, diluted, processed or composed of more than one ingredient, insofar as no specific maximum levels are fixed for such products, the maximum level applicable shall be that laid down in Annex I of that Regulation, taking into account respectively:
(1) changes of the concentration of the contaminant caused by drying or dilution processes,
(2) changes of the concentration of the contaminant caused by processing,
(3) the relative proportions of the ingredients in the product, and
(4) the analytical limit of quantification.
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paragraphs: With effect from 5 April 2002, the maximum levels specified in Annex I of Commission Regulation (EC) No. 466/2001 shall apply also to food intended for infants and young children covered by Directive 91/321/EEC and Directive 96/5/EC, taking into account respectively, the changes of the concentration of the contaminant caused by drying, dilution or processing and the relative concentrations of the ingredients in the product.
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paragraphs: With effect from 5 April 2002, and without prejudice to Articles 3(1) and 4(3) of Commission Regulation (EC) No. 466/2001, it is prohibited to use products as food ingredients for the production of compound foodstuffs which do not comply with the maximum levels set in Annex I of that Regulation.
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paragraphs: For the purposes of these Regulations the sampling method applied shall be in accordance with the methods described in the Annexes.
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paragraphs: For the purposes of these Regulations the analysis method applied shall comply with the criteria described in the Annexes.
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paragraphs: (1) With effect from 5 April 2002, Commission Regulation (EC) No. 194/97, as amended, is repealed.
(2) With effect from 5 April 2002, references to the repealed Regulation shall be construed as references to Commission Regulation (EC) No. 466/2001, and shall be read in accordance with the correlation table in Annex II of Commission Regulation (EC) No. 466/2001.
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paragraphs: Sections 3 and 4 of Annex I of Commission Regulation (EC) No. 466/2001 shall not apply to products which have been lawfully placed on the Community market before 5 April 2002.
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paragraphs: The Minister for Health and Children, after consultation with the Food Safety Authority of Ireland, may, by order, temporarily suspend or restrict the application of these Regulations where, as a result of new information or of a reassessment of existing information, there is reason to suspect that a contaminant in food, although complying with these Regulations, constitutes a health risk.
PART III
Enforcement
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paragraphs: Control of foodstuffs shall be carried out in accordance with the provisions of these Regulations.
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paragraphs: These Regulations shall be enforced by the Food Safety Authority of Ireland.
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paragraphs: These Regulations shall be deemed to be food legislation for the purposes of the Act of 1998 and the enforcement provisions contained in that Act shall accordingly apply for the purpose of ensuring compliance with these Regulations.
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paragraphs: (1) Without prejudice to Regulation 19, the powers contained in the European Communities (Official Control of Foodstuffs) Regulations, 1998 ( S.I. No. 85 of 1998 ), as amended, may be exercised for the purpose of ensuring compliance with these Regulations;
(2) An official certificate given in accordance with sub-article (1) of Article 14 of the said Regulations of 1998, as amended, may be adduced in evidence in a prosecution under these Regulations and shall be prima facie evidence of the matters contained therein, until the contrary is proved;
(3) An official certificate given by the State Laboratory may be adduced in evidence in a prosecution under these Regulations and shall be prima facie evidence of the matters contained therein, until the contrary is proved.
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paragraphs: (1) Without prejudice to Regulations 18, 19 and 20, before the European Communities (Certain Contaminants in Foodstuffs) Regulations, 2001 are added to Schedule 1 of the service contract entered into by a health board and the Food Safety Authority under the Act of 1998, the powers contained in Regulations 22 to 26 may be exercised by an authorised officer of a health board for the purpose of ensuring compliance with these Regulations.