European Communities (Food Additives Other Than Colours and Sweeteners) Regulations, 2002
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the European Communities (Food Additives other than Colours and Sweeteners) Regulations, 2002 and they shall come into operation on 13th day of December, 2002.
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paragraphs: (1) In these Regulations:
“acidity regulators” means substances which alter or control the acidity or alkalinity of a foodstuff;
“acids” means substances which increase the acidity of a foodstuff and/or impart a sour taste to it;
“the Act of 1998” means the Food Safety Authority of Ireland Act 1998 (No. 29 of 1998);
“the Act of 1999” means the Health (Eastern Regional Health Authority) Act, 1999 (No. 13 of 1999);
“the Annexes” means the Annexes to European Parliament and Council Directive No. 95/2/EC5 of 20 February 1995 on food additives other than colours and sweeteners as amended by Directive 96/85/EC6 of the European Parliament and of the Council of 19 December 1996 and Directive 98/72/EC7 of the European Parliament and of the Council of 15 October 1998, and Directive 2001/5/EC8 of the European Parliament and of the Council of 12 February 2001, and cognate words shall be construed accordingly;
“anti-caking agents” means substances which reduce the tendency of individual particles of a foodstuff to adhere to one another;
“anti-foaming agents” means substances which prevent or reduce foaming;
“antioxidants” means substances which prolong the shelf-life of foodstuffs by protecting them against deterioration caused by oxidation, such as fat rancidity and colour changes;
“approved examiner” for the purposes of these Regulations has the meaning assigned to it by the European Communities (Official Control of Foodstuffs) Regulations, 1998 ( S.I. No. 85 of 1998 );
“authorised officer” means -
(a) an authorised officer appointed under Section 49 of the Act of 1998, or
(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;
“the Authority” means the Food Safety Authority of Ireland established under Section 9 of the Act of 1998;
“bulking agents” means substances which contribute to the volume of a foodstuff without contributing significantly to its available energy value;
“carriers” (including carrier solvents) means substances used to dissolve, dilute, disperse or otherwise physically modify a food additive without altering its technological function (and without exerting any technological effect themselves) in order to facilitate its handling, application or use;
“controlled item” means
- foodstuff,
- food additives, vitamins, mineral salts, trace elements and other additives intended to be sold as such,
- materials and articles intended to come into contact with foodstuffs;
“the Directive” means European Parliament and Council Directive No. 95/2/EC9 of 20 February 1995 on food additives other than colours and sweeteners as amended by Directive 96/85/EC10 of the European Parliament and of the Council of 19 December 1996, and Directive 98/72/EC11 of the European Parliament and of the Council of 15 October 1998, and Directive 2001/5/EC12 of the European Parliament and of the Council of 12 February 2001;
“emulsifiers” means substances which make it possible to form or maintain a homogenous mixture of two or more immiscible phases such as oil and water in a foodstuff;
“emulsifying salts” means substances which convert proteins contained in cheese into a dispersed form and thereby bring about homogenous distribution of fat and other components;
“firming agents” means substances which make or keep tissues of fruit or vegetables firm or crisp, or interact with gelling agents to produce or strengthen a gel;
“flavour enhancers” means substances which enhance the existing taste and/or odour of a foodstuff;
“flour treatment agents” means substances other than emulsifiers which are added to flour or dough to improve its baking quality;
“foaming agents” means substances which make it possible to form a homogenous dispersion of a gaseous phase in a liquid or solid foodstuff;
“food additives” excludes the following:
(a) substances used for treatment of drinking water as provided for in Directive 80/778/EEC13 ,
(b) products containing pectin and derived from dried apple pomace or peel of citrus fruits, or from a mixture of both by the action of dilute acid followed by partial neutralization with sodium or potassium salts (‘liquid pectin’),
(c) chewing gum bases,
(d) white or yellow dextrin, roasted or dextrinated starch starch modified by acid or alkali treatment, bleached starch physically modified starch and starch treated by amylolitic enzymes,
(e) ammonium chloride,
(f) blood plasma, edible gelatin, protein hydrolysates and their salts, milk protein and gluten,
(g) amino acids and their salts other than glutamic acid glycine, cysteine and cystine and their salts and having no additive function,
(h) caseinates and casein, and
(i) inulin;
“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 established under Section 4 of the Health Act, 1970 (No. 1 of 1970), the functional area of the health board as specified in the Health Boards Regulations 1970 ( S.I. No. 170 of 1970 );
(b) in relation to an Area Health Board established by Section 14(1) of the Act of 1999, the functional area of each Area Health Board as specified in Section 14(4) of the Act of 1999;
“functions” includes powers and duties, and reference to the performance of functions includes, as respects powers and duties references to the exercise of the powers and the performance of the duties;
“gelling agents” means substances which give a foodstuff texture through the formation of a gel;
“glazing agents” (including lubricants) means substances which, when applied to the external surface of a foodstuff, impart a shiny appearance or provide a protective coating;
“health board” means
(a) a board established under Section 4 of the Health Act, 1970 (No. 1 of 1970), and/or
(b) an Area Health Board established by Section 14(1) of the Act of 1999;
“humectants” means substances which prevent foodstuffs from drying out by counteracting the effect of an atmosphere having a low degree of humidity, or promote the dissolution of a powder in an aqueous medium;
“import” means importation from a country other than a Member State;
“Member State” means a Member State of the European Community;
“Minister” means the Minister for Health and Children;
“modified starches” means substances obtained by one or more chemical treatments of edible starches, which may have undergone a physical or enzymatic treatment and may be acid or alkali thinned or bleached;
“official control of foodstuffs” hereinafter called “control of foodstuffs” means an inspection by authorised officers 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” for the purposes of these Regulations means a laboratory approved in writing by the Minister or by the chief executive officer of a health board pursuant to the European Communities (Official Control of Foodstuffs) Regulations, 1998 ( S.I. No. 85 of 1998 );
“packaging gases” means gases other than air, introduced into a container before, during or after the placing of a foodstuff in that container;
“place on the market” means-
(a) import,
(b) sell,
(c) offer or expose for sale,
(d) hold for the purposes of sale,
(e) invite the making by a person of an offer to purchase,
(f) distribute free of charge,
(g) supply for any of those purposes (whether or not for profit and cognate words shall be construed accordingly;
“premises” includes any place, building, aircraft, vehicle, railway wagon, container or vessel or temporary premises at or in or on which any trade, business or activity in connection with the production preparation, processing, manufacture, exportation, importation storage, distribution or sale of food is or has been carried on;
“preservatives” means substances which prolong the shelf-life of foodstuffs by protecting then against deterioration caused by micro-organisms;
“propellants” means gases other than air which expel a foodstuff from a container;
“raising agents” means substances or combinations of substances which liberate gas and thereby increase the volume of a dough or a batter;
“sequestrants” means substances which form chemical complexes with metallic ions;
“stabilizers” means substances which make it possible to maintain the physico-chemical state of a foodstuff, and includes substances which enable the maintenance of a homogenous dispersion of two or more immiscible substances in a foodstuff and includes also substances which stabilize, retain or intensify an existing colour of a foodstuff;
“thickeners” means substances which increase the viscosity of a foodstuff;
“unprocessed” means not having undergone any treatment resulting in a substantial change in the original state of the foodstuffs; however, the foodstuffs may have been, for example, divided, parted, severed boned, minced, skinned, pared, peeled, ground, cut, cleaned, trimmed deep frozen or frozen, chilled, milled or husked, packed or unpacked.
(2) A word or expression that is used in these Regulations and that is also used in the Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive.
(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: (1) These Regulations concern and apply to food additives other than colours and sweeteners.
(2) These Regulations do not apply to enzymes other than those mentioned in the Annexes.
(3) The provisions of these Regulations shall apply also to the corresponding foodstuffs intended for particular nutritional uses in accordance with European Communities (Foodstuffs Intended for Particular Nutritional Uses) Regulations, 2002 ( S.I. No. 379 of 2002 ).
(4) These Regulations shall apply without prejudice to specific Directives permitting additives listed in the Annexes to be used as sweeteners or colours.
(5) From the date of coming into effect of these Regulations, a person shall not use food additives in or on any foodstuffs, or place foodstuffs on the market, unless the requirements of these Regulations are complied with.
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paragraphs: (1) Only those substances listed in Annexes I, III, IV and V, as amended, may be used in foodstuffs for the purposes of use as preservatives antioxidants, carriers, acids, acidity regulators, anti-caking agents, anti-foaming agents, bulking agents, emulsifiers, emulsifying salts, firming agents, flavour enhancers, foaming agents, gelling agents, glazing agents humectants, modified starches, packaging gases, propellants, raising agents, sequestrants, stabilizers, thickeners or flour treatment agents.
(2) Food additives listed in Annex I, as amended, are permitted in foodstuffs for the purpose of the uses mentioned in paragraph (1), with the exception of those foodstuffs listed in Annex II, as amended, following the ‘quantum satis’ principle.
(3) Except where specifically provided for, paragraph (2) shall not apply to:-
(a) unprocessed foodstuffs,
(b) honey as defined in Directive 74/409/EEC14 ,
(c) non-emulsified oils and fats of animal or vegetable origin,
(d) butter,
(e) pasteurised and sterilised (including UHT) milk (including plain skimmed and semi-skimmed) and plain pasteurised cream,
(f) unflavoured, live fermented milk products,
(g) natural mineral water as defined in Directive 80/777/EEC15 and spring water,
(h) coffee (excluding flavoured instant coffee) and coffee extracts,
(i) unflavoured leaf tea,
(j) sugars as defined in Directive 73/437/EEC16 ,
(k) dry pasta, excluding gluten-free and/or pasta intended for hypoproteic diets, in accordance with Directive 89/398/EEC17 , and
(l) natural unflavoured buttermilk (excluding sterilised buttermilk).
(4) Except where specifically provided for, paragraph (2) shall not apply to foodstuffs for infants and young children as referred to in Directive 89/398/EEC18 (including foodstuffs for infants and young children not in good health) which foodstuffs are subject to the provisions of Annex VI as amended.
(5) Except where specifically provided for, paragraph (2) shall not apply to the foodstuffs listed in Annex II, as amended, which may contain only those additives referred to in that Annex and those additives referred to in Annexes III and IV, as amended, under the conditions specified therein.
(6) Additives listed in Annexes III and IV, as amended, may only be used in the foodstuffs referred to in those Annexes and under the conditions specified therein.
(7) Only those additives listed in Annex V, as amended, may be used as carriers or carrier solvents for food additives and must be used under the conditions specified therein.
(8) Maximum levels indicated in the Annexes refer to foodstuffs as marketed unless otherwise stated.
(9) In the Annexes, ‘quantum satis’ means that no maximum level is specified. However, additives shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and provided that they do not mislead the consumer.
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paragraphs: (1) The presence of a food additive in a foodstuff is permissible
(a) in a compound foodstuff other than one mentioned in paragraphs (3) (4) and (5) of Regulation 4, to the extent that the food additive is permitted in one of the ingredients of the compound foodstuff, or
(b) if the foodstuff is destined to be used solely in the preparation of a compound foodstuff and to an extent such that the compound foodstuff conforms to the provisions of these Regulations.
(2) Paragraph (1) shall not apply to infant formulae, follow-on formulae and weaning foods, as referred to in Directive 89/398/EEC,19 except where specially provided for.
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 8, 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 Regulation 14(1) 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.
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paragraphs: Without prejudice to Regulations 8 and 9, before the European Communities (Food Additives other than Colours and Sweeteners) Regulations, 2002 are added to Schedule 1 of the service contract entered into by a health board and the Authority under the Act of 1998, the powers contained in Regulations 11 to 16 may be exercised by health boards in their functional areas, for the purpose of ensuring compliance with these Regulations.
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paragraphs: (1) The Chief Executive Officer of a health board may appoint in writing such and so many officers of the health board as he or she thinks fit to be authorised officers for the purposes of ensuring compliance with these Regulations in the functional area of the health board;
(2) A person appointed as an authorised officer under the European Communities (Food Additives other than Colours and Sweeteners Regulations, 1999 ( S.I. No. 288 of 1999 ) and holding office as an authorised officer immediately before the coming into operation of these Regulations shall continue in office as if appointed under this Regulation;
(3) An authorised officer shall be furnished with a certificate of his appointment as an authorised officer and when exercising any power conferred on an authorised officer under these Regulations, shall, if requested by any person affected, produce the certificate to that person;
(4) For the purpose of ensuring compliance with these Regulations after entry into a service contract by a health board with the Authority, the appointments referred to in paragraphs (1) and (2) shall continue in force.
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paragraphs: (1) An authorised officer may for the purpose of ensuring that these Regulations are being complied with -
(a) require any employee of the health board, a former employee of the health board or any person otherwise currently or previously retained by the health board, or any person who carries or has carried on any trade, business or activity to which these Regulations relate or any person currently or previously employed in connection with that trade, business or activity to produce to him or her such records, and in the case of such information in a non-legible form to reproduce it in a permanent legible form, or to give him or her such information as the officer may reasonably require in relation to any entries in such records;
(b) at all reasonable times enter any premises, subject to paragraph (3), at which there are reasonable grounds to believe that any trade, business or activity in connection with the production processing disposal, manufacture, exportation, importation storage, distribution, sale, marketing or labelling for the purposes of marketing, of any foodstuff to which these Regulations apply is or has been carried on, or that records in relation to such trade, business or activity are kept, and search and inspect the premises and any foodstuff, label or records found in or on the premises;
(c) secure for later inspection any premises or any part thereof in which such foodstuff, label or records are kept or in respect of which there are reasonable grounds for believing that such foodstuff, labels or records are kept;
(d) inspect and take copies of or extracts from any such records (including in the case of information in a non-legible form a copy of or extract from such information in a permanent legible form);
(e) seize, remove, detain and/or direct the withdrawal from the market of any foodstuff intended for sale for human consumption which is suspected by him to fail to comply with the provisions of these Regulations;
(f) remove and retain the said foodstuff, labels or records for such period as may be reasonable for further examination or until the conclusion of any legal proceedings;
(g) as regards any product or any article or substance used in the manufacture or preparation of a foodstuff the officer finds at or in a premises, require any person in charge thereof or any person who appears to the officer to be in possession of the product or the article or substance, to supply without payment for test, examination or analysis sufficient samples thereof;
(h) require any person to afford the officer such facilities and assistance within his or her control or responsibilities as are reasonably necessary to enable the officer to exercise any of the powers conferred on an authorised officer under this Regulation;
(i) require a person referred to in subparagraph (a) to give to the officer any information which the officer may reasonably require in regard to the trade, business or activity or in regard to the persons carrying on such trade, business or activity or employed in connection with that trade, business or activity;
(j) require any person referred to in subparagraph (a) by or on whose behalf data equipment is or has been used in relation to a business within the meaning of subparagraph (b) or any person having charge of, or otherwise concerned with the operation of the data equipment or any associated apparatus or material, to afford the officer all reasonable assistance in relation to its use thereto;
(k) summon, at any reasonable time, any other person being or having been an employee of the health board or retained or having been retained by the health board or employed in connection with the trade, business or activity under examination by the health board to give to the officer any information which the officer may reasonably require in regard to that trade, business or activity and to produce to the officer any records which are in that person's power or control;
(l) examine any procedure connected with the manufacture of a foodstuff;
(m) exercise such other powers as may be necessary to ensure that these Regulations are being complied with;
(2) Where an authorised officer has reasonable grounds for believing that a person has contravened any provision of these Regulations and so informs such person, the authorised officer may require such person to state his name and address, and, if the authorised officer thinks it necessary, to produce corroborative evidence of his name and address.
(3) An authorised officer shall not, other than with the consent of the occupier, enter a private dwelling unless he or she has obtained a warrant from the District Court under paragraph (6) authorising such entry;
(4) Where an authorised officer in the exercise of the officer's powers under this Regulation is prevented from entering any premises, an application may be made to the District Court under paragraph (6) for a warrant authorising such entry;
(5) An authorised officer, where he or she considers it necessary, may be accompanied by a member of the Garda SÃ­ochÃ¡na when performing any powers conferred on an authorised officer under this Regulation;
(6) If a judge of the District Court is satisfied on the sworn information of an authorised officer that there are reasonable grounds for suspecting that there is information required by an authorised officer under this Regulation held on or in any premises or any part of any premises or there is a foodstuff which an authorised officer requires to inspect for purposes of these Regulations or that such inspection is likely to disclose evidence of a contravention of these Regulations, the judge may issue a warrant authorising an authorised officer, accompanied, if appropriate, by other authorised officers or by a member of the Garda SÃ­ochÃ¡na, at any time or times within one month from the date of issue of the warrant, on production, if so requested, of the warrant, to enter if need be by reasonable force, the premises and exercise all or any of the powers conferred on an authorised officer under this Regulation;
(7) An application under paragraph (6) shall be made to the judge of the District Court in whose district court district the premises is situated.
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paragraphs: (1) An authorised officer may destroy or otherwise dispose of any foodstuff seized, removed and detained by him or her under Regulation 12(1)(e), with the consent of the owner or person responsible for the foodstuff or upon the granting of an order under paragraph (3);
(2) An authorised officer who has seized, removed and detained any foodstuff under Regulation 12(1)(e) may, on giving notice in writing to the owner or person responsible for the foodstuff apply to a judge of the District Court in whose district court district the foodstuff was seized for an order directing that the foodstuff be destroyed or otherwise disposed of as being a foodstuff which is not in compliance with these Regulations;
(3) A judge of the District Court to whom an application is made under paragraph (2) 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 14 days, as may be specified in the order, as being a foodstuff which is not in compliance with these Regulations;
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paragraphs: (1) An authorised officer may, for the purpose of these Regulations purchase or take without payment a sample of any controlled item.
(2) An authorised officer may for the purpose of taking a sample of a controlled item open any receptacle.
(3) Where an authorised officer purchases or takes without payment, with the intention of having it analysed by an approved examiner, a sample of a controlled item which is suspected by him to fail to comply with the provisions of any other Regulations applicable to such a controlled item, he may, by notice in writing to the seller, owner or person in apparent charge or control of such item (as the case may be) prohibit the removal of the controlled item except to any place which may be specified in the notice, during such period as may be specified in the notice, but not exceeding fourteen days from the date of the taking of the sample.
(4) Where an authorised officer purchases or takes without payment a sample of a controlled item with the intention of having it analysed by an approved examiner within the meaning of the European Communities (Official Control of Foodstuffs) Regulations, 1998, as amended, in an official laboratory approved under the European Communities (Official Control of Foodstuffs) (Approved Laboratories Order, 1998 ( S.I. No. 95 of 1998 ), he shall after purchasing or taking the sample forthwith notify the seller, owner or person in apparent charge or control of the controlled item (as the case may be) of his intention of having the sample analysed.
(5) Nothing in this Regulation shall authorise the examination or detention of a controlled item without the consent of an officer of the Revenue Commissioners where the duties of such officer in relation to such item have not been wholly discharged.
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paragraphs: (1) Where a sample of any product, article or substance is supplied pursuant to Regulation 12(1)(g) and where the division of the sample is reasonably practicable, the authorised officer concerned may divide the sample into not more than three approximately equal parts each of which he shall mark in such a way as to identify it as a part of the sample so supplied;
(2) The authorised officer shall mark, seal and fasten each part in such a manner as its nature will permit, forward one part to an official laboratory where it may be tested, examined or analysed for the purposes of these Regulations by an approved examiner, give or send one part to the seller, owner or person in apparent charge or control of the product, article or substance and retain the third part;
(3) Where an authorised officer takes a sample consisting of a product article or substance contained in unopened containers and its division into parts-
(a) is not reasonably practicable, or
(b) might affect the composition or impede the proper analysis of the sample,
the provision of paragraph (1) as regards the division of samples into parts shall be deemed to be complied with if the authorised officer divides the containers into three lots and deals with each lot as if it were a sample as specified under paragraph (1);
(4) In proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or report on a sample of a product article or substance taken pursuant to these Regulations shall not be adduced unless before the proceedings were instituted the sample was divided as specified in paragraphs (1), (2) and (3) of this Regulation. The part, package or container retained by the authorised officer shall be produced at the hearing.
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paragraphs: (1) The approved examiner or a person under his direction shall analyse as soon as possible any sample of a product, article or substance submitted to him in pursuance of these Regulations and the approved examiner shall certify to the person who submitted the sample to him the result of such analysis;