S.I. No. 58/2004 -- European Communities (Food Additives Other Than Colours and Sweeteners) Regulations 2004
STATUTORY INSTRUMENTS. |
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EUROPEAN COMMUNITIES (FOOD ADDITIVES OTHER THAN COLOURS AND SWEETENERS) REGULATIONS 2004. |
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EUROPEAN COMMUNITIES (FOOD ADDITIVES OTHER THAN COLOURS AND SWEETENERS) REGULATIONS 2004. |
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I, MICHEÁL MARTIN, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 ( No. 27 of 1972 ), and for the purpose of giving further effect to European Parliament and Council Directive No. 95/2/EC1 of 20 February 1995 on food additives other than colours and sweeteners as amended by Directive 96/85/EC2 of the European Parliament and of the Council of 19 December 1996, and Directive 98/72/EC3 of the European Parliament and of the Council of 15 October 1998, and Directive 2001/5/EC4 of the European Parliament and of the Council of 12 February 2001, and Directive 2003/52/EC5 of the European Parliament and of the Council of 18 June 2003, hereby make the following regulations: |
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PART 1 Preliminary 1. These Regulations may be cited as the European Communities (Food Additives other than Colours and Sweeteners) Regulations 2004. 2. (1) In these Regulations-- |
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“acidity regulators” means substances which alter or control the acidity or alkalinity of a foodstuff; |
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“acids” means substances which increase the acidity of a foodstuff or impart a sour taste to it, or both; |
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“Act of 1998” means the Food Safety Authority of Ireland Act 1998 (No. 29 of 1998); |
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“Annexes” means the Annexes to European Parliament and Council Directive No. 95/2/EC1 of 20 February 1995 on food additives other than colours and sweeteners as amended by Directive 96/85/EC2 of the European Parliament and of the Council of 19 December 1996, and Directive 98/72/EC3 of the European Parliament and of the Council of 15 October 1998, and Directive 2001/5/EC4 of the European Parliament and of the Council of 12 February 2001, and Directive 2003/52/EC5 of the European Parliament and of the Council of 18 June 2003, and cognate words shall be construed accordingly; |
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“anti-caking agents” means substances which reduce the tendency of individual particles of a foodstuff to adhere to one another; |
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“anti-foaming agents” means substances which prevent or reduce foaming; |
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“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; |
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“approved examiner” in these Regulations means-- |
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(a) the Public Analyst, |
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(b) a Deputy Public Analyst, or |
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(c) an Executive Analytical Chemist, |
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located at an official laboratory; |
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“authorised officer” means an authorised officer appointed under section 49 of the Act of 1998; |
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“Authority” means the Food Safety Authority of Ireland, established under section 9 of the Act of 1998; |
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“bulking agents” means substances which contribute to the volume of a foodstuff without contributing significantly to its available energy value; |
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“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; |
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“Directive” means European Parliament and Council Directive No. 95/2/EC1 of 20 February 1995 on food additives other than colours and sweeteners as amended by Directive 96/85/EC2 of the European Parliament and of the Council of 19 December 1996, and Directive 98/72/EC3 of the European Parliament and of the Council of 15 October 1998, and Directive 2001/5/EC4 of the European Parliament and of the Council of 12 February 2001, and Directive 2003/52/EC5 of the European Parliament and of the Council of 18 June 2003; |
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“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; |
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“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; |
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“export” means exportation to a third country; |
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“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; |
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“flavour enhancers” means substances which enhance the existing taste or odour, or both, of a foodstuff; |
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“flour treatment agents” means substances other than emulsifiers which are added to flour or dough to improve its baking quality; |
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“foaming agents” means substances which make it possible to form a homogenous dispersion of a gaseous phase in a liquid or solid foodstuff; |
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“food” or “foodstuff” means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be, ingested by humans; |
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“food” includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC6 and without prejudice to the requirements of Directives 80/778/EEC7 and 98/83/EC6 ; |
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“food” shall not include-- |
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(a) feed, |
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(b) live animals unless they are prepared for placing on the market for human consumption, |
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(c) plants prior to harvesting, |
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(d) medicinal products within the meaning of Council Directives 65/65/EEC8 and 92/73/EEC9 , |
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(e) cosmetics within the meaning of Council Directive 76/768/EEC10 , |
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(f) tobacco and tobacco products within the meaning of Council Directive 89/622/EEC11 , |
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(g) narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971, or |
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(h) residues and contaminants; |
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“food additives” excludes the following-- |
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(a) substances used for treatment of drinking water as provided for in Directive 80/778/EEC7 , |
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(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'), |
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(c) chewing gum bases, |
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(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 amylolytic enzymes, |
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(e) ammonium chloride, |
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(f) blood plasma, edible gelatin, protein hydrolysates and their salts, milk protein and gluten, |
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(g) amino acids and their salts other than glutamic acid, glycine, cysteine and cystine and their salts and having no additive function, |
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(h) caseinates and casein, and |
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(i) inulin; |
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“gelling agents” means substances which give a foodstuff texture through formation of a gel; |
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“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; |
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“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; |
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“import” means importation from a country other than a Member State, except in the context of paragraphs (6) and (7) of Regulation 3 where “import” means importation from a Member State into a third country; |
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“manufacture” includes the production and processing of food, other than primary production for private domestic use and domestic preparation, handling and storage of food for private domestic consumption, and cognate words shall be construed accordingly; |
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“Member State” means a Member State of the European Community and shall be construed as including reference to those States that are Contracting Parties to the EEA Agreement; |
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“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; |
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“official agency” means an official agency carrying out functions under a service contract and acting on behalf of the Authority pursuant to section 48 of the Act of 1998; |
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“official laboratory” in these Regulations means-- |
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(a) the Public Analyst's Laboratory, Cork, |
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(b) the Public Analyst's Laboratory, Dublin, or |
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(c) the Public Analyst's Laboratory, Galway; |
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“packaging gases” means gases other than air, introduced into a container before, during or after the placing of a foodstuff in that container; |
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“place on the market” means-- |
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(a) import, |
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(b) sell, |
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(c) offer or expose for sale, |
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(d) invite the making by a person of an offer to purchase, |
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(e) distribute free of charge, |
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(f) supply for any of those purposes (whether or not for profit), |
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and cognate words shall be construed accordingly; |
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“preservatives” means substances which prolong the shelf-life of foodstuffs by protecting them against deterioration caused by micro-organisms; |
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“propellants” means gases other than air which expel a foodstuff from a container; |
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“raising agents” means substances or combinations of substances which liberate gas and thereby increase the volume of a dough or a batter; |
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“sequestrants” means substances which form chemical complexes with metallic ions; |
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“service contract” means a contract entered into between the Authority and an official agency pursuant to section 48 of the Act of 1998; |
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“stabilisers” 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; |
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“thickeners” means substances which increase the viscosity of a foodstuff; |
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“third country” means a country which is not a Member State; |
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“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. |
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(2) A word or expression which is used in these Regulations and which is also used in the Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive. |
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(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 Regulations is intended. |
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(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. |
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(c) A reference in these Regulations to a Schedule is to a Schedule to these Regulations, unless it is indicated that reference to some other Regulations is intended. |
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PART 2 General Provisions 3. (1) These Regulations concern and apply to food additives other than colours and sweeteners. |
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(2) These Regulations do not apply to enzymes other than those mentioned in the Annexes. |
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(3) The provisions of these Regulations shall apply also to foodstuffs intended for particular nutritional uses in accordance with Directive 89/398/EEC12 , as amended. |
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(4) These Regulations shall apply without prejudice to specific Directives permitting additives listed in the Annexes to be used as sweeteners or colours. |
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(5) From the date of coming into effect of these Regulations, a person shall not manufacture foodstuffs containing food additives or otherwise 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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(6) Subject to paragraphs (7) and (8), these Regulations shall also apply in respect of foodstuffs intended for export, unless otherwise requested by the authorities of the importing country or established by the laws, regulations, standards, codes of practice and other legal and administrative procedures as may be in force in the importing country. |
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(7) Notwithstanding paragraph (6), foodstuffs which are not in compliance with these Regulations may nonetheless be exported or re-exported, provided that-- |
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(a) the competent authorities of the country of destination have expressly agreed to such importation, after having been fully informed of the reasons for which and the circumstances in which the foodstuffs concerned could not be placed on the market in the Community, and |
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(b) the foodstuffs in question are not injurious to health. |
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(8) Notwithstanding paragraph (6), where the provisions of a bilateral agreement concluded between the Community or the State and a third country are applicable, foodstuffs exported from the State to that third country shall comply with the said provisions. 4. (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, stabilisers, thickeners or flour treatment agents. |
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(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. |
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(3) Except where specifically provided for, paragraph (2) shall not apply to-- |
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(a) unprocessed foodstuffs, |
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(c) non-emulsified oils and fats of animal or vegetable origin, |
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(d) butter, |
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(e) pasteurised and sterilised (including UHT) milk (including plain, skimmed and semiskimmed) and plain pasteurised cream, |
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(f) unflavoured, live fermented milk products, |
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(g) natural mineral water as defined in Directive 80/777/EEC14 and spring water, |
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(h) coffee (excluding flavoured instant coffee) and coffee extracts, |
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(i) unflavoured leaf tea, |
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(k) dry pasta, excluding gluten-free or pasta intended for hypoproteic diets, or both, in accordance with Directive 89/398/EEC12 , and |
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(l) natural unflavoured buttermilk (excluding sterilised buttermilk). |
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(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/EEC12 (including foodstuffs for infants and young children not in good health) which foodstuffs are subject to the provisions of Annex VI, as amended. |
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(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. |
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(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. |
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(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. |
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(8) Maximum levels indicated in the Annexes refer to foodstuffs as marketed, unless otherwise stated. |
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(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. 5. (1) The presence of a food additive in a foodstuff is permissible-- |
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(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 |
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(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. |
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(2) Paragraph (1) shall not apply to infant formulae, follow-on formulae and weaning foods, as referred to in Directive 89/398/EEC12 , except where specially provided for. |
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PART 3 Enforcement 6. Control of the foodstuffs affected by these Regulations and the enforcement of these Regulations shall be carried out in accordance with the provisions of these Regulations. 7. These Regulations shall be deemed to be food legislation for the purposes of the Act of 1998. 8. These Regulations shall be enforced by the Authority or by an official agency pursuant to a service contract with the Authority and, without prejudice to Regulations 6, the enforcement provisions contained in the Act of 1998 shall apply for the purposes of ensuring compliance with these Regulations. 9. (1) An authorised officer may, for the purposes of these Regulations, purchase or take without payment a sample of foodstuffs. |
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(2) An authorised officer may, for the purpose of taking a sample of foodstuffs, open any receptacle. |
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(3) Where an authorised officer purchases or takes without payment, with the intention of having it analysed, a sample of foodstuffs which are suspected by him or her to fail to comply with the provisions of these Regulations, he or she may, by notice in writing to the seller, owner or person in apparent charge or control of such foodstuffs, prohibit the removal of the foodstuffs except to any place which may be specified in the notice, during such period as may be specified in the notice, but not exceeding 15 days from the date of the detention of the sample. |
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(4) Where an authorised officer purchases or takes without payment a sample of foodstuffs with the intention of having it analysed, he or she shall after purchasing or taking the sample forthwith notify the seller, owner or person in apparent charge or control of the foodstuffs of his or her intention of having the sample analysed. |
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10. (1) Where a sample of foodstuffs is taken pursuant to these Regulations 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 or she shall mark in such a way as to identify it as a part of the sample taken by the officer. The authorised officer shall mark, seal and fasten each part in such a manner as its nature will permit, forward one part to the approved examiner in an official laboratory for analysis, give or send one part to the seller, owner or person in apparent charge or control of the foodstuffs, and retain the third part. |
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(2) Where an authorised officer takes a sample consisting of foodstuffs contained in unopened containers and its division into parts-- |
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(a) is not reasonably practicable, or |
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(b) might affect the composition or impede the proper analysis of the sample, |
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the provisions of paragraph (1) of this Regulation 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) of this Regulation. |
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(3) In proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or report on a sample of foodstuffs taken pursuant to these Regulations shall not be adduced unless before the proceedings were instituted the sample was divided as specified in paragraphs (1) and (2) of this Regulation. The part, package or container retained by the authorised officer shall be produced at the hearing. 11. (1) The approved examiner or a person under his or her direction shall analyse as soon as possible any sample of foodstuffs submitted to him or her in pursuance of these Regulations and the approved examiner shall certify to the person who submitted the sample to him or her the result of such analysis. The form of certificate set out in the Schedule to these Regulations or a certificate in like form shall be used. |
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(2) An official certificate given in accordance with paragraph (1) of this Regulation shall be prima facie evidence of the matters contained therein until the contrary is proved. 12. Where a sample of foodstuffs is taken by an authorised officer in pursuance of these Regulations for analysis by an approved examiner, and where the seller, owner or person in apparent charge or control of the foodstuffs requests in writing the results of such analysis, the request shall be made to-- |
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(a) the Authority, where the officer was appointed by the Authority, or |
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(b) the official agency, where the officer was appointed by an official agency |
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and the Authority, or the official agency (as the case may be) shall comply with such request. 13. An authorised officer may, for the purposes of these Regulations, inspect and take copies, or samples, of labels used on foodstuffs. 14. (1) An authorised officer may, for the purposes of these Regulations, seize, remove, detain or direct the withdrawal from the market of any foodstuffs which are suspected by him or her to fail to comply with the provisions of these Regulations. |
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(2) An authorised officer may, with the consent in writing of the owner or person in apparent charge or control of such foodstuffs, or in accordance with an order of a judge of the District Court under paragraph (4) of this Regulation, destroy or otherwise dispose of same as to prevent them being used for human consumption. |
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(3) An authorised officer who has seized, removed, detained or directed the withdrawal from the market of, foodstuffs in pursuance of the provisions of this Regulation may, on giving notice in writing to the owner or person in apparent charge or control of such foodstuffs of his or her intention to do so, apply to a judge of the District Court for an order directing that such foodstuffs be destroyed or otherwise disposed of. |
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(4) A judge of the District Court, to whom an application is made for an order under paragraph (3), may, if satisfied that such foodstuffs fail to comply with these Regulations, order that they be destroyed or otherwise disposed of, after such period, not exceeding 14 days, as may be specified in such order, and an authorised officer shall destroy or dispose of them accordingly. 15. (1) A person who fails to comply with these Regulations is guilty of an offence. |
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(2) Paragraph (1) shall not apply to an authorised officer acting in the course of his or her duties pursuant to these Regulations. 16. Where an offence is committed under these Regulations by a body corporate and is proved to have been so committed with the consent, connivance or approval of or to have been attributable to the wilful neglect on the part of any person, being a director, manager, secretary or other officer of the body corporate or a person who was purporting to act in any such capacity, that person, as well as the body corporate, is guilty of an offence and is liable to be proceeded against and punished as if he or she was guilty of the first-mentioned offence. 17. (1) Any person who forges, or utters knowing it to be forged, a certificate of analysis or other document purporting to be issued, granted or given under these Regulations, or required for the purposes of these Regulations, (hereafter in this Regulation referred to as “a forged document”), is guilty of an offence. |
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(2) Any person who alters with intent to defraud or deceive, or who utters knowing it to be so altered, a certificate of analysis or other document issued, granted or given under these Regulations, or required for the purposes of these Regulations (hereafter in this Regulation referred to as “an altered document”), is guilty of an offence. |
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(3) Any person who, without lawful authority, has in his or her possession a forged document or an altered document is guilty of an offence. |
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(4) Any person who, with intent to defraud or deceive-- |
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(a) tampers with any thing so as to procure that any sample taken pursuant to these Regulations does not correctly represent the substance sampled, or |
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(b) tampers or interferes with any sample taken under these Regulations |
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is guilty of an offence. 18. (1) For the purposes of these Regulations, every contravention of a Regulation shall be deemed a separate contravention and every contravention of a paragraph or a subparagraph shall also be deemed to be a separate contravention and shall carry the same penalty as for a single contravention of any Regulation of these Regulations. |
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(2) A person who is guilty of an offence under these Regulations is liable on summary conviction to a fine not exceeding £3,000 or at the discretion of the Court to imprisonment for a term not exceeding 12 months or both. 19. An offence under these Regulations may be prosecuted by-- |
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(a) the Authority, or |
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(b) an official agency. |
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PART 4 Revocations 20. (1) The European Communities (Food Additives other than Colours and Sweeteners) Regulations 2002 ( S.I. No. 613 of 2002 ) are revoked. |
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(2) References in any other instrument to the Regulations revoked under paragraph (1) shall be construed as references to these Regulations, as appropriate. |
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Schedule |
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Form of official certificate to be given by an approved examiner to an authorised officer. |
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European Communities (Food Additives other than Colours and Sweeteners) Regulations 2004 |
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Certificate of Analysis |
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To(1)............................................. |
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I, the undersigned(2)............................................. |
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being an Approved Examiner for the purpose of the above Regulations |
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certify that on the ............................ day of .......................... 20 ........ |
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a sample marked(3)........................................................... |
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Date .................................................. |
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Number ................................................ |
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Weight or Measure ............................................ |
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was submitted to me by you and I certify that the sample was prepared and analysed/examined by me or under my direction(4) |
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and as a result I am of the opinion that(5) |
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Observations:(6) |
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I further certify that the sample has undergone no change which would affect my opinion/observations expressed above. |
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Certified by me this .............................. day of ..................... 20........ |
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at(7)....................................... |
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Name in BLOCK LETTERS............................................................ ........................ |
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Status.................................................... |
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Signature.................................................... |
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_______________________ |
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Official Stamp |
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NOTES |
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(1) Insert the name and address of the person submitting the sample for analysis. |
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(2) Insert description (e.g. Executive Analytical Chemist in a Public Analyst's Laboratory). |
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(3) Insert particulars of marking (e.g. name, date etc.) and the weight or measure (this may be left unanswered if the sample cannot be conveniently weighed or measured or if the weight or measurement is not material to the result of analysis). |
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(4) Indicate whether the approved examiner carried out the analysis himself or herself or whether it was carried out by another under the direction of the approved examiner. |
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(5) Here the approved examiner should specify the result of the analysis having regard to the provisions of the relevant legislation. |
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(6) Here the approved examiner may insert, at his or her discretion, his or her opinion whether the analysis indicates any addition, abstraction, deficiency or the presence of foreign matter or other defect and whether the composition or quality is thereby affected; any physical, chemical or other properties bearing on the composition or quality of the article; whether the article is injurious to health or unfit for human consumption; whether and in what respect a label and description relating to the sample is incorrect or misleading; and he or she may add any other observations as he or she may consider relevant. |
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(7) Insert the name and address of the laboratory carrying out the analysis/examination. |
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EXPLANATORY NOTE. |
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(This note is not part of the Instrument and does not purport to be a legal interpretation.) |
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These Regulations revoke the European Communities (Food Additives other than Colours and Sweeteners) Regulations 2002 ( S.I. No. 613 of 2002 ) and bring into effect new Regulations. The new Regulations give further effect to European Parliament and Council Directive No. 95/2/EC1 of 20 February 1995 on food additives other than colours and sweeteners as amended by Directive 96/85/EC2 of the European Parliament and of the Council of 19 December 1996, and Directive 98/72/EC3 of the European Parliament and of the Council of 15 October 1998, and Directive 2001/5/EC4 of the European Parliament and of the Council of 12 February 2001 [previously transposed by the European Communities (Food Additives other than Colours and Sweeteners) Regulations 2002 ( S.I. No. 613 of 2002 )]. |
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These Regulations also give effect to Directive 2003/52/EC5 of the European Parliament and of the Council of 18 June 2003 which amends Annex IV to Directive 95/2/EC1 , as amended, by modifying the conditions of use for E 425 Konjac as regards its use in jelly confectionery, including jelly-mini-cups. This amendment is based on information provided by Member States that jelly-mini-cups containing E 425 Konjac constitute a life-threatening risk. |
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These Regulations may be cited as the European Communities (Food Additives other than Colours and Sweeteners) Regulations 2004. |
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10 OJ L 262, 27.9.1976, p. 169. 12 OJ L 186, 30.6.1989, p. 27. 13 OJ L 221, 12.8.1974, p. 10. 15 OJ L 356, 27.12.1973, p. 71. 12 OJ L 186, 30.6.1989, p. 27. 12 OJ L 186, 30.6.1989, p. 27. |