European Union (Food Additives) Regulations 2015.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the European Union (Food Additives) Regulations 2015.
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paragraphs: (1) In these Regulations—
(a) a Deputy Public Analyst located at a Public Analyst’s Laboratory,
(b) an Executive Analytical Chemist located at a Public Analyst’s Laboratory,
(c) a Public Analyst located at a Public Analyst’s Laboratory,
(d) a person, or member of a class of persons, designated by the Minister pursuant to Regulation 23;
(a) Public Analyst’s Laboratory, Cork,
(b) Public Analyst’s Laboratory, Dublin,
(c) Public Analyst’s Laboratory, Galway,
(d) a laboratory designated by the Minister pursuant to Regulation 23;
(2) A word or expression which is used in these Regulations and which is also used in the EU Regulations or in the General Food Law Regulation has, unless the context otherwise requires, the same meaning in these Regulations as it has in the EU Regulations or in the General Food Law Regulation.
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paragraphs: (1) Subject to paragraph (2), the requirements of these Regulations shall apply to food additives.
(2) Paragraph (1) shall not apply to the substances referred to in Article 2(2) of EC Regulation 1333/2008 unless they are used as food additives.
(3) The requirements of these Regulations shall apply to food enzymes falling within the scope of Regulation (EC) 1332/2008 of the European Parliament and of the Council of 16 December 200872 , until a Community list of food enzymes is adopted pursuant to Article 17 of that Regulation, whereupon the aforesaid requirements shall only apply to such food enzymes where and insofar as they are used in the production of food additives falling within the scope of EC Regulation 1333/2008.
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paragraphs: A food business operator is guilty of an offence if he or she places on the market a food additive or any food in which a food additive is present, if the use of the food additive does not comply with these Regulations or with the EU Regulations.
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paragraphs: A food business operator is guilty of an offence if he or she fails to ensure that food additives that he or she places on the market—
(a) are included in the Community list in Annex II to EC Regulation 1333/2008 and that where included in the said list, the food additive concerned is not considered a different additive requiring a new entry in the Community list before being placed on the market, in accordance with Article 12 of EC Regulation 1333/2008,
(b) are used in foods under the conditions of use and in accordance with the level of use specified in Annex II to EC Regulation 1333/2008, including where no maximum numerical level is specified in accordance with the principle of quantum satis referred to in Article 11(2) of EC Regulation 1333/2008,
(c) comply with any restrictions on sales directly to the consumer in accordance with Article 10(2)(d) of EC Regulation 1333/2008,
(d) comply with the ‘carry-over principle’ in accordance with Article 18 of EC Regulation 1333/2008, and
(e) comply with the specifications as laid down in the Annex to Commission Regulation 231/2012.
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paragraphs: A food business operator is guilty of an offence if he or she fails to ensure that the additives used in food additives, in food enzymes and in food flavourings that he or she places on the market—
(a) are included in the Community list in Annex III to EC Regulation 1333/2008 and that where included in the said list, the food additive concerned is not considered a different additive requiring a new entry in the Community list before being placed on the market, in accordance with Article 12 of EC Regulation 1333/2008,
(b) are used in foods under the conditions of use and in accordance with the level of use specified in Annex III to EC Regulation 1333/2008, including where no maximum numerical level is specified in accordance with the principle of quantum satis referred to in Article 11(2) of EC Regulation 1333/2008,
(c) comply with any restrictions on sales directly to the consumer in accordance with Article 10(2)(d) of EC Regulation 1333/2008,
(d) comply with the ‘carry-over principle’ in accordance with Article 18 of EC Regulation 1333/2008, and
(e) comply with the specifications as laid down in the Annex to Commission Regulation 231/2012.
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paragraphs: A food business operator is guilty of an offence if he or she uses a food additive in unprocessed foods, except where such use is specifically provided for in Annex II to EC Regulation 1333/2008.
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paragraphs: A food business operator is guilty of an offence if he or she uses a food additive in foods for infants and young children as referred to in Directive 2009/39/EC of the European Parliament and of the Council of 6 May 200973 , including dietary foods for infants and young children for special medical purposes, except where specifically provided for in Annex II to EC Regulation 1333/2008.
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paragraphs: A food business operator is guilty of an offence if he or she uses a food colour other than those colours listed in Annex II to EC Regulation 1333/2008—
(a) for the purpose of health markings or other markings applied directly to fresh meats or meat products, and
(b) for the decorative colouring of eggshells and for the stamping of eggshells,
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paragraphs: (1) Subject to paragraphs (4) and (5), a food business operator is guilty of an offence if he or she markets food additives not intended for sale to the final consumer, whether such food additives are sold:
(i) singly;
(ii) mixed with each other;
(iii) mixed with other food ingredients;
(iv) mixed with other substances added to them;
(v) mixed with each other and with other food ingredients; or sold
(vi) mixed with each other and with other substances added to them,
(a) the name and at least one of the following:
(i) the E-number laid down in EC Regulation 1333/2008 in respect of each food additive, or
(ii) a sales description which includes the name or E-number of each food additive;
(b) the statement ‘for food’ or the statement ‘restricted use in food’ or a more specific reference to its intended food use;
(c) the special conditions of storage or use, or both if necessary;
(d) a mark identifying the batch or lot;
(e) instructions for use, if the omission thereof would preclude appropriate use of the food additive;
(f) the name or business name and address of the manufacturer, packager or seller;
(g) one or both, if necessary, of the following:
(i) an indication of the maximum quantity of each component or group of components subject to quantitative limitation in food;
(ii) appropriate information in clear and easily understandable terms, enabling the purchaser to comply with EC Regulation 1333/2008 and other relevant European Union law provided, for the purpose of (i) above, that, where the same limit on quantity applies to a group of components used singly or in combination, the combined percentage may be given as a single figure, and that all limits on quantity shall be expressed either numerically or by the quantum satis principle;
(h) the net quantity;
(i) the date of minimum durability or use-by date;
(j) where relevant, information on a food additive or other substances referred to in Article 22 of EC Regulation 1333/2008 and listed in Annex II to Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 201174 as regards the indication of the ingredients present in foodstuffs.
(2) Subject to paragraphs (4) and (5), a food business operator is guilty of an offence if he or she sells food additives not intended for sale to the final consumer, whether such food additives are sold:
(i) mixed with each other;
(ii) mixed with other food ingredients; or sold
(iii) mixed with each other and with other food ingredients
(3) Subject to paragraphs (4) and (5), a food business operator is guilty of an offence if substances, including food additives or other food ingredients, are added to food additives, not intended for sale to the final consumer, to facilitate their storage, sale, standardisation, dilution or dissolution and their packaging or containers fail to bear a list of all such substances in descending order of their percentage by weight of the total.
(4) The information required in paragraphs (1)(e) to (1)(g) and paragraphs (2) and (3) may be provided on the documents relating to the consignment which are to be supplied with or prior to the delivery, provided that the indication ‘not for retail sale’ appears on an easily visible part of the packaging or container of the product in question.
(5) Where food additives, not intended for sale to the final consumer, are supplied in tankers, the information required in paragraphs (1), (2) and (3) may be provided on the accompanying documents relating to the consignment which are to be supplied with the delivery.
(6) A food business operator is guilty of an offence if he or she fails to ensure that—
(a) the labelling required in paragraphs (1) to (3) is easily visible, clearly legible and indelible, or,
(b) where no labelling is required because paragraphs (4) or (5) apply, the documents referred to in paragraphs (4) and (5) are clearly legible and indelible, and
(c) the information required under (a) and (b) is provided in at least the English language, or in the Irish and the English languages.
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paragraphs: (1).Subject to paragraph (2) and without prejudice to Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 201153, Council Directive 89/396/ EEC of 14 June 198975 , and Regulation (EC) No. 1829/2003 of the European Parliament and of the Council of 22 September 200376 , a food business operator is guilty of an offence if he or she markets food additives intended for sale to the final consumer, whether such food additives are sold:
(i) singly;
(ii) mixed with each other;
(iii) mixed with other food ingredients; or sold
(iv) mixed with each other and with other food ingredients,
(a) the name and E-number laid down in EC Regulation 1333/2008 in respect of each food additive or a sales description which includes the name and E-number of each food additive, and
(b) a statement ‘for food’ or a statement ‘restricted use in food’ or a more specific reference to its intended food use.
(2) A food business operator is guilty of an offence if he or she fails to ensure that the sales description of a table-top sweetener includes the term ‘ —based table-top sweetener’, using the name of the sweetener used in the composition of that table-top sweetener.
(3) A food business operator is guilty of an offence if he or she fails to ensure that the labelling of a table-top sweetener containing polyols or aspartame or aspartame-acesulfame salt bears one, or where polyols and aspartame or polyols and aspartame-acesulfame salt or polyols and aspartame and aspartame-acesulfame salt are present, both of the following warnings:
(a) polyols: ‘excessive consumption may induce laxative effects’;
(b) aspartame/aspartame-acesulfame salt: ‘contains a source of phenylalanine’.
(4) Manufacturers of table-top sweeteners are guilty of an offence if they fail to make available by appropriate means the necessary information to allow their safe use by consumers.
(5) In relation to the information provided for in paragraphs (1) to (3) of this Regulation, it shall be marked in accordance with the requirements of Article 13 (1) of Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 201153.
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paragraphs: (1) A food business operator is guilty of an offence if he or she fails to ensure that the labelling of food containing the food colours listed in Annex V to EC Regulation 1333/2008 include the additional information set out in that Annex.
(2) In relation to the information provided for in paragraph (1), it shall be marked in accordance with the requirements of Article 13 (1) of Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 201153.
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paragraphs: A producer or user of a food additive is guilty of an offence if he or she fails to inform the Commission immediately of—
(a) any new scientific or technical information which might affect the assessment of the safety of the food additive, or
(b) the actual use of the food additive if so requested,
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paragraphs: The Authority shall be responsible for ensuring that the functions of the State referred to in Article 27 of EC Regulation 1333/2008 are performed.
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paragraphs: (1) The enforcement of these Regulations and of EC Regulation 1333/2008, shall be carried out in accordance with the provisions of these Regulations.
(2) These Regulations shall be deemed to be food legislation for the purposes of the Act of 1998.
(3) These Regulations shall be enforced by the Authority or by an official agency acting pursuant to a service contract with the Authority, or by both, and, without prejudice to paragraph (1), the enforcement provisions contained in the Act of 1998 shall apply for the purposes of ensuring compliance with the requirements of these Regulations.
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paragraphs: (1) An authorised officer may, for the purposes of these Regulations, purchase or take without payment a sample of food.
(2) An authorised officer may, for the purpose of taking a sample of food open any receptacle.
(3) Where an authorised officer purchases or takes without payment a sample of food with the intention of having it analysed, he or she shall after purchasing or taking the sample forthwith notify the food business operator, or the person in apparent charge or control of the food of his or her intention of having the sample analysed.
(4) Where an authorised officer purchases or takes without payment, with the intention of having it analysed, a sample of food which is suspected by him or her of failing to comply with the provisions of these Regulations, he or she may, by notice in writing to the food business operator, or the person in apparent charge or control of such food, prohibit its removal 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 working days from the date of the taking of the sample.
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paragraphs: (1) Where a sample of food is taken pursuant to these Regulations, for the purposes of official analysis and where the division of the sample is reasonably practicable, the authorised officer concerned shall divide the sample into three approximately equal parts (enforcement, trade (defence) and referee), 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.
(2) Where an authorised officer divides a sample in accordance with paragraph (1), he or she shall—
(a) in the presence of the food business operator, or the person in apparent charge or control of such food, mark seal and fasten each part in such a manner as its nature will permit, and in such a way that the integrity of the sample is not compromised,
(b) forward one part to the approved examiner in an official laboratory for analysis,
(c) give or send one part to the food business operator, and
(d) retain the third part.
(3) Where an authorised officer takes a sample of food 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,
(4) In proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or report on, a sample of food taken pursuant to these Regulations shall not be adduced unless before the proceedings were instituted the sample was divided as specified in this Regulation. The part, package or container retained by the authorised officer shall be produced at the hearing.
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paragraphs: (1) An authorised officer may, for the purposes of these Regulations, inspect, take or make copies, whether in writing, by photography, electronically or otherwise, of a relevant thing.
(2) Where a sample of a relevant thing, related to a food sample taken in accordance with Regulation 16, is taken pursuant to these Regulations, for the purposes of official analysis, the authorised officer shall obtain three identical such relevant things, or take three copies or photographs of such relevant thing.
(3) Where an authorised officer takes a relevant thing related to a food sample taken in accordance with Regulation 16, or a copy or photograph thereof, with the intention of having it analysed, he or she shall:
(a) forthwith notify the food business operator, or the person in apparent charge or control of the relevant thing, of his or her intention of having the relevant thing, copy or photograph analysed;
(b) mark, seal and fasten each relevant thing, or copy or photograph of the relevant thing, in such a manner as its nature will permit, and in such a way that the integrity of the sample is not compromised;
(c) forward one of the relevant things, or one of the copies or photographs of the relevant thing, to the approved examiner in an official laboratory for analysis;
(d) give or send one of the relevant things, or one of the copies or photographs of the relevant thing, to the food business operator, and
(e) retain the third relevant thing, or the third copy or photograph of the relevant thing.
(4) Where a sample of a relevant thing is taken pursuant to these Regulations, for the purpose of inspection, the authorised officer shall obtain three identical such relevant things, or take three copies or photographs of such relevant thing.
(5) Where an authorised officer takes a relevant thing, or a copy or photograph thereof, with the intention of having it inspected, he or she shall:
(a) forthwith notify the food business operator, or the person in apparent charge or control of the relevant thing, of his or her intention of having the relevant thing, copy or photograph inspected;
(b) mark, seal and fasten each relevant thing, or copy or photograph of the relevant thing, in such a manner as its nature will permit, and in such a way that the integrity of the sample is not compromised;
(c) give or send one of the relevant things, or one of the copies or photographs of the relevant thing, to the food business operator;
(d) retain one of the relevant things, or one of the copies or photographs of the relevant thing, for the purpose of inspection; and
(e) retain the third relevant thing, or the third copy or photograph of the relevant thing.
(6) In proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or report on, a sample of a relevant thing taken pursuant to these Regulations shall not be adduced unless before the proceedings were instituted the sample was divided as specified in this Regulation. The relevant thing or the copy or photograph of the relevant thing 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 or her direction shall analyse as soon as possible any sample of food, relevant thing or copy or photograph of a relevant thing 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.