ARRANGEMENT OF REGULATIONS

PART 1

PRELIMINARY

1. Citation.

2. Interpretation.

3. Scope.

PART 2

GENERAL PROVISIONS

4. Prohibition of non-compliant food additives or non-compliant food.

5. Placing on the market of food additives.

6. Placing on the market of food additives in food additives, food enzymes and food flavourings.

7. Use of food additives in unprocessed foods.

8. Use of food additives in foods for infants and young children.

9. Use of colours for markings.

10. Labelling of food additives not intended for sale to the final consumer.

11. Labelling of food additives intended for sale to the final consumer.

12. Labelling requirements for foods containing certain food colours.

13. Information obligation.

14. Monitoring of food additive intake.

PART 3

ENFORCEMENT, OFFENCES AND PENALTIES

15. Enforcement generally.

16. Taking of food samples.

17. Division of food samples.

18. Taking of relevant things.

19. Analysis of food samples and relevant things.

20. Report on official controls.

21. Powers of authorised officers.

22. Seizure, removal, detention and destruction.

23. Designation of official laboratories and approved examiners.

24. Offences.

25. Bodies corporate.

26. Prosecution of offences.

PART 4

TRANSITIONAL MEASURES AND REVOCATIONS

27. Transitional measures.

28. Revocations.

SCHEDULE

S.I. No. 330 of 2015

EUROPEAN UNION (FOOD ADDITIVES) REGULATIONS 2015

Notice of the making of this Statutory Instrument was published in

"Iris Oifigiúil" of 31st July, 2015.

I, LEO VARADKAR, Minister for Health, 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 Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 2008¹ , Commission Regulation (EU) No. 238/2010 of 22 March 2010² , Commission Regulation (EU) No. 257/2010 of 25 March 2010³ , Commission Regulation (EU) No. 1129/2011 of 11 November 2011⁴ , Commission Regulation (EU) No. 1130/2011 of 11 November 2011⁵ , Commission Regulation (EU) No. 1131/2011 of 11 November 2011⁶ , Commission Regulation (EU) No. 231/2012 of 9 March 2012⁷ , Commission Regulation (EU) No. 232/2012 of 16 March 2012⁸ , Commission Regulation (EU) No. 380/2012 of 3 May 2012⁹ , Commission Regulation (EU) No. 470/2012 of 4 June 2012¹⁰ , Commission Regulation (EU) No. 471/2012 of 4 June 2012¹¹ , Commission Regulation (EU) No. 472/2012 of 4 June 2012¹² , Commission Regulation (EU) No. 570/2012 of 28 June 2012¹³ , Commission Regulation (EU) No. 583/2012 of 2 July 2012¹⁴ , Commission Regulation (EU) No. 675/2012 of 23 July 2012¹⁵ , Commission Regulation (EU) No. 1049/2012 of 8 November 2012¹⁶ , Commission Regulation (EU) No. 1050/2012 of 8 November 2012¹⁷ , Commission Regulation (EU) No. 1057/2012 of 12 November 2012¹⁸ , Commission Regulation (EU) No. 1147/2012 of 4 December 2012¹⁹ , Commission Regulation (EU) No. 1148/2012 of 4 December 2012²⁰ , Commission Regulation (EU) No. 1149/2012 of 4 December 2012²¹ , Commission Regulation (EU) No. 1166/2012 of 7 December 2012²² , Commission Regulation (EU) No. 25/2013 of 16 January 2013²³ , Commission Regulation (EU) No. 244/2013 of 19 March 2013²⁴ , Commission Regulation (EU) No. 256/2013 of 20 March 2013²⁵ , Commission Regulation (EU) No. 438/2013 of 13 May 2013²⁶ , Commission Regulation (EU) No. 497/2013 of 29 May 2013²⁷ , Commission Regulation (EU) No. 509/2013 of 3 June 2013²⁸ , Commission Regulation (EU) No. 510/2013 of 3 June 2013²⁹ , Commission Regulation (EU) No. 723/2013 of 26 July 2013³⁰ , Commission Regulation (EU) No. 724/2013 of 26 July 2013³¹ , Commission Regulation (EU) No. 738/2013 of 30 July 2013³² , Commission Regulation (EU) No. 739/2013 of 30 July 2013³³ , Commission Regulation (EU) No. 816/2013 of 28 August 2013³⁴ , Commission Regulation (EU) No. 817/2013 of 28 August 2013³⁵ , Commission Regulation (EU) No. 818/2013 of 28 August 2013³⁶ , Commission Regulation (EU) No. 913/2013 of 23 September 2013³⁷ , Commission Regulation (EU) No. 1068/2013 of 30 October 2013³⁸ , Commission Regulation (EU) No. 1069/2013 of 30 October 2013³⁹ , Commission Regulation (EU) No. 1274/2013 of 6 December 2013⁴⁰ , Commission Regulation (EU) No. 59/2014 of 23 January 2014⁴¹ , Commission Regulation (EU) No. 264/2014 of 14 March 2014⁴² , Commission Regulation (EU) No. 298/2014 of 21 March 2014⁴³ , Commission Regulation (EU) No. 497/2014 of 14 May 2014⁴⁴ , Commission Regulation (EU) No. 505/2014 of 15 May 2014⁴⁵ , Commission Regulation (EU) No. 506/2014 of 15 May 2014⁴⁶ , Commission Regulation (EU) No. 601/2014 of 4 June 2014⁴⁷ , Commission Regulation (EU) No. 685/2014 of 20 June 2014⁴⁸ , Commission Regulation (EU) No. 923/2014 of 25 August 2014⁴⁹ , Commission Regulation (EU) No. 957/2014 of 10 September 2014⁵⁰ , Commission Regulation (EU) No. 966/2014 of 12 September 2014⁵¹ , Commission Regulation (EU) No. 969/2014 of 12 September 2014⁵² , Commission Regulation (EU) No. 1084/2014 of 15 October 2014⁵³ , Commission Regulation (EU) No. 1092/2014 of 16 October 2014⁵⁴ , Commission Regulation (EU) No. 1093/2014 of 16 October 2014⁵⁵ , Commission Regulation (EU) 2015/463 of 19 March 2015⁵⁶ , Commission Regulation (EU) 2015/537 of 31 March 2015⁵⁷ , Commission Regulation (EU) 2015/538 of 31 March 2015⁵⁸ , Commission Regulation (EU) 2015/639 of 23 April 2015⁵⁹ , Commission Regulation (EU) 2015/647 of 24 April 2015⁶⁰ and Commission Regulation (EU) 2015/649 of 24 April 2015⁶¹ , hereby make the following regulations:

PART I

PRELIMINARY

Citation

1. These Regulations may be cited as the European Union (Food Additives) Regulations 2015.

Interpretation

2. (1) In these Regulations-

"Act of 1998" means the Food Safety Authority of Ireland Act 1998 (No. 29 of 1998);

"Annex to Commission Regulation 231/2012" means Annex to Commission Regulation (EU) No. 231/2012 of 9 March 20127 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 20081 as amended by Commission Regulation (EU) No. 1050/2012 of 8 November 201217, Commission Regulation (EU) No. 25/2013 of 16 January 201323, Commission Regulation (EU) No. 497/2013 of 29 May 201327, Commission Regulation (EU) No. 724/2013 of 26 July 201331, Commission Regulation (EU) No. 739/2013 of 30 July 201333, Commission Regulation (EU) No. 816/2013 of 28 August 201334, Commission Regulation (EU) No. 817/2013 of 28 August 201335, Commission Regulation (EU) No. 1274/2013 of 6 December 201340, Commission Regulation (EU) No. 264/2014 of 14 March 201442, Commission Regulation (EU) No. 298/2014 of 21 March 201443, Commission Regulation (EU) No. 497/2014 of 14 May 201444, Commission Regulation (EU) No. 506/2014 of 15 May 201446, Commission Regulation (EU) No. 685/2014 of 20 June 201448, Commission Regulation (EU) No. 923/2014 of 25 August 201449, Commission Regulation (EU) No. 957/2014 of 10 September 201450, Commission Regulation (EU) No. 966/2014 of 12 September 201451 and Commission Regulation (EU) 2015/463 of 19 March 201556;

"Annex II to EC Regulation 1333/2008" means Annex II to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 20081 on food additives as amended by Commission Regulation (EU) No. 1129/2011 of 11 November 20114, Commission Regulation (EU) No. 1131/2011 of 11 November 20116, Commission Regulation (EU) No. 232/2012 of 16 March 20128, Commission Regulation (EU) No. 380/2012 of 3 May 20129, Commission Regulation (EU) No. 470/2012 of 4 June 201210, Commission Regulation (EU) No. 471/2012 of 4 June 201211, Commission Regulation (EU) No. 472/2012 of 4 June 201212, Commission Regulation (EU) No. 570/2012 of 28 June 201213, Commission Regulation (EU) No. 583/2012 of 2 July 201214, Commission Regulation (EU) No. 675/2012 of 23 July 201215, Commission Regulation (EU) No. 1049/2012 of 8 November 201216, Commission Regulation (EU) No. 1057/2012 of 12 November 201218, Commission Regulation (EU) No. 1147/2012 of 4 December 201219, Commission Regulation (EU) No. 1148/2012 of 4 December 201220, Commission Regulation (EU) No. 1149/2012 of 4 December 201221, Commission Regulation (EU) No. 1166/2012 of 7 December 201222, Commission Regulation (EU) No. 25/2013 of 16 January 201323, Commission Regulation (EU) No. 438/2013 of 13 May 201326, Commission Regulation (EU) No. 509/2013 of 3 June 201328, Commission Regulation (EU) No. 510/2013 of 3 June 201329, Commission Regulation (EU) No. 723/2013 of 26 July 201330, Commission Regulation (EU) No. 738/2013 of 30 July 201332, Commission Regulation (EU) No. 739/2013 of 30 July 201333, Commission Regulation (EU) No. 816/2013 of 28 August 201334, Commission Regulation (EU) No. 817/2013 of 28 August 201335, Commission Regulation (EU) No. 913/2013 of 23 September 201337, Commission Regulation (EU) No. 1068/2013 of 30 October 201338, Commission Regulation (EU) No. 1069/2013 of 30 October 201339, Commission Regulation (EU) No. 1274/2013 of 6 December 201340, Commission Regulation (EU) No. 59/2014 of 23 January 201441, Commission Regulation (EU) No. 264/2014 of 14 March 201442, Commission Regulation (EU) No. 298/2014 of 21 March 201443, Commission Regulation (EU) No. 497/2014 of 14 May 201444, Commission Regulation (EU) No. 505/2014 of 15 May 201445, Commission Regulation (EU) No. 506/2014 of 15 May 201446, Commission Regulation (EU) No. 601/2014 of 4 June 201447, Commission Regulation (EU) No. 685/2014 of 20 June 201448, Commission Regulation (EU) No. 923/2014 of 25 August 201449, Commission Regulation (EU) No. 957/2014 of 10 September 201450, Commission Regulation (EU) No. 969/2014 of 12 September 201452, Commission Regulation (EU) No. 1084/2014 of 15 October 201453, Commission Regulation (EU) No. 1092/2014 of 16 October 201454, Commission Regulation (EU) No. 1093/2014 of 16 October 201455, Commission Regulation (EU) 2015/537 of 31 March 201557, Commission Regulation (EU) 2015/538 of 31 March 201558, Commission Regulation (EU) 2015/647 of 24 April 201560 and Commission Regulation (EU) 2015/649 of 24 April 201561;

"Annex III to EC Regulation 1333/2008" means Annex III to Regulation (EC) 1333/2008 of the European Parliament and of the Council of 16 December 20081 on food additives as amended by Commission Regulation (EU) No. 1130/2011 of 11 November 20115, Commission Regulation (EU) No. 25/2013 of 16 January 201323, Commission Regulation (EU) No. 244/2013 of 19 March 201324, Commission Regulation (EU) No. 256/2013 of 20 March 201325, Commission Regulation (EU) No. 510/2013 of 3 June 201329, Commission Regulation (EU) No. 818/2013 of 28 August 201336, Commission Regulation (EU) No. 1274/2013 of 6 December 201340, Commission Regulation (EU) 2015/639 of 23 April 201559 and Commission Regulation (EU) 2015/649 of 24 April 201561;

"Annex V to EC Regulation 1333/2008" means Annex V to Regulation (EC) 1333/2008 of the European Parliament and of the Council of 16 December 20081 on food additives as amended by Commission Regulation (EU) No. 238/2010 of 22 March 20102;

"approved examiner" means-

(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;

"authorised officer" means an authorised officer appointed under section 49 of the Act of 1998;

"Authority" means the Food Safety Authority of Ireland, established under section 9 of the Act of 1998;

"Commission Regulation 231/2012" means Commission Regulation (EU) No. 231/2012 of 9 March 201244 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 20081, as amended by Commission Regulation (EU) No. 1050/2012 of 8 November 201217, Commission Regulation (EU) No. 25/2013 of 16 January 201323, Commission Regulation (EU) No. 497/2013 of 29 May 201327, Commission Regulation (EU) No. 724/2013 of 26 July 201331, Commission Regulation (EU) No. 739/2013 of 30 July 201333, Commission Regulation (EU) No. 816/2013 of 28 August 201334, Commission Regulation (EU) No. 817/2013 of 28 August 201335, Commission Regulation (EU) No. 1274/2013 of 6 December 201340, Commission Regulation (EU) No. 264/2014 of 14 March 201442, Commission Regulation (EU) No. 298/2014 of 21 March 201443, Commission Regulation (EU) No. 497/2014 of 14 May 201444, Commission Regulation (EU) No. 506/2014 of 15 May 201446, Commission Regulation (EU) No. 685/2014 of 20 June 201448, Commission Regulation (EU) No. 923/2014 of 25 August 201449, Commission Regulation (EU) No. 957/2014 of 10 September 201450, Commission Regulation (EU) No. 966/2014 of 12 September 201451 and Commission Regulation (EU) 2015/463 of 19 March 201556;

"Commission" means the European Commission as referred to in Article 13(1) of the Treaty on European Union;

"EC Regulation 1333/2008" means Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 20081 on food additives as amended by Commission Regulation (EU) No. 238/2010 of 22 March 20102, Commission Regulation (EU) No. 257/2010 of 25 March 20103, Commission Regulation (EU) No. 1129/2011 of 11 November 20114, Commission Regulation (EU) No. 1130/2011 of 11 November 20115, Commission Regulation (EU) No. 1131/2011 of 11 November 20116, Commission Regulation (EU) No. 232/2012 of 16 March 20128, Commission Regulation (EU) No. 380/2012 of 3 May 20129, Commission Regulation (EU) No. 470/2012 of 4 June 201210, Commission Regulation (EU) No. 471/2012 of 4 June 201211, Commission Regulation (EU) No. 472/2012 of 4 June 201212, Commission Regulation (EU) No. 570/2012 of 28 June 201213, Commission Regulation (EU) No. 583/2012 of 2 July 201214, Commission Regulation (EU) No. 675/2012 of 23 July 201215, Commission Regulation (EU) No. 1049/2012 of 8 November 201216, Commission Regulation (EU) No. 1057/2012 of 12 November 201218, Commission Regulation (EU) No. 1147/2012 of 4 December 201219, Commission Regulation (EU) No. 1148/2012 of 4 December 201220, Commission Regulation (EU) No. 1149/2012 of 4 December 201221, Commission Regulation (EU) No. 1166/2012 of 7 December 201222, Commission Regulation (EU) No. 25/2013 of 16 January 201323, Commission Regulation (EU) No. 244/2013 of 19 March 201324, Commission Regulation (EU) No. 256/2013 of 20 March 201325, Commission Regulation (EU) No. 438/2013 of 13 May 201326, Commission Regulation (EU) No. 509/2013 of 3 June 201328, Commission Regulation (EU) No. 510/2013 of 3 June 201329, Commission Regulation (EU) No. 723/2013 of 26 July 201330, Commission Regulation (EU) No. 738/2013 of 30 July 201332, Commission Regulation (EU) No. 739/2013 of 30 July 201333, Commission Regulation (EU) No. 816/2013 of 28 August 201334, Commission Regulation (EU) No. 817/2013 of 28 August 201335, Commission Regulation (EU) No. 818/2013 of 28 August 201336, Commission Regulation (EU) No. 913/2013 of 23 September 201337, Commission Regulation (EU) No. 1068/2013 of 30 October 201338, Commission Regulation (EU) No. 1069/2013 of 30 October 201339, Commission Regulation (EU) No. 1274/2013 of 6 December 201340, Commission Regulation (EU) No. 59/2014 of 23 January 201441, Commission Regulation (EU) No. 264/2014 of 14 March 201442, Commission Regulation (EU) No. 298/2014 of 21 March 201443, Commission Regulation (EU) No. 497/2014 of 14 May 201444, Commission Regulation (EU) No. 505/2014 of 15 May 201445, Commission Regulation (EU) No. 506/2014 of 15 May 201446, Commission Regulation (EU) No. 601/2014 of 4 June 201447, Commission Regulation (EU) No. 685/2014 of 20 June 201448, Commission Regulation (EU) No. 923/2014 of 25 August 201449, Commission Regulation (EU) No. 957/2014 of 10 September 201450, Commission Regulation (EU) No. 969/2014 of 12 September 201452, Commission Regulation (EU) No. 1084/2014 of 15 October 201453, Commission Regulation (EU) No. 1092/2014 of 16 October 201454, Commission Regulation (EU) No. 1093/2014 of 16 October 201455, Commission Regulation (EU) 2015/537 of 31 March 201557, Commission Regulation (EU) 2015/538 of 31 March 201558, Commission Regulation (EU) 2015/639 of 23 April 201559, Commission Regulation (EU) 2015/647 of 24 April 201560 and Commission Regulation (EU) 2015/649 of 24 April 201561;

"EU Regulations" means EC Regulation 1333/2008 and Commission Regulation 231/2012;

"food additive" means any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods;

"General Food Law Regulation" means Regulation (EC) 178/2002 of the European Parliament and of the Council of 28 January 2002⁶² ;

"Minister" means the Minister for Health;

"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;

"Official Controls Regulation" means Regulation (EC) No. 882/2004 of the European Parliament and of the Council of 29 April 2004⁶³ , as affected by the Corrigendum to Regulation (EC) No. 882/2004 of 28 May 2004⁶⁴ , as amended by Commission Regulation (EC) No. 1029/2008 of 20 October 2008⁶⁵ , Regulation (EC) No. 596/2009 of the European Parliament and of the Council of 18 June 2009⁶⁶ , Commission Regulation (EU) No. 208/2011 of 2 March 2011⁶⁷ (as corrected by Commission Regulation (EU) No. 880/2011 of 2 September 2011⁶⁸ ), Commission Regulation (EU) No. 563/2012 of 27 June 2012⁶⁹ , Council Regulation (EU) No. 517/2013 of 13 May 2013⁷⁰ and Regulation (EU) No. 652/2014 of the European Parliament and of the Council of 15 May 2014⁷¹ ;

"official laboratory" means-

(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;

"quantum satis" shall mean that no maximum numerical level is specified and substances shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and provided the consumer is not misled;

"relevant thing" means a label, labelling, packaging, container or documents;

"service contract" means a contract entered into between the Authority and an official agency pursuant to section 48 of the Act of 1998.

(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.

Scope

3. (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.

PART 2

GENERAL PROVISIONS

Prohibition of non-compliant food additives or non-compliant food

4. 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.

Placing on the market of food additives

5. 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.

Placing on the market of food additives in food additives, food enzymes and food flavourings

6. 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.

Use of food additives in unprocessed foods

7. 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.

Use of food additives in foods for infants and young children

8. 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.

Use of colours for markings

9. 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,

and in accordance with Article 17 of EC Regulation 1333/2008.

Labelling of food additives not intended for sale to the final consumer

10. (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,

where the packaging or containers of such food additives fail to bear the following labelling information:

(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

and the packaging or containers of such food additives fail to bear a list of all ingredients in descending order of their percentage by weight of the total.

(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.

Labelling of food additives intended for sale to the final consumer

11. (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,

where the packaging or containers of such food additives fail to bear the following labelling information:

(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.

Labelling requirement for foods containing certain food colours

12. (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.

Information obligation

13. 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,

in accordance with Article 26 of EC Regulation 1333/2008.

Monitoring of food additive intake

14. 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.

PART 3

ENFORCEMENT, OFFENCES AND PENALTIES

Enforcement generally

15. (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.

Taking of food samples

16. (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.

Division of food samples

17. (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,

the provisions of paragraph (1) and (2) 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) and (2).

(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.

Taking of relevant things

18. (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.

Analysis of food samples and relevant things

19. (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.

(2) The form of certificate set out in the Schedule to these Regulations or a certificate in like form shall be used for the purpose of paragraph (1).

(3) An official certificate given in accordance with paragraph (1) shall be evidence of the matters contained therein until the contrary is shown.

Report on official controls

20. (1) Where a sample of food or relevant thing or a copy or photograph of a relevant thing is taken by an authorised officer in pursuance of these Regulations for inspection or analysis, the Authority, or an official agency as the case may be, shall draw up a report in accordance with Article 9 of the Official Controls Regulation.

(2) Where the certificate given in accordance with Regulation 19(1) indicates that there has been non-compliance with these Regulations, the Authority, or the official agency, as the case may be, shall provide the food business operator or person in apparent charge or control of such food or relevant thing, with a copy of the report referred to in paragraph (1).

Powers of authorised officers

21. An authorised officer may, for the purposes of these Regulations-

(a) examine any procedure connected with the manufacture of food, and

(b) require a person to state his or her name and address and, if the authorised officer thinks it necessary, to produce corroborative evidence of same.

Seizure, removal, detention and destruction

22. (1) An authorised officer may seize, remove or detain food or a relevant thing which is suspected by him or her of failing to comply with the provisions of these Regulations.

(2) An authorised officer may, with the consent in writing of the food business operator, or the person in apparent charge or control of such food or in accordance with an order of a judge of the District Court under paragraph (5) of this Regulation, destroy or otherwise dispose of food so as to prevent the food being used for human consumption.

(3) An authorised officer may, with the consent in writing of the food business operator, or the person in apparent charge or control of such relevant thing or in accordance with an order of a judge of the District Court under paragraph (5) of this Regulation, destroy or otherwise dispose of the relevant thing so as to prevent consumers from being misled or a risk to human health.

(4) An authorised officer who has seized, removed or detained food or a relevant thing in pursuance of the provisions of this Regulation may, on giving notice in writing to the food business operator, or the person in apparent charge or control of such food or relevant thing, of his or her intention to do so, apply to a judge of the District Court for an order directing that such food or relevant thing be destroyed or otherwise disposed of.

(5) A judge of the District Court, to whom an application is made for an order under paragraph (4), may, if satisfied that the food or relevant thing fails to comply with these Regulations, order that same 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 the food or relevant thing accordingly.

Designation of official laboratories and approved examiners

23. The Minister may, for the purposes of these Regulations designate, by notice in writing published in Iris Oifigiúil:

(a) a laboratory as a laboratory at which samples taken under these Regulations may be analysed, and testing and verification may be carried out, and

(b) a person as being a person who, or a class of persons the members of which, may, at a designated laboratory, engage in analysis, testing and verification for the purposes of these Regulations.

Offences

24. (1) The offences provided for in these Regulations shall not apply to an authorised officer or an approved examiner, or to a person acting under such an officer’s or examiner’s express direction, acting in the course of his or her duties pursuant to these Regulations.

(2) A person is guilty of an offence if he or she-

(a) obstructs or interferes with an authorised officer in the exercise of the officer’s powers under these Regulations,

(b) fails or refuses to state his or her name or address in compliance with a request under these Regulations,

(c) fails to comply with a request or notice from an authorised officer under these Regulations,

(d) makes a statement or provides information to an authorised officer which the person knows is false or misleading,

(e) provides records or documents, or copies thereof, which the person knows to be false or misleading in content, or

(f) gives, in purported compliance with a request under these Regulations, a name, an address or corroborative evidence which is false or misleading.

(3) A person is guilty of an offence if he or she 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 referred to as "a forged document").

(4) A person is guilty of an offence if he or she alters with intent to defraud or deceive, or 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 referred to as "an altered document").

(5) A person is guilty of an offence if he or she, without lawful authority, has in his or her possession a forged document or an altered document.

(6) A person is guilty of an offence if he or she with the intent to defraud or deceive:

(a) tampers with any food or relevant thing, or

(b) tampers or interferes with any sample taken under these Regulations.

(7) A person is guilty of an offence if he or she falsely represents himself or herself to be an authorised officer.

(8) 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.

Bodies corporate

25. Where a body corporate, or a person acting on behalf of a body corporate, commits an offence under these Regulations and the offence is committed with the consent, connivance or approval of, or is attributable to any neglect or default on the part of, any director, manager, secretary or any other officer of such body, or a person purporting to act in any such capacity, such person is also guilty of an offence and is liable to be proceeded against and punished as if he or she were guilty of the first-mentioned offence.

Prosecution of offences

26. (1) A person who is guilty of an offence under these Regulations is liable-

(a) on summary conviction, to a class A fine or at the discretion of the Court to imprisonment for a term not exceeding 6 months, or both, or

(b) on conviction on indictment, to a fine not exceeding €500,000, or imprisonment for a term not exceeding 3 years, or both.

(2) No prosecution on indictment shall be taken on foot of these Regulations in respect of an offence that occurred before the entry into force of these Regulations.

(3) Where a person is convicted of an offence under these Regulations, the court shall, unless it is satisfied that there are special and substantial reasons for not so doing, order the person to pay to the Authority or the official agency, as the case may be, the costs and expenses, measured by the court, incurred by the Authority or official agency in relation to the investigation, detection and prosecution of the offence, including costs and expenses incurred in the taking of samples, the carrying out of tests, examinations and analyses and in respect of the remuneration and other expenses of employees, consultants and advisors engaged by the Authority or official agency.

(4) An order for costs and expenses under paragraph (3) is in addition to, and not instead of, any fine or penalty the court may impose under paragraph (1).

(5) Notwithstanding section 57 of the Act of 1998, a summary offence under these Regulations may be prosecuted by:

(a) the Authority, or

(b) an official agency.

PART 4

TRANSITIONAL MEASURES AND REVOCATIONS

Transitional measures

27. (1) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Article 22(1)(i) and (4) of EC Regulation 1333/2008 in respect of foods placed on the market or labelled prior to 20 January 2010, which may continue to be marketed after that date until their date of minimum durability or use-by date, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(2) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Article 24 of EC Regulation 1333/2008 in respect of foods placed on the market or labelled prior to 20 July 2010, which may continue to be marketed after that date until their date of minimum durability or use-by date, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(3) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Annex II to EC Regulation 1333/2008 as amended by Commission Regulation (EU) No. 1129/2011 of 11 November 20114, in respect of foods placed on the market prior to 1 June 2013, which may continue to be marketed after that date until their date of minimal durability or use-by date, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(4) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Annex II to EC Regulation 1333/2008 as amended by Commission Regulation (EU) No. 232/2012 of 16 March 20128, in respect of foods containing Quinoline Yellow (E 104), Sunset Yellow FCF/ Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124) placed on the market prior to 1 June 2013, which may continue to be marketed after that date until stocks are exhausted, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(5) Subject to paragraph (6) and notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Annex II to EC Regulation 1333/2008 as amended by Commission Regulation (EU) No. 380/2012 of 3 May 20129, in respect of foods placed on the market prior to 1 February 2014, which may continue to be marketed after that date until their date of minimum durability or use-by date, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(6) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Annex II to EC Regulation 1333/2008 as amended by Commission Regulation (EU) No. 380/2012 of 3 May 20129 in respect of foods containing aluminium lakes, placed on the market prior to 1 August 2014, which may continue to be marketed after that date until their date of minimum durability or use-by date, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(7) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Annex II to EC Regulation 1333/2008 as amended by Commission Regulation (EU) No. 1274/2013 of 6 December 201340 in respect of the food additives ‘Brilliant Black BN, Black PN’ (E 151) or ‘Carboxy methyl cellulose, Sodium carboxy methyl cellulose, Cellulose gum’ (E 466) and foods containing those food additives, labelled or placed on the market prior to 27 December 2015, which may continue to be marketed after that date until stocks are exhausted, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(8) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Annex II to EC Regulation 1333/2008 as amended by Commission Regulation (EU) No. 957/2014 of 10 September 201450 in respect of foods containing the food additive montan acid esters (E 912) placed on the market prior to 1 October 2014, which may continue to be marketed after that date until stocks are exhausted, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(9) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Annex III to EC Regulation 1333/2008, as amended by Commission Regulation (EU) No. 1130/2011 of of 11 November 20115, in respect of preparations not complying with Parts 2, 3 or Section A of Part 5 of Annex III to EC Regulation 1333/2008, as amended by Commission Regulation (EU) No. 1130/2011 of 11 November 20115, placed on the market prior to 2 December 2013, which may continue to be marketed after that date until stocks are exhausted, provided that, in all such cases, foods containing such preparations were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(10) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Annex III to EC Regulation 1333/2008 as amended by Commission Regulation (EU) No. 1130/2011 of 11 November 20115 in respect of preparations not complying with Parts 1 and 4 of Annex III to EC Regulation 1333/2008, as amended by Commission Regulation (EU) No. 1130/2011 of 11 November 20115, placed on the market prior to 31 May 2013, which may continue to be marketed after that date until stocks are exhausted, provided that, in all such cases, foods containing such preparations were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(11) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Annex III to EC Regulation 1333/2008 as amended by Commission Regulation (EU) No. 1274/2013 of 6 December 201340 in respect of the food additives ‘Carboxy methyl cellulose, Sodium carboxy methyl cellulose, Cellulose gum’ (E 466) and foods containing those food additives, labelled or placed on the market prior to 27 December 2015, which may continue to be marketed after that date until stocks are exhausted, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(12) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Commission Regulation (EU) No. 231/2012 of 9 March 20127 in respect of foodstuffs containing food additives placed on the market prior to 1 December 2012, which may continue to be marketed after that date until stocks are exhausted, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(13) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Commission Regulation 231/2012 as amended by Commission Regulation (EU) No. 1274/2013 of 6 December 201340 in respect of the food additives ‘Brilliant Black BN, Black PN’ (E 151) or ‘Carboxy methyl cellulose, Sodium carboxy methyl cellulose, Cellulose gum’ (E 466) and foods containing those food additives, labelled or placed on the market prior to 27 December 2015, which may continue to be marketed after that date until stocks are exhausted, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

(14) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with the Annex to Commission Regulation 231/2012 as amended by Commission Regulation (EU) No. 957/2014 of 10 September 201450 in respect of foods containing the food additive montan acid esters (E 912) placed on the market prior to 1 October 2014, which may continue to be marketed after that date until stocks are exhausted, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.

Revocations

28. (1) The following are revoked:

(a) the European Communities (Food Additives) (Purity Criteria Verification) Regulations 1983 ( S.I. No. 60 of 1983 );

(b) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) Regulations 2000 ( S.I. No. 437 of 2000 );

(c) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) Regulations 2002 ( S.I. No. 342 of 2001 );

(d) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) Regulations 2002 ( S.I. No. 344 of 2002 );

(e) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) (No. 3) Regulations 2002 ( S.I. No. 380 of 2002 );

(f) the European Communities (Food Additives other than Colours and Sweeteners) Regulations 2004 ( S.I. No. 58 of 2004 );

(g) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) Regulations 2005 ( S.I. No. 61 of 2005 );

(h) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) (No. 2) Regulations 2005 ( S.I. No. 192 of 2005 );

(i) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) (No. 3) Regulations 2005 ( S.I. No. 193 of 2005 );

(j) the European Communities (Food Additives other than Colours and Sweeteners) (Amendment) Regulations 2005 ( S.I. No. 369 of 2005 );

(k) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) Regulations 2007 ( S.I. No. 171 of 2007 );

(l) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) Regulations 2008 ( S.I. No. 34 of 2008 );

(m) the European Communities (Food Additives other than Colours and Sweeteners) (Amendment) Regulations 2008 ( S.I. No. 40 of 2008 );

(n) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) (No. 2) Regulations 2008 ( S.I. No. 59 of 2008 );

(o) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) (No. 3) Regulations 2008 ( S.I. No. 369 of 2008 );

(p) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) Regulations 2009 ( S.I. No. 126 of 2009 );

(q) the European Communities (Purity Criteria on Food Additives other than Colours and Sweeteners) Regulations 2009 ( S.I. No. 277 of 2009 );

(r) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) Regulations 2010 ( S.I. No. 522 of 2010 );

(s) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) (No. 2) Regulations 2010 ( S.I. No. 534 of 2010 );

(t) the European Communities (Food Additives other than Colours and Sweeteners) (Amendment) Regulations 2011 ( S.I. No. 93 of 2011 );

(u) the European Communities (Purity Criteria on Food Additives other than Colours and Sweeteners) (Amendment) Regulations 2011 ( S.I. No. 128 of 2011 ); and

(v) the European Communities (Additives, Colours and Sweeteners in Foodstuffs) (Amendment) Regulations 2011 ( S.I. No. 130 of 2011 ).

(2) References in any other instrument to the Regulations revoked under paragraph (1) shall be construed as references to these Regulations or the EU Regulations, as appropriate.

Regulation 19(2)

Schedule

European Union (Food Additives) Regulations 2015.

Certificate of Analysis

To(1) ........................................

I, the undersigned(2) .........................................

being an approved examiner for the purpose of the above Regulations certifythat on

the .........................day of .......................... 20 ......

a sample marked(3) ....................................

Date .....................................

Number .....................................

Weight or Measure(4) ..................................

was submitted to me by you and I certify that the sample was prepared and analysed/examined by me or under my direction(5)

and as a result I am of the opinion that(6)

Observations:(7) I further certify that the sample has undergone no change which would affect my opinion/observations expressed above.

Certified by me this ..................... day of ............................... 20 .....

At(8) .....................................

Name in BLOCK LETTERS ...............................................................

Status ...........................................................

Signature .........................................................

........................................................

Official Stamp

NOTES

(1) Insert the name and address of the person submitting the sample for analysis.

(2) Insert description (e.g. Public Analyst located at a Public Analyst’s Laboratory).

(3) Insert particulars of marking (e.g. name, date etc.).

(4) This may be left unanswered if the sample cannot be conveniently weighed or measured or the weight or measurement is not material to the result of analysis.

(5) 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.

(6) Here the approved examiner should specify the result of the analysis having regard to the provisions of the relevant legislation.

(7) 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 such other observations as he or she may consider relevant.

(8) Insert the name and address of the laboratory carrying out the analysis/examination.

GIVEN under my Official Seal,

28 July 2015.

LEO VARADKAR,

Minister for Health.

EXPLANATORY NOTE

(This note is not part of the instrument and does not purport to be a legal interpretation.)

These Regulations have been adopted for the purpose of giving further effect to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, as amended.

These Regulations also give further effect to Commission Regulation (EU) No. 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council, as amended.

These Regulations revoke and replace the European Communities (Food Additives) (Purity Criteria Verification) Regulations 1983, ( S.I. No. 60 of 1983 ), the European Communities (Purity Criteria on Food Additives other than Colours and Sweeteners) Regulations 2009 and 2011, the European Communities (Additives, Colours and Sweeteners in Foodstuffs) Regulations 2000 to 2011 and the European Communities (Food Additives other than Colours and Sweeteners) Regulations 2004 to 2011. They provide for a number of very specific transitional measures.

These Regulations may be cited as the European Union (Food Additives) Regulations 2015 and they come into effect on the date they are signed.

1 OJ No. L. 354, 31.12.2008, p. 16.

2 OJ No. L. 75, 23.3.2010, p. 17.

3 OJ No. L. 80, 26.3.2010, p. 19.

4 OJ No. L. 295, 12.11.2011, p. 1.

5 OJ No. L. 295, 12.11.2011, p. 178.

6 OJ No. L. 295, 12.11.2011, p. 20.

7 OJ No. L. 83, 22.3.2012, p. 1.

8 OJ No. L. 78, 17.3.2012, p. 1.

9 OJ No. L. 119, 4.5.2012, p. 14.

10 OJ No. L. 144, 5.6.2012, p. 16.

11 OJ No. L. 144, 5.6.2012, p. 19.

12 OJ No. L. 144, 5.6.2012, p. 22.

13 OJ No. L. 169, 29.6.2012, p. 43.

14 OJ No. L. 173, 3.7.2012, p. 8.

15 OJ No. L. 196, 24.7.2012, p. 52.

16 OJ No. L. 310, 9.11.2012, p. 41.

17 OJ No. L. 310, 9.11.2012, p. 45.

18 OJ No. L. 313, 13.11.2012, p. 11.

19 OJ No. L. 333, 5.12.2012, p. 34.

20 OJ No. L. 333, 5.12.2012, p. 37.

21 OJ No. L. 333, 5.12.2012, p. 40.

22 OJ No. L. 336, 8.12.2012, p. 75.

23 OJ No. L. 13, 17.1.2013, p. 1.

24 OJ No. L. 77, 20.3.2013, p. 3.

25 OJ No. L. 79, 21.3.2013, p. 24.

26 OJ No. L. 129, 14.5.2013, p. 28.

27 OJ No. L. 143, 30.5.2013, p. 20.

28 OJ No. L. 150, 4.6.2013, p. 13.

29 OJ No. L. 150, 4.6.2013, p. 17.

30 OJ No. L. 202, 27.7.2013, p. 8.

31 OJ No. L. 202, 27.7.2013, p. 11.

32 OJ No. L. 204, 31.7.2013, p. 32.

33 OJ No. L. 204, 31.7.2013, p. 35.

34 OJ No. L. 230, 29.8.2013, p. 1.

35 OJ No. L. 230, 29.8.2013, p. 7.

36 OJ No. L. 230, 29.8.2013, p. 12.

37 OJ No. L. 252, 24.9.2013, p. 11.

38 OJ No. L. 289, 31.10.2013, p. 58.

39 OJ No. L. 289, 31.10.2013, p. 61.

40 OJ No. L. 328, 7.12.2013, p. 79.

41 OJ No. L. 21, 24.1.2014, p. 2.

42 OJ No. L. 76, 15.3.2014, p. 22.

43 OJ No. L. 89, 25.3.2014, p. 36.

44 OJ No. L. 143, 15.5.2014, p. 6.

45 OJ No. L. 145, 16.5.2014, p. 32.

46 OJ No. L. 145, 16.5.2014, p. 35.

47 OJ No. L. 166, 5.6.2014, p. 11.

48 OJ No. L. 182, 21.6.2014, p. 23.

49 OJ No. L. 252, 26.8.2014, p. 11.

50 OJ No. L. 270, 11.9.2014, p. 1.

51 OJ No. L. 272, 13.9.2014, p. 1.

52 OJ No. L. 272, 13.9.2014, p. 8.

53 OJ No. L. 298, 16.10.2014, p. 8.

54 OJ No. L. 299, 17.10.2014, p. 19.

55 OJ No. L. 299, 17.10.2014, p. 22.

56 OJ No. L. 76, 20.3.2015, p. 42.

57 OJ No. L. 88, 1.4.2015, p. 1.

58 OJ No. L. 88, 1.4.2015, p. 4.

59 OJ No. L. 106, 24.4.2015, p. 16.

60 OJ No. L. 107, 25.4.2015, p. 1.

61 OJ No. L. 107, 25.4.2015, p. 17.

62 OJ No. L. 31, 1.2.2002, p. 1.

63 OJ No. L. 165, 30.4.2004, p. 1.

64 OJ No. L. 191, 28.5.2004, p. 1.

65 OJ No. L. 278, 21.10.2008, p. 6.

66 OJ No. L. 188, 18.7.2009, p. 14.

67 OJ No. L. 58, 3.3.2011, p. 29.

68 OJ No. L. 228, 3.9.2011, p. 8.

69 OJ No. L. 168, 28.6.2012, p. 24.

70 OJ No. L. 158, 10.6.2013, p. 1.

71 OJ No. L. 189, 27.6.2014, p. 1.

72 OJ No. L. 354, 31.12.2008, p. 7.

73 OJ No. L. 124, 20.5.2009, p. 21.

74 OJ No. L. 304, 22.11.2011, p. 18.

75 OJ No. L. 186, 30.6.1989, p. 21.

76 OJ No. L. 268, 18.10.2003, p. 1.