S.I. No. 376/2017 - European Union (Addition of Vitamins and Minerals and of Certain Other Substances to Foods) Regulations 2017

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 18th August, 2017.

I, SIMON HARRIS, 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 full effect to Regulation (EC) No. 1925/2006 of the European Parliament and of the Council of 20 December 2006¹ , Regulation (EC) No. 108/2008 of the European Parliament and of the Council of 15 January 2008² , Commission Regulation (EC) No. 1170/2009 of 30 November 2009³ , Commission Regulation (EU) No. 1161/2011 of 14 November 2011⁴ , Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 2011⁵ , Commission Implementing Regulation (EU) No. 307/2012 of 11 April 2012⁶ , Commission Regulation (EU) No. 119/2014 of 7 February 2014⁷ and Commission Regulation (EU) 2015/403 of 11 March 2015⁸ , hereby make the following regulations:

Part I Preliminary

Citation

1.

Interpretation

2.

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

“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 17(b);

“Annex I to EC Regulation 1925/2006” means Annex I to Regulation (EC) No. 1925/2006 of the European Parliament and of the Council of 20 December 2006¹, as amended by Commission Regulation (EC) No. 1170/2009 of 30 November 2009³;

“Annex II to EC Regulation 1925/2006” means Annex II to Regulation (EC) No. 1925/2006 of the European Parliament and of the Council of 20 December 2006¹, as amended by Commission Regulation (EC) No. 1170/2009 of 30 November 2009³, Commission Regulation (EU) No. 1161/2011 of 14 November 2011⁴ and Commission Regulation (EU) No. 119/2014 of 7 February 2014⁷;

“Annex III to EC Regulation 1925/2006” means Annex III to Regulation (EC) No. 1925/2006 of the European Parliament and of the Council of 20 December 2006¹, as amended by Commission Regulation (EU) 2015/403 of 11 March 2015⁸;

“Annex XIII to EU Regulation 1169/2011” means Annex XIII to EU Regulation 1169/2011 of the European Parliament and of the Council of 25 October 2011⁵;

“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;

“EC Regulation 1925/2006” means Regulation (EC) No. 1925/2006 of the European Parliament and of the Council of 20 December 2006¹, as amended by Regulation (EC) No. 108/2008 of the European Parliament and of the Council of 15 January 20082, Commission Regulation (EC) No. 1170/2009 of 30 November 2009³, Commission Regulation (EU) No. 1161/2011 of 14 November 2011⁴, EU Regulation 1169/20115, Commission Implementing Regulation (EU) No. 307/2012 of 11 April 2012⁶, Commission Regulation (EU) No. 119/2014 of 7 February 2014⁷ and Commission Regulation (EU) 2015/403 of 11 March 2015⁸;

“EU Regulation 1169/2011” means Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 2011⁵, as affected by Corrigendum to Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 2011⁹ and as amended by Commission Delegated Regulation (EU) No. 1155/2013 of 21 August 2013¹⁰ , Commission Delegated Regulation (EU) No. 78/2014 of 22 November 2013¹¹ , Commission Implementing Regulation (EU) No. 828/2014¹² and Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015¹³ ;

“EU Regulation 307/2012” means Commission Implementing Regulation (EU) No. 307/2012 of 11 April 2012⁶;

“General Food Law Regulation” means Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002¹⁴ , as amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council of 22 July 2003¹⁵ , Commission Regulation (EC) No. 575/2006 of 7 April 2006¹⁶ , Commission Regulation (EC) No. 202/2008 of 4 March 2008¹⁷ , Regulation (EC) No. 596/2009 of the European Parliament and of the Council of 18 June 2009¹⁸ and Regulation (EU) No. 652/2014 of the European Parliament and of the Council of 15 May 2014¹⁹ ;

“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 2004²⁰ , as affected by the Corrigendum to Regulation (EC) No. 882/2004 of 28 May 2004²¹ , as amended by Commission Regulation (EC) No. 1029/2008 of 20 October 2008²² , Regulation (EC) No. 596/2009 of the European Parliament and of the Council of 18 June 2009¹⁸, Commission Regulation (EU) No. 208/2011 of 2 March 2011²³ (as corrected by Commission Regulation (EU) No. 880/2011 of 2 September 2011²⁴ ), Commission Regulation (EU) No. 563/2012 of 27 June 2012²⁵ , Council Regulation (EU) No. 517/2013 of 13 May 2013²⁶ and Regulation (EU) No. 652/2014 of the European Parliament and of the Council of 15 May 2014¹⁹;

“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 17(a);

“other substance” means a substance other than a vitamin or a mineral that has a nutritional or physiological effect;

“relevant thing” means—

• (a) a label, labelling, packaging, a container or commercial documents relating to food, or

• (b) materials or media used in the presentation or advertising of food or other accompanying material;

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

“significant amount” has the meaning assigned to it under point 2, Part A of Annex XIII to EU Regulation 1169/2011;

“unprocessed food” means food that has not undergone processing, including but not limited to fruit, vegetables, meat, poultry and fish, and including food that has been divided, parted, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep-frozen or thawed.

• (2) A word or expression which is used in these Regulations and which is also used in EC Regulation 1925/2006 or in the General Food Law Regulation has, unless the context otherwise requires, the same meaning in these Regulations as it has in EC Regulation 1925/2006 or in the General Food Law Regulation.

Scope

3.

• (2) The provisions of these Regulations regarding vitamins and minerals do not apply to food supplements covered by Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002²⁷ .

Part 2

General Provisions

Requirements for the addition of vitamins and minerals

4.

• (a) a vitamin listed in Annex I to EC Regulation 1925/2006, in a formulation listed in Annex II to EC Regulation 1925/2006, or

• (b) a mineral listed in Annex I to EC Regulation 1925/2006, in a substance listed in Annex II to EC Regulation 1925/2006,

has been added, is guilty of an offence.

Restrictions on the addition of vitamins and minerals

5.

• (a) unprocessed food, or

• (b) beverages containing more than 1.2 per cent by volume of alcohol, other than products in compliance with the conditions laid down in Article 4 of EC Regulation 1925/2006,

to which vitamins or minerals have been added, is guilty of an offence.

Conditions for the addition of vitamins and minerals

6.

Labelling, presentation and advertising

7.

• (a) states or implies that a balanced and varied diet cannot provide appropriate quantities of nutrients, or

• (b) misleads or deceives the consumer as to the nutritional merit of the food that may result from the addition of these nutrients,

is guilty of an offence.

• (2) A food business operator who places on the market food to which a vitamin or a mineral has been added and who fails to ensure that the labelling, presentation, advertising of that food includes—

• (a) the nutrition information specified in Article 30(1) of EU Regulation 1169/2011, or

• (b) the total amounts present of the vitamin or mineral when added to the food,

is guilty of an offence.

Substances prohibited and restricted

8.

• (a) a prohibited substance listed in Part A of Annex III to EC Regulation 1925/2006, or

• (b) a restricted substance listed in Part B of Annex III to EC Regulation 1925/2006 in a manner contrary to the conditions specified therein,

is guilty of an offence.

Part 3

Enforcement, offences and penalties

Enforcement generally

9.

• (2) These Regulations shall be deemed to be food legislation for the purposes of the Act of 1998.

• (3) Subject to Regulation 18, 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.

• (4) The Authority shall submit requests to the European Commission under Article 3(2) of EU Regulation 307/2012.

Taking of food samples

10.

• (2) An authorised officer may, for the purpose of taking a sample of food, open any receptacle.

• (3) An authorised officer who purchases or takes without payment a sample of food with the intention of having it analysed, 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) An authorised officer who suspects that a food fails to comply with the provisions of these Regulations and who purchases or takes a sample of that food without payment, with the intention of having it analysed, 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

11.

• (2) An authorised officer who divides a sample in accordance with paragraph (1), shall—

• (a) in the presence of the food business operator, or the person in apparent charge or control of the 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 or the person in apparent charge or control of such food, 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 and the part, package or container retained by the authorised officer shall be produced at the hearing.

Taking of relevant things

12.

• (2) An authorised officer who takes a sample of a relevant thing related to a food sample taken in accordance with Regulations 10 and 11, for the purposes of official analysis, shall obtain three identical such relevant things, or take three copies or photographs thereof.

• (3) An authorised officer who takes a relevant thing related to a food sample taken in accordance with Regulations 10 and 11, or a copy or photograph thereof, with the intention of having it analysed, 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 or the person in apparent charge or control of such relevant thing, and

• (e) retain the third relevant thing, or the third copy or photograph of the relevant thing.

• (4) An authorised officer who takes a sample of a relevant thing pursuant to these Regulations, for the purpose of inspection, shall obtain three identical such relevant things, or takes three copies or photographs of such relevant thing.

• (5) An authorised officer who takes a relevant thing, or a copy or photograph thereof, with the intention of having it inspected, 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 or the person in apparent charge or control of such relevant thing,

• (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 analysis or inspection 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 three identical relevant things, copies or photographs were taken as specified in this Regulation and the relevant thing or the copy or photograph of the relevant thing retained by the authorised officer is produced at the hearing.

Analysis of food samples and relevant things

13.

• (2) For the purposes of paragraph (1), the form of certificate set out in the Schedule to these Regulations or a certificate in like form shall be used.

• (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

14.

• (2) Where the certificate given in accordance with Regulation 13(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 the 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

15.

• (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

16.

• (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), 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), destroy or otherwise dispose of a 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 fail 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

17.

• (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.

Safeguard measures

18.

• (2) Any notice issued under these Regulations shall be published in Iris Oifigiúil.

Offences

19.

• (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 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 referred to as “a forged document”), is guilty of an offence.

• (4) A person who 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”), is guilty of an offence.

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

• (6) A person who, 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

is guilty of an offence.

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

• (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

20.

Prosecution of offences

21.

• (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) 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.

• (3) An order for costs and expenses under paragraph (2) is in addition to, and not instead of, any fine or penalty the court may impose under paragraph (1).

• (4) 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.

Schedule

Form of official certificate to be given by an approved examiner to an authorised officer.

European Union (Addition of Vitamins and Minerals and of Certain Other Substances to Foods) Regulations 2017

Certificate of Analysis

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

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

being an approved examiner for the purpose of the above Regulations certify that 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 / relevant thing/ copy/photograph of relevant thing 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. Executive Analytical Chemist 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 any other observations as he or she may consider relevant. In the case of analysis or examination of a relevant thing, or a copy or photograph thereof, the approved examiner may insert, at his or her discretion, any observations in relation to the relevant thing that 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,

16 August 2017.

SIMON HARRIS,

Minister for Health.

EXPLANATORY NOTE

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

These Regulations give full effect to Regulation 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods, as amended by Regulation (EC) No. 108/2008 of the European Parliament and of the Council of 15 January 2008, Commission Regulation (EC) No. 1170/2009 of 30 November 2009, Commission Regulation (EU) No. 1161/2011 of 14 November 2011, Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 2011, Commission Implementing Regulation (EU) No. 307/2012, Commission Regulation (EU) No. 119/2014 of 7 February 2014 and Commission Regulation (EU) 2015/403 of 11 March 2015.

These Regulations specify the requirements, restrictions and conditions for the addition of vitamins and minerals to food. They also set out the provisions for prohibitions and restrictions applying to the addition of certain other substances to food.

These Regulations may be cited as the European Union (Addition of Vitamins and Minerals and of Certain Other Substances to Foods) Regulations 2017.

Footnotes