S.I. No. 49/2017 - European Union (Plastics and other materials) (Contact with food) Regulations 2017.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 21st February, 2017.

I, MICHAEL CREED, Minister for Agriculture Food and the Marine, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972), for the purpose of giving effect to Council Directive No.78/142/EEC of 30 January 1978¹ , Council Directive No. 84/500/EEC of 15 October 1984² (as amended by Commission Directive No. 2005/31/EC of 29 April 2005³ ), Commission Directive No. 93/11/EEC of 5 March 1993⁴ , and Commission Directive No. 2007/42/EC of 29 June 2007⁵ and full effect to Regulation (EC) No. 1935/2004 of the European Parliament and of the Council of 27 October 2004⁶ , Commission Regulation (EC) No. 1895/2005 of 18 November 2005⁷ , Commission Regulation (EC) No. 2023/2006 of 22 December 2006⁸ (as amended by Commission Regulation (EC) No. 282/2008 of 27 March 2008)⁹ ; Commission Regulation (EC) No. 450/2009 of 29 May 2009¹⁰ , Commission Regulation (EU) No. 10/2011 of 14 January 2011¹¹ (as amended by Commission Implementing Regulation (EU) No 321/2011 of 1 April 2011¹² , Commission Regulation (EU) No 1282/2011 of 28 November 2011¹³ , Commission Regulation (EU) No 1183/2012 of 30 November 2012¹⁴ ,Commission Regulation (EU) No 202/2014 of 3 March 2014¹⁵ , Commission Regulation (EU) No 865/2014 of 8 August 2014¹⁶ ,Commission Regulation (EU) 2015/174 of 5 February 2015¹⁷ and Commission Regulation (EU) 2016/1416 of 24 August 2016¹⁸ ), and Commission Regulation (EU) No. 284/2011 of 22 March 2011¹⁹ , hereby make the following regulations:

Citation and commencement.

1. These Regulations may be cited as the European Union (Plastics and other materials) (Contact with food) Regulations 2017.

Interpretation.

2. (1) In these Regulations

“active and intelligent material Regulation” means Commission Regulation (EC) No. 450/2009 of 29 May 2009;

“authorised officer” means—

(a) an authorised officer within the meaning of the Food Safety Authority of Ireland Act 1998 (No. 29 of 1998),

(b) a person appointed under Regulation 8, (c) a member of the Garda Siochana, or

(d) an officer of Customs and Excise;

“Cellulose Film Directive” means Commission Directive No. 2007/42/EC of 29 June 2007;

“Ceramics Directive” means Council Directive No. 84/500/EEC of 15 October 2004 as amended by Commission Directive No. 2005/31/EC of 29 April 2005;

“Epoxy Derivatives Regulation” means Commission Regulation (EC) No. 1895/2005 of 18 November 2005;

“Framework Regulation” means Regulation (EC) No. 1935/2004 of the Euro- pean Parliament and of the Council of 27 October 2004;

“GMP Regulation” means Commission Regulation (EC) No. 2023/2006 of 22 December 2006 as amended by Commission Regulation (EC) No. 282/2008 of 27 March 2008;

“manufacture” means total or partial manufacture and includes processing, com- pounding, formulating, filling, dividing up, packing, labelling and presentation;

“Official Agency” means an official agency within the meaning of the Food Safety Authority of Ireland Act 1998 (No. 29 of 1998);

“Plastics Regulation” means Commission Regulation (EC) No. 10/2011 of 14 January 2011 (as amended by Commission Implementing Regulation(EU) No 321/2011 of 1 April 2011, Commission Regulation (EU) No 1282/2011 of 28 November 2011, Commission Regulation (EU) No 1183/2012 of 30 November 2012, Commission Regulation (EU) No 202/2014 of 3 March 2014, Commission Regulation (EU) No 865/2014 of 8 August 2014, Commission Regulation (EU) 2015/174 of 5 February 2015 and Commission Regulation (EU) 2016/1416 of 24 August 2016);

“Recycled Plastics Regulation” means Commission Regulation (EC) No. 282/2008 of 27 March 2008;

“sell” includes offer, expose or keep for sale, invite an offer to buy, or distribute for reward and cognate words shall be construed accordingly;

“supply” includes giving without payment;

“Teats and Soothers Directive” means Commission Directive 93/11/EEC of 5 March 1993;

“Vinyl Chloride Directive” means Council Directive No. 78/142/EEC of 30 January 1978, Commission Directive No. 80/766/ EEC, of 8 July 1980 and Com- mission Directive No. 81/432/EEC of 29 April 1981.

(2) A word or expression that is used in the active and intelligent material Regulation, Cellulose Film Directive, the Ceramics Directive, the Epoxy Derivatives Regulation, the Framework Regulation, the GMP Regulation, the Recycled Plastics Regulation, the Plastic Regulation, the Teats and Soothers Directive, the Vinyl Chloride Directive or Commission Regulation (EU) No. 284/2011 of 22 March 2011 and that is also used in these Regulations has, in these Regulations, the same meaning as in the act of the institutions of the European Union in which the word or expression occurs..

Cellulose Film.

3. (1) This Regulation applies to—

(a) uncoated regenerated cellulose film (hereafter in this Regulation referred to as “type 1 film”),

(b) coated regenerated cellulose film with coating derived from cellulose (hereafter in this Regulation referred to as “type 2 film”), and

(c) coated regenerated cellulose film with coating consisting of plastic (hereafter in this Regulation referred to as “type 3 film”).

(2) A person shall not cause or permit a printed surface of regenerated cellulose film to come in contact with a foodstuff.

(3) A person shall not sell or supply a material or article that consists of or contains regenerated cellulose film in respect of which special conditions of use are indicated, unless the material or article is labelled with the special conditions of use

(4) A person shall not manufacture, sell, supply, import, engage in trade in or use in the course of a business in connection with the storage, preparation, packaging, sale, supply or serving of a foodstuff type 1 film or type 2 film unless the film is manufactured—

(a) in accordance with Annex II to the Cellulose Film Directive using only a substance or group of substances listed in that Annex, or

(b) using a substance not listed in Annex II to the Cellulose Film Directive when the substance is used as a dye, pigment or adhesive, provided there is no trace of migration of the substance onto or into a foodstuff.

Plastics

4. (1) A person who places on the market a plastic material or article that does not comply with Article 4 of the Plastics Regulation commits an offence.

(2) A person who manufactures or imports a plastic material or article intended to come into contact with a foodstuff using a substance that is not on the Union list, in contravention of Article 5 of the Plastics Regulation commits an offence.

(3) Paragraph (2) does not apply to the use of a substance permitted by Article 6 of the Plastics Regulation, subject to compliance with Article 19 of that Regulation.

(4) A person who, in the manufacture of a plastic layer in a plastic material or article intended to come into contact with a foodstuff, uses a substance that does not comply with Article 8 or 9 of the Plastics Regulation commits an offence.

(5) A person who manufactures, imports, sells or supplies, a plastic material or article that does not comply with Article 10 of the Plastics Regulation commits an offence.

(6) A person who manufactures, imports, sells or supplies, a plastic material or article that transfers its constituents to food in quantities exceeding—

(a) the specific migration limit in contravention of Article 11, or

(b) the overall migration limit in contravention of Article 12,

of the Plastics Regulation commits an offence.

(7) A person who manufactures, imports, sells or supplies, a plastic multi-layer material or article that does not comply with Article 13 of the Plastics Regulation commits an offence.

(8) A person who manufactures, imports, sells or supplies, a multi-material multi-layer material or article that does not comply with Articles 14 and 19 of the Plastics Regulation commits an offence.

(9) A person who does not make

(a) a written declaration available, as required by Article 15, or

(b) supporting documentation available as required by Article 16,

of the Plastics Regulation commits an offence.

(10) A person who imports polyamide or melamine plastic kitchenware from China, including Hong Kong, other than in accordance with Article 3 and 4 of Commission Regulation (EU) No. 284/2011 of 22 March 2011 commits an offence.

(11) The designated first points of introduction for the purposes of Article 5 of Commission Regulation (EU) No. 284/2011 of 22 March 2011 are Dublin airport and Dublin port.

Ceramics.

5. A person shall not manufacture, sell, supply, import, engage in trade, in or use in the course of a business in connection with the storage, preparation, packaging, sale, supply or serving of a foodstuff a ceramic article which in its finished state is—

(a) intended to come in contact with a foodstuff, or

(b) in contact with a foodstuff and is intended for a purpose related to a foodstuff,

which transfers, or may transfer, to a foodstuff a quantity of lead or cadmium in excess of the limits laid down in Article 2(4) of the Ceramics Directive or which does not comply with Article 2A of the Ceramics Directive.

Teats and Soothers.

6. A person shall not manufacture, import, export, sell or supply a teat or soother that does not comply with the Teats and Soothers Directive,

Vinyl Chloride Monomer.

7. A person shall not manufacture, sell, supply, import or use in the course of a business in connection with the storage, preparation, packaging, sale, supply or serving of a foodstuff a material or article prepared with a vinyl chloride polymer or copolymer and which contains vinyl chloride monomer exceeding 1 milligram per kilogram of the material or article.

Authorised Officers.

8. (1) The Food Safety Authority of Ireland or an official agency may, by instrument in writing, appoint such and so many of its officers as it thinks fit to be authorised officers for the purpose of some or all of the functions conferred by these Regulations as may be specified in the instrument.

(2) The Food Safety Authority of Ireland or an official agency may terminate the appointment of an authorised officer appointed by it whether or not the appointment was for a fixed period.

(3) An appointment as an authorised officer ceases—

(a) if it is terminated pursuant to paragraph (2),

(b) if it is for a fixed period, on the expiry of that period, or

(c) if the person appointed is an officer of the Food Safety Authority of Ireland, or an official agency, upon him or her ceasing to be such an officer.

(4) Nothing in paragraph (3) prevents the Food Safety Authority of Ireland, or an official agency from reappointing as an authorised officer a person to whom that paragraph relates.

(5) An officer of the Food Safety Authority of Ireland, or an official agency shall furnish an authorised officer with evidence of his or her appointment as an authorised officer and when exercising a power conferred on him or her, the officer, an officer of Customs and Excise or a member of the Garda Siochana shall, if requested by a person affected, produce evidence that he or she is such an officer or member to the person.

Powers of Authorised Officers.

9. (1) If an authorised officer, member of the Garda Siochana or officer of Customs and Excise has reasonable cause to suspect that—

(a) food or a material or article to which these Regulations apply is present, has been present or may be present on a premises,

(b) food or a material or article to which these Regulations apply is or has been processed, stored or otherwise dealt with on a premises,

(c) a document relating to food or a material or article to which these Regulations apply is present, was present or may be present on a premises, or

(d) an offence is being or has been committed under these Regulations,

the officer or member may enter the premises and he or she may—

(i) search the premises,

(ii) stop a person, vehicle, vessel or container,

(iii) board and search a vehicle, vessel or container,

(iv) search a person, where the authorised officer considers it necessary,

(v) examine food or a material or article to which these Regulations apply, vehicle, vessel, container or other thing that may consist of or contain food or a material or article to which these Regu- lations apply,

(vi) take, without payment, samples of food or a material or article to which these Regulations apply as he or she may reasonably require and carry out or cause to be carried out on a sample such tests, analyses, examinations or inspections as he or she considers necessary or expedient,

(vii) seize and detain (for so long as is necessary) any food, a material or article to which these Regulations apply, vehicle or container,

(viii) require the production of a document or thing relating to food, a material or article to which these Regulations apply, vehicle, ves- sel or container,

(ix) retain a document or thing (for so long as is necessary),

(x) dispose of, or require the owner or person in charge of or in pos- session of food or a material or article to which these Regulations apply to deal with or dispose of it (or any equipment, machinery, plant or other thing used in connection with, or that may have been in contact with, the food or a material or article to which these Regulations apply) in a manner that the authorised officer sees fit,

(xi) give a direction to, or request information of, a person regarding food, a material or article to which these Regulations apply, or a premises as he or she considers necessary,

(xii) require the name and address of a person and the name and address of any other relevant person including the person to whom food or a material or article to which these Regulations apply is being delivered or who is causing it to be delivered,

(xiii) require of a person the ownership, identity and origin of food or a material or article to which these Regulations apply,

(xiv) mark or otherwise identify food, a material or article to which these Regulations apply or a specimen taken under subparagrap(vi), or

(xv) require of a person any information required by the framework Regulation, the Epoxy Regulation, the GMP Regulation or the Plastics Regulation, the Recycled Plastics Regulation, the active and intelligent material Regulation, the Teats and Soothers Directive or Commission Regulation (EU) No. 284/2011 of 22 March 2011., Ceramics Directive, Cellulose Film Directive

(2) An authorised officer shall not enter, except with the consent of the occu- pier, a private dwelling, unless he or she has obtained a search warrant under Regulation 10 other than if he or she has reasonable cause to suspect that before a search warrant could be sought in relation to the dwelling anything to which paragraph (1) relates is being or is likely to be destroyed or disposed of.

(3) An authorised officer may use reasonable force, if necessary, in exercise of his or her powers under this Regulation.

(4) An authorised officer, when exercising a power under this Regulation may be accompanied by other persons and may take with him or her, or those persons may take with them, any equipment or materials to assist the officer in the exercise of the power.

(5) An authorised officer is not liable in any proceedings for anything done in the purported exercise of his or her powers under these Regulations if the Court is satisfied that the act was done in good faith and that there were reason- able grounds for doing it.

(6) Without prejudice to the generality of paragraph (1), a direction or requirement of an authorised officer may include conditions prohibiting, restricting or otherwise controlling the use, processing or movement of food or a material or article to which these Regulations apply as may be specified by the authorised officer.

(7) If a member of the Garda Siochana has reasonable grounds to suspect that a person has committed an offence under these Regulations, the member may without warrant arrest the person.

Search warrant.

10. (1) If a judge of the District Court is satisfied by information on oath of an authorised officer, member of the Garda Siochana or officer of Customs and Excise that there are reasonable grounds for suspecting—

(a) evidence of or relating to the commission or intended commission of an offence under these Regulations is to be found on a premises,

(b) there is or was food or a material or article to which these Regulations apply or equipment or other thing made used or adapted for use (including manufacture and transport) in connection with food or a material or article to which these Regulations apply,

(c) a document or other record related to a thing to which subparagraph (a) or (b) refers

is or may be on the premises, vehicle, vessel or aircraft the Judge may issue a search warrant.

(2) A search warrant under this Regulation shall be expressed and operate to authorise a named authorised officer, member of the Garda Siochana or officer of Customs and Excise accompanied by such authorised officers, membersof the Garda Siochana, officers of Customs and Excise or other persons as the named authorised officer thinks necessary, at any time, within one month from the date of issue of the warrant, on production if so requested of the warrant, to enter (if necessary by use of reasonable force) the premises, vehicle, vessel or aircraft named in the warrant.

(3) If a premises vehicle, vessel or aircraft is entered pursuant to a warrant issued under this Regulation, an authorised officer, member of the Garda Siochana or officer of Customs and Excise so entering may exercise all or any of the powers conferred on an authorised officer under these Regulations.

Compliance notice.

11. (1) If an authorised officer is of the opinion that an act of the institutions of the European Union or these Regulations are not being or have not been complied with or there are reasons to believe that they will not be complied with, he or she may, by a notice in writing (“compliance notice”) stating that opinion and served on the person who appears to be the owner, importer, operator or person in charge of the premises, substance, material or article to which either an act of the institutions of the European Union or these Regulation relates–

(a) seize and detain the substance, material or article, or

(b) require him or her to take such action as the authorised officer considers necessary.

(2) A compliance notice may-

(a) require that a substance, material or article be disposed of or destroyed in a manner specified in the notice,

(b) prohibit or regulate any operation or processing on the premises to which the notice relates,

(c) prohibit the transport or the further transport of a substance, material or article either absolutely or unless such conditions as may be specified in the notice are complied with,

(d) require a person to return a substance, material or article to the place of departure by a route which in the opinion of the authorised officer is the most direct or prudent,

(e) require that such alterations be made to a premises or means of transport as may be specified in the notice, or

(f) require a person to secure in a manner specified by the authorised officer (if any) a substance, material or article.

(3) A person shall comply with a compliance notice or a requirement of a compliance notice unless and until the notice is annulled under paragraph (8).

(4) A requirement contained in a compliance notice may specify a time limit within which it is to be complied with.

(5) A requirement specified in a compliance notice may be modified or withdrawn in a further notice and the earlier notice has effect subject to the modification or withdrawal.

(6) A compliance notice may require a person to choose between two or more of the requirements specified in the notice.

(7)(a) A person affected by a compliance notice may, within 7 days of the service of the notice, apply to the Judge of the District Court having jurisdiction in the District Court District where the substance, material or article is situated or to the Judge of the District Court having jurisdiction in the District Court District where the person bringing the appeal ordinarily resides or carries on business on the grounds that the notice or any of the terms thereof are not justified having regard to an Act of the institutions of the European Union or these Regulations (in this Regulation referred to as “an appeal”).

(b) An appeal may be heard at any sitting of the District Court within the appropriate District Court District.

(c) Notice of an appeal shall contain a statement of the grounds upon which it is alleged that the notice or any of the terms thereof are not justified and shall be served on the authority or official agency at least 48 hours prior to the hearing of the appeal.

(d) A copy of the notice of appeal shall be lodged with the District Court Clerk at least 48 hours prior to the hearing of the appeal.

(8) On the hearing of an appeal a Judge of the District Court may confirm, modify, or annul a notice.

(9) A person, including a person on whom a compliance notice has been served, shall not —-

(a) pending the determination of an appeal, deal with a substance, material or article relates, or a premises, to which the notice relates, other than in accordance with the terms of the notice, or

(b) after the appeal, deal with a substance, material or article, a premises, concerned other than in accordance with the compliance notice or compliance notice as modified.

(10)(a) Without prejudice to Regulation 9(1), if-

(i) the person in control of a substance, material or article fails to comply with the terms of a compliance notice within the time specified therein,

(ii) an authorised officer has reasonable grounds for believing that the terms of a compliance notice will not be complied with,

(iii) a compliance notice has been confirmed with or without modification under paragraph (8) and the notice has not been complied with,

(iv) an authorised officer has reasonable grounds for believing that the terms of a compliance notice which has been confirmed with or without modification under paragraph (8) will not be complied with, or

(v) pending the determination of an appeal, an authorised officer has reasonable grounds for believing that directions given pursuant to paragraph (9) have not been or shall not be complied with,

an authorised officer may at any time seize the substance, material or article concerned.

(b) If a substance, material or article is seized in accordance with subparagraph (a), an authorised officer may-

(i) sell, destroy or dispose of the substance, material or article or cause it to be sold, destroyed or be disposed of, or

(ii) take such other measures in relation to the substance, material or article as the authorised officer considers appropriate in the circumstances of the case.

(c) Any profits arising out of the sale, destruction or disposal of a substance, material or article in accordance with subparagraph (b) shall be paid to the owner of the substance, material or article less any expenses incurred in connection with the seizure, sale, destruction or disposal.

(11) The costs (including ancillary costs) of a measure taken under this Regulation is recoverable by the Authority or official agency,as a simple contract debt in a court of competent jurisdiction from the person who was the owner of the premises, substance, material or article at the time the measure was carried out.

Evidence on certificate etc.

11. In proceedings for an offence under these Regulations, a certificate purporting to be signed by a person employed at a laboratory where a sample taken under these Regulations is analysed stating the capacity in which the person is employed and stating—

(a) that the person received a sample,

(b) that for the period specified in the certificate, the person had the sample in his or her possession,

(c) that the person gave the sample to another person named in the certificate, or

(d) the person carried out a procedure for the purpose of detecting in the sample, a substance or contamination or that the sample contained a substance as is, or was contaminated in a manner, specified in the certificate,

is (without proof of the signature of the person or that he or she is employed at the laboratory), unless the contrary is proved, evidence of the matters stated in the certificate.

Obstruction etc.

12. A person shall not—

(a) obstruct or impede an authorised officer, member of the Garda Siochana or officer of Customs and Excise in the exercise of his or her powers under Regulation 9,

(b) fail, without reasonable cause, to comply with a requirement or direction of an authorised officer under Regulation 9,

(c) in purporting to give information to an authorised officer, member of the Garda Siochana or officer of Customs and Excise for the perormance of the officer’s or member’s powers under Regulation 9—

(i) make a statement that he or she knows to be false in a material particular or recklessly make a statement which is false in a material particular, or

(ii) fail to disclose a material particular,

(d) tamper or otherwise interfere with a sample taken under Regulation 9, or

(e) aid or abet an offence under these Regulations.

13. (1) A person who, by act or omission, contravenes—

(a) Article 3, 4, 11(4), 11(5), 15, 16(1) 17 of the Framework Regulation,

(b) Article 4,5,6,9,10,11,12 or 13 of the active and intelligent material Regulation, subject to Article 14 of that Regulation,

(c) Article 4,5,6 or 7 of the GMP Regulation,

(d) Article 2,3, 4 or 5 of the Epoxy Derivatives Regulation,

(e) Article 2, 3, 4, 5, 7, 8, 10(3),11, 12, 13 or 14 of the Recycled Plastic Regulation, subject to Articles 14 and 16 of that Regulation, or

(f) Regulation 3, 5, 6, 7, 11(3), 11(9) or 12 of these Regulations.

commits an offence and is liable—

(i) on summary conviction to a Class A fine or to a term of imprisonment not exceeding 6 months, or to both,

or

(ii) on conviction on indictment, to a fine not exceeding €250,000 or to a term of imprisonment not exceeding 5 years or to both.

(2) An offence under these Regulations may be prosecuted in a summary manner by an official agency or the Food Safety Authority of Ireland.

(3) If an offence under these Regulations is committed by a body corporate and is proven to have been so committed with the consent, connivance or approval of or to have been attributable to the wilful neglect on the part of any person, being a director, manager, secretary or other officer of the body corpor ate or a person who was purported to act in any such capacity, that person, as well as the body corporate, commits an offence and is liable to be proceeded against and punished as if he or she was guilty of the offence.

(4) If the affairs of a body corporate are managed by its members, paragraph (3) applies in relation to the acts and defaults of a member in connection with the functions of management as if the member were a director or manager of the body corporate.

Revocations.

15. The following are revoked:

(a) European Communities (Plastics and other materials) (Contact with food) Regulations 2007 ( S.I. No. 587 of 2007 ),

(b) the European Communities (Plastics and other materials)(Contact with Food)(Amendment) Regulations 2009 ( S.I. No. 88 of 2009 ),

(c) the European Communities (Plastics and other materials) (Contact with Food) (Amendment) (No. 2) Regulations 2009. ( S.I. No. 463 of 2009 ),

(d) the European Communities (Plastics and other materials)(Contact with Food) (Amendment) (No. 2) Regulations 2010 ( S.I. No.301 of 2010 ), and

(e) the European Communities (Plastics and other materials)(Contact with Food) (Amendment) Regulations 2011 ( S.I. No. 105 of 2011 ).

GIVEN under my Official Seal,

15 February 2017.

MICHAEL CREED TD,

Minister for Agriculture, Food and the Marine.

EXPLANATORY NOTE

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

This Order consolidates S.I. 139/2006, 566/2006 and 80/2007 and gives effect to: Commission Regulation (EC) No. 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food.

Commission Directive 2007/19/EC of 30 March 2007 amending Directive 2002/72 relating to plastices materials and articles intended to come into contact with food and Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs.

Commission Regulation (EC) No. 372/2007 of 2 April 2007 laying down transitional migration limits for plasticisers in gasket in lids intended to come into contact with foods.

Commission Directive 2007/42/EC of 29th June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs.

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