S.I. No. 297/2000 - European Communities (Foodstuffs Treated With Ionising Radiation) Regulations, 2000

I, MICHEÁL MARTIN, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purpose of giving effect to Directive 1999/2/EC¹ of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation and Directive 1999/3/EC² of the European Parliament and of the Council of 22 February 1999 on the establishment of a Community list of foods and food ingredients treated with ionising radiation, hereby make the following Regulations:

1.

2.

“the Act of 1991” means the Radiological Protection Act, 1991 (No. 9 of 1991);

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

“approved irradiation facility” means an irradiation facility in respect of which a permit is in force;

“authorised officer” means -

• (a) an authorised officer appointed under section 49 of the Act of 1998,

• (b) in relation to the functional area of a health board, a person or a person belonging to a class of persons, authorised by the chief executive officer of the health board concerned to perform the functions of an authorised officer under these Regulations, or

• (c) a member of the Garda Síochána;

“the Authority” means the Food Safety Authority of Ireland established under section 9 of the Food Safety Authority of Ireland Act, 1998 (No. 29 of 1998);

“Codex Alimentarius” means the Joint FAO/WHO Codex Alimentarius Commission Recommended Code of Practice for the operation of irradiation used for the treatment of foods;

“designated laboratory” has the meaning assigned to it by Regulation 17(1);

“the Directives” means the framework Directive and the implementing Directive;

“framework Directive” means Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation;

“food irradiation licence” has the meaning assigned to it by Regulation 11;

“functions” includes powers and duties and references to the performance of functions include references to the exercise of powers and the performance of duties;

“health board” means -

• (a) a board established under section 4 of the Health Act, 1970 (No. 1 of 1970), or

• (b) the Eastern Regional Health Authority established under section 7 of the Health (Eastern Regional Health Authority) Act, 1999 (No. 13 of 1999);

“implementing Directive” means Directive 1999/3/EC of the European Parliament and of the Council of 22 February 1999 on the establishment of a Community list of foods and food ingredients treated with ionising radiation;

“inspector” means an inspector appointed under section 28 of the Act of 1991;

“Institute” means the Radiological Protection Institute of Ireland;

“permit” has the meaning assigned to it by Regulation 12;

“place on the market” means—

• (a) import,

• (b) sell,

• (c) offer or expose for sale,

• (d) invite the making by a person of an offer to purchase,

• (e) distribute free of charge, or

• (f) in the case of a person who treats a foodstuff with ionising radiation, supply for any of those purposes,

and cognate words shall be construed accordingly;

• (2) A word of expression that is used in these Regulations and that is also used in the Directives has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directives;

• (3)
• (a) A reference in these Regulations to a Regulation is to a Regulation of these Regulations, unless it is indicated that reference to some other Regulation is intended;

• (b) A reference in these Regulations to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended.

3.

4.

• (2) Foodstuffs shall, when being treated with ionising radiation, be in a suitably wholesome state.

• (3) A person who contravenes this Regulation shall be guilty of an offence.

5.

• (2) A person who treats a foodstuff, other than one specified in the implementing Directive, with ionising radiation shall be guilty of an offence.

• (3) A person who places on the market, or has in his or her possession for the purpose of placing on the market, a foodstuff in respect of which the overall average absorbed radiation dose exceeds that specified in the implementing Directive shall be guilty of an offence.

• (4) A person who treats with ionising radiation a foodstuff that has already been subjected to chemical treatment for the same purpose as that for which it is treated with such ionising radiation shall be guilty of an offence.

6.

7.

• (a) Article 8 of the framework Directive, or

• (b) the rules for the application of that Article adopted in accordance with Article 12 of that Directive.

8.

9.

10.

• (2) A person shall not place on the market, or have in his or her possession for the purpose of placing on the market, a foodstuff in respect of which there has been a contravention of paragraph (1).

• (3) A person who contravenes this Regulation shall be guilty of an offence.

11.

• (2) An application under paragraph (1) shall be in such form as may be determined by the Institute, and shall be accompanied by such fee as may be so determined, being not more than such amount as is equal to the expense that the Institute is likely to incur in considering the application concerned including the expense incurred in the carrying out of inspections (if any) of the irradiation facility concerned for the purpose of fully considering the application (hereafter in this Regulation referred to as the “appropriate fee”).

• (3) The Institute may require an applicant for a food irradiation licence to provide it with such further information or documentation as may reasonably be necessary to enable it to perform its functions under this Regulation.

• (4) Upon receipt of an application under this Regulation and the appropriate fee the Institute shall, not later than 3 months from the date of its receiving the application concerned, grant to the applicant a licence authorising, subject to his or her being granted a permit, the carrying on of the business of irradiating foodstuffs at such irradiation facility as is specified in the licence (in these Regulations referred to as a “food irradiation licence”) for such period as is so specified, being a period of not more than 3 years commencing on the date of the grant of such licence, where it is satisfied that—

• (a) there is in force in respect of the irradiation facility to which the application relates a licence granted by the Institute under the Radiological Protection Act, 1991 (Ionising Radiation) Order, 2000, to the applicant,

• (b) in relation to that facility, there is compliance with—

• (i) the provisions of the Codex Alimentarius, and

• (ii) any supplementary requirements referred to in the 1st indent of Article 7.2 of the framework Directive, relating to the matters specified in the Schedule to these Regulations.

• (5) The Institute may, for the purposes of Article 3 of the framework Directive, attach such conditions as it considers appropriate to a food irradiation licence.

• (6) Notwithstanding paragraph (4), the Institute may refuse to grant a food irradiation licence where—

• (a) the applicant concerned fails or refuses to comply with a requirement under paragraph (3),

• (b) the applicant concerned has been convicted of an offence under these Regulations, or

• (c) a food irradiation licence previously granted to him or her was revoked or stands revoked.

• (7) Where, upon consideration of an application under paragraph (1), the Institute refuses to grant a food irradiation licence, or grants a food irradiation licence subject to conditions, the Institute shall so inform the applicant concerned by notice in writing.

• (8) The Institute may revoke a food irradiation licence where—

• (a) in respect of the irradiation facility concerned there is a failure to comply with the provisions or supplementary requirements referred to in paragraph (4) (b),

• (b) there is a contravention of a condition attached to the licence concerned under paragraph (5), or

• (c) the person to whom the food irradiation licence is granted is convicted of an offence under these Regulations.

• (9) A food Irradiation licence shall stand revoked where the licence referred to in paragraph (4) (a) is revoked or otherwise ceases to be in force.

• (10) Where the Institute revokes a food irradiation licence under paragraph (8) it shall so inform the person to whom the food irradiation licence was granted by notice in writing.

12.

• (2) An application under paragraph (1) shall be in such form as may be determined by the Authority and shall be accompanied by such fee as may be so determined, being not more than such amount as is equal to the expense that the Authority is likely to incur in considering the application concerned including the expense incurred in carrying out inspections (if any) of the irradiation facility concerned for the purpose of fully considering the application (hereafter in this Regulation referred to as the “appropriate fee”).

• (3) The Authority may require an applicant for a permit to provide it with such further information or documentation as may reasonably be necessary to enable it to perform its functions under this Regulation.

• (4) Upon receipt of an application under this Regulation and the appropriate fee the Authority shall, not later than one month from the date of its receiving the application concerned, grant to the applicant a permit authorising the carrying on of the business of irradiating foodstuffs at such irradiating facility as is specified in the permit (in these Regulations referred to as a “permit”), for such period as is so specified, being a period of not more than 3 years commencing on the date of the grant of such permit, where it is satisfied that—

• (a) there is in force in respect of the irradiation facility to which the application relates a food irradiation licence granted to the applicant,

• (b) in relation to that facility there is compliance with the provisions of—

• (i) the European Communities (Official Control of Foodstuffs) Regulations, 1998 ( S.I. No. 85 of 1998 ),

• (ii) the European Communities (Hygiene of Foodstuffs) Regulations, 2000 ( S.I. No. 165 of 2000 ),

• (iii) the Codex Alimentarius (other than those provisions to which Regulation 11(4) (b) (i) relates), and

• (c) any supplementary requirements referred to in the first indent of Article 7.2 of the framework Directive (other than those to which Regulation 11(4) (b) (ii) relates).

• (5) The Authority may, for the purposes of Article 3 of the framework Directive, attach such conditions as it considers appropriate to a permit.

• (6) Notwithstanding paragraph (4), the Authority may refuse to grant a permit under this Regulation where—

• (a) the applicant concerned fails or refuses to comply with a requirement under paragraph (3),

• (b) the applicant concerned has been convicted of an offence under these Regulations, or

• (c) a permit previously granted to him or her was revoked or stands revoked

• (7) Where, upon consideration of an application under paragraph (1), the Authority refuses to grant a permit, or grants a permit subject to conditions, the Authority shall so inform the applicant concerned by notice in writing.

• (8) The Authority may revoke a permit where—

• (a) in respect of the irradiation facility concerned there is a failure to comply with the provisions referred to in paragraph (4) (b) or the supplementary requirements referred to in paragraph (4) (c),

• (b) there is a contravention of a condition attached to the permit concerned under paragraph (5), or

• (c) the person to whom the permit is granted is convicted of an offence under these Regulations.

• (9) A permit shall stand revoked where the food irradiation licence granted in respect of the irradiation facility concerned is revoked or otherwise ceases to be in force.

• (10) Where the Authority revokes a permit under paragraph (8) it shall so inform the person to whom the permit was granted by notice in writing.

13.

• (a) not later than 3 weeks after receiving notice of the refusal or such later date as may be permitted by the court, or

• (b) in the case of a grant of a food irradiation licence subject to conditions, not later than 3 weeks after receiving notice of the conditions to which the food irradiation licence is subject, or such later date as may be so permitted,

appeal to the court for an order directing the Institute to—

• (i) grant a food irradiation licence to the applicant, or

• (ii) remove any one or more of such conditions,

as may be appropriate.

• (2) Where the Authority, upon consideration of an application under Regulation 12(1), refuses to grant, or grants subject to conditions, a permit, the applicant concerned may—

• (a) not later than 3 weeks after receiving notice of the refusal, or such later date as may be permitted by the court,

• (b) or in the case of a grant of a permit subject to conditions, not later than 3 weeks after receiving notice of the conditions to which the permit is subject, or such later date as may be so permitted, appeal to the court for an order directing the Authority to—

• (i) grant a permit to the applicant, or

• (ii) remove any one or more of such conditions,

as may be appropriate.

• (3) The court may upon the hearing of an appeal under this Regulation—

• (a) affirm the refusal by the Institute or Authority, as the case may be,

• (b) in the case of a refusal by the Institute to grant the applicant a food irradiation licence, direct the Institute to grant the applicant such a licence, subject to such conditions (if any) as may be specified by the court,

• (c) in the case of a refusal by the Authority to grant the applicant a permit, direct the Authority to grant the applicant a permit, subject to such conditions (if any) as may be specified by the court, or

• (d) in the case of an appeal against the attachment of conditions to a food irradiation licence or a permit—

• (i) affirm the decision of the Institute or Authority, as may be appropriate, to so attach such conditions, or

• (ii) direct the Institute or Authority, as may be appropriate, to remove such conditions as the court may specify.

• (4) The Institute or Authority, as the case may be, shall comply with a direction of the court under this Regulation.

• (5) In this Regulation “the court” means the Circuit Court for the circuit in which the irradiation facility to which the appeal relates is situated.

14.

15.

• (a) at all reasonable times enter, subject to paragraph (2), any premises at which he or she has reasonable grounds for believing that—

• (i) foodstuffs are being, or have been, treated with ionising radiation,

• (ii) any trade, business or activity connected with the irradiation of foodstuffs, or the production, processing, disposal, manufacture, placing on the market, storage or labelling of any foodstuff treated with ionising radiation, is or has been carried on, or

• (iii) records relating to such trade, business or activity are kept,

• (b) at such premises inspect and take copies of, any books, records, other documents (including documents stored in non-legible form) or extracts therefrom which he or she finds in the course of his or her inspection,

• (c) carry out or have carried out such examinations, tests, inspections and checks of—

• (i) the premises,

• (ii) any foodstuff, article or substance used in the treatment of foodstuffs with ionising radiation, or the manufacture, processing or storage of foodstuffs, at the premises, or

• (iii) any equipment, machinery or plant at the premises,

as he or she reasonably considers to be necessary for the purposes of his or her functions under these Regulations or the Directives,

• (d) require any person at the premises or the owner or person in charge of the premises and any person employed there to give to him or her such assistance and information and to produce to him or her such books, documents or other records (and in the case of documents or records stored in non-legible form produce to him or her a legible reproduction thereof) that are in that person's power or procurement, as he or she may reasonably require for the purposes of his or her functions under these Regulations or the Directives,

• (e) take samples of foodstuffs found at the premises for the purposes of analysis and examination,

• (f) direct that such foodstuffs found at the premises as he or she, upon reasonable grounds, believes contravene a provision of these Regulations or the Directives not be placed on the market or moved from the premises without his or her consent,

• (g) secure for later inspection any premises or part of any premises in which a foodstuff, substance or article is found, or ordinarily kept, for such period as may reasonably be necessary for the purposes of these Regulations or the Directives, or

• (h) take possession of and remove from the premises for examination and analysis foodstuffs found there, and detain them for such period as he or she considers reasonably necessary for the purposes of his or her functions under these Regulations or the Directives.

• (2) An authorised officer or an inspector shall not enter a dwelling, other than—

• (a) with the consent of the occupier, or

• (b) in accordance with a warrant issued under paragraph (3).

• (3) On the application of an authorised officer or inspector, a judge of the District Court may, if satisfied that there are reasonable grounds for believing that—

• (a) a foodstuff is being or has been treated with ionising radiation in any dwelling, or is being, or has been, subjected to any process or stored in any dwelling,

• (b) books, records or other documents (including documents stored in non-legible form) relating to the treatment of foodstuffs with ionising radiation is or are being stored or kept in any dwelling, or

• (c) a dwelling is occupied in whole or in part by an undertaking engaged in the treatment of foodstuffs with ionising radiation, or the processing or placing on the market of foodstuffs so treated,

issue a warrant authorising a named authorised officer or inspector accompanied by such other authorised officers or inspectors as may be necessary, at any time or times, within one month of the date of issue of the warrant, to enter the dwelling and perform the functions of an authorised officer or inspector under subparagraphs (b), (c), (d), (e), (f), (g) and (h) of paragraph (1), and, in the case of an inspector, the functions of an inspector referred to in paragraph (4).

• (4) An inspector may, for the purposes of these Regulations and the Directives, perform any or all of the functions of an inspector under section 29 of the Act of 1991, and the provisions of the said section 29 shall apply accordingly.

• (5) Any person who obstructs or interferes with an authorised officer or inspector in the course of exercising a power conferred on him or her by these Regulations or impedes the exercise by the officer or inspector, as the case may be, of such power or fails or refuses to comply with a request made by, or to answer a question asked by, the officer or inspector pursuant to these Regulations, or in purported compliance with such request or in answer to such question gives information to the officer or inspector that he or she knows to be false or misleading in any material respect, shall be guilty of an offence.

• (6) In this Regulation “premises” means any place, ship or other vessel, aircraft, railway wagon or other vehicle, and includes a container used to transport foodstuffs.

16.

• (2) Where an authorised officer has complied with paragraph (1) he or she shall—

• (a) offer one of the sealed containers to the owner or person for the time being in charge or possession of the foodstuff from which the sample concerned was taken,

• (b) retain one of the said sealed containers, and

• (c) forward, or cause to be forwarded, one of the sealed containers to a designated laboratory for the purposes of analysis.

• (3) Where a foodstuff is contained in an impermeable container and its division into parts is (for whatever reason) not practicable, an authorised officer, who wishes to take samples of such foodstuff for the purpose of analysis, shall, for that purpose, take possession of 3 of such containers belonging to the same batch, and each such container of foodstuff shall for the purposes of paragraph (1) be deemed to be part of a sample for the purposes of paragraph (1), and the provision of paragraphs (1) and (2) shall apply thereto accordingly.

• (4) In this Regulation “impermeable container” means a container so constructed as to prevent the adulteration, contamination or infection of the foodstuff concerned while it is in that container.

17.

• (2) As soon as practicable after a sample taken by an authorised officer under Regulation 15 has been received at a designated laboratory it shall be analysed by a person referred to in paragraph (1).

• (3) In proceedings for an offence under these Regulations, a certificate purporting to be signed by a person employed, or engaged in the analysis of samples, at a designated laboratory stating the capacity in which that person is so employed or engaged and stating any one or more of the following namely—

• (a) that the person received a sample submitted to the designated laboratory concerned,

• (b) that, for such period as is specified in the certificate, the person had in his or her custody the sample so submitted,

• (c) that the person gave to such other person as is specified in the certificate the sample so submitted,

• (d) that the person carried out any procedure for the purpose of detecting the overall average absorbed radiation dose in the sample so submitted, or

• (e) that the sample concerned was found to have an overall average absorbed radiation dose of such amount as is specified in the certificate,

shall unless the contrary is proved, be evidence of the matters stated in the certificate.

• (4) In proceedings for an offence under these Regulations the court may, if it considers that the interests of justice so require, direct that oral evidence of the matters stated in a certificate under this Regulation be given, and the court may, for the purposes of receiving such oral evidence, adjourn the proceedings to a later date.

18.

• (2) Any person who alters with intent to defraud or deceive, or who utters knowing it to be so altered, a food irradiation licence, permit, certificate or other document issued, granted or given under these Regulations (hereafter in this Regulation referred to as “an altered document”), shall be guilty of an offence.

• (3) Any person who, without lawful authority, has in his or her possession a forged document or an altered document shall be guilty of an offence.

• (4) Any person who, with intent to defraud or deceive—

• (a) tampers with anything so as to procure that any sample taken pursuant to these Regulations does not correctly represent the substance sampled, or

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

shall be guilty of an offence.

19.

• (a) by delivering it to the person,

• (b) by leaving it at the address at which the person ordinarily resides or, in a case in which an address for service has been furnished, at that address,

• (c) by sending it by post in a prepaid registered letter to the address at which the person ordinarily resides or, in a case in which an address for service has been furnished, to that address,

• (d) where the address at which the person ordinarily resides cannot be ascertained by reasonable inquiry and the notice, direction or other document relates to land, by delivering it to some person over 16 years of age resident or employed on the land or by affixing it in a conspicuous position on or near the land.

• (2) It shall not be lawful for a person at any time during the period of 12 months after a direction or other document is affixed under paragraph (d) of paragraph (1) to remove, damage or deface the notice, direction or other document without lawful authority.

• (3) For the purposes of this Regulation, a company within the meaning of the Companies Acts, 1963 to 1999, shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or place of business.

20.

• (2) A person guilty of an offence under section 29 of the Act of 1991 by virtue of Regulation 15(4) shall be liable on summary conviction to a fine not exceeding £1,500 or a term of imprisonment not exceeding 6 months, or to both, and accordingly the provisions of section 40(2) of that Act shall not apply.

• (3) Where an offence under these Regulations is committed by a body corporate and is proved to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of any person being a director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in any such capacity, that person shall be guilty of an offence and shall be liable to be proceeded against and punished as if he or she were guilty of the first-mentioned offence.

• (4) Summary proceedings for an offence under these Regulations may be brought and prosecuted by the Institute, the Authority or, in the case of an offence committed, or alleged to have been committed, within the functional area of a health board, the health board concerned.

21.

SCHEDULE Matters to which Regulation 11(4)(b) relates

• (a) the particular foodstuffs to be irradiated;

• (b) the beam power of the machinery or apparatus intended to be used to irradiate the foodstuffs concerned;

• (c) the setting of the machine parameters on the machine or apparatus intended to be used to irradiate the foodstuffs concerned;

• (d) the likely distribution of the dose of ionising radiation;

• (e) the dosimetry measurement system;

• (f) the testing and commissioning requirements in relation to the administration to foodstuffs of ionising radiation;

• (g) maintenance of records relating to the matters specified in paragraphs (a), (b), (c), (d), (e) and (f).

	GIVEN under my Official Seal, this 20th day of September, 2000.
	MICHEÁL MARTIN,
	Minister for Health and Children.

EXPLANATORY NOTE.

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

These Regulations give effect to Directive 1999/2/EC (the framework Directive) of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation and Directive 1999/3/EC (the implementing Directive) of the European Parliament and of the Council of 22 February 1999 on the establishment of a Community list of foods and food ingredients treated with ionising radiation.

The effect of these Regulations is to lay down the general provisions for the treatment of foodstuffs with ionising radiation. Provisions concerning the approval and control of irradiation facilities and rules on labelling are also included.

A positive list of foodstuffs authorised for treatment with ionising radiation and their maximum radiation doses are defined in the implementing Directive.

These Regulations should be read together with the two Directives.

Footnotes