S.I. No. 4/2002 - European Communities (Gelatine) Regulations, 2002

I, Joe Walsh, Minister for Agriculture, Food and Rural Development, 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 Commission Decision No. 1999/724/EC¹ of 28 October 1999, hereby make the following Regulations:-

1. (1) These Regulations may be cited as the European Communities (Gelatine) Regulations, 2002.

(2) These Regulations shall come into operation on the 14th day of January, 2002.

2. (1) In these Regulations -

“authorised officer” means a person who, for the time being, stands appointed under Regulation 12 or an inspector;

“the Commission Decision” means Commission Decision No. 1999/724/EC of 28 October 1999;

“inspector” means an inspector within the meaning of the Diseases of Animals Act, 1966 (No. 6 of 1966);

“Member State” means a Member State of the European Communities;

“the Minister” means the Minister for Agriculture, Food and Rural Development;

“third Country” means a country that is not a Member State of the European Communities.

(2) In these Regulations -

(a) a reference to a Regulation is to a Regulation of these Regulations, unless it appears that reference to some other provision is intended;

(b) a reference to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs unless it appears that reference to some other provision is intended.

(3) A word or expression that is used in these Regulations and is also used in the Commission Decision has, unless the contrary intention appears the meaning in these Regulations that it has in the Commission Decision.

3. (1) A person shall not produce, place on the market or import gelatine intended for human consumption other than in compliance with these Regulations.

(2) The requirements of these Regulations shall not apply to gelatine destined for pharmaceutical, cosmetic or other technical uses and medical devices.

4. The Minister may, on application, authorise and register an establishment for the production of gelatine for human consumption in accordance with the provision of the European Communities (Meat Products and other Products of Animal Origin) Regulations, 1995 ( S.I. No. 126 of 1995 ) where the Minister is satisfied that such an establishment meets -

(a) the conditions for establishments producing gelatine laid down in Regulation 6;

(b) the requirements for raw materials to be used for the production of gelatine set down in Regulation 7;

(c) the standards for the transport and storage of raw materials destined for the production of gelatine set down in Regulation 9;

(d) the processing requirements for the manufacture of gelatine and the microbiological criteria and residue limits laid down in Regulation 10;

(e) the packaging, storing and transport conditions for gelatine laid down in Regulation 11.

5. (1) Gelatine intended for human consumption may only be produced in a premises authorised by the Minister in accordance with Regulation 4.

(2) Gelatine intended for human consumption may only to be placed on the market having met the requirements set down in Regulations 6, 7 9, 10 and 11.

(3) Gelatine produced in a third country and destined for human consumption may only be imported in compliance with the requirements of Paragraph II.9 and Paragraph VII of the Annex to the Commission Decision.

6. Gelatine intended for human consumption shall come from establishments which -

(a) comply with the conditions laid down in Parts I, II, V, VI, VII, VIII, IX and X of the Second Schedule to the European Communities (Hygiene of Foodstuffs) Regulations, 2000 ( S.I. No. 165 of 2000 );

(b) are authorised by the Minister in accordance with the provisions of the European Communities (Meat Products and other Products of Animal Origin) Regulations, 1995 ( S.I. No. 126 of 1995 );

(c) are subject to supervision of production under the conditions set out in Chapter IV of the Second Schedule to the European Communities (Meat Products and other Products of Animal Origin) Regulations 1995 ( S.I. No. 126 of 1995 );

(d) carry out an own checks programme in accordance with the terms of Regulation 12 of the European Communities (Meat Products and other Products of Animal Origin) Regulations, 1995 ( S.I. No. 126 of 1995 );

(e) keep records for two years, for examination, upon request of an authorised officer, on all sources of incoming raw material and on all outgoing products;

(f) introduce and implement, to the satisfaction of an authorised officer, a system that makes it possible to link each production batch dispatched the incoming raw material consignments, the production conditions and the time of production.

7. (1) Gelatine intended for human consumption shall be produced from the following raw materials -

(a) bones;

(b) hides and skins of farmed ruminant animals;

(d) poultry skin;

(e) tendons and sinews;

(f) wild game hides and skins;

(g) fish skin and bones.

(2) The use of bones obtained from ruminant animals born, reared or slaughtered in category 4 countries or regions, as defined in the Commission Decision, is prohibited.

(3) The use of hides and skins submitted to tanning processes is prohibited.

(4) Raw materials listed in subparagraphs (1)(a) to (e) shall be derived from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption by an official veterinarian following ante and post mortem inspection.

(5) Raw materials listed in subparagraph (1)(f) shall be derived from animals whose carcases have been found fit for human consumption following the inspections laid down in the European Communities (Wild Game) Regulations, 1995 ( S.I. No. 298 of 1995 ).

(6) Raw materials listed in subparagraphs (1)(a) to (f) shall come from slaughterhouses, cutting plants, meat processing establishments, wild game processing houses, bone degreasing plants, tanneries, collection centres, retail shops, or premises adjacent to sales points where the cutting and the storage of meat and poultry meat is performed for the sole purpose of supplying the final consumer directly.

(7) Raw material listed in subparagraph (1)(g) shall come from plants manufacturing fish products for human consumption and shall be specifically approved in accordance with the European Communities (Fishery Products) (Health Conditions and Hygiene Rules for Production and Placing on the Market) Regulations, 1996 ( S.I. No. 170 of 1996 ).

8. (1) Collection centres and tanneries intending to supply raw material for the production of gelatine intended for human consumption shall be authorised and registered by the Minister for this purpose. The Minister may, on application by the owner or person in charge authorise a collection centre or tannery provided he is satisfied that the centre or tannery can fulfil the following requirements -

(a) it must have storage rooms with hard floors and smooth walls which are easy to clean and disinfect;

(b) where appropriate, and in the opinion of an authorised officer the centre or tannery must be provided with refrigeration facilities;

(c) the storage rooms must be kept in a satisfactory state of cleanliness and repair, so they do not constitute a source of contamination for the raw materials;

(d) if raw materials not in conformity with this Regulation are stored or processed in these premises, they must be segregated to the satisfaction of an authorised officer, throughout the period of receipt, storage, processing and dispatch from raw materials to be processed in conformity with this Regulation.

(2) The owner or person in charge of the tannery or collection centre must retain all accounting documents, commercial documents and health certificates for a period of two years to allow, upon request, for the examination of such documents or certificates by an authorised officer to enable the origin of the raw materials to be traced.

(3) The Minister may, if he is not satisfied that the provisions of these Regulations are being or have been complied with by a person granted an authorisation under this Regulation or will be complied with by an applicant for such an authorisation, revoke the authorisation or refuse to grant such an authorisation.

(4) Where the Minister proposes to revoke an authorisation granted under this Regulation or refuse to grant such an authorisation, he shall —

(a) notify the person concerned in writing of the proposal and the reasons therefor,

(b) notify the person in writing that he, or a person acting on his behalf, may make representations to the Minister in relation to the proposal within 14 days of the receipt by him of the notification, and

9. (1) The transport of raw materials destined for the production of gelatine must be carried out under clean conditions using appropriate means of transport. During transportation, at the time of delivery in the collection centre or tannery and in the gelatine processing establishment, raw materials must be accompanied by the commercial document set out in the Schedule.

(2) Raw materials must be transported and stored chilled or frozen, unless they are processed within 24 hours after their departure.

(3) By way of derogation from the provisions of paragraph (2), degreased and dried bones or ossein, salted, dried and limed hides and skins and hides and skins treated with alkali or acid may be transported and stored at ambient temperature.

(4) The storage rooms must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the raw materials.

10. Gelatine intended for human production shall be subjected to a process as set down in Paragraph IV of the Annex to the Commission Decision. The finished product shall be subjected to the tests to meet the microbiological criteria and residues limits set out in Paragraph V of the Annex to the Commission Decision.

11. (1) Gelatine intended for human consumption must be wrapped, packaged stored and transported under satisfactory hygiene conditions, in particular -

(a) a room must be provided for storing, wrapping and packaging materials,

(b) wrapping and packaging must take place in a room or in a place intended for that purpose.

(2) Wrapping and packaging containing gelatine must bear an identification mark showing the letters “IRL” in printed capitals, the registration number of the establishment and the set of initials “EC” and must carry the words “Gelatine for human consumption”.

(3) Gelatine must be accompanied during transport by a commercial document in compliance with the provisions of the European Communities (Meat Products and other Products of Animal Origin Regulations, 1995 ( S.I. No. 126 of 1995 ) which must bear the words “Gelatine for human consumption” and the date of preparation.

12. (1) The Minister may appoint such and so many persons as he thinks fit to be authorised officers for the purposes of these Regulations.

(2) An inspector or an authorised officer, when exercising any power conferred on him for the purposes of these Regulations, shall, if so requested by any person affected, produce evidence in writing of his appointment as an authorised officer or inspector.

13. (1) An authorised officer may for the purposes of these Regulations or the Commission Decision -

(a) at all reasonable times, enter any premises or place, and any vehicle, wagon, vessel or other means of transport (other than any premises, place or means of transport consisting of a dwelling or other than so much thereof as consists of a dwelling) where he reasonably suspects that any animal product or document which he considers should be examined or inspected for the purposes of his functions under these Regulations is to be found,

(b) there or at any other place, examine and inspect any animal product or document and in the case of an animal, an inspector may carry out a clinical inspection thereof,

(c) take, without payment of compensation, such samples of any product at the premises or place or on or in the means of transport as he may reasonably require for the purposes of his functions under these Regulations and carry out or have carried out on the samples such analyses, examinations, checks and inspections as he considers necessary or expedient for the purposes of such functions,

(d) there or at any other place, carry out or have carried out such examinations, checks and inspections of the premises, place or means of transport and any equipment, machinery or plant and any product found there as he reasonably considers necessary or expedient for the purposes of such functions,

(e) require any person at the premises or place or on or in the means of transport and the owner or person in charge thereof and any person employed in connection therewith to give to him such information and to produce to him such books certificates, documents and other records, including any records required to be kept by these Regulations, within the power or procurement of the person as he may reasonably require for the purposes of his functions under these Regulations,

(f) examine and take copies of, or of extracts from, any such records as aforesaid,

(g) seize and detain anything found there which he reasonably believes to be evidence of an offence under these Regulations.

(2) A person shall not, in purported compliance with a requirement under paragraph (1)(e) above, give information to an authorised officer that he knows to be false or misleading in a material respect.

14. (1) A person who contravenes a provision of these Regulations shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding €1,900 or to imprisonment for a term not exceeding six months or to both.

(2) A person shall not obstruct or impede an authorised officer in the due exercise of any of the functions of the officer under these Regulations.

(3) Where an offence under these Regulations is committed by a body corporate and is proven 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, as well as the body corporate, shall be guilty of an offence and shall be liable to be proceeded against and punished as if he were guilty of the first-mentioned offence.

15. An offence under these Regulations may be prosecuted by the Minister.

16. These Regulations are in addition to and not in substitution for the European Communities (Meat Products and other Products of Animal Origin Regulations, 1995 ( S.I. No. 126 of 1995 ).

SCHEDULE

Model of commercial document for raw material destined to the production of gelatine for human consumption

COMMERCIAL DOCUMENT

For raw material destined to the production of gelatine for human consumption

Number of the commercial document ............................................................ ............................................................ ............

I. Identification of the raw material

Nature of the raw material: ............................................................ ............................................................ ..................

Raw material derived from the following animal species: ............................................................ ...................................

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

Net weight: ............................................................ ............................................................ .........................................

Identification mark (pallet or container): ............................................................ ...........................................................

II. Origin of the raw material (² )

Slaughterhouse