Commission Decision

of 10 January 2003

amending Council Directive 92/118/EEC as regards requirements for collagen

(notified under document number C(2002) 5557)

(Text with EEA relevance)

(2003/42/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC(1), as last amended by Directive 2002/33/EC of the European Parliament and of the Council(2), and in particular the second paragraph of Article 15 thereof,

Whereas:

(1) Specific public health conditions for the preparation of collagen intended for human consumption should be laid down. Provided that these conditions are the same for collagen intended for human consumption and collagen not intended for human consumption, and provided that hygiene conditions are also the same, it should be possible to produce and/or store both types of collagen in the same establishment.

(2) The authorisation and registration, inspection and hygiene conditions for the establishments preparing collagen should be set. Certain health conditions contained in Council Directive 77/99/EEC of 21 December 1976 on health problems affecting the production and marketing of meat products and certain other products of animal origin(3), as last amended by Directive 97/76/EC(4), and in Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs(5), are relevant for the preparation of collagen.

(3) Article 2.3.13.7 of the International Animal Health Code (2001) issued by the International Office of Epizootics on BSE recommends that if gelatine and collagen are prepared exclusively from hides and skins, veterinary administrations should authorise their import and transit through their territories without restriction, regardless of the status of the exporting countries.

(4) Under Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(6), as last amended by Commission Regulation (EC) No 1494/2002(7), hides and skins within the meaning of Directive 92/118/EEC, derived from healthy ruminants and collagen derived from such hides and skins are not subject to restrictions on placing on the market.

(5) The Scientific Steering Committee adopted an opinion on the safety of collagen on 10 and 11 May 2001, addressing the question of the safety in relation to transmissible spongiform encephalopathies (hereinafter TSE) of collagen produced from ruminant hides.

(6) The raw material used for the production of collagen consists mainly of bovine connective tissue of hides and tendons, calf skins, sheep skins and pig skins. To ensure the safety of the raw material, it must derive from animals that pass ante and post-mortem inspections as fit for human consumption. Such material must also be collected, transported, stored and handled in the most hygienic ways possible.

(7) To guarantee traceability of the raw material, collection centres and tanneries, which intend to supply the raw material, should be authorised and registered. A model commercial document should also be prescribed to accompany the raw material during transportation and at time of delivery to the collection centres, tanneries and collagen processing plants.

(8) It is appropriate to amend the current commercial document for raw material destined for the production of gelatine for human consumption, to take into account particulars in relation to control procedures in certain Member States.

(9) The standards for the finished product should be fixed to ensure that it is not contaminated with substances or micro-organisms presenting a risk to consumer health. Pending a scientific evaluation of such standards, it is appropriate to include, on a provisional basis, generally accepted standards as regards contamination. The requirements for packaging, storage and transport of the finished product should also be laid down.

(10) It is necessary to lay down specific health rules for the importation of collagen and raw material destined for the production of collagen intended for human consumption. Specimens of health certificates to accompany the imported collagen and raw material destined for the production of collagen for human consumption should be drawn up. It is also necessary for the Commission to recognise conditions offering equivalent guarantees based on a proposal submitted by a third country.

(11) The adoption of specific rules for the production of collagen should be without prejudice to the adoption of rules for the prevention and control of TSE.

(12) Directive 92/118/EEC should therefore be amended accordingly.

(13) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Annex II to Directive 92/118/EEC is amended in accordance with the Annex to this Decision.

Article 2

This Decision shall apply from 30 June 2003.

It shall not apply to collagen intended for human consumption that was produced or imported before that date.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 10 January 2003.

For the Commission

David Byrne

Member of the Commission

(1) OJ L 62, 15.3.1993, p. 49.

(2) OJ L 315, 19.11.2002, p. 14.

(3) OJ L 26, 31.1.1977, p. 85.

(4) OJ L 10, 16.1.1998, p. 25.

(5) OJ L 175, 19.7.1993, p. 1.

(6) OJ L 147, 31.5.2001, p. 1.

(7) OJ L 225, 22.8.2002, p. 3.

ANNEX

Chapter 4 of Annex II to Directive 92/118/EEC is amended as follows:

1) The heading "Section A" is inserted before the title;

2) In Part VIII, point II, under the headings "Other animal products plant", "Centres of collection" and "Tannery", the second line is replaced by the following: "Registration number";

3) The following section B is added:

Section B

SPECIFIC HEALTH CONDITIONS FOR THE COLLAGEN INTENDED FOR HUMAN CONSUMPTION

I. General

1. This Section lays down the health conditions for putting on the market and imports of collagen intended for human consumption.

2. For the purposes of this Section, the definitions of "hides and skins" and "tanning" in section A shall apply.

The following definitions shall also apply:

(a) "collagen" means protein-based product derived from hides, skins and tendons of animals, including bones in the case of pigs, poultry and fish only, manufactured using the method set in Part V below;

(b) "collagen intended for human consumption" means collagen intended for consumption either as food or incorporated into or wrapped around food or product to be consumed by humans.

3. Collagen intended for human consumption shall comply with the conditions in Parts II to X below.

II. Establishments producing collagen

Collagen intended for human consumption shall come from establishments that fulfil the conditions in Part I of Section A.

III. Raw materials and establishments supplying them

1. The following raw materials may be used for the production of collagen intended for human consumption:

(a) hides and skins of farmed ruminant animals;

(b) pigskins, bones and intestines;

(c) poultry skin and bones;

(d) tendons;

(e) wild game hides and skins; and

(f) fish skin and bones.

2. The use of hides and skins submitted to tanning processes is prohibited.

3. The raw materials shall meet the following requirements:

- for the raw materials listed in paragraph 1(a) to (d) above, the requirements set in Paragraph 4 of Part II of Section A apply;

- for the raw material referred to in paragraph 1(e) above, the requirements set in paragraph 5 of Part II of Section A apply;

- for the raw materials listed in paragraph 1(a) to (e) above, the requirements set in paragraph 6 of Part II of Section A apply, except that no raw material shall come from plants degreasing ruminant bones; and

- for the raw material referred to in paragraph 1(f) above, the requirements set in paragraph 7 of Part II of Section A apply.

4. The collection centres and tanneries supplying the raw material for the production of collagen intended for human consumption shall be specifically authorised for the purpose and registered by the competent authorities and fulfil the requirements set in Paragraph 8 of Part II of Section A.

IV. Transport and storage of the raw material

1. Transport and storage of the raw material destined for the production of collagen shall be done in accordance with Part III of Section A.

2. During transportation and at the time of delivery at the collection centres, tanneries and collagen processing plants, raw materials must be accompanied by a commercial document in conformity with the model laid down in Part IX of this Section.

V. Manufacture of collagen

1. Collagen must be produced by a process that ensures that the raw material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion; or by an equivalent process approved by the Commission after consultation of the appropriate Scientific Committee.

2. After having been subjected to the process referred to at paragraph 1 above, collagen may undergo a drying process.

3. Collagen not intended for human consumption may be produced and stored in the same establishment as collagen intended for human consumption only if it is produced and stored using exactly the same conditions set in this Section.

4. The use of preservatives other than those permitted under Community legislation is prohibited.

VI. Finished products

Appropriate measures, including tests shall be carried out to ensure that each production batch of collagen meets the microbiological and residues criteria set in Part V of Section A, but where necessary to achieve desired products such as collagen-based casings, no moisture and ash limit shall apply.

VII. Packaging, storage and transport

1. Collagen intended for human consumption must be wrapped, packaged, stored and transported under satisfactory hygiene conditions and, in particular, fulfil the conditions set in paragraph 1 of Part VI of Section A.

2. Wrappings and packages containing collagen must bear an identification mark giving the particulars listed in the first indent of paragraph 2 of Part VI of Section A; and carry the words "Collagen fit for human consumption" and the date of preparation and the batch number.

3. During transportation collagen must be accompanied by a commercial document, in accordance with Article 3(A)(9)(a) of Directive 77/99/EEC, bearing the words "Collagen fit for human consumption" and the date of preparation and the batch number.

VIII. Import from third countries of collagen and raw materials intended for the production of collagen for human consumption

1. Member States shall authorise import into the Community of collagen intended for human consumption only if it:

(a) comes from third countries listed in Part XIII of the Annex to Commission Decision 94/278/EC(1);

(b) comes from establishments meeting the conditions laid down in Part II of this Section;

(c) has been produced from raw material that met the requirements of Parts III and IV of this Section;

(d) has been manufactured in compliance with the conditions set out in Part V of this Section;

(e) satisfies the criteria in Part VI and the wrapping, packaging, storage and transport conditions in Part VII(1) of this Section;

(f) bears on its wrappings and packages an identification mark giving the particulars specified in the sixth indent of Part VII(A) of Section A; and

(g) is accompanied by a health certificate that conforms to the model laid down in Part X(a) of this Section.

2. Member States shall authorise import into the Community of the raw material listed in Part III(1) of this Section for the production of collagen intended for human consumption only if:

(a) it comes from third countries listed in Council Decision 79/542/EEC(2) or in Commission Decision 94/85/EC(3) or in Decision 94/86/EC(4) or in Decision 97/296/EC(5), as appropriate; and

(b) a health certificate conforming to the model laid down in Part X(b) of this Section accompanies each consignment of the raw material.

3. The health certificates referred to in paragraphs 1(g) and 2(b) shall consist of one sheet, and shall be completed in at least one official language of the Member State through which the consignment first enters the Community, and in at least one official language of the Member State of destination.

4. The Commission may recognise, in accordance with the procedure of Article 18, the health measures applied by a third country for the production of collagen intended for human consumption as offering guarantees equivalent to those offered for putting collagen on the market in the Community, if the third country concerned supplies objective proof in this respect. When the Commission recognises such equivalence, it shall adopt in accordance with the same procedure, the conditions governing the importation of collagen for human consumption.

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(1) OJ L 120, 11.5.1994, p. 44.

(2) OJ L 146, 14.6.1979, p. 15.

(3) OJ L 44, 17.2.1994, p. 31.

(4) OJ L 44, 17.2.1994, p. 33.

(5) OJ L 122, 14.5.1997, p. 21.