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The Production of Bovine Collagen Intended for Human Consumption in the United Kingdom (Scotland) Regulations 2005

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Regulation 6

SCHEDULE

PART 1General provisions

Raw materials and establishments supplying raw materials

1.—(1) Only the hides and skins of bovine animals may, subject to sub-paragraph (2), be used as raw materials for the production of collagen intended for human consumption in the United Kingdom.

(2) The use as raw materials of hides and skins submitted to tanning processes is prohibited.

(3) Raw materials shall be derived from bovine animals which have been slaughtered in a slaughterhouse and whose meat can be legally sold for human consumption.

(4) Raw materials shall be derived from bovine animals which have been found fit for human consumption following ante and post mortem inspection and that fact shall be certified in the commercial document referred to in paragraph 2(5) below.

(5) Raw materials shall come from slaughterhouses, collection centres or tanneries.

(6) Collection centres and tanneries supplying raw materials shall be authorised under regulation 4 of the Collagen and Gelatine (Intra–Community Trade) (Scotland) (No. 2) Regulations 2003(1).

(7) If raw material not in conformity with sub paragraphs (1) to (6) above is stored and/or processed in collection centres or tanneries supplying raw material for the purposes of these Regulations, it must be segregated throughout the period of receipt, storage, processing and dispatch from raw material in conformity with sub-paragraphs (1) to (6) above.

Transport and storage of raw materials

2.—(1) Raw materials destined for the production of collagen shall be transported under clean conditions using appropriate means of transport.

(2) Subject to sub paragraph (3) raw materials shall be transported and stored in a chilled or frozen state, unless they are processed within 24 hours of their dispatch.

(3) 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) Storage rooms shall be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the raw materials.

(5) During transportation and at the time of delivery at collection centres and establishments producing collagen, raw materials shall be accompanied by a commercial document in accordance with the model laid down in Part 2 of this Schedule.

Establishments producing collagen

3.—(1) The production of collagen intended for human consumption shall take place in an establishment authorised under regulation 5 of the Collagen and Gelatine (Intra–Community Trade) (Scotland) (No. 2) Regulations 2003.

(2) There shall be implemented at the establishment a system that makes it possible to link each production batch dispatched with the associated incoming raw material consignments, the production conditions and the time of production.

Manufacture of collagen

4.—(1) Collagen shall 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 with the appropriate Scientific Committee.

(2) Collagen produced in accordance with sub paragraph (1) shall not undergo further processing other than a drying process.

(3) Collagen not intended for human consumption shall not be produced and stored in the same establishment as collagen intended for human consumption unless the collagen not intended for human consumption is produced and stored under the same conditions as set out in this Schedule.

(4) The use of preservatives other than those permitted under European Parliament and Council Directive 95/2/EC on food additives other than colours and sweeteners(2) (as that Directive is amended as at the date these Regulations are made) is prohibited.

Finished products

5.—(1) Appropriate measures, including tests, shall be carried out to ensure that, subject to sub paragraph (2), each production batch of collagen meets the microbiological and residues criteria set in the Table in Part 3 of this Schedule.

(2) Where the nature of a finished product is such that it would be inappropriate to require it to comply with the moisture and ash limits specified in Part 3 of this Schedule, those limits shall not apply to that product.

Wrapping, packaging, storage and transport

6.—(1) Collagen intended for human consumption must be wrapped, packaged, stored and transported under satisfactory hygiene conditions, and in particular–

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

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

(2) Wrappings and packages containing collagen must–

(a)bear an identification mark containing the name “United Kingdom” or initial letters “UK” followed by the registration number of the establishment and the initials “EC”;

(b)carry the words “Collagen fit for human consumption in the United Kingdom”; and

(c)bear the date of preparation and the batch number.

(3) Collagen must be accompanied during transportation by a commercial document which must bear–

(a)the words “Collagen fit for human consumption in the United Kingdom”; and

(b)the date of preparation and the batch number.

PART 2

Commercial document to accompany raw materials derived from bovine animals destined for the production of collagen intended for human consumption in the United Kingdom

PART 3Microbiological and residues criteria for collagen intended for human consumption

Microbiological criteria

Microbiological parametersLimit
Total aerobic bacteria103/g
Coliforms (30°C)0/g
Coliforms (44.5°C)0/10g
Anaerobic sulphite–reducing bacteria (no gas production)10/g
Clostridium perfringens0/g
Staphylococcus aureus0/g
Salmonella0/25g

Residues

ElementsLimit
As1 ppm
Pb5 ppm
Cd0.5 ppm
Hg0.15 ppm
Cr10 ppm
Cu30 ppm
Zn50 ppm
Moisture (105°C)15%
Ash (550°C)2%
SO2 (Reith Williems)50 ppm
H2O2 (European Pharmacopia 1986 (V2O2))10 ppm
(2)

O.J. No. L 161, 18.3.95, p.1 as last amended by Regulation (EC) No. 1882/2003 (O.J. No. L 284, 31.10.2003 p.1).

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