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

© Crown Copyright 2005

Statutory Instruments printed from this website are printed under the superintendence and authority of the Controller of HMSO being the Queen's Printer of Acts of Parliament.

The legislation contained on this web site is subject to Crown Copyright protection. It may be reproduced free of charge provided that it is reproduced accurately and that the source and copyright status of the material is made evident to users.

It should be noted that the right to reproduce the text of Statutory Instruments does not extend to the Queen's Printer imprints which should be removed from any copies of the Statutory Instrument which are issued or made available to the public. This includes reproduction of the Statutory Instrument on the Internet and on intranet sites. The Royal Badge of Wales may be reproduced only where it is an integral part of the original document.

The text of this Internet version of the Statutory Instrument has been prepared to reflect the text as it was Made. A print version is also available and is published by The Stationery Office Limited as the The Production of Bovine Collagen Intended for Human Consumption in the United Kingdom (Wales) Regulations 2005, ISBN 011091144X. The print version may be purchased by clicking here. Braille copies of this Statutory Instrument can also be purchased at the same price as the print edition by contacting TSO Customer Services on 0870 600 5522 or e-mail: customer.services@tso.co.uk.

Further information about the publication of legislation on this website can be found by referring to the Frequently Asked Questions.

To ensure fast access over slow connections, large documents have been segmented into "chunks". Where you see a "continue" button at the bottom of the page of text, this indicates that there is another chunk of text available.

the expressions "collection centre" and "establishment" have the same meaning as in Section B of Chapter 4 of Annex II to Directive 92/118/EEC 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 (as that Directive is amended as at the date these Regulations are made) [6];

"hides and skins" ("crwyn") means cutaneous and sub-cutaneous tissues;

"slaughterhouse" ("lladd-dy") has the same meaning as in Section A of Chapter 4 of Annex II to Directive 92/118/EEC (as that Directive is amended as at the date these Regulations are made); and

"tanning" ("barcio") means the hardening of hides using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents.

Amendment of the Bovines and Bovine Products (Trade) Regulations 1999
     3. The Bovines and Bovine Products (Trade) Regulations 1999[7] are amended in accordance with regulations 4 and 5.

     4. For paragraph (1) of regulation 6 (production of bovine by-products and consignment and placing on the market of bovine meat, products and certain by-products), substitute the following paragraph  - 

    " (1) No person will  - 


(a) produce any gelatin derived from a bovine animal slaughtered in the United Kingdom, being gelatin which is liable to enter the human food or animal feed chain or is destined for use in cosmetics or in medical or pharmaceutical products; or

(b) produce any collagen, derived from a bovine animal slaughtered in the United Kingdom, being collagen which is liable to enter the human food or animal feed chain or is destined for use in cosmetics or in medical or pharmaceutical products, unless it is collagen intended for human consumption in the United Kingdom.".

     5. In paragraph (3) of regulation 9 (use of controlled bovine by-products and other products)  - 

(a) delete the words "gelatin or collagen produced" where they first appear;

(b) insert the words "gelatin or collagen produced" at the beginning of each of sub-paragraphs (a) and (b); and

(c) insert "; or" and the following sub-paragraph after sub-paragraph (b)  - 


" (c) collagen produced in accordance with regulation 6 of the Production of Bovine Collagen Intended for Human Consumption in the United Kingdom (Wales) Regulations 2005."

Control of production of collagen intended for human consumption in the United Kingdom derived from bovine animals slaughtered there
     6.  - (1) Until the end of 2005 no person will produce any collagen derived from any bovine animal slaughtered in the United Kingdom, being collagen intended for human consumption there, unless the requirements specified in paragraphs 1 to 5 of the Schedule are complied with.

    (2) The occupier of any establishment where collagen of the kind referred to in paragraph (1) is produced will keep records for two years  - 

(a) on the sources of all incoming raw material, from the date of their receipt at the establishment; and

(b) on all outgoing products, from the date of their dispatch.

    (3) Until the end of 2005 no person will wrap, package, store or transport any collagen derived from any bovine animal slaughtered in the United Kingdom, being collagen intended for human consumption there, unless the requirements specified in paragraph 6 of the Schedule are complied with.

Offences and penalties
     7.  - (1) Any person who contravenes any provision of regulation 6 will be guilty of an offence.

    (2) Any person guilty of an offence under this regulation will be liable  - 

(a) on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding six months or to both; or

(b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both.

whichever is the earlier.

Application of various provisions of the Food Safety Act 1990 for the purposes of regulations 6 and 7
     8. The following provisions of the Act will apply for the purposes of regulations 6 and 7, with the modification that any reference in those provisions to the Act or Part thereof will be construed as a reference to regulation 7  - 

(a) section 20 (offences due to fault of another person);

(b) section 21 (defence of due diligence)[8] as it applies for the purposes of section 14 or 15;

(c) section 30(8) (which relates to documentary evidence);

(d) section 33(1) (obstruction etc. of officers);

(e) section 33(2), with the modification that the reference to "any such requirement as is mentioned in subsection 1(b) above" will be deemed to be a reference to any such requirement as is mentioned in section 33(1)(b) as applied by sub-paragraph (d);

(f) section 35(1)[9] (punishment of offences), in so far as it relates to offences under section 33(1) as applied by sub-paragraph (d);

(g) section 35(2) and (3)[10], in so far as it relates to offences under section 33(2) as applied by sub-paragraph (e);

(h) section 36 (offences by bodies corporate);

(i) section 36A[11] (offences by Scottish Partnerships); and

(j) section 44 (protection of officers acting in good faith).

Enforcement
     9.  - (1) Regulation 6 will be executed and enforced by the food authority within its area.

    (2) On an inspection of any collagen intended for human consumption, an authorised officer of the food authority within whose area the premises where it was inspected is situated may certify that the collagen concerned has not been produced, wrapped, packaged, stored or transported in accordance with regulation 6.

    (3) Where any collagen intended for human consumption is certified as mentioned in paragraph (2), it will be treated for the purposes of section 9[12] of the Act as failing to comply with food safety requirements.



Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998[13].


D. Elis-Thomas
The Presiding Officer of the National Assembly

24 May 2005

(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 solely for that purpose.

    (2) Wrappings and packages containing collagen must  - 

(a) bear an identification mark giving the following particulars  - 


(i) the name "United Kingdom" or initial letters "UK",

(ii) followed by the registration number of the establishment and the initials "EC"; and



(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.

 -  Slaughterhouse

Address of the establishment: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Veterinary approval/registration number: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

 -  Collection centre

Address of the establishment: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Registration number: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

 -  Tannery

Address of the establishment: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Registration number: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

     3. Destination of the raw material
Name of the collection centre/establishment producing collagen[^{Note 1}] where the raw material is sent:

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

Address: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

     4. Declaration
I, the undersigned, declare that I have read and understood the provisions of paragraphs 1 and 2 of the Schedule to the Production of Bovine Collagen Intended for Human Consumption in the United Kingdom (Wales) Regulations 2005, and that hides/skins[Note 1] from bovine animals as described above are derived from animals that have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante and post mortem inspection.

Done at . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

     (place)      (date)

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

(Signature of the owner of the plant or his/her representative[^{Note 2}]

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

(Name in block letters)

Note 1  -  Delete as appropriate

Note 2  -  The signature must be a colour different from that of printing.

The Regulations also impose requirements on the production of collagen derived from a bovine animal slaughtered in the United Kingdom and intended for human consumption in the United Kingdom until the end of 2005 (regulation 6) ("domestic production"). The Regulations apply to domestic production requirements that reflect those which, under Council Directive 92/118/EEC[16], apply to production of collagen for human consumption for intra-Community trade. The Regulations - 

• apply requirements relating to raw materials and establishments supplying them, transport and storage of raw materials, establishments producing collagen, manufacture of collagen, finished products, and wrapping, packaging, storage and transport of collagen intended for human consumption in the United Kingdom (The Schedule, Part 1);

• require establishments producing collagen, and collection centres and tanneries supplying the raw materials for such production, to be authorised in accordance with regulations 4 and 5 respectively of the Collagen and Gelatine (Intra-Community Trade) (Wales) Regulations 2003 (S.I. 2003/3229) which implement the requirements of Commission Decision 2003/721/EC amending Council Directive 92/118/EEC (The Schedule, Part 1); and

• provide that contravention of the requirements of regulation 6 is an offence, specify penalties for that offence, apply certain provisions of the Food Safety Act 1990 (1990 c.16, as amended by S.I. 2004/2990) for the purposes of regulation 6 and 7, and provide for the enforcement of regulation 6 by the relevant food authority (regulations 7, 8 and 9).

A regulatory appraisal has been prepared for this instrument. Copies may be obtained from the Animal Health Division of the Welsh Assembly Government, Cathays Park, Cardiff CF10 3NQ.

[2] 1972 c.68.back

[3] 1990 c.16. Section 1(1) and (2) (definition of "food") was substituted by S.I. 2004/2990. Section 53(2) was amended by paragraph 19 of Schedule 16 to the Deregulation and Contracting Out Act 1994 (1994 c.40), Schedule 6 to the Food Standards Act 1999 (1999 c.28) and S.I. 2004/2990.back

[4] Functions formerly exercisable by "the Ministers" (being, in relation to England and Wales and acting jointly, the Minister of Agriculture, Fisheries and Food and the Secretaries of State respectively concerned with health in England and food and health in Wales and, in relation to Scotland, the Secretary of State) are now exercisable in relation to England by the Secretary of State pursuant to paragraph 8 of Schedule 5 to the Food Standards Act 1999 (1999 c.28). Those functions, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by S.I. 1999/672 as read with section 40(3) of the 1999 Act. Those functions, so far as exercisable in relation to Scotland, were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (1998 c.46) as read with section 40(2) of the 1999 Act. Sections 16(1) and (2), 19(1) and 48(1) were amended by paragraph 8 of Schedule 5 to the 1999 Act, section 26(3) was amended by Schedule 6 to that Act and section 48(4A) was inserted by paragraph 21 of Schedule 5 to that Act. Section 48 was also amended by S.I. 2004/2990.back

[5] OJ No. L31, 1.2.2002, p.1, as last amended by Regulation (EC) No. 1642/2003 (OJ No. L245, 29.9.2003, p.4). By virtue of regulation 5 of the Food Safety Act 1990 (Amendment) Regulations 2004 (S.I. 2004/2990) with effect from 7th December 2004 the consultation requirement contained in section 48(4) of the 1990 Act is disapplied in any case in which consultation is required by Article 9 of Regulation (EC) No. 178/2002.back

[6] OJ No. L62, 15.3.93, p.49. Chapter 4, Section B of Annex II to that Directive was first inserted by Commission Decision 2003/42/EC (OJ No. L13, 18.1.2003, p.24) and was replaced by Commission Decision 2003/721/EC (OJ No. L260, 11.10.2003 p.21). The Directive was last amended by Commission Regulation (EC) No. 445/2004 (OJ No. L72, 11.3.2004, p.60).back

[7] S.I. 1999/1103, as amended by S.I. 1999/1154, S.I. 2000/656, S.I. 2002/1174, S.I. 2002/2325.back

[8] Section 21 has been amended by S.I. 2004/3279.back

[9] Section 35(1) is amended by the Criminal Justice Act 2003 (2003 c.44), Schedule 26, paragraph 42, from a date to be appointed.back

[10] Section 35(3) has been amended by S.I. 2004/3279.back

[11] Section 36A was inserted by the Food Standards Act 1999 (1999 c.28), Schedule 5, paragraph 16.back

[12] Section 9 has been amended by S.I. 2004/3279.back

[13] 1998 c.38.back

[14] S.I. 2003/3229back

[15] OJ No. L61, 18.3.95, p.1, as last amended by Directive 2003/114/EC of the European Parliament and of the Council (OJ No. L24, 29.1.2004, p.58).back

[16] OJ No. L62, 15.3.93, p. 49, 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, as last amended by Commission Regulation (EC) No. 445/2004 (OJ No. L72, 11.3.2004, p. 60).back