Commission Regulation (EC) No 1662/2006 of 6 November 2006 amending Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin (Text with EEA relevance)

of 6 November 2006

amending Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin

(Text with EEA relevance)

Preamble

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin ¹ , and in particular Article 10(1) thereof,

Whereas:

(1) When subject to the provisions of Annex III to Regulation (EC) No 853/2004, food business operators should ensure that each product of animal origin has an identification mark applied in compliance with the provisions laid down in Section I of Annex II to that Regulation. Unless expressly indicated and for control reasons, products of animal origin should not bear more than one identification mark.

(2) Section I of Annex III to Regulation (EC) No 853/2004 lays down rules on the production and placing on the market of meat from domestic ungulates. Exceptions to the complete skinning of the carcase and other parts of the body intended for human consumption are set out in point 8 of Chapter IV of that Section. Provision should be made to extend these exceptions to the muzzle and lips from bovine animals, provided they comply with the same conditions as those applying to heads of ovine and caprine animals.

(3) The tonsils serve as a filter of all noxious agents entering the oral cavity of animals and should be removed for hygienic and safety reasons during the process of slaughtering domestic ungulates. Since the removal was inadvertently omitted as mandatory for domestic swine, the requirement for removal of porcine tonsils should be re-inserted.

(4) Section VIII of Annex III to Regulation (EC) No 853/2004 sets out the requirements governing the production and placing on the market of fishery products intended for human consumption. Fish oil is included in the definition of fishery products. Specific requirements for production and placing on the market of fish oil for human consumption should, therefore, be laid down. Transitional arrangements should also be foreseen to give the possibility to establishments in third countries to adapt to the new situation.

(5) Colostrum is considered as a product of animal origin but is not covered by the definition of raw milk as referred to in Annex I to Regulation (EC) No 853/2004. Colostrum is produced in a similar way and can be considered as presenting a similar risk to human health as raw milk. It is therefore necessary to introduce specific hygiene rules for colostrum production.

(6) Section XV of Annex III to Regulation (EC) No 853/2004 sets out the requirements for the production of collagen. It specifies that collagen must be produced using 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 approved equivalent process. A different process resulting in a hydrolysed collagen that cannot be extruded was submitted for assessment to EFSA. EFSA adopted on 26 January 2005 an opinion on safety of collagen and a processing method for the production of collagen. It concluded that the production process proposed above ensures equivalent or higher health safety for collagen intended for human consumption compared to the safety achieved by applying the standards of Section XV. The conditions for the production of collagen should therefore be modified.

(7) Regulation (EC) No 853/2004 should be amended accordingly.

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

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 853/2004 is amended as follows:

1. Annex II is amended in accordance with Annex I to this Regulation.

2. Annex III is amended in accordance with Annex II to this Regulation.

Article 2

This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Union .

Final provisions

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 6 November 2006. For the Commission Markos KYPRIANOU Member of the Commission

¹ OJ L 139, 30.4.2004, p. 55 , as corrected by OJ L 226, 25.6.2004, p. 22 . Regulation as last amended by Commission Regulation (EC) No 2076/2005 ( OJ L 338, 22.12.2005, p. 83 ).

Section I, Part A, point (2) of Annex II to Regulation (EC) No 853/2004 is replaced by the following:

‘2. However, when a product's packaging and/or wrapping is removed or it is further processed in another establishment, a new mark must be applied to the product. In such cases, the new mark must indicate the approval number of the establishment where these operations take place.’

Annex III to Regulation (EC) No 853/2004 is amended as follows:

1.	(a): Point 8 is replaced by the following: ‘8. Carcases and other parts of the body intended for human consumption must be completely skinned, except in the case of porcine animals, the heads of ovine and caprine animals and calves, the muzzle and lips of bovine animals and the feet of bovine, ovine and caprine animals. Heads, including muzzle and lips, and feet must be handled in such a way as to avoid contamination.’ — ‘8. — Carcases and other parts of the body intended for human consumption must be completely skinned, except in the case of porcine animals, the heads of ovine and caprine animals and calves, the muzzle and lips of bovine animals and the feet of bovine, ovine and caprine animals. Heads, including muzzle and lips, and feet must be handled in such a way as to avoid contamination.’ ‘8.: Carcases and other parts of the body intended for human consumption must be completely skinned, except in the case of porcine animals, the heads of ovine and caprine animals and calves, the muzzle and lips of bovine animals and the feet of bovine, ovine and caprine animals. Heads, including muzzle and lips, and feet must be handled in such a way as to avoid contamination.’	(a)	‘8.: Carcases and other parts of the body intended for human consumption must be completely skinned, except in the case of porcine animals, the heads of ovine and caprine animals and calves, the muzzle and lips of bovine animals and the feet of bovine, ovine and caprine animals. Heads, including muzzle and lips, and feet must be handled in such a way as to avoid contamination.’
(a)	‘8.: Carcases and other parts of the body intended for human consumption must be completely skinned, except in the case of porcine animals, the heads of ovine and caprine animals and calves, the muzzle and lips of bovine animals and the feet of bovine, ovine and caprine animals. Heads, including muzzle and lips, and feet must be handled in such a way as to avoid contamination.’	‘8.	Carcases and other parts of the body intended for human consumption must be completely skinned, except in the case of porcine animals, the heads of ovine and caprine animals and calves, the muzzle and lips of bovine animals and the feet of bovine, ovine and caprine animals. Heads, including muzzle and lips, and feet must be handled in such a way as to avoid contamination.’
‘8.	Carcases and other parts of the body intended for human consumption must be completely skinned, except in the case of porcine animals, the heads of ovine and caprine animals and calves, the muzzle and lips of bovine animals and the feet of bovine, ovine and caprine animals. Heads, including muzzle and lips, and feet must be handled in such a way as to avoid contamination.’
(b)	‘(a): the tonsils of bovine animals, porcine animals and solipeds must be removed hygienically;’.	‘(a)	the tonsils of bovine animals, porcine animals and solipeds must be removed hygienically;’.
‘(a)	the tonsils of bovine animals, porcine animals and solipeds must be removed hygienically;’.

2.	1.: they must derive from fishery products which have been found fit for human consumption;	1.	they must derive from fishery products which have been found fit for human consumption;	2.	they must come from establishments, including vessels, approved in accordance with this Regulation;	3.	they must be transported and stored until processing in hygienic conditions.’
1.	they must derive from fishery products which have been found fit for human consumption;
2.	they must come from establishments, including vessels, approved in accordance with this Regulation;
3.	they must be transported and stored until processing in hygienic conditions.’

3.	1.: “Colostrum” means the fluid secreted by the mammary glands of milk-producing animals up to three to five days post parturition that is rich in antibodies and minerals, and precedes the production of raw milk.

4.	‘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 approved equivalent process. The extrusion step may be not carried out when manufacturing low molecular collagen from raw materials of non-ruminant origin.’	‘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 approved equivalent process. The extrusion step may be not carried out when manufacturing low molecular collagen from raw materials of non-ruminant origin.’
‘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 approved equivalent process. The extrusion step may be not carried out when manufacturing low molecular collagen from raw materials of non-ruminant origin.’

¹ Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine ( OJ 121, 29.7.1964, p. 1977/64 ). Directive as last amended by Regulation (EC) No 21/2004 ( OJ L 5, 9.1.2004, p. 8 ).

² Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals ( OJ L 46, 19.2.1991, p. 19 ). Directive as last amended by Commission Decision 2005/932/EC.

³ OJ L 123, 24.4.1998, p. 1 . Directive as last amended by Commission Directive 2006/50/EC ( OJ L 142, 30.5.2006, p. 6 ).

Rolling geometric average over a two-month period, with at least two samples per month.

Rolling geometric average over a three-month period, with at least one sample per month, unless the competent authority specifies another methodology to take account of seasonal variations in production levels.