Regulation (EC) No 853/2004 of the European Parliament and of the CouncilShow full title

[X1 SECTION XIV: U.K. GELATINE

1. Food business operators manufacturing gelatine must ensure compliance with the requirements of this section. U.K.

2. For the purpose of this section, ‘ tanning ’ 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. U.K.

CHAPTER I: U.K. REQUIREMENTS FOR RAW MATERIALS

1. For the production of gelatine intended for use in food, the following raw materials may be used: U.K.

(a)

[F1 bones, other than specified risk materials as defined in Article 3(1)(g) of Regulation (EC) No 999/2001 of the European Parliament and of the Council (1) ;]

(b)

hides and skins of farmed ruminant animals;

(c)

pig skins;

(d)

poultry skin;

(e)

tendons and sinews;

(f)

wild game hides and skins;

and

(g)

fish skin and bones.

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 558/2010 of 24 June 2010 amending Annex III to 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).

2. The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this process was completed. U.K.

3. Raw materials listed in point 1(a) to (e) must derive from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante-mortem and post-mortem inspection or, in the case of hides and skins from wild game, found fit for human consumption. U.K.

4. Raw materials must come from establishments registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation. U.K.

5. Collection centres and tanneries may also supply raw material for the production of gelatine intended for human consumption if the competent authority specifically authorises them for this purpose and they fulfil the following requirements. U.K.

(a)

They must have storage rooms with hard floors and smooth walls that are easy to clean and disinfect and, where appropriate, provided with refrigeration facilities.

(b)

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.

(c)

If raw material not in conformity with this chapter is stored and/or processed in these premises, it must be segregated from raw material in conformity with this chapter throughout the period of receipt, storage, processing and dispatch.

CHAPTER II: U.K. TRANSPORT AND STORAGE OF RAW MATERIALS

1. In place of the identification mark provided for in Annex II, Section I, a document indicating the establishment of origin and containing the information set out in the Appendix to this Annex must accompany raw materials during transport, when delivered to a collection centre or tannery and when delivered to the gelatine-processing establishment. U.K.

2. Raw materials must be transported and stored chilled or frozen unless they are processed within 24 hours after their departure. However, degreased and dried bones or ossein, salted, dried and limed hides, and hides and skins treated with alkali or acid may be transported and stored at ambient temperature. U.K.

[F2 CHAPTER III: U.K. REQUIREMENTS FOR THE MANUFACTURE OF GELATINE

1. The production process for gelatine must ensure that: U.K.

(a)

all ruminant bone material derived from animals born, reared or slaughtered in countries or regions with a controlled or undetermined BSE risk in accordance with Community legislation is subjected to a process which ensures that all bone material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at minimum concentration of 4 % and pH < 1,5) over a period of at least two days. This treatment is followed either by:

• an alkaline treatment of saturated lime solution (pH > 12,5) for a period of at least 20 days with a heat treatment step of 138 °C minimum during at least four seconds, or

• an acid treatment (pH < 3,5) during 10 hours minimum with a heat treatment step of 138 °C minimum during at least four seconds, or

• a heat-and-pressure process for at least 20 minutes with saturated steam of 133 °C at more than 3 bars, or

• any approved equivalent process;

(b)

other raw material is subjected to a treatment with acid or alkali, followed by one or more rinses. The pH must be adjusted subsequently. Gelatine must be extracted by heating one or more times in succession, followed by purification by means of filtration and heat treatment.

2. A food business operator may produce and store both gelatine intended for human consumption and gelatine not intended for human consumption in the same establishment provided that the raw materials and the production process comply with the requirements applying to gelatine intended for human consumption. U.K.

Textual Amendments

F2 Substituted by Commission Regulation (EC) No 1243/2007 of 24 October 2007 amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and the Council laying down specific hygiene rules for food of animal origin (Text with EEA relevance).

CHAPTER IV: U.K. REQUIREMENTS FOR FINISHED PRODUCTS

Food business operators must ensure that gelatine complies with the residue limits set out in the following table:

Residue	Limit
As	1 ppm
Pb	5 ppm
Cd	0,5 ppm
Hg	0,15 ppm
Cr	10 ppm
Cu	30 ppm
Zn	50 ppm
SO 2 (European Pharmacopoeia 2005)	50 ppm
H 2 O 2 (European Pharmacopoeia 2005)	10 ppm

CHAPTER V: U.K. LABELLING

Wrapping and packaging containing gelatine must bear the words ‘ gelatine fit for human consumption ’ and must indicate the date of minimum durability.] ]

Editorial Information

X1 Substituted by Corrigendum 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 (Official Journal of the European Union L 139 of 30 April 2004).

(1)

[X1 [F1 OJ L 147, 31.5.2001, p 1 .] ]

Editorial Information

X1 Substituted by Corrigendum 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 (Official Journal of the European Union L 139 of 30 April 2004).

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 558/2010 of 24 June 2010 amending Annex III to 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).