Annex

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

1. 1..

   in point 3 of Section VIII, the following paragraph is added:

   ‘By way of derogation from point (a), point 7 of Part A of Annex I to Regulation (EC) No 852/2004 may not apply to operators engaged in small-scale coastal fishing within the meaning of Article 26(1) of Council Regulation (EC) No 1198/2006^f1, and carrying out their activities only for short periods of less than 24 hours.’;

2. 2..

   in Section XIV, Chapters III, IV and V are replaced by the following:

   ‘CHAPTER III:

   REQUIREMENTS FOR THE MANUFACTURE OF GELATINE

   1.

   The production process for gelatine must ensure that:

   1. (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;

   2. (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.

   CHAPTER IV:

   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
   SO2 (European Pharmacopoeia 2005)	50 ppm
   H2O2 (European Pharmacopoeia 2005)	10 ppm

   CHAPTER V:

   LABELLING

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

3. 3..

   in Section XV, Chapter III, point 3 is replaced by the following:

   ‘3.

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

4. 4..

   the Appendix is replaced by the following:

   ‘Appendix to ANNEX III

   MODEL DOCUMENT TO ACCOMPANY RAW MATERIAL DESTINED FOR THE PRODUCTION OF GELATINE OR COLLAGEN INTENDED FOR HUMAN CONSUMPTION

   Number of the commercial document: …

   I.

   Identification of raw material

   Nature of the raw material: …

   Animal species: …

   Type of packaging: …

   Number of packages: …

   Net weight (kg): …

   II.

   Origin of raw material

   Type, name, address and approval/registration/special authorisation number of the establishment of origin:

   …

   Name and address of the consignor^f2: …

   III.

   Destination of raw material

   Type, name, address and approval/registration/special authorisation number of the production establishment of destination:

   …

   Name and address of the consignee^f3: …

   IV.

   Means of transport: …

   Done at …, on …

   …

   (Signature of the operator of the establishment of origin or its representatives)