They are applicable subject to the import bans effective on the day of import, temporary restrictions and special conditions (see links).
Regulations
For approval and import procedures and application form, see page on "Animal by-products (ABP) from third countries in 2011" (see links).
Gelatine or collagen for the manufacture of pharmaceutical products may be imported as "food" (see relevant subpage) or as "technical products" as stipulated in these regulations. The veterinary importation regulations do not apply to ready-to-use gelatin capsules. In all cases, however, the manufacturers are responsible for ensuring compliance also with the provisions laid down in legislation on medicines, especially the pharmacopoeial requirements.
Gelatine and hydrolysed protein must have been manufactured in accordance with Annex X Chapter II Section 5 of Regulation (EU) 142/2011.
Collagen must have been manufactured in accordance with Annex X Chapter II Section 8 of Regulation (EU) 142/2011.
Photogelatine must meet the requirements set forth in Annex XIV Chapter II Section 11 of Regulation (EU) 142/2011.
Approved countries of origin
The following applies according to Annex XIV Chapter I Section 1 Table 1 of Regulation (EU) 142/2011:
a) In the case of collagen, gelatine and hydrolysed protein: countries as set forth in Annex II Part 1 of Regulation (EU) No 206/2010 (see also (EU) 144/2011).
Plus: Republic of Korea, Malaysia, Pakistan, Taiwan
b) In the case of gelatine and hydrolysed protein from fish: countries as set forth in Annex II of Regulation 2006/766/EC
The following applies according to Annex XIV Chapter II Section 1 Table 2 of Regulation (EU) 142/2011: photogelatine may only be imported from approved businesses of origin in the United States and in Japan, as set forth in Annex XIV Chapter 2 Section 11 of Regulation (EU) 142/2011.
Approved supplying establishments in third countries
Lists of suppliers in third countries must be included in the TRACES system according to the technical specifications published by the Commission on its website. The veterinary authorities of the approved country of origin are responsible for permitting goods for export only from suppliers that meet the requirements of Regulation (EC) 1069/2009 and Regulation (EU) 142/2011.
Photogelatine may only be imported from approved businesses of origin in the United States and in Japan, as set forth in Annex XIV Chapter 2 Section 11 of Regulation (EU) 142/2011.