. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/103/Add.14 
6 July 2006 
 (06-3260) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
Addendum
 
 
 
 The following communication, received on 3 July 2006, is being circulated at the request of 
the Delegation of the European Communities. 
 
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Animal by-products and produc ts derived therefrom not intended for human consumption
 
 
1. Regulation (EC) No.1774/2002 of the European Parliament and of the Council of 
3 October 2002 laying down health rules con cerning animal by-products not intended for human 
consumption  (Official Journal L273, 10 October 2002 pp.1-95) notified in G/SPS/N/EEC/103 
(24 November 2000) set conditions to ensure that th e products imported from a third country are of a 
hygiene standard equal, or equivalent  to, the standards applied by the EC and to this aim it introduced 
a system of approval for the third countries and their establishments, an EC inspection (or audit) 
procedure, and model health certificates, which must accompany the imported products.  This 
regulation lays down inter alia  the rules for the importation, placing on the market and export of 
materials of animal origin that are intended fo r the manufacturing of technical products such as 
cosmetics , medicinal products  and medical devices .  As a general rule, it provides that only safe 
animal by-products may be used as starting materi als for the manufacturing of cosmetics, medicinal 
products and medical devices.  Animal by-products mu st comply with specific health requirements;  
inter alia  they must: 
(a) come from safe animal carcases that have  undergone ante and post mortem veterinary 
inspections and found to be fit, as a result of such inspections, for human 
consumption;  and 
(b) have been treated to standards involving heat to destroy possible biological risks. 
A Consolidated version (May 2003) is available in: 
http://europa.eu.int/eur-lex/lex/LexUriServ/s ite/en/consleg/2002/R/ 02002R1774-20050315-en.pdf . 
 
2. Further to this, in G/SPS/N/EEC/103/Add.10 (18 J une 2004) the EC informed of the adoption 
of a trade facilitating Commission Regulation (EC) No 878/2004 of 29 April 2004 laying down 
transitional measures in accordance with Regul ation (EC) No 1774/2002 for certain animal by-
products classified as Category 1 and 2 ma terials and intended for technical purposes  (Official 
Journal of the EU L162, Voume.47, 30 April 2004, pp. 62-64) that in order to avoid disruption of 
trade, among other measures, provided for a reas onable period of time for the continuing acceptance 
of imported animal by-products arriving at the bor der inspection posts after 1 May 2004, and which 
may still be accompanied by old models of certificates.  G/SPS/N/EEC/103/Add.14 
Page 2  
 
  3. Article 35 of Regulation (EC) N° 1774/20021  requires the EC Member States to inform the 
Commission of the measures taken to ensure compliance with the Regulation.  All 25 Member States have now submitted the required information, and the Commission, submitted to the European 
Council a report on animal by-products
1 that reflects the difficulties concerning the definition of 
certain material as Category 2 material and envi sages a number of amendments to Regulation (EC) 
No 1774/2002 in the course of the review of that legislation scheduled to start from the end of 2006. 
The full text of the report can be downloaded from the internet address indicated below or be 
requested to the EC SPS Enquiry Point.  http://ec.europa.eu/food/food/biosafety/animalbyproducts/index_en.htm  
 
4. Pending those amendments, in Doc. SANCO/ 10100/2006 Rev.5 the European Commission 
notifies a " Draft Commission Regulation amending Re gulation (EC) No 878/2004 laying down 
transitional measures in accordance with Regul ation (EC) No 1774/2002 for certain animal by-
products classified as Category 1 and 2 mat erials and intended for technical purpose".  Consisting of 
trade facilitation measures, the scope of Regulation (EC) No 878/2004 is extended in order to permit 
the use of certain low risk material for the manufact ure of technical products and for certain feeding 
purposes. 
5. The commission intends to keep the proposed changes in the new proposal for amendment of 
Regulation (EC) No 1774/2002. 
Proposed date of adoption:  September 2006 
Proposed date of application:  Cannot be given at this stage although the Commission 
intends to propose 1 January  2007. 
Final date for comments: Not applicable (it is a trade facilitation measure).  
 The notified document can be obtained from the EC Enquiry Point.  
 
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1 COM(2005) 521 Final.