12.6.2008 EN Official Journal of the European Union L 153/23
COMMISSION REGULATION (EC) No 523/2008
of 11 June 2008
amending Annexes VIII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the import of blood products for the manufacture of technical products
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (1), and in particular Article 4(4), the second paragraph of Article 28, the first subparagraph of Article 29(3) and Article 32(1),
Whereas:
(1) Regulation (EC) No 1774/2002 lays down animal and public health requirements for the import into and transit through the Community of blood products intended for technical purposes, including model import health certificates and list of countries authorised for imports.
(2) Regulation (EC) No 1774/2002 provides that animal by-products which have been derived from animals treated with certain substances prohibited under Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stock farming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (2) may only be imported into the Community in accordance with Regulation (EC) No 1774/2002 or with specific rules to be laid down.
(3) The possibility to import such blood products is vital for the biotechnology industry for the manufacture of various technical products used mainly by the pharmaceutical and research community. As those products are not intended either for human or animal consumption and during their processing and technical use they pose no risk to animal and human health by reason of being derived from animals treated with certain substances prohibited under Directive 96/22/EC, it is appropriate to allow the imports into the Community of such blood products.
(4) Regulation (EC) No 1774/2002 provides that the blood products used for the manufacture of technical products must be specifically treated or the country or region of origin of the products must be free from certain diseases without vaccination. However, several countries or certain regions are eligible to deliver fresh meat of ruminants to the Community by reason of being free from foot-and-mouth disease with vaccination, provided that the risk against possible virus circulation is mitigated. Similarly, it is appropriate to allow imports of untreated blood products of ruminants from such countries or regions, provided that those products are channelled to their place of destination under secure conditions for further processing.
(5) Regulation (EC) No 1774/2002 also provides, in case of blood products of ruminant origin that the region of origin must be eligible for the import of live animals of the same species into the Community. According to international standards, blood products are less likely to transmit diseases of concern than live animals. It is therefore appropriate to delete this condition from the relevant requirements.
(6) Part VI(A) of Annex XI to Regulation (EC) No 1774/2002 sets out lists of third countries from which Member States may authorise imports of blood products intended for technical purposes. Those lists are currently limited to countries from which the import of all categories of fresh meat of the respective species for human consumption is authorised.
(7) Since the applicable requirements allow for the treatment of the blood products, those lists should be extended also to countries which are not authorised to export fresh meat of the respective species into the Community but are able to comply with the treatment requirements. However, for the sake of clarity, separate health certificates should be laid down for treated and untreated blood products.
(8) It is appropriate to update the requirements related to the import of blood products from poultry and other avian species by referring to the international standards laid down in the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE).
(9) Annexes VIII, X and XI to Regulation (EC) No 1774/2002 should therefore be amended accordingly.
(10) A transitional period should be provided for after the date of entry into force of this Regulation, in order to provide the necessary time for the stakeholders to comply with the new rules and to allow for the continued importation into the Community of the blood products as currently covered by Regulation (EC) No 1774/2002.
(11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
Annexes VIII, X and XI to Regulation (EC) No 1774/2002 are amended in accordance with the Annex to this Regulation.
Consignments of blood products accompanied by health certificates completed and signed in accordance with the provisions of Regulation (EC) No 1774/2002 applicable before the date of entry into force of this Regulation shall be accepted for import into the Community until 12 December 2008 at the latest.
Such consignments shall also be accepted until 12 February 2009 at the latest if the accompanying health certificates were completed and signed by 12 December 2008 at the latest.
This Regulation shall enter into force and apply on the third day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.