28.12.2006   

EN

Official Journal of the European Union

L 379/98

(1)

Regulation (EC) No 1774/2002 provides that certain animal by-products may be imported into the Community for the production of technical products provided that they comply with that Regulation.

(2)

Annex VIII to Regulation (EC) No 1774/2002 sets out the requirements for the placing on the market of certain technical products including starting materials to be used for or in the production of technical products which may include medical devices, in vitro diagnostics and laboratory reagents.

(3)

However, certain Member States, trading partners and operators have expressed concerns over the importation of certain products sourced from Category 3 material intended for the production of medical devices, in vitro diagnostics and laboratory reagents (‘the intermediate products’). It is therefore necessary to clarify the importation requirements and to lay down specific conditions for those intermediate products.

(4)

Although the intermediate products concerned may have been subjected to preliminary processing, the way in which they are transported to the Community does not make it possible to differentiate them from other types of animal by-products intended for other technical uses, except by taking into account their intended destination and uses. The monitoring of their intended destination and uses under other Community legislation should be sufficient to ensure that they are not diverted into the food and feed chains at a later stage, provided that risk-appropriate channelling, recording and control measures are put in place.

(5)

The placing on the market of the intermediate products concerned should therefore be channelled in accordance with Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (2), and subjected to specific identification and control measures, in order to reduce the risk of diversion into the food and feed chains and other unintended uses.

(6)

Annex VIII to Regulation (EC) No 1774/2002 sets out the requirements for the placing on the market of technical products. A comprehensive review and clarification of that Annex is to be undertaken once the transitional regime provided for in that Regulation has expired. It is therefore, appropriate to lay down in the meantime the rules required for the importation of intermediate products intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents in a specific regulation complementing the rules already laid down in that Annex.

(7)

Until a full review and clarification has been undertaken, it is necessary to clarify the scope of Chapters IV and XI of Annex VIII to Regulation (EC) No 1774/2002 to take into account this specific Regulation being laid down. The rules set out in Chapter IV should concern blood used for all technical purposes and blood products other than the serum of equidae used for technical purposes other than medical devices, in vitro diagnostics or laboratory reagents. The rules set out in Chapter V should continue to concern the serum of equidae intended for any technical purposes, including medical devices, in vitro diagnostics or laboratory reagents, and thus such rules do not need to be amended. The rules set out in Chapter XI should concern the importation of other non-processed animal by-products, which are not covered by this Regulation, imported for any purposes, including medical devices, in vitro diagnostics or laboratory reagents.

(8)

As a consequence of such clarification, some amendments need to be made to certain model health certificates laid down in Annex X to Regulation (EC) No 1774/2002.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)

they come from a third country listed as member of the World Organisation for Animal Health (OIE) in the OIE Bulletin;

(b)

they come from a plant registered or approved by the competent authority of a third country referred to in point (a) of this Article in accordance with the conditions set out in Annex I to this Regulation;

(c)

they are derived exclusively from Category 3 material;

(d)

each consignment must be accompanied by a commercial document indicating:

The commercial document must be in at least one of the official languages of the EU Member State in which the inspection at the border inspection post shall be carried out and of the EU Member State of destination. These Member States may allow other languages, if necessary, accompanied by an official translation.

(e)

they are accompanied by a declaration of the importer in accordance with the model declaration set out in Annex II to this Regulation. The declaration must be in at least one of the official languages of the EU Member State in which the inspection at the border inspection post shall be carried out and of the EU Member State of destination. These Member States may allow other languages, if necessary, accompanied by an official translation.

(a)

to a technical plant approved in accordance with Article 18 of Regulation (EC) No 1774/2002, where the intermediate products shall be further mixed, used for coating, assembled, packaged or labelled before they are placed on the market or put into services in accordance with the Community legislation applicable to the final product; or

(b)

to a Category 3 intermediate plant or storage plant approved in accordance with Article 10(3) or with Article 11 of Regulation (EC) No 1774/2002.