COMMISSION DECISION
of 28 October 1999
amending Annex II to Council Directive 92/118/EEC laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC
(notified under document number C(1999) 3493)
(Text with EEA relevance)
(1999/724/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC(1), as last amended by Directive 97/79/EC(2), and in particular the second paragraph of Article 15,
(1) Whereas specific rules applicable to the preparation of gelatine intended for pharmaceutical, cosmetic or other technical use and medical devices are under preparation; whereas, therefore, the regulation of these products may be excluded from the scope of this Decision;
(2) Whereas the specific public health conditions applicable to the preparation of gelatine intended for human consumption should be laid down; whereas, provided that these conditions are the same for gelatine intended for human consumption and gelatine not intended for human consumption and provided that hygiene conditions are also the same, both types of gelatine may be produced and/or stored in the same establishment;
(3) Whereas the autorisation and registration, inspection and hygiene requirements which establishments preparing gelatine must meet should be determined; whereas certain health conditions contained in Council Directive 77/99/EEC of 21 December 1976 on health problems affecting the production and marketing of meat products and certain other products of animal origin(3), as last amended by Directive 97/76/EC(4), and in Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs(5), are relevant for the preparations of gelatine;
(4) Whereas the Scientific Steering Committee adopted an opinion on safety of gleatine on 26 and 27 March 1998 which was updated on 18 and 19 February 1999; whereas this opinion addresses the questions under which conditions of sourcing of the material and/or of type of material used and/or production process gelatine destined for human consumption can be considered free of bovine spongiform encephalapathy (BSE) infectivity; whereas in this opinion, the Scientific Steering Committee distinguishes the recommended measures between different categories of geographical risk; whereas a final implementation can only follow after classification of countries and regions; whereas on 21 May 1999, at the general session of the International Office of Epizootics (IOE) Committee, a proposal of the IOE International Animal health Code Commission concerning the criteria for the determination of the BSE status of a country or zone was adopted; whereas in accordance to the procedure laid down in Commission Recommendation 98/477/EC(6), concerning information necessary to support applications for the evaluation of the epidemiological status of countries with respect to transmissible spongiform encephalopathies, certain Member States and third countries submitted data necessary to allow assessment of their geographical risk; whereas, considering recent development of the IOE Code on BSE, pending the above scientific assessment and the subsequent decision making, the entry into force of rules for the production of gelatine derived from ruminant bones should be suspended until Community legislation concerning classification of countries or regions as regards their BSE status is applicable; whereas the Commission will initiate the procedure for the entry into force of rules for the production of gelatine derived from ruminant bones without delay after the adoption of Community legislation concerning classification of countries or regions as regards their BSE status;
(5) Whereas the Commission as adopted Decision 97/534/EC(7), as last amended by Council Decision 98/745/EC(8) on the prohibition of the use of material presenting risks as regards transmissible spongiform encephalopathies;
(6) Whereas the Commission has adopted Decision 98/272/EC(9) on epidemio-surveillance for transmissible spongiform encephalopathies and amending Decision 94/474/EC; whereas this Decision lays down measures to bed applied in case of animals suspected of having a transmissible spongiform encephalopathy (TSE);
(7) Whereas a revision of the Animal Health Code of the (IOE) on BSE (IOE Code on BSE) was adopted in the general assembly of the IOE in Paris on 29 May 1998; whereas Article 3.2.13.3 of that Code recommends that if gelatine and collagen are prepared exclusively from hides and skins derived from healthy animals, veterinary administration can authorise, without restriction, the import and transit through their territories of this gelatine and collagen, regardless the status of the exporting countries; whereas Article 3.2.13.15 of that Code recommends under which sourcing and processing conditions gelatine and collagen prepared from bones can be traded;
(8) Whereas gelatine is prepared from bones, farmed ruminant and wild game hides and skins, pig and poultry skins, tendons and sinews and fish skins and bones; whereas supervided hygienic slaughtering of cattle in a slaughterhouse prevents contamination of hides with material presenting risks as regards transmissible spongiform encephalopathies; whereas it is appropriate that these raw materials originate from healthy animals and are dealt with hygienically when being collected, transported stored and handled; whereas in order to guarantee traceability of these raw materials it is appropriate to require collection centres and tanneries which intend to supply these materials ot be authorised and registered, whereas, furthermore, it is appropriate to lay down a model of commercial document which should accompany these raw materials during transportation a time of delivery in the collection centres and in the tanneries and in the gelatine processing plants;
(9) Whereas the Scientific Steering Committee in the above opinion strongly recommends that gelatine manufacturers implement and respect hazard analysis and critical control points procedures; whereas the measures relating to establishments' own checks provided for in Article 7 of Directive 77/99/EEC are relevant for own checks carried out by establishments producing gelatine as referred to in Article 4(2) of Directive 92/118/EEC;
(10) Whereas standards for the finished product should be fixed in order to ensure that it is not contaminated by substances or micro-organisms presenting a threat to the health of consumers; whereas pending a scientific evaluation of such standards, it is appropriate to provisionally include generally accepted standards as regards contamination;
(11) Whereas requirements as regards packaging, storage and transport of the finished product should be laid down;
(12) Whereas it is necessary to lay down specific health rules governing the importation of raw materials destined to the production of gelatine intended for human consumption and of gelatine intended for human consumption; whereas where it is possible to recognise conditions offering equivalent guarantees, a third country may submit a proposal for such recognition to the Commission for appropriate consideration;
(13) Whereas the adoption of specific rules for gelatine production is without prejudice to the adoption of rules for the organisation of the prevention and control of transmissible spongiform encephalopathies;
(14) Whereas the measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,
HAS ADOPTED THIS DECISION:
Article 1
The second indent of Chapter 2 of Annex II to Directive 92/118/EEC is hereby deleted.
Article 2
The Annex to this Decision is hereby added as Chapter 4 to Annex II to Directive 92/118/EEC.
Article 3
The Annex to this Decision may be amended in accordance with the procedure provided for in Article 18 of Directive 92/118/EEC, in particular to take into account scientific and technological developments, and in light of the advice of the appropriate Scientific Committee of the Commission.
Article 4
This Decision shall apply from 1 June 2000. It does not apply to gelatine intended for human consumption which was produced before that date.
Nevertheless, Part II, point 2 and Part IV, point 1, first indent, of the Annex shall apply from such time as the Commission, acting in accordance with the procedure laid down in Article 18 of Directive 92/118/EEC, shall determine.
Article 5
This Decision is addressed to the Member States.
Done at Brussels, 28 October 1999.