WRITTEN QUESTION P-1887/96 by Salvador Jové Peres (GUE/NGL) to the Commission (5 July 1996)

Subject: Measures related to bovine spongiform encephalopathy (BSE)

In its answer to Written Question P-1164/86 ((OJ C 365, 6.12.1996, p.1. )), the Commission states explicitly that it has not proposed any reclassification of budget heading B2-51 in the preliminary draft budget for 1997. However, the Commission has in fact made such a proposal in paragraph 2(1)(b) of its proposal for the revision of the financial perspective (SEC(96)0492, 28 March 1996). Given that the earlier question by the author of the present question made no reference to the preliminary draft budget:

1. Can the Commission explain the reasons for this lack of rigour in its answer to a parliamentary question?

Under Decision 96/362/EC ((OJ L 139, 12.6.1996, p. 17. )), the UK is forbidden to export materials obtained from bovine animals slaughtered within its territory intended for use in medicinal, pharmaceutical or cosmetic products.

2. As the restrictions have been lifted for finished products, what guarantees can the Commission offer that British industry will not use raw materials deriving from animals slaughtered in the UK?

With respect to the modification of the rules on gelatine, the Commission appears to have used a report supplied by the association 'Gelatine Manufacturers in Europe' (GME).

3. Can the Commission supply a copy of this report? Can it state whether the report was requested by it? Can it state whether it has compared its findings with those of other independent scientific reports? Can it guarantee the 100% safety of gelatine obtained under the conditions specified in Decision 96/362/EC?

4. Does the Commission consider that a selective slaughtering plan can provide sufficient guarantees, in the absence of a centralized register of bovine animals?

Answer given by Mr Fischler on behalf of the Commission (18 September 1996)

1. With reference to its reply to point 1 of written question No 1164/96, the Commission wishes to specify that, at the time when it made its proposal for the revision of the financial perspective ((Sec(96) 492 final. )), it considered that, based on the then estimate of the development of agricultural expenditure under the European agricultural guidance and guarantee fund (EAGGF) guarantee section, there would be a narrow margin under the ceiling for heading 1 in 1997. This expectation of a margin was at the basis of the proposal that the agricultural expenditure covered by chapter B2-51 (about 160 MECU a year in commitment appropriations) should be transferred from heading 3 to the agricultural guideline (heading 1) as from 1997.

Since the adoption of the proposal for the revision of the financial perspective and with the onset of the crisis in the beef sector, it has become apparent that the whole of the expected margin under the agricultural guideline for 1997 must now be used to finance the new costs for the EAGGF guarantee section, entailed by bovine spongiform encephalopathy (BSE) eradication measures and other costs linked to this disease. Thus, in the preliminary draft budget for 1997, the credits of the EAGGF guarantee section, including a temporary BSE reserve of 505 MECU, have been presented at the level of the agricultural guideline, leaving no margin for the inclusion of expenditures for chapter B2-51 under heading 1 of the financial perspective. In these circumstances, the envisaged transfer of chapter B2-51 from heading 3 to heading 1 would have to be delayed until after 1997.

For its part, the European Council at its meeting in Florence on 21 - 22 June 1996 concluded that the coverage of the agricultural guideline should remain unchanged for the period 1997-1999.

2. There are categories of materials destined for use in medicinal, pharmaceutical and cosmetic products which may be traded from the United Kingdom under the provisions of Commission Decision 96/362/EC:

a) gelatin, tallow and related products produced in accordance with the Annex of this Decision, which may be derived from material from bovine animals slaughtered in the United Kingdom.

b) materials obtained from bovine animals not slaughtered in the United Kingdom.

c) the finished products.

Materials mentioned under a) above must come from establishments under official veterinary control which have been shown to be operating in accordance with the conditions set out in the Annex, and appearing on a list of establishments to be provided by the United Kingdom. These rules apply equally to materials for national use or trade.

Decision 96/362/EC does not set up specific controls for the other two categories. However, the citations of the Decision refer to a declaration from the liaison committee of European associations of the perfume, cosmetic products and toiletries industries that its members do not use source materials from the United Kingdom, and to confirmation from Community marketing authorisation holders to the European medicines evaluation agency that the products concerned (for medicinal and pharmaceutical products) do not contain bovine tissue of British origin. These assurances apply equally to producers in the United Kingdom and in other Member States.

All BSE-related measures in the United Kingdom are subject to regular Community inspections. These measures in particular will be checked by the Commission, and immediate action will be taken in the event that infringements are detected.

3. Commission Decision 96/362/EC lays down the method for production of gelatin for trade from the United Kingdom.

Publication and distribution of the Inveresk interim report on the 'Validation of the clearance of scrapie from the manufacturing process of gelatin' was authorized by the Gelatin manufacturers of Europe on 18 April 1996 following a request from the Commission. This was noted in the scientific veterinary committee on 26 April 1996 as one part of the information used to assess the safety of gelatin. The interim report has now been superceded by the final report received on 14 June 1996 which invalidated the interim report. No definite conclusions regarding the degree of inactivation of the scrapie agent in gelatin manufacture can thus be drawn from the study. The effectiveness of the different steps in gelatin manufacture to inactivate the agent are therefore under review by the scientific veterinary committee and the multidisciplinary committee. However, other scientific evidence supports the hypothesis that the chemical and heat treatments used in gelatin manufacturing will contribute to the inactivation of any agent which could be present.

One of the most important criteria in assessing the safety of the gelatin is the sourcing of the raw material. In this respect therefore, all tissues which have been shown to contain infectivity or could be contaminated with the infective agent are excluded, that is skull, vertebral column, brain, spinal cord, eye, tonsil, thymus, intestines and spleen. The skin and bones which may used in gelatin manufacture belong to the low risk tissues as regards infectivity.

However, Decision 96/362/EC requires that the export of gelatin from the United Kingdom will not take place until the Commission has carried out inspections and found the production to be in accordance with the Decision. This will not be implemented until the scientific advice is clarified.

4. It is easier to implement a selective slaughter plan with a central register of animals and animal movements. The selective slaughter plan whereby cattle identified as being at risk of having been exposed to the agent will be subject to accelerated slaughter is based on identifying birth cohorts to known infected animals. This information has been stored in the United Kingdom on a central computerized system since 1988. However, there is no central data on animal movements. It is necessary, therefore to rely upon herd books on farms, breeders' records, dealers' records etc. These books are a legal requirement in the United Kingdom, but are less reliable than a centrally maintained system. Nevertheless, the system approved by the Commission is considered to be a satisfactory way of identifying a high percentage of animals exposed to the infected feed.