WRITTEN QUESTION E-1541/96 by Salvador Jové Peres (GUE/NGL) to the Commission (17 June 1996)

Subject: Control of bovine spongiform encephalopathy (BSE)

On 27 June 1994 the Commission defined high-risk animal products and recognized treatments to inactivate the BSE agent. However in its decision of 6 March 1995 it stated that 'it is not possible at present to define processes which can guarantee total inactivation of the [TSSE] agents in the commercial rendering industry'.

1. In view of the fact that these decisions were motivated by health concerns, has the Commission assessed the risks which were taken in the past on account of changes to the assessment of scientific evidence? To what extent does the Commission intend to take responsibility for risks to human health as a result of such changes?

In view of the Commission's proposal to lift the ban on tallow, gelatine and semen,

2. What new information has the Commission obtained that enables it to put forward a proposal for the partial lifting of the ban on tallow, gelatine and semen from the United Kingdom?

3. Can the Commission forward the scientific evidence it holds which enables it to put forward a proposal for the partial lifting of the ban? Can the Commission forward a description of the new scientific experiments carried out and the results thereof and say who carried them out and what the relevant scientific bodies' assessment of them is?

4. Does the Commission regard as sufficient the evidence forwarded to it by economic operators with interests in the sector (reports drawn up by gelatine manufacturers' associations)?

5. Can the Commission submit the relevant scientific bodies' assessment of the implementation of the plan to eradicate BSE in the United Kingdom?

6. In the Commission's proposal, has the scientific evidence relating to consumer protection outweighed political pressure exerted by the United Kingdom, or vice versa?

Supplementary answer given by Mr Fischler on behalf of the Commission (3 April 1997)

1. Further to its answer of 2 August 1996 the Commission adopted two measures during 1994 to prevent the exposure of animals to the agents of spongiform encephalopathies:

- Decision 94/381/EC ((Commission Decision of 27 June 1994 concerning certain protection measures with regard to bovine spongiform encephalopathy and the feeding of mammalian derived protein - OJ L 172, 7.7.1994. )) which prohibited the use of mammalian protein for ruminant feed, and

- Decision 94/382/EC ((Commission Decision of 27 June 1994 on the approval of alternative heat treatment systems for processing animal waste of ruminant origin, with a view to the inactivation of spongiform encephalopathy agents - OJ L 172, 7.7.1994. )) which laid down minimum standards for the processing of animal waste of ruminant origin.

These decisions were based on the preliminary results of a study of the inactivation of the agent of bovine spongiform encephalopathy (BSE) funded by the Commission. The standards were stated at the time to be provisional, recognising the possibility that it might be necessary to amend them in the light of future knowledge. However, they were based on scientific evidence then available that the BSE agent was inactivated in systems which complied with these standards. The Commission supported further studies to establish the effectiveness of the same processes to inactivate the scrapie agent. The results of these studies became available in February 1996. In summary, they demonstrated that only one system out of those tested (133° C at 3 bar for 20 minutes) was capable of inactivating the agent of scrapie. Accordingly, the Commission adopted Decision 96/449/EC ((Commission Decision of 18 July 1996 - OJ L 184, 24.7.1996. )) in order to strengthen the parameters introduced in 1994 to bring them up to the standards identified as effective in the scrapie study.

Since 1994, therefore, ruminants have been protected by the ban on use of mammalian protein, and other species have been protected by the minimum rendering standards. The protection for non-ruminants has been improved by Decision 96/449/CE.

However, according the the report of the scientific veterinary committee of October 1996 on risks from certain specified risk material, even 133°C at 3 bar for 20 minutes does not give absolute guarantees. In view of this and the uncertainty over the true status of Member States with respect to transmissible spongiform encephalopathies, the Commission proposed measures to remove specified risk materials from food and feed across the Community. This was rejected in December 1996 by the majority of Member States both in the standing veterinary committee and the Council. This was particularly disappointing in view of the agreement by the Member States to a Commission proposal to exclude brain, eyes and spinal cord from cosmetics. The Commission regrets that its proposals aimed at discharging its responsibilites to protect human and animal health did not enjoy the support of a sufficient number of Member States to be enacted. The Commission may return to this issue, with appropriate proposals, in the light of the results of inspections carried out in Member States on the implementation of BSE legislation.

2. Commission Decision 96/362/EC ((Commission Decision of 11 June 1996 - OJ L 139, 12.6.1996. )) amending Decision 96/239/EC ((Commission Decision of 27 March 1996 - OJ L 78, 28.3.1996. )) was based on a scientific assessment that gelatine and tallow produced in accordance with the rules laid down in the annex to the Decision, and semen, were considered safe. One of the most important criteria in assessing the safety of tallow and gelatine 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 (skull, vertebral column, brain spinal cord, eye, tonsil, thymus, intestines and spleen) are excluded. The skin and bones which may be used in gelatine manufacture are classified as low risk tissues.

An interim report by Inverest research international limited, an independent research laboratory, on the validation of the clearance of scrapie from the manufacturing process of gelatine (IRI Project No 851180) was another element used in the risk assessment of gelatine. The study was financed by the Gelatine manufacturers of Europe (GME), an organisation with members throughout Europe. GME presented summary data on the interim report of the study to the scientific committee on food on 15 April 1996, and the complete interim report to the scientific veterinary committee on 26 April 1996.

On 26 June 1996, the Commission was made aware of a final report on the Inveresk study which brought into question the results on which the Commission had based its decision to lift the ban on gelatine. Full details, as well as the two versions of the Inveresk report, have been provided to the committee of inquiry into BSE.

Draft protocols for a new independent study on inactivation of BSE in gelatine production have been discussed in the scientific veterinary committee and the multi-disciplinary scientific committee.

With respect to tallow, tests have been carried out on tallow produced during the rendering studies previously mentioned. No infectivity was found even in samples from processes where the protein fraction was positive. Additional safeguards are provided by the exclusion of the high risk tissues and by filtration of the end product.

However, neither gelatine nor tallow derived from UK cattle can be exported at present, since the preconditions of Decision 96/362/EC lifting the ban on these products have not been fulfilled. No further steps in this process will be taken with respect to gelatine until a re-evaluation of the risk from gelatine has been carried out in the light of the latest scientific findings.

Both transmission studies and epidemiological studies have failed to provide evidence that semen is a risk factor for BSE.

3. The reports of the scientific veterinary committees and the two Inveresk research reports (interim and final) have been provided to Parliament's committee of inquiry.

4. The system under which manufacturers are required to provide data to support their claims for the efficacy and safety of their products is well-established and accepted, particularly for the approval of pharmaceutical compounds. This approach does depend on the integrity of the laboratory which carries out the work and the manufacturer which pays for it. As such, the Commission has no particular reason to doubt the integrity of the research laboratory in this case, but the Commission has noted and subsequently made clear to GME that the final results had been available to GME before the presentation made by GME to the scientific committee on food on 15 April 1996. Any scientific information or data used by the Commission is scrutinised by the appropriate scientific committees, and it is their advice, not the advice of the scientists which produce the data, which the Commission uses for its proposals.

5. The plan submitted by the United Kingdom for the eradication of BSE was appraised by the standing veterinary committee, and given a unanimous positive opinion on 24 June 1996. Commission Decision 96/385/EC ((Commission Decision of 24 June 1996 - OJ L 151, 26.6.1996. )) was adopted on the basis of that vote, and published. This is the usual procedure for the adoption of eradication programmes in the veterinary field.

6. All Commission proposals are based on scientific advice, and the interests of the consumer are the first priority when acting on this advice.