Health Scientific Committees Scientific Steering Committee (former MDSC) Outcome of discussions

Minutes of the Scientific Steering Committee Meeting of 16-17 July 1998

1. Welcome, apologies, introductory remarks

The chairman welcomed the participants and provided apologies of Profs. J.Bridges and V.Silano. The complete list of participants is given in annex 1.

2. Approval of the agenda

The agenda was approved with minor modifications (annex 2).

3. Approval of the minutes of the meeting of 25-26 June 1998

The minutes where approved with one minor modification. On behalf of the rapporteur for the opinion on organophosphates, adopted in June 98, the secretariat proposed a textual modification. No decision was taken.

4. Work plan for the SSC

4.1. Progress on multidisciplinary matters, not primarily related to TSE/BSE:

- Genetically modified organisms

Prof Silva Fernandes reported that the Scientific Committee Plants has adopted 7 opinions on genetically modified crops since May 1998.

The SSC also confirmed its opinion that no confusion should exist on the scope of application covered by a scientific opinion issued by the Scientific Committee for Plants, and which excludes the safety and risk aspects related to consumption as a food of GMOs or products containing or derived from GMOs and covered by the Novel Food Directive. This should be stated in a pre-amble to the opinions. Where necessary, a separate opinion should be prepared by the Scientific Committee for Food.

On a general level the SSC discussed the need for general guidelines for the assessment of GMOs. The SCP is working on guidelines for the preparation of a GMO-dossier on which basis the scientific opinion on its safety could be based. The SSC supported this action. It underlined the importance to take due account of the work going on in the OECD and the guidelines developed by the SCF.

The SSC noted that the criteria presently used for the evaluation of an GMO dossier were entirely based on the scientific knowledge of possible hazards related to the cultivation, multiplication, transport, use, etc., of genetically modified organisms. A discussion was held on the desirability to broaden risk evaluation exercises so as to include also factors other then the presently recognised possible hazards and which may emerge according as science progresses. Some of the examples given were the fate of GMOs once released in the environment, the possible risks resulting from involuntary (accidental) cross-fertilisation between genetically modified plants, the development over time of resistance against the characteristic(s) that are specific for a given GMO, etc. It was decided that a reflection document on this subject would be prepared. A first draft would be prepared by Prof. G.Pascal and discussed during the SSC meeting of 24-25 September.

Finally the issue of risk communication was raised and the SSC agreed on its importance, especially but not exclusively in the field of GMOs. Different measures to improve the risk communication where discussed but no final recommendation formulated. It was, however clear that good risk communication has to be transparent as to the basis of the risk assessment as well as to the temporary nature of scientific knowledge. It was also generally agreed that scientists would need support from professional "communicators", "translators" for transmitting their messages to the concerned non-scientific audience.

- resistance to antimicrobials

Prof.Jones, chairman of the WG-Antimicrobials, reported on the very successful first meeting of that WG. A general consensus was established as to the importance of that issue in the veterinary but in particular also in the human medical field and an approach was agreed upon. Members of the working group have undertaken to provide input and a first position paper with general orientations on the issue is scheduled for December. A final opinion is not expected before early summer 1999.

On behave of SCAN Prof.Bories underlined the importance of the position paper and the opinion because several antimicrobial feed-additives are in front of that committee.

As to the composition to the WG a short discussion was held concerning the question of independence and it was agreed that any interest should be clearly declared.

4.2. Multidisciplinary matters relating to TSE/BSE

- Report from the chairman of the TSE/BSE ad hoc Group:

Prof.Gibney, chairman of the TSE/BSE ad-hoc group, reported on the last meeting of the group. As the technical questions are dealt with under the next agenda items, he highlighted a concern which is building up: the relationship and responsibilities of the different levels in the SSC have to be clarified in order to avoid duplication of work. He had prepared a position paper on this that will be discussed at the next meeting of the ad-hoc group.

The SSC agreed to that concern and the outlined approach and looks forward to the outcome of the discussion in the TSE/BSE ad-hoc group.

Another general point made by M.Gibney was the risk that to high time pressure might endanger the quality of the work of the working groups. Time is needed to gather scientific information and to put it in context. Erroneous opinions would finally generate longer delays than appropriate schedules.

The SSC agreed to this problem but could not propose a solution.

- Reports on specific issues:

a. Production systems and products

> WG-Semen and Embryos

The TSE/BSE ad-ho group has decided to merge this issue with the pending question on maternal transmission and to create a WG "vertical transmission". This working group would also include the members of the existing working group on the Safety of bovine semen and embryos, as well as a specialist in BSE epidemiology. Prof. P.P.Pastoret, U.Liege, accepted to chair this group. A draft opinion is expected for September.

The SSC agreed to this move.

> WG-BSE in sheep

The report is under revision by the group, who has been informed of the comments of the SSC made at its June-meeting, and a new draft opinion shall be prepared by the TSE/BSE ad-hoc group at its meeting on 11/9/98. This should allow adoption of an opinion at the September meeting of the SSC. The WG-sheep has been informed to focus on scientific aspects.

The SSC appreciated this planning and underlined that a balanced view on the issue would be appropriate.

> WG-MBM for fur animals, cross contamination and organic fertilisers.

The SSC discussed in detail the combined draft proposal and provided several textual amendments and corrections, which have been noted by the secretariat.

Finally it was decided to formulate clear questions and ask the WG to respond to these questions in its next report. The TSE/BSE ad-hoc group should verify this at its next meeting and send a draft proposal to the SSC-meeting of September if appropriate. Members of the SSC who had additional comments on the issue should send these to the secretariat not later than 28/8/98.

> Safety of peptides and amino acids

The draft opinion was discussed in length because of the proposed quantitative approach. The SSC largely shared the conclusion and appreciated the effort made to carry out a quantitative risk assessment. However, the SSC felt that the remaining uncertainties are still too large and that values, which are based on assumptions and logic conclusions alone, could be misleading. The draft report was therefore send back to the working group with the request the prepare an opinion in line with the qualitative approach employed in the opinions of the SSC on the safety of gelatine, meat-and-bone meal and tallow.

In parallel the work done with the quantitative risk assessment should be continued because it was felt to be a useful tool for the assessment of the order of magnitude of a risk, even if the uncertainty do not allow to come up with a definite risk value. Scenarios, for example, demonstrating the impact of different assumptions, could help to illustrate the dimensions of a given risk.

The TSE/BSE ad-hoc group was invited to develop a methodology for quantitative risk assessment at the example of the hydrolysed proteins but with a view to apply it also to gelatine, meat-and-bone meal, tallow, dicalcium phosphate and other products, as soon as this would become possible.

> Working Groups on Fallen stock, recycling of poultry and pig waste, disposal by burial, disposal by incineration, environmental impacts of disposing of potentially BSE infected materials: (progress report);

The importance to have in the near future an opinion on fallen stock was underlined. A report is under preparation by the Working Group. A draft opinion may be expected for submission and discussion at the Scientific Steering Committee meetings of September of October 1998.

> Information by the Commission on the further follow-up given to the draft Decision proposals on gelatine, tallow and meat and bone meal.

Detailed additional questions appeared during the legislative implementation of the opinions. They have now been received and are distributed to the appropriate scientific committees or rapporteurs.

b. Human exposure risk

> WG-Human exposure risk

Prof.James presented briefly a paper which provides a conceptual framework the assessment of the Human Exposure Risk as regards BSE. It also contains a questionnaire which would provide useful insight into the critical parameters.

The SSC was supportive to the approach and invited Prof.James to finalise it and to send it to the secretariat. The secretariat should then distribute it to appropriate sources of information.

> Blood, blood products, implantables, sutures

Prof.Jones, chairman of the responsible Scientific Committee, reported that good progress was been made and that an opinion is expected in September. Quantification of the risk has proven to be extremely difficult.

c. Geographical risk

> Up-date on the Commission’s position as to the assessment of the TSE status of countries after the recent OIE-meetings

The Commission is preparing a recommendation to Member States and third countries as to the information requested for the evaluation of the TSE-status of a country. This information shall be prepared in accordance with the scheme established by the SSC in its opinion of February 1998. It should be sent in until September, 1 ^st.

> WG-Sourcing & Modelling

The Working group sourcing and modelling has made good progress with regard to the modelling part. It is behind schedule as to the development of a methodology for the exploitation of the data requested and a classification. This is partly due to the fact that the OIE has not yet finally defined its classification system. It would be preferable if the work of the OIE could be taken into account. However the SSC confirmed its opinion of 23 January 1998 on BSE risk, implying that in the evaluation of the TSE status of countries, both the incidence and propagation risks should be taken into account.

A tentative timetable for the evaluation of country dossiers was discussed and, while being very optimistic, accepted as a first attempt. The secretariat was asked to explore the possibilities of a closer collaboration with the OIE on this issue in order to avoid unnecessary duplication of work and frictions. It shall report at the next meeting.

As to the evaluation of country dossiers the problem of data quality was risen and it was recommended that inspectors from the commission’s FVO would be available to inform the evaluators on the results of inspections carried out in the countries under assessment.

As the issue is of eminent importance the SSC underlined the need for full transparency. The assessment methodology should be published in order to minimise the risk of arbitrary judgements. The handbook, announced to be discussed by the TSE/BSE ad-hoc group and the SSC in September, will play a key role in this context.

d. Monitoring

> Evaluation programme of diagnostic tests for TSE in bovines

The Commission informed the Committee on the outcome of the call for expression of interest for participation in an evaluation exercise for diagnostic tests for Transmissible Spongiform Encephalopathies in bovines. An encouraging response had been obtained from both provate companies and research bodies. The selection process is nearly terminated and successful applicants with a suitable test will be informed in the near future. It was hoped to commence the evaluation exercise in September.

The Commission also presented the draft protocol for the test evaluation, which had been developed by a special expert group and the Commission. The presented elements of the protocol covered the protocol criteria: (specificity of a diagnostic test, its sensitivity, its detection limits and its repeatability), the tissues to be tested (brain stem, spinal cord and specially prepared samples of tissues), the type of trial, the number of samples, the origin of the positive and negative samples, on-the-spot verifications in the participating laboratories, the time limits for carrying out the tests and for notification of the results to the Commission, etc.. A discussion was held and the SSC endorsed the proposed protocol.

5. Organisational matters

No organisational matters were discussed.

6. Co-ordination

6.1. Reports of the Chairmen of the 8 Scientific Committees

Annex 3 provides information on the activities of the various Scientific Committees since May 1998. This annex largely repeats the annex to the report of the SSC meeting of 25-26 June, which has been updated where necessary

6.2. Harmonisation of working procedures,

Due to time constraints, no discussion as such was held on this subject. R.Kroes was asked to further promote his work and to start working with the working group established at the June meeting of the SSC.

However, the SSC considered that the definition of "acceptable" or "negligible" risk levels was a priority issue. Prof.Kroes was therefore invited to put this item also as a priority item on the agenda of the Working Group, so that an opinion on this subject could be finalised as soon as possible and preferably before the end of 1998.

7. Information by the Commission services on matters related to consumer health

Due to time constraints, no Information by the Commission services on matters related to consumer health was provided. However, an Information note on the status of publication reports on Scientific Co-operation tasks was distributed by the DGIII representative.

8. Any other business.

> On the questions whether Scientific Committee meetings could be sponsored or supported by external bodies and possibly held outside Brussels, it was decided that such was not permitted

> It was further decided that SSC members could attend the Swedish initiative to study of Animal Production in Sweden (3-4.09.98), but only on a strictly personal basis, thus not as representatives of any Scientific Committee.

Next meeting in September will be a full two days meeting.

The meeting ended at 18h00.

Annex 1: List of participants of the Scientific Steering Committee meeting of 16 July 1998

List of presence

Members of the SSC :

Prof. Georges Bories, Prof. F.Garrido-Abellán, Prof. Michael J. Gibney, Prof. Philip James, Prof. Keith H.Jones, Prof. Fritz H.Kemper, Prof. Werner Klein, Prof. Ib Knudsen, Prof. Robert Kroes, Prof. Albert Osterhaus, Prof. Gérard Pascal, Prof. Antonio Silva Fernandes, Prof. Marcel Vanbelle, Prof. Martin Wierup

Participants from the Commission :

DGIII: L.Bansil, O.Rohte, J. Silva

DG VI A. Checchi Lang

DGXII: . A. Fabre, M.L.Vidal

DG XV A. Matton

DGXXIV: B.Carsin, S.Clarke, M.de Sola, C.Diez Ubierna, F. Drion, J.Kreysa, M.Lauridsen, G.Morrison, J.Moynagh, A. Sanabria, R. Vanhoorde, J. Vergnettes, P.Vossen, P. Wagstaffe, M. Walsh

Stagiaire: A. Wilhelm

Annex 2: Agenda of the Scientific Steering Committee Meeting of 16 July 1998

1. Welcome, apologies, introductory remarks

2. Approval of the agenda

3. Approval of the minutes of the meeting of 25-26 June 1998

4. Work plan for the SSC

4.1. Progress on multidisciplinary matters, not primarily related to TSE/BSE:

- Genetically modified organisms (progress report, Prof.Silva-Fernandes):

> Summary of opinions adopted since May 1998

> Guidelines for the submission of GMO dossiers (progress report)

- resistance to antimicrobials (progress report, Prof.K.Jones )

> report on the meeting of 15 July 1998 and further planning

4.2. Multidisciplinary matters relating to TSE/BSE

- General report of the work of the TSE/BSE ad-hoc group (M.Gibney)

- Reports on specific issues:

a. Production systems and products (M.Vanbelle)

> WG-Semen and Embryos (report);

> WG-BSE in sheep (report);

> WG-MBM for fur animals, cross contamination and organic fertilisers (progress report and possible adoption of an opinion);

> Safety of peptides and amino acids (report, possible adoption of opinion).

> Working Groups on Fallen stock, recycling of poultry and pig waste, disposal by burial, disposal by incineration, environmental impacts of disposing of potentially BSE infected materials: (progress report);

> Information by the Commission on the further follow-up given to the draft Decision proposals on gelatine, tallow and meat and bone meal.

b. Human exposure risk (P.James)

> WG-HER (progress report)

> blood, blood products, implantables, sutures (state of affairs)

c. Geographical risk (Osterhaus)

> Up-date on the Commission’s position as to the assessment of the TSE status of countries after the recent OIE-meetings (DG VI)

> WG-Sourcing & Modelling (progress report and work-schedule with regard to the assessment of TSE-status dossiers).

d. Monitoring (Osterhaus)

> Evaluation of diagnostic tests for TSE in bovines (progress report)

5. Organisational matters

6. Co-ordination

6.1. Reports of the Chairmen of the 8 Scientific Committees (for information)

6.2. Harmonisation of working procedures (discussion of the reports by K.Bridges and R.Kroes and adoption of a draft mandate for a working group)

7. Information by the Commission services on matters related to consumer health.

8. Any other business.

> Organo-phosphates (update);

> Scientific Committee meetings outside Brussels

> Invitation to study of Animal Production in Sweden (3-4.09.98)

Annex 3

Reports from the secretariats of Scientific Committees on the major activities and milestones since the SSC meeting of 14-15 May 1998.

Scientific Committee for Food

The SCF adopted two opinions at the plenary session of 3-4 June 1998.

The first opinion is a further advice on a previous opinion concerning pesticides in baby foods. It was requested as a matter of extreme urgency by the Commission in order to prepare legislation in this area. Members of the SCP and invited experts had taken part in the discussions for the preparation of this advice. This question had been outlined in the previous SSC meeting. The SCP was also involved with some other questions on similar matters.

The second opinion adopted concerns the risks to public health from fruits and vegetables and their products grown in countries where cholera has reached epidemic levels. The Committee provided with a thorough opinion evaluating these risks on the basis of the report from the Working Group Food Hygiene and Microbiology.

Scientific Committee Veterinary Measures related to Public Health

At its plenary of 22 June the SCVMPH adopted the following opinions:

1. Detection of Trichinella spiralis in pork with a pooled sample digestion method using a magnetic stirrer and two separatory funnels.

2. Detection of Trichinella spiralis in horse meat.

It also discussed the draft scientific opinion concerning the 9th code of Federal Regulations Part 304, et al. Pathogen reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Final rule;. In order to avoid any misunderstanding, the US was invited to explain the Megareg to the Committee and to answer any possible questions. This was however, without participation in the scientific debate or in the drafting of the final opinion. It is foreseen to adopt the draft opinion at the next plenary that is scheduled for 20 July.

Considering the comprehensiveness of the issue there was ample time left to discuss other issues.

Working group meetings were held on the following subjects:

1. Final decontamination

The working group concerning the use of antimicrobial treatments of poultry carcasses, the various methods of carcass rinsing including trisodium monophosphates (TSP), organic acids and hyperchlorinated water finalised its draft opinion at the end of May. The final draft is circulated to all the members of the Committee with a view of its discussion and possible adoption at the plenary on 20 July.

2. BST

At its second meeting on 16 June the working group discussed a first draft report. The latter will be reviewed in the light of the discussion and considering the outcome of the work in the second group that is concentrating on the animal health and animal welfare aspects of the issue.

3. Simplification

On 18 June a working group had an exchange of views on a first reflection document concerning the evaluation of microbiological criteria and temperatures for storage and transport of products of animal origin intended for human consumption. The next meeting is scheduled for 29 September.

Members of SCVMPH alsoe contributed to the following working groups:

- working group hygiene and microbiological criteria of the Scientific Committee on Food that adopted an opinion on cholera,

- BST (animal health and animal welfare aspects),

- Johne’s / Crohn’s disease

Scientific Committee on Animal Health and Animal Welfare

18 May 1998: Subcommittee on Animal Welfare

The subcommittee approved a report on gas stunning which was forwarded to the plenary meeting of the Committee. The subcommittee also set up a working group to examine the welfare of broiler chickens.

19 May 1998: Subcommittee on Animal Health

The subcommittee approved a report on the eradication of scrapie and on research developments in Swine Vesicular Disease. Both reports were forwarded to the plenary meeting of the Committee. The subcommittee also nominated an expert to participate in the steering group on antimicrobial resistance.

23 June 1998: Plenary meeting of the Committee. Two reports were adopted unanimously by the Committee

- The use of gas mixtures containing CO2 for the stunning or killing of poultry.

- Standards for running eradication programmes for Scrapie

A third report on Swine Vesicular Disease was discussed. This is now undergoing written procedure for adoption.

The following working group meetings have also been held:

- 28 May 1998: Meeting Working Group of Animal Health subcommittee on Directive 64/432 – Diagnostic Methods for Tuberculosis, Brucellosis and Enzootic Bovine leucosis. A working document is now being drafted which will form the basis of the report.

- 8 June 1998: Working group on BST. This group is looking at the welfare and health aspects of the use of BST. Areas identified for examination include, increased incidence of mastitis, lameness and injection site reactions. This report will need to carefully drafted and be based on solid science .

- 10 June 1998: Meeting Working Group of Animal Welfare Subcommittee on Forced Feeding of Ducks and Geese – Gavage. Difficult issue needing much discussion. The text of the report is now complete and discussions are taking place on the conclusions and recommendations.

- 17 June 1998: Meeting Working Group of Animal Health subcommittee on Emergency vaccination for Foot and Mouth Disease. The text is now virtually finalised. One final meeting will be necessary in September to complete this.

Scientific Committee on Toxicity, Ecotoxicity and Environment

The meeting of the working group on ‘Endocrine disrupters’, foreseen for the 29 ^th of June 1998, was called off and the decision taken to postpone it for the 8 ^th of September 1998.

Before the summer period only two other meetings, one of the working group ‘Chrysotile asbestos’ and another of the working group ‘Creosotes’ are foreseen. The former will take place on the 22 ^nd of July and the latter on the 10 ^th of August. It is expected that at both meetings the final working group draft opinions will be agreed with a view to submission to the next CSTEE plenary (14/15 September 1998).

DG III finally sent to the CSTEE secretariat the terms of reference for the consultation of the committee on the subject ‘Azo dyes’. These have just been sent, together with a few background documents, to CSTEE members. A working group had been set up at the CSTEE plenary meeting of April 98 and consideration is being given to what may be the best working arrangements to tackle this opinion request (either a straight drafting of an opinion in view of its discussion at the next plenary or organising a working group meeting- unlikely before the summer break).

On the subjects ‘Tin, Arsenic, Cadmium and PCP’, DG III, the opinion requesters, organised a meeting with M. States (working group on Directive 76/769/EEC on restrictions of marketing and use of certain dangerous substances and preparations) that took place the 7 ^th of July. The CSTEE secretary attended and presented, for information of M. States, the draft opinions (in a not yet finally adopted form by the committee, something explicitly emphasised by the CSTEE secretary and the DG III officials present). The general reaction of M. States was positive but Industry representatives complained at the fact that the draft PCP opinion, as presented, did not reflect correctly (their views) on the real risks posed by that chemical.

As indicated in the previous report on the activities of the CSTEE the subject 'Phthalates in toys' was followed up in the form of a meeting of the Emergencies committee that took place on the 14th of July 98. The meeting was organised by Unit XXIV/A/4 (Consumers' safety and Environment) and staff from the Dutch RIVM presented the so-called 'Dutch study', the aim of which is to allow for the standardisation of a test method on phthalate release (the CSTEE had indicated in its opinion on 'Phthalates in toys' that the results of such study could lead them to revise their opinion). During the meeting there was ample opportunity to comment on some conceptual aspects characterising the study. The representatives of Greenpeace in particular made a detailed presentation of their reading of the available scientific evidence, questioned some of the relative (as they saw it) mild nature of the conclusions of the CSTEE on the subject, something on which they were largely backed by the BEUC (Consumers organisation), and voiced strong criticisms at the Commission for not having taken a stronger stance than just proposing a recommendation. They also questioned the independence of the 'Dutch study' given that it is being largely financed by Industry. The 'Phthalates in toys' working group was represented by its chairman, Prof. Erik Dybing who, at some point during the meeting, had to point out that there was a distinction to be made between 'effects assessment - hazard characterisation' and 'risk' (it is important to realise that people at a significant level of responsibility can still mix the two amazingly easily). Regarding the future role to be played by the CSTEE on the follow up to the 'Phthalates in toys' issue, it was agreed that the first conclusions of the 'Dutch study' will be forwarded to the CSTEE for comments; hopefully their first reaction should be possible by the next CSTEE plenary meeting (14/15 September 1998).

The chairman of the working group ‘Water framework directive - WFD’, Dr Tarazona, was invited by Unit XI/E/1 of the Commission to attend the meeting they organised with M. States on the 2 ^nd and 3 ^rd of July 98. The meeting was an opportunity to inform M. States of the status of development of the procedure for selection of priority substances for the WFD. The CSTEE secretariat could only be present at the start of the meeting but Dr Tarazona will provide later a short report on the meeting where he had a chance to explain to those present the opinion adopted by the CSTEE on the selection of priority substances.

Scientific Committee for Medicinal Products and medical Devices

The Committee met in plenary meeting on 24 June 1998. Before this meeting several Working Group meet several times.

The Working Group concerning "Equivalency of alternative products for the use of intestine of animal origin for surgical sutures" prepared a draft report that would be approved by written procedure, if necessary, or in the next plenary meeting of the SCMPMD.

Concerning "Orphan Medicinal Products: guidance on the notion of ‘same medicinal product’ and ’clinical superiority’ for the purpose of marketing exclusivity", the Working Group made progress with its reports, but while for the notion of "same medicinal product" the report is almost finalised, the report on "clinical superiority" needs further improvement.

The Working Group on "Transmission of CJD by blood and its derivatives, and transplantation of human organs" met several times, and an interim report was presented to the Plenary. An overview on the general scope of the issue is now available, but the specific reply to the request made by the Commission will be redrafted in a next meeting of the W.G. in September. Several request are, according to the group, very difficult or impossible to answer given the actual scientific knowledge.

The Working Group on "Antimicrobial Resistance (partim: medicinal products)" had met two times, and is presently establishing the issues that will be addressed in the report.

Other Working groups such as "GMP for starting materials", "Colouring matters for use in medicinal products", "Draft guidelines on the use of specified risk materials for the manufacture of implantable medical devices" made also progress, particularly for what concerns the subject of "Colouring matters".

Scientific Committee Cosmetic and non-Food Products

Two working party meetings took place. The points dealt with are :

a) Inventory (96/335/EC): in the framework of the 1 ^st updating of the inventory and common nomenclature of ingredients employed in cosmetic products, a discussion with the cosmetic industry took place concerning the cosmetic functions.

b) UV filters : As mentioned during the SSC meeting of April 1998, the Working Party concerned started its preparatory work on the organisation of an "expert panel workshop" to address issues of ‘sun protection’ such as the use of sunscreen formulations or other sun protection measures and their relation to (skin)diseases, including melanoma and cancer, and/or to address health risks in general in relation to exposure to the sun. The list of experts to be invited was established as well as the draft agenda of the workshop.

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