Health and Consumer Protection - Scientific Steering Committee

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Scientific Committees

Scientific Steering Committee (former MDSC)

Outcome of discussions

The chairman welcomed the participants and provided apologies of Prof.Dr.M.Gibney, Prof.Dr.W.Bridges (for 23.10.98) and Prof.Dr.R.Kroes (for 22.10.98). The complete list of participants is given in annex 1.

Prof.Dr.G.Pascal further informed the SSC of the resignation of Prof.Dr.Silva Fernandes as chairman of the Scientific Committee Plants (SCP) and as member of the Scientific Steering Committee (SSC). Prof.Silva Fernandes resigned for personal reasons. Prof. Pascal thanked Prof.Silva Fernandes on behalf of all the members of the SSC for his involvement and contributions in both Committees.

The agenda was approved with minor changes. The approved version is attached as Annex 2.

The draft minutes were approved, after introduction of minor changes. The approved version is published on the INTERNET. SSC- members have received copies.

a. The mandate for a working group reflecting on "Considerations for the evolution of scientific advice to address emerging health issues".

Prof. Dr. G. Pascal, chairman of this group introduced a reflection paper on the main points.

It was agreed to continue the work on a general reflection paper in close co-operation with the work on the "harmonisation of working procedures" (see next point).

At the last SSC-plenary meeting the chairpersons of the Scientific Committees have been asked to appoint representatives as members in the WG. Until now, only the SC-AHAW, SC-CNF and SC-P have responded. The chairpersons of the other Committees are urgently asked to do so without any further delay.

To get the work on the way an inventory should be established of the use of terms like "negligible risk", "acceptable risk", "threshold value", etc. Prof.Bridges offered to look into the matter and to come back to the secretariat. The chairmen where reminded of the request to provide information on the risk assessment methods used in their respective committees.

Prof.K.Jones briefed the SSC members of the progress made by the Working Group. The present planning is maintained. Before end 1998 a first working document providing general indications on the issue of antimicrobial resistance will be prepared. A draft opinion will be submitted to the SSC by April 1999.

On behalf of Prof.Dr.M.Gibney, chairman of the ad hoc Group, who had to be absent, Prof Vanbelle reported briefly on the last meeting of the group. He mentioned that Dr.Malmfors resigned and that Prof.Smith, London, did not accept the invitation to become a member of the group. The secretariat is asked to get in contact with other candidates in order to replace Dr.Malmfors and Prof.Anderson, who resigned in July.

Reporting on the specific topics addressed by the group was left to the detailed discussion, reported hereafter.

Prof.Dr.M.Vanbelle, rapporteur, presented a scientific report and the draft opinion prepared by the TSE/BSE ad-hoc group. This final draft was based on the written consultation organised following the agreement reached during the previous SSC meeting and on further discussions held by the TSE/BSE ad hoc Group during its meeting of 15 October 1998.

In the short discussion the aspect of quantitative risk assessment was raised. It was underlined that such approaches should be developed and used, at least as tool for verifying a qualitative judgement. Clarification as to the industrial process was requested, underlining the 140°/30 min/3.6 bar is not meant to become a new standard for safe heat/pressure treatment. The opinion should make clear that the described process, to which the opinion refers, is in fact a process currently applied by industry, and not an ideal process which should be taken as norm, replacing 133/20/3.

The Report and Scientific Opinion on the safety of hydrolysed proteins produced from bovine hides was adopted after discussion and amendments. (See annex).

b.2. The protection against the risk of infectious agents or non conventional transmissible agents entering the human food or animal feed chains via raw material from "fallen stock" (including also, for example, exotic/zoo animals, fur animals, dead animals, condemned materials, sick animals and laboratory animals).

The opinion prepared by the TSE/BSE ad-hoc Group on the basis of the draft report prepared by the Working Group "Products" was discussed in detail. The SSC concluded that the draft opinion and the supporting report, although of high scientific quality, were covering too many subjects at the same time. It would be preferable to prepare a separate opinions on the different issues covered by the report.

In the view of the SSC the section covering the risks related to toxic and undesirable substances needed to be revised and further expanded.

The working group was therefore invited to revise its report in the light of the preceding comments. The SSC will discuss the matter again, once the TSE/BSE ad hoc Group has prepared new draft opinions covering the various aspects of the isue.

b.3. Intra-species recycling of animals recycling waste, and environmental aspects of disposing of potentially infected materials.

The Working Group is expected to submit a draft report to the TSE/BSE ad hoc Group at its meeting of 3 December 1998. It might then be discussed by the SSC at its meetings of December 1998 or January 1999.

A meeting was held on 8/10/98 where it was agreed to try to produce a framework that would allow estimating the number of human servings derived from one normally processed adult cattle. Special emphasis should be put on the use made of SRMs and the routes by which they could be consumed by humans. If appropriate data could be obtained, such a framework should allow estimating the theoretical number of consumers who could be exposed to any SRM of the assumed model cow. In this context it is also going to be necessary to look into the diets of different consumer groups.

Based on FR and UK data the WG-HER will try to calculate some scenarios, mainly for demonstrating why precise data would be needed.

Prof.Dr.K.Jones, chairman of the Scientific Committee Medicinal Products and Medical Devises (SC-MPMD), presented and explained the Opinion on the risk quantification for CJD transmission via substances of human origin, adopted by this Committee on 21 October 1998. He also clarified a number of issues raised by the SSC members.

The SSC congratulated the members and chairman of the SC-MPMD for the quality of this very comprehensive opinion.

The 10 ^th version of the handbook was distributed to the members and introduced by the secretariat. A short discussion indicated general agreement but formal adoption was postponed until the TSE/BSE ad-hoc group would have finalised it in the light of the planned trial and further discussions. The quality of data was mentioned as a critical bottleneck in the assessment process.

As a general point the SSC underlined the need to define assessment criteria before the assessment.

The assessment process was outlined as follows: Independent external experts, who will report to the TSE/BSE ad-hoc group, will carry out the risk assessment. These experts have to be briefed on the basis of the final version of the handbook. They should receive support from the Commission and the Country under assessment in order to be able to judge and interpret the data correctly. Their final product will be a report identifying the geographical BSE-risk and justifying this conclusion. It has clearly to explain where solid scientific information was used and where expert judgement was employed. On the basis of this report the ad-hoc group will prepare a draft opinion of the SSC on the geographical BSE-risk in a given country.

The SSC agreed to this process and requested that the assessment panel is chaired by a member of the TSE/BSE ad-hoc group or of the SSC.

The following criteria for the selection of experts where presented to, and adopted by the SSC:

Expertise in one or several of the following fields: husbandry of dpmestic ruminants; quantitative epidemiology of animal diseases, preferably TSEs, with expertise in statistics; slaughterhouse and rendering practices, veterinary control (surveillance, preferably of TSEs) and legislation.
Language skills: english (obligatory), french and spanish (advantage), any other additional official language would be welcome.
Nationality is only a secondary criterion but as no country should be assessed by an expert from that country, a balanced composition of the assessment panel is required.

b.8. BSE status-categories of a country or region and modulation of the list of specified risk materials

The SSC agreed that work on the definition of categories of BSE-status would start from the recent OIE-proposal for a BSE-Code. A non-conclusive first exchange of views was held.

It was agreed that an opinion on these categories should be issued before the first country dossier would be assessed.

The SSC was reminded of the comparison table prepared by the secretariat for the compatibility of the recent OIE proposal with the existing SSC opinions. No detailed discussion was held but the ad-hoc group was asked to look into the matter.

In June 1998, Directorate General VI - Agriculture invited the Scientific Steering Committee to evaluate a new process for the production of gelatine from bones regarding its equivalency with commonly used industrial gelatine production processes in terms of its capacity of inactivating/eliminating possible TSE infectivity in the raw material. A description of the production process, developed by a Swedish company, was provided.

The evaluation was referred to the "Safety of Products" Working Group of the TSE/BSE ad hoc Group. Prof.Dr.Vanbelle presented the report of the Working Group and its main conclusions. These were adopted by the SSC:

The SSC considers it impossible evaluate at present the equivalency of the alternative production process in terms of the inactivation/elimination of TSE infectivity.
As for the classical acid alkaline process, a study with spiked BSE infected raw material is needed in order to estimate the infectivity reduction factor of the production process. An example of such study is described in Inveresk (1998), and was commented on in the Scientific Steering Committee's Opinion on the Safety of Gelatine adopted on 26-27 March 1998 and updated on 3 April 1998. The Scientific Steering Committee invites the company to carry out such an independent research on the TSE inactivation/elimination capacity of the alternative process. The inactivation should be assessed for the process as a whole. It is only when the results of such research will be available that a comprehensive evaluation of the equivalency of the alternative process in terms of TSE inactivation/elimination can be carried out.
For gelatine derived from ruminant bones, the Scientific Steering Committee's Opinion on the Safety of Gelatine adopted on 26-27 March 1998 and updated on 3 April 1998, remains valid. At present, the only preliminary conclusion can be that ruminant bones from animals certified fit for human consumption, to be used for production of gelatine with the alternative system, will have to come from BSE-free or BSE-negligible risk countries

The SSC further expressed its wish to draw the attention of the Commission on the possible formation of chloropropanol or nitrosamines if hydrochloric acid or nitric acid is used in gelatine production processes such as the one evaluated.

b.10. Updating of the Scientific Opinion on the Safety of Gelatine, adopted on 26-27 March 1998.

Since the date of adoption of the opinion on the Safety of gelatine, the final versions of the Inveresk Research reports (1998) on the Validation of the clearance of scrapie from the manufacturing process of gelatine have become available.

In its opinion on the Safety of Hydrolysed Proteins, the SSC recommends that the raw material (hides) should be obtained from healthy animals. However, the opinion on gelatine states that the material should be obtained from animals that are fit for human consumption.

The Scientific Opinion on the Safety of Gelatine needs thus to be updated in the light of the above final results and amended to avoid possible inconsistencies with the opinion on the Safety of Hydrolysed Proteins. Prof.Dr.M.Vanbelle accepted to prepare an updated draft, which would be discussed by the TSE/BSE ad hoc Group and submitted for adoption to the SSC at its meeting of 10-11 December 1998.

b.11. The safety of bones produced as by-product of the Date Based Export Scheme (DBES).

Prof.Dr.P.James, chairman of the Working Group Human Exposure Risk, and member of the TSE/BSE ad hoc Group presented a draft report and opinion on the above subject, prepared by the TSE/BSE ad hoc Group following an urgent request from Directorate VI - Agriculture.

Following discussion and amendments, the report and opinion were adopted. They are attached to these minutes as Annex 4.

The SSC stressed that this opinion was only valid under for the specific conditions in the UK Date Based Export Scheme. It could not be generalised other situations were conditions such as age at slaughter, surveillance, traceability of animals, etc. would be different.

With regard to the safety of bones in general it was stated that a verification of the existing information on BSE-infectivity of bone-marrow of "normal" BSE-cases would be needed before addressing that issue.

b.12. Comments on the Opinion on Cross-contamination, adopted on 24-25 September 1998. Following the publication on internet of this opinion, a written comment was received questioning the validity of the risk assessment carried out in the frame of this opinion. The comment was distributed to all SSC members and it was agreed that the Working Group would further look into the matter and possibly prepare an answer and, if necessary, an update of the opinion.

c. The EU conference on food security: lessons from the BSE crisis (information; contributions from the SSC)

Mr.J.J.Rateau (Adviser to the Director general of DGXXIV) presented the programme of the Conference, which is being organised jointly by the European Commission and the European Parliament and which will be in Brussels on 30.11.98 and 1.12.98.

Mr.J.J.Rateau presented also the new version of the Vademecum on BSE, which was finalised by Commission Services in the course of October 1998. Copies were distributed.

The proposal to change the normal distance of the SSC-plenary meetings to 6 weeks was discussed and it was agreed that this could be envisaged from September 1999 onwards. Until then the members felt unable to change their agendas. The Secretariat was asked to propose as soon as possible a schedule for the period September 1999 to September or October 2000.

The chairmen of Scientific Committees reported on the activities of their committees since the last SSC meeting (22-23 September 1998). A summary of their reports is given in annex 3.

Mrs.Colombo (DGVI-Agriculture) presented the progress regarding the various legislative proposals and amendments that were presently under preparation related to gelatine, tallow and meat-and-bone meal. Their scientific justification is largely based on the corresponding SSC opinions and reports. In addition, proposals are being prepared covering the production and trade requirements for hydrolysed proteins and dicalcium-phosphate.

A.M. HALSBERGHE, DGV/F informed the Committee on the recent adoption by the European Parliament and the Council of the Decision N° 2119/98/EC on the setting up of European network for the surveillance of communicable diseases. The objectives of the network are twofold. Firstly, the epidemiological suveillance of certain categories of communicable diseases listed in the Annex of the Decision, including those diseases transmissible by non-conventional agents such as TSEs. Secondly, early warning and response system for the prevention and control of these diseases. In relation to antimicrobial resistance, DGV/F will continue its input into the work of the WG-Resistance to antimicrobials, and will transmit to the SSC-secretariate more details about projects financed by DGV which are of interest to the WG and, in particular, the European Antimicrobial Resistance System (EARSS).

Finally, she thanked the chairman of the SCMPMD for the excellent report and Opinion on the risk quantification for CJD transmission via substances of human origin, opinion which had been requested by DGV.

Annex 1: List of participants of the Scientific Steering Committee meeting of 22-23 October 1998

Annex 2: Agenda of the Scientific Steering Committee Meeting of 22-23 October 1998

a. The mandate for a working group reflecting on the possible need to broaden risk evaluation exercises so as to include potential hazards not yet recognised, including regarding Genetically Modified Organisms. (Progress report)

b.3. Intra-species recycling of animals recycling waste, and environmental aspects of disposing of potentially infected materials (progress report);

b.5. Blood, blood products, implantables (Progress report by the Scientific Committee for Medicinal Products and Medical Devises)

b.8. BSE status-categories of a country or region and modulation of the list of specified risk materials (discussion).

c. The EU conference on food security: lessons from the BSE crisis (information; contributions from the SSC)

Reports from the secretariats of Scientific Committees on the major activities and milestones since the SSC meeting of 24-25 September 1998.

On its meeting of 29-30 September 1998, the Committee adopted an additional list of microorganisms proposed as feed additives for different animal species. An extended discussion of the draft opinion on the critical analysis of the scientific arguments supporting the german safeguard clause against the use of dimetridazole in turkeys did not allow to reach a final opinion. Another meeting of the corresponding Working group is planed for 30 October 1998. Different Working groups reported on the progress of the following matters: use of formaldehyde as preservative agent for feed, extension of use of virginiamycin for sows and gilts, and use of diclazuril for rabbits.

At the plenary meeting the Committee adopted a report on Bluetongue dealing in particular with the importation of live ruminants from both endemic countries. It also dealt with a specific question concerning the importation of animals from Australia.

3. The welfare aspects of the use of BST in dairy cows. This is a joint report with the Committee on Veterinary Public Health

The foie gras report and the report on BST are scheduled to be completed before the end of the year as is also a report on emergency vaccination against Foot and Mouth disease.

At its plenary of 15 July the SCVMPH adopted the " Opinion of the SCVMPH on the 9th code of Federal Regulations Part 304, et al. Pathogen reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Final rule".

The Committee also discussed the comprehensive draft opinion concerning the use of antimicrobial treatments of poultry carcasses, the various methods of carcass rinsing including trisodium monophosphates (TSP), organic acids and hyperchlorinated water.

2.1 BST. The next meeting of the Working Group concentrating on the public health aspects of this issue is scheduled for 02 October.

2.2 Simplification. The next meeting of the Working Group is scheduled for 29 September.

2.3 Cooling of carcasses during transport. Substantial progress has recently been made on this since long outstanding question. A final Working Group meeting should take place on 09 October.

2.4 Cysticercosis. The Committee established a Working Group to examine this question.

2.5 Revision of ante- and post-mortem inspection procedures for an alternative inspection system for the slaughter of pigs. A draft report is being circulated amongst the members of the Working group.

Prof. Kemper, the chairman, reported on the topics dealt with since the last SSC meeting. He said that, since the SSC meeting of 24-25 September 1998, one working party meeting took place on the updating of the inventory.

During this WP meeting, the new entries were discussed with Joint Research Centre and COLIPA. These new entries are to be inserted in the present version of the inventory.

On 15 October, COLIPA submitted its draft first update. This document will be the basis of discussion during future meetings in order to come to an acceptable version for the 3 partners concerned, namely the Commission, the SCCNFP and Industry.

Since the previous SSC meeting (24/25 September 1998) the CSTEE did not have any plenary meeting, the next one being scheduled for 26/27 November 1998. However the following working group meetings and/or activities took place:

A working group meeting took place on the 16 ^th of October 1998. This meeting was an opportunity to revisit the draft that has reached a fairly advanced stage. Major changes to the structure (reordering of points/chapters) of the draft were proposed following comments from a JRC representative that attended the meeting. Prof. Brandt, an external expert which is member of the working group, has brought a major contribution on reproductive effects of EDCs on birds and also a more general one on EDCs and wildlife health.

An official of the Risk Evaluation Unit of DG XXIV made a presentation on the issue of hormones, a subject which that Unit is following, namely by means of a series of research initiatives on six hormones used for animal growth promotion. The EDCs working group agreed to include a reference in its paper to this problem.

It was also agreed to make it clear in the report that its focus is on the European situation and this because it was acknowledged that the concerns in the US for instance (e.g. importance of effects to wildlife species) are somewhat different.

As a follow up to this activity it was agreed that two sub groups of the EDCs working group should meet separately to finalise the bits for which each is responsible. One subgroup will meet in Madrid on the 9 ^th of November and the other in an as yet place and date to be decided. They will finalise their bits in view of the next main EDCs working group meeting on the 13 ^th of November 1998 in Brussels.

The so-called 'Dutch consensus group' study has in the meantime been concluded, its results made public (22 September 1998) and copies sent to CSTEE members. Other studies/data have also been made available, in particular a preliminary summary of a study under the title 'Migration of DEHP and DINP from PVC articles' from the Austrian Institute of Food Chemistry and Food Technology of the Vienna University of Technology and still another from the 'Instituto Tecnológico del Juguete' (AIJU), Spain, on 'Analytical method for the determination of the migration of phthalates in plasticized PVC'. These too have been made available to the CSTEE. More recently the CSTEE Secretariat received a copy of still another study, this one from the Laboratory for the Government Chemist - UK; its title is 'Laboratory-based Agitation Methods for Determining Phthalate Plasticiser Migration from PVC Toys and Childcare Articles'.

Given this new set of data the CSTEE were sent recently the following new terms of reference for a new consultation on the subject :

1. In the light of the new evidence ('Dutch Consensus Group' study and other data/studies made available to the CSTEE since its plenary meeting of June 1998) how do the respective results change the previous opinions of the CSTEE, in particular the concern expressed before in the opinion on 'Phthalate migration from soft PVC toys and child-care articles' of 24th of April 1998?

2. What further work/activities does the CSTEE deem necessary in order to develop and validate reference methodologies for the purposes of the safety control of those articles in respect of which the CSTEE has expressed its previous opinions.

Members of the 'Phthalates in toys' working group are due to meet on the 13 ^th of November at the margins of the EDCs working group and again on the 23 ^rd of November in view of adopting a draft opinion for submission to the CSTEE plenary (26/27 November 1998).

Furthermore an Industry delegation met DGXXIV officials to provide information on substitutes for phthalates (citric acid esters). It is likely that the CSTEE will be asked to give an opinion on substitutes to phthalates (very much as it considered implications of substitutes for Chrysotile asbestos).

A working group meeting will take place on the 23 ^rd of October in view of putting the finishing touches in the two respective opinions for adoption by written procedure the following week.

Final draft opinions have been sent to the CSTEE secretariat by the respective rapporteurs and will be included in a single package, together with the other two mentioned in i) above, also in view of an adoption by written procedure at the same time.

iv) First package of four chemicals (Regulation 793/93 on existing substances) whose risk assessments have been concluded by the respective rapporteur M. State(s)

The data set on the four chemicals mentioned in the previous update to the SSC have been sent to the working group members. First opinion drafts are expected before the end of the current month of October 98.

Opinion of the SSC on The safety of bones produced as by-product of the Date Based Export Scheme adopted on 23 October 1998

Report and Scientific Opinion on the safety of hydrolysed proteins produced from bovine hides.adopted by the Scientific Steering Committee at its meeting of 22-23 October 1998


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