Report on the Working of the Scientific Committees 1998
In November 1997 the Scientific Steering Committee and the eight new scientific committees had been constituted and had begun their work. Therefore in the year 1998, the tasks for all the Scientific Committees were twofold:
First, they have to fulfil their role of providing the scientific basis for Commission initiatives The Scientific Steering Committee and the eight specialised Scientific Committees issued in total 132 opinions during 1998.
In the same period, the committees had to develop their identity and working methods based on the principles established in the Commission Communication of April 1997 on Consumer Health and Food Safety. These principles are: scientific eminence and independence of the members and transparency in the work of the committees. To fulfil these tasks:
-The committees had adopted internal procedures, reflecting and specifying the main principles of independence and transparency.
Each year the members inform the Commission in writing of any interest which could be regarded as prejudicial to their independence. At each meeting of the comity the members declare any particular interest which could be regarded as prejudicial to their independence in the light of the topics on the agenda of the meeting.
The scientific opinions as well as the minutes of the plenary meetings are published on the Internet shortly after their adoption by the Committees.
- The committees had established a methodological approach on the evaluation of risks which not only strengthens the scientific basis of the opinions but also makes them clearer and easier to understand due to the common structure,
The workload for the independent members of the Scientific Committees has been considerable, and has stretched their capacities to their limits. Bearing in mind the fact that the members are appointed in their personal capacity and only receive reimbursement of their travel costs and an indemnity, the Commission would like to applaud the commitment of all the members.
THE WORK OF THE COMMITTEES
The Scientific Steering Committee
Besides being responsible for delivering scientific opinions on multidisciplinary issues including multidisciplinary aspects of BSE (bovine spongiform encephalopathies), the Scientific Steering Committee (SSC) is responsible for co-ordination of the work of the Scientific Committees including when necessary harmonization of working procedures.
Because of the urgency of the matter and its potential major effects on public health, most efforts by the SSC have concentrated on addressing the risks for humans and animals related to transmissible spongiform encephalopathies (TSE), especially bovine spongiform encephalopathy (BSE). In 1998, opinions on 17 questions related to TSE/BSE were adopted by the SSC.
In general terms the most important of these opinions were opinions adopted on the following subjects:
- BSE risk (general),
- Specified Risk Materials (SRMs)
- BSE risk for specified geographical areas,
- UK Date Based Export Scheme,
- BSE in sheep
-The safety of gelatine, meat-and-bone meal, tallow, dicalcium-phosphate, hydrolysed proteins and organic fertilisers and
- Possible links between organo-phosphates used as pesticides and BSE.
Major efforts have been initiated with the objective of identification of relevant criteria and development of a methodology for the evaluation of the geographical BSE risk. A "Handbook" for the assessment of the geographical BSE risk of member states and third countries was developed.
Not related to BSE was the opinion on possible health hazards linked to exposure to electromagnetic fields.
Other aspects of its mandate were addressed by the SSC. These included:
-An initiative aimed at the introduction in all Committees of harmonised procedures for risk assessment, based on current practice within each Committee. The objectives are to establish common ways of approaching risk assessment issues, to introduce, where possible and relevant, standardisation of threshold and reference values, to adopt common principles for the development and use of models for assessment of human exposure risk etc.
-The multidisciplinary aspects of the use of antimicrobials. The SSC established a specific working group, composed of experts from each of the Scientific Committees, with a wide ranging mandate aimed at providing an overall frame and common basic principles to serve as the scientific basis for policy making in this complex field. More specific aspects of the use of antimicrobials e.g. in animal feed, in plant protection or for therapeutical use are managed by the relevant specialized Committee.
-Work was initiated - through the establishment of a working group - on the development of scientific approaches to emerging health issues, including the application of the precautionary principle, ways and means to address perceived, but not scientifically verified, risks and to address uncertainties related to a scientific opinion e.g. insufficient data and thus possible assumptions made.
Scientific Committee on Food (SCF).
Work carried out by the SCF has been dominated by questions arising though the obligatory requirement in foodstuff legislation to consult the Committee in relation to proposals for health related measures. During 1998, the Committee expressed opinions concerning a number of food additives and more than 80 individual substances intended to be used in the manufacture of plastics as food packaging materials.
The SCF re-assessed Ochratoxin A, a naturally occurring, fungal toxin with carcinogenic properties which may be found at low levels in products such as cereals, coffee beans and pulses. The Committee also addressed the general adequacy of toxicological data-bases for pesticides for the fixing of individual limits for these substances in food intended for infants and young children.
The SCF examined the potential risk from vegetables imported from regions where cholera is endemic and also the safety of the presence of the bacterium Aeromonas in certain natural mineral waters. It also responded to an urgent question regarding the safety of the irradiation of 8 specific irradiated food products. The Committee addressed the issue of possible adverse effects of ß-carotene as reported in clinical and chemo-preventive trials designed to assess the protective effect of ß-carotene supplementation for smokers. The SCF concluded its consideration of the applicability of the concept of the ADI (Acceptable Daily Intake) to additives used in food intended for infants.
The Committee embarked on a comprehensive examination of the safe upper levels of intake for vitamins and minerals in the context of food fortification and supplements.
Four new reports incorporating 28 opinions of the SCF have been published in 1998 by the Commission (Series 38 to 41). These opinions were adopted during the years 1995 and 1996.
Scientific Committee on Animal nutrition (SCAN);
The primary task of the SCAN is to assess the safety of feed additives with respect to animal, human and environmental health.
During 1998 the Committee issued opinions the following antibiotics used as feed additives: tylosine, spyramicine and viginiamycine, and as growth promoters, carbadox and olaquindox. The opinions stemmed from questions arising through the application of safe-guard clauses which permit a Member State to temporarily suspend the use of a product that it considers to be dangerous. The SCAN also expressed opinions on a series of micro-organisms relating to improved feed digestibility and on enzymes used in animal feeds.
The SCAN is currently examining, inter alia, the feed additives dimetridazole, diclazuril, narasin, and a further series of enzymes and micro-organisms.
Scientific Committee on Animal Health and Animal Welfare
The Scientific Committee on Animal Health and Animal Welfare is divided into two sub-Committees dealing with animal health and animal welfare respectively. Opinions are adopted by the Committee in plenary session and cover both animal health and animal welfare issues.
The Committee adopted an opinion on the definition of Newcastle disease. The disease, which occurs in poultry, is serious for the animals and has considerable trade implications.
Other opinions were related to standards for eradication programs for Scrapie, a disease that occurs in sheep, and is related to BSE, and new research developments concerning in Swine Vesicular Disease. This disease, which only occurs in pigs, can be similar to Foot and Mouth disease but often presents itself as a very mild clinical condition.
The Committee likewise adopted two opinions relating to Bluetongue, an insect borne disease that occurs in warmer parts of the world such as Australia, the US and Asia. Incursions of the disease have also occurred in Greece. These reports dealt in particular with the problems relating to importation of live animals from infected regions.
A major report was adopted on the welfare aspects of the production of foie gras using ducks and geese. The report concluded that current methods of production are detrimental to the welfare of the animals.
A report on the acceptability from an animal welfare point of view of the use of certain mixtures of carbon dioxide for stunning poultry at slaughter was also adopted.
The Committee is currently producing a report on the animal health and welfare aspects of the use of Bovine somatotrophin (BST). This is in co-operation with the Scientific Committee on Veterinary Public Health which is examining the public health aspects. BST is a hormonally active substance that is used in some countries to increase the milk yield in dairy cows. Its use in the EU is currently prohibited until the year 2000.
Considerable efforts in 1998 were devoted to the following topics on which reports are expected to be adopted in the near future: Emergency vaccination against Foot and Mouth disease; possible links between Johnes disease in animals and Crohns disease in man; standards for tests for the diagnosis of tuberculosis, brucellosis and enzootic bovine leukosis in cattle; Classical Swine Fever surveillance and control in wild boar; welfare of chickens kept for meat production.
Scientific Committee on Veterinary Public Health. (SCVPH).
The SCVPH worked in close co-operation with SCF on hygiene questions relating to food of animal origin. Special attention was given to zoonosis in general and to food-borne infections and intoxications in particular.
The Committee adopted two opinions on the detection of Trichinella spiralis larvae in meat. Trichinellosis is a worldwide zoonotic disease caused by an intestinal roundworm in various animal species whose larvae (trichinae) migrate to and become encapsulated in muscles. One report referred to methods to detect this zoonotic agent in pork whereas the other referred to its detection in horsemeat.
Opinions were also delivered on allergic reactions to ingested Anisakis simplex (a nematode parasite in fish, and on the risk of spread of BSE infectivity through cross contamination of different tissues by using pneumatic stunning during the slaughter process of ruminants.
SCVPH provided comprehensive reports on two major issues; the scientific aspects of new U.S. regulation on "Pathogen reduction, Hazard Analysis and Critical Control Point (HACCP) Systems, final rule" and the benefits and limitations of antimicrobial treatments for poultry carcasses.
Substantial progress was made in the assessment of potential risks from the use of Bovine Somatotrophin (BST). The SCVPH is concentrating on the public health aspects whilst the Scientific Committee on Animal Health and Animal Welfare (see above) is addressing the animal health and animal welfare aspects
Other major questions under examination include the evaluation of microbiological criteria and temperatures for storage and transport of products of animals intended for human consumption, cooling of carcasses during transport and the review of current meat inspection procedures. Members of the Committee have also provided assistance for working groups of other Scientific Committees e.g. on BSE related issues and Johnes / Crohn's disease.
Scientific Committee on Plants (SCP).
The Committee issued opinions on genetically modified (GM) plants, plant protection product and pesticide residues in food products.
The opinions adopted on plant GMs were primarily in the context of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms which requires that a risk assessment is made before a product containing or consisting of genetically modified organisms (GMOs) can be placed on the market. The objective of the assessments was to evaluate possible risks to human health and the environment connected with the release of the GMOs. These opinions took into account the genetic modifications as well as safety and environmental aspects. The plants covered by the evaluations included maize, cotton, potato, fodder beet and rape and the main traits involved were herbicide tolerance and insect resistance. The Committee decided on the basis of its experiences with the evaluation of plant GM dossiers to publish a guidance document to facilitate notifiers in the preparation of such dossiers for consideration by the SCF. The Committee stated that it intended to publish periodically similar guidance documents as the need arises.
The opinions on plant protection products involved the examination of five new and/or existing active substances in the context of their inclusion in Annex 1 to Directive 91/414/EEC on the marketing of plant protection products. The Committee's work in this area also involved considerations of the data requirements for carrying out risk assessments for microorganisms for use as plant protection products.
The Committee also issued two opinions on pesticide residues in foodstuffs in relationship to the implementation of the Community legislation. These opinions dealt with the updating of maximum pesticide residue limits and the implications of residue variability in fruit and vegetables for consumer risk assessment.
Scientific Committee on Cosmetic Products and Non-Food products (SCCNFP)
The Committee continued its activities within the framework of the adaptation to technical progress of the Annexes to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products.
An important task was the adoption of opinions concerning sixteen active substances which have been prohibited by Directive 76/767/EEC without obtaining consulting the Committee as provided for in the Directive.
Other priorities were the contribution of the SCCNFP to the first updating of the cosmetic ingredients inventory and the evaluation of the applicability in the domain of cosmetic ingredients of alternative methods to animal testing, validated by the Scientific Committee of the European Centre for the Validation of Alternative Methods ( ECVAM Scientific Advisory Committee).
Scientific Committee on Medicinal Products and Medical Devices(SCMPMD)
The Committee in first year of operation has worked on several subject such as toxicity of colouring agents used for medical products, guidelines on the concept of "similarity" regarding legislation on orphan medical products, starting materials used in human and veterinarian medical products, etc.
Several reports on the above mentioned subjects were adopted, but the following two reports are a particular importance:
- Risk quantification for Creutzfelt Jacobs Disease (CDJ) transmission via substances of human origin. The opinion estimates that there is no evidence that transmission of CJD from one individual to another occurs by human tissues, cells or products derived from them other than cornea, dura mater and growth hormone. Epidemiological studies did not detect a link between CJD and the administration of blood and blood products. As a precautionary measure it is, however, recommended to continue excluding individuals having, or being at risk for CJD, from blood donation.
The same statement cannot be made for new-variant CJD due to the limited experience with this disease.
- The equivalency of alternative products to intestines of animal origin for use as surgical sutures. According to the opinion there are sufficient synthetic alternative products to catgut suture that provide equal, or even better clinical performance than catgut and that there are no clinical indications for the preferred use of catgut.
With regard to any continued commercial supply of catgut sutures, the Committee holds the opinion that in the light of the bovine and ovine origin of the material, and the classification of intestines as tissues of medium infectivity, special conditions have to be met in order to manage the risks related to transmissible spongiform encephalopathy (TSE).
Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE).
The majority of opinions adopted by the CSTEE were related to Directive 76/769/EEC on the limitations of marketing and use of certain dangerous substances and preparations.
The opinions includeed assessment of the risks to health and the environment of the following compounds: (i)Tin, (ii)Arsenic, (iii)Pentachlorophenol, (iv)Creosote containing less than 50 ppm benzo-[a]-pyrene, (v)Chrysotile asbestos and substitute fibres (2 opinions).
The CSTEE adopted 4 opinions within the framework of Directive 92/59/EEC on General Product Safety Directive), all related to the subject of Phthalates ( migration from soft PVC toys and child-care articles).
Another important opinion was related to practical implications of the proposed modification to the Council Directive establishing a framework for Community action in the field of water policy. This also included consideration of a procedure for selection of priority substances with a view to the establishing of a Community list of priority substances.
Finally 4 opinions were adopted related to Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances and were related to the results of the risk assessments of (i)2-(2-butoxyethoxy)ethanol, (ii)2-(2-methoxyethoxy)ethanol, (iii)Alkanes, C10-13, chloro and (iv)Benzene, C10-13-alkyl derivs.
In addition to the work of the scientific committees, a Commission action was undertaken to identify and evaluate well developed, post-mortem BSE tests which could be considered for Community recognition. One or more excellent tests would greatly contribute to restoring consumer confidence as well as to the primary aim of protecting consumer health. The exercise is unique, difficult and challenging. It requires the preparation of large numbers of coded samples of brain and spinal cord obtained from animals known to be free from or infected by BSE. Laboratory work started late 1998 and provided that no major practical problems are encountered, results may be expected for spring 1999. The activity is undertaken in close co-operation with the Commission's Joint Research Laboratory, the Institute for Reference Measurements and Methods, situated in Geel, Belgium.