The lion's share of the 157 opinions dealt with BSE-related questions (23), followed by opinions relating to the safety of genetically modified plants (15) and the assessment of pesticides, food additives, food contact material and cosmetic ingredients. Antibiotics and other additives in animal feeding stuffs were another important issue. Although the Scientific Committees have an advisory role, many of these opinions have served as a basis for the Commission to propose legislation. The Scientific Committees are consulted whenever a legal act requires it. They are also increasingly consulted on a voluntary basis. In addition, they can act as a "whistleblower" by drawing the Commission┤s attention to new risks for consumer health.
The multidisciplinary Scientific Steering Committee is the main advisory body of the Commission as regards BSE. Opinions were adopted on a number of complex questions such as the listing of specified risk material, the UK┤s date based export scheme, the risk of infection of sheep and goats with BSE, the safety of organic fertilisers, production standards for gelatine, tallow and meat and bone meal, to mention only a few. The Commission followed-up most of these opinions with corresponding legislative proposals. On other issues such as the safety of organic fertilisers derived from mammalians, legislation still has to be adapted to the last up-to-date scientific advice. Following a wide consultation process, work on the assessment of the geographical risk of countries and regions on the basis of a preliminary handbook is ongoing. An opinion on this risk has yet to be delivered.
Genetically Modified Organisms
The Commission submitted all applications for authorisation for placing on the market of genetically modified organisms (Directive 90/220/EEC) to the scientific committees for a safety check. Opinions were adopted on genetically modified organisms, ranging from pesticide resistant maize to tomatoes, Swede rape, cotton plants and potatoes. In the case of a genetically modified high-starch potato, the scientists concluded that the data for an adequate risk assessment were not complete. The experts also prepared on their own initiative a guidance document for applicants based on the experience of evaluating the first 13 dossiers.
This was another hot issue during the first 18 months of operation of the new committee system. The experts looked at the efficacy and risks of three antibiotics used as feed additives in view of wide spread concern about increasing incidence of antimicrobial resistance. The Commission suspended the use of these substances as feed additives as a precautionary measure. An expert group with members of all the scientific committees is examining the problem of antibiotic resistance on a broad basis, taking into account all aspects of the use of antibiotics in humans, animals and plants. Opinions on the safety of carbadox and olaquindox used for growth promotion in pigs, led to a ban of the use of these substances in the European Union (EU).
About 800 active substances are currently authorised for use in pesticides throughout the EU and new substances are constantly being developed. For the existing substances, which were authorised by the Member States before harmonised EU legislation entered into force, a review programme has been established. Before taking a decision on keeping an existing active substance on the market or before authorising a new active substance, the Commission consults experts. A number of opinions relating to pesticides old ones, new ones and for maximum residue levels for some pesticides on a rage of crops - have been adopted. The Commission based its proposals for maximum residue limits of pesticides in infant formulae and baby foods on two opinions, in order to ensure that young children's health is adequately protected. Advice is likewise given on the methodologies for carrying out chronic and acute risk assessments for pesticide residues in food.
BST is a substance obtained by genetic engineering. It is similar to a cow's natural growth hormone and is injected into dairy cows to increase milk production. Prior to decisions on how to proceed with the moratorium of the EU prohibiting the marketing and use of BST which expires on 31 December 1999, the scientific committees were asked for their opinion on this question. The scientists recommended not using BST in dairy cows, as it causes significantly poorer welfare in the cows particularly because of increased foot disorders and mastitis. The scientists likewise noted a potential risk of use of BST to public health, which required further research.
Concerning the use of six growth hormones for growth promotion in cattle, the scientists identified a risk to the consumers, but with different levels of conclusive evidence. The natural hormone 17-▀-oestrodiol was considered as a complete carcinogen, having both tumour initiating and tumour promoting effects. Following this opinion, which represents an up-to-date and comprehensive risk assessment respecting WTO requirements, the Commission agreed that there was no longer any question of lifting the existing ban on hormone-treated beef.
A wide range of opinions was adopted, such as on food additives, packing materials, ingredients of energy drinks, ochratoxin A and on irradiation of foodstuffs. In the latter case the scientists had no concerns about eight foodstuffs (frogs' legs, shrimps, gum arabic, casein, egg white, cereal flakes, rice flour, blood products) to the EU list of foods which may be irradiated. However, they emphasised that irradiation must not be used to cover negligence in handling foodstuffs or to mask their unsuitability for use as food. Regarding certain substances in "energy drinks", the experts considered that the scientific data available were insufficient to conclude that the substances were safe in the concentrations reported. The scientists pointed to increasing concerns about ochratoxin A, a mycotoxin produced by fungi and occurring naturally in a variety of plants such as cereals, coffee beans, beans, pulses or dry fruit. They recommended reducing exposure to this substance as much as possible.
Chemical Substances (phthalates, etc)
A big part of the work of in this area was devoted to the evaluation of risks from phthalate migration from soft PVC toys and child-care articles. Phthalates are used to soften PVC, but they are considered to be liable to provoke negative health effects when they are washed out by saliva while children suck or chew the toys. The experts considered that the margins of safety for child exposure to phthalates from these products in some cases raised some concern (DINP) and in others raised clear concern (DEHP). The Commission recommended to closely watch soft PVC child-care articles intended to be put into the mouth and act if necessary while it considers possible risk management options (e.g. immediate ban or limitations on the marketing and use of phthalates in the articles in question). Another opinion on endocrine disrupting chemicals will serve as a basis for possible Commission actions, including a Communication and further research. These substances are suspected to disrupt normal functions in both humans and animals, therefore possibly leading to among other health effects - an increased risk of cancer and malformation of sexual organs. The main conclusions of the opinion do not, at this stage, substantiate the concerns as regards human health effects. They do so, however, as regards effects on wildlife.
Pharmaceuticals, medical devices
The committee did not see a "recognisable risk" that Creutzfeldt-Jacob disease (CJD) can be transmitted by blood and blood products. However, as a precautionary measure, they recommended to continue excluding individuals having or being at risk for CJD from blood donation. The experts also endorsed the present policy of recalling plasma-derivatives which have been prepared with a donation from donors who developed subsequently new variant CJD as a precautionary measure.
The first alternative methods to animal testing for assessing the safety of cosmetic substances were approved. Two in vitro tests to assess skin corrosivity of chemicals (aggressiveness of substances to the skin) and one in vitro test assessing their phototoxic potential (reaction of the skin after application of a chemical substance and exposure to light) have been approved by the Committee. Once put into legislation, this is a first and important step towards replacing animal testing by alternative methods. The Cosmetic Directive is constantly updated with regard to adaptation to technical progress. A large number of opinions have been issued indicating that the use of some ingredients may be allowed, generally or under specific conditions, or, on the contrary, must be prohibited.
What is in the pipeline ?
For the second half of their mandate, the scientists will be asked to place emphasis on requirements for upper safe levels for vitamins and minerals, foods for athletes, welfare of chickens reared for meat production, relationship between animal welfare and product quality or standards for forced ventilation for animal transport vehicles.
BSE-related issues, pesticides, feeding stuffs and cosmetic ingredients are also constantly on the agenda. The BSE tests, once evaluated, will also be submitted to the scientific committees for opinion. The aim of this exercise is to evaluate rapid post-mortem BSE tests to determine their capabilities for official use.
The committees have increasing workload and therefore a reflection process on their way of operating may be necessary. Preparatory work for the renewal of the scientific committee system in the year 2000 is under way.