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Päivi Jokiniemi and Paul Trouth
Article related to: News from ECHA
The busy years of risk assessment starting
At the end of January, ECHA's Committee for Risk Assessment (RAC) reached its opinion concerning the harmonised classification and labelling of three chemical substances in the EU and in Norway, Iceland and Liechtenstein. In RAC's opinion, Di-tert-butyl peroxide – DTBP which is currently classified at EU level for certain physico-chemical hazards, should be also classified as a mutagen. The classification of the other substances is currently not harmonised at EU level. In RAC's opinion, Trixylyl phosphate should have a harmonised classification as toxic for reproduction, and Indium phosphide should be classified as carcinogenic, toxic for reproduction and for repeated dose toxicity through prolonged or repeated inhalation.
RAC also appointed rapporteurs for the opinion it will give on restrictions that ECHA is preparing for mercury in measuring devices. RAC's decision on the risk of boric acid and other boron compounds in photographic applications was postponed, as new information to be provided by industry should be assessed by the Committee.
"The main challenge for RAC will be to adopt opinions of top scientific quality and at a fast pace" says Jose Tarazona, Chair of RAC.
Consumer risk assessment not easy
RAC's opinion on borates is a special task. The European Commission asked ECHA for an opinion, and the Executive Director of ECHA gave RAC the mandate. Borates are used in photographic applications by consumers, but they are classified as toxic for reproduction in a category which should not be used by consumers. "Some applications use concentrations above the limits that should be provided for consumers," says Jose Tarazona, Chair of the RAC. "The Commission has initially estimated that this specific use could remain, if it is demonstrated that there is no risk for those consumers. There is very little information on exposure to borates under those particular conditions. So the Committee is working on the exposure scenario and will also review relevant toxicological information to identify if there is a possibility of adverse effects to consumers using those products."
The Chair of RAC adds that the assessment of risk for consumers is particularly challenging. "In industrial facilities, there are regular measurements and even bio-monitoring and surveillance studies. You can have a much clearer idea of conditions of exposure for the workers, but for consumers exposure may depend on behaviour – and becomes a real challenge! But, it is clear that it is absolutely essential to protect consumers as well!"
Busy years ahead
RAC has prepared for its work intensively since the start of ECHA's activities. Mr. Tarazona assumes that with its 40, potentially up to 60 members, it is the largest risk assessment committee in Europe. The expertise covers a wide range of fields related to human health and environmental risk assessment and management. External experts can be invited if necessary. Harmonised classification and labelling, restriction proposals and applications for authorisation will keep the Committee busy in the years to come, and the Committee needs to adopt opinions at a fast pace, while maintaining top scientific quality.
"Most REACH and CLP processes involve risk assessment for human health and environment and hazard identification for classification and labelling. There is a huge amount of work ahead of us. RAC is already evaluating dozens of classification proposals, and according to the registry of intentions, the first proposals for restrictions will arrive soon, opening new challenges. The Committee should indicate the appropriateness of the proposed management measures in reducing the risk and work in close cooperation with the Committee for Socio- Economic Analysis," says Mr. Tarazona.
The risk assessment tasks of RAC include identification and characterisation of hazards and evaluation of exposure. "As regards harmonised classification and labelling, we are mostly involved in the harmonised classification criteria for carcinogenicity, mutagenicity, toxicity for reproduction and respiratory sensitisation. The proposals can request harmonised classification also for other endpoints. For active substances in pesticides and biocides, a full harmonised classification covering all the endpoints is requested," Mr. Tarazona adds.
For its opinions on harmonised classification and labelling, for instance, the Committee is reviewing all the information in the proposal, and a public consultation is organised to ensure that RAC receives all information from industry, NGOs and the scientific community on further studies available. "The experience shows that the consultation is a very relevant part of the process," says Mr. Tarazona. The Committee evaluates the information considering the weight of evidence and applying the criteria in the legislation. Then it agrees on its opinion concerning the classification category and the proper labelling.
The RAC opinion is just one step in the process, it is the European Commission who makes the final decision on classification.
Expert in risk assessment methodology
Jose Tarazona is Spanish, originally from Barbastro in Aragon. He is a veterinarian, and has a PhD in veterinary toxicology. Later he worked also in the field of ecotoxicology. Since the 1990s, Mr. Tarazona has concentrated on the scientific development of a methodology for assessing the environmental risks of chemicals. He has participated in the work of many EU Scientific Committees serving as vice-chair of CSTEE and SCHER, and in activities of the OECD, the UN Stockholm Convention as a member of the Persistent Organic Pollutants Review Committee, and has been an expert for several panels in different EU Agencies.
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
Committee for Socio-Economic
18-22 March (tentative)
Management Board meeting:
Member State Committee:
13-17 May (tentative)