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(57-06) Substances and product related marketing restrictions on chemicals in the EU legal framework - rationale and tendencies. Jakl, Th.*,1, 1 Umweltbundesamt, Wien, Austria ABSTRACT- This presentation reviews selected authorisation schemes from a regulatory authority viewpoint. It undertakes comparisons and highlights contrasts to be made between the various regulatory regimes and will give an evaluation with respect to other Risk managing instruments. The following product groups will be covered a) Pesticides b) Biocides c) Industrial chemicals d) Pharmaceutical products The analysis will compare the following parameters: 1. What is the trigger? 2. Time period 3. Conditions imposed 4. Transparency of process / Confidentiality 5. Other concerns. All of the authorisations schemes are operated by Government agencies - however, in the case of Pharmaceuticals, there is an alternative agency, a central European entity that can grant authorisations when a product is to be marketed in a number of Member States. In the case of Biocides and Pesticides, one Member State can grant authorisation, and the authorisation is then subject to peer review by other Member States. If accepted, it will then apply throughout the Community. All of these schemes, except to some extent Biocides, are inclusive, i.e. the substances or products which are covered by the legislation are subject to authorisation, with the possibility of exemptions/exceptions. Pesticides and Biocides differ slightly in that all new pesticides actives are subject to authorisation, and existing ones are on a 10-year review basis. Authorisation priority requirements are done on a hazard identification basis, with socio economic aspects also to be considered. There is a two-tier system for Biocides, based on risk assessment; i.e. low risk substances are registered in order to fast track their availability. Others are subject to a risk assessment similar to pesticides and existing chemicals. The presentation will evaluate the various authorisation schemes with respect to the goods they intend to protect and with respect to the level of protection they intend to ensure. These findings will allow for a comparison with restriction measures outside the authorisation procedures. Key words: EU legal framework, risk managing instruments, authorisation schemes, chemical policy |
