title: European medicines and feed additives regulation are not in compliance with environmental legislation and policy.
abstract: Environmental legislations for water and soil aim at the protection of quality of these compartments. This legislation has major consequences for product registration, amongst others the setting of environmental quality standards. A thorough risk assessment at registration of all products is crucial for the proper operationalisation of the environmental policy. A regulatory problem arises when the registration procedure is harmonised at a European level by the communautarian authority, while the authorities at the national level are responsible for maintaining the desired environmental quality. This problem can be tackled in two ways: firstly, the environmental risk assessment (ERA) should be based on common principles based on EU regulations and policy that steer the national authorities; secondly, the ERA should be developed under the supervision of competent authorities. Both options are not reflected in the forging of the ERA for medicines and feed additives. The formalisation of the contents and the procedure is not transparent nor open to input by scientists and other interested parties; the formalisation has no legal status, and European legislation cannot provide common protection goals in a global setting. The VICH Phase I and the EMEA Phase II guidance do not contain all communautarian environmental quality criteria, nor clear acceptability standards, nor harmonised methodology. Assessments are not made for all products, and the decision-making principles and practical procedures are not operational. It is therefore unlikely that any result of an ERA can be taken into consideration at registration, which undermines the legitimacy of the process. Both applicants and assessors are uncertain how to perform the risk assessment. The current developments may ultimately not only compromise product availability but also fail to protect the environment.
authors: National Institute for Public Health and the Environment (RIVM), P.O. Box 1, NL-3720BA Bilthoven, The Netherlands. mark.montforts@rivm.nl
authors: Mark H M M
authors: MH
authors: Montforts
authors: Joop A
authors: JA
authors: de Knecht
mesh_terms: D000821:Animal Feed / Q000592:standards*; D000818:Animals; D064420:Drug-Related Side Effects and Adverse Reactions; D004785:Environmental Pollutants / Q000633:toxicity*; D005062:European Union; D005503:Food Additives / Q000009:adverse effects / Q000032:analysis; D006801:Humans; D007391:International Cooperation; D007880:Legislation, Drug / Q000592:standards*; D007886:Legislation, Veterinary / Q000592:standards*; D018570:Risk Assessment
chemical_list: D004785:Environmental Pollutants; D005503:Food Additives