Transparency in product authorisation – The handling of commercially confidential information in environmental risk assessments of industrial chemicals, biocidal products, plant protection products and pharmaceuticals

Abstract

The public has a right of access to environmental information on substances. The results of the ecotoxicological studies (e.g. endpoint values) and the derived predicted no effect concentrations (generated by substance-specific legal acts) are information of central importance to assess the environmental risk of substances.The legal acts of industrial chemicals, biocidal products and plant protection products establish a mandatory procedure for the classification of commercially confidential information as well as a subsequent obligation to publish legally prescribed information. This mechanism classifies the results of the ecotoxicological studies as well as the derived predicted no effect concentrations for all three substance groups as environmental information, which can never be considered confidential and must always be published. In coherence with the other substance-specific legal acts and to meet the requirements of environmental information law, this classification should also be enshrined in pharmaceutical legislation.In addition, product law stipulates in general under specified conditions a mandatory data sharing on ecotoxicological data as well as a time-limited data protection of ecotoxicological data. An exception to the foregoing is the pharmaceutical law. According to this law, data sharing is not even mandatory for studies involving vertebrate animals and there are no defined data protection periods on ecotoxicological data.In order to avoid product-related, heterogeneous environmental risk assessments on one active substance, it would be necessary, also with a view to animal protection law, to enshrine an enforceable obligation in pharmaceutical legislation as well. This would also be compatible with the authorisation holders’ fundamental property rights.