A Voluntary Environmental Classification System for Pharmaceutical Substances
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Bengt Mattson Pfizer Health AB Chairman of the Environmental Committee, The Swedish Association of the Pharmaceutical Industry
Key Words Pharmaceuticals in the environment; Environmental risk assessments; Exotoxicology; Persistence; Bioaccumulation Correspondence Address Bengt Mattson, Pfizer Health AB Lindhagensgatan 133, SE-11287 Stockholm, Sweden (e-mail: [email protected]).
A Voluntary Environmental Classification System for Pharmaceutical Substances
BACKGROUND The possible impact of pharmaceutical substances on the environment is a subject that attracts increasing attention. Several reports on the occurrence of active pharmaceutical ingredients (APIs) in the environment have been published. The existence of APIs in the water in drinking water reservoirs has created questions among stakeholders in the society, such as whether there is a threat to the environment and perhaps even to human health. The Swedish Medical Products Agency (MPA) was instructed by the Swedish government to develop a commission, and a report was presented in August 2004: “Environmental Impact From Pharmaceuticals as Well as Cosmetics and Hygienic Articles.” The full report is only available in Swedish (1). However, Carina Carlsson et al. at the Swedish MPA have published two articles describing the work and the results (2,3). Some comments and conclusions from the report are as follows: Environmental data are missing for a considerable number of substances, especially older ones developed before requirements existed on environmental risk assessments on regulatory filing (ie, substances from the 1980s and older). Of 30 APIs selected for environmental risk assessment, there were only sufficient data for 12. The
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As a consequence of increasing interest in the area of pharmaceuticals in the environment, the Swedish Association of the Pharmaceutical Industry has in collaboration with a range of stakeholders developed an environmental classification scheme for active pharmaceutical ingredients. This article describes the background of the system, its design, and future development.
selection of the 30 APIs was based on “volume of sales on the Swedish market” (eg, paracetamol) or “suspected potential to affect the environment” (eg, etinyl-estradiol). Of these 12 substances, 9 were found to be environmentally hazardous. However, only in the case of sex hormones (ie, estradiol and etinyl-estradiol) was the concentration in the environment high enough potentially to cause a risk. Any environmental risk related to excipients or pharmaceutical packaging materials could not be identified. For cosmetics and hygienic articles, it was not possible to perform any assessment because verifiable data on volumes were not available. The MPA also concluded in the report that EU rules apply, and that it is not legally possible to implement a mandatory environmental classification and labeling system in Sweden.
In a roundtable meeting with stakeholders in the Swedish market following the issuing of the MPA report, Swedish Minister for the Environ
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