Self-declarations of environmental classification at

Since 2005 Sweden has a unique environmental classification system for pharmaceutical substances. It is a self-declaration system where each pharmaceutical company is responsible for their own environmental information, which is published on the open web-based portal Prior to publication the environmental risk assessments are reviewed by IVL Swedish Environmental Research Institute (IVL) as an independent, external part. The present report describes the experiences from the review process during the year 2020. 

In 2020, environmental risk assessments (ERAs) were sent in for review 773 times. 68% of the reviewed assessments received the comment no remarks and were recommended to be published, whereas the other 32% were either recommended or needed to be corrected before publication. 694 unique substances were published at during 2020. Of these substances 52% were exempted from classification, 27% were classified regarding environmental risk, and 21% could not gain any classification due to lack of data. 

The work of improving the review system is an on-going process. As a part of this work IVL performs studies to increase the knowledge of pharmaceuticals in the environment. During the last four years the focus for this type of work has been on proposing and developing a model for environmental risk assessment of pharmaceutical products. In 2020 the focus was on improving the understanding of different stakeholder needs by mapping roles and responsibilities as well as drivers, incentives and barriers for different actors along the value chain. The results were published in the report (B2395) “Reduce environmental impacts of pharmaceuticals along the value chain” in September 2020.

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