Self-declarations of environmental classification at Fass.se

Since 2005 Sweden has a unique environmental classification system for pharmaceutical products. 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 www.Fass.se" External link.. 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 2018.

In 2018, 373 environmental risk assessments (ERAs) were sent in for review. Almost 60% of the reviewed assessments received the comment no remarks and were recommended to be published, whereas the other 40% were recommended or needed to be corrected before publication. The number of unique substances that were published at Fass.se during 2018 was 361. Of these substances a little more than half of them were exempted from classification, one fourth were classified regarding environmental risk, and the rest quarter 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 and activities to increase the knowledge of pharmaceuticals in the environment. In 2018/2019 a model was developed for environmental assessment of pharmaceutical products, in regard to environmental risks related to emissions of Active Pharmaceutical Ingredient (API) from production processes and product carbon footprint in a life cycle perspective.