Self-declarations of environmental classification at Fass.se - Experiences from the reviewing process during 2019

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 2019.

In 2019, environmental risk assessments (ERAs) were sent in for review 421 times. 63% of the reviewed assessments received the comment no remarks and were recommended to be published, whereas the other 37% were recommended to be corrected or needed to be corrected before publication. The number of unique substances that were published at Fass.se during 2019 was 315. Of these substances 43% were exempted from classification, 27% were classified regarding environmental risk, and 30% 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.