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. The environmental risk assessments are published on the web based portal www.Fass.se, which is open to the public. Prior to publication the environmental risk assessments are reviewed by IVL as an independent, external part to make sure that the classifications are based on a scientifically acceptable interpretation of the guidance for the pharmaceutical companies. The present report describes the experiences from the review process during the year 2016. Data for the statistical analyses are gained both from the Fass.se database and from the “progression list”, a spreadsheet the audit team uses to keep track of documents that have been reviewed or are under current review.
In 2016, 450 environmental risk assessments were sent in for review. Of these 48% received the comment no remarks and were recommended to be published. 27% received the assessment remark and were recommended to be corrected before publication and 26% needed to be corrected and sent in for another review before publication. The total number of unique substances that were published at Fass.se during 2016 was 371. Of these 26% were classified regarding environmental risk, 34% were exempted from classification and 40% were reviewed, but no classification could be made due to lack of data. Of the classified substances 82% received the assessment insignificant risk. No substance was classified as posing high risk or being hazardous. Two substances (Estradiol and Terbinafine), published during 2016, were classified as posing a moderate risk. 60% of the unique substances were assessed for bioaccumulation potential but 90% of these were classified with low potential for bioaccumulation. 31% of the unique substances were assessed for degradation and 73% of these were classified as potentially persistent.
The work of improving the review system is an on-going process. As a part of this work IVL Swedish Environmental Research Institute performs studies and activities to increase the knowledge of pharmaceuticals in the environment. During 2016 IVL organized a Dialogue meeting, “10 years of environmental classification of pharmaceuticals at Fass.se”, with representatives from administrative authorities, industry, stakeholders and scientists in order to present and discuss the work with environmental classification of pharmaceuticals (Graae et al. 2017). In addition, experiences from the reviewing process of the self-declaration system of environmental classification of pharmaceuticals at Fass.se were summarized and evaluated in a peer-reviewed article (Magnér et al. 2017).