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 review of pre-published environmental risk assessments and system evaluation is an on-going task and the present report describes the experiences from the review process during the year 2014. With its iterative process, IVL gives feedback to LIF regarding the system as such, both from a scientific perspective as well as from a quality assurance perspective.

In 2015, 400 environmental risk assessments were sent in for review. Of these 41% received the comment no remarks and were recommended to be published. Another 41% received the assessment remark and were recommended to be corrected before publication and 19% needed to be corrected and sent in for another review before publication. The number of times a document is re-sent in for revision has decreased during the last three years. One of the reasons is the development and implementation of the assessment tool, which has improved the review process and clarified the comments sent to the companies. The statistical calculations of the environmental risk assessments in this report are based on documents that were published at Fass.se during 2015. The total number of unique substances was 391 and 19% of these were classified regarding environmental risk. 50% were exempted from classification and 31% were reviewed, but no classification could be made due to lack of data. The work of improving the review system is an on-going process.