IVL act as an independent and external reviewer of environmental information that pharmaceutical companies use for environmental classification of pharmaceutical products. The report describes the experiences from the review process during the year 2017.
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. 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 2017. Data for the statistical analyses are gained both from the Fass.se database and from a spreadsheet that the audit team develop and use to keep track of documents that have been reviewed or are under current review. In 2017, 775 environmental risk assessments (ERAs) were sent in for review. Almost half of the reviewed assessments received the comment no remarks and were recommended to be published, whereas the other half were recommended or needed to be corrected before publication. The number of unique substances that were published at Fass.se during 2017 was almost 500. Of these substances nearly half were exempted from classification, one fourth 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. During 2017 a two-year project started with the aim to develop, test and evaluate criteria for the implementation of a voluntary system for ERAs on pharmaceutical products instead of active substances. The new assessment system would include carbon dioxide and API emissions along the entire lifecycle of pharmaceutical products, both at production and at formulation.
Report number: B2315
Authors: Lisette Graae, Emelie Westberg, Elin Belleza, Ann-Sofie Allard, Linda ÖrtlundDownload publication