IVL Swedish Environmental Research Institute

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  • 1.
    Graae, Lisette
    et al.
    IVL Swedish Environmental Research Institute.
    Westberg, Emelie
    IVL Swedish Environmental Research Institute.
    Belleza, Elin
    IVL Swedish Environmental Research Institute.
    Allard, Ann-Sofie
    IVL Swedish Environmental Research Institute.
    Örtlund, Linda
    IVL Swedish Environmental Research Institute.
    Self-declarations of environmental classification at Fass.se - Experiences from the reviewing process during 20172018Report (Other academic)
    Abstract [en]

    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.

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  • 2.
    Graae, Lisette
    et al.
    IVL Swedish Environmental Research Institute.
    Westberg, Emelie
    IVL Swedish Environmental Research Institute.
    Örtlund, Linda
    IVL Swedish Environmental Research Institute.
    10 år med miljöklassificering av läkemedel på Fass.se2017Report (Other academic)
    Abstract [en]

    Temat för mötet var att sammanfatta vad som hittills har gjorts och att diskutera hur framtiden ser ut för miljöklassificering av läkemedel. Dagen var indelad i fyra olika sessioner, som behandlade följande: bakgrunden och syftet med miljöklassificeringen av läkemedel på www.fass.se; användningen av miljöklassificering av läkemedel på Fass.se; begränsningar och möjligheter vid lagstiftning och reglering samt hur arbetet med miljöinformation för läkemededel kan förbättras och få en bredare användning.

    This report is only available in Swedish.

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    FULLTEXT01
  • 3.
    Graae, Lisette
    et al.
    IVL Swedish Environmental Research Institute.
    Örtlund, Linda
    IVL Swedish Environmental Research Institute.
    Westberg, Emelie
    IVL Swedish Environmental Research Institute.
    Self-declarations of environmental classification at Fass.se2017Report (Other academic)
    Abstract [en]

    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).

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  • 4.
    Pålsson, Ann-Christin
    et al.
    IVL Swedish Environmental Research Institute.
    Belleza, Elin
    IVL Swedish Environmental Research Institute.
    Ryding, Sven-Olof
    IVL Swedish Environmental Research Institute.
    Örtlund, Linda
    IVL Swedish Environmental Research Institute.
    Westberg, Emelie
    IVL Swedish Environmental Research Institute.
    Environmental assessment model for pharmaceutical products - Environmental risks related to Active Pharmaceutical Ingredients (API) and carbon footprint in a life cycle perspective2019Report (Other academic)
    Abstract [en]

    To be able to assess the environmental consequences of pharmaceutical products, reliable, comparable and relevant information is needed about the environmental impacts along the life cycle of the product.

    This project has developed and proposed a model 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. The two parts is intended to supplement and expand the current environmental classification at Fass.se, which covers environmental risks from release of API from patient excretion in Swedish water recipients. The model is aimed to facilitate comparability of performed assessments of products with the same API and allow for third party review and validation, to ensure credibility and quality of reported results.

    The environmental risk part of the proposed model includes production stages where API can be/is released to the environment and builds on the current environmental classification at Fass.se. The carbon footprint part of the model covers greenhouse gas emissions in a life cycle perspective. We propose to use the framework described in ISO 14025 for environmental product declarations and initiate the development of Product Category Rules (PCR) for pharmaceutical products. Different potential options for such development are outlined in the report.

    The proposed model is aimed to deliver product specific environmental assessment results that may be used in a wide variety of different applications to control, manage and reduce impacts along the pharmaceutical value chain and drive improvements in different parts of the chain. The report includes an overview of potential use of the information, such as pharmaceutical benefits subsidy systems, procurement, process and product improvement, guidance in product choice as well as assessments in conjunction with product approval. The actual intended application of results, however, needs to be better understood in order to prioritise and guide further development and implementation of the model.

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  • 5.
    Rosenqvist, Lars
    et al.
    IVL Swedish Environmental Research Institute.
    Vestergren, Robin
    IVL Swedish Environmental Research Institute.
    Westberg, Emelie
    IVL Swedish Environmental Research Institute.
    Eliaeson, Karin
    IVL Swedish Environmental Research Institute.
    Liljeberg, Marcus
    IVL Swedish Environmental Research Institute.
    Strandberg, Johan
    IVL Swedish Environmental Research Institute.
    Rahmberg, Magnus
    IVL Swedish Environmental Research Institute.
    Norström, Karin
    Spridning av högfluorerade ämnen i mark från Stockholm Arlanda Airport2017Report (Other academic)
    Abstract [en]

    Högfluorerade ämnen (PFAS) utgör en stor grupp syntetiska kemikalier som har tillverkats sedan 1950-talet för en mängd olika användningsområden i industriella processer och konsumentprodukter. Användningen av PFAS har dock ifrågasatts av forskare och myndigheter sedan början av 2000-talet då ett flertal av dessa ämnen har visats vara persistenta (ej nedbrytbara), bioackumulerande (anrikas i organismer) och toxiska (giftiga) i miljön. Ett av de mest uppmärksammade föroreningsproblemen med PFAS är den historiska användningen av filmbildande brandsläckningsskum (AFFF) som har lett till lokalt förhöjda halter av perfluoroktansulfonat (PFOS) i miljön runt brandövningsplatser. I denna rapport presenteras resultaten från projektet Re-PATH II som syftade till att studera spridningen av PFAS i mark, yt och grundvatten kring brandövningsplatsen på Stockholm Arlanda Airport (Arlanda flygplats). Fältundersökningar och provtagning har utförts i flera omgångar mellan september och november 2015. Jord, yt- och grundvattenprover analyserades för 13 PFAS och karakteriserades med avseende på organisk kol, mineralsammansättning, pH och konduktivitet. Tolkning av data utfördes med hjälp av multivariata statistiska metoder och en mekanistisk transportmodell.

    Detektionsfrekvensen av PFAS varierade mellan de olika provmatriserna, var i undersökningsområdet provet togs och de olika ämnenas kemiska struktur. PFAS-ämnen med upp till åtta perfluorerade kolatomer detekterades i stort sett i alla jord- och vattenprover medan de PFAS-ämnen med fler än åtta perfluorerade kolatomer endast återfanns i proverna nära källan.

    Halterna av samtliga PFAS uppvisade en exponentiellt minskande trend med ökande avstånd till källan vid brandövningsplatsen. En principalkomponentanalys visade signifikanta skillnader i kompositionen av olika PFAS i jord respektive vattenprover samt att dessa förändrades längs med provtagningsgradienten. Dessa trender i sammansättningen av olika PFAS kunde i sin tur förklaras av experimentellt bestämda fördelningskoefficienter från parade jord- och grundvattenprover. I överenstämmelse med tidigare studier observerades ett starkt positivt samband mellan Kd och antalet perfluorerade kolatomer (fluor bundet till kol). Simulerade och uppmätta koncentrationer av PFOS i grundvatten uppvisade relativt god överensstämmelse då platsspecifik inputdata användes. Transportmodellen underskattade dock halterna i grundvatten nära källtermen vilket indikerar att en linjär sorptionsmodell inte kan beskriva de komplexa interaktionerna mellan PFAS och jordmatrisen vid höga koncentrationer och förekomst av andra organiska föroreningar från brandövningsplatser.

    Med ledning av resultatet från denna studie bedöms grundvattnet inte vara en källa för långväga transport av PFOS och andra PFAS-ämnen med reservation för transport via sprickor i berggrunden som inte undersöktes här. Den främsta transportvägen av PFAS från brandövningsplatsen är istället via ytligt grundvatten, grunda dräneringsdiken eller lokala fördjupningar i terrängen. Baserat på dessa slutsatser skulle uppsamling och rening av dessa ytliga vattenflöden kunna utgöra en rimlig åtgärdsstrategi för att minska belastningen av PFAS till Mälaren.

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    FULLTEXT01
1 - 5 of 5
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