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Transcript of NEWSLETTER SEPTEMBER-OCTOBER 2019 - ChemSafe · PDF file NEWSLETTER SEPTEMBER-OCTOBER 2019 1...

  • NEWSLETTER SEPTEMBER-OCTOBER 2019

    1

    BIOCIDES FOCUS

    On October 29, 2019, the seventh Biocide Day was held by ECHA in Helsinky.

    In this one-day workshop the latest developments on review program, endocrine disruptors, active substance approval and biocide product families were discussed.

    In particular: 1. What Member States, ECHA and Commission are doing to revitalize the Review Programme 3

    2. How to assess endocrine disrupting properties

    3. How to apply the new framework for a biocidal product family

    In short (key slides from different presentation are here reported):

    1. Review program

    Acquired and well known delays limited the authorities from achieving the expected high level of safety

    for human health and the environment as many active substances and products remain on the market

    without proper assessment.

    Level playing field not yet achieved, as companies’ situations vary depending on the status of their

    active substance in the Review Programme

    Working on an action plan together with Member States and the Commission

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    2. Endocrine Disrupting properties

    Assessing ED properties requires time and resources

    Outcome of the assessment has important consequences

    - Can restrict or prevent marketing of products

    - Can require reformulation when this relates to co-formulants

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    3. Biocidal product family approach

    Revised framework for biocide product families has been agreed this year to facilitate the

    establishment and the assessment of product families

    - Will guide companies in organizing the product portfolio

    - May impact costs

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    REACH

    New substance evaluation conclusions published

    New substance evaluation conclusion documents are now available on ECHA’s website for: Triphenyl phosphite (EC 202-908-4, CAS 101-02-0), added to the CoRAP list in 2013 and evaluated by United Kingdom; A mixture of: N,N'-ethane-1,2-diylbis(decanamide);12-hydroxy-N-[2-[1- oxydecyl)amino]ethyl]octadecanamide;N,N'-ethane-1,2-diylbis(12-hydroxyoctadecanamide) (EC 430-050-2, CAS -), added to the CoRAP list in 2017 and evaluated by Spain; Reaction mass of 4,4'-methylenediphenyl diisocyanate and o-(p-isocyanatobenzyl)phenyl isocyanate / methylene diphenyl diisocyanate (EC 905-806-4, CAS -), added to the CoRAP list in 2015 and evaluated by Estonia.

    Four proposals to identify substances of very high concern (SVHCs)

    The substances and examples of their uses are: Perfluorobutane sulfonic acid (PFBS) and its salts (EC -, CAS -). The substances are used in polymer production; Diisohexyl phthalate (EC 276-090-2, CAS 71850-09-4). The substance is not registered under REACH; 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone (EC 404-360-3; CAS 119313-12-1). The substance is used in polymer production; and 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one (EC 400-600-6; CAS 71868-10-5). The substance is used in polymer production.

    Authorisation process

    18 substances of very high concern (SVHCs) are recommended to be added to the REACH Authorisation List.

    ECHA's ninth recommendation to the European Commission to prioritize substances of very high concern for authorization includes 18 substances. Thirteen of these substances are toxic for reproduction, of which one has also endocrine disrupting properties. The other substances are an endocrine disruptor, a carcinogen, a very persistent and very bioaccumulative (vPvB) substance and two respiratory sensitizers.

    The substances have been prioritized from the Candidate List because of their intrinsic properties in combination with high volume and widespread uses, which may pose a threat to human health or the environment. Some of these substances are currently not used in the EU but could replace other substances recommended for the Authorization List (Annex XIV). Their inclusion should avoid regrettable substitution.

    ECHA took into account the comments and registration updates as well as the MSC's opinion when deciding on the substances now recommended to be added to the REACH Authorization List and for proposing the related latest application and sunset dates. All substances that underwent public consultation are included in the final recommendation.

    The final decision on the inclusion of the substances in the Authorization List and on the dates by which companies will need to apply for authorization to ECHA will be taken by the European Commission in collaboration with the Member States and the European Parliament.

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