News about Environment and Toxicology

Sept 2013


Chemicals

GHS revision

The 5th revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) has been published by UNECE.

This revision includes:

  • a new test method for oxidizing solids
  • miscellaneous provisions intended to further clarify the criteria for some hazard classes (skin corrosion/irritation, severe eye damage/irritation, and aerosols) and to complement the information to be included in the Safety Data Sheet
  • revised and simplified classification and labelling summary tables
  • a new codification system for hazard pictograms, and
  • revised and further rationalised precautionary statements

    To download the electronic copy of the 5th edition click here

    The amendments are summarized here (131 pages)

    If you want to know more about the implementation status around the world, please visit our GHS Web Portal

    For further information, please contact

    Henriette Christiansen
    hc@dhigroup.com

  • Approval of active substance suppliers of biocidal products

    In accordance with Article 95 of the Biocidal Products Regulation, ECHA aims to break a prevailing tradition under the previous Biocidal Products Directive. Under the Directive it was possible for active substance suppliers to market and sell active substances in the EU without participating in the funding of the dossier for the active substance.

    List of approved suppliers
    As of 1 September 2013 up to and including 31 August 2015 all manufacturers and importers of active substances in the EU must document to ECHA that they are actively contributing to the cost of an active substance dossier. ECHA will continuously publish an updated list of approved active substance suppliers on their website. As of 1 September 2015 biocidal products can only be marketed in the EU if they contain active substances from the list of approved suppliers.

    Extended deadline for evaluation of active substances
    The evaluation of active substances has been heavily delayed. Consequently, the EU has now officially extended the deadline of the evaluations until 2024. In order to achieve the goal of completing the evaluations by the end of 2024, the EU member states have agreed to complete the evaluation of approx. 50 active substances a year.

    Furthermore, the active substances expected to be completed during 2013-16 have been announced. It is primarily active substances concerning wood preservation (PT8), insecticides (PT18), repellents (PT19) and disinfectants within product categories 2, 3 and 4.

    For more information, please contact

    Michael Fink
    mif@dhigroup.com
    Tel +45 4516 9156

    ECHA adds broad group of substances to Candidate list

    In June ECHA added new entries to the Candidate list for Authorisation, also known as the Substances of Very High Concern (SVHC). The entries included the substance 4-Nonylphenol, branched and linear, ethoxylated. This entry is worth noticing as it is not a single substance but a very broad group of substances.

    In fact the definition is so broad that likely more substances fall under that entry, than under all other entries on the Candidate list combined. As stated by ECHA the entry covers all “substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof”.

    Cannot be searched by CAS number
    The concern with ethoxylated 4-Nonylphenol is that it degrades in nature to 4-Nonylphenol, which is an endocrine disruptor (and in itself an SVHC substance added to the Candidate list). From that perspective it makes a lot of sense to include the entire group of substances that can degrade in this way.

    It does, however, pose a challenge for everyone trying to find out whether a given substance is an SVHC, since a search by CAS number will not yield a hit. And it does require significant knowledge on chemical nomenclature to discern by name whether a given substance is an “ethoxylated 4-Nonylphenol homologue”.

    Impact on articles
    It should be noted that the concern with these substances is not new and a restriction on their use in cleaning products has been in effect for years. However, the Candidate list impacts much more broadly.

    As an example, importers of articles into the EU are required to know if their products contain SVHC’s. This task is not made easier by the fact that even if they have a complete breakdown of all substances (and CAS numbers) contained in their products, they still need expert chemical knowledge to claim that products are SVHC-free.

    Contact
    Lise Møller
    lmm@dhigroup.com
    Tel +45 4516 9133

    New sensitisation tests expected before 2018 REACH registration

    One of the interesting topics at this year’s CIR Conference was the development of new test methods to reduce animal testing. According to the regulatory demands under REACH, substances must be studied for their potential irritation and sensitisation effects and classified in accordance with the CLP regulation.

    The mechanism of sensitisation
    A number of new in vitro test methods were presented. These are based solely on the use of cell systems and focuses on the mechanism of sensitisation. New OECD test guidelines have been prepared which are presently being validated. It is expected that the new methods will replace the present LLNA test (Local Lymph Node Assay) for classification of substances under REACH by the next registration deadline in 2018.

    The biocidal products regulation The new regulation on biocidal products was another topical issue at CIR. The regulation is an improvement of the previous directive. Specific industry requirements have been implemented, thus outlining and clarifying data requirements and application options. On the other hand the regulation is more complex and comprehensive than the directive and now also includes treated articles and biocidal products generated in-situ. The regulation came into force on 1 September 2013 and is managed by ECHA.

    CIR Conference 2013
    This year’s CIR conference (Chemical Industries Regulations) took place in Barcelona in early September. With more than 500 participants from industry and the authorities it is one of the largest regulatory conferences in Europe and encompasses regulation as well as environmental and health aspects within pesticides, biocidal products, REACH and veterinary medicines.

    For more details, please contact

    Brian Svend Nielsen (REACH)
    bsn@dhigroup.com
    Tel +45 4516 9140

    Michael Fink (pesticides, biocides)
    mif@dhigroup.com
    Tel +45 4516 9156

    Environment

    China and environmental testing of chemicals

    At the recent ChemCon Asia 2013 Conference, testing chemicals in China was largely discussed.

    For environmental hazard, Chinese authorities are requiring a number of endpoints to be done in a Chinese approved lab. Of course there are some concerns raised by global players on that requirement. And it is surely not a matter of competency of the Chinese labs.

    “Do I need to contract with a Chinese testing facility?” and “Will my existing data, or new data, produced at an overseas testing facility, be accepted by Chinese Authorities?” and “Will the data produced in Chinese testing facilities be accepted by other Competent Authorities?” are the three main questions asked by industry on that topic.

    Some overseas studies accepted by Chinese Authorities
    It is now clearer, that the number of tests that need to be conducted in China is limited only to a few endpoints, mainly the acute toxicity test on fish and the biodegradation. The other studies can thus be conducted in an overseas testing facility and will be accepted by Chinese Authorities as soon as it has i) appropriate quality accreditation, GLP at a minimum, ii) performed the tests according to Chinese guidelines or OECD or ISO standards.

    Approval process still uncertain Several Chinese testing facilities are now compliant with OECD Good Laboratory Practice. However, since the OECD’s Mutual Acceptance of Data has still not been signed by China, it is not told whether Competent Authorities will eventually accept data produced in Chinese “GLP-like” testing facilities. If clarity has come on the above question, the exact process to get overseas data approved by Chinese Competent Authorities is still uncertain. It also remains unclear whether tests need to be done strictly on freshwater species.

    DHI owns two ecotoxicology testing facilities, one in Denmark and one in Singapore. Singapore Ecotoxicology lab has developed OECD tests and ISO standard tests using Asian species. It is involved in ISO ring test to validate new standards. Singapore has signed MAD in January 2010 and has launched the Singapore GLP Compliance Monitoring Programme since November 2007.

    For more information, please contact
    Matthieu Duchemin
    mdu@dhigroup.com

    Swedish study of perfluorinated compounds

    The Swedes exposure to perfluorinated compounds is generally decreasing, but regular consumption of fish from contaminated lakes in Sweden may cause elevated exposure. This appears from a new risk assessment report (in Swedish) from the Swedish competent food authority, Livsmedelsverket.

    It also turns out that recent immunotoxicological animal studies indicate that PFOS is more toxic than what EFSA found in 2008.

    Environmentally damaging
    Perfluorinated compounds can tolerate very high temperatures and are used as impregnation in paper and textiles and as firefighting foams. However, the compounds are very damaging to the environment and may contaminate lakes, streams and also leak into the groundwater. Polluted groundwater and fish from contaminated areas may be harmful to health.

    Perfluorinated compounds (PFCs) are not naturally occurring. They exist in many forms, such as PFOS, PFOA and PFHxS, which are included in the Swedish study.

    For more information, please contact

    Helle Buchardt Boyd
    hbb@dhigroup.com
    Tel +45 4516 9097

    Food

    Limit alkaloid levels in teas

    Incarnate consumers of herbal tea and tea are exposed to levels of pyrrolizidine alkaloids that worry researchers.

    The German Federal Institute for Risk Assessment (BfR) has conducted a research project and examined 221 commercial herbal teas and teas. Unexpected high levels of pyrrolizidine alkaloids (PAs) were found in some of the samples. Even with teas of the same variety there were considerable fluctuations in the concentrations.

    Pyrrolizidine alkaloids and their effects PAs are naturally occurring chemical compounds produced by a large number of plant species worldwide. The alkaloids protect plants against insect herbivores. Their harmful effects are also undesirable in food and feed as they can have carcinogenic and genotoxic effects in humans. PAs also occur in other food sources like honey, grain and milk.

    Consumers with an average consumption of herbal tea and tea are not at risk, but consumers drinking large quantities are at risk of health impairment. Consequently, the BfR recommends that children and pregnant women limit their consumption of herbal tea and tea. Further, efforts should be made in industry to reduce the PA contents in herbal tea and tea.

    For a more exhaustive account, please refer to the BfR Opinion on Pyrrolizidine alkaloids in herbal teas and teas.

    Contact

    Helle Buchardt Boyd
    hbb@dhigroup.com
    Tel +45 4516 9097

    New Danish strategy on health claims

    The Danish Veterinary and Food Administration (DVFA) has launched a new strategy which will entail not only increased inspections but also improved guidance of consumers and businesses. When using health and nutritional claims it is important that they do not mislead consumers with regard to healthy dietary habits.

    In the future it must be expected that DVFA will clamp down on the use of non-specific claims such as “antioxidant”, “revitalising” or the like. In most cases non-specific claims are against regulations when used on their own and not in conjunction with an approved health claim.

    We can guide you through the options for use of nutrition and health claims on food. This also includes assistance with submission of the correct documentation for approval of a health claim.

    For more information, please contact

    Helle Buchardt Boyd
    hbb@dhigroup.com
    Tel +45 4516 9097


    Meet us

    DanFish International and DanAqua, Denmark
    Meet DHI at our booth at the 23rd international fisheries & aquaculture exhibition in Aalborg, Denmark, on 9-11 October, 2013. Read more here: danfish.com and danaqua.net

    Free lunch meeting at DHI Singapore
    Meet two of our experts during our free lunch meetings at DHI Singapore. The next meeting is on 21 October. The topic of the meeting is GHS labelling of containers – responsibilities of all users of chemicals. For registration, please email marketing@dhigroup.com


    Courses

    Courses Asia-Pacific region:
    GHS – Classification and labeling of chemical mixtures, Singapore – 11-12 November
    Environmental Hazard Assessment, Indonesia – 13 November
    Chemicals compliance and hazard communication
    , Indonesia – 14 November

    For more information and registration, please contact courses.sg@dhigroup.com

    Courses in Denmark
    QSAR WORKSHOP – An introduction to the OECD Toolbox
    APPLIED TOXICOLOGY: two-day-course

    Browse all our courses and seminars in Denmark here

    Contact

    DHI | Agern Allé 5 | 2970 Hørsholm | Denmark
    Tel: +45 4516 9200 | Fax: +45 4516 9292 | www.tox.dhigroup.com



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