Nano and Other Emerging Chemical Technologies Law Blog: Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotech and Chemical Legal Developments

On November 3, 2011, the European Chemicals Agency (ECHA) began a consultation on a testing proposal for multi-wall carbon nanotubes, synthetic graphite in tubular shape. Under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, manufacturers and importers must obtain information on toxic effects of substances.  REACH requires that new testing of a substance involving vertebrate animals be carried out only as a last resort, however. ECHA states that, to ensure that the best use has been made of existing information, it publishes all test proposals involving vertebrate animals for endpoints specified in Annexes IX and X under REACH.  After a testing proposal has been published, third parties have 45 days to submit “scientifically valid information and studies that address the relevant substance and hazard endpoint, relating to the testing proposal.” The hazard endpoint for which vertebrate testing was proposed is long-term toxicity to fish. The deadline for submitting information is December 19, 2011. ECHA will consider any scientifically valid information and studies that address the relevant substance and hazard endpoint.  ECHA publishes its responses to these contributions for the testing proposals after adoption of the related final decision.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The European Commission (EC) began in 2009 a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIPoN), which it intended to provide advice on key aspects of the implementation of REACH with regard to nanomaterials. The EC recently posted final reports concerning nanomaterials and information requirements (RIPoN 2) and chemical safety assessment (RIPoN 3). The EC states that, based on the scientific and technical state of the art with regard to nanomaterials, the reports were developed so that the advice on specific issues related to nanomaterials can be integrated into the existing REACH guidance documents. The EC notes that “inclusion of any of the advice from the reports into the [European Chemicals Agency (ECHA)] guidance is exclusively the responsibility of ECHA.  The presented reports do not represent ECHA guidance.” Nevertheless, the EC states, “while awaiting the official guidance up-date, companies are invited to consult the two reports and take the recommendations into account as appropriate when preparing or updating REACH registration dossiers and evaluating hazard information for potential classification under CLP.” The EC also posted a third report on substance identity. The EC cautions, however, that since it was not possible to reach consensus amongst the experts on the recommendations in the third report, “further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA.”

• Email This
• Print
• Comments
• Trackbacks
• Share Link

During the September 23, 2011, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) conference organized by the European Chemicals Agency (ECHA) and European Commission (EC), Astrid Schomaker, Directorate-General (DG) Environment, stated that the EC has been working on a definition of nanomaterials, and that it “should be coming after the summer.” The EC previously stated in a letter to the Dutch Environment Ministry that it would publish a definition by the end of June. Karl Falkenberg, Director-General for DG Environment, stated that the issue is “triangular -- we have to put together environmental, trade and health perspectives.” Conference delegates disagreed whether nanomaterials are appropriately addressed under REACH. According to Alexander Nies, Deputy Director-General for Germany’s Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, ECHA has found only three cases where substances qualify as nanomaterials, even though there are “more than 900 companies in Germany that produce nanomaterials.” Nies urged the EC to adapt REACH to deal with the specific features of nanomaterials. Adrian Harris, Director-General for the European Engineering Industries Association, responded that the Association supports “rationalization” rather than increasing demands under the registration process. Harris stated that “REACH in its present form is fit to address nanotechnology.”

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The European Chemicals Agency (ECHA) is compiling an inventory of nanomaterials included in the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossiers and Classification, Labeling, and Packaging (CLP) notifications for the European Commission (EC), and intends to deliver the inventory by the end of June 2011. The EC requested the inventory in response to the 2009 European Parliament communication on nanomaterials. An ECHA spokesperson stated that detailed results from the inventory would be available towards the end of 2011, and the inventory may be disseminated at a later date, but this has not yet been discussed. According to the spokesperson, ECHA has found three registration dossiers and 14 CLP notifications in which “nanomaterial” was selected as the form of the substance. The spokesperson stated that ECHA will be able to identify 50-60 REACH registration dossiers that include information on nanomaterials that will be sent to the Joint Research Centre for assessment under a separate project to address if and how information on nanomaterials is included in REACH registration dossiers.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On June 11, 2010, the European Chemicals Agency (ECHA) announced the availability of a technical manual for including nanoforms in an International Uniform Chemical Information Database (IUCLID) dossier. The Nanomaterials in IUCLID 5.2 Industry User Manual “gives practical instruction to [Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)] registrants on how to include information on different forms of a substance in a IUCLID 5.2 dossier.” The Manual introduces a book-keeping principle, where each form gets a specific label that enables it to be tracked throughout the dossier. Instructions are given on how to create labels for form-specific reference substances, composition blocks, endpoint study records, and analytical data. In particular, the Manual “gives instructions that will enable registrants to consistently create and label Endpoint study records such that it is clear which composition or form was used as the test substance for that study.”

• Email This
• Print
• Comments
• Trackbacks
• Share Link

During the Helsinki Chemicals Forum 2010, Jukka Malm, European Chemicals Agency (ECHA) Assessment Director stated that ECHA is revising its Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) guidance documents to include technical instructions to help companies include nanomaterials in their registration dossiers and other compliance obligations for substances they make or import. According to Malm, ECHA is following “international developments,” particularly work by the Organization for Economic Cooperation and Development (OECD) concerning nanomaterial safety and testing. Malm stated: “As results become available, we are trying to introduce them into our guidance documents for steering industry on how to implement REACH in practice in their registration dossiers and other obligations.”

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On May 28, 2009, during the Helsinki Chemicals Forum organized by the European Commission (EC) and European Chemicals Agency (ECHA), governmental spokespersons said that the way the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program applies to nanoscale substances is being reconsidered. ECHA Executive Director Geert Dancet stated that specific regulation of nanomaterials could be considered when the EC reviews REACH, which it is required to do by June 1, 2012. According to Dancet, the review could cover both the scope and implementation of REACH. Dancet stated that “nanomaterials will be covered in a more systematic way” following the review. European Union (EU) Environment Commissioner Stavros Dimas stated that “further work needs to be done to consider if further legislation is needed” to regulate nanomaterials. After the Forum, Dimas stated that separate legislation could be necessary to ensure to protect the environment and human health. According to Dimas, ECHA could manage nanomaterials, or EU legislation concerning fine particles could be used to regulate nanomaterials. The fine particle legislation concerns particles in air rather than in products, however, and a spokesperson for Dimas stated that the EC is “looking at all sorts of possibilities” and that specific approaches are “unexplored as yet.”

• Email This
• Print
• Comments
• Trackbacks
• Share Link