ECHA committee takes step towards reclassifying BPA as 1B reprotoxicant.

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The Risk Assessment Committee of the European Chemicals Agency (ECHA) has adopted an opinion to strengthen the harmonized classification and labeling (CLH) of bisphenol A (BPA), in line with a proposal by France regarding the substance’s adverse effects on sexual function and fertility. BPA is currently classified as a category 2 reproductive toxicant and would be reclassified as a category 1B reproductive toxicant.

The committee’s consensus-made action was based on “‘rock-solid’ multigenerational rodent studies” and tees up a final decision to be made by the European Commission. France’s reclassification proposal has received mixed responses [PDF] from member states and industry. If approved, the reclassification of BPA as category 1B would trigger Substance of Very High Concern (SVHC) criteria under REACH.

BPA is a monomer widely used in the production of polycarbonate plastics and epoxy resins and as a developer in thermal paper. In late 2013, ECHA followed up a German substance evaluation of BPA by issuing a request for further data on skin absorption and environmental exposure. The European Found Safety Authority (EFSA) also recently closed a public consultation period on a draft assessment of the human health risks of BPA via food exposure. A recent rodent study conducted by U.S. researchers at the National Center for Toxicology Research, however, concluded that orally-ingested BPA did not affect body weight, reproductive organs, or hormones at levels comparable to the amount Americans typically ingest.

ECHA Publishes the 2011- 2013 Work Program of the REACH and CLP Enforcement Forum

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REACH/CLP Enforcement:

On July 6, 2011, the European Chemicals Agency (ECHA) published the 2011 -2013 work program for the Forum on Exchange of Information on Enforcement of the REACH and CLP Regulations.  The program lists the Forum’s current and upcoming activities, a description of the activities, the expected time frame for each, and its priority.  Readers less familar with the REACH and CLP Regulations should know that the Forum coordinates a network of authorities responsible for enforcement of the regulations in each country or “Member State.”

Very high priority activities for the work period include the follwing: 

  • EU-wide coordinated REACH Enforcement Projects (REFs) such as the coordinated project concerning downstream user obligations of formulators of mixtures;
  • clarification of the links between ECHA, Member State competent authorities and Member State enforcement authorities;
  • access to REACH-IT by Member State enforcement authorities;
  • cooperation with customs authorities, including execution of a coordinated enforcement initiative; and
  • preparation of advice concerning the enforceability of REACH restriction proposals.

In addition, new rules of procedure for the Forum adopted at the recent ECHA Management Board meeting are published, along with minutes of the Forum meeting held in March of this year. 

Copies of the documents are avaialble here.

EU Environmental Law Group Releases Reports on Member State Implementation and Enforcement of REACh

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REACh:

The EU public interest environmental law group, ClientEarth, recently released a series of progress reports summarizing Member State activities under the European Union (EU) regulation: Registration, Evaluation, and Authorisation of Chemicals (REACh).  Each report reviews a different Member State’s efforts to implement and enforce REACh.  Reports also are available for three non-Member State countries that have enacted REACh – Lichtenstein, Norway, and Iceland.

The reports are essentially responses to a lengthy questionnaire from the European Commission.  Activities reviewed include communications between Member State authorities and EU authorities, such as the European Chemicals Agency (ECHA); operation of the national helpdesks; development and promotion of alternative test methods; participation on REACH committees; evaluation of substances; preparation of Annex XV dossiers; and details concerning enforcement-related activities, such as inspections and the imposition of sanctions.  The reports may prove useful to companies wanting insight into the level and types of enforcement activity occurring within the countries regulating their operations.

ClientEarth received the reports through a public records request, insisting that their broad dissemination was necessary “so that [the public] can know if REACH is really working.” (Critics probably think they know the answer already.)  The reports are available here.

Consultation Periods Open on Proposals to Harmonize Classification and Labeling of Four Substances under the EU's CLP Regulation

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EU CLP Regulation:

Public consultation periods have opened on propoosals to harmonize the classification and labeling of four substances under the EU Regulation on Classification, Labelling and Packaging of Substances and Mixtures (the so-called “CLP Regulation,” (EC) No 1272/2008). The CLP Regulation implements the UN’s Globally Harmonized System of Classification and Labeling of Chemicals (“GHS“). The substances are:  2-Ethoxyethanol (CAS No. 203-804-4); Reaction mass of 2,4,4-Trimethylpent-1-ene and 2,4,4-Trimethylpent-2-ene (CAS No. 246-690-9); Vinyl acetate (CAS No. 203.545-4); and Indoxacarb and Indoxacarb (enantiomeric reaction mass S:R 75:25 (Indoxocarb CAS No. 173584-44-6).   Copies of the proposals, and other details such as the deadlines for submitting comments, are available on the website of the European Chemicals Agency (“ECHA”).

If a proposal is accepted, the substance would be added to the list of harmonised classifications in Annex VI, part 3 of the CLP Regulation.  Thereafter, all manufacturers, importers and users of the substance in the EU would need to abide by the new harmonised classification and labelling.  Persons potentially affected may be interested in submitting comments.

Background on CLP Regulation and Harmonization

The so-called CLP Regulation entered into force on January 20, 2009.   The regulation will gradually replace the Dangerous Substances Directive (67/548/EEC) and Dangerous Preparations Directive (1999/45/EC).  Both directives will be repealed by June 1, 2015. 

Under the Regulation, individual EU Member States (“Competent Authorities” or “CAs”) and industry may propose harmonization of the classification and labelling of substances.  The decision on a particular classification for a substance or mixture is usually made by the supplier (“self-classification”).  However, in certain cases the decision on the classification of a substance is made at the Community level, which is then called “harmonized classification.”  A harmonized classification must be applied by default by the suppliers of the respective substance.

Hamonized classification and labeling may be approved:

  • when the substance is either:

    • carcinogenic;

    • mutagenic;

    • toxic for reproduction; and/or

    • a respiratory sensitiser;

  • when the substance is an active substance in a biocidal or plant protection products; or

  • when there is a need to harmonize a classification at EU level, as supported by a justification demonstrating the need for such action.

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Check back periodically for future postings on CLP developments.