Directorate-General for Environment
Green Economy
Chemicals
Directorate-General for Internal Market, Industry, Entrepreneurship and SME's
Consumer, Environmental and Health Technologies
REACH
Chemicals
Brussels, 03/11/2015
Doc. CA/90/2015
19th Meeting of Competent Authorities for REACH and CLP (CARACAL)
12 – 13 November 2015
Room Robert Schuman, BERLAYMONT
Brussels
Concerns: Biological availability in the context of Art. 12(B) CLP
Agenda Point: 18
Action Requested: For information (Draft minutes of the second meeting on biological availability) and discussion (see below).
Issues to be discussed:
- Need for a political support for the validation of the test method as well as the development of a OECD TG (see Annexes I and II)
- Comments raised by some members states (see annex III and annex IV), in particular:
- Is the use of bioelution test results for the CMR hazard classes in accordance with article 6(3) of CLP?
- Does article 12(b) of CLP apply to harmonised classification?
- What is the meaning of “not biologically available” under the scope of article 12(b).
Annex I: Draft minutes of the second meeting on biological availability
Annex II: Development of an OECD test guideline
1. Background and objectives of the second meeting on biological availability
On the 27th of April, a meeting took place on biological availability in the framework of art. 12 (b) of the Regulation N° 1272/2008 on Classification, Labelling and Packaging of substances and mixtures. As the list of open questions addressed at this meeting was not fully exhausted, it was decided to convene another meeting to further discuss biological availability. This meeting took place on the 5th of October 2015. The aim of the meeting was to further address these questions and list of actions that resulted from the first meeting, plus the additional questions that were developed by the Commission in March 2015.
During this meeting, the Commission further stressed the importance to move forward with the work on 'bioavailability’. There was agreement that the best approach to get a commonly agreed test protocol would be the development of an OECD test guideline. This requires the submission of a specific proposal to the OECD by a party prepared to take the lead in the guideline development. The Commission may take on this role via the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) of the Commission's Joint Research Centre. However, the Commission would then need sufficient agreement and commitment from Member States to this approach to take this further. Therefore a discussion at CARACAL is warranted.
2. Issue under discussion
Suggested procedure for the development of an OECD proposal for a method on bioelution testing on metals, inorganic metal compounds and metal-containing complex materials.
If enough acceptability from Member States is obtained related to the use of bioelution data in the framework of the CLP Regulation and on the impact on the Reduction, Refinement or Replacement (3R's) of animal testing, the Commission will commit to supporting the validation efforts and, if successful, ensuring the sponsorship for the development of an OECD test guideline on bioelution testing on metals, inorganic metal compounds and metal-containing complex materials.
During the October 2015 meeting, Industry provided data on correlations between metal bioaccessibility and in vivo bioavailability and/or toxicity for the different exposure routes (i.e. oral, dermal and inhalation). Most data was provided for the oral route for various metals and metalloids. Industry considered that the data shows that for several metals (e.g. lead, arsenic, zinc, cadmium and nickel) there is good evidence that bioaccessibility of metal ion in simulated gastric fluid correlates well with in vivo systemic bioavailability and/or toxicity.
Taking stock of the data that has been developed by Industry so far, the Commission suggests to focus the development therefore on a method for the oral route as a pilot case as here most data seems available, including the consideration of the gastric fluid compartment. Additional methods may be developed when more data becomes available for additional routes, where considered relevant.
Since relevance to the 3R's is a prerequisite for EURL ECVAM to enter into a validation activity, there is a need to clearly refer to avoidance of animal testing. Therefore, CARACAL is encouraged to also express its opinion on the animal welfare consequences of using the bioelution test method in the framework of the CLP regulation.
Prior to sending a proposal to the OECD secretariat the following steps will have to be taken:
a. As soon as CARACAL agreement is obtained, EUROMETAUX should provide EURL ECVAM with the full submission package, using the EURL ECVAM Test Submission Template (TST). EURL ECVAM will provide support to EUROMETAUX concerning the form and the content of this submission.
b. EURL ECVAM will perform a comprehensive evaluation of the submitted information and will draft an evaluation report. This activity will allow the Commission services to assess the level of maturity of the bioelution method and the additional work necessary for the validation of the method.
c. After a positive outcome of the EURL ECVAM assessment, the validation activities will be initiated with the involvement of EURL ECVAM and Industry, and other Commission services, MS, ECHA and other stakeholders as appropriate. This should aim at presenting a robust proposal to the OECD by November 2016 and to initiating the technical discussion at OECD level in 2017 when the EU proposal is endorsed by OECD member countries.
Parallel to these activities related to the development of a testing method on bioelution, ECHA, together with the Commission services, will continue the discussion with stakeholders on the use of data from bioelution testing in the framework of the CLP Regulation. This discussion should lead to the development of ECHA guidance by the end of 2016. This timing will be adapted, if necessary, to take account of the outcome of the EURL ECVAM assessment described above. The discussion should also cover the relevance and adequacy to develop additional methods for the other route of exposure.
Annex III: Member States Comments
Annex IV: Commission legal analysis note from January 2015