- Through the deadlines towards safer chemicals
- High-quality data - a key factor for industry and ECHA
- Is the substance identifier in your registration correct?
- Follow-up of the December 2013 SME workshop
- Biocides – important changes for companies
- Improving supply chain communication
- From registrant to downstream user – implementing REACH the Yara way
- Progress in using alternative testing methods
- Evaluation underway for testing proposals from the 2013 registration deadline
- Continuous development of the QSAR Toolbox
- Enforcement - planning ahead
- Findings from the third enforcement project
- Time to start preparing for REACH 2018
- Registration lessons from an SME
- Guest column: Using existing information to support high-quality REACH registrations
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Article related to: News from ECHA
Evaluation underway for testing proposals from the 2013 registration deadline
ECHA has started evaluating testing proposals in the registrations submitted for the 2013 deadline. In total, about 770 proposals in 374 dossiers will have been examined by 1 June 2016. Around 560 of these include tests on vertebrate animals. Third parties are able to provide scientifically relevant information on the proposals published on ECHA's website.
Most of the new testing proposals relate to human health: the most common endpoints are repeated dose toxicity and developmental toxicity. The studies proposed are those required in Annex IX of REACH, including sub-chronic toxicity studies (90 days) and pre-natal developmental toxicity studies. As the two-generation reproduction toxicity study is not a standard information requirement for Annex IX dossiers, there are now fewer proposals for these than in the dossiers submitted for the first registration deadline in 2010.
Substance identity examined first
To evaluate all testing proposals as efficiently as possible, ECHA's scientists have started by screening the substance identity of the relevant dossiers. Where there is an ambiguous substance identity, it is checked first, so the rest of the evaluation can then take place.
Clear substance identification is particularly important when registrants follow a category or grouping approach. So far, several testing proposals contain category or read-across references, with similar substances grouped to reduce animal testing and costs. Read-across and chemical categories rely on the physicochemical, toxicological and ecotoxicological properties of substances being similar or following a regular pattern due to their structural similarity.
ECHA checks if the proposed testing with another substance is properly justified. If not, it will request a test with the registered substance. If registrants have any doubts about their read-across justification, they can update their dossier now. Updates submitted before the testing proposal proceeds to decision-making can then be taken into account in the decision.
Third parties invited to submit relevant information on testing proposals
Every testing proposal involving vertebrate animals is published on ECHA's website. The Agency invites third parties to submit scientifically valid information on the proposals within 45 days. ECHA evaluates this information and forwards it to the registrant together with the draft decision.
To stagger the evaluation of testing proposals, ECHA launches third party consultations in monthly batches. These will be published regularly until early 2015.
Big variety in information received from third parties
So far, third parties have participated actively in responding to the public consultations. Regarding testing proposals submitted for the registration deadline in 2010, ECHA held 542 consultations and received over 640 third party comments. Most of the comments were made by animal welfare organisations, followed by industry groups.
In a few cases, the third parties found scientifically valid studies on the registered substance. For example, a non-governmental organisation identified a guideline study conducted outside the EU. ECHA passed this information onto the registrants. They considered that the information met their requirements, obtained legal access to use the study and used it to fulfil the information requirements. Consequently, the registrants withdrew their testing proposal.
More often, however, third parties provided information on a more general level: they highlighted the availability of information or suggested strategies to use the adaptation possibilities provided by REACH. In particular, they identified information that might be used in predictions based on read-across and weight of evidence approaches. Applying such techniques is not always straightforward, but experience is growing. For example, last year ECHA's Member State Committee approved a number of decisions on testing proposals, where the read-across justifications provided by registrants were considered to be plausible.
ECHA's decisions on testing proposals
Text by Tiiu Bräutigam
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
6-8 March and
Committee for Socio-Economic
Management Board meeting:
23-27 March (tentative)
Member State Committee:
20-24 April (tentative)