Testing proposal evaluation

Where information requirements addressing a number of intrinsic properties of a substance (as specified by the REACH Annexes) cannot be fulfilled, registrants are responsible for generating this data and providing it in their registration dossier. In some cases the filling of data gaps means that new animal testing will be necessary. REACH however obliges registrants to limit new studies and to conduct animal studies only as a last resort. Registrants must first collect and assess all existing data, precisely identify data gaps and consider whether these can be filled by using either in vitro/ex vivo studies or other alternative approaches, including prediction, methods before any new animal tests are conducted. A testing proposal should be submitted to ECHA and receive prior approval from ECHA before testing can start. ECHA´s role in evaluating testing proposals is to ensure that if a test is performed the results will be acceptable for REACH purposes.

 

 

ECHA will publish every testing proposal that involves vertebrate animals and invite third parties to submit scientifically valid information or studies addressing the substance and hazard endpoints in question that could be taken into account by ECHA in preparing its decision on the testing proposal. The information has to be submitted within 45 days.

 

 

Consultations on testing proposals can be found here : http://echa.europa.eu/web/guest/information-on-chemicals/testing-proposals

ECHA will consider any scientifically valid information and studies that address the relevant substance and hazard endpoint, relating to the testing proposal when preparing its decision. ECHA publishes non-confidential versions of its dossier evaluation decisions after they have been sent to the registrants.

 

 

The options for the draft decision are: a) Acceptance of the testing proposal, b) Acceptance of the testing proposal with modifications of the testing conditions, c) Acceptance or rejection of the testing proposal but requiring one or more additional tests or d) Rejection of the testing proposal

 

More information can be found here : http://echa.europa.eu/regulations/reach/evaluation/examination-of-testing-proposals

 

Grouping of substances and read-across is a commonly used alternative approach for filling data gaps in REACH registrations and has extensively been used by the metal sector. This approach uses relevant information from analogous (‘source') substances to predict the properties of ‘target' substances. For each standard information requirement that applies, registrants must indicate whether they are making an adaptation using read-across, and they must justify its use. However, registrants need to make sure that their approach falls within the conditions for using grouping and read-across approaches set out in Annex XI, section 1.5 of the REACH Regulation. A read-across approach can also support a conclusion for a REACH endpoint using a weight-of-evidence approach. In all cases, the grouping of substances and read-across approach needs to be adequately and appropriately documented (e.g. assumptions made, conclusions drawn).

 

When checking dossiers for compliance and evaluating testing proposals, ECHA will assess read-across based adaptations and the justifications. To ensure consistency and transparency in their evaluation, ECHA is using the Read-Across Assessment Framework (RAAF), which can be found here: http://echa.europa.eu/documents/10162/13628/raaf_en.pdf

 

The RAAF also provides insights for registrants making use of expertise in read-across on how to assess, and improve where they can, their explanations of why and how read-across can be used. It is recommended to consult it for new registrations and when read-across justifications are questioned in the context of a compliance check or testing proposal

 

 

Latest update : 6 January 2016