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ECHA improves transparency of dossier evaluation

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Media enquiries: ECHA Press

REACH requires that new testing of a substance involving vertebrate animals should only be carried out as a last resort. To ensure that the best use has been made of existing information REACH obliges ECHA to take account of scientifically valid information received from third parties when preparing its decision on a testing proposal. In February 2011 ECHA will start to publish brief conclusions drawn from the information provided by third parties. This information will be published after the adoption of the final testing proposal decision.

Helsinki, 31 January 2011 - In line with Article 40(2) of the REACH Regulation, ECHA publishes on its website information on all testing proposals from registrants involving vertebrate animals before taking a decision on the proposal and invites third parties to submit scientifically valid information and study results. All scientific information thus collected is taken into account by ECHA in preparing the final decision.

By publishing the conclusions of the evaluation of the scientific information submitted by third parties ECHA wishes to improve the transparency of the process and encourage the submission of relevant information. In addition an overview of responses and ECHA observations on third party information will be given in the 2010 annual Evaluation report which will be published by the end of February. 

Case-owners and stakeholder observers present at evaluation discussions for the first time

At its meeting this week (1-3 February) the Member State Committee (MSC) will focus on dossier evaluation cases. If the Committee comes to unanimous agreement on the content of ECHA's draft decisions on four compliance checks and one testing proposal examination, ECHA will take the decisions in accordance with MSC agreement. If agreement is not reached, the case is forwarded to the Commission for decision.

According to the new rules adopted recently by MSC the case-owners (registrants) have been given the opportunity for the first time to participate in discussion when their case was presented to the Committee. At the same time nominated stakeholder observers are also given the chance to be present during the discussions of dossier evaluation cases when the confidentiality rules do not prevent their participation. The intention is to improve the transparency of the compliance check and testing proposal processes.

MSC will test this practice for one year and then review the situation based on the experience gained.

ECHA also publishes Practical Guide 12 on Evaluation

ECHA's new practical guide explains to industry and third parties what dossier evaluation is, how accepted dossiers are processed. It also gives advice on how and when registrants should react to communications sent by ECHA related to the evaluation of their registration dossier.

ECHA is to examine at least 5% of received registration dossiers in each tonnage band and all submitted testing proposals. If during dossier evaluation ECHA finds out that the data provided does not fulfil the information requirements of the REACH Regulation, registrants will be requested to submit such missing data. 

ECHA has a new organisational structure to reflect its current priorities. As of 1 January there has been a new directorate for Evaluation responsible for the dossier and substance evaluation workload. Leena Ylä-Mononen is the director of the Evaluation Directorate.


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