REACH Evaluation Report 2012: Quality information required for REACH compliance


The Evaluation Report 2012 shows that a large part of the examined registration dossiers still raise quality and subsequently compliance concerns. ECHA strongly encourages registrants, in particular if they are preparing registration dossiers for the second REACH registration deadline, to read the recommendations of the report and act accordingly.

Helsinki, 27 February 2013 – Last year was a crucial year for evaluating REACH registration dossiers. The evaluation report presents details and figures on the Agency's evaluation activities and their respective output. During 2012, ECHA examined all the testing proposals received for the first REACH registration deadline in 2010. The Agency adopted 171 decisions on testing proposals, and sent 364 draft decisions to registrants.

In 2012, ECHA also launched a new strategy for selecting dossiers for compliance check that may contain typical shortcomings. This approach complements the traditional compliance check, where dossiers are manually selected for examination. The new, additional approach increases the chances of finding and addressing information gaps in all registration dossiers.

By using both methods, the Agency concluded 354 compliance checks during 2012. However, ECHA did not have to request registrants to provide further information and were able to close the case in only 33% of these cases.

In 2012, ECHA further developed its compliance check follow-up process with the involvement of the national enforcement authorities. Action focused last year on substance identity decisions triggered by the examined testing proposals to which registrants had not or insufficiently responded. In 14 cases, ECHA requested enforcement action on those decisions and had to suspend the associated testing proposal examinations.

"I need to remind registrants that registration under REACH is not just a paper exercise and that high quality data is not an end in itself. The purpose of describing a substance clearly and assessing potential hazards and exposure with scientific rigour is to ensure that the risks are properly identified and controlled in order to protect workers and the public at large," says ECHA's Executive Director Geert Dancet.

The report lists the most common shortcomings found in the dossiers and gives specific recommendations for registrants concerning the following five topics:
• Identifying your substance.
• Identifying the test material.
• Making full use of all relevant information.
• Providing clear use and exposure information.
• Making use of ECHA support.

Finally, it should be noted that the report does not cover our assessment of the quality of
dossiers for intermediates that were the subject of a large-scale screening action in the past
year. Registrants that prepare such dossiers for the next registration deadline are urged to
also take note of the news alerts and web pages covering this action.

Further information

Pursuant to Article 54 of the REACH Regulation, ECHA publishes a report on evaluation by the
end of February each year.