ECHA has examined all proposals to test substances submitted by the first REACH Registration deadline and has issued draft or final decisions to companies by the legal deadline of 1 December 2012. This is an important step in the REACH process – making sure that data gaps are filled but at the same time avoiding unnecessary testing on animals.
The REACH Regulation requires registrants to submit proposals for testing to ECHA when they identify a data gap for certain information requirements. ECHA has the obligation to examine all the proposals in a certain timeframe. For all testing proposals submitted by the first registration deadline of 30 November 2010, ECHA had to prepare a draft decision by 1 December 2012. This deadline has been met successfully.
A total of 571 dossiers (with altogether 1 184 individual testing proposals) have been examined. Nearly 130 cases were terminated due to the withdrawal of the proposals, testing already being initiated or for other reasons. Draft decisions were issued in 436 cases, of which 146 have already resulted in a final decision. In the other 290 cases the decision making procedure will continue in 2013. In 24 of these cases, the proposals for reproduction toxicity tests have been referred to the Commission because the Member State Committee did not reach agreement on them.
For the remaining 14 cases the examination of the testing proposals has been suspended due to the non-compliance of the substance identity information. Instead, a compliance check decision has been prepared. In these cases, the deadline of 1 December does not apply. There are also several other cases where the involved registrants have been requested to clarify the identity of the substance first before the draft decision on testing proposal can be processed further.
ECHA's Executive Director of Geert Dancet said: "Examining the first wave of testing proposals within the legal timeframe is another successful step in REACH implementation. When these information gaps for high volume chemicals are filled, additional risk management measures may be needed not only at company level but possibly also at the European level."