The Ombudsman did not require ECHA to report on its implementation of the second proposal. It may also be worth reminding the Ombudsman of the three stages of registration which are relevant to the dispute: this is where ECHA checks that a registrant Completeness (Article 20 of REACH): has included information pertaining to the endpoints which are relevant for the tonnage at which the substance is manufactured and imported. There is no assessment of the quality or relevance of information at this point: see Article 20(2) Compliance check (Article 41): this is where ECHA can check that the information supplied by a registrant meets the requirements of REACH. Quality and relevance are assessed at this stage a registrant must submit a proposal to carry out tests Testing proposal (Article 40): where there is a data gap at Annex IX and X tonnage. There is an opportunity for third parties to provide information relevant to proposals involving live animals (Article 40(2)). Based on its examination of the proposal, ECHA is mandated to accept, vary or reject it (Article 40(3)). Recent events Implementation of the first proposal has been discussed at the Commission’s Competent Authorities for REACH and CLP committee (CARACAL). On 8 2016, the European Commission wrote to ECHA giving is opinion on the measures adopted by ECHA to implement the proposals (attached). On 11 March 2016, ECHA wrote to the Ombudsman to explain how it was implementing the first proposal. On ECEAE sent an email to Ms Hirsch-Ziembinska, requesting that the 15 March 2016, Ombudsman should not make any decision on the adequacy or otherwise of what ECHA was doing in relation to the first proposal until ECEAE had had the opportunity of clarifying some matters with ECHA.
The Ombudsman did not require ECHA to report on its implementation of the second proposal. It may also be worth reminding the Ombudsman of the three stages of registration which are relevant to the dispute: Completeness (Article 20 of REACH): this is where ECHA checks that a registrant has included information pertaining to the endpoints which are relevant for the tonnage at which the substance is manufactured and imported. There is no assessment of the quality or relevance of information at this point: see Article 20(2) Compliance check (Article 41): this is where ECHA can check that the information supplied by a registrant meets the requirements of REACH. Quality and relevance are assessed at this stage Testing proposal (Article 40): a registrant must submit a proposal to carry out tests where there is a data gap at Annex IX and X tonnage. There is an opportunity for third parties to provide information relevant to proposals involving live animals (Article 40(2)). Based on its examination of the proposal, ECHA is mandated to accept, vary or reject it (Article 40(3)). Recent events Implementation of the first proposal has been discussed at the Commission’s Competent Authorities for REACH and CLP committee (CARACAL). On 8 2016, the European Commission wrote to ECHA giving is opinion on the measures adopted by ECHA to implement the proposals (attached). On 11 March 2016, ECHA wrote to the Ombudsman to explain how it was implementing the first proposal. On 15 March 2016, ECEAE sent an email to Ms Hirsch-Ziembinska, requesting that the Ombudsman should not make any decision on the adequacy or otherwise of what ECHA was doing in relation to the first proposal until ECEAE had had the opportunity of clarifying some matters with ECHA.
TP%20complaint%20friendly%20solution%20ECEAE%20Observations%20(May%2016).docx