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Report Overview
Evaluation is the E in REACH. It is a fundamental part of the EU legislative framework that ensures the protection of human health and the environment from the potentially harmful effects of chemicals. The safe use of substances starts under REACH with high quality registration dossiers that are industry’s responsibility. The REACH Regulation is relatively new and both ECHA and individual companies are learning to apply it for the first time.
The report gives a sense of ECHA’s experience of evaluation and, crucially, feedback on the quality of the initial dossiers registered and evaluated. It also makes recommendations for registrants on how to improve their dossiers and help ensure a successful registration. The adequacy of the registered data and the quality of dossiers was evaluated in three ways:
- Compliance check of at least 5 % of the dossiers received by ECHA per tonnage
- Examination of testing proposals
- Substance evaluation checks whether use of a substance may cause a serious risk to human health or the environment
- In 2010, ECHA completed 70 compliance checks; another 21 were in the decision-making phase at year end; and the evaluation of 60 dossiers continued into 2011.
- 12 resulted in an ECHA decision asking the registrant to provide further information
- 33 cases, data was not missing but recommendations were given for the registrants on how to improve their dossier quality
- 25 cases, no action was needed.
- ECHA screened 303 dossiers for on-site and transported intermediates to check if the registrations fulfilled the requirements to be considered as intermediates, or whether they should have been a normal registration.
- Eleven dossiers for transported isolated intermediates were compliance checked and in all cases, letters were sent to the registrants requesting further information.
- ECHA started the examination of 123 testing proposals, adopted four final decisions and issued another eleven draft decisions. In three of the final decisions, the tests were requested as proposed by the registrant while in one decision the tests proposed by the registrant were modified.
- Substance evaluation will formally start in 2012 and the criteria for prioritising substances for the Community Rolling Action Plan (CoRAP) and the timelines and processes leading to the first CoRAP have been agreed upon.
Quality
Many of the dossiers evaluated had quality problems. These dossiers were the very first to be submitted and represent only the tip of the iceberg in terms of numbers. The most significant recommendations were:
- The identity of the registered substance needs to be clearly described;
- Any adaptation to the standard testing regime must meet the conditions set out in Annex XI or in column 2 of Annexes VII – X of the REACH Regulation; and a clear justification for any adaptation must be provided;
- The robust study summaries should contain enough detail to allow an independent assessment of the information provided;
- Classification and labelling should be in line with the hazards identified or with the harmonized classification and labelling of the substance;
- A proposal to do testing must be submitted first (for tests under Annex IX and X) before the test is done. Doing a test before getting ECHA’s decision may lead to legal action;
- Registrants have an obligation to share data resulting from animal tests and to share the costs before submitting the dossier.
The full report can be found HERE.
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