Below are the key issues which became apparent during the series of presentations at the European Chemicals Agency (ECHA) 7th Stakeholders’ Day on the key topic of Evaluation. Key messages from the presentations on the REACH registration process were covered last week in “5 key issues Registration issues from ECHA’s 7th stakeholder day” and authorization will be covered in a future blog.
ECHA have conducted a comprehensive analysis of the dossiers submitted for the 2010 deadline; they have presented their findings in the 2011 Evaluation Report- http://echa.europa.eu/documents/10162/13628/evaluation_report_en.pdf
When Compliance of Dossiers was checked;
- Only 8% did not require further action from the Registrant
- 72% of dossiers examined received Final decisions, requiring further information to be supplied by the registrant
- A further 13% of dossiers received Quality Observation Letters, noting deficiencies in the dossiers not warranting a formal request for information
The top five reasons for Final Decisions to be issued after compliance checks;
1) Incomplete or inconclusive substance identity
2) In vitro mammalian gene mutation study missing
3) PNEC missing from the environmental hazard assessment
4) Prenatal developmental toxicity study missing
5) Growth inhibition study in aquatic plants missing
The top 5 reasons for Quality Observation letters to be issued after compliance checks;
1) Incorrect or incomplete Classification and labeling
2) Inconclusive substance identity
3) Deficiencies in the Chemical Safety report
4) Insufficient level of detail/inconsistencies in the Robust Study summaries
5) Consideration of further studies required.
Recommendations from ECHA;
ECHA is urging all registrants to significantly improve the quality of the dossiers submitted. Of particular concern is the need for registrants to ensure that the identity of the registered substance is accurately and adequately described, with appropriate representative analytical data about the substance being manufactured or imported.
ECHA are also asking that registrants update their dossiers if testing proposals for higher tier endpoints are missing to avoid Decisions being made on the dossiers.
Compliance checking- the new strategy
As an outcome of the 2011 dossier evaluation, ECHA are introducing a newAll Dossiers will now be automatically screnned for non compliance
strategy for identifying dossiers for compliance checking.
Specific hazard endpoints have been identified which are important for human or environmental safety. All submitted dossiers will be screened against these endpoints to identify those registrations which are potentially non-compliant.
The identified dossiers will then be evaluated manually under a REACH compliance check.This will result in targeted compliance checks comprising 70% of the total dossiers checked, with the remaining 30% will be chosen at random.
In addition there are several criteria for automatic selection for compliance checking, these include but are not limited to: individual registrations outside a joint registration and dossiers where the chemical safety report is missing.
Any dossier found to be incomplete will receive a compliance check decision from ECHA.
With the advent of intelligent screening the probability of poor quality dossiers being compliance checked has increased dramatically from the 1 in 20 envisioned in the legislation. Once the compliance check process starts there is unlikely to be an opportunity to discuss your dossier with ECHA due to the high volumes of targeted compliance check decisions expected. Companies can avoid compliance check decisions by pro actively updating their dossiers.
If you want to ensure your company submits a high quality Registration Dossier, Contact H2 Compliance today to avail of our latest offer of a Free 30minute Consultation with a Senior Consultant to assess your situation.
Alternatively check out our new Dossier Modus Registration Service and discover how H2 Compliance use Dossier Modus to maintain a 100% sucess rate when submitting Dossiers.