E – Evaluation
Even after the submission of the registration dossier, further obligations may arise for you as a registrant of a member of a joint registration. According to Article 41 (5) of the REACH Regulation, at least 5% of the registration dossiers submitted per tonnage band has to be checked by ECHA.
ECHA and the Member States examine and evaluate the quality of the registration dossiers and the testing proposals submitted by the companies to validate if a specific substance poses a threat to human health or the environment.
Here again, we are able to assist you in your communication with the authorities or can take over the entire process.
Together with our customers, we have already gained a lot of experience in communication with ECHA. For example, in the course of evaluation of testing proposals by the authority, we convinced ECHA several times to perform only one test on repeated dose toxicity (90-day-trial) and development toxicity (OECD 414).
For other substances, we have succeeded in convincing ECHA to waive a two-generation study due to negligible exposure even although the substance has a widespread use for customers (deviation from the standard test routine in Annexes VIII, IX and X in accordance with Annex XI (3) by substance-specific and expositions dependent test).
Our services at a glance:
- Competent and comprehensive strategy advice and support
- Preparation of justification papers for communication with authorities
- Extended exposure calculations (“higher tiers”)
- Revision of existing dossiers
- Service for communication with the authorities