E – Evaluation
After successful submission of your registration dossier, further obligations may arise for you as a registrant or a member of a joint registration.
Pursuant to Article 41 (5) of the REACH Regulation, at least 5% of the registration dossiers submitted per tonnage band has to be evaluated 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.
In this ‘Compliance check’ certain strategies are used by ECHA to identify submission of incomplete data (requirements). The potential hazards that may arise for humans and for the environment and the produced or imported quantities of the substance were described as most decisive reasons for evaluation of substance. Besides, IT-tools are used to identify lack of data. Furthermore, another minor part of the submitted dossiers is chosen for evaluation by a random-principle. Another part of many registration dossiers, namely justifications for applying the read-across approach, are checked by ECHA for conclusiveness and additional information may be requested if necessary. Thus, each dossier can be evaluated at random and registrants are encouraged to regularly update their existing dossiers without any request from ECHA. In addition, the dossiers, which were created with the IUCLID 5 software or older, should also be updated to the current IUCLID 6 format.
We can assist you on the revision of already submitted dossiers, either before or after a decision from ECHA was provided. Additionally, we can provide competent support in communicating with the authorities. Upon request, we can take over the complete 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).
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