The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (EC) No. 1907/2006 demands that manufacturers or importers of most chemicals into the EU above 1 ton per year will need to register the chemicals with the European Chemical Agency (ECHA) – no matter whether the chemicals are part of a pure substance, preparation or article.
We can help you design the right registration strategy to achieve full compliance for the REACH registration process. Arcerion can assist you in assessing data requirements, evaluating data and preparing registration dossiers. For non-EU manufacturers Arcerion can also perform the role of an Only Representative; for importers or EU manufacturers, we can act as your Third-Party Representative.
Our roadmap to a successful REACH registration includes:
Identification of substances, volume information, use mapping and collection of in-house data.
For phase-in substances that have not been preregistered and all non-phase-in substances an inquiry process at ECHA will be performed before placing the substances on the market for the first time.
3. Late pre-registration
If applicable a late pre-registration will be performed to benefit from an extended deadline for REACH registration in June 2018.
4. Data evaluation
Collection of existing data on the chemicals from Substance Information Exchange Fora (SIEF) and literature research.
5. Determination of data gaps
Evaluation of data gaps in the REACH registration dossier.
6. Completion of data requirements
If applicable “grouping of substances and read across” and “(quantitative) structure-activity relationship” [(Q)SAR} will be applied to fill data gaps.
7. Chemical safety assessment (CSA)/Chemical safety report (CSR)
A chemical safety assessment (CSA) needs to be completed for substances subject to REACH registration in quantities of ten tonnes or more per year. The CSA is the process that identifies the conditions under which the manufacturing and use of a substance is considered to be safe. The chemical safety report (CSR) documents the chemical safety assessment undertaken as part of the REACH registration process, and is the key source from which the registrant provides information to all users of chemicals through the exposure scenarios.
8. Preparation of a test proposal
For chemicals above 100 tonnes per year that have data gaps new tests might be necessary. Testing on vertebrate animals is the last resort for obtaining missing information on a substance and to be able to meet the information requirements of REACH. Proposals for testing need to be submitted to ECHA to check that reliable and adequate data will be produced and to prevent unnecessary animal testing.
9. Dossier preparation and submission
All data for REACH registration will be brought together in IUCLID, the registration dossier is created, and submitted to ECHA via REACH-IT.
10. Material Safety Data Sheet and CLP Labelling
A safety data sheet and CLP compliant labelling of the product containg the chemical is created.