Another important milestone in the European REACH directive on chemicals has been achieved. On May 31 the bell rang for substances within the 100-1000 MT range. This second step takes place two and a half years after the first deadline for chemicals with a manufactured or imported volume of > 1000 MT per company.
The aim of REACH (Registration, Evaluation, Authorization and Restriction of Chemical substances) is to improve the protection of human health and environment through better and earlier identification of the intrinsic properties of chemical substances. As such it will contribute to the save use of chemicals; not only within but also outside the European Union.
As communicated earlier, Axcentive is Lead Registrant for 4 substances, for all of which a Joint Submission File has been drawn up on behalf of all potential registrants. These products are:
- ortho toluene sulfonamide (Ketjenflex 2)
- para toluene sulfonamide (Ketjenflex 6)
- o/p toluene-sulfonamide (Ketjenflex 9S)
- and para toluene sulfonyl chloride (PTSC)
By working at the same time on all 3 amides, Axcentive has been able to save substantially on overhead costs as well as on test data. In recent months a Joint Submission Dossier for all 4 substances was filed at the European Chemical Agency and the price for a Letter of Access (LoA) was determined. Then the LoA shop opened at REACHCentrum – our service provider – and the process of companies procuring a LoA and filing a co-registration went smooth.
The extensive preparations hereto have been executed by our regulatory department and several external parties, all coordinated by Patrick Karpe – Regulatory Manager and Paul Raadsen – Executive Director. Patrick comments:” all went according to our schedule, but the final weeks before the submission have definitely been a challenge for those involved, inside Axcentive but also outside. We like to thank our external partners for their continuous support”.
The next deadline for the remaining volumes (1-100 MT) will be in 2018. Again Axcentive will be Lead Registrant for some of the products in our portfolio; the final selection to take place well before the next deadline.
Interested SIEF-members have bought access to the dossiers so that all market parties that so wished have been able to properly register.