On 6 January 2016, the European Commission published the Implementing Regulation 2016/9 on the joint submission of data and data-sharing (the Regulation). Concerns have been raised that the Regulation is likely to increase the administrative burden that prospective Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regime registrants are subject to.
The Regulation is intended to improve the mechanism for sharing information and costs under the REACH regime. The Regulation will enter into force on 26 January 2016 and it has retrospective effect.
REACH requires manufacturers and importers of certain substances to register with the European Chemicals Agency before that substance is manufactured or brought into the EU above certain specified quantities. Manufacturers or importers of the same substance are required to prepare a single joint submission for registration. The Regulation clarifies what the terms “fair, transparent and non-discriminatory” mean in the context of data-sharing between joint registrants under REACH.
The Regulation gives prospective REACH registrants joining a Substance Information Exchange Forum (the mandatory group made up of manufacturers and importers of the same substance which leads to the joint submission) the right to request a breakdown of the costs associated with making the joint registration.
The retrospective effect of the Regulation means that data-sharing agreements which are entered into on or before 26 January 2016 will need to be reviewed and, if required, amended to ensure compliance with the Regulation.
The Regulation is available here.