Earlier in the year the European Commission issued new REACH legislation concerning data-sharing, which can be found here.
By way of brief reminder, the EU has a comprehensive regulatory regime concerning chemicals known as REACH (Registration, Evaluation, Authorisation and Restriction of CHemicals), which was set up under a very complex 2006 EU Regulation that entered into force in 2007.
REACH aims at improving the protection of human health and the environment from the risks that can be posed by chemicals. Under the REACH regime manufacturers and importers must register chemicals with the European Chemicals Agency in order to maintain those chemicals on the EU market. Market tonnage criteria essentially set the REACH threshold registration and this tonnage criteria has been phased in over the years.
Under the REACH regime manufacturers and importers are required to share data and costs as part of the regulatory process. The latest rules aim to clarify the situation as regards data-sharing and the joint submission of registrations in the lead-up to the last registration deadline under REACH of 31 May 2018, which concerns chemicals that are manufactured or imported in the EU above one tonne per year per business.
The overall aim is to ensure that the costs of data-sharing for registration are “fair, transparent and non-discriminatory”. The new rules mandate: itemising the data to be shared; itemising and justifying management data-sharing and registration costs; and, having a cost-sharing model, to include a reimbursement mechanism. The possibility of waiver exists for the first two of these mandatory requirements for existing data-sharing agreements.
The requirements of the new rules apply to both new and existing agreements, i.e they are retrospective, and, prospective registrants under REACH joining a mandatory grouping of manufacturers and importers (Substance Information Exchange Forum – “SIEFs”) making a joint REACH submission have the right to request a costs breakdown of joint registration.
The new rules entered into force on 26 January 2016, and, the European Commission has also recently published FAQs on data-sharing and competition/anti-trust law under REACH (and other guidance), which can be found here.
The most immediate concern for affected businesses will be to review existing agreements and amend them accordingly in order to comply with the new rules. Care must also be taken to ensure EU competition/anti-trust law compliance.
We have written previously on REACH, which can be found here.
For more information please contact André Bywater who is a commercial-regulatory lawyer with Cordery in London where his focus is on compliance issues.
André Bywater, Cordery, Lexis House, 30 Farringdon Street, London, EC4A 4HH
Office: +44 (0)207 075 1785