On 26 January 2016 Implementing Regulation 2016/9 of the EU Commission on the REACH Regulation will come into effect. Under REACH manufacturers and importers need to register their chemical substances. In the case of identical chemical substances, the required data shall be shared by all registrants. The new implementation requirements are designed to facilitate distribution of the costs arising from data sharing.
“The Implementing Regulation in particular include more specific information on the requirements and obligations for shared data from tests”, says Dr. Daniel Mauder, REACH expert at TÜV SÜD Industrie Service GmbH. “In practice, the issue of how costs can be shared in a fair, transparent and non-discriminatory way has been the subject of repeated debates.” In the case of shared data, the individual registrants need only pay the costs for the data requirements in their tonnage band. The regulation differentiates between the following segments: substances in quantities of 1,000 tonnes or more per year, over 100 tonnes, over 10 tonnes and over 1 tonne per year.
One substance, one joint registration and shared costs
Data-sharing agreements are to include a clear and understandable itemisation of the costs of any study or test and all administrative costs. These costs must be documented annually over a period of at least twelve years. If the companies agree on a cost-sharing model, they must consider the number of potential registrants for that substance and the possibility of future additional information requirements. The model must also provide for a reimbursement mechanism to adjust the share of costs paid by the individual registrants if additional registrants join the agreement at a later stage. Dr. Daniel Mauder comments, “Under REACH, the ECHA (European Chemicals Agency) continues to consistently follow the principle of ‘one substance, one registration’. From February 2016 on, when the REACH-IT update comes into effect, registrations outside the joint submission of data will no longer be possible.”
The registration deadline for smaller quantities of substances exceeding 1 tonne per year will expire in mid-2018. Smaller and medium-sized enterprises will be particularly affected by this deadline. TÜV SÜD’s REACH experts support manufacturers and importers of substances in all issues related to data sharing and registration and on all issues related to the European Chemicals Legislation. Further information on this subject is available on the internet at www.tuv-sud.com/activity/testing/reach.
Press-contact: Dr Thomas Oberst