Cefic has pointed to the need for legal certainty in the matter of data-sharing regarding REACH, the EU chemical safety law. This is important in order to avoid duplication of work, cut unnecessary costs and reduce animal testing.

Vincent Navez, Cefic Executive Director for Legal Affairs, took part in a recent panel debate to present Cefic’s views on data-sharing in the context of REACH. There he explained that at the start of 2016, the EU Commission adopted an Implementing Act – the kind that gives effect to regulations - which made this cooperation between operators subject to very precise rules.

All producers of each chemical substance must prepare and submit joint registrations to ECHA, the EU chemical agency. These companies have to share data on studies about, for example, the safety and applications of the substance concerned. This spreads the burden – research can be prohibitively expensive, so by selecting the most relevant studies about that substance, costs are saved.

For existing and newly generated data, companies making that substance should contribute to the costs of that study. The new Implementing Act ensures companies don’t benefit from an unfair cost advantage. In view of the coming 2018 registration deadline, more SMEs will be impacted and therefore more newcomers to the REACH registration process. Clear and comprehensive guidance will be critical for legal certainty.

Coming Steps

An important step will be an update of ECHA guidance incorporating the new Implementing Act to be published by the end of 2016, designed to support companies to put it into practice. Its understanding and interpretation will be critical. Cefic, along with other stakeholders, worked with ECHA in the run up to the release of this Guidance. Cefic will in parallel update its support template agreements to include, for instance, a section helping companies itemise costs and data. This will give companies –particularly SMEs - a needed 18 month period to digest and prepare for the 2018 deadline.

European consumers benefit from the strictest chemical safety laws of any global region. As these laws come under the microscope towards the 2018 registration deadline, now is the time for greater clarity to ensure companies are empowered to best implement them.

For further follow-up, please contact Dervla Gleeson, Media Relations Manager, Cefic – EU Chemical Industry Council (dgl@cefic.be)