The European Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals EC No 1907/2006 (REACH Regulation) aims to protect humans as well as the environment against hazardous substances, but tries, at the same time, to enhance competition and innovation in the chemical sector in the European Economic Area (EEA). The REACH Regulation not only applies to chemicals produced in the EEA, but also on chemicals imported in the EEA. The essential tool is the REACH registration of these chemicals. The burden of the initiative to do a registration lies on the importer or manufacturer of a chemical substance. In this update we will discuss the essential steps of such REACH registration and some changes and improvements in the registration process that are scheduled to be implemented during the next years.
By making a REACH registration, the manufacturer/importer of a chemical substance is obligated to compile a dossier in which he has to make an assessment of the traits, risks, use and precautions for each chemical (substance) it wants to release/import. The registration has to be submitted to the European Chemicals Agency (ECHA), which will assess the registration and, together with the National Designated Authorities of the Member States (and sometimes the European Commission), will approve the authorisation for a chemical product to be released on the market. Following the REACH Regulation, which was adopted in 2006, there have been two registration rounds (2010 and 2013) for the most hazardous chemicals and for volumes exceeding 100 tonnes. The next registration round sets a registration deadline of 31 May 2018 for substances manufactured or imported in ‘low volumes’ from 1 to 100 tonnes per year, per company.
REACH Roadmap 2018
It is expected that around 70,000 registrations will be made by the next registration deadline of 31 May 2018. Registrations will be made in a large part by SMEs. ECHA, with the help of the chemical sector stakeholders, has published the ‘REACH Roadmap 2018’ (ECHA-15-R-01-EN, published 14 January 2015), to provide guidance and documentation to the industry (mainly SMEs) on how to comply with REACH obligations and registration. In the Roadmap, ECHA and the stakeholders have set out several steps to help companies preparing a successful REACH registration.
Phase one – application of REACH. ECHA will try to communicate to the companies to help them to determine whether the 2018 registration deadline affects them. ECHA will provide the sector with checklists, webpages with Q&As, webinars and an outreach campaign to explain the registration obligations and inform companies about the registration deadline.
Phase two – finding co-registrants. Through the REACH notification, there can only be one single registration per chemical substance. Companies registering the same substance are expected to share their data and submit a registration jointly. Therefore, ECHA will provide information on their website to help companies to find out who intends to submit a registration for the same substance. Once a co-registrant has been identified, a joint registration should be made. ECHA is trying to facilitate this process by creating a tool for finding co-registrants.
Phase three – cooperation with co-registrants. Co-registrants (companies which have to register the same substance through a joint registration) are often competitors to each other on the EU chemicals market. Means have to be found so that these companies share their data about their substances, to avoid unnecessary (animal) tests. Especially for SMEs, ECHA will try to minimize the research burden trough data-sharing. ECHA tries to enhance the data sharing through data-exchange forums, providing guidelines and training for data and cost-sharing negotiations, leading to improved negotiation practices between companies which have to make a joint registration.
Phase four – Assessment of the risks. The next step in the registration process of a chemical substance is making an assessment of the use, dangers and exposure of the chemical. It is key for the effectiveness of REACH that the correct data is provided and correct assessment is being done for each chemical, as only then the real risks for each chemical substance can be determined and protection for the public and environment can be provided. ECHA will provide a practical guide for registrants of chemicals of 1-10 tonnes and provide guidance for SMEs in assessing complex substances.
Phase five – Preparing the registration. Once all information has been gathered, it needs to be inputted into the ECHA system by using a mandatory software programme. This is found to be one of the most complex steps of the registration process by the industry. ECHA will make some amendments of the dossier preparation tools to enhance user friendliness.
Phases six and seven – Submitting the registration and keeping the registration up to date. Once the registration file is complete, the registration has to be submitted. ECHA will add a ‘completeness check tool’ to the IT module. Companies should also be aware that they have the obligation to keep their registration up to date, for example in case of a new use for the registered chemical substance.