R E GU L AT ORY I S S UE S
REACH Countdown Introducing our new regular section on Regulatory and Compliance Issues, we look toward the next REACH deadline in June 2018, and consider what it entails.
EACH is an EU regulation concerning the Registration, Evaluation, Authorization and restriction of Chemicals. It came into force in June 2007, when it replaced a number of European Directives and Regulations with a single system. It aims to protect human health and the environment from the use of chemicals, and it applies to all substances manufactured or imported into the EU in quantities of 1 tonne or more per year. If manufacturers or importers fail to register their substances, they will no longer be able to manufacture or supply them legally. A major part of REACH is the requirement for manufacturers or importers to register their substances with the central European Chemicals Agency (ECHA). The registration of these substances has been phased over 11 years, beginning with the highest-volume (more than 1,000 tons/year) or potentially most toxic substances needing to be registered by December 2010, medium-volume (at least 100 tons/year) substances by June 2013, and finally – 1st June 2018 is the deadline for registration of substances supplied at least 1 ton/year. This obviously means that – despite the current huge focus on the June 2018 deadline – many companies have already completed at least some of their obligations, during Phases 1 (December 2010) and 2 (June 2013). It could even be argued that the schedule demanded the submission of the more ‘difficult’ registrations during the first two phases. Certainly, dossiers for Phases 1 and 2 required more annexes (pertaining to standard information requirements for substances manufactured in quantities of 10, 100 or 1,000 tons or more per year). With only 16 months to the Phase 3 deadline, all manufacturers or importers of substances requiring registration during this phase should have performed their inventories and pre-registered their substances. The next step is the development of the registration dossier, an extensive document that must be compliant with the requirements of the International Uniform Chemical Information Database (IUCLID; available from www.iuclid.eu), as stated in Article 111 of the REACH legislation. This software is used to capture, store, submit, and exchange data on chemical substances, according to the format of the Organization for Economic Cooperation and Development Harmonized Templates.2 If you shudder at the thought of producing this detailed documentation yourself, be reassured others are happy to do it for you. An entire industry seems to have launched itself to support beleaguered chemical manufacturers, and help you through the demands placed upon you by the REACH legislation. The European Medical Writers Association (EMWA), a professional organization that sets guidelines and standards for medical writers in Europe, even published a paper in 2014 entitled, “REACH chemical dossiers? Yes, please!”1 While larger manufacturers may have in-house chemists, toxicologists, regulatory experts and technical writers capable of producing these documents, smaller companies – perhaps those in niche markets, more likely to be affected by the looming Phase 3 deadline in June 2018 – may benefit from external expertise. Not only could professional help save time, resources and stress on the part of existing employees, but a smooth and successful registration, with documentation following all of the appropriate guidelines, may hopefully speed approvals and ensure your ability to continue manufacturing or supplying your products to market. The REACH Centre, TGSE Consulting and Envigo are probably among some of the best-known providers of regulatory guidance in the field of chemicals management and risk assessment. These companies (and others) create and submit dossiers, and offer information intended to guide you through to 2018. For example, Envigo recently launched a REACH insights area on their website, which contains an array of white papers, webinars and e-books. In addition, the REACH Centre offers training on REACH-related matters, while TGSE and Envigo organize the annual European REACH Congress; by the time of this year’s event in November 2017, there will be only 6 months to run to the June 2018 deadline. As the clock keeps ticking, we at Speciality Chemicals Magazine hope to guide you through some of the challenges ahead. If you have any particular questions about the REACH process, or if you’d like to see any particular topic covered in this new regular section focussing on Regulatory and Compliance Issues, send your suggestions to the Editor, email@example.com. We’ll do what we can to help you REACH your goals!
REFERENCES 1. LF Tilbury, P Adrian. Medical Writing 2014;23:190-3. 2. ECD Harmonised Templates for Reporting Chemical Test Summaries. www.oecd.org/ehs/templates/templates.htm
48 Speciality Chemicals Magazine 37.01 February 2017