By the 31st May 2018, all companies manufacturing or importing chemical substances in the European Union in quantities over one tonne per annum must register these substances with the European Chemicals Agency (ECHA). More than 70,000 registrations are anticipated in the 2018 round of REACH, over three times those submitted in 2013, many of which will be done by first time registrants.
The implications of failing to register with ECHA are severe. Ultimately, organisations will be excluded from trading within the European Union which will come at a massive detriment to business operations.
Registration remains a complex and costly process, particularly for small to medium enterprises (SMEs) which are predicted to make up much of the 2018 intake. As the cost of failing to register is exclusion from trading in the EU, developing a clear path to submission that takes into account all supply chain risks and identifies the financial and technical support required is essential to ensuring business continuity.
Here Caroline Raine, global regulations and compliance expert for the UK National Chemical Emergency Centre (NCEC), shares the practical tips and the lessons learned from supporting companies to prepare for REACH and secure regulatory compliance.
One of the greatest challenges in REACH preparation is the generation and sharing of chemical information. ECHA’s REACH 2018 Roadmap foresees only one registration per substance and companies are expected to share data and submit registrations jointly, which is particularly complicated when exchanging knowledge with competitors.
This first step to this process requires companies to prove “substance sameness”. Ensuring that all materials are correctly identified is critical, as incorrect identification will add time and cost to the process. Sameness can be demonstrated using spectral data, however an approved laboratory is not required for testing. Instead, documentation detailing the analytical methodology must be submitted so that it can be repeated to get the same results. Impurities above 1% must also be accounted for, along with any impurities that are relevant to the classification, ensuring that all constituents add up to 100%. Appointing an external partner can help streamline document collection, while also bridging the gap between collaborative submissions and ensuring competitive information remains private.
Registrants are also expected to collect information on the supply chain for their substance. As the REACH deadline draws closer it is becoming increasingly clear that many suppliers plan to withdraw from the market place. During preparation, companies must consider a range of market variables, such as whether their supplier is likely to withdraw, and, if so, what alternative sources for formulations and substances are available. It is also important to determine whether substances will have restrictions at the time of submission and what plans are in place to compensate for this. Without supply chain insight, many companies risk being caught out with little time to react.
REACH registration financing is often difficult to predict and budget for as data costs depend on the number of registrants as well as the level of hazards. Companies must determine whether the cost of building the internal capacity to ensure REACH registration is viable, or whether partnering with a regulatory consultancy is a more cost-effective approach to securing compliance.
Companies must also set aside funds to ensure that ECHA charges are promptly paid, as ECHA enforces strict payment terms. During the previous REACH stages some companies with otherwise exemplary submissions have found their registrations rejected for late payment. Considering payment terms and accruing costs during planning is therefore a critical part of preparation.
REACH registration is a complex process, however with careful planning an organisation can overcome many costly and time consuming challenges.
REACH 2018 registrations are submitted via dossier creation in IUCLID and completed via the REACH-IT website. The current version of IUCLID is 5.6 but a new version (IUCLID 6) is expected in 2016. Creating the dossier in the correct version of IUCLID, and ensuring that the legal entity (LEOX file) matches the one in your REACH-IT account, is key to successful submission. Again, registrants must identify whether they have sufficient in-house resource to submit effectively, or whether external support is required. Clearly the more submissions you need to make the more resources you may require. It is also worth noting that the REACH-IT account is only accessible during the week, Monday 10:00 to Friday 21:00.
REACH registration is a complex process, however with careful planning an organisation companies can overcome many costly and time consuming challenges. For more information on EU compliance, visit the NCEC website’s REACH service page at http://the-ncec.com/reach-services/ or contact Caroline Raine at email@example.com for helpful advice.