In a turbulent world, where the geopolitical order is in transition, the one thing you can rely on is the constancy of the May 2018 REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) deadline. Yes, Thursday May 31st 2018 is the deadline for registering existing substances used in low volumes (one to 100 tonnes per year) in the EU. Although this marks the formal finish of dossier generation for existing substances, it is by no means the end of the process. Read on to find out about the hurdles you’ll meet on the road post-REACH submission.
Hurdle 1: completeness and compliance checks
The European Chemicals Agency (ECHA) will check your submitted dossier for completeness. This now involves both IT and manual checks. Since the introduction of completeness checks and until the end of 2016, manual checks were carried out in 33% of dossiers. The main areas where gaps in completeness were identified related to the chemical safety report (CSR) and the substance uses.
In preparation for the 2018 deadline, the number of submissions is large, which is putting some pressure on capacity in contract research organizations. ECHA has stated that if this is a limiting factor, it may allow submission of incomplete dossiers using a token system.
ECHA also conducts compliance checks on at least 5% of all dossiers received within each tonnage band. In 2016, 91% of the dossiers compliance-checked had non-compliances severe enough to require further action and require generation of new information.
Hurdle 2: information requests and follow-up decisions
The substance evaluation process may throw up requests for additional information to complete gaps, clarify a concern or to bring a dossier into compliance with REACH. Addressing concerns and generating new information in response to these requests can take a significant amount of time and add to costs.
Hurdle 3: changes in tonnage
Once registered, you need to monitor the annual tonnage of your substance because increasing tonnage may put you in the next band for registration. If this occurs you will need to upgrade the registration, at potential significant cost. The key to ensuring that you do not need an unwanted upgrade is through forward planning and knowing the options available to you.
Hurdle 4: maintaining up-to-date dossiers and data sheets
All dossiers should be updated with new information that impacts the substance hazard profile. This could be due to new data availability or because of changes in manufacturing. You need to ensure all changes are reflected in the dossier. IUCLID software updates may also mean that when you come to update your dossier, you will find that further additional information is required.
Changes to dossiers may require changes to the safety data sheets (SDSs). Creating and maintaining SDSs or electronic SDSs (eSDSs) can be time-consuming, especially because these must be supplied in the language of the user.
The real key to success: communication and collaboration
The drive by REACH to ensure ‘one substance, one registration’ has promoted collaboration and joint working between registrants. The latest report evaluating the use of non-animal technologies in REACH registrations found that 98% of over 6,000 substances analyzed were registered jointly. Collaborative working needs good communication and well-drawn agreements. Having robust and forward-looking Substance Information Exchange Forum (SIEF) agreements should cover these eventualities.
Communication and collaboration with downstream users (DSUs) is also important; for example, requests from a DSU may reveal that they use the substance in a way that is not specified in the registration. This may lead to various actions such as communication with the ECHA or creation of a CSR if the substance is hazardous. Many DSUs can create and maintain CSRs but others will need more help. Effective communication and collaborative working can again ensure this happens smoothly.
So, although you can’t relax just yet, you can make the process simpler in the long run. So as well as booking that June 2018 ‘get away from it all’ holiday, why not further prepare yourself for post-deadline REACH activities by reading the Developments in Life Sciences article 'Life beyond May 2018: does it all end there?'