Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) is a ten-year program for registering, describing, and evaluating risks to humans from thousands of substances sold in the European Union. Prior to REACH, many substances were assumed to be safe without conclusive information, and the quantities of those substances being used in different industries by different companies were not quantified.
That has changed. Manufacturers and importers were given the responsibility of testing and providing information on the safety of those substances. The largest vendors and importers, those using 1,000 metric tonnes or more, had the first deadline in 2010. Those using more than 100 but less than 1,000 metric tonnes had their registration deadline in 2013. Those using 1 to 99 metric tonnes per year have their registration deadline in 2018.
So far, 9,064 EU companies (including EU reps of non-EU companies) have registered 4,454 substances.
The Finish Line?
ECHA has been using the metaphor of a race, with May 31, 2018 as the finish line. Joyful celebrating teams are the image being featured. The focus is on meeting that registration deadline.
That’s completely appropriate. There are many companies that have not started their compliance project for REACH2018, including new companies that have just entered the European market or just crossed the 1 metric tonne threshold. There are also companies that have been taking a “wait and see” approach, or which haven’t had the resources to start the process. Meeting the deadline is the highest priority for these companies.
Think more deeply about the image of a race, though, and you’ll see that the finish line isn’t usually the end. Successful runners continue to train. They have more races ahead. The finish line isn’t really the end.
And May 31, 2018 isn’t really the end for REACH, either.
A successful registration gives your company a REACH registration number. It’s certainly an accomplishment, and your team has every right to celebrate. But that’s just the beginning. Next, ECHA evaluates the information presented.
This begins with an evaluation of the testing proposals submitted. Then there is evaluation of the dossiers submitted — your company’s dossier, as well as those of any co-registrants. Then the substance itself is evaluated. At any point along the way, ECHA can request additional information, either as part of a random check or for cause.
It may take years for this process to be conducted.
When ECHA asks for more information, a deadline will be set. The company must provide the additional data by the deadline. If this new information resolves the issue (or satisfies a random check), the evaluation will be closed. However, a company may not be able to provide the data in time or may have specific arguments (for example, they may argue to use a read-across method), and the process will then continue until the issue is resolved.
There may be appeals or new concerns may be raised. Once the evaluation is closed, the dossier goes to the Member States, which may also raise concerns. Substances of Very High Concern will then also have an Authorization and/or Restriction stage to deal with.
At no point during this process, which may go on for years, do you want to have to say, “Ummm… I know I have that information somewhere. Let me check on that and get back to you.”
Get your data under control
Even when the REACH2018 process is completed, dossiers must be updated when circumstances change or new information comes to light. There is no end date. In fact, even if your company stops manufacturing or importing a given substance, any responsibilities connected with registration will still have to be completed.
The best thing you can do is to make sure that you have the entire process, and all relevant data, organized and in hand. What tools are you using? We recommend that you check out EUPHOR.