This is part 1 in our series looking at the chemical regulation REACH. We begin with an introduction to the regulation and identifying your registration obligations.
What is REACH Registration?
In the industrial chemicals industry, virtually everyone has heard of ‘(EC) No 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals’ (REACH) regulation. For those left wondering, here’s a short history: back in 2008, REACH came into force in an effort to improve protection of the environment and human health from potential risks posed by certain chemicals. Previously to REACH, data on historic substances (‘existing’, or phase-in substances) was considered weak, low or non-existent; so under REACH, a 10 year, tiered registration plan was put into place to fill any data gaps and create robust dossiers and risk assessments to prove the safety of these historic substances. REACH puts the onus on industry to pull together data for evaluation by the authorities, with data requirements banded based upon high risk chemicals (carcinogenic, mutagenic and reproductive toxic (CMR) or highly toxic to the environment) and tonnage. The first tier registration deadline, for high concern CMR and highly toxic to the environment substances, and those manufactured or imported at greater than 1,000 tonnes per annum, occurred in 2010. The second, for substances at greater than 100 tonnes, occurred in 2013. The last registration deadline, for all remaining substances at greater than 1 tonne is May 31, 2018.
2018 Registration
On Friday June 1, 2018, many chemical companies will be starting their day with new focus; all substances at greater than 1 tonne per annum placed onto the EU market will (should) have been registered. While we are now into Q4 of 2016, the May 2018 deadline still appears a fair way down the path. But, given we are over 8 years into the game-changing REACH regulation, and moving towards the biggest registration deadline yet (the European Chemicals Agency (ECHA) estimate a huge 60,000 registrations for approximately 25,000 substances will be submitted[1]), the 2018 registration deadline is closing in fast.
Many companies have been planning their 2018 registrations for years, to ensure they remain compliant without adversely affecting their business. Some entities, however, have struggled to begin preparations for registration, for many reasons. Perhaps they are a small or medium-sized enterprise (SME) and do not have the resources or expertise at hand. Or perhaps they had been told by their supply chain that they would not need to register, only to find that now they do. Whatever the reason, these companies must not bury their heads in the sand. The time to prepare for registration is now!
In a short series of blog posts, I hope to shed some light on how to prepare for the final registration deadline, and share some hints and tips on how to avoid the many pitfalls of REACH. First, let’s consider what you need to do to ensure that your company can submit a successful and compliant registration:
Ensure that you have reviewed your substance portfolio in detail.
If you are importing a substance or mixture (including polymers; monomers in polymers require registration under REACH), check with your supplier whether they have covered, or intend to cover, the registration via an Only Representative (OR). Do not assume that if your supplier has appointed an OR that you are in the clear; non-EU entities are not obligated to register or cover your imports, even if they appoint an OR.
All substances greater than one tonne must have been pre-registered.
If this has not occurred and if the tonnage has been greater than one tonne for more than six months since first import, an immediate registration is needed and you may experience delays in your supply. If the volume has been historically less than one tonne, but has exceeded this one tonne threshold within the past 12 months, a late pre-registration is allowed, but must be done before May 31, 2017. It must be reiterated that if you do not have a valid pre-registration, and cannot take advantage of late pre-registration, you cannot wait for the 2018 deadline to register – you must register right now!
Some substances may be exempt from registration.
The guidance produced by the United Kingdom Health and Safety Executive (UK HSE) may be helpful in identifying whether any of your substances are exempt (available here). Please note, some substances are exempt from registration, but not pre-registration. Take care to ensure that you follow the correct exemption procedure.
If you have identified that all your substances will be covered by your supplier, ensure that all paper work is up to date. Schedule regular communications to ensure that you are supplying the correct registration numbers and that your specific (non-confidential) uses are covered. Please do not assume that because you have no registration obligations you can ignore REACH – ensuring that you have all the correct documentation is equally important.
If, however, you realize that you have to conduct your own registrations, then you will need to start preparing by communicating with the Substance Information Exchange Forum (SIEF). This will be the topic of part 2 in this blog series: SIEF communication and substance identification.
Take a look at other blogs in this series here.
[1] https://echa.europa.eu/press/press-material/pr-for-reach-2018
