Small fIrms manufacturing or importing chemicals from outside the EU need to ensure they comply with REACH regulations. Raphael Prais looks at what’s involved
The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations were adopted in 2006 to protect consumers from hazardous chemicals.
If you manufacture or import – from outside the EU – more than one tonne a year of a chemical substance, you must register it with the European Chemicals Agency in Helsinki by 31 May 2018.
To register a chemical, you need to compile a technical dossier using the agency’s IUCLID software. If you make or import more than 10 tonnes a year, you also need to compile a chemical safety report.
You can download a link to the registration software from the agency’s website. You’re expected to share information with other firms registering the same substance.
The fee depends on the amount being registered, but registering jointly brings down the cost.
So what is a chemical? Article 3 of REACH says: “A chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.”
Some chemicals are covered by specific legislation as well as or instead of REACH, and some substances are excluded, including radioactive substances, waste and some naturally occurring low-hazard substances.
The agency will manage the technical, scientific and administrative aspects of REACH. Under ‘evaluation’, authorities require registrants – and occasionally downstream users – to provide further information.
At the ‘compliance’ stage, the agency assesses a proportion of the registration dossiers. There is also specific testing for substances where animal toxicity tests have been proposed, and ‘substance evaluation’ by member states, in which particular substances are analysed and further regulation considered. ‘Substances of very high concern’ (SVHCs) require authorisation for specific uses.
REACH also covers other obligations. You are more likely to be a downstream user, in which case your duty is to use chemicals in accordance with the measures provided by your supplier’s safety data sheet (SDS), which may be accompanied by ‘exposure scenarios’.
Also, you must pass on relevant safety information when supplying chemicals to customers. If your intended use is not in the SDS, you could liaise with the supplier, which might realise your usage is safe and amend the SDS; liaise with different suppliers; or use a different substance. Or you could prepare a downstream user report.
Whether you need to do that depends on factors including the amount of the substance and its concentration.
If you use a hazardous substance, it is advisable to check whether it is subject to authorisation. If you disagree with a decision by the agency, you can file an appeal with the agency’s board of appeal within three months of notification. If you still disagree, you may appeal to the European General Court or the European Court of Justice.
What about Brexit? Several non-EU countries are adopting REACH, in a move towards a more global system. In any event, until we leave the EU, companies must comply with REACH.
European Chemicals Agency: echa.europa.eu
The Health and Safety Executive’s guidance: bit.ly/2dseXJu
The actual regulations: bit.ly/1SZLpwq
Full guidance from the agency: bit.ly/29OFvou
The REACH legislation is already law, so opportunities to alter this legislation are limited. However, FSB is keen to see small businesses provided with as much help and guidance in the run-up to the 2018 registration deadline.
We have been gathering case studies from members to understand the potential impact on small businesses, and are sharing our concerns with Government.
FSB is a member of the UK Chemical Stakeholder Forum.
Much of the focus of this group is to explore the impact of REACH regulations on businesses and industry, and what opportunities there are for mitigating the impact.
The group has produced guidance for small businesses, which you can find at gov.uk/government/groups/uk-chemicals-stakeholder-forum