It’s already been eleven years since the introduction of REACH, the European Union’s regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals.
The latest milestone in its history came recently when chemical companies were given the final deadline to register substances they manufacture or import from outside of the EU of over one metric ton per year.
Until this deadline, companies were able to sell and import pre-registered substances of this quantity freely on the EU market. Companies must now commit to a complex and lengthy registration process through the European Chemicals Agency (ECHA) to become REACH compliant. Failure to comply can result in administrative and/or criminal penalties, which are managed on a national level in each member state.
If you are not yet on the road to becoming one of the 13,620 companies already registered under REACH, here are some important thoughts for you to consider.
There are many benefits to gain from becoming REACH compliant. Ultimately, the aim of REACH is to help build better knowledge and awareness on the hazards of chemicals. Having a standardized approach to managing these hazards offers better protection for those working in the chemical industry, as well as for the environment.
With instant access to a wealth of online reports and news articles, today’s consumers are far more conscious of health and safety issues surrounding the chemical industry. As a downstream user, being REACH compliant would help boost final consumer confidence in your products and give your business a competitive advantage in the market.
To make a registration, a technical dossier containing all required data on physio-chemical, toxicological and eco-toxic properties, manufacture and uses of a substance must be submitted. If a substance classified as hazardous is to be sold in quantities of over ten metric tons per year, the registrant must additionally carry out a chemical safety assessment to define the conditions of use and exposure levels under which the risks can be controlled. The assessment data must then be documented in a chemical safety report, to be submitted with the technical dossier to ECHA.
Registering just a single substance requires a huge investment in both time and cost. Companies must make sure that a registration is compiled accurately with the scientific data behind a substance to avoid rejection or even withdrawal of the dossier.
According to ECHA, out of the 106,211 substances listed in the European Chemical Inventory, only 21,551 were registered under REACH as of August 6, 2018. The most common chemicals, like ethanol, propane-1, 2-diol, silicon dioxide and titanium dioxide, have already been registered by various companies. If your business relies on using substances that are not very common or readily available, you will need to work closely with your supply chain network to ensure long-term commitment and investment in the REACH registration process.
It is possible that some companies, for business reasons, may decide not to pursue the registration process and withdraw specific substances from the market. If so, downstream users would need to secure an alternative manufacturer, or importer, to avoid production issues.
Becoming REACH compliant can be a tedious and time-consuming process. Many businesses have opted to work with an experienced European-based business partner to help them become compliant and undertake the tasks and responsibilities of importers.
Companies with extensive supply chain networks and a broad knowledge of regulatory environments can act as invaluable consultants, helping inexperienced companies to maximize their return-on-investment. For example, DKSH, a global distributor of specialty chemicals, supports its business partners to become REACH compliant through its dedicated regulatory function. It has already registered more than 70 substances to date and is currently working on the registrations of more than 20 additional substances for this year.
Joaquim Pires has a PhD in Organic Chemistry and is based in France. He is responsible for DKSH’s Business Unit Performance Materials Regulatory Affairs in Europe.