4 May 2018
Last REACH Deadline for Registration of Substances Approaching Fast: Missing Deadline May Disrupt Business Dealings on EU Market
On 31 May 2018, the third and final REACH registration deadline will expire. By this date, all Hong Kong entities selling registrable existing substances, or mixtures or articles containing such substances, will have to ensure that those substances (imported into the EU in quantities between 1 tonne and 100 tonnes) have been registered with the European Chemicals Agency (ECHA). It is a key date in the EU regulatory calendar, as after that, if such substances sold in the EU have not been registered, they will no longer be allowed on the EU market.
Moreover, if the trade for those substances is disrupted, downstream users (e.g., customers of Hong Kong sellers) will be affected, disrupting their respective activities in turn, and forcing them to seek other suppliers of validly registered substances, mixtures, etc. Lack of registration could therefore harm Hong Kong traders’ businesses, and they should be made aware of the final registration deadline, and their duties in respect thereof.
Hong Kong sellers should first of all evaluate whether they are affected by the deadline, if they have not done so already. If an EU-based entity manufactures chemical substances or imports them from outside the EU (e.g., from Hong Kong or mainland China) above one tonne per year, that entity may have registration obligations under REACH. Additionally, if it manufactures or imports a product (mixture, article), it may contain substances that need to be registered individually. If the entity concerned has pre-registered substances it manufactures or imports from outside the EU above one tonne but not more than 100 tonnes per year, and has not already registered them, the REACH registration deadline of 31 May 2018 concerns that entity.
Registration occurs when a company submits documentation to ECHA which shows that the substance being dealt with is handled safely throughout the supply chain. The documentation that has to be submitted along with the registration includes the hazards of the substance, and it needs to be provided in a registration dossier. The registration dossier includes a description of the uses of the substance, the physico-chemical, ecotoxicological and toxicological properties, and a hazard and risk assessment showing how the risks posed by the use of the substance are controlled. Registrations are submitted to ECHA in a IUCLID format through a tool called REACH-IT. In most cases, the registrant will have to pay a registration fee.
While Hong Kong-based entities cannot themselves register, they will need to either depend on their EU importers for registration, or appoint an “only representative”, which is a natural or legal person based in the EU, to carry out the registration on their behalf.
While today it is very unlikely that any company will be able to prepare a registration dossier from scratch (given the enormous amount of information that needs to be assembled, and the costs of doing so) in time for the 31 May deadline, companies may wish to look into whether their substances have already previously been registered. This may have happened in keeping with two earlier deadlines. In such case, entities will have to check for others that have registered their substances. A list of already registered substances is published on ECHA's website. If companies’ substances are already registered, it will be necessary to find out who the “lead registrant” is. Once companies are in touch, it may be necessary to agree on a so-called letter of access (for a fee). On this basis, a registration can, in principle, be carried out.
Hong Kong companies who fear they may miss the deadline should urgently contact their importers or seek specialist legal advice. For more information, please click into the ECHA website for more details.