According to the REACH Regulation (consolidated version of July 14, 2016) all substances manufactured in or imported into the European Union in quantities greater than one ton per year by a manufacturer or an importer must be registered by May 31, 2018. The basic principle of “no data, no market” applies. Failure to comply can result in a stoppage of production or importation and can endanger the very existence of a company.
Many manufacturers and importers, particularly small and midsize companies, face uncertainty about whether they must register their substances. We’d like to address two questions that often come up in this context:
- Must a preregistered substance be registered by May 31, 2018 if the quantity manufactured or imported after June 1, 2018 is lower than one ton?
Yes. The manufacturer or importer must register the substance because the transition period ends on May 31, 2018. The calculation of the quantity is based on the average annual tonnage from 2015 to 2017, and, in this case, it was greater than one ton in this period.
But the situation is different if the manufacturer stops production or the importer stops imports as of June 2018. In this case, the obligations of a manufacturer or importer no longer apply to such previously active manufacturers or importers. They are not required to register the substance, even though the average annual tonnage calculated for 2018 was more than one ton in 2015 to 2017.
You can find a comprehensive answer with legal examples in the list of FAQ at FAQ 0454 on the REACH CLP Biocide Help Desk (German only).
- May preregistered substances that were manufactured or imported before June 1, 2018 (warehouse stock) be marketed after that date?
Yes. If the manufacture or import of the material stops before June 1, 2018, the remaining stock may be sold.
However, if manufacturers and importers have not halted their manufacturing or importing activities before the relevant registration deadline, they retain their status and must submit a registration dossier for all the quantities of the substances manufactured or imported before and after the relevant registration deadline. Submission of the dossier is required to continue manufacturing, importing, and marketing such substances.
However, if such a manufacturer or importer does not submit a registration dossier, all parties along the supply chain that are not obligated to register the substance can continue to use or supply the quantities of the substance that the manufacturer or importer delivered before the registration deadline.
You can find a comprehensive answer with legal examples in the list of FAQ at FAQ 0126 on the REACH CLP Biocide Help Desk (German only).
If you need more extensive advice about or support with the registration of your substances, please contact us at firstname.lastname@example.org.