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The clock is ticking down for North American companies that export chemicals to the European Union (EU). The six-month window for the preregistration phase of the REACH chemical control legislation started on June 1. Companies exporting at least one metric ton (MT) of a chemical substance to the EU need to take urgent actions if they have not already done so. REACH requires that all chemical substances manufactured in the EU or imported to the EU at quantities of at least one MT be registered (see sidebar).
Although there are some exemptions, almost all lubricants and additives are caught in the preregistration and registration requirements. In order to carry out a preregistration, a company must have an EU-based company submit the necessary information to the European Chemicals Agency. Lubricants can contain as many as 20 to 30 chemical substances, each of which may need to be preregistered separately. By carrying out the preregistration, companies gain an additional two to 9.5 years, depending on volume and hazard, to complete the registration phase.
Information Exchange Forum
The European Chemicals Agency does not charge fees for preregistration; however, fees for registration can be as high as $47,500 for a high-volume (greater than 1,000 MT/year) substance. Different companies that preregister the same substance will be placed in a Substance Information Exchange Forum (SIEF). One SIEF will be formed per substance. The purpose of the SIEF is to exchange toxicological/ecotoxicological data and to agree on the hazard classification for each substance.
Options for Compliance
North American lubricant manufacturers and formulators have a number of options to ensure that they comply with the REACH requirements upon preregistration. If they know the full formulations down to substance level of the products they export to the EU, then they could communicate this to their EU importer(s) and ask them to complete the preregistration.
If the importer(s) are unable or unwilling to carry out the preregistration, then it may be possible to appoint an Only Representative. This could be an EU affiliate of the North American exporter or another company willing to take on the REACH duties that the importer(s) would otherwise have to perform.
Alternatively, if the full compositions of the products are not known and are unlikely to be disclosed by suppliers (usually due to trade secrecy reasons), then the lubricant manufacturer should consider requesting his supplier to carry out the preregistration via the supplier's Only Representative. If the supplier agrees to do this, then his Only Representative will be required to be informed of the annual volume of his product that the lubricant manufacturer is exporting to the EU and also the names of the EU importers.
If lubricant manufacturers cannot establish that the substances in their products will be preregistered, then they may have to consider blending their product within the EU using EU-sourced ingredients. This allows the lubricant manufacturers to claim "downstream user" status, which alleviates the need to preregister the substances in their products because this will be carried out by the upstream EU suppliers.
REACH is a hard-hitting piece of legislation, and one that many companies thought would never happen. However, the fact is that it has been enacted and implementation is well under way. Noncompliance with REACH can result in penalties such as fines and removal of a product from the EU market.
For More Information About the Association
REACH is the regulation for Registration, Evaluation, Authorization and Restriction of Chemicals. It entered into force on June 1, 2007 to streamline and improve the former legislative framework on chemicals of the EU. The regulation places greater responsibility on industry to manage the risks that chemicals may pose to health and the environment.
European Chemicals Agency