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Legal Spotlight: REACH rights, rules and traps in identifying substance uses

REACH requires manufacturers and importers to cover “identified uses” of substances in their registration dossiers and allows downstream users to make their use known to manufacturers and importers (M/Is) “with the aim of making it an identified use”. For phase-in substances, downstream users need to do so at least 12 months before their supplier’s registration deadline. For substances to be registered by 1 December 2010, this would mean by November this year. This is not as straightforward as it seems, says Jean-Philippe Montfort.

M/I duties

REACH does not require M/Is to cover all uses in their registration dossier, only “identified uses”, which are defined as “use of a substance on its own or in a preparation, or a use of a preparation, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user” (Article 3.26).

This means that “identified uses” include the M/I’s own use and the uses identified by an immediate downstream user. A more difficult question is whether this provision also requires the M/I to cover uses that are “intended” by the M/I, for example, uses that are advertised in the company’s product brochures, technical documents and websites, even if they are not “made known” by a downstream user.

Downstream users’ rights

M/Is do not have a duty to ask downstream users to identify their uses. The onus is on downstream users to ensure that their particular uses of a substance are covered by a chemical safety assessment. They have the right to “make a use, as a minimum the brief general description of a use, known in writing (on paper or electronically) to the manufacturer, importer, downstream user or distributor who supplies him with a substance… with the aim of making this an identified use” (Article 37(2)).

However, in order to be covered by the M/I, an identified use must be provided with “sufficient information to allow the manufacturer, importer or downstream user who has supplied the substance to prepare an exposure scenario, or if appropriate a use and exposure category” (Article 37.2). The question here is what constitutes “sufficient information”. This may be subject to various interpretations.

Also, if a downstream user wants an identified use of a phase-in substance to be covered in the registration dossier, he must identify it one year before the relevant registration deadline, that is, before 1 December 2009 for substances to be registered by 1 December 2010. The problem here is that downstream users in general do not know and cannot easily determine the registration deadline applicable to their suppliers or a supplier further up their supply chain, which means that to be on the safe side, they should in most cases communicate their request before 1 December 2009, unless their suppliers inform them otherwise!

Downstream users also have no obligation to communicate uses up the supply chain. If they prefer to keep a use confidential or to assess it themselves, they can do so. They will then need to prepare a chemical safety report (CSR) themselves in certain circusmtances to demonstrate that these confidential uses are “safe” uses.

Can M/Is say no?

Yes they can. The REACH Regulation (Article 37.3 paragraph 3) provides that where the M/I or downstream user, having assessed the use for the CSR, “is unable to include it as an identified use for reasons of the protection of human health or the environment”, he shall provide the European Chemicals Agency (ECHA) and the downstream user with the reasons(s) for that decision in writing without delay and shall not supply the downstream user with the substance without including these reasons in the safety data sheet. To be clear, this means that it can continue to supply the substance to that downstream user but its safety data sheet must advise against that use.

The question is whether protection of human health or the environment is the only justification that M/Is may apply in order to not cover an identified use? The general interpretation is that M/Is can also refuse to cover an identified use for other reasons, but then would have to “stop supplying that substance for that use”.

To sum up, there are three possible ways for a M/I to deal with an “identified use”:

• conclude that the use of the substance constitutes a manageable risk and provide a relevant exposure scenario,
• assess the use and identify it as ‘not safe’, which must be communicated to the downstream user and to ECHA, or
• stop supplying the substance for that use.

But then, how can a M/I “stop supplying for a use”? This may seem easy if the contentious use is that of an immediate downstream user that only uses the substance for that contentious use. However, it becomes more difficult if the immediate downstream user has several uses, or if the use is that of one of its many downstream customers. Could the M/I in that case “advise against” the use (for example, for use of a plastic material in implantable medical devices) but continue supply to its immediate downstream user? This may be more delicate. Companies would also be well advised to verify that stopping sales does not raise antitrust concerns with respect to specific customers and/or cause other legal concerns (for example, “refus de vente” under French law).

Proactive communication

While M/Is have no obligation to communicate uses down the chain they can decide to be proactive and communicate the uses they intend to cover, requesting downstream users to identify any other uses that they want covered by their registration.

The advantage of this proactive approach is that M/Is may receive use information in a format of their own choosing and in good time, thereby reducing the risks of eleventh hour or late filing of uses. M/Is may think that this is not their problem but the REACH Regulation obliges them to cover newly identified uses for registered substances within one month from the request or before the next supply, which is likely to be a logistical nightmare.

The problem with this pro-active approach is that it may lead to uses being identified that M/Is will have to either assess and cover in their exposure scenario, assess and recommend against and/or stop supplying for (or advise against) if they do not want to assess the uses or the downstream user does not want to support the assessment for economic reasons.

Liability mitigation

It is important for M/Is to be aware of potential liabilities that may be incurred by their supply chain communications. Standard communications are required to handle thousands and sometimes more communications. M/Is should ensure that these communications are carefully drafted so as not to commit the M/I to actually cover a use communicated by them or identified in return, nor to constitute a certificate of compliance or liability for the uses in questions.

Finally, M/Is should also ensure consistency between their decisions and communications on identified uses under REACH and all other communications on the same substances/uses on product labels, brochures, safety data sheets, company websites and other material. Inconsistent language will confuse downstream users and may eventually trigger M/I liabilities.

Jean-Philippe Montfort leads the REACH team of Mayer Brown, a global law firm with extensive experience in the field of chemicals regulation.

JPMontfort@mayerbrown.com

www.mayerbrown.com