Dr Reach - Does double pre-registration make sense?

If a substance has already been pre-registered, was it (and is it) necessary to pre-register the substance again if re-imported, recycled, covalently bound during polymer reactions or intentionally released from articles?

Although the question was raised well-before the start of pre-registration, issues surrounding double pre-registration appeared unresolved at ECHA’s stakeholder event in October and the question continues to be asked as companies still have the possibility to late pre-register.

Confusion coupled with a lack of preparedness, resulted in the double pre-registration phenomenon troubling companies during the last days of November.

Guidance

When reading the REACH legal text, double pre-registrations appear mandatory. This approach was incorporated in official guidance, parts of the online REACH Navigator and FAQs.

An example of the rationale appears in the RIP guidance on articles (May, 2008):

"If he [a producer/importer of an article with intended release] does not pre-register and if the substance has not (yet) been registered for his use, he has to cease his production/importation until he has made a registration as his substances would be considered a non-phase-in substance, or until someone else registers his use (which may take several years)!"

And in the guidance on monomers and polymers (May, 2008):

"If the monomer or any other substance is a phase-in substance, it is recommended that the recycler of the polymer pre-register that substance in order to benefit from the transitional provisions laid down in Article 23 even if later on that substance is exempted from the registration requirements by virtue of the fact that another pre-registrant registers the substance."

Although not explicitly stated in the first official REACH guidance documents, the same logic can be applied to re-import, as well as substances used in polymerisation or polymer post-reaction. A single substance may thereby be pre-registered multiple times through a supply chain.

Whether or not double pre-registrations are the intention of the Regulation is debatable. The legal text changed significantly during drafting; for instance, the initial two deadlines for pre-registration would have avoided most of the problem.

As established in the legal preamble, pre-registration serves for data-sharing and joint registration dossier submission. In some cases double pre-registration may therefore be unnecessary, as argued by some lawyers.

On the other hand, pre-registration is necessary for phase-in status. And pre-registration applies even if manufacture or import ceases before a registration deadline.

A potential solution could be to allow the transfer of ‘phase-in’ status along a supply chain. In other words, once a substance is pre-registered by one actor, there is not a need for another pre-registration in that same supply chain. A condition would have to be that there must be confirmation of pre-registration available.

Relying on a pre-registration from one supply chain during re-import can however present an obstacle to trade. Because late pre-registration as a ‘first time importer’ would not apply, not pre-registering during re-import can result in becoming ‘locked’ in that supply chain. Changing the source of the supply of that ingredient would then result in an immediate registration by the importer. Therefore, regulators would have to grant the possibility of late pre-registrations in such cases. Otherwise, it could be perceived as a trick to favour EU sourced materials.

Until clear systems exist to verify pre-registration and cope for the practical eventualities, double pre-registration appears as the only viable regulatory recommendation for re-import.

In contrast, despite the legal requirement, it is difficult to see the corresponding arguments for multiple pre-registrations of most monomers during production and modification of polymers, or for many cases in recycling.

Help or hinder SIEFs?

The extent that double pre-registration contributed to the large number of pre-registrations is unknown. Relative to the total 2.6 million pre-registrations, it is expected to be low.

Multiple pre-registration does however reinforce the need for efficient and effective techniques for sorting between companies with a serious intention to register and those that have pre-registered to be ‘on the safe side’ for business continuity.

Because of the intensity, the large number of superfluous pre-registrations may actually help ensure that appropriate Substance Information Exchange Forum (SIEF) formation processes occur.

Many anomalies and differences in interpretation of the legal text will continue to be revealed during implementation, especially where REACH interlinks with vertical legislation. Revisions of legal texts are politically difficult and so rarely an option.

ECHA and the European Commission will need methods to identify, communicate and reconcile diverging opinions. When legal opinion is lacking but clarification is needed, ECHA will need to form its own voice. Transparency and flexibility may prove key to its success.

To post responses to this article email: steffen@chemicalwatch.com

Legal Disclaimer: The information contained in this communication follows a technical interpretation of REACH to serve as a thought-starter for discussions; it does not constitute legal or any other form of advice. Note that technical aspects are subject to review and references should be checked for updates. The legal text of the REACH Regulation must serve as the basis for REACH compliance and it may be advisable to seek legal and/or other expert advice on any given issue. The author and Chemical Watch accept no liability whatsoever with regard to the use of information contained in this communication.

• To post responses to this article email: steffen@chemicalwatch.com