Sellers of chemical substances, preparations and articles that contain substances that must be registered according to the EU Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) will almost certainly have ensured by now that their substances are registered with the European Chemicals Agency (ECHA). The registration requirement applies to substances that are manufactured in or imported into the European Union at 1,000 tonnes or more per year per importer or manufacturer, and to substances at lower volumes which are particularly hazardous (eg, carcinogenic). Later deadlines apply to other substances which are imported at lower volumes.
The deadline for the registration of such substances was November 30 2010. Businesses which ought to have registered by that deadline but failed to do so may well see the sale of their goods on the EU market being disrupted and, if they continue with their sales, are likely to be penalised.
On December 1 2010 the ECHA list of registered substances showed that the number of substances that had been registered by the November 30 2010 deadline was 4,300, of which almost 3,400 were phase-in substances. However, in 2010 companies had expressed the intention to register nearly 4,900 substances, meaning that there were many substances that were still to be registered. On December 1 2010 it was reported that the ECHA had received 24,675 registration dossiers.
Immediate problems in relation to substances that have not been registered on time will be experienced by downstream users, which could face a sudden prohibition on the use of substances that they would normally depend on because of the supplier's failure to register the substances in a timely manner.
However, there appears to be no panic among downstream users. For example, a spokesperson for the International Association for Soaps, Detergents and Maintenance Products has reportedly claimed not to have heard of any panic thus far, despite the apparent tardiness on the part of certain potential registrants. The spokesperson stated that the association had listed 855 key chemical substances for this product sector, but expected about 15% of these to remain unregistered by November 30 2010.
Similarly, some businesses may not need to panic unduly. Lower volume thresholds for substances that businesses might have felt at the time of pre-registration would need to be pre-registered by November 30 2010, may after all only need to be registered by either the 2013 deadline or even the 2018 deadline. However, even if one substance which a businesses sells – and an EU downstream user needs – has not been duly registered, it could mean an end to that product line.(1)
On November 19 2010 the ECHA also warned that businesses that wished to register must ensure that their dossiers are technically complete, as there is only one chance after an initial rejection to correct the information therein. Registrants are given a reasonable deadline of a minimum of four months to provide the requested missing information after the first rejection. Products containing the relevant substance may legally remain on the market during this period.
The ECHA has warned that some registrations have failed for a second time for reasons of technical completeness because the necessary updates do not contain the information required. A second rejection can have a severe negative impact on the potential registrant – and downstream users – involved. The ECHA urged the use of the so-called 'technical completeness tool' to check for completeness.(2) On the compilation side, it will probably already be well known that potential registrants needed to come together with others wishing to register the same substance, via the Substance Information Exchange Forum (SIEF). The registrations could then be carried out by means of online submission to the ECHA of a joint dossier by the so-called lead registrant (via REACH-IT). Importers, or sole representatives standing in for exporters, are likely to have already signed SIEF agreements with other SIEF members, mainly so as to allocate tasks among members and ensure the fair distribution of costs for the compilation or generation of data.
However, according to recent press reports, the sharing of costs has in certain cases been far from fair. The complexity of SIEF agreements is said to have posed a major challenge for companies, and negotiations for cost-sharing have been frequently loaded well in favour of lead registrants, with in some cases large profits being made at the cost of small companies that lack negotiating prowess or resources. Businesses should ensure that, if they have not already had to contribute to SIEF agreements (whether for the just-passed registration deadline or for either of the two later deadlines), they should at the very least ensure that their rights are not compromised and seek expert legal advice if necessary.
Unfortunately, in certain aspects, REACH has proven to be not only a legal and technical minefield, but also many more times expensive for companies than was originally foreseen.
Endnotes
(1) Up-to-date information on registration can be accessed at
http://echa.europa.eu/home_en.asp.
(2) See http://echa.europa.eu/reachit/registration-it_en.asp.
