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The Keller and Heckman LLP List of Ten Little Known Facts About REACH Pre-Registration and Registration That You Should Know

Date: Jul 21, 2008

  1. A non-EU distributor can Not appoint an Only Representative. Instead, the volumes of the substance exported into the EU by the non-EU distributor must be pre-registered/ registered by either (i) the Only Representative of the non-EU manufacturer that supplied the substance, or (ii) the EU importers in the distributor's supply chain.
  1. If you change your Only Representative after the substance is registered, there is a 1500 Euro fee per substance to update the Registration File. The same is true if the Only Representative changes its name or address. Provision needs to be made in the Only Representative agreement as to the party that will be responsible for paying these costs.
  1. If you pre-register a substance that you do Not intend to register, you are stuck in the SIEF until 1 January 2019. However, if you do Not own relevant data, you can play an inactive role in the SIEF without being penalized.
  1. If your Only Representative joins a Consortium on your behalf, your Affiliates will Not automatically have the right to access the data unless the Consortium Agreement so provides.
  1. The Only Representative of a non-EU manufacturer can cover in its Registration the volumes of a substance exported by its non-EU customers as part of preparations. This option also applies to polymers and additives in polymer preparations. However, the non-EU manufacturer of a polymer must still arrange for the pre-registration of the monomers by either (i) its Only Representative, or (ii) the polymer importer. At the registration stage, the registration of the monomer by the Only Representative of the non-EU monomer manufacturer will discharge the obligation of the importers of the polymer preparation to register the monomers in the polymer.
  1. The notifier of an ELINCS substance below 1 tonne per year can claim the Registration No. for the substance at any time but must do so before the annual volume reaches 1 tonne per year.
  1. If a suitable UVCB name for your substance is not on EINECS, one can often establish the phase-in status by naming the substance as a multi-constituent substance.
  1. For many naturally-occurring substances, there may be insufficient information available about the environmental properties to establish an exemption under Annex V(8). It is advisable to pre-register and then conduct targeted ecotox testing later to establish the exempt status.
  1. If one registers a phase-in substance early, there is still the need to either conform to, or opt-out of, the joint dossier developed in the SIEF. If one opts out, there is a high likelihood that the dossier will be selected by the ECHA for a compliance check.
  1. It is not correct that a downstream user's exact use must be registered by the supplier. It is sufficient that the use conforms to the conditions of use described in the exposure scenario appended to the supplier's safety data sheet (SDS). Indeed, if the substance is not classifiable as Dangerous, is Not a PBT/ vPvB, or is Not manufactured/ imported at 10 tonnes/ year or more per legal entity, there is no need to advise your supplier of the use as no exposure scenarios will be prepared by the supplier.

Through our office in Brussels, Belgium, Keller and Heckman LLP has been offering legal services in the European Union since 1992. With respect to REACH, our Brussels and Washington offices have been actively involved in REACH counseling and assistance since the release of the 2001Commission White Paper on the Strategy for a Future Community Policy for chemicals, the internet consultation, the publication of the Commission's 2003 proposal, and the legislative processes at the Council and European Parliament to adopt a consensus and final REACH regulatory text. With the release of the final REACH Regulation, we have been counseling on strategies for implementing REACH on a daily basis, assisting companies in organizing consortia, developing supply chain communications, resolving issues concerning the phase-in status of existing product lines, developing supply chain agreements, preparing Annex IV petitions and providing many other REACH services. We have organized a series of well-received courses designed to help industry understand the practical aspects of REACH and to prepare for REACH compliance. Keller and Heckman LLP also has long-standing experience in testing consortia management and counsels on various aspects of EU competition law.