Deadline Fast Approaching For Businesses Exporting Chemicals (And Certain Products Containing Chemicals) Into EU
There is now just over a month remaining before a key deadline for businesses manufacturing in, or exporting to, the European Union. Under the EU's Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals ("REACH"), businesses are required to pre-register their phase-in (i.e. existing) chemical substances with the European Chemicals Agency ("ECHA") before 1 December 2008 or they risk losing access to EU markets.
Non-EU businesses will be affected if they export to the EU:
- chemical substances (e.g. base chemicals, speciality chemicals, metals, natural substances if they are chemically modified) as such or in preparations (e.g. cleaning products, paints, lubricants, ink) in amounts of 1 tonne or more per year;
- articles (i.e. "finished products") containing substances which are intentionally released during their use (e.g. fragrance in a scented candle, perfume from an eraser, scented toys) and present in those articles in quantities of 1 tonne or more per year.
Non-EU businesses are urged to meet the pre-registration deadline so that they:
- can continue importing into the EU market until the substance has been registered (which is a much longer and more detailed process) - marketing affected substances or articles after 1 December 2008 without pre-registration or registration is in breach of REACH and subject to enforcement measures backdated to 1 June 2008;
- benefit from the extended registration deadlines (30 November 2010, 31 May 2013, and 31 May 2018) applicable to their volume band or substance, and thus will have additional time to organize the collection and assessment of data on their substances; and
- do not risk interrupting the supply chain for downstream users using their chemical substances.
However, businesses from outside the EU are not able to pre-register substances themselves. Instead, they have to decide whether to let the importer pre-register their substances or to appoint an EU-based representative of a non-EU manufacturer - a so-called only representative ("OR"). By appointing an OR, the non-EU entity has more control over the pre-registration process and avoids having to disclose potentially sensitive information to the importer.
In order to properly pre-register, applicants must supply the following information to ECHA via the REACH-IT portal on the ECHA website:
- the name of the substance identified by the EINECS, CAS, IUPAC-name or other identity codes;
- the contact information of the manufacturer, importer, or OR;
- the envisaged deadline for the full registration and the tonnage band (1-10, 10-100, 100-1000 or 1000 tonnes or more per year);
- if applicable, names of any relevant substances which may facilitate the risk assessment of the substance.
Pre-registration is free of charge and it does not establish any obligation to continue production or import of substances. Nevertheless, for each substance that a business (manufacturer, importer, or OR) pre-registers, the business concerned will be required to be part of a Substance Information Exchange Forum (SIEF) until 1 June 2018 and may have to participate in SIEF activities for example, data gathering and testing.
By 1 January 2009, a list of all pre-registered substances will be published on the ECHA website. This information will only be visible by those who have pre-registered the same or related substances and provides the basis for the formation of a SIEF to share information among manufacturers and importers of the same substances.
On 7 October 2008, ECHA published an intermediate list of pre-registered substances on its website, containing nearly 40 thousand substances that had been pre-registered by 1 October 2008, i.e. two months before the deadline (see: http://apps.echa.europa.eu/preregistered/pre-registered-sub.aspx ). This intermediate list provides businesses with an insight into the status of pre-registrations, but has been published primarily to help downstream users check whether substances of interest to them have already been pre-registered; if not, downstream users should remind their suppliers (manufacturers and importers) to undertake the necessary pre-registration.
Before a business undertakes the pre-registration process, a number of preparatory steps, including the following, need to be taken:
- create an inventory of all products that your business exports to the EU;
- identify whether these products are single substances or preparations or contain substances released from articles;
- find out if the substances or uses in your inventory are exempted from registration under REACH;
- collect the available information on the name of the substances and analytical data from the laboratory;
- identify the likely registration deadline corresponding to the volume of the substance in tonnes per year and its classification and labeling.
If a business is manufacturing or importing phase-in substances in quantities of 1 tonne or more for the first time after 1 December 2008, the business can still benefit from the extended registration deadlines if it pre-registers:
- at the latest six months after manufacturing or importing exceeds the one-tonne threshold; and
- at least 12 months before the relevant deadline for registration.
For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.