The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulations allow manufacturers and importers of chemicals to pre-register certain chemicals with the European Chemical Agency (ECHA) in the six-month period from 1 June 2008 to 30 November 2008. Pre-registration is not a legal requirement, but it enables manufacturers and importers to benefit from extended registration deadlines. If manufacturers and importers do not take advantage of pre-registration, then from 1 December 2008 they will not be able to continue to manufacture or import chemicals caught by REACH until they have registered them with ECHA. Of course, manufacturers and importers are free to register a chemical without pre-registration from 1 June 2008; the pre-registration process is a mechanism to assist those manufacturers and importers who will not be in a position to fully register by 1 December 2008.
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The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulations allow manufacturers and importers of chemicals to pre-register certain chemicals with the European Chemical Agency (ECHA) in the six-month period from 1 June 2008 to 30 November 2008. Pre-registration is not a legal requirement, but it enables manufacturers and importers to benefit from extended registration deadlines. If manufacturers and importers do not take advantage of pre-registration, then from 1 December 2008 they will not be able to continue to manufacture or import chemicals caught by REACH until they have registered them with ECHA. Of course, manufacturers and importers are free to register a chemical without pre-registration from 1 June 2008; the pre-registration process is a mechanism to assist those manufacturers and importers who will not be in a position to fully register by 1 December 2008.
Who can pre-register?
REACH applies to companies that manufacture chemicals or mixtures of chemicals in the EU or import chemicals or mixtures of chemicals into the EU. It also applies to companies that manufacture or import articles in or into the EU (articles are defined as objects which during manufacture are given shape, surface or design which determines their function to a greater degree than their chemical composition) if chemicals are intentionally released from these articles (i.e. a finished product whose end function involves the release of chemicals).
Downstream users and distributors may pre-register a chemical if they buy it from non-EU suppliers. Such downstream users will be considered importers for the purposes of REACH.
REACH includes a useful exemption for manufacturers or importers who after the pre-registration deadline manufacture or import a chemical in or into the EU for the first time. After 1 December 2008, such manufacturers and importers may pre-register chemicals anytime before 6 months after the first manufacturing or importing of the chemical in or into the EU or twelve months before the relevant registration deadline (whichever is the later date). They will then benefit from the extended registration deadlines.
To which chemicals does pre-registration apply?
Pre-registration applies to chemicals currently on the EU market that are 'phase-in' substances which are manufactured or imported in quantities of 1 tonne or more per company per year. Phase-in chemicals are those (1) listed on the European Inventory of Existing Commercial Chemical Substances or (2) manufactured in the EU but not placed on the market in the EU after 1 June 1992.
Non phase-in chemicals (normally new chemicals) cannot be pre-registered, but it is recommended by ECHA that companies should proceed with registration of these chemicals from 1 June 2008 in order to minimise disruptions to manufacturing, placing on the market or use.
How to pre-register
Pre-registration is free of charge. It should be carried out electronically via the REACH-IT portal on the EHCA website. Before pre-registering a chemical, companies must sign-up and create an account in REACH-IT. Companies must then pre-register chemicals on REACH-IT by providing:
- the name of the chemical and any identification
codes;
- the name and address of the contact person or
representative;
- the envisaged deadline for the registration and the
tonnage band; and
- information on any structurally similar chemical which
may facilitate the risk assessment and data sharing of the
chemical.
The next steps
Once a company has pre-registered, it can monitor who else has pre-registered the same chemical. This can be done via a substance specific pre-SIEF (Substance Information Exchange Forum) page of ECHA. It is envisaged that this will allow the initiation of negotiations between pre-registrants to share available data and costs of generating new data.
By 1 January 2009, ECHA will publish a list of pre-registered substances on its website. A SIEF will then be formed for each pre-registered substance with the same identity. The participants in a SIEF will all be manufacturers and importers that have pre-registered. A SIEF will allow such participants to share data and other information on a given substance. SIEF participants must then nominate a Lead Registrant and prepare common parts of the registration (joint submission). This knowledge-sharing element of REACH has caused some controversy within industry. It is expected that sharing of data will lead to a reduction in costs. However, many organisations have expressed concern about the protection of intellectual property and commercially sensitive manufacturing know-how. It has also been suggested that it could lead to breaches of commercial confidence and unwitting cartel-like behaviour.
There is an 'opt-out' available under REACH which allows registrants to protect confidential business information by submitting their own registration dossier where "submitting the information jointly would lead to disclosure of information which is commercially sensitive and is likely to cause substantial commercial detriment".
Deadlines
The deadlines for full registration of chemicals are staggered depending on the tonnage (per manufacturer or importer) and the hazards of the substance:
- 30 November 2010 for chemicals that are (1) carcinogenic,
mutagenic or toxic to reproduction in quantities of 1 tonne
or more per year, (2) very toxic to aquatic organisms in
quantities of 100 tonnes or more per year or (3) other
chemicals in quantities of 1000 tonnes or more per
year;
- 31 May 2013 for chemicals in quantities of 100 tonnes or
more per year; and
- 31 May 2018 for chemicals in quantities of 1 tonne or
more per year.
This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq
Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.
The original publication date for this article was 05/06/2008.
