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[November 2008]
REACH Pre-registration: Time is running out
REACH Pre-registration: Time is running out
Questions and Answers for Industry
The European Union’s new chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) entered into force on 1 June 2007. It covers all chemical substances, manufactured or imported into the EU, in quantities of one tonne or more per year. Mandatory registration of new substances began on 1 June 2008, but later deadlines exist for substances that have been pre-registered.If a company fails to pre-register a phase-in substance by 1 December 2008 they may neither import nor manufacture it after that date until it has fully registered the substance with the European Chemicals Agency (ECHA).
What is the purpose of REACH pre-registration and registration?
REACH requires manufacturers and importers of chemical substances (≥ 1 tonne/year) to obtain information on the physicochemical, health and environmental properties of their substances and use it to determine how these can be used safely. Each manufacturer and importer must submit to ECHA a registration dossier documenting the data and assessments.All users of dangerous chemicals will be obliged to ensure the safe use of those chemicals through risk management measures identified in the registration dossiers and communicated to the users of chemicals through extended Safety Data Sheets.
Thousands of companies across the EU have been affected by the pre-registration and registration obligations.Pre-registration
What is pre-registration?
Pre-registration of phase-in substances [1] allows companies to benefit from the extended registration deadlines (2010, 2013 or 2018). Otherwise, they would have to register their substances immediately if they wish to continue manufacturing or importing.Why should companies pre-register?
The objective of pre-registration is to facilitate sharing of data between registrants, where possible, in order to reduce unnecessary testing, especially on vertebrate animals, and to decrease costs for the industry.
Companies are strongly encouraged to pre-register to benefit from the extended registration deadlines (2010, 2013 or 2018). Pre-registration ensures that there will be no interruption in manufacturing, importing or supplying substances to users. Only limited information needs to be sent to ECHA and there is no pre-registration fee.What will happen to companies that do not pre-register a substance?
A company that has not pre-registered a phase-in substance must suspend manufacturing or importing it after 1 December 2008 until it has submitted a full registration dossier [2] for the substance to ECHA.What are the duties linked to pre-registration?
All companies that pre-register the same substance will become a member of a Substance Information Exchange Forum (SIEF) the aim of which is to avoid duplication on the testing of substances. In a SIEF, companies are obliged to share animal testing studies to keep these tests to an absolute minimum. They may also share other data.Who should pre-register?
All EU-based companies that manufacture in, or import chemical substances into, the EU should pre-register if the quantities of the substance are ≥ 1 tonne/year.EU-based producers or importers of articles should also pre-register those phase-in substances which are intentionally released from their articles, unless the substances were already registered for use in those articles.
Companies that manufacture substances, formulate preparations or produce articles outside the EU cannot pre-register substances. However, they can nominate a representative established within the EU to carry out the required pre-registration of their substances that are imported into the EU. Their EU-based importers are then relieved from the duty to pre-register.
When can companies pre-register?
Pre-registration started on 1 June and closes on 1 December 2008.What does a company need to do for pre-registration?
A company needs only to submit limited information on each substance to ECHA. The information consists of the substance name/identifiers, company information, envisaged registration deadline, tonnage band and potentially an indication of related substances that can help assessment of the substance. If a company does not want to disclose its identity to other SIEF participants, it can inform the Agency that it has appointed a so-called third party representative that will act as its agent in the SIEF.Pre-registration must be carried out electronically via the REACH-IT portal on the ECHA website at: http://echa.europa.eu/pre-registration_en.asp
There are two possible ways to submit a pre-registration file:
• On-line pre-registration - Enter the required information directly on the REACH-IT website
• Computer file pre-registration - Import a pre-registration prepared separately (via IUCLID 5 provided by ECHA or industry’s own IT-tools) in an XML file for submission to REACH-IT. The format is specified by ECHA.How can one find out what has been pre-registered?
ECHA recently published on its website an intermediate list of all substances which were pre-registered by 1 October 2008. This list contains the names of substances, related identity codes and the first envisaged registration deadline. It also includes the names and other identifiers of related substances that pre-registrants have, but no information on the companies which have communicated them.ECHA will then publish the full list of pre-registered substances on its website by 1 January 2009. It may also help users of chemicals to find potential registrants after the pre-registration period is over.
What is the timeframe for the registration of pre-registered chemical substances?
The following extended registration deadlines apply to phase-in substances that have been pre-registered:Until 30 November 2010 - substances produced or imported in quantities equal to or greater than 1000 tonnes/year; carcinogens, mutagens and substances toxic to reproduction (CMR category 1 and 2) equal to or greater than one tonne/year and substances classified as very toxic to aquatic organisms (R50/53) at and above 100 tonnes/year;
Until 31 May 2013 - substances produced or imported in quantities equal to or greater than 100 tonnes/year;
Until 31 May 2018 - substances produced or imported in quantities equal to or greater than one tonne/year.
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[1] Substances fulfilling at least one of the following criteria are phase-in substances:
1. Substances listed in the European INventory of Existing Commercial Chemical Substances (EINECS);
2. Substances that have been manufactured in the EU (including accession countries) but have not been placed on the EU market after 1 June 1992;
3. Substances that qualify as a so-called "no-longer polymer";[2] A registration of a substance will comprise:
1. Compilation and assessment of the hazard properties of the substance and its conditions for safe use;
2. Submission of this information to the European Chemicals Agency (ECHA); and
3. Payment of the relevant registration fee.
ENDS