FAQ on Preregistration of Chemicals Under REACH

April 26, 2008 // Published as a news service by IHS

REACH covers all chemical substances, manufactured or imported into the European Union (EU), in quantities of one tonne or more per year.

Mandatory registration of new substances begins on June 1, 2008. Later deadlines exist for substances that have been preregistered. These deadlines depend on the quantities involved and range from November 2010 to May 2018.

A company that fails to preregister a phase-in substance by Dec. 1, 2008 may neither import nor manufacture it after that date until it has fully registered the substance with the European Chemicals Agency (ECHA).

Which countries are implementing REACH?
REACH applies in the 27 EU member states. Iceland, Lichtenstein and Norway are in the process of implementing it through the European Economic Area agreement.

What is the scope of REACH?
REACH covers all chemical substances manufactured in, or imported into, the EU in quantities of one tonne or more per year. Registration under REACH is for substances only. However, the provisions of the regulation apply to the manufacture, placing on the market or use of substances on their own, in preparations or in articles.

There are some exemptions from certain parts of the legislation. For example, substances in food and medicine are covered by separate EU legislation. Natural substances are also exempt from registration under REACH, if they are not dangerous and have not been chemically modified.

What is the purpose of REACH preregistration and registration?
REACH requires manufacturers and importers of chemical substances to obtain information on the physicochemical, health and environmental properties of their substances and use it to determine how these substances 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.

Tens of thousands of companies across the EU are expected to be affected by the preregistration and registration obligations. It has been estimated that over 180,000 preregistration files will be submitted. They are expected to cover some 30,000 substances and 40,000 intermediates.

Guidance is provided below on the preregistration obligations, which apply to substances for which the REACH requirements will be progressively phased in. In the case of substances that won't be phased in, registration starts on June 1, 2008.

What is preregistration?
Preregistration 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 preregister?
The objective of preregistration is to facilitate sharing of data between registrants, where possible, in order to reduce unnecessary testing, especially on vertebrate animals, and to decrease industry costs.

Companies are strongly encouraged to preregister to benefit from the extended registration deadlines. Preregistration ensures that there will be no interruption in manufacturing, importing or supplying substances to users. Only limited information needs to be sent to the ECHA, and there is no preregistration fee.

What will happen to companies that do not preregister a substance?
A company that has not preregistered a phase-in substance must suspend manufacturing or importing it after Dec. 1, 2008 until it has submitted a full registration dossier^[2] for the substance to the ECHA.

What are the duties linked to preregistration?
All companies that preregister the same substance will become a member of a Substance Information Exchange Forum (SIEF), the aim of which is to avoid duplicate 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 preregister?
All EU-based companies that manufacture in, or import chemical substances into, the EU should preregister if the quantities of the substance are one tonne or more per year.

EU-based producers or importers of articles should also preregister those phase-in substances that 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 preregister/register substances. However, they can nominate an "Only Representative" established within the EU to carry out the required preregistration/registration of their substances that are imported into the EU. Their EU-based importers are then relieved from the duty to preregister/register.

When can companies preregister?
Preregistration starts on June 1 and closes on Dec. 1, 2008.

What does a company need to do for preregistration?
A company needs to submit limited information on each substance to the 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 with the assessment of the substance. If a company does not want to disclose its identity to other SIEF participants, it can inform the ECHA that it has appointed a so-called third party representative that will act as its agent in the SIEF.

There are two possible ways to submit a preregistration file:

• On-line preregistration - Enter the required information directly on the REACH-IT portal on the ECHA web site.
• Computer file preregistration - Import a preregistration prepared separately (via IUCLID 5 provided by the ECHA or industry's own IT tools) in an XML file for submission to the REACH-IT portal. The format is specified by the ECHA.

How can one find out what has been preregistered?
The ECHA will publish a list of preregistered substances on its web site by Jan. 1, 2009. The published list will contain the names of substances, related identity codes and the first envisaged registration deadline. It will also include the names and other identifiers of related substances that preregistrants have, but no information on the companies that have communicated them.

Can a company benefit from the extended registration deadlines if a substance is not preregistered by Dec. 1, 2008?
Only if the company is a so-called first-time manufacturer or importer of that substance in quantities of one tonne or more per year after the preregistration deadline (Dec. 1, 2008) has passed. Manufacture or import for the first time refers to the first time after the entry into force of REACH (June 1, 2007).

First-time manufacturers or importers must preregister within six months after the first manufacture or import reaches the one-tonne threshold, and not later than 12 months before the relevant deadline for registration.

The same applies for imported articles that contain a phase-in substance for which registration is required.

What is the time frame for the registration of preregistered chemical substances?
The following extended registration deadlines apply to phase-in substances that have been preregistered:

• Until Nov. 30, 2010 - Substances produced or imported in quantities equal to or greater than 1,000 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 May 31, 2013 - Substances produced or imported in quantities equal to or greater than 100 tonnes/year.
• Until May 31, 2018 - Substances produced or imported in quantities equal to or greater than one tonne/year.

What is the ECHA's role in preregistration?
The ECHA has prepared guidance information and tools on its multilingual web site, and its help desk is assisting companies in preregistering on-line.

The ECHA is responsible for the management of the REACH-IT portal - the sole channel for submitting preregistrations to ECHA. The portal will be launched by June 1.

The ECHA will publish the list of preregistered substances on its web site by Jan. 1, 2009. It may also help users of chemicals to find potential registrants after the preregistration period is over.

Further information
For more information, see the web streaming information on the web site for the REACH Workshop and the European Chemicals Agency web site.

^[1] Substances fulfilling at least one of the following criteria are phase-in substances:

• Substances listed in the European Inventory of Existing Commercial Chemical Substances (EINECS).
• Substances that have been manufactured in the EU (including accession countries) but have not been placed on the EU market after June 1, 1992.
• Substances that qualify as a so-called "no-longer polymer."

^[2] A registration of a substance will comprise:

• Compilation and assessment of the hazard properties of the substance and its conditions for safe use.
• Submission of this information to the ECHA.
• Payment of the relevant registration fee.

Source: European Commission (EC).