REACH

Registration

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One of the fundamental aims of REACH is to improve protection of human health and the environment from the risks of chemicals. To do so, information is first needed about those substances which are manufactured or imported into the EU/EEA. ECHA and the Member States use such information to assess whether the risks are being managed or whether further controls, such as Authorisation or Restriction, are needed.

The registration requirement

Registration is by substance, not product. EU/EEA companies that manufacture or import substances are responsible for registration. Non-EU/EEA substance manufacturers, formulators of mixtures and producers of articles supplying into the EEA cannot register themselves but they may appoint an Only Representative to register on behalf of their importing customers.

A threshold of 1 tonne per year per legal entity (“natural or legal person”) applies. Where the quantity of a substance manufactured or imported by a legal entity is less than 1 tonne per year registration is not required. The total quantity of a given substance must be considered, for example the combined tonnage of Substance x present in all imported mixtures.

Registration deadlines

EU/EEA manufacturers and importers of phase-in substances with valid pre-registrations had the opportunity to benefit from transitional registration provisions. Three registration deadlines featured and were triggered by the highest “per year” tonnage since 1 June 2007:

Type of substanceRegistration deadline
  • Phase-in substances classified as CMR categories 1 or 2 under DSD and manufactured or imported in quantities of 1 tonne or more per year;

  • Phase-in substances classified as R50/53 under DSD and manufactured or imported in quantities of 100 tonnes or more per year;

  • Phase-in substances manufactured or imported in quantities of 1000 tonnes or more per year

30 November 2010

Phase-in substances manufactured or imported in quantities of 100 tonnes or more per year.

31 May 2013

Phase-in substances manufactured or imported in quantities of 1 tonne or more per year.

31 May 2018

 

After May 2018, all substances must be registered before they are manufactured or imported into the EU in quantities of 1 tonne or more per year, unless they are exempted from registration.

Exemptions and exceptions

Some substances are excluded from REACH itself, for example radioactive substances and non-isolated intermediates. Others, for example those listed in Annexes IV and V to REACH, are exempted from registration.

Waste itself is exempt from REACH, but the recovery of substances may bring with it registration and supply chain communication responsibilities. See our guidance on recycling and substance recovery from waste for more information.

Some uses of a substance may not require registration, for example the quantity used in foods or medicinal products. Also, substances manufactured or imported for R&D into process or product development may benefit from a PPORD notification (see our guidance), effectively delaying the registration for that quantity.

Isolated intermediates under strictly controlled conditions are subject to registration but may benefit from reduced information requirements.

Joint registration

Registration is based on the principle of “one substance, one registration”. Information on the intrinsic properties of a substance should be submitted by a Lead Registrant; company-specific information is submitted separately by each registrant.

To achieve joint registration potential registrants must work together to share data. In the case of pre-registered phase-in substances, potential registrants were automatically put in contact with each other to form a Substance Information Exchange Forum (SIEF). For non-phase-in substances, and phase-in substances which a company did not pre-register, the potential registrant had to submit an Inquiry dossier to ECHA to be put in touch with other registrants. Since the end of the phased registration period, any company that may have to register a substance need to submit an inquiry to ECHA before registration.

Find out more about the registration process here.

Legal entities are usually created under national law and as such how they are established may be vary across the EU/EEA. However they do not normally cross national borders; their Member State authorities would be responsible for any inspection or intervention.

Your Company Secretary or legal adviser should be able to help you understand the structure of your company and what are your legal entities.

REACHReady guidance

  • Guidance on metals and inorganic substances

You can call our Helpdesk number on +44 (0) 20 7901 1444. Or e-mail us on enquiries@reachready.co.uk.

REACHReady Guidance

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PPORD Dossier Creation

The PPORD exemption allows manufacture or import of 1 tonne or more per year of a substance for production and process oriented research and development by yourself or customers without full registration. Only if the trials are successful and there is a need for commercial production or use, will a full registration be needed.

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Guidance in metals and inorganic substances

Most of the guidance on testing and evaluation for REACH, and indeed the test methods themselves, is aimed at organic chemicals. If registering metals and other inorganic substances, testing and evaluation will be ‘different’; in many cases, endpoints will not be possible to assess. Even substance identity is not without issue – crystal form, impurities, mixtures, for example, must be considered.