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Download Avery Dennison compliance certificates
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Data Sharing Fact Sheet
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Registration Guidance in a Nutshell
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Registration Guidance
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Data Sharing Guidance
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Guidance for Monomer and Polymers
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Guidance on Information Requirements and Chemical Safety Assessment
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Other REACH guidance

Registration

REACH requires manufacturers and importers to generate data on the substances they manufacture or import, to use the data to assess risks and to develop risk management measures to address the risks of the substances. The data and assessments must be provided to ECHA in the form of a Registration Dossier. Only registered substances (or those exempt from registration) can be legally on the market in the EU.

What is Registration?

Registration is the duty of the manufacturer of a substance or the importer of a substance on its own or in a mixture. The registrant must be a legal entity in the EU, and a third party or industry association may not register. There is a process for non-EU entities that manufacture substances, or produce mixtures and articles outside the EU (to enter commerce in the EU) to appoint an only representative within the EU to register a substance imported into the EU. 

 

Registration Obligations.

Registration obligations apply for substances manufactured or imported in quantities of 1 tonne or more per year, with different obligations for phase-in versus non phase-in substances.

Phase-in

Non Phase-in
  • Phase-in substances were already being manufactured or placed on the market before REACH entered into force on June 1, 2007. These substances generally can be registered under transitional deadlines as long as they were pre-registered between June 1, 2008 and December 1, 2008. The transitional deadlines vary based on tonnage (per manufacturer or importer) and chemical hazard properties. SeeRegistration Deadlines.
  • Non phase-in substances (and phase-in substances that were not pre-registered) must be registered before they can be manufactured, imported, or placed on the market in the EU, unless exempt.

Manufacturers and importers have the obligation to collect available information on the intrinsic properties of a substance and to provide information in a registration dossier according to information requirements laid out in REACH annexes. Annexes VII to X specify the standard information requirements according to four tonnage bands from 1 tonne per year to ≥ 1000 tonnes per year. The general scheme to be followed by registrants involves gathering and sharing existing information, assessing information needs based on tonnages and exposures, identifying information gaps, and generating new information as necessary (e.g., by testing).

  • In general, REACH registration dossiers contain information on substance identity, physicochemical properties, mammalian toxicity, ecotoxicity, environmental fate, manufacture and use scenarios, and risk management measures. The dossier, submitted through the IUCLID system, contains a technical dossier and a Chemical Safety Report (CSR) for substances manufactured or imported in a quantity of 10 tonnes or more per year.
    • The CSR is the document reporting the Chemical Safety Assessment (CSA). The CSA incorporates both hazard assessment and exposure assessment to arrive at risk characterization and risk management measures, and is developed iteratively in cooperation with others in the supply chain.
  • ECHA has developed various guidance documents on how to generate a CSR and registration dossier, including a detailed Guidance on information requirements and chemical safety assessment.

 

Registration Exemptions.

Some substances are exempt from registration (or covered under reduced requirements):

  • Polymers (but their monomers and other bound substances must be registered)
  • Substances/groups named in Annex IV, certain low risk substances
  • Substances falling within Annex V exemptions (e.g. unrefined natural substances, substances that result from certain incidental reactions, hydrates, and others)
  • Substances to the extent used in food or pharmaceuticals
  • Recycled or recovered substances already registered
  • Reimported substances
  • Substances used for research and development
  • Isolated intermediates
Note: Some substances are exempt from REACH altogether. Also, active substances for use in biocides and plant protection products, as well as some substances notified under the previous directive 67/548/EEC, are regarded as registered. 

 

Data Sharing.

REACH provisions include processes for sharing data among registrants, to reduce animal testing and costs. Sharing is allowed for all types of data and required for data collected through vertebrate animal testing.

Phase-in Non Phase-in
  • For a phase-in substance, data sharing is accomplished through a Substance Information Exchange Forum (SIEF) established based on pre-registration of the substance.
  • For non phase-in substances, an inquiry dossier is required to determine whether a registration or another inquiry has already been submitted for the same substance, so that data sharing mechanisms can be established as appropriate.

ECHA has issued a Guidance on data sharing.

Suppliers must provide safety data sheets (SDSs) to all downstream users and distributors for substances classified as hazardous according to the EU CLP Regulation or as dangerous mixtures under Directive 1999/45/EC, for PBT or vPBT substances, and for substances on the Candidate List. For a mixture or substance for which an SDS is not required, the supplier still has to communicate certain information (outlined in Article 32) to downstream users and distributors by the time of first delivery.

The registrant must submit a notice of classification and labeling to ECHA:

  • if the substance is subject to registration, but has not yet been registered, or
  • if the substance is within the scope of the CLP Regulation, meets the criteria for classification as hazardous and is placed on the market either on its own or contained in a hazardous mixture above specified concentration limits.

Detailed information on CLP requirements is available on the ECHA website CLP section.

Registrants need to update their registrations when they obtain new information on the substance or dossier information, including changes in the tonnage band or cessation of manufacture or import. Updates may also be required as a result of decisions under the evaluation procedure.