FAQs

Where can I get more information on REACH?

Further information about REACH can be found on the European Chemicals Agency (ECHA) website.

A list of the Member State (MS) Competent Authority (CA) contact details can be found here.

A complete FAQ document, as prepared by the Agency, can be found here.

What if I don’t register?

Companies failing to register their substances within the required timescales will be in breach of the REACH Regulation, and open to sanction by the Member State Competent Authorities, if they continue to manufacture or import the substance into the EU.

What is the role of the European Chemicals Agency?

The European Chemicals Agency (ECHA), located in Helsinki, Finland, will manage the registration, evaluation, authorisation and restriction processes for chemical substances to ensure consistency across the European Union. It will be the public face of REACH and will be a key player in ensuring that the system has credibility with all stakeholders and the public.

Who has to comply?

EU producers and importers are obliged to register substances they produce or import in quantities of 1 tonne, or more, per year. Failure to register means that the substance cannot be manufactured, imported or used on the EU market.

Who can register a substance (on its own or in a preparation)?

EU manufacturers (each legal entity of a company must register the substance), importers and EU-based representatives of non-EU manufacturers (called Only Representatives).

What is included in the registration dossier?

The registration dossier consists of:
• a technical dossier
and, for tonnages of >10 tonnes per year,
• a chemical safety report

All technical dossiers must contain the following information:
• Registrant identity
• Substance identity
• Information about the manufacturing and uses of the substance
• Classification and labelling of the substance
• Guidelines for the safe use of the substance
• Study summaries of tests carried out
• Robust study summaries of tests carried out
• Information regarding which of the above mentioned points has been reviewed by an assessor, having appropriate experience
• Test recommendations, in the case tests are required according to Annexes IX and/or X
• All physico-chemical, toxicological and ecotoxicological information that is relevant and available to the registrant. The data requirements here depend on production and import quantities.

What is a CSR?

A Chemical Safety Report (CSR) should be completed for all substances subject to registration in quantities of 10 tonnes or more per year per registrant. The CSR shall document the Chemical Safety Assessment (CSA). The CSA of a substance aims to establish the safe conditions of manufacture and use of a substance for all life cycle stages.

What is included in the CSR?

The chemical safety report contains the following information:
Part A
• Overview of risk management measures
• Explanations about the implementation of risk management measures
• Explanations about communication of risk management measures
Part B
• Identity and physical and chemical properties of the substance
• Manufacturing and uses
• Classification and labelling
• Movement and fate in the environment
• Human health risk assessment
• Human health risk assessment based on physical and chemical properties
• Environmental risk assessment
• PBT- and vPvB assessment
• Exposure assessment
• Risk characterisation

 

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