The Basics of REACH Registration for Manufacturers and Importers

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Information required for pre-registration

 
 

The information needed for pre registration is not yet finalised but will include at least the following:

  • the name of the substance as specified in section 2 of Annex VI, including its EINECS and CAS number or, if not available, any other identity codes;
  • the registrant company name, address and contact person and, where appropriate, the name and address of the person acting as a representative in accordance with article 4 as specified in section 1 of Annex VI;
  • the envisaged deadline for the registration/tonnage band;
  • the name(s) of substance(s) as specified in section 2 of Annex VI, including their EINECS and CAS number or, if not available, any other identity codes, for which the available information is relevant for the application of sections 1.3 and 1.5 of Annex XI.

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Information requirements for registration
 
 

The information requirement for full registration will depend on the quantity imported or manufactured.  The basic requirements are set out in REACH Article 10, which cross-refers to the Annexes.

 

In order to complete the registration, the registrant will have to provide information, to a central European Chemicals Agency and depending on the tonnage, the usage and substance type, the sort of information that may be required includes:

 

  • identity of the registrant and the substance
  • known hazards
  • gaps in information, which needs to be filled
  • manufacture and uses
  • classification and labelling
  • risk management for identified uses
  • exposures arising from use
  • a chemical safety report.

(This is not a comprehensive list.)

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Submission Deadline

 

The "final" deadline for submission of a full registration for pre-registered substances is set out in Article 23 of REACH.  The detail is still subject to the eventual outcome of the REACH regulatory process and any advice is therefore provisional.  Within the current text, the tonnage bands range from three years after entry in force for the substances of most concern or very high tonnages, to 11 years for substances manufactured or imported at below 10 tonnes per year.

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Substance Information Exchange Forum Operation

 
 

Pre-registration will result in the identification of other potential registrants of the same substance.  SIEF participation is obligatory with the aim of sharing data to avoid unnecessary testing.  The SIEF also provides a forum to agree and carry out further investigative work to fill information gaps and agree on classification and labelling.  Work involving tests on vertebrate animals should strictly follow the procedures intended to minimise such testing.

 

REACH recognises that data has value and will need to be paid for a fair market rate.  Procedures and guidance are under development to ensure transparency and equality in data sharing.

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Registration preparation in co-operation with your customers

 
 

REACH seeks to establish significant improvements in the provision of risk management information down the supply chain.  One step in this is to require importers and manufacturers to identify the appropriate precautions to ensure protection of people and the environment.  This can only be done when the registrant knows the uses of the substance.  This will demand close working relationships between "actors" in the supply chain.

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Joint Registration Submissions
 
 

If there is another potential registrant of the same substance then the registration must be submitted jointly unless certain conditions apply.  These include considerations cost, intellectual property, or technical disagreements on information.  Separate submissions must be justified and will attract a higher fee.

Registration with one or more joint registrants will consist of two steps: the submission of common information by an agreed leader and the provision of registrant information by individual firms.

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Other information available in our REACH - the basics range: The Basics of REACH Registration for Manufacturers and Importers Downstream Users - Actions to take now and in the first year of REACH
 
 
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