The information needed for pre-registration is as follows :
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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 information that may be required includes:
The "final" deadlines for submission of a full registration for pre-registered substances are set out in Article 23 of REACH. The closing date for registration depends on tonnage band and the hazard classification of the substance. The first registration deadline, in late 2010, is for the substances of most concern or very high tonnages; the final deadline is in 2018, 11 years after REACH entered into force, for substances manufactured or imported in quantities below 100 tonnes per year
Pre-registration results in the identification of other potential registrants of the same substance. SIEF participation is obligatory with the aim of sharing data to avoid unnecessary animal 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, including the use of "read-across".
REACH recognises that data has value and will need to be paid for a fair market rate. Procedures and guidance is given in ECHA's Guidance on Data Sharing to help SIEFs ensure transparency and equality in data sharing.
REACH seeks to establish significant improvements in the provision of risk management information down the supply chain. One step in achieving this aim is requires importers and manufacturers to identify the appropriate precautions to ensure protection of people and the environment. This work can only be done when the registrant knows the uses of the substance, demanding close working relationships between "actors" in the supply chain.
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.
Aimed at business, regulatory managers and practitioners working in companies that will need to notify mixtures they place on the market. The day is ideal for anyone who needs to understand more about their obligations under the new Annex VIII of the Classification, Labelling, and Packaging (CLP) Regulations.
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