Duties in the Supply Chain

Registration

What is registration?
At registration manufacturers and importers, of substances (including metals) supplied in quantities of 1 and more tonnes per year, are required to submit a dossier of information to the European Chemicals Agency (ECHA), in Helsinki, containing information on the substance properties and guidance on how to use the substance safely. Quantities starting at 10 tonnes additionally require submission of a Chemical Safety Report (CSR) to document the in-depth Chemical Safety Assessment (CSA) in order to demonstrate that the level of eventual risk a substance might pose to the environment or humans can be adequately controlled. Quantities produced or supplied at 1000 tonnes and above are priority substances for this assessment. The amount of information required in the dossier is related to the tonnage of substance manufactured/imported as presented in this data list (the information required is also stipulated in the REACH annexes). The dossier must be submitted in IUCLID format and by the relevant deadline; failure to complete registration by the required deadline will result in loss of access to the EU market.

Further information on registration can be found on the ECHA Website

One Substance One Registration (OSOR)
REACH is based on the principle ‘One Substance, One Registration’ whereby a single dossier is completed for each substance. Under this rule the registration dossier is completed, and submitted, by one company on behalf of the others a process which necessitates information to be shared between all manufactures and importers registering the same substance. The OSOR rule aims to increase efficiency, reduce cost, and to reduce testing on vertebrate animals. REACH also requires communication with ‘downstream users’ of chemicals to help ensure that any hazards, and risks, posed by a substance, are managed effectively throughout the supply chain.

Tonnage bands and deadlines
Manufacturers and importers that have pre-registered their substances qualify for the phased-in registration deadlines which are dependent on the classification and tonnage of the substances supplied. The final REACH deadline is:

1 June 2018
• ≥ 1 tpa

What information is included in the registration dossier?
There are two components to the registration dossier, a technical dossier and a chemical safety report (CSR). The technical dossier contains information on the substance properties, classification, and use. The extent of information to be submitted on the substance properties increases with the relevant tonnage band as outlined in the REACH Annexes VI to XI.

A CSR is only required for substances supplied in quantities of ≥10 tpa. The CSR documents the risk assessment associated with the relevant hazards and exposures of the substance.

Actors in the supply chain

EU traders and distributors
Although the REACH Regulation does not specifically include terms for traders and distributors, certain obligations could be relevant to such actors in the supply chain. If a trader or distributor imports substances into the EU they are likely to have full registration obligations. Traders and distributors who do not directly import their substances from outside the EU do not have to register but are required to pass information up and down the entire supply chain.

Non-EU producers
REACH is an EU Regulation and, as such, it does not place any direct obligations on companies based outside the EU; registration requirements are only relevant to producers and importers based in the EU. However, REACH does provide a method for non-EU producers to register the substances they manufacture outside the EU; although they are not able to register directly themselves, they can register via a company, based in the EU, acting as their Only Representative (OR). Several non-EU producers are choosing to register their substances by this route in an attempt to maintain their current EU supply chains. Many non-EU producers understand that when the REACH requirements are realized, most of their EU customers will choose to buy substances from registered sources to relieve themselves of the burden of registering themselves as importers. As such, many non-EU producers are registering to maintain their EU customer base.

To register or for more information please contact: [email protected]

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