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New support for companies registering low tonnage, low risk chemicals

ECHA/NA/16/19

ECHA has published an inventory of substances, which are likely to fulfil the criteria to be hazardous. The inventory helps REACH registrants, who manufacture or import between 1 to 10 tonnes per year, in deciding whether they may be able to register their substance with limited information.

Helsinki, 18 May 2016 – If you manufacture or import your phase-in substance between 1-10 tonnes per year, you may be able to register it with a reduced set of information, covering only its physicochemical properties.

However, a reduced set can only be used if the Annex III criteria do not apply, meaning that:

  • there is no indication that a substance is likely to have carcinogenic, mutagenic or toxic to reproduction (CMR, category 1A or 1B); persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) properties, or
  • there is no indication that a substance with dispersive or diffuse uses would be classified as hazardous for human health and/or as an environmental hazard under the CLP Regulation.

If your substance fulfils one of the Annex III criteria, it needs the full set of information including physicochemical, toxicological and ecotoxicological information.

The Annex III inventory helps you to decide which set of information is necessary for your registration. You can search the inventory to find out whether your substance is likely to fulfil any of the Annex III criteria, and needs to be registered with the full set of data. However, even though your substance appears in the inventory, you may still benefit from the reduced requirements. In this case, you will need to gather further information and give a justification in your registration dossier.

Together with the inventory, ECHA is publishing a checklist that will help you to conclude whether you can benefit from the limited information requirements. In addition, advice on how to use the inventory, including illustrative examples, is available.

You can make your case for not meeting the Annex III criteria in a new template in IUCLID 6. Help for using the template is also available together with the inventory.

Background

For the lowest tonnage levels from 1-10 tonnes per year, the standard information requirements are defined in Annex VII, which includes information on physicochemical properties required for all substances and information on toxicological and ecotoxicological properties.

Annex III was introduced in the REACH Regulation to reduce testing on low volume phase-in substances where there is no predicted risk. As a result, the toxicological and ecotoxicological information is only required in the registration dossier if it is predicted that a substance is likely to meet the criteria defined in Annex III.


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