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Q Does the analytical data included in an inquiry dossier have to be generated on the manufactured or imported substance?
A

In principle, the analytical data included in an inquiry or a registration dossier must reflect the substance as manufactured or imported. Hence, if you are an EU manufacturer, you must submit analytical data generated from a sample that you have manufactured. If you import from outside the EU, you must submit analytical data generated from a sample manufactured by the non-EU manufacturer.

We are aware that this can be problematic if you have to register your substance before taking up manufacture or import. For such cases we may accept submitting analytical data from another source.

For these exceptional cases, you need to explain the following in your inquiry dossier:

  • Why the analytical data cannot be generated on the manufactured substance.
  • Why the substance you intend to manufacture or import will be the same as the one used to generate the analytical data. For example, a statement that the manufacturing process and/or plant specification used to produce the analysed substance will mirror that for the inquired substance.

You also need to provide the following information in your inquiry dossier:

  • The source of the analysed substance i.e. manufacturing site name and address.
  • A short description of the production process and the raw materials for both the inquired substance and the analysed substance.
  • The foreseen manufacturing or import volume for the inquired substance.
  • A statement from the owner of the analytical data indicating that you have their permission to use their analytical data.

You are required to update the substance identification information in the registration dossier within 6 months after the submission to reflect the substance as manufactured or imported. If the registration is not updated, ECHA may initiate a targeted compliance check on substance identity.

Date de modification: 12/10/2015
Topic: REACH
Scope: Demande
ID: 0434
Version: 1.1

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