Registrants must provide a public name if they want to keep the chemical IUPAC name for their substance as confidential.
The new manual tells registrants how to derive a public name for a substance for which they request to keep the IUPAC name as confidential, as permitted in certain circumstances in accordance with Article 10(a)(xi) of the REACH Regulation. The rules presented in the manual describe the masking of various structural elements from the IUPAC name in order to derive a public name with a single level of masking. In certain circumstances up to three levels of masking may be permitted if the registrant provides a valid justification for each additional level of masking.
A public name for the substance is, in particular, needed for publication of the non-confidential registration information on ECHA’s website (Article 119) and also for public consultation to call for relevant scientific information on substances with testing proposals for new animal studies (Article 40-2).
In order to ensure that ECHA can accept confidentiality requests for a IUPAC name, registrants must include a public name in their dossier and make sure this public name corresponds to the requirements in the manual. The provision of an adequate public name is a pre-condition for the acceptance of a confidentiality claim for the IUPAC name. If ECHA rejects a confidentiality claim for the IUPAC name, the IUPAC name will be published.
Existing registrants who have not yet provided an adequate public name can do so by submitting an update to their registration dossier, and they are recommended to do this before 1 March 2011 when dissemination of registration data is anticipated. ECHA will assess confidentiality claims for IUPAC names in registrations. In case of deficiencies regarding the public name the registrant will be informed and will have one opportunity to correct it.
Hence there is a clear incentive for registrants who know they have not provided a public name according to the manual to update their registration. If then there is a problem with the public name they have chosen there is still one more opportunity to correct it when challenged by ECHA in the course of the confidentiality claim assessment.
The Data Submission Manual, Part 16, on confidentiality claims will be updated in due course to reflect the changes made to the assessment workflow for confidentiality claims on the IUPAC name and the corresponding justification template.
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