In previous blogs we have discussed confidentiality and dissemination of registration dossiers. This blog will continue on that theme and focus on confidentiality claims of the IUPAC name and what is a public name under REACH.
Does your substance qualify for confidentiality of its IUPAC name?
In accordance with REACH Article 119 (Electronic Public Access) the substance’s name following IUPAC nomenclature will be disseminated unless the substance meets certain criteria and a justification has been accepted by ECHA. There are two exceptions to this routine dissemination; the IUPAC name can be claimed confidential when it is a substance which has been classified in one of the hazard classes referred to in Article 119(1)(a) (essentially a hazardous substance per the Classification, Labeling and Packaging Regulation (EC 1272/2008) and the substance is a “new” or non-phase-in substance (Article 119 (2)(f). Once approved this exception applies for a six year period. The second exclusion from IUPAC dissemination applies to hazardous substances per CLP which are only used as one or more of the following; as an intermediate, in product and process oriented research and development or in scientific research & development. (Article 119(2)(g).
What is covered in the confidentiality claim for the “IUPAC Name”?
The IUPAC name also covers the additional fields easily deduced from the IUPAC name and listed in the reference substance data set in IUCLID. This includes the EC number, CAS number, synonyms, molecular formula, molecular weight range, SMILES notation, InChl code and structural formula. These fields are connected to the IUPAC name and are either disseminated or confidential, aligned with what is done for the IUPAC name.
How do you claim confidentiality?
A template for justifying confidential business information (CBI) needs to be completed for each CBI claim and inserted into the registration dossier. ECHA will then review the claim and accept or reject it. The template section include a declaration of the need to keep the information confidential, demonstration of commercial interest, demonstration of potential harm, and optional the limitation to validity of claim and contact person. Where the IUPAC name is claimed confidential, a public name must be provided for dissemination and the justification for the confidentiality claim will also need to include a masking justification. In case of one level masking, this will be a simple statement on what is masked in the public name. In case of two or three levels of masking a valid justification of why the second/third level masking is necessary is also required.
What are your options for masking the IUPAC name?
The underlying principle of a ‘public name’ (sometimes referred to as a ‘masked name’, ‘generic name’ or ‘disguised name’) is that the chemical identity of the substance is revealed to the maximum extent possible, but without disclosing trade secrets or other confidential information that would potentially harm the commercial interests of the registrant or any other party concerned. One of the characteristics of a suitable public name is such that it should permit a scientist to gain sufficient knowledge of the chemical structure as to allow understanding of the intrinsic properties.
Public names may be created for well-defined substances by masking structurally-descriptive fragments of the IUPAC name. For example this could be the locant(s) that indicate(s) the position(s) of a specific chemical group, the multiplicative prefixes that specify the number of a given chemical group (e.g. di-, tri-, and/or tetramethyl), the identity (but not position and number) of a given chemical group (e.g. sulfonyl), the identity of a given parent structure, (e.g. a chain or ring system) or the locant(s) of substituent chemical group(s) for a given parent structure. One level of masking uses only one of the following mask techniques, e.g. number of chlorine atoms, or an ethyl group or a hydroxyl group. Two-level masking would include masking two of these, e.g. butane parent (plus parent locant). Third level of masking would involve masking three of these.
So remember that ECHA can only accept a confidentiality request as valid for the IUPAC name if an adequate public name with the associated justification is provided. In addition, the derivation of a public name for REACH confidentiality purposes is not the same as what is followed for the Classification, Labeling and Packaging Regulation (EC 1272/2008). It is important that the public name format and methodology per each regulation be followed and not interchanged.
Need support with your REACH Dossier? Then contact the experts at H2 Compliance and ask how they can assist with registration updates and confidentiality claims and justification.
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