Consultazioni relative a classificazione ed etichettatura armonizzate
Parties concerned are invited to comment on hazard classes open for consultation, which are indicated in the substance table below.
The indicated hazard classes were assessed and concluded by the dossier submitter in their proposal for harmonised classification and labelling (CLH) of the substance.
A hazard class may be open for commenting even if the dossier submitter did not conclude that it warrants a classification. The CLH consultation lasts for 60 days (unless specified otherwise).
Which hazard classes are open for commenting?
Active substance in plant protection products (PPPs)/biocidal products (BPs): All hazard classes for which the dossier submitter has provided an appropriate information basis, assessment and conclusion, including hazard classes for which classification is not proposed.
All other substances: All hazard classes for which the dossier submitter has proposed classification and provided an appropriate information basis, assessment and conclusion. This could include carcinogenicity, mutagenicity, reproductive toxicity, respiratory sensitisation (CMR-RS) hazard classes for which classification is not proposed by the dossier submitter, but which were assessed in the dossier.
- Hazard classes for which an amendment is proposed by the dossier submitter;
- CMR-RS for which classification is not proposed if the dossier submitter has provided an appropriate information basis, assessment and conclusion.
Further information on the dossier submitter’s assessment of hazard classes and evaluation by the Committee for Risk Assessment (RAC) is available in the document 'Dossier submitter’s assessment of hazard classes and evaluation by RAC'.
Comments during consultation
Comments can be submitted on general issues (e.g. substance identification, physicochemical properties and data sources) and may also request clarifications in the text of the CLH report.
The text of the CLH report will not be updated following the consultation, but the comments will be reflected by the dossier submitter in their response to comments.
Comments related to hazard class can only be given on the hazard classes open for commenting during the consultation in question. These comments can be related to the classification itself, the information considered in the proposal, or the justification of the conclusions.
Please note that RAC may conclude that a classification other than that proposed by the dossier submitter is warranted in its opinion. This is limited to those hazard classes open for commenting during the consultation and for which there is information available in the CLH report.
RAC may also agree to propose a specific concentration limit for a hazard class open for commenting, even if this was not proposed by the dossier submitter. For example, during its assessment, RAC might consider that based on the information in the CLH report, a harmonised classification is warranted for a hazard class even if the dossier submitter has proposed that no classification is necessary.
RAC may also conclude that a more severe or less severe classification should apply than what the dossier submitter has proposed. However, RAC may not conclude on the hazard classes not open for comments during the consultation.
In the event that the substance identity proposed to be classified is a group entry or a substance with various forms, if warranted by the data, RAC may also apply a CLH to a subset of the substance identity proposed to be classified in the CLH dossier that was subject to consultation.
Comments supporting the proposed classification are also encouraged. Additional relevant data can also be submitted relating to the hazard classes open for comments.
Any comments arriving after the commenting deadline will not be included in the Response to Comments table, and will not be responded to by the dossier submitter and RAC.
The comments received during the consultation are available on the Registry of CLH intentions until outcome.
Consultations close at 23:59 Helsinki time (EET)