Traduction De Courtoisie

Traduction de courtoisie

French paper regarding biocidal products classification rules and national authorisations

The French Authorities consider that there might be an inconsistency between the responsibility of classification given to the supplier according to CLP regulation and the responsibility of SPC update given to the Member States according to the Biocidal Product Regulation. It appears that the BPR could lead to a conveyance of responsibility from the supplier to Member States. Yet, the very large number of different biocidal products on the market would prevent any update in due time of all authorisation every time a classification is changed. As an example, the 1671 products containing Sodium Hypodhlorite in France would need to have their authorisations updated in a very short time after the future potential modification of M-factor under CLP regulation. The French Authorities suggest to adopt a two step approach maintaining the responsibility of the supplier while providing a way to modify the authorisations when risk mitigation measures need to be updated.

French Competent Authorities ask the Commission for clarification regarding classification and labelling rules of biocidal products and their link with national authorisations.

Issue at stake

CLP regulation applies to Biocidal Product, as to any other chemicals. According to article 4 of this regulation, suppliers have to classify their substances and mixtures before making them available on the market. As a consequence, they are responsible for the classification of their product.

According to articles 22-2 and 69 of the Biocide Product Regulation, authorisation holders “shall ensure that biocidal products are classified, packaged and labelled in accordance with the approved summary of biocidal product characteristic, in particular the hazard statements and the precautionary statements”.

These articles seem to be contradictory:

-according to CLP regulation, the supplier is responsible for assessment and communication of the classification

-according to the BPR, the authorisation holder is responsible for the communication the classification given in the authorisation.

As a consequence, France asks the Commission to clarify whether:

-the authorisation holder is the only one in charge of the BP classification

-the classification given in the authorisation is systematically applied, conveying the responsibility of the update and accuracy to the Member States.

French competent authorities would like to underline two specific situations where the management of the SPC could lead to problematic issues:

-Situation #1: classification in the SPC of one Member state differs from the one of another member State. This situation has already happened through a mutual recognition procedure, as the harmonisation of the classification was underway. The RMS anticipated the future classification on the basis of ongoing works, non validated according to CLP process. In such a situation, experts can have different interpretations: out of 45 classification dossiers submitted, more than 20 are different from the first proposal. Such a difference in classification between SPC will no longer be possible under the BPR. As a consequence, it is proposed to take into account the classification dossier only after a RAC decision has been issued, when a proposal for harmonisation has been submitted.

When no harmonisation dossier has been submitted, only data submitted by the applicant should be taken into account. France Competent Authorities ask the Commission to validate or define alternative rules.

-Situation #2: evolution of classification since national authorisation was delivered. The draft regulation on changes to authorisation does not mention classification change as a type of change. This could mean either that it should not lead to a submission of a dossier or that is it a major change, which is deemed as excessive a many situations. Annex II of this draft regulation mentions the possibility of “grouping” of classification changes.

French Competent Authorities ask the Commission its opinion on the following points:

-should a change of classification resulting from a new CLP classification of the active substance lead each and every time to review the national authorisation of products containing this active substance?

-should a change of classification following a request by the authorisation holder lead to review this authorisation as, according to article 4 of CLP regulation, it remains the only one responsible of its product classification?

The French competent authorities underlines that any interpretation that would give the responsibility to the Member States would lead to a major increase in the time needed to process the applications. Furthermore, in the case of a new ATP, the French Competent Authorities would like to make sure that the update of the labelling of the product does not depend on the review of the national authorisation, meaning a conveyance of responsibility of the implementation of the ATP from the supplier to the Member State. However, the French Competent Authorities acknowledge that a change of classification could lead to review risk management measures, which would need a review of the national authorisation.

As a consequence, the French Competent Authorities suggest the following process, already applied in the PPP regulation:

-case of a change of classification of a biocidal product following a regulation (ATP, CLP in 2015…). The authorisation horlder implement the new classification without any delay. In parallel, it infoms the Member States of this change in a limited time (for example, 2 months before entry into force of the ATP). On the basis of ECHA recommendations, the Member State decides if the new classification should lead to a review of the risk management measures. The authorisation is updated only if there are changes in risk management measures.

-Case of a change of classification of a biocidal product following a new study. In such a case, the classification review needs a technical assessment of the submitted study. As a consequence, this change of classification must leas to an application (and not only a notification). The new classification would apply only after the update of the authorisation.

This two steps approach has two advantages:

-it prevents any conveyance of responsibility from the supplier to the Member States.

-The authorisation would be changed only if risk management measures need to be modified due to the new classification.

As a matter of fact, the large quantities of different products on the market would prevent the change in due time of all the authorisations every time a classification changes. As an example, the future change of classification of sodium hypochlorite (proposal for a modification of the M-factor) would lead to the update of 1671 authorisation in France (number of products containing this active substance in France), whereas risk mitigation measures may not need to be modified.