FRANCE – ANSES: Products classified as CMR2 – Safety distances setting for residents and bystanders

Published by Chloé Trinchese at 17 February 2022

On 21 December 2021, the Government asked ANSES to speed up the update of the approvals of PPPs classified CMR2 (suspected of being carcinogenic, mutagenic or reprotoxic) currently on the market, in order to explicitly set a safety distance providing that the holders request it.

The products concerned are those with at least one of the following hazard statements:

H341: Suspected of causing genetic defects
H351: Suspected of causing cancer
H361: Suspected of damaging fertility or the unborn child
H361f: Suspected of damaging fertility
H361d: Suspected of damaging the unborn child.
H361fd: Suspected of damaging fertility. Suspected of damaging the unborn child.

Thus, for the reference products and generic products currently authorised and for which a safety distance has not yet been set, an application for updating the safety distances will have to be submitted before 1 June 2022. As of 1 October 2022, products that have not been the subject of an admissible application to ANSES (= acknowledgement of the completeness check receipt) will have a minimal default 10-meter safety distance applied by regulation.

The type of dossier to be submitted is an application for an amendment of the conditions of use of the product (code PMOD).

For the applications concerning a reference product or a generic product currently under assessment and already including the data required to set a safety distance, only a declaration is to be sent to ANSES before 1 june 2022.

For currently authorised resale products, an application for a product with an identical composition has to be submitted (code PDPI). The update of the safety distance will be done once the distance set for the reference product. If no application has been submitted for the reference product, the default minimum distance of 10 metres will be applied for both reference and resale products.

To download:

ANSES note of 01.02.2022 (revision 1) (in French)

See also our previous articles:

FRANCE – Public consultation: Draft decrees and orders on measures to protect persons when using plant protection products

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