FRANCE – ANSES: Procedures for updating PPE in marketing authorisations

Published by Chloé Trinchese at 11 December 2020

Following the entry into force on 1 January 2020 of the Order of 27 December 2019 on measures for the protection of persons using plant protection products, users should replace the personal protective equipment (PPE) currently mentioned in the marketing authorisations by equipment complying with the new requirements.

On 26 November 2020, ANSES published a note on procedures for updating PPE:

For marketing authorisations issued before 1 January 2020, the user will have to replace the PPE, but without notifying it to ANSES.
For marketing authorisations issued after 1 January 2020, a request to update PPE is sent to the authorisation holder, who will have to reply within 2 months by email.
For all new marketing authorisation applications submitted from 26 November 2020, PPE proposed by the applicant must comply with the new requirements.
For the applications currently under instruction, applicants are encouraged to send a single letter to ANSES to update the PPE in all applications under examination. For each application (including the type of application, the brand name of the product and ANSES reference number), a table of equivalence between the PPE initially proposed and the updated PPE must be provided. If no letter is provided, a request to update PPE will be sent directly to the applicants by ANSES departments.

The PPE updates concern in particular clothing and gloves:

PPE type	Old requirements	New requirements
Clothing	Water-repellent working coveralls (polyester 65% / cotton 35% – minimum weight 230 g/m²)	Clothing PPE certified NF EN ISO 27065/A1
Reusable gloves	Nitrile gloves certified EN 374-3	Nitrile gloves certified NF EN ISO 374-1/A1 and NF EN 16523-1+A1 (type A)
Single use gloves	Single use nitrile gloves certified EN 374-2	Single use nitrile gloves certified NF EN ISO 374-1/A1 and NF EN ISO 374-2 (types A, B or C)