Commercialising of hand sanitizers: extension of derogations in France

7/7/2020

Extension of the derogations

The new decree of 29 June 2020 amending the decree of 13 March 2020 extends the application of the latter. The application of the derogation measures facilitating the marketing of hydroalcoholic products in France now extends until 31 December 2020. Companies therefore have just under six months to prepare for the end of these derogations. This period, which may seem long, should not be taken lightly: the compliance of biocidal products is a complex subject that requires preparation well in advance.

However, in order to provide for and facilitate the bringing into conformity of products marketed in recent months under the derogation arrangements, a transitional phase will be introduced from 1st October 2020. This will allow progress towards full compliance of products with the usual provisions of the EU Biocidal Regulation No 528/2012 (BPR) as well as national requirements.

The transition period from 1st October to 31st December 2020

This transition period will run from 1st October to 31st December 2020 and involves specific obligations. With regard to labelling, the Order lays down the following provisions:

  • For batches manufactured until 1st October 2020, the labelling remains the same as that defined in the annexes to the 13th March 2020 decree;
  • For batches manufactured from 1st October 2020 onwards, the labelling must comply with Article 10 of the decree of 19 May 2004, i.e. the requirements of Article 69 of the BPR.

From 1st October 2020, as regards declarations for the placing on the market of products:

  • For ethanol-based formulations (i.e. formulations 1, 3 and 4 of the Order), the declaration must be made to ANSES on the Simmbad platform;
  • For isopropanol-based products (formulation 2 of the order), the declaration is made by e-mail to the Ministry of Ecological and Solidarity Transition and ANSES (biocides@developpement-durable.gouv.fr and simmbad@anses.fr).

Extension of the derogations

The new decree of 29 June 2020 amending the decree of 13 March 2020 extends the application of the latter. The application of the derogation measures facilitating the marketing of hydroalcoholic products in France now extends until 31 December 2020. Companies therefore have just under six months to prepare for the end of these derogations. This period, which may seem long, should not be taken lightly: the compliance of biocidal products is a complex subject that requires preparation well in advance.

However, in order to provide for and facilitate the bringing into conformity of products marketed in recent months under the derogation arrangements, a transitional phase will be introduced from 1st October 2020. This will allow progress towards full compliance of products with the usual provisions of the EU Biocidal Regulation No 528/2012 (BPR) as well as national requirements.

The transition period from 1st October to 31st December 2020

This transition period will run from 1st October to 31st December 2020 and involves specific obligations. With regard to labelling, the Order lays down the following provisions:

  • For batches manufactured until 1st October 2020, the labelling remains the same as that defined in the annexes to the 13th March 2020 decree;
  • For batches manufactured from 1st October 2020 onwards, the labelling must comply with Article 10 of the decree of 19 May 2004, i.e. the requirements of Article 69 of the BPR.

From 1st October 2020, as regards declarations for the placing on the market of products:

  • For ethanol-based formulations (i.e. formulations 1, 3 and 4 of the Order), the declaration must be made to ANSES on the Simmbad platform;
  • For isopropanol-based products (formulation 2 of the order), the declaration is made by e-mail to the Ministry of Ecological and Solidarity Transition and ANSES (biocides@developpement-durable.gouv.fr and simmbad@anses.fr).