Last week the JORF (Official Journal of the French Republic) published the 18th March 2021 decree extending the deadline for the disposal of stocks. This means that companies that have produced hydroalcoholic gels according to the 13th March 2020 decree have more time to make these products available on the market.
This new derogation only applies to formulations that comply with formula 2 of the 13th March 2020 decree, i.e. WHO�s (World Health Organisation) formula, based on isopropanol. Companies now have until 31st March 2022 to sell off their stocks and make these products available on the market.
As a reminder, the 13th March 2020 decree aimed to make hydroalcoholic gels available to consumers in larger quantities and more quickly, in order to deal with the Covid-19 pandemic. The order proposed a derogatory system for making hydroalcoholic gels available that was simpler and quicker than the usual process, provided that they were formulated in accordance with different formulas agreed by the WHO.
As far as isopropanol is concerned, the biocidal active substance is already approved under the Biocidal Products Regulation. This means that, in order to market hand sanitizers containing it (Type 1 biocidal product, for human hygiene), a company would normally have to submit an application for a Marketing Authorisation (MA). This is a lengthy and costly process, so we recommend that all formulators of isopropanol-based sanitizers start their compliance process now.
For more information on the compliance of your hydroalcoholic gels, do not hesitate to register to our webinar on the subject! You can also find out more about the support required for compliance here.
For more information, do not hesitate to contact Cornelia Garaudel or one of our experts !
Last week the JORF (Official Journal of the French Republic) published the 18th March 2021 decree extending the deadline for the disposal of stocks. This means that companies that have produced hydroalcoholic gels according to the 13th March 2020 decree have more time to make these products available on the market.
This new derogation only applies to formulations that comply with formula 2 of the 13th March 2020 decree, i.e. WHO�s (World Health Organisation) formula, based on isopropanol. Companies now have until 31st March 2022 to sell off their stocks and make these products available on the market.
As a reminder, the 13th March 2020 decree aimed to make hydroalcoholic gels available to consumers in larger quantities and more quickly, in order to deal with the Covid-19 pandemic. The order proposed a derogatory system for making hydroalcoholic gels available that was simpler and quicker than the usual process, provided that they were formulated in accordance with different formulas agreed by the WHO.
As far as isopropanol is concerned, the biocidal active substance is already approved under the Biocidal Products Regulation. This means that, in order to market hand sanitizers containing it (Type 1 biocidal product, for human hygiene), a company would normally have to submit an application for a Marketing Authorisation (MA). This is a lengthy and costly process, so we recommend that all formulators of isopropanol-based sanitizers start their compliance process now.
For more information on the compliance of your hydroalcoholic gels, do not hesitate to register to our webinar on the subject! You can also find out more about the support required for compliance here.
For more information, do not hesitate to contact Cornelia Garaudel or one of our experts !