Updated 'How to comply with French sanitisers [...]'

Introduction

We have received a lot of questions regarding a French decree that would circumvent the Biocides Regulation during the COVID-19-crisis. In this article we will explain the original Decree of 13 March 2020 plus changes as in force today (May 20). 

Update

The French government has notified the European Commission on 15 May of draft legislation supplementing the Order of 23 March 2020 prescribing the organisational and operational health system measures necessary to deal with the COVID-19 epidemic in the context of the state of health emergency. Products concerned are Hydro-alcoholic gel/boxes of masks/medicinal products/telecare/medical devices/in vitro diagnostic medical devices.

In particular, the draft text provides that: 
- the provisions on hydro-alcoholic solutions are now applicable until the end of the state of health emergency. In addition, details are provided on the labelling of these solutions; 
- the distribution of masks has been extended to certain professionals and patients; 
- the provisions on telecare from certain professionals are specified and extended; 
- the provisions on the possibility of using in vitro diagnostic medical devices which do not have CE marking are specified; 
- certain provisions on the dispensing of medicinal products or medical devices in the event of an expired prescription are applicable until 11 June 2020 or until the end of the state of emergency.

These measures have already been the subject of previous notifications.

The full alert can be downloaded via this link. 

Previous blog post

Key points

• The French Government has published a decree that, as of 13 March 2020, facilitates the commercialisation of hand gels by exempting the active biocidal substances in those gels from the obligation to register them.
• After 1 September 2020, the active substances in hand sanitisers must comply to Regulation (EU) No 528/2012 (Biocidal Products Regulation, or BPR).

French Decree TREX2007745A

In order to combat the COVID-19 crisis the French government has recognised that hand washing is not always possible. Hydro-alcoholic products are among the most effective solutions for the rapid and efficient inactivation of a wide range of micro-organisms that may be present on the hand. The French industrialists have indicated that they will be able bring to the market new formulations. However the registration process under the BPR would delay this process. The French government has decided to postpone the registration process under the BPR until 1 September 2020; initially the period ended on May 31^st, but the period has been extended on April 17^th. This decision has been published under Decree TREX2007745A; link to the orginal legal tekst (opens in new window). 

The decree makes it possible to produce one of 4 given formulas of hand sanitisers, if your company is:

• A pharmaceutical establishment (under art. R.5124-2 of the French Code)
• A cosmetic products manufacturing company
• A company manufacturing biocidal products (under the French Environment Code)
• Classified facility under the protection if the environment

In the text of the Decree 4 formulations are given, as well as requirements for labelling and use.

After 1 September 2020, this legislation expires and the obligations under the BPR must be adhered again (unless the emergency legislation is again extended).

If you would like to learn more on Handgels and sanitising wipes, ProductIP has written a free Guide for supplying hand gel or sanitising wipes to the EU market. Also read our blog articles on the subject here (scroll down to 'Handgels (disinfecting)') and here.