Placing disinfectants and sanitizers on the market
Exemptions in place to face Covid-19 pandemic
Because of the Covid-19 health crisis, ECHA accelerates and simplifies the usual processes to commercialise biocidal products. Exceptional measures have been taken for biocides which active substance (AS) has already been approved to avoid that the MA (Marketing Authorisation) should take several months, or more, as is usually the case.
Thus, a Member State is temporarily authorised to accept the commercialisation on its national market of a product which has not yet submitted an authorisation dossier or obtained validation. This is also true for products composed of a new AS. Additionally, ECHA established a quick process, specially for propanol-based products, allowing to obtain a technical equivalence in a short period of time for products using a new source of propanol.
Regarding AS still under evaluation, no specific measure was taken because their MA depends on member states, which is already, in itself, a simplification. In France for example derogatory measures have been taken, allowing, among other things, not to have to comply with Article 95, temporarily. However, it should be noted that the usual transitory measures will go back to applying at the end of this period (1st September 2020). This date will need to be anticipated as best as possible to stay compliant.
For more information on the exemptions implemented in Europe, do not hesitate to watch the replay of our webinar on the subject. For information on the exemptions in Canada and the US, please sign up for the corresponding webinar.
The usual process for biocidal products compliance
Hand sanitizers and disinfectants need to comply with several regulations in order to be placed on the European market. Because of their disinfectant action, they are considered biocidal products. Outside of any exemption, the requirements are:
- Compliant composition: the AS/PT couple (Active Substance/Product type) needs to be approved or under evaluation from ECHA. Furthermore, in case of cutaneous application, the product should comply with the cosmetic regulation annexes
- Product compliant with Article 95: depending on the product type, the AS supplier needs to appear on the approved suppliers list of Article 95
- Safety Data Sheet (SDS): it should comply with REACH and CLP regulations
- Compliant label and packaging: biocidal products regulation and CLP regulation.
Additionally, other steps need to be taken depending on the AS:
- If the substance is still under evaluation (for instance ethanol), the product is in transitional period and it is not possible to get a marketing authorisation for the European Union. The national processes must then be considered. For the case of France, a SIMMBAD declaration must be carried out, followed by a SYNAPSEdeclaration. In this case, the marketing timeframe is less than a month. For disinfectants, there are 90 AS under evaluation.
- If the AS has been approved (for example propanol), the product is in “long term period”, and a marketing authorisation dossier must be submitted to ECHA, which may take several years. 39 AS have already been approved for hand sanitizers and disinfectants.
Disinfectants: biocidal products which must be compliant
Disinfectants and hand sanitizers are biocidal products since they contain an active substance capable of destroying harmful organisms through chemical action. The disinfectant function of these products corresponds to 3 types of products out of the 22 that exist:
- PT1: Human hygiene (healthy skin)
- PT2: Surface disinfectant (no cutaneous application or contact)
- PT4: Surface disinfectant with food contact
You can look through the details of the different product types on our dedicated “key concept” page.
Ecomundo guides you through all the steps of your biocidal products’ compliance, specifically disinfectants and hand sanitizers to prevent any potential shortage affecting these products in the context of Covid-19 pandemic.
Wish to know more about biocidal products?
For more information, do not hesitate to contact Fang Zhou or one of our experts via our contact form, indicating the purpose of your inquiry.
