Accelerated new authorisations or extension of existing authorisations with a virus claim not possible
To begin with, we would like to refer consumers to the advice given by RIVM to prevent infection with the coronavirus.
It is not possible to apply for authorisation of a new product or to extend an existing authorisation with an accelerated procedure. This is because additional data is needed to demonstrate that the new use is effective and is safe for humans, animals and the environment. Extension of an authorisation with a new use (e.g. with a use against a virus or product type – e.g. PT01 human hygiene disinfectant) takes place according to the existing extension/change procedure for an authorisation.
Authorised disinfectants with a virus claim
Authorised disinfectants almost always fall into the category product type PT01 for hand/skin disinfection and PT02 for surface disinfection. Efficacy against the coronavirus is not a distinguishing criterion in this category of products. In principle, all disinfectants with both a virus claim and the correct scope of permitted use can be used to combat the coronavirus.
The actual use must be in accordance with the Legal Conditions for Use and Instructions for Use; (WGGA) of the relevant authorisation; for biocidal products authorised under the European Biocidal Products Regulation (BPR), the prescribed use is included in the Summary of Product Characteristics (SPC).
Furthermore, Article 72 of the Biocidal Products Regulation applies to all biocidal products on the Dutch market. According to the Regulation, “Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy. In any case, the advertising of a biocidal product shall not mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or any similar indication.”
In addition, hand gel should not be recommended for disinfection and incorrect claims must not be used for the authorised products. Article 72 of the Plant protection products and biocidal products Act includes the following provisions:
- It is prohibited to recommend or endorse an unauthorised biocidal product.
- It is prohibited to recommend or endorse the use of a biocidal product if this is conflict with the conditions/instructions that apply to that use.