Are they correctly labelled? Is there any human risk derived from their use? How can their efficacy be measured?
Treated Articles that incorporate a biocidal product with the intention to add new properties or functions to this article, not related to its primary use, are Biocidal Products themselves, for example:
- Antibacterial clothing
- Keyboard treated to prevent bacterial growth.
- Hospital bedside cabinet treated to kill germs on contact.
- Door handles that prevent cross-infection.
- Antiviral coatings
The majority of these articles intend to improve hygiene but the benefit can be unclear to the consumer/user.
The article treated with a biocidal active substance can be harmful to both the user and the environment, and this risk needs to be prevented.
The treatment of the article with the biocide should be fully justified and the efficacy must be proven. No standard methods exit; the methodology must simulate the target application as maximum as possible.
EU Member States are requesting the EU Commission to set risk mitigation measures (RMMs) for treated articles (and related labelling obligations). However, setting these RMMs is only possible if such a requirement is specified in the approval conditions of the active substance(s) contained in the biocidal product according to Art. 58(2) of the BPR. So, for these biocidal products that are currently used to treat articles and where this treatment can pose any risk for the human and the environment, it is possible to set RMM in the biocidal product authorisation to prevent its use in articles. However, it is currently under discussion (latest CA Meeting June 21) that certain RMMs cannot be realistically applied/controlled, especially in the case of non-professional users.
In addition to this, the EU Commission will adopt an implementing act (based on Article 58(7)) further specifying labelling requirements under Article 58(4) which sets the obligation for the person placing the treated article on the market to ‘label it with any relevant instructions for use, including any precautions to be taken, if this is necessary to protect humans, animals and the environment’.
If your company has any doubts regarding the treated articles that you market, please contact our regulatory experts.