The European Commission issues guidelines for the production of leave-on hand cleaners and hand disinfectants
As the demand for hand disinfectants increased drastically during the current Corona virus crisis, the European Commission has released on 30 March 2020 a guideline document to advise economic operators producing hand cleaners and hand disinfectants.
The guidance clarifies that several factors, such as claims, composition, and purpose of use, should be taken into careful consideration to assess the appropriate EU legal framework for these products.
Depending on these elements, hand cleaners or hand disinfectants will subject to either:
- Regulation (EU) 1223/2009 on cosmetic products (Cosmetic Products Regulation) or
- Regulation (EU) 528/2012 concerning biocidal products (Biocidal Products Regulation).
According to the Commission, the classification as a cosmetic or a biocidal productwill depend first of the product’s main purpose:
- When a product is supplied with a main or exclusive cosmetic purpose, such as “cleaning” or “cleansing the skin”, it will be subject to the Cosmetic Products Regulation.
- If, on the other hand, the product contains an active substance and it is presented as having a primary biocidal purpose beyond the general perception of personal hygiene (e.g. “disinfecting”, “kill viruses”, “kill bacteria”), it will fall within the scope of the Biocidal Products Regulation.
Furthermore, as stated in the guidance, although claims are not the determining element to be considered, the following would certainly contribute to support a biocidal purpose:
- “Unique antibacterial formulation”
- “Kills bacteria”
- “Kills viruses, Virokill”
- “Effective against coronavirus”
As these examples would seem to suggest the presence of an active substance and a main biocidal function, the products carrying them would likely be excluded from the scope of the Cosmetics Products Regulation and would need to comply with the Biocidal Products Regulation.
Regulatory Affairs Department
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