Biocidal Regulation for Hand Sanitizers

Do you manufacture or supply disinfectants, preservatives, insecticides or other products designed to control harmful organisms? Or alternatively do you use these to protect your formulations or products? If you answer “yes” to either of these questions then Biocidal Products Regulation will affect you.

The EU Biocidal Products Regulation (BPR) came into force on 1 September 2013 and from that date it placed duties on manufacturers and importers of substances, formulators, importers of mixtures and importers of articles and end users. A summary of these duties are listed below.

Manufacturers or importers of substances

If the substance has an action on or against harmful organisms and is placed on the market for use in a biocidal product the manufacturer or importer must ensure that the active substance is approved for use in the biocidal product-type in which it is to be incorporated*, for example those who manufacture ethanol which is supplied to be used in disinfectants. The manufacturer or importer must also ensure they are included on the list of active substance suppliers for that active substance/product-type combination.

If the substance itself does not have an action on or against harmful organisms, but has been treated with a biocidal product, for example an in-can preservative, then it is in fact a mixture and is regarded as a ‘treated article’. The active substance within the biocidal product used for the treatment must be approved under the BPR for the product-type in which it was used. Specific labelling related to this treatment may be required, depending on the claims made by the supplier and on the conditions of approval of the active substance.

Formulators of mixtures

If the mixture has a biocidal function – i.e. it is placed on the market with a purpose of protecting humans, animals, materials or articles against harmful organisms through the action of the active substance it contains – an authorisation must be obtained. One of the requirements for the granting of an authorisation is that the active substance has been approved for the product-type in which it is contained. For example, if supplying an anti-microbial hand soap, the active substance contained (e.g. ethanol) must be approved for product-type 1 (human hygiene biocidal products). The formulator must also ensure that the supplier of the active substance is included on the list of approved active substance suppliers, or otherwise be included himself.

If the mixture itself does not have a biocidal function, but it has been treated with or intentionally incorporates a biocidal product in order to exert a protective effect on the mixture itself, for example an in-can preservative, then the mixture is a ‘treated article’. The active substance within the biocidal product must be approved under the BPR for the product-type in which it was used. Specific labelling related to this treatment may be required, depending on the claims made by the supplier and on the conditions of approval of the active substance.

Importers of mixtures

If the mixture has a biocidal function – i.e. it is placed on the market with a purpose of protecting humans, animals, materials or articles against harmful organisms through the action of the active substance it contains – an authorisation must be obtained. One of the requirements for the granting of an authorisation is that the active substance has been approved for the product-type in which it is contained. For example, if supplying an anti-microbial hand soap, the active substance within it, e.g. ethanol, must be approved for product-type 1 (human hygiene biocidal products). The importer must also ensure that they are included on the list of active substance suppliers for that active substance/product-type combination.

If the mixture itself does not have a biocidal function, but it has been treated with or intentionally incorporates a biocidal product such as an in-can preservative prior to or following import, then the mixture is a ‘treated article’. The active substance within the biocidal product must be approved under the BPR for the product-type in which it was used, even if the treatment took place outside the EU. Specific labelling related to this treatment may be required, depending on the claims made by the supplier and on the conditions of approval of the active substance.

Producers or importers of articles

If the primary function of the article is biocidal – that is, it is placed on the market with the primary purpose of protecting humans, animals, materials or articles by means other than solely physical or mechanical action – an authorisation must be obtained. One of the requirements for the granting this authorisation is that the substance which provides this biocidal function is approved under the BPR for the product-type in which it is used. For example, if an insecticide-soaked mosquito net is placed on the market, the active substance (e.g. pyrethrin) must be approved for product-type 18 (insecticides, acaricides and products to control other arthropods).

If the article does not have a primary biocidal function but it has been treated with or incorporate a biocidal product, then the active substance within that biocidal product must be approved under the BPR for the product-type in which it was used. Specific labelling related to this treatment may be required, depending on the claims made by the supplier and on the conditions of approval of the active substance.

End users

End users may not use a biocidal product that has not been authorised under the BPR*, and must use it in accordance with any provisions stated in the authorisation.

*Please note, approvals for active substance-product type combinations are currently being reviewed and transitional arrangements are in place to allow the continued supply of biocidal products until an approval decision is made.

Implications

Unfortunately due to the lack of preparation around Europe for Corona 19 there resulted in a huge shortfall of sanitizers to meet public demand. This resulted in many companies converting over to the production of santizers, and well as people importing products from outside of the EU. A very high percentage of this new supply does not conform to EU regulation. This causes a number of problems. Firstly, due to the use of chemicals from outside of this list there is no guarantee of the quality of the product. This lack of standardisation could make the product unsafe for consumption. The product may cause skin irritation or may not be effective at fighting bacteria and viruses resulting in a poor quality product. Secondly, a provider or distributer of an unregulated sanitizer could be subject to enforcement and litigation proceedings.