The Biocidal Products Regulation (EU No 528/2012) is a common EU legislation that aims to ensure a high level of protection when using biocidal products. Biocidal products are used to protect people, animals and other property against pests or microorganisms. Examples of biocidal products are disinfectants, wood preservatives, mosquito repellents, rodenticides, and boat anti-fouling paints, so the legislation covers a wide range of products.
22 different product types
All biocidal products are divided into 22 different so-called product types. The division corresponds to the area of use for which the product is to be used. The product type is very central for an active substance such as ethanol, which can be approved for use in one product type, e.g. PT1 Disinfectant for human hygiene, while it may be prohibited in another group, such as PT3 Disinfectant for veterinary hygiene.
The product types relevant for disinfectants are:
- PT1 Disinfectants for human hygiene
- PT2 Disinfectants and algaecides not intended for direct use on humans and animals
- PT3 Disinfectants for veterinary hygiene
- PT4 Disinfectants for surfaces in contact with food and animal feed
- PT5 Disinfectants for drinking water
Active substances must be approved
A biocidal product contains one or more so-called active substances. These are substances that give the products the desired biocidal properties. For disinfection products, the active substance can be e.g. ethanol, isopropyl alcohol, hydrogen peroxide, chlorhexidine, n-propanol, sodium hypochlorite etc.
All active substances are evaluated in the EU review programme and the EU chemicals agency ECHA decides on the approval or non-approval of active substances within the different product types. Both the active substance and the finished formulation must be approved under the Biocidal Products Regulation.
ECHA reviews the human health and environmental risks of the active substances, and after the evaluation, the substance is either approved or non-approved. When an active substance is approved, an application must be submitted for all formulations/products containing this substance. If the application is not submitted to the EU and approved, the product cannot continue to be sold within the EU.
Step 1.
The active substance (e.g. ethanol, IPA etc.) is approved at EU level.
Step 2.
Creation of a dossier of products that contain the active substance.
Step 3.
Apply for either National authorization or Union authorization.
Step 4.
The dossier is evaluated by ECHA in regard to product safety, efficacy and compliance.
Step 5.
Product is authorized.
Steps 3–5 usually take 3–6 years.
EU has not yet had time to evaluate all active substances, including ethanol, which means that transitional rules apply until the active substance is approved. This may mean that there are different national requirements for biocidal products until EU has approved the active substance and ultimately also the finished product.
The application for product approval is both lengthy and costly
An application to have a biocidal product approved is very extensive and you must be able to document efficacy, safety, stability, human health risk, environmental toxicology assessment, etc.
An authorisation of a biocidal product means that the authorisation holder has been able to demonstrate that the product is safe for human health and the environment when used as intended, and that it is effective against the claimed target organisms, e.g. bacteria and viruses.
Article 95 List
The Article 95 List is a list showing which companies have submitted documentation or has a letter of access to submitted dossier documentation for active substances. As of September 2015, a biocidal product consisting of, containing or generating a relevant active substance may not be made available on the EU market if the substance or product supplier is not included in the list for the product type to which the product belongs.
An updated list is available on the ECHA website. Kiilto is included in the Article 95 List as an authorised supplier for both substances and products (Substance- and Product Supplier).
What are the consequences of the Biocidal Products Regulation on the market for disinfection products?
As stated, the main purpose of the Biocidal Products Regulation is to regulate the market so that all biocides used in the EU are safe for both humans and the environment, and this will lead to the gradual disappearance of unscrupulous operators and products without the required documentation. This is something that we welcome with open arms.
Unfortunately, the rather heavy administration of the Biocidal Products Regulation will mean that product development in the disinfection area will be limited, and the launch of new products will take much longer time as they will in the future require approval before being placed on the market. Approval can often be expected to take several years.
Having approved biocidal products involves a lot of costs linked to the application for approval and an annual authorisation fee, which in the long term will lead to increased prices of disinfection products.