According to Regulation 528/2012 the marketing authorization of a biocidal product is issued only if the active substance(s) contained in it has/have been approved for the relevant product type (PT) of interest.
Biocidal products were divided into four different groups for a total of 22 product types (PTs)
- Group 1: Disinfectants
- PT1 – Human hygiene
- PT2 – Disinfectants and algaecides not intended for direct application to humans or animals
- PT3 – Veterinary hygiene
- PT4 – Food and feed area
- PT5 – Drinking water
- Group 2: Preservatives
- PT6 – Preservatives for products during storage
- PT7 – Film preservatives
- PT8 – Wood preservatives
- PT9 – Fibre, leather, rubber and polymerised materials preservatives
- PT10 – Construction material preservatives
- PT11 – Preservatives for liquid-cooling and processing systems
- PT12 – Slimicides
- PT13 – Working or cutting fluid preservatives
- Group 3: Pest control
- PT14 – Rodenticides
- PT15 – Avicides
- PT16 – Molluscicides, vermicides and products to control other invertebrates
- PT17 – Piscicides
- PT18 – Insecticides, acaricides and products to control other arthropods
- PT19 – Repellents and attractants
- PT20 – Control of other vertebrates
- Group 4: Other biocidal products
- PT21 – Antifouling products
- PT22 – Embalming and taxidermist fluids
In order to be placed on the market a biocidal product must be authorized, therefore there are different authorization processes depending on the characteristics of the product and the number of countries of interest. TEAM mastery can assist the customers through all these processes.
This authorization is aimed to place on the market biocidal product /family of biocidal products in a single country and the Competent Authority of the Member State evaluates the application and delivers its decision within 365 days.
The authorization can concern a single product or a group of similar products, organized according to the provisions contained in the dedicated European guideline. The maximum validity that can be granted is 10 years.
The mutual recognition practice is intended to allow the biocidal product/family of biocidal products to be authorized and marketed in more than one Member State.
There are two types of application:
- mutual recognition in sequence: it applies to authorizations already granted in one Member State and allows the holder to extend its validity in other Member States. Requires approximately 6 months from validation of the application
- mutual recognition in parallel: it applies to authorizations in the process of evaluation and allows the holder to apply for authorization in several Member States at the same time, designating one of them as “Member State of reference”. Requires approximately 6 months to be added to the timeframe of a national authorization
This is aimed to place on the market biocidal product/family of biocidal products throughout Europe and can be obtained through the submission of a single procedure.
However, it requires the appointment of a “Reference” Competent Authority of a Member State that evaluates the application and delivers its decision within 365 days.
The authorization can be granted only to biocidal products having similar conditions of use throughout the European Union, with the exception of those containing active substances that meet the exclusion criteria and those belonging to PT 14, 15, 17, 20 and 21.
The maximum validity that can be granted is 10 years.
This type of authorization is aimed to encourage the use of biocidal products that are less harmful to human and animal health and the environment.
The criteria that a biocidal product/ family of biocidal products must meet are:
- all active substances contained in the biocidal product are listed in Annex I of the Biocidal Products Regulation and comply with specified limits
- the biocidal product does not contain any substance of concern
- the biocidal product does not contain nanomaterials
- the biocidal product is sufficiently effective
- the handling of the biocidal product and its intended use does not require personal protective equipment
The application requires the designation of a Competent Authority of a Member State that evaluates the application and delivers its decision within 90 days.
The simplified authorization is valid all over Europe and the authorisation holder shall notify each Member State no later than 30 days before placing the biocidal product on the market within the territory of that Member State and shall use the official language or languages of that Member State in the product’s labelling.
The Biocides mastery division since 2008 has gained considerable experience in the different types of authorization listed above, offering its customers a service and support that accompanies them throughout the process and helps them to understand the complexity and importance of the Biocides Regulation.