Biocides authorization

Biocides authorization

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market of all those products used for the protection of humans, animals, materials or articles against harmful organisms, such as parasites or bacteria, through the action of the active ingredients contained in the biocide.

All biocidal products must obtain an authorization before they can be placed on the national or European market.

The authorization process can be chosen based on the product and the number of countries in which you intend to market it:

  • National authorization and mutual recognition : If the product is placed on one market only, the authorization of the relevant country is sufficient. If a company wishes to place the product on the markets of different countries, it can apply for mutual recognition in order to authorize it.
  • Union authorization : If the product is placed on the whole Community market, it is possible to apply for authorization at EU level in a single process.
  • Simplified authorization a: if the product meets certain criteria, specified in the regulation (for example, products that do not contain substances of concern).

autorizzazione biocidi

To be authorized, the biocidal product must contain an active substance approved for the corresponding PT and supplied by one of the companies registered in the list of recognized suppliers pursuant to Article 95 of the BPR.

ECHA publishes and updates the list of relevant substances and their suppliers of substances and products, in accordance with Article 95 of the Biocidal Products Regulation (BPR), as amended by Regulation (EU) No. 334/2014 of 11 March 2014. The purpose of this list is “to ensure equal treatment of persons placing active substances on the market” (recital 8 of the Biocidal Products Regulation).

Since 1 September 2015, a biocidal product cannot be made available on the EU market unless the supplier of the substance or the supplier of the product is included in the Article 95 list for the PT to which the product belongs.

In Annex V of the BPR, biocides are classified into the 22 product types (PT), grouped into four main sectors (Disinfectants, Preservatives, Pest Control, Other Biocides).

Group 1: Disinfectants
These types of products do not include detergents not intended to have biocidal effects, including liquid and powder detergents and similar products.
PT 1Human hygiene
PT 2Disinfectants and algaecides not intended for direct application to humans or animals
PT 3Veterinary hygiene
PT 4Human and animal nutrition sector
PT 5Drinking water

 

Group 2: Preservatives
Unless otherwise specified, these types of products only include products to prevent microbial and algal growth.
PT 6Preservatives for products during storage
PT 7Film preservatives
PT 8Wood preservatives
PT 9Preservatives for fibers, leather, rubber and polymerised materials
PT 10Preservatives for building materials
PT 11Preservatives for liquids in industrial cooling and treatment systems
PT 12Preservatives against the formation of slimy substances (slimicides)
PT 13Preservatives for fluids used in processing or cutting

 

Group 3: Control of vermin
PT 14Rodenticides
PT 15Avicides
PT 16Molluscicides, vermicides and products intended for the control of other invertebrates
PT 17Piscicides
PT 18Insecticides, acaricides and products intended for the control of other arthropods
PT 19Repellents and attractants
PT 20Control of other vertebrates

 

Group 4: Other biocides
PT 21Anti-fouling products
PT 22Fluids used in embalming and taxidermy

If the product contains an active substance not yet approved (under review), it falls under the national authorization procedures. For more details see here

Chemicals consulting offers companies wishing to register a biocidal product a complete consulting service ranging from the choice of analyzes and efficacy tests to be performed according to the product and its action, to the preparation, transmission of the application and possible interaction with the authorities. The support ends when the authorization is granted.

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