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The Biocidal Products Regulation

Biocidal products are helpful for controlling harmful organisms.

Biocidal products are necessary for the control of organisms that are harmful to human or animal health. They contribute to the hygiene of humans and animals and are used to control organisms that cause damage to natural or manufactured materials.

Agar plates Characterisation of micro-organisms on different-coloured agar plates and active agent plate-lets, © Monika Krause, BAuA

In addition to products that act directly on pests, such as disinfectants, insecticides, rodenticides and wood preservatives, biocidal products also include products that are intended to prevent damage. They can therefore also include attractants and repellents. Biocidal products can have a very diverse range of applications and are therefore classified into "product-types".

Biocides Regulation

Regulation (EU) No 528/2012 (Biocidal Products Regulation) regulates the sale, supply (making available on the market) and use of biocidal products throughout Europe. The Biocidal Products Regulation therefore applies not only to distributors and persons who place biocidal products on the market but also to users of biocidal products.

The aim of the Regulation is to harmonise the making available of biocidal products on the market and their use within the European Union; at the same time, a high level of protection is to be ensured of both human and animal health and the environment.

The Biocidal Products Regulation also regulates biocidal products in which the biocidal active substance is generated in situ, or so-called in situ active substances, either without precursors or from precursors.

The Biocidal Products Regulation also regulates the placing of treated articles on the market.

Approval of a biocidal active substance

In accordance with the Biocidal Products Regulation, biocidal products may contain biocidal active substances only if they are set out in a positive list known as the "Union list of approved active substances". Biocidal active substances must therefore undergo an approval procedure before the active substances can be used in biocidal products. All EU Member States participate in this procedure. Transitional measures apply to so-called existing active substances.

Authorisation of biocidal products

A biocidal product must be authorised before it can be made available on the market and used. Accordingly, every biocidal product undergoes a national or EU-wide authorisation or notification procedure. Transitional measures may apply to biocidal products that contain only existing active substances. In Germany, however, it is necessary to notify the Federal Office for Chemicals (BfC) of the biocidal product in accordance with the Biocide Notification Ordinance (ChemBiozidMeldeV).

Competent authorities in Germany

All EU Member States work closely together on the approval of biocidal active substances and the authorisation of biocidal products. Each Member State has a competent authority. In Germany, this is the Federal Office for Chemicals (BfC) at the Federal Institute for Occupational Safety and Health (BAuA).

The role of the Federal Office for Chemicals is to coordinate the biocides procedure in Germany. The Office is also responsible for the evaluation in cooperation with other natioanl authorities. In addition to this, it is the point of contact for the notification of biocidal products in accordance with the national Biocide Notification Ordinance.
At the same time, the Office works closely with other national authorities on the evaluation of applications for biocidal active substances and biocidal products.

Further information

Further information on the implementation of the Biocidal Products Regulation is provided by the BAuA on the website of the REACH-CLP-Biozid Helpdesk.
The website of the European Chemicals Agency (ECHA) provides important guidance documents, as well as instructions for the IT tools to be used in the biocides procedure.

Definitions

Expressions and definitions in accordance with Article 3 of the Biocidal Products Regulation.

Existing active substance

A substance which was on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development.

Treated articles

Any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.

Making available on the market

Any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge.

Biocidal product

  • any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action;
  • any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

Placing on the market

The first making available on the market of a biocidal product or of a treated article.

Product-types

Disinfectants
Product-type 1Human hygiene
Product-type 2Disinfectants and algaecides not intended for direct application to humans or animals
Product-type 3Veterinary hygiene
Product-type 4Food and feed area
Product-type 5Drinking water
Preservatives
Product-type 6Preservatives for products during storage
Product-type 7Film preservatives
Product-type 8Wood preservatives
Product-type 9Fibre, leather, rubber and polymerised materials preservatives
Product-type 10Construction material preservatives
Product-type 11Preservatives for liquid-cooling and processing systems
Product-type 12Slimicides
Product-type 13Working or cutting fluid preservatives
Pest control
Product-type 14Rodenticides
Product-type 15Avicides
Product-type 16Molluscicides, vermicides and products to control other invertebrates
Product-type 17Piscicides
Product-type 18Insecticides, acaricides and products to control other arthropods
Product-type 19Repellents and attractants
Product-type 20Control of other vertebrates
Other biocidal products
Product-type 21Antifouling products
Product-type 22Embalming and taxidermist fluids

Harmful organism

An organism, including pathogenic agents, which has an unwanted presence or a detrimental effect on humans, their activities or the products they use or produce, on animals or the environment.

Use

All operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with a view to exporting the biocidal product or the treated article outside the Union.

Active substance

A substance or a micro-organism that has an action on or against harmful organisms.

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