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.
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 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 agent
In accordance with the Biocidal Products Regulation, biocidal products may contain biocidal agents only if they are included in a positive list known as the "Union list of approved active substances". Biocidal 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 only contain 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 Law Implementation Ordinance (ChemBiozidDV).
Notification of the quantity of biocidal products made available on the market
The Biocide Law Implementation Ordinance (ChemBiozidDV) introduces a notification procedure according to which the annual quantity of biocidal products made available on the market or exported in Germany (Section 16 ChemBiozidDV) has to be notified. Manufacturers or importers who make biocidal products available on the market in Germany or export them are obliged to notify. The notification is made electronically to the Federal Chemicals Agency by 31 March each year using an electronic form provided on the website of the Federal Institute for Occupational Safety and Health. The notification obligation serves to create a data basis for the targeted design of measures to reduce risks and for the tailor-made development of monitoring programmes.
Quantity notification according to §16 ChemBiozidDV for the year 2023
By 31 March 2024, manufacturers and importers of biocidal products that are made available on the market in Germany or manufactured in Germany for export are obliged to report the type and quantity of these biocidal products manufactured or imported in 2023 and the active substances they contain in eBIOMELD.
The quantities of all manufactured or imported biocidal products must be reported, regardless of whether they are still marketable under transitional regulations or have already been authorised.
Competent authorities in Germany
All EU Member States work closely together on the approval of biocidal agents 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 national authorities. In addition to this, it is the point of contact for the notification of biocidal products in accordance with the national Biocide Law Implementation Ordinance. At the same time, the Office works closely with other national authorities on the evaluation of applications for biocidal agents and biocidal products.
Further information
Further information on the implementation of the Biocidal Products Regulation is provided by 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
| Product-type | Name |
|---|---|
| Product-type 1 | Human hygiene |
| Product-type 2 | Disinfectants and algaecides not intended for direct application to humans or animals |
| Product-type 3 | Veterinary hygiene |
| Product-type 4 | Food and feed area |
| Product-type 5 | Drinking water |
| Product-type | Name |
|---|---|
| Product-type 6 | Preservatives for products during storage |
| Product-type 7 | Film preservatives |
| Product-type 8 | Wood preservatives |
| Product-type 9 | Fibre, leather, rubber and polymerised materials preservatives |
| Product-type 10 | Construction material preservatives |
| Product-type 11 | Preservatives for liquid-cooling and processing systems |
| Product-type 12 | Slimicides |
| Product-type 13 | Working or cutting fluid preservatives |
| Product-type | Name |
|---|---|
| Product-type 14 | Rodenticides |
| Product-type 15 | Avicides |
| Product-type 16 | Molluscicides, vermicides and products to control other invertebrates |
| Product-type 17 | Piscicides |
| Product-type 18 | Insecticides, acaricides and products to control other arthropods |
| Product-type 19 | Repellents and attractants |
| Product-type 20 | Control of other vertebrates |
| Product-type | Name |
|---|---|
| Product-type 21 | Antifouling products |
| Product-type 22 | Embalming 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 to export 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.