Definition of biocides

What is to be classified as a biocide? The definition of “biocide” is worded broadly in the Biocidal Products Regulation. It includes insecticides and rodenticides, for instance, but also mould removers, wood preservatives, mosquito and gnat repellents, embalming fluids, and hand sanitisers.

These biocidal products are required to combat organisms that are harmful to human or animal health. They contribute to hygiene and are also used against organisms that damage natural or manufactured materials.

Apart from the above-mentioned products, which act directly on harmful organisms, products that are intended to prevent damage are classified as biocidal products too. As a result, attractants and repellents can also be biocidal products.

In some cases, however, it is not easy to answer the question whether a product is actually a biocidal product. If used accordingly, for example, an insecticide could also be a plant protection product and a hand sanitiser could be a medical product. This is why the Biocidal Products Regulation says products that are already regulated in other fields such as pharmaceuticals, cosmetics, or plant protection products are not to be classified as biocides, even when they would fulfil the definition of a biocide in formal terms. The intention behind this is to avoid regulatory duplication.

Biocidal Products Regulation

Regulation (EU) No 528/2012 (Biocidal Products Regulation) governs the sale, supply (making available on the market), and use of biocidal products throughout the EU. The Biocidal Products Regulation therefore has implications for retailers, distributors, and users of biocidal products alike. It stipulates a two-stage procedure for the assessment of biocides. First of all, biocidal active substances are assessed and, where appropriate, granted approval. This is followed by a procedure for the authorisation of biocidal products that contain these approved active substances.

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

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).

baua: Aktuell 4/25 - Focus on biocides in occupational safety and health and the regulation of biocidal products

The Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, BAuA) has two divisions that work on biocides, each with its own distinct tasks and priorities. One of them investigates the safe use of biocides, while the other is crucially involved in the regulatory assessment and authorisation of biocidal substances and products. An interview in (German) brings together the head of the Federal Office for Chemicals (Bundesstelle für Chemikalien) and the head of the Biological Agents, Biocides Section within BAuA’s Hazardous Substances and Biological Agents Division. They explain the challenges faced when seeking to reconcile OSH goals with societal and regulatory concerns.

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.

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.

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	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

Preservatives

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

Pest control

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

Other biocidal products

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.