Biocides

Go to: What are biocides? What to do? Regulation Restricted biocides Authorised biocides

What are biocides?

Biocides are pesticides of non-agricultural use i.e. chemical substances or mixtures (products) used for the elimination of living organisms through chemical or biological action.

Many products or chemicals used to eliminate or mitigate pests that affect agriculture or livestock are not classified as biocides. They are known as Plant Protection Products (PPP), disinfectants or sanitizers, but are technically biocides.

Biocides may have a series of adverse effects on human health, livestock, pets, as well as harmful environmental effects since they are meant to kill living organisms (they are in fact poisonous substances).

Furthermore, biocides are increasingly designed to be more effective and resistant which implies serious toxicity problems for all living organisms and are environmentally persistent. Some biocides are extremely hazardous and are classified as carcinogens, endocrine disruptors and toxic for the environment.

The EU Regulation on Biocides (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by the action of the active substances contained in the biocidal product.

The EU Regulation on biocidal products establishes a list of approved active substances in the Union in accordance with Directive 98/8/EC ((formerly Annex I of the Biocidal Products Directive) and Regulation (EU) No 528/2012 and an additional list that includes biocidal product-types, grouped in four main areas (Annex V of BPR). Some daily-use household and healthcare disinfectants as insecticides, acaricides, rodenticides, preservatives and insect repellents are included in that list.

What to do?

All biocidal products must get an authorization before they can be made available on the market, and active substances contained in them must be approved by the European Chemicals Agency (ECHA). Manufacturing companies must submit an approval request to the ECHA. Following the approval of an active substance, companies interested in marketing biocidal products in a Member State must file an additional request for the authorization of the product.

Biocides can only be placed on the market and used in the EU if they have been previously authorized, included in the list of approved active substances, and in the Annex V of BPR, i.e.: once their health and environmental risks have been assessed and authorized by relevant authorities.

The register includes all biocidal products authorized for use in the EU, as well as information about authorized uses, expiration date for the authorization, conditions of use, composition, physical state, information on the manufacturer, etc.

The manufacture, marketing and use of any pesticide of non-agricultural use that is not included in the list of approved active substances and in Annex V of BPR is forbidden in the EU.

Hazardous biocides must be avoided or substituted by other less hazardous ones. When substitution is not feasible, proper use shall involve the rational application of a combination of physical, biological, chemical or other measures as appropriate, whereby the use of biocidal products is limited to the minimum necessary and appropriate precautionary steps are taken. Workplace use must be carried out in compliance with regulation on workers’ protection against harmful effects.

Biocides must be classified, labelled and packaged according EU BPR Regulation.

Labels must not be misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy and, in any case, do not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or similar indications.

In addition, the label must show clearly and indelibly the following information:

• the identity of every active substance and its concentration


• the authorisation number allocated to the biocidal product by the competent authority or the Commission


• the uses for which the biocidal product is authorised (e.g.: wood protection, disinfection, surface biocide, etc.).

Furthermore, the following information must be included in the product label when appropriate:

• if accompanied by a leaflet, the sentence ‘Read attached instructions before use’ and, where applicable, warnings for vulnerable groups


• where applicable, the categories of users to which the biocidal product is restricted

The information below must also be shown clearly on the label:

• the type of formulation.


• directions for use, frequency of application and dose rate, expressed in metric units, in a manner which is meaningful and comprehensible to the user, for each use provided for under the terms of the authorisation


• particulars of likely direct or indirect adverse side effects and any directions for first aid


• directions for the safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on the reuse of packaging


• the formulation batch number or designation and the expiry date relevant to normal conditions of storage


• where applicable, the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the product treated, or the next access by humans or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use and transport


• where applicable, information on any specific danger to the environment particularly concerning protection of non- target organisms and avoidance of contamination of water


• for biocidal products containing micro-organisms, labelling requirements in accordance with Directive 2000/54/EC.

Workers, professional and industrial users exposed to biocides must have access to safety data sheets of the products in order to adopt the necessary workplace measures to grant human and environmental protection.

Workers’ exposure to unauthorized biocides must be immediately reported.

Use of authorised biocides must comply with all legal requirements (included authorization and CLP) Failure to comply with these obligations must be reported to company managers and if necessary to labour authorities in the given region.

Biocidal products of concern must be substituted to facilitate the development of safer products and processes.

Regulation

• Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products


• Council Directive of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (89/391/EEC)


• Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC).


• Regulation (EC) No 1272/2008 (CLP) on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals.


• Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

Last update

February 2014