This regulation harmonises the existing European Union (EU) rules on the making available on the market and the use of biocidal products. It also creates a Union authorisation of biocidal products which allows products to be directly placed on the entire EU market without the need for separate national authorisations or mutual recognition.
Regulation (EC) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
This Regulation applies to:
A list of the products concerned can be found in Annex V to the Regulation.
Conditions for authorisation of biocidal products
For biocidal products, the following conditions must be met for authorisation:
- the active substance are approved for the relevant product-type;
- the biocidal product, when used as authorised, is sufficiently effective, has no unacceptable effects on the target organisms, on the health of humans or animals, or on the environment;
- the physical and chemical properties of the product are considered acceptable with regard to the use and transport of the product;
- where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product;
- where nanomaterials are used in the product, the risk to human health, animal health and the environment has been assessed separately.
An active substance shall be approved for a maximum initial period of 10 years if at least one biocidal product containing that active substance may be expected to meet the above criteria.
National authorisation and mutual recognition
The Regulation provides for harmonised procedures for the authorisation of biocidal products in the EU. Once a first authorisation is granted by an EU country, the applicant can ask for the recognition of that authorisation by other EU countries. The authorisation shall be granted under identical terms and conditions.
The centralised authorisation procedure will result in a Union authorisation which allows the industry to place biocidal products directly on the entire EU market without the need to obtain separate national authorisations or go through the mutual recognition procedure. This centralised authorisation is voluntary and if, for whatever reason, the applicant is not interested in a Union authorisation, he can instead apply for a national authorisation and, if appropriate, mutual recognition of that authorisation in other EU countries.
Simplified authorisation procedure
Certain biocidal products may be eligible for a simplified authorisation procedure, if the following conditions are met:
- all the active substances contained in the biocide appear in and satisfy any restrictions in Annex I to this regulation;
- the biocide does not contain any substance of concern or any nanomaterials;
- the biocide is sufficiently effective;
- the handling of the biocidal product and its intended use do not require personal protective equipment.
If the above conditions are met, applicants must submit applications to the European Chemicals Agency (ECHA), designating a competent authority to evaluate its application.
A biocidal product authorised by the above simplified procedure may be made available on the market in all EU countries without the need for mutual recognition. However, the authorisation holder must notify each EU country no later than 30 days before placing the product on the market within that country. The official language or languages of that country must be used on the product’s labelling, unless the country provides otherwise.
This Regulation extends the scope from previous legislation on biocides to now also cover articles which have been treated or which incorporate a biocidal product. Articles can only be treated with active substances which have been approved in the EU for that purpose. Manufacturers and importers of treated articles are required to label products when:
- a claim is made that the treated article has biocidal properties;
- the conditions of the approval of the active substance used to treat the article require specific labelling provisions to protect public health or the environment.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EC) No 528/2012
OJ L 167 of 27.6.2012
- For further information, please consult the European Commission website for the Biocides Regulation.