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Biocides

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Biocides

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.

ACT

Regulation (EU) 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.

SUMMARY

This Regulation applies to:

  • biocidal products ;
  • articles and materials treated with biocidal products;
  • active substances.

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.

Union authorisation

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.

Treated articles

This Regulation extends the scope from previous legislation on biocides to now also cover articles which have been treated with 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.

REFERENCES

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Regulation (EU) No 528/2012

17.7.2012

-

OJ L 167 of 27.6.2012

Amending acts

Entry into force

Deadline for transposition in the Member States

Official Journal

Regulation (EU) No 283/2013

23.4.2013

-

OJ L 93 of 3.4.2013

Regulation (EU) No 284/2013

23.4.2013

-

OJ L 93 of 3.4.2013

Regulation (EU) No 354/2013

9.5.2013Application: 1.9.2013

-

OJ L 109 of 19.4.2013

Regulation (EU) No 736/2013

20.8.2013

-

OJ L 204 of 31.7.2013

Regulation (EU) No 837/2013

23.9.2013

-

OJ L 234 of 3.9.2013

REFERRED DOCUMENTS

Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. [Official Journal L 93 of 3.4.2013]

Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. [Official Journal L 93 of 3.4.2013]

Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council [Official Journal L 109 of 19.4.2013]

Commission Delegated Regulation (EU) No 736/2013 of 17 May 2013 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the duration of the work programme for examination of existing biocidal active substances. [Official Journal L 204 of 31.7.2013]. This regulation extends the work programme for the systematic examination of all existing active substances used in biocidal products until 31 December 2024.

Commission Delegated Regulation (EU) No 837/2013 of 25 June 2013 amending Annex III to Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the information requirements for authorisation of biocidal products. [Official Journal L 234 of 3.9.2013]

Last updated: 20.01.2014

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