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Biocides

  • Application in accordance with the BPD
  • Application in accordance with the Danish authorisation scheme
  • Find authorised biocidal products
  • Legislation

Regulation of biocides

Links to the current biocide legislation may be found below. Statutory Orders are part of current law in Denmark and are used to detail regulation by the Act of Parliament. Directives must be implemented in Danish law through an Act of Parliament or a Statutory Order.

An EU Regulation is current law in Denmark. A Regulation shall not be implemented in Danish law through an Act of Parliament or a Statutory Order but such legislation may need to be supplemented by national legislation, for example on how to determine punishment.

Regrettably, most of the Danish Acts and Statutory Orders have not been translated into English.

The links below refer to the main act or statutory order and you should therefore be aware of any subsequent amendment orders.

Danish legislation

Danish Chemicals Act
Danish Chemicals Act, Consolidated Act No. 878 of 26 June 2010, as amended.

General Statutory Orders

Statutory Order No. 702 of 24 June 2011 on pesticides and biocides, as amended

Statutory Order No. 1075 of 24 November 2011 on the classification, packaging, labelling, sale and storage of substances and mixtures

Consolidated Act on a pesticides' duty, Consolidation Act No. 57 of 30 January 2008


Regulation on usage restrictions
Many chemical substances regulated in Annex XVII of the REACH Regulation have previously been regulated in Danish Statutory Orders. This applies inter alia to arsenic, creosote and PCP.

The latest Consolidated REACH Regulation may be found here (issued in 2012) 

Statutory Order No. 1257 of 15 December 2011 on restrictions on the import, sale and use of biocidal antifouling products (in Danish) 

The Antifouling Statutory Order has been translated into English for reference. Only the Danish version is legally binding.

Although creosote is now regulated by REACH, Annex XVII, No. 31, some national Danish legislation is still in force:

Statutory Order No. 665 of 4 July 1996 on restrictions on the sale and use of creosote 

Statutory Order No. 535 of 18 June 2003 amending Statutory Order on restrictions on the sale and use of creosote

Other Statutory Orders
Statutory Order No. 243 of 19 April 2002 on certain substances degrading the ozone layer (prohibition and usage restrictions). (Also regulated by a regulation (pdf)).

Statutory Order No. 1069 of 23 November 2011 on the spraying of pesticides from aircraft

EU legislation - the Biocidal Products Directive (BPD)

The Biocidal Products Directive 98/8/EC (pdf)

The Commission's Web Page on the BPD with links to all directives and regulation and various guidance documents

The approved active substances are included in Annexes I, I A and I B of the BPD, depending on the risks associated with the active substance concerned.

Annex I contains by far the greatest proportion of authorised active substances that have a biocidal effect.

Annex I and the other Annexes list:

  • Annex I: Active substances which may be used in biocidal products
  • Annex I A: Low-risk substances that do not give cause for concern for people, animals or the environment.
  • Annex I B: Basic substances whose primary use is not as a pesticide, but which can be used as a biocide to a limited extent. Currently no substances are included in Annex IB.
  • Annex II A: Core data requirements for the active substance.
  • Annex II B: List of the core data requirements for the product.
  • Annex III A: Additional data requirements for the active substance.
  • Annex III B: Additional data requirements for the product.
  • Annex IV A: Data requirements for microbiological active substances
  • Annex IV B: Data requirements for microbiological products
  • Annex V: The 23 Product-types (PT)
  • Annex VI: The principles for the evaluation of biocidal products

Annexes with information of significance for enterprises that wish to market a biocidal product in the EU:

Biocides Regulation
From 1 September 2013 the new Biocides Regulation will apply. The Regulation replaces the Biocidal Products Directive.

Regulation (EC) No. 528/2012 of 22 May 2012 concerning the making available on the market and use of biocidal products (pdf)

 

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