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Front page●Biocides●Legislation

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Biocides

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

Legislation in the area of biocides

Links to the current biocide legislation can be found below. Statutory orders are applicable law in Denmark. Directives are not applicable in themselves. They must be implemented in Danish law through an act of parliament or a statutory order. EU regulations are applicable law in Denmark. They do not need to be implemented in Danish law through an act of parliament or a statutory order.

Most of the Danish Statutory Orders and Acts have not been translated into English. These are links to the main statutory orders and you should therefore be aware of any subsequent amendment orders.

Danish legislation

Danish Chemicals Act
Danish Act on chemical substances and products. Consolidation Act on chemical substances and products. Consolidation Act No 878 of 26 June 2010.

General statutory orders

Statutory Order No 702 of 24 June 2011 on pesticides

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

Consolidation Act on a tax on pesticides. Consolidation Act No 57 of 30 January 2008.


Rules concerning usage restrictions
Many EU-regulated chemical substances were previously regulated in Danish statutory orders, but are now regulated directly in the REACH Regulation. This applies for example to arsenic, creosote and PCP. 
The Regulation can be found in Annex XVII to the Regulation.

Statutory Order No 1257 of 15 December 2011 on restrictions on the import, sale and use of biocidal antifouling products (in Danish). 
This Statutory Order has been translated into English. Please note that you are obliged to comply with the Danish version.
The English version is for information only and is not legally binding.

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 the Statutory Order on restrictions on the sale and use of creosote.


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

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

EU legislation

Biocidal Products Directive 98/8/EC 

The Commission's web pages on 98/8/EC with links to all directives and regulations

The various annexes to the Biocidal Products Directive
The approved active substances are included in the first three annexes to the Biocidal Products Directive, depending on the risks associated with the active substance concerned. The annexes are called I, IA and IB. Annex I contains by far the greatest proportion of authorised active substances that have a biocidal effect.
All annexes can be found on the EU's website.

  • Annex I: List of active substances which may be used in biocidal products
  • Annex IA: List of low-risk substances that do not give cause for concern for people, animals or the environment.
  • Annex IB: Basic substances whose primary use is not as a pesticide and that can be used as a biocide to a limited extent. However, there are currently no substances included in Annex IB.

The Directive also contains a series of other annexes with information of significance for enterprises that wish to market a biocidal product in the EU:

  • Annex IIA: List of the core data requirements for the active substance.
  • Annex IIB: List of the core data requirements for the product.
  • Annex IIIA: List of the additional data requirements for the active substance.
  • Annex IIIB: List of the additional data requirements for the product.
  • Annex IV A: List of the data requirements for microbiological active substances.
  • Annex IVB: List of the data requirements for microbiological products.
  • Annex V: List of product-types (PT).
  • Annex VI: The principles for the evaluation of biocidal products.


Biocides Regulation
From 1 September 2013 the new Biocides Regulation applies. The Regulation will replace the Biocidal Products Directive.
Regulation No 528/2012 of 22 May 2012 concerning the making available on the market and use of biocidal products (pdf)

 

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