Regulatory Update: 26/2010
Issued: 16 November 2010
This Regulatory Update explains that it is unlawful to place on the market in the UK plant protection products that contain azadirachtin, the active ingredient of neem oil.
The Chemical Regulations Directorate (CRD) of HSE is concerned that plant protection products containing the active substance azadirachtin, might be being sold and used unlawfully in the UK.
Azadirachtin is a substance with pesticidal properties found in plant extracts such as “neem” and “neem oil” and it is likely to be present in all products which contain “neem” or “neem oil”. Such products are likely to be marketed for use as insect repellents or insecticides and might be claimed to be “safe”, “natural” or “organic”. CRD is concerned to dispel the belief that these products are outside regulatory controls on plant protection products (pesticides). This is not the case; azadirachtin is within scope of UK and EU pesticide regulations and any products containing this substance require authorisation before they can be placed on the market or used.
Authorisations for pesticides may only be granted if the active substance(s) they contain have been assessed and determined to be acceptable under EC Directive 91/414 and listed on Annex 1 to that Directive. Although azadirachtin was originally put forward for consideration under 91/414 it was voluntarily withdrawn by its notifiers (details can be found in Commission Decision 2008/941/EC dated 8 December 2008 and CRD Regulatory Update 38/2008 dated 11 December 2008). The effect of this decision is that to market or use any pesticide product containing azadirachtin is illegal in the UK.
Commission Decision 2008/941/EC allowed existing national authorisations for products containing azadirachtin to continue until 31 December 2010 (extended to 31 December 2011 under Commission Decision 2010/455/EC dated 13 August 2010). However, as there were no such authorisations in the UK there are no pesticide products containing azadirachtin or neem oil approved for advertising, sale, supply, storage or use in the UK.
An application for the inclusion of azadirachtin in Annex I of Directive 91/414 was re-submitted to the European Commission on 12 June 2009. This application is still being considered by the Commission but this does not permit the sale or use of products containing azadirachtin in the UK.
To market or use a product containing azadirachtin in the UK is an offence.
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