Mycotoxins legislation

An introduction and overview of legislation relevant to mycotoxins.

Maximum legal levels

The principal piece of EU legislation regarding mycotoxins is Commission Regulation (EC) No. 1881/2006, as amended. This Regulation sets out specific rules in relation to mycotoxins and other contaminants. It includes specific maximum levels for certain mycotoxins in individual foodstuffs, which are laid down in Section 2 to the annex of the Regulation. Those mycotoxins for which there are currently specific maximum levels include aflatoxins, ochratoxin A, patulin and the Fusarium toxins including deoxynivalenol, zearalenone and fumonisins.

In addition to the maximum levels laid down in Commission Regulation (EC) No. 1881/2006, as amended, foodstuffs containing mycotoxins for which there are no specific maximum levels may, under certain circumstances, also be considered non-compliant with more general food safety requirements, for example those requirements laid down in Regulation (EC) No. 178/2002. Further details of this Regulation and how it is implemented in domestic legislation can be found through the link at the bottom of this page.

Commission Regulation (EC) No. 1881/2006, as amended, applies to all food business operators involved, for example, in the import, production, processing, storage, distribution and sale of food. Definitions of a 'food business', 'food business operator' and that which constitutes 'placing on the market' can be found in Regulation (EC) No. 178/2002.

Sampling and analysis

In conjunction with Commission Regulation (EC) No. 1881/2006, provisions for sampling and analysis for the official control of the maximum levels for mycotoxins have been made and are currently laid down in Commission Regulation (EC) No 401/2006, as amended by Regulation (EU) 178/2010. This Regulation is intended to ensure a harmonised and consistent approach by European member states for checking compliance with maximum levels for mycotoxins.

For this reason, these specific provisions for sampling and analysis are strictly applicable in the UK to enforcement bodies only, including local authorities, port health authorities and public analysts. However, it is prudent for food business operators to be aware of these provisions and they may wish to bear them in mind when carrying out due diligence checks.

An overview of legislation on contaminants, including legislation specific to mycotoxins, can be found on the European Commission's website.

Enforcement in domestic legislation

Although Commission Regulation (EC) No. 1881/2006 is directly applicable in all member states of the European Union, provisions for the enforcement and execution of Commission Regulation (EC) No. 1881/2006 and the allied sampling and analysis Regulations for official control purposes are contained in The Contaminants in Food (England) Regulations 2009.

This is a statutory instrument made under provisions laid out in The Food Safety Act 1990, as amended. Corresponding legislation also exists for Wales, Scotland and Northern Ireland. More information on the statutory instrument can be found in Guidance on The Contaminants in Food (England) Regulations 2009 at the link below.

Special conditions for certain products from specified third countries

The European Commission has also expanded and reinforced the border control measures it has taken to protect consumers from aflatoxin-contaminated products.

Special conditions governing certain foodstuffs imported from specified third countries due to risk of contamination by aflatoxins are laid down in Commission Regulation 1152/2009, as amended by Regulation (EU) 274/2012.

In addition, there is also a list of 'high-risk' products in the annex to Commission Regulation (EC) No. 669/2009, which specifies products from certain third countries that must undergo official control for mycotoxins and other substances upon import into the EU. This regulation is amended every quarter. The latest amendments can be found at the link below.