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MRL Residue Regulation 396/2005/EC

MRL Regulation 396/2005/EC

Regulation 396/2005/EC sets the EU Maximum Residue Limit (MRL) for EU produced or imported agricultural commodities and processed food.

MRL is the legal tolerance of residue in food. It is set for all combination of food item and pesticide active substance.

PPP Regulation 1107/2009/EC

Regulation 1107/2009/EC sets the rules for placing Plant Protection Products on the the EU market.

With regard to residue in food, the dossier must demonstrate compliance with the MRL set by Regulation 396/2005/EC.

This means that residue trials located in the PPP dossier, or other scientific case, will prove that the uses intented will lead to residue inferior or equal to the MRL established under Regulation 396/2005/EC.

In case the intented uses of the PPP lead to exceedance of the existing MRLs, then an application for modification of the MRL is necessary prior to registration of the product.

The same data requirements (Regulation 283/2013/EU) and Guidance Documents (so called « Lundhen document ») apply to the residue section for application under Regulation 396/2005/EC or 1107/2009/EC.

So far, Regulation 396/2005/EC only assesses the nature and magnitude of residue in food and its toxicological impact on the consumer health. However, the EU wants in the future to consider environmental aspects to the MRL evaluation of active substances forbidden in EU.