# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division: Circumstances in which required

Extent: E+W+S+N.I.

Feeding studies are only required:
when significant residues (≥ 0,1 mg/kg of the total diet as received, except special cases, such as active substances which accumulate) occur in crops or part of the crop (e.g. trimmings, waste) fed to animals, and
when metabolism studies indicate that significant residues (0,01 mg/kg or above the limit of determination if this would be higher than 0,01 mg/kg) may occur in any edible animal tissue taking into account the residue levels in potential feedingstuffs obtained at the 1 × dose rate.
Where appropriate separate feeding studies for lactating ruminant and/or laying poultry shall be submitted. Where it appears from the metabolism studies submitted in accordance with point 6.2 that metabolic pathways differ significantly in the pig as compared to ruminants, a pig feeding study must be conducted unless the expected intake by pigs is not significant.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/6/division/6.4/division/2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-6/division-6.4/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.