Article 1Subject matter
1
This Regulation sets out the methodological principles for the scientific risk assessment and risk management recommendations referred to in Articles 6 and 7 of Regulation (EC) No 470/2009 that shall be applied by the F2appropriate authority when F3producing an assessment report in respect of MRLs of pharmacologically active substances which may be permitted in food of animal origin under that Regulation.
2
The methodological principles for the scientific risk assessment are set out in Annex I.
3
The methodological principles for the risk management recommendations are set out in Annex II.
Article 2Definitions
For the purposes of this Regulation, in addition to the definitions set out in Regulation (EC) No 470/2009, the following definitions shall apply:
‘major metabolites’ means metabolites comprising ≥ 100 μg/kg or ≥ 10 % of the total residue in a sample collected from the target animal species in the metabolism study,
‘marker residue’ means a residue whose concentration is in a known relationship to the concentration of total residue in an edible tissue,
‘dairy starter cultures’ means prepared cultures of microorganism employed in the manufacture of a variety of dairy products including butter, cheese, yoghurt and cultured milk.
Article 3Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.