Source

Commission Implementing Regulation (EU) 2018/470 of 21 March 2018 on detailed rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC (Text with EEA relevance. )

Implementing Regulation (EU) 2018/470 · Regulation · 6 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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This Regulation lays down the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC.

Article 2

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1. For the purposes of this Regulation, food-producing animals shall be grouped as follows: (a) ruminants; (b) monogastric mammals; (c) poultry and ratites; (d) fin fish; (e) bees; (f) crustaceans; (g) molluscs. 2. For the purposes of this Regulation, animal species shall be considered to be ‘related’ or ‘more closely related’ to each other as follows: (a) animal species belonging, according to paragraph 1, to the same group shall be considered to be ‘related’ species; (b) within the ruminants group, ovine and caprine species shall be considered to be ‘more closely related’ to each other than to bovine species and bovine species shall be considered to be ‘more closely related’ to each other than to either ovine or caprine species; (c) Equidae and rabbits shall be considered to be equally related to monogastric mammals and ruminants. However, ruminants shall not be considered to be related to either Equidae or rabbits. 3. For the purposes of this Regulation, different target tissues shall be equated as follows: (a) the target tissue ‘skin and fat’ in porcine and poultry species shall be equated to the target tissue ‘fat’ in other animal species, and vice versa; (b) the target tissue ‘skin and muscle’ in fin fish shall be equated to the target tissue ‘muscle’ in other animal species, and vice versa; (c) the edible parts of crustaceans and molluscs shall be equated to the target tissue ‘muscle’ in other animal species.

Article 3

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For pharmacologically active substances included in Table 1 of the Annex to Regulation (EU) No 37/2010 (‘Table 1’) for which at least one MRL or provisional MRL has been established, the MRL to be considered for control purposes for a target tissue derived from an animal species treated in the EU under Article 11 of Directive 2001/82/EC (‘the treated species’) shall be as follows: (a) if at least one MRL is established in Table 1 for that target tissue in any species related to the treated species: (1) the MRL to be considered for control purposes shall be the lowest of all the MRLs established in Table 1 for that target tissue in species related to the treated species; (2) if, however, the treated species is a species referred to in Article 2(2)(b) of this Regulation and MRLs are established in Table 1 for that target tissue in species that are more closely related to the treated species, the MRL to be considered for control purposes shall be the lowest of the MRLs established for that target tissue in those more closely related species; (b) if point (a) does not apply, the MRL to be considered for control purposes shall be the lowest of all the MRLs established in Table 1 for that target tissue in species that are not related to the treated species; (c) if neither point (a) nor point (b) produces the MRL to be considered for control purposes, the MRL to be considered for control purpose shall be the lowest of all the MRLs established in Table 1 for other target tissues in any animal species; (d) in case in Table 1 restrictions are defined regarding the application of the MRL for certain uses, these restrictions equally apply when considering an MRL under article 3(a), 3(b) and 3(c) for possible uses on other animal species and/or target tissues.

Article 4

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For pharmacologically active substances included in Table 1 of the Annex to Regulation (EU) No 37/2010 for which no MRL is required, in accordance with Article 14(5) of Regulation (EC) No 470/2009, there shall be no MRL required for control purposes for any target tissue derived from animal species treated in the EU under Article 11 of Directive 2001/82/EC, provided that the restrictions established in Table 1 are complied with.

Article 5

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The MRLs applicable in Table 1 of the Annex to Regulation (EU) No 37/2010 at the time of placing on the market of foodstuffs of animal origin, shall be applicable to the controlled products.

Article 6

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This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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