Commission Delegated Regulation (EU) 2024/1229 of 20 February 2024 supplementing Regulation (EU) 2019/4 of the European Parliament and of the Council by establishing specific maximum levels of cross-contamination of antimicrobial active substances in non-target feed and methods of analysis for these substances in feed

• CELEX: Delegated Regulation (EU) 2024/1229
• Articles: 5

Article 1 Subject matter and scope

This Regulation establishes specific maximum levels of cross-contamination in non-target feed for the antimicrobial active substances listed in Annex II to Regulation (EU) 2019/4, and methods of analysis for those antimicrobial active substances in feed, as provided for in Article 7(3) of Regulation (EU) 2019/4.

Article 2 Specific maximum levels of cross-contamination of antimicrobial active substances in non-target feed

1.   The specific maximum levels of cross-contamination in non-target feed for the antimicrobial active substances listed in Annex II to Regulation (EU) 2019/4 shall be set:

(a)

where the last batch manufactured, processed, stored or transported before the manufacturing, processing, storage or transport of the non-target feed is medicated feed, at 1 % of the antimicrobial active substance contained in that last batch of medicated feed, relative to a moisture content of 12 % in the non-target feed;

(b)

where the last batch manufactured, processed, stored or transported before the manufacturing, processing, storage or transport of the non-target feed is an intermediate product, at 1 % of the antimicrobial active substance to be contained in the medicated feed derived from that last batch of intermediate product, relative to a moisture content of 12 % in the non-target feed.

2.   By way of derogation from paragraph 1, the specific maximum levels of cross-contamination in non-target feed for the antimicrobial active substances listed in Annex II to Regulation (EU) 2019/4 shall be set at the limit of quantification (‘LOQ’) laid down in the Annex to this Regulation, where the non-target feed is intended for the following animals:

(a)

food-producing animals other than fish where the non-target feed is manufactured, processed, stored or transported after the manufacturing, processing, storage or transport of medicated feed or intermediate products intended for aquaculture;

(b)

animals during the production of eggs or milk intended for human consumption;

(c)

food-producing animals intended for slaughter in the period for slaughter corresponding to the longest withdrawal period for the target animal species.

Article 3 Methods of analysis for antimicrobial active substances in feed

The reference methods of analysis for the quantification of the level of cross-contamination in non-target feed for each antimicrobial active substance listed in Annex II to Regulation (EU) 2019/4, as referred to in Article 2(1) and (2) of this Regulation, are laid down in the Annex to this Regulation.

However, alternative methods of analysis may be used provided they are validated in accordance with internationally accepted scientific protocols, are suitable to detect the same or a lower LOQ as the LOQ for the same antimicrobial active substance laid down in the Annex to this Regulation and are considered as equivalent by the competent authorities of the Member States.

Article 4 Entry into force and application

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

It shall apply from 20 May 2025.

Schedules & Appendices

ANNEX Maximum levels of cross-contamination in non-target feed as referred to in Article 2(2) and reference methods of analysis for the quantification of the level of cross-contamination of antimicrobial active substances in feed as referred to in Article 3

ANNEX

Maximum levels of cross-contamination in non-target feed as referred to in Article 2(2) and reference methods of analysis for the quantification of the level of cross-contamination of antimicrobial active substances in feed as referred to in Article 3

Chemical class

Name of substance

CAS number 1

EU number 2

Multi-analyte method a b c

Reference analytical method 3 4 5

Maximum levels of cross-contamination in non-target feed referred to in Article 2(2) (set at the limit of quantification (LOQ))

(μg/kg)

Polymixins (polypeptide antibiotics)

Colistin

1264-72-8

—

(b)

LSE – A – C – SPE – E – LC-MS/MS

150 (Colistin A)

300 (Colistin B)

Pyrimidine inhibitor of dihydrofolate reductase

Trimethoprim

738-70-5

212-006-2

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

25

Macrolides

Tylvalosin

63409-12-1

—

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

100

Tilmicosin

108050-54-0

639-676-2

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

100

Tylosin

1401-69-0

215-754-8

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

100

Lincosamides

Lincomycin

154-21-2

205-824-6

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

25

Pleuromutilins

Tiamulin

55297-96-6

259-580-0

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

10

Valnemulin

101312-92-9

—

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

50

Penicillins

Amoxicillin

26787-78-0

612-127-4

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

150

Penicillin V

1098-87-9

—

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

50

Aminoglycosides

Apramycin

65710-07-8

265-890-7

253-460-1

(a)

LSE – A – C – SPE – LC-MS/MS

50

Neomycin

1404-04-2

1404-04-2

(a)

LSE – A – C – SPE – LC-MS/MS

50

Paromomycin

1263-89-4

—

(a)

LSE – A – C – SPE – LC-MS/MS

50

Spectinomycin

1695-77-8

—

(a)

LSE – A – C – SPE – LC-MS/MS

500

Amphenicols

Florfenicol

73231-34-2

642-986-0

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

150

Tiamfenicol

15318-45-3

239-355-3

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

200

Coccidiostats

Amprolium

137-88-2

204-458-4

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

100

(a)

LSE – A – C – SPE – LC-MS/MS

5

Fluoroquinolones

Flumequine

42835-25-6

255-962-6

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

25

Oxolinic Acid

14698-29-4

238-750-8

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

25

Sulphonamides

Sulfamonomethoxine

1220-83-3

624-483-8

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

25

Sulfadimethoxine

122-11-2

204-523-7

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

25

Tetracyclines

Chlortetracycline

57-62-5

200-341-7

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

100

Doxycycline

564-25-0

209-271-1

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

100

Tetracycline

60-54-8

200-481-9

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

100

Oxytetracycline

79-57-2

—

(c)

LSE – US – A – C – F – LC-MS/MS or LC-HRMS

100

(1)

Chemical Abstracts Service.

(2)

European Union number – not available for all substances.

(3)

Extraction methods:

—

LSE – liquid solid extraction,

—

US – Ultrasonication,

—

A – Agitation.

(4)

Clean-up methods:

—

C – Centrifugation,

—

SPE – Solid Phase Extraction,

—

E – Evaporation, re-dissolution,

—

F – Filtration.

(5)

Analytical methods:

—

LC-MS/MS – Liquid chromatography tandem mass spectrometry,

—

LC-HRMS – Liquid chromatography coupled to high resolution mass spectrometry.

(a):

multi-analyte method for the aminoglycosides and amprolium.

(b):

multi-analyte method for the polymixins colistin A and B.

(c):

multi-analyte method for trimethoprim, amprolium, lincomycin, the macrolides, the pleuromutilins, the penicillins, the amphenicols, the fluoroquinolones, the sulphonamides and the tetracyclines.