F1ANNEX I

Annotations:
Amendments (Textual)
MAXIMUM LEVELS OF UNDESIRABLE SUBSTANCES, AS REFERRED TO IN ARTICLE 3(2)

SECTION I:INORGANIC CONTAMINANTS AND NITROGENOUS COMPOUNDS

Undesirable substance

Products intended for animal feed

Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %

F61.

Arsenic19

Feed materials

with the exception of:

2

meal made from grass, from dried lucerne and from dried clover, and dried sugar beet pulp and dried molasses sugar beet pulp;

4

palm kernel expeller;

420

phosphates, calcareous marine algae;

10

calcium carbonate; calcium and magnesium carbonate28; calcareous marine shells;

15

magnesium oxide; magnesium carbonate;

20

fish, other aquatic animals and products derived thereof;

2520

seaweed meal and feed materials derived from seaweed.

4020

Iron particles used as tracer.

50

Feed additives belonging to the functional group of compounds of trace elements

with the exception of:

30

cupric sulphate pentahydrate; cupric carbonate; di copper chloride trihydroxide; ferrous carbonate;

50

zinc oxide; manganous oxide; cupric oxide.

100

Complementary feed

with the exception of:

4

mineral feed;

12

complementary feed for pet animals containing fish, other aquatic animals and products derived thereof and/or seaweed meal and feed materials derived from seaweed;

1020

long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed;

30

Complete feed

with the exception of:

2

complete feed for fish and fur animals;

1020

complete feed for pet animals containing fish, other aquatic animals and products derived thereof and/or seaweed meal and feed materials derived from seaweed.

1020

F72.

Cadmium

Feed materials of vegetable origin

1

Feed materials of animal origin

2

Feed materials of mineral origin

2

with the exception of:

phosphates.

10

Feed additives belonging to the functional group of compounds of trace elements

10

with the exception of:

cupric oxide, manganous oxide, zinc oxide and manganous sulphate monohydrate.

30

Feed additives belonging to the functional groups of binders and anti-caking agents

2

Premixtures24

15

Complementary feed

0,5

with the exception of:

mineral feed

– –

containing < 7 % phosphorus26

5

– –

containing ≥ 7 % phosphorus26

0,75 per 1 % phosphorus26, with a maximum of 7,5

complementary feed for pet animals

2

long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed;

15

Complete feed

0,5

with the exception of:

complete feed for cattle (except calves), sheep (except lambs), goats (except kids) and fish;

1

complete feed for pet animals.

2

F63.

Fluorine25

Feed materials

with the exception of:

150

feed materials of animal origin except marine crustaceans such as marine krill; calcareous marine shells;

500

marine crustaceans such as marine krill;

3 000

phosphates;

2 000

calcium carbonate; calcium and magnesium carbonate28

350

magnesium oxide;

600

calcareous marine algae.

1 000

Vermiculite (E 561).

3 000

Complementary feed:

containing ≤ 4 % phosphorus26;

500

containing > 4 % phosphorus26.

125 per 1 % phosphorus26

Complete feed

with the exception of:

150

complete feed for pigs;

100

complete feed for poultry (except chicks) and fish;

350

complete feed for chicks;

250

complete feed for cattle, sheep and goats

– –

in lactation;

30

– –

other.

50

4.

Lead29

Feed materials

with the exception of:

10

forage21;

30

phosphates, calcareous marine algae and calcareous marine shells;

15

calcium carbonate; calcium and magnesium carbonate28;

20

yeasts.

5

Feed additives belonging to the functional group of compounds of trace elements

with the exception of:

100

zinc oxide;

400

manganous oxide, ferrous carbonate, cupric carbonate.

200

Feed additives belonging to the functional groups of binders and anti-caking agents

with the exception of:

30

clinoptilolite of volcanic origin; natrolite-phonolite;

60

Premixtures24

200

Complementary feed

with the exception of:

10

mineral feed;

15

long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed;

60

Complete feed.

5

5.

Mercury22

Feed materials

with the exception of:

0,1

fish, other aquatic animals and products derived thereof;

0,531

calcium carbonate; calcium and magnesium carbonate28

0,3

Compound feed

with the exception of:

0,1

mineral feed;

0,2

compound feed for fish;

0,2

compound feed for dogs, cats, ornamental fish and fur animals.

0,3

F76.

Nitrite23

Feed materials

15

with the exception of:

fishmeal;

30

silage;

products and by-products from sugar beet and sugarcane and from starch and alcoholic drink production.

Complete feed

15

with the exception of:

complete feed for dogs and cats with a moisture content exceeding 20 %.

F87.

Melamine27

Feed

2,5

with the exception of

canned pet food

2,529

the following feed additives:

– –

guanidino acetic acid (GAA);

– –

urea;

– –

biuret.

The maximum levels refer to total arsenic.

Upon request of the competent authorities, the responsible operator must perform an analysis to demonstrate that the content of inorganic arsenic is lower than 2 ppm. This analysis is of particular importance for the seaweed species Hizikia fusiforme.

Forage includes products intended for animal feed such as hay, silage, fresh grass, etc.

The maximum levels refer to total mercury.

The maximum levels are expressed as sodium nitrite.

The maximum level established for premixtures takes into account the additives with the highest level of lead and cadmium and not the sensitivity of the different animal species to lead and cadmium. As provided in Article 16 of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29), in order to protect animal and public health, it is the responsibility of the producer of premixtures to ensure that, in addition to compliance with the maximum levels for premixtures, the instructions for use on the premixture are in accordance with the maximum levels for complementary and complete feed.

Maximum levels refer to an analytical determination of fluorine, whereby extraction is performed with hydrochloric acid 1 N for 20 minutes at ambient temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.

The % of phosphorus is relative to a feed with a moisture content of 12 %.

The maximum level refers to melamine only. The inclusion of the structurally related compounds cyanuric acid, ammeline and ammelide in the maximum level will be considered at a later stage.

Calcium and magnesium carbonate refers to the natural mixture of calcium carbonate and magnesium carbonate as described in Commission Regulation (EU) No 575/2011 of 16 June 2011 on the Catalogue of feed materials (OJ L 159, 17.6.2011, p. 25).

The maximum level is applicable to canned pet food as sold.

For the determination of lead in kaolinitic clay and in feed containing kaolinitic clay, the maximum level refers to an analytical determination of lead, whereby extraction is performed in nitric acid (5 % w/w) for 30 minutes at boiling temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.

The maximum level is applicable on wet weight basis to fish, other aquatic animals and products derived thereof intended for the production of compound feed for dogs, cats, ornamental fish and fur animals.

SECTION II:MYCOTOXINS

Undesirable substance

Products intended for animal feed

Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %

1.

Aflatoxin B1

Feed materials

0,02

Complementary and complete feed

0,01

with the exception of:

compound feed for dairy cattle and calves, dairy sheep and lambs, dairy goats and kids, piglets and young poultry animals,

0,005

compound feed for cattle (except dairy cattle and calves), sheep (except dairy sheep and lambs), goats (except dairy goats and kids), pigs (except piglets) and poultry (except young animals).

0,02

2.

Rye ergot (Claviceps purpurea)

Feed materials and compound feed containing unground cereals.

1 000

SECTION III:INHERENT PLANT TOXINS

Undesirable substance

Products intended for animal feed

Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %

1.

Free gossypol

Feed materials

20

with the exception of:

cottonseed,

5 000

cottonseed cakes and cottonseed meal.

1 200

Complete feed

20

with the exception of:

complete feed for cattle (except calves),

500

complete feed for sheep (except lambs) and goats (except kids),

300

complete feed for poultry (except laying hens) and calves,

100

complete feed for rabbits, lambs, kids and pigs (except piglets).

60

2.

Hydrocyanic acid

Feed materials

50

with the exception of:

linseed,

250

linseed cakes,

350

manioc products and almond cakes.

100

Complete feed

50

with the exception of:

complete feed for young chickens (< 6 weeks).

10

3.

Theobromine

Complete feed

300

with the exception of:

complete feed for pigs,

200

complete feed for dogs, rabbits, horses and fur animals.

50

4.

vinyl thiooxazolidone (5-vinyloxazolidine-2-thione)

Complete feed for poultry

1 000

with the exception of:

complete feed for laying hens.

500

F75.

Volatile mustard oil32

Feed materials

100

with the exception of:

Camelina seed and products derived thereof33, products derived from mustard seed33, rape seed and products derived thereof.

4 000

Complete feed

150

with the exception of:

complete feed for cattle (except calves), sheep (except lambs) and goats (except kids);

1 000

complete feed for pigs (except piglets) and poultry.

500

The maximum levels are expressed as allyl isothiocyanate.

Upon request of the competent authorities, the responsible operator must perform an analysis to demonstrate that the content of total glucosinolates is lower than 30 mmol/kg. The method of analysis of reference is EN-ISO 9167-1:1995.

SECTION IV:ORGANOCHLORINE COMPOUNDS (EXCEPT DIOXINS AND PCBs)

Undesirable substance

Products intended for animal feed

Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %

1.

Aldrin34

Feed materials and compound feed

0,0135

2.

Dieldrin34

with the exception of:

fats and oils,

0,135

compound feed for fish.

0,0235

3.

Camphechlor (toxaphene) – sum of indicator congeners CHB 26, 50 and 6236

Fish, other aquatic animals and products derived thereof

0,02

with the exception of

fish oil.

0,2

Complete feed for fish.

0,05

4.

Chlordane (sum of cis- and trans-isomers and of oxychlordane, expressed as chlordane)

Feed materials and compound feed

0,02

with the exception of:

fats and oils.

0,05

5.

DDT (sum of DDT-, DDD- (or TDE-) and DDE-isomers, expressed as DDT)

Feed materials and compound feed

0,05

with the exception of:

fats and oils.

0,5

F66.

Endosulfan (sum of alpha- and beta-isomers and of endosulfansulphate expressed as endosulfan)

Feed materials and compound feed

with the exception of:

0,1

cotton seed and products derived from the processing thereof, except crude cotton seed oil

0,3

soybean and products derived from the processing thereof, except crude soybean oil

0,5

crude vegetable oil

1,0

complete feed for fish except for Salmonids

0,005

complete feed for Salmonids

0,05

7.

Endrin (sum of endrin and of delta-ketoi-endrin, expressed as endrin)

Feed materials and compound feed

0,01

with the exception of:

fats and oils.

0,05

8.

Heptachlor (sum of heptachlor and of heptachlorepoxide, expressed as heptachlor)

Feed materials and compound feed

0,01

with the exception of:

fats and oils.

0,2

9.

Hexachlorobenzene (HCB)

Feed materials and compound feed

0,01

with the exception of:

fats and oils.

0,2

10.Hexachlorocyclohexane (HCH)

alpha-isomers

Feed materials and compound feed

0,02

with the exception of:

fats and oils.

0,2

beta-isomers

Feed materials

0,01

with the exception of:

fats and oils.

0,1

Compound feed

0,01

with the exception of:

compound feed for dairy cattle.

0,005

gamma-isomers

Feed materials and compound feed

0,2

with the exception of:

fats and oils.

2,0

Singly or combined expressed as dieldrin.

Maximum level for aldrin and dieldrin, singly or combined, expressed as dieldrin.

Numbering system according to Parlar, prefixed by either CHB or Parlar:

  • CHB 26: 2-endo,3-exo,5-endo,6-exo,8,8,10,10-octochlorobornane,

  • CHB 50: 2-endo,3-exo,5-endo,6-exo,8,8,9,10,10-nonachlorobornane,

  • CHB 62: 2,2,5,5,8,9,9,10,10-nonachlorobornane.

F9SECTION V:DIOXINS AND PCBs

Undesirable substance

Products intended for animal feed

Maximum content in ng WHO-PCDD/F-TEQ/kg (ppt)37 relative to a feed with a moisture content of 12 %

F101.

Dioxins [sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005)38]

Feed materials of plant origin

0,75

with the exception of:

vegetable oils and their by-products.

0,75

Feed materials of mineral origin

0,75

Feed materials of animal origin:

Animal fat, including milk fat and egg fat,

1,5

Other land animal products including milk and milk products and eggs and egg products.

0,75

Fish oil,

5,0

Fish, other aquatic animals, and products derived thereof with the exception of fish oil, hydrolysed fish protein containing more than 20 % fat40 and crustacea meal,

1,25

Hydrolysed fish protein containing more than 20 % fat; crustacea meal.

1,75

The feed additives kaolinitic clay, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin belonging to the functional groups of binders and anti-caking agents.

0,75

Feed additives belonging to the functional group of compounds of trace elements.

1,0

Premixtures

1,0

Compound feed

0,75

with the exception of:

compound feed for pet animals and fish,

1,75

compound feed for fur animals.

Undesirable substance

Products intended for animal feed

Maximum content in ng WHO-PCDD/F-PCB-TEQ/kg (ppt)37 relative to a feed with a moisture content of 12 %

2.

Sum of dioxins and dioxin-like PCBs (sum of polychlorinated dibenzo-para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors), 200538)

Feed materials of plant origin with the exception of:

1,25

vegetable oils and their by-products

1,5

Feed materials of mineral origin

1,0

Feed materials of animal origin:

Animal fat, including milk fat and egg fat

2,0

Other land animal products including milk and milk products and eggs and egg products

1,25

Fish oil

20,0

Fish, other aquatic animals, and products derived thereof with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat40

4,0

Fish protein, hydrolysed, containing more than 20 % fat

9,0

The feed additives kaolinitic clay, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin belonging to the functional groups of binders and anti-caking agents

1,5

Feed additives belonging to the functional group of compounds of trace elements

1,5

Premixtures

1,5

Compound feed with the exception of:

1,5

compound feed for pet animals and fish

5,5

compound feed for fur animals

Undesirable substance

Products intended for animal feed

Maximum content in μg/kg (ppb) relative to a feed with a moisture content of 12 %37

3.

Non-dioxin-like PCBs (sum of PCB 28, PCB 52, PCB 101, PCB 138, PCB 153 and PCB 180 (ICES – 6)37)

Feed materials of plant origin

10

Feed materials of mineral origin

10

Feed materials of animal origin:

Animal fat, including milk fat and egg fat

10

Other land animal products including milk and milk products and eggs and egg products

10

Fish oil

175

Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat41

30

Fish protein, hydrolysed, containing more than 20 % fat

50

The feed additives kaolinitic clay, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin belonging to the functional groups of binders and anti-caking agents

10

Feed additives belonging to the functional group of compounds of trace elements

10

Premixtures

10

Compound feed with the exception of:

10

compound feed for pet animals and fish

40

compound feed for fur animals

Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification.

Table of TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like PCBs:

WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) – International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organisation Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006))

Congener

TEF value

Dibenzo-para-dioxins (PCDDs) and Dibenzo-para-furans (PCDFs)

2,3,7,8-TCDD

1

1,2,3,7,8-PeCDD

1

1,2,3,4,7,8-HxCDD

0,1

1,2,3,6,7,8-HxCDD

0,1

1,2,3,7,8,9-HxCDD

0,1

1,2,3,4,6,7,8-HpCDD

0,01

OCDD

0,0003

2,3,7,8-TCDF

0,1

1,2,3,7,8-PeCDF

0,03

2,3,4,7,8-PeCDF

0,3

1,2,3,4,7,8-HxCDF

0,1

1,2,3,6,7,8-HxCDF

0,1

1,2,3,7,8,9-HxCDF

0,1

2,3,4,6,7,8-HxCDF

0,1

1,2,3,4,6,7,8-HpCDF

0,01

1,2,3,4,7,8,9-HpCDF

0,01

OCDF

0,0003

Dioxin-like PCBs: Non-ortho PCBs + Mono-ortho PCBs

Non-ortho PCBs

PCB 77

0,0001

PCB 81

0,0003

PCB 126

0,1

PCB 169

0,03

Mono-ortho PCBs

PCB 105

0,00003

PCB 114

0,00003

PCB 118

0,00003

PCB 123

0,00003

PCB 156

0,00003

PCB 157

0,00003

PCB 167

0,00003

PCB 189

0,00003

Abbreviations used: T = tetra; Pe = penta; Hx = hexa; Hp = hepta; O = octa; CDD = chlorodibenzodioxin; CDF = chlorodibenzofuran; CB = chlorobiphenyl.

Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 3,5 ng WHO-PCDD/F-TEQ/kg product and 6,5 ng WHO-PCDD/F-PCB-TEQ/kg product are applicable to fresh fish and 20,0 ng WHO-PCDD/F-PCB-TEQ/kg product is applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.

Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 75 μg/kg product are applicable to fresh fish and 200 μg/kg product are applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.

F6SECTION VI:HARMFUL BOTANICAL IMPURITIES

Undesirable substance

Products intended for animal feed

Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %

1.

Weed seeds and unground and uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or in combination including

Feed materials and compound feed

3 000

Datura sp.

1 000

2.

Crotalaria spp.

Feed materials and compound feed

100

3.

Seeds and husks from Ricinus communis L., Croton tiglium L. and Abrus precatorius L. as well as their processed derivatives42, separately or in combination

Feed materials and compound feed

1043

4.

Unhusked beech mast — Fagus sylvatica L.

Feed materials and compound feed

Seeds and fruit as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable

5.

Purghera — Jatropha curcas L.

Feed materials and compound feed

Seeds and fruit as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable

6.

Seeds from Ambrosia spp.

Feed materials44

with the exception of

50

Millet (grains of Panicum miliaceum L.) and sorghum (grains of Sorghum bicolor (L) Moench s.l.) not directly fed to animals44

200

Compound feed containing unground grains and seeds

50

7.Seeds from

  • Indian mustard — Brassica juncea (L.) Czern. and Coss. ssp. integrifolia (West.) Thell.

  • Sareptian mustard — Brassica juncea (L.) Czern. and Coss. ssp. juncea

  • Chinese mustard — Brassica juncea (L.) Czern. and Coss. ssp. juncea var. lutea Batalin

  • Black mustard — Brassica nigra (L.) Koch

  • Ethiopian mustard — Brassica carinata A. Braun

Feed materials and compound feed

Seeds may only be present in feed in trace amounts not quantitatively determinable

In so far determinable by analytical microscopy.

Includes also seed husk fragments.

In case unequivocal evidence is provided that the grains and seeds are intended for milling or crushing, there is no need to perform a cleaning of the grains and seeds containing con-compliant levels of seeds of Ambrosia spp. before milling or crushing on the condition that:

  • the consignment is transported as a whole to the milling or crushing plant, and — the milling or crushing plant is informed in advance of the presence of high level of Ambrosia spp. seeds in order take additional prevention measures to avoid dissemination into the environment, and

  • solid evidence is provided that prevention measures are taken to avoid dissemination of Ambrosia spp. seeds into the environment during transport to the crushing or milling plant, and

  • the competent authority agrees to the transport, after having ensured that the abovementioned conditions are fulfilled.

In case these conditions are not fulfilled, the consignment must be cleaned before any transport into the EU and the screenings must be appropriately destroyed.

SECTION VII:AUTHORISED FEED ADDITIVES IN NON-TARGET FEED FOLLOWING UNAVOIDABLE CARRY-OVER

Coccidiostat

Products intended for animal feed45

Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %

1.

Decoquinate

Feed materials

0,4

Compound feed for

laying birds and chickens reared for laying (> 16 weeks),

0,4

chickens for fattening for the period before slaughter in which the use of decoquinate is prohibited (withdrawal feed),

0,4

other animal species.

1,2

Premixtures for use in feed in which the use of decoquinate is not authorised.

46

F102.

Diclazuril

Feed materials

0,01

Compound feed for

laying birds and chickens reared for laying (> 16 weeks),

0,01

rabbits for fattening and breeding for the period before slaughter in which the use of diclazuril is prohibited (withdrawal feed),

0,01

other animal species other than chickens reared for laying (< 16 weeks), chickens for fattening, guinea fowl and turkeys for fattening.

0,03

Premixtures for use in feed in which the use of diclazuril is not authorised.

46

3.

Halofuginone hydrobromide

Feed materials

0,03

Compound feed for

laying birds, chickens reared for laying and turkeys (> 12 weeks),

0,03

chickens for fattening and turkeys (< 12 weeks) for the period before slaughter in which the use of halofuginone hydrobromide is prohibited (withdrawal feed),

0,03

other animal species.

0,09

Premixtures for use in feed in which the use of halofuginone hydrobromide is not authorised.

46

F104.

Lasalocid A sodium

Feed materials

1,25

Compound feed for

dogs, calves, rabbits, equine species, dairy animals, laying birds, turkeys (> 16 weeks) and chickens reared for laying (> 16 weeks),

1,25

chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of lasalocid A sodium is prohibited (withdrawal feed),

1,25

pheasants, guinea fowl, quails and partridges (except laying birds) for the period before slaughter in which the use of lasalocid A sodium is prohibited (withdrawal feed),

1,25

other animal species.

3,75

Premixtures for use in feed in which the use of lasalocid A sodium is not authorised.

46

5.

Maduramicin ammonium alpha

Feed materials

0,05

Compound feed for

equine species, rabbits, turkeys (> 16 weeks), laying birds and chickens reared for laying (> 16 weeks),

0,05

chickens for fattening and turkeys (< 16 weeks) for the period before slaughter in which the use of maduramicin ammonium alpha is prohibited (withdrawal feed),

0,05

other animal species.

0,15

Premixtures for use in feed in which the use of maduramicin ammonium alpha is not authorised.

46

6.

Monensin sodium

Feed materials

1,25

Compound feed for

equine species, dogs, small ruminants (sheep and goat), ducks, bovine, dairy cattle, laying birds, chickens reared for laying (> 16 weeks) and turkeys (> 16 weeks),

1,25

chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of monensin sodium is prohibited (withdrawal feed),

1,25

other animal species.

3,75

Premixtures for use in feed in which the use of monensin sodium is not authorised.

46

7.

Narasin

Feed materials

0,7

Compound feed for

turkeys, rabbits, equine species, laying birds and chickens reared for laying (> 16 weeks),

0,7

other animal species.

2,1

Premixtures for use in feed in which the use of narasin is not authorised.

46

8.

Nicarbazin

Feed materials

1,25

Compound feed for

equine species, laying birds and chickens reared for laying (> 16 weeks),

1,25

other animal species.

3,75

Premixtures for use in feed in which the use of nicarbazin (alone or in combination with narasin) is not authorised.

46

9.

Robenidine hydrochloride

Feed materials

0,7

Compound feed for

laying birds and chickens reared for laying (> 16 weeks),

0,7

chickens for fattening, rabbits for fattening and breeding and turkeys for the period before slaughter in which the use of robenidine hydrochloride is prohibited (withdrawal feed),

0,7

other animal species.

2,1

Premixtures for use in feed in which the use of robenidine hydrochloride is not authorised.

46

10.

Salinomycin sodium

Feed materials

0,7

Compound feed for

equine species, turkeys, laying birds and chickens reared for laying (> 12 weeks),

0,7

chickens for fattening, chickens reared for laying (< 12 weeks) and rabbits for fattening for the period before slaughter in which the use of salinomycin sodium is prohibited (withdrawal feed),

0,7

other animal species.

2,1

Premixtures for use in feed in which the use of salinomycin sodium is not authorised

46

11.

Semduramicin sodium

Feed materials

0,25

Compound feed for

laying birds and chickens reared for laying (> 16 weeks),

0,25

chickens for fattening for the period before slaughter in which the use of semduramicin sodium is prohibited (withdrawal feed),

0,25

other animal species.

0,75

Premixtures for use in feed in which the use of semduramicin sodium is not authorised.

46

Without prejudice to the authorised levels in the frame of Regulation (EC) No 1831/2003 of the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 29).

The maximum level of the substance in the premixture is the concentration which shall not result in a level of the substance higher than 50 % of the maximum levels established in the feed when the instructions for use of the premixture are followed.

F9ANNEX II

ACTION THRESHOLDS TRIGGERING INVESTIGATIONS BY MEMBER STATES, AS REFERRED TO IN ARTICLE 4(2)SECTION: DIOXINS AND PCBs

Undesirable substances

Products intended for animal feed

Action threshold in ng WHO-PCDD/F TEQ/kg (ppt)49 relative to a feedingstuff with a moisture content of 12 %

Comments and additional information (e.g. nature of investigations to be performed)

F101.

Dioxins [sum of polychlorinated dibenzo-para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005)47]

Feed materials of plant origin

0,5

50

with the exception of:

vegetable oils and their by-products.

0,5

50

Feed materials of mineral origin

0,5

50

Feed materials of animal origin:

Animal fat, including milk fat and egg fat,

0,75

50

Other land animal products including milk and milk products and eggs and egg products,

0,5

50

Fish oil,

4,0

51

Fish, other aquatic animals and products derived thereof with the exception of fish oil, hydrolysed fish protein containing more than 20 % fat and crustacea meal,

0,75

51

Hydrolysed fish protein containing more than 20 % fat; crustacea meal.

1,25

51

Feed additives belonging to the functional groups of binders and anti-caking agents

0,5

50

Feed additives belonging to the functional group of compounds of trace elements

0,5

50

Premixtures

0,5

50

Compound feed with the exception of:

0,5

50

compound feed for pet animals and fish,

1,25

51

compound feed for fur animals.

2.

Dioxin-like PCBs (sum of polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005)47)

Feed materials of plant origin with the exception of:

0,35

50

vegetable oils and their by-products

0,5

50

Feed materials of mineral origin

0,35

50

Feed materials of animal origin:

Animal fat, including milk fat and egg fat

0,75

50

Other land animal products including milk and milk products and eggs and egg products

0,35

50

Fish oil

11,0

51

Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat50

2,0

51

Fish protein, hydrolysed, containing more than 20 % fat

5,0

51

Feed additives belonging to the functional groups of binders and anti-caking agents

0,5

50

Feed additives belonging to the functional group of compounds of trace elements

0,35

50

Premixtures

0,35

50

Compound feed with the exception of:

0,5

50

compound feed for pet animals and fish

2,5

51

compound feed for fur animals

Table of TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like PCBs:

WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) – International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organisation Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006))

Congener

TEF value

Dibenzo-para-dioxins (PCDDs) and Dibenzo-para-furans (PCDFs)

2,3,7,8-TCDD

1

1,2,3,7,8-PeCDD

1

1,2,3,4,7,8-HxCDD

0,1

1,2,3,6,7,8-HxCDD

0,1

1,2,3,7,8,9-HxCDD

0,1

1,2,3,4,6,7,8-HpCDD

0,01

OCDD

0,0003

2,3,7,8-TCDF

0,1

1,2,3,7,8-PeCDF

0,03

2,3,4,7,8-PeCDF

0,3

1,2,3,4,7,8-HxCDF

0,1

1,2,3,6,7,8-HxCDF

0,1

1,2,3,7,8,9-HxCDF

0,1

2,3,4,6,7,8-HxCDF

0,1

1,2,3,4,6,7,8-HpCDF

0,01

1,2,3,4,7,8,9-HpCDF

0,01

OCDF

0,0003

Dioxin-like PCBs: Non-ortho PCBs + Mono-ortho PCBs

Non-ortho PCBs

PCB 77

0,0001

PCB 81

0,0003

PCB 126

0,1

PCB 169

0,03

Mono-ortho PCBs

PCB 105

0,00003

PCB 114

0,00003

PCB 118

0,00003

PCB 123

0,00003

PCB 156

0,00003

PCB 157

0,00003

PCB 167

0,00003

PCB 189

0,00003

Abbreviations used: T = tetra; Pe = penta; Hx = hexa; Hp = hepta; O = octa; CDD = chlorodibenzodioxin; CDF = chlorodibenzofuran; CB = chlorobiphenyl.

Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification.

Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species etc., shall be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.

ANNEX III

CORRELATION TABLE

Directive 1999/29/EC

This Directive

Article 1

Article 1

Article 2(a)

Article 2(a)

Article 2(b)

Article 2(b)

Article 2(c)

Article 2(g)

Article 2(d)

Article 2(f)

Article 2(e)

Article 2(e)

Article 2(f)

Article 2(i)

Article 2(g)

Article 2(j)

Article 2(h)

Article 2(c)

Article 2(d)

Article 2(h)

Article 2(k)

Article 2(l)

Article 3

Article 3

Article 4(1)

Article 4(1)

Article 4(2)

Article 4(2)

Article 5

Article 6

Article 7

Article 5

Article 8

Article 6

Article 9

Article 7

Article 10

Article 8

Article 11

Article 9

Article 12

Article 10

Article 13

Article 11

Article 14

Article 12

Article 15

Article 13

Article 16

Article 14

Article 15

Article 17

Article 16

Article 18

Article 17

Annex I

Annex I

Annex II

Annex III

Annex IV

Annex II