Commission Regulation (EU) No 574/2011
of 16 June 2011
amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels for nitrite, melamine, Ambrosia spp. and carry-over of certain coccidiostats and histomonostats and consolidating Annexes I and II thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Directive 2002/32/EC provides that the use of products intended for animal feed that contain levels of undesirable substances exceeding the maximum levels laid down in Annex I to that Directive is prohibited. For certain undesirable substances, Member States are to carry out investigations identifying the sources of those substances if the thresholds set out in Annex II of that Directive are exceeded.
As regards coccidiostats and histomonostats, transfer from one production lot to another may occur when such substances are used as authorised feed additives. Such transfer may result in the contamination of feed produced subsequently by the presence of technically unavoidable traces of such substances, referred to as unavoidable carry-over or cross-contamination, in feed for which coccidiostats and histomonostats are not authorised, referred to as non-target feed. Taking into account the application of good manufacturing practices, maximum levels of unavoidable carry-over of coccidiostats or histomonostats in non-target feed should be established following the ALARA (As Low As Reasonably Achievable) principle. For the purpose of enabling the feed manufacturer to manage unavoidable carry-over, a carry-over rate of approximately 3 % of the authorised maximum content should be considered acceptable as regards feed for less sensitive non-target animal species while a carry-over rate of approximately 1 % of the authorised maximum content should be considered acceptable for feed intended to sensitive non-target animal species and feed used for the period before slaughter. The carry-over rate of 1 % should also be considered acceptable for cross-contamination of other feed for target species to which no coccidiostats or histomonostats are added, and as regards non-target feed for ‘continuous food-producing animals’, such as dairy cows or laying hens, where there is evidence of transfer from feed to food of animal origin. Where feed materials are fed directly to the animals or where complementary feedingstuffs are used, this should not lead to an exposure of the animals to a higher level of coccidiostats or histomonostats than the corresponding maximum levels of exposure where only complete feedingstuffs are used in a daily ration.
Annexes I and II to Directive 2002/32/EC had already been adapted substantially and many times in the past. It is therefore appropriate to consolidate those Annexes. To improve the clarity and readability of those Annexes, it is appropriate to restructure them and to harmonise terminology. Given that the provisions contained in the Annexes have a direct application and are binding in their entirety, it is appropriate to establish these Annexes by a Regulation.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,
HAS ADOPTED THIS REGULATION
Article 1
Annexes I and II to Directive 2002/32/EC are replaced by the text in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 July 2011.
The provisions as regards Ambrosia spp. shall apply from 1 January 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 June 2011.
For the Commission
The President
José Manuel Barroso
ANNEX
Annexes I and II to Directive 2002/32/EC are replaced by the following:
‘ANNEX I
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 %
1.
Arsenic7Feed materials
2
with the exception of:
—
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,
48—
phosphates and calcareous marine algae,
10
—
calcium carbonate,
15
—
magnesium oxide and magnesium carbonate,
20
—
fish, other aquatic animals and products derived thereof,
258
—
seaweed meal and feed materials derived from seaweed.
408
Iron particles used as tracer.
50
Feed additives belonging to the functional groups of compounds of trace elements
30
with the exception of:
—
cupric sulphate pentahydrate and cupric carbonate,
50
—
zinc oxide, manganous oxide and cupric oxide.
100
Complementary feed
4
with the exception of:
—
mineral feed.
12
Complete feed
2
with the exception of:
—
complete feed for fish and fur animals.
108
2.
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
Premixtures1215
Complementary feed
0,5
with the exception of:
—
mineral feed
- -
containing < 7 % phosphorus14,5
- -
containing ≥ 7 % phosphorus14,
0,75 per 1 % phosphorus14, with a maximum of 7,5
—
complementary feed for pet animals.
2
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
3.
Fluorine13Feed materials
150
with the exception of:
—
feed materials of animal origin except marine crustaceans such as marine krill,
500
—
marine crustaceans such as marine krill,
3 000
—
phosphates,
2 000
—
calcium carbonate,
350
—
magnesium oxide,
600
—
calcareous marine algae.
1 000
Vermiculite (E 561).
3 000
Complementary feed:
—
containing ≤ 4 % phosphorus14,
500
—
containing > 4 % phosphorus14.
125 per 1 % phosphorus14
Complete feed
150
with the exception of:
—
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.
Lead
Feed materials
10
with the exception of:
—
forage9,30
—
phosphates and calcareous marine algae,
15
—
calcium carbonate,
20
—
yeasts.
5
Feed additives belonging to the functional group of compounds of trace elements
100
with the exception of:
—
zinc oxide,
400
—
manganous oxide, ferrous carbonate, cupric carbonate.
200
Feed additives belonging to the functional group of binders and anti-caking agents
30
with the exception of:
—
clinoptilolite of volcanic origin.
60
Premixtures12.
200
Complementary feed
10
with the exception of:
—
mineral feed.
15
Complete feed.
5
5.
Mercury10Feed materials
0,1
with the exception of:
—
fish, other aquatic animals and products derived thereof,
0,5
—
calcium carbonate.
0,3
Compound feed
0,1
with the exception of:
—
mineral feed,
0,2
—
compound feed for fish,
0,2
—
compound feed for dogs, cats and fur animals.
0,3
6.
Nitrite11Feed materials
15
with the exception of:
—
fishmeal,
30
—
silage,
—
—
products and by-products from sugar beet and sugarcane and from starch production.
—
Complete feed
15
with the exception of:
—
complete feed for dogs and cats with a moisture content exceeding 20 %.
—
7.
Melamine15Feed
2,5
with the exception of the feed additives:
—
guanidino acetic acid (GAA),
—
—
urea,
—
—
biuret.
—
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
5.
Volatile mustard oil16Feed materials
100
with the exception of:
—
rapeseed cakes.
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
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.
Aldrin17Feed materials and compound feed
0,01182.
Dieldrin17
with the exception of:
—
fats and oils,
0,118
—
compound feed for fish.
0,0218
3.
Camphechlor (toxaphene) – sum of indicator congeners CHB 26, 50 and 6219Fish, 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
6.
Endosulfan (sum of alpha- and beta- isomers and of endosulfansulphate expressed as endosulfan)
Feed materials and compound feed
0,1
with the exception of:
—
maize and maize products derived from the processing thereof,
0,2
—
oilseeds and products derived from the processing thereof, except crude vegetable oil,
0,5
—
crude vegetable oil,
1,0
—
complete feed for fish.
0,005
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
SECTION V:DIOXINS AND PCBs
Undesirable substance
Products intended for animal feed
1.
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, 199723)Feed materials of plant origin
0,75
with the exception of:
—
vegetable oils and their by-products
0,75
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.
0,75
—
Fish oil
6,0
—
Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat221,25
—
Fish protein hydrolysates containing more than 20 % fat.
2,25
The feed additives kaolinitic clay, calcium sulphate dihydrate, 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,
2,25
—
compound feed for fur animals.
—
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, 199723)
Feed materials of plant origin
1,25
with the exception of:
—
vegetable oils and their by-products.
1,5
Feed materials of mineral origin
1,5
Feed materials of animal origin:
—
Animal fat, including milk fat and egg fat,
3,0
—
Other land animal products including milk and milk products and eggs and egg products.
1,25
—
Fish oil
24,0
—
Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat22
4,5
—
Fish protein hydrolysates containing more than 20 % fat.
11,0
The feed additives kaolinitic clay, calcium sulphate dihydrate, 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
1,5
with the exception of:
—
compound feed for pet animals and fish,
7,0
—
compound feed for fur animals.
—
SECTION 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 derivatives25, separately or in combinationFeed materials and compound feed
10264.
Unhusked beech mast – Fagus silvatica L.
5.
Purghera – Jatropha curcas L.
6.
Indian mustard – Brassica juncea (L.) Czern. And Coss. ssp. integrifolia (West.) Thell.
7.
Sareptian mustard – Brassica juncea (L.) Czern. And Coss. ssp.juncea
8.
Chinese mustard – Brassica juncea (L.) Czern. And Coss. ssp. juncea var. lutea Batalin
9.
Black mustard – Brassica nigra (L.) Koch
10.
Ethiopian mustard – Brassica carinata A. Braun
Feed materials and compound feed
Seeds and fruit of the plant species listed opposite as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable
11.
Seeds from Ambrosia spp.
Feed materials
50
with the exception of:
—
Millet (grains of Panicum miliaceum L.) and sorghum (grains of Sorghum bicolor (L) Moench s.l.) not directly fed to animals.
200
Compound feed containing unground grains and seeds
50
SECTION VII:AUTHORISED FEED ADDITIVES IN NON-TARGET FEED FOLLOWING UNAVOIDABLE CARRY-OVER
Coccidiostat
Products intended for animal feed27Maximum 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.
2.
Diclazuril
Feed materials
0,01
Compound feed for
—
laying birds, chickens reared for laying (> 16 weeks) and turkeys for fattening (> 12 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 (< 12 weeks).
0,03
Premixtures for use in feed in which the use of diclazuril is not authorised.
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.
4.
Lasalocid 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 sodium is prohibited (withdrawal feed),
1,25
—
other animal species.
3,75
Premixtures for use in feed in which the use of lasalocid sodium is not authorised
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.
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.
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.
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.
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.
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
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.
ANNEX 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
Comments and additional information (e.g. nature of investigations to be performed)
1.
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, 199729)Feed materials of plant origin
0,5
with the exception of:
—
vegetable oils and their by-products,
0,5
Feed materials of mineral origin
0,5
Feed materials of animal origin:
—
Animal fat, including milk fat and egg fat,
1,0
—
Other land animal products including milk and milk products and eggs and egg products.
0,5
—
Fish oil
5,0
—
Fish, other aquatic animals, and products and by-products with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat31.
1,0
—
Fish protein hydrolysates containing more than 20 % fat.
1,75
Feed additives belonging to the functional groups of binders and anti-caking agents.
0,5
Feed additives belonging to the functional group of compounds of trace elements
0,5
Premixtures
0,5
Compound feed
0,5
with the exception of:
—
compound feed for pet animals and fish,
1,75
—
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, 199729)
Feed materials of plant origin
0,35
with the exception of:
—
vegetable oils and their by-products,
0,5
Feed materials of mineral origin
0,35
Feed materials of animal origin:
—
Animal fat, including milk fat and egg fat,
0,75
—
Other land animal products including milk and milk products and eggs and egg products.
0,35
—
Fish oil
14,0
—
Fish, other aquatic animals, and products derived thereof with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat31,
2,5
—
Fish protein hydrolysates containing more than 20 % fat.
7,0
Feed additives belonging to the functional groups of binders and anti-caking agents.
0,5
Feed additives belonging to the functional group of compounds of trace elements.
0,35
Premixtures
0,35
Compound feed
0,5
with the exception of:
—
compound feed for pet animals and fish,
3,5
—
compound feed for fur animals.
—’