Commission Regulation (EU) No 574/2011

law://eu/reg/2011/574@2026-11-13

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed^note, and in particular Article 8(1) and the first indent of Article 8(2) thereof,Whereas:

(1)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.

(2)As regards nitrite, it was found that the products and by-products from sugar beet and sugarcane and from the starch production contain under certain conditions levels of nitrite exceeding the maximum levels recently established in Annex I to Directive 2002/32/EC. Furthermore, it appears that the method of analysis for the determination of nitrite in feed does not always provide reliable analytical results with regard to the products and by-products from sugar beet and sugarcane and from the starch production. Given that the European Food Safety Authority (EFSA) concluded in its opinion of 25 March 2009^note that the presence of nitrite in animal products does not raise any concern for human health, the products concerned should be exempted for the time being from the maximum level for nitrite in feed materials, while nitrite levels in those products and appropriate methods of analysis are further examined.

(3)As regards melamine, the EFSA adopted on 18 March 2010 a scientific opinion on melamine in food and feed^note. EFSA findings show that exposure to melamine can result in the formation of crystals in the urinary tract. These crystals cause proximal tubular damage and have been observed in animals and children as a result of incidents involving adulteration of feed and infant formula with melamine, leading to fatalities in some instances. The Codex Alimentarius Commission has established maximum levels for melamine in feed and food^note. It is appropriate to include these maximum levels in Annex I to Directive 2002/32/EC to protect animal and public health as these levels are in accordance with the conclusions of the EFSA opinion. It is appropriate to exempt some feed additives from the maximum levels as they contain unavoidably a level of melamine above the maximum level as a result of the normal production process.

(4)As regards Ambrosia spp., EFSA concluded in its opinion of 4 June 2010^note that bird feed may be an important means of Ambrosia spp. dispersal, especially in previously uninfested areas, as it often contains significant quantities of unprocessed seeds of Ambrosia spp. Therefore, the prevention of the use of bird feed contaminated with unprocessed seeds of Ambrosia spp. is likely to attenuate the further dispersal of Ambrosia spp. in the Union. Ambrosia spp. are of public health concern due to the allergenic properties of their pollen. Inhalation of the plant pollen may, amongst other conditions, cause rhino-conjunctivitis and asthma. There is also some evidence for allergenicity of Ambrosia spp. pollen in animals. It is therefore appropriate to limit the presence of Ambrosia spp. seeds in feed materials and compound feed containing unground grains and seeds and to establish a maximum level of Ambrosia spp. seeds in unground grains and seeds as low as reasonably achievable (ALARA) by good agricultural practices and cleaning techniques.

(5)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.

(6)As regards the coccidiostats narasin, nicarbazin and lasalocid-sodium, Annex I to Directive 2002/32/EC should be amended to take into account recent modifications of the authorisations of those substances and Commission Regulation (EC) No 124/2009 of 10 February 2009 setting maximum levels for the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed^note should consequently be amended.

(7)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.

(8)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

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.Arsenic^note	Feed 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,	4^note
—phosphates and calcareous marine algae,	10
—calcium carbonate,	15
—magnesium oxide and magnesium carbonate,	20
—fish, other aquatic animals and products derived thereof,	25^note
—seaweed meal and feed materials derived from seaweed.	40^note
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.	10^note
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
Premixtures^note	15
Complementary feed	0,5
with the exception of:
—mineral feed
- -containing < 7 % phosphorus^note,	5
- -containing ≥ 7 % phosphorus^note,	0,75 per 1 % phosphorus^note, 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.Fluorine^note	Feed 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,	3000
—phosphates,	2000
—calcium carbonate,	350
—magnesium oxide,	600
—calcareous marine algae.	1000
Vermiculite (E 561).	3000
Complementary feed:
—containing ≤ 4 % phosphorus^note,	500
—containing > 4 % phosphorus^note.	125 per 1 % phosphorus^note
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:
—forage^note,	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
Premixtures^note.	200
Complementary feed	10
with the exception of:
—mineral feed.	15
Complete feed.	5
5.Mercury^note	Feed 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.Nitrite^note	Feed 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.Melamine^note	Feed	2,5
with the exception of the feed additives:
—guanidino acetic acid (GAA),	—
—urea,	—
—biuret.	—

Annex II

ACTION THRESHOLDS TRIGGERING INVESTIGATIONS BY MEMBER STATES, AS REFERRED TO IN ARTICLE 4(2)
Congener	TEF value
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	0,0001
2,3,7,8-TCDF	0,1
1,2,3,7,8-PeCDF	0,05
2,3,4,7,8-PeCDF	0,5
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	0,0001

PCB 77	0,0001
PCB 81	0,0001
PCB 126	0,1
PCB 169	0,01
PCB 105	0,0001
PCB 114	0,0005
PCB 118	0,0001
PCB 123	0,0001
PCB 156	0,0005
PCB 157	0,0005
PCB 167	0,00001
PCB 189	0,0001


Undesirable substances	Products intended for animal feed	Action threshold in ng WHO-PCDD/F-TEQ/kg (ppt)^note,^note relative to a feed with a moisture content of 12 %	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, 1997^note)	Feed materials of plant origin	0,5	^note
with the exception of:
—vegetable oils and their by-products,	0,5	^note
Feed materials of mineral origin	0,5	^note
Feed materials of animal origin:
—Animal fat, including milk fat and egg fat,	1,0	^note
—Other land animal products including milk and milk products and eggs and egg products.	0,5	^note
—Fish oil	5,0	^note
—Fish, other aquatic animals, and products and by-products with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat^note.	1,0	^note
—Fish protein hydrolysates containing more than 20 % fat.	1,75	^note
Feed additives belonging to the functional groups of binders and anti-caking agents.	0,5	^note
Feed additives belonging to the functional group of compounds of trace elements	0,5	^note
Premixtures	0,5	^note
Compound feed	0,5	^note
with the exception of:
—compound feed for pet animals and fish,	1,75	^note
—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, 1997^note)	Feed materials of plant origin	0,35	^note
with the exception of:
—vegetable oils and their by-products,	0,5	^note
Feed materials of mineral origin	0,35	^note
Feed materials of animal origin:
—Animal fat, including milk fat and egg fat,	0,75	^note
—Other land animal products including milk and milk products and eggs and egg products.	0,35	^note
—Fish oil	14,0	^note
—Fish, other aquatic animals, and products derived thereof with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat^note,	2,5	^note
—Fish protein hydrolysates containing more than 20 % fat.	7,0	^note
Feed additives belonging to the functional groups of binders and anti-caking agents.	0,5	^note
Feed additives belonging to the functional group of compounds of trace elements.	0,35	^note
Premixtures	0,35	^note
Compound feed	0,5	^note
with the exception of:
—compound feed for pet animals and fish,	3,5	^note
—compound feed for fur animals.	—

Annexes I and II to Directive 2002/32/EC are replaced by the following:

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Commission Regulation (EU) No 574/2011

Commission Regulation (EU) No 574/2011

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Annex I

Annex II

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