委员会条例(EU) No 574/2011,就亚硝酸盐,三聚氰胺,豚草属和某些球虫药和抑制药的遗留物的最大限值,修订欧洲议会和理事会指令2002/32/EC的附录I,并巩固该指令的附录I和II
技术法规类型:欧盟Eurlex法规 来源:tbtmap
EURLEX ID:32011R0574
OJ编号:OJ L 159, 17.6.2011, p. 7-24
中文标题:委员会条例(EU) No 574/2011,就亚硝酸盐,三聚氰胺,豚草属和某些球虫药和抑制药的遗留物的最大限值,修订欧洲议会和理事会指令2002/32/EC的附录I,并巩固该指令的附录I和II
原文标题: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 (1)
分类:03.50.10_动物饲料
文件类型:二级立法 Regulation|条例
生效日期:2011-07-07
废止日期:2058-12-31
法规全文:查看欧盟官方文件
17.6.2011 Official
Journal
of
the
European
Union L
159/7
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,
(3) As
regards
melamine,
the
EFSA
adopted
on
18
March
2010 a scientific opinion on melamine in food and
feed ( 3 ). 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
Having regard to the Treaty on the Functioning of the European
have been observed in animals and children as a result of
Union,
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
Having regard to Directive 2002/32/EC of the European
food ( 4 ). It is appropriate to include these maximum
Parliament and of the Council of 7 May 2002 on undesirable
levels in Annex I to Directive 2002/32/EC to protect
substances in animal feed (
animal and public health as these levels are in accordance
1 ), and in particular Article 8(1) and
the first indent of Article 8(2) thereof,
with the conclusions of the EFSA opinion. It is appro
priate 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.
Whereas:
(1) Directive
2002/32/EC
provides
that
the
use
of
products
intended for animal feed that contain levels of unde
sirable substances exceeding the maximum levels laid
(4) As
regards Ambrosia spp., EFSA concluded in its opinion
down in Annex I to that Directive is prohibited. For
of 4 June 2010 ( 5 ) that bird feed may be an important
certain undesirable substances, Member States are to
means of Ambrosia spp. dispersal, especially in previously
carry out investigations identifying the sources of those
uninfested areas, as it often contains significant quantities
substances if the thresholds set out in Annex II of that
of unprocessed seeds of Ambrosia spp. Therefore, the
Directive are exceeded.
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
(2) As
regards
nitrite,
it
was
found
that
the
products
and
by-
to the allergenic properties of their pollen. Inhalation of
products from sugar beet and sugarcane and from the
the plant pollen may, amongst other conditions, cause
starch production contain under certain conditions levels
rhino-conjunctivitis and asthma. There is also some
of nitrite exceeding the maximum levels recently estab
evidence for allergenicity of Ambrosia spp. pollen in
lished in Annex I to Directive 2002/32/EC. Furthermore,
animals. It is therefore appropriate to limit the presence
it appears that the method of analysis for the deter
of Ambrosia spp. seeds in feed materials and compound
mination of nitrite in feed does not always provide
feed containing unground grains and seeds and to
reliable analytical results with regard to the products
establish a maximum level of Ambrosia spp. seeds in
and by-products from sugar beet and sugarcane and
from the starch production. Given that the European
( 3 ) EFSA Panel on Contaminants in the Food Chain (CONTAM) and
Food Safety Authority (EFSA) concluded in its opinion
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and
of 25 March 2009 (
Processing Aids (CEF); Scientific Opinion on Melamine in Food and
2 ) that the presence of nitrite in
Feed. EFSA Journal 2010; 8(4):1573. [145 pp.]. doi:10.2903/j.efsa.
animal products does not raise any concern for human
2010.1573. Available online: http://www.efsa.europa.eu/en/scdocs/
health, the products concerned should be exempted for
doc/1573.pdf
the time being from the maximum level for nitrite in
( 4 ) Report on the Thirty-Third Session of the Joint FAO/WHO Food
feed materials, while nitrite levels in those products and
Standards Programme, Codex Alimentarius Commission, Geneva,
appropriate methods of analysis are further examined.
Switzerland, 5-9 July 2010 (ALINORM 10/33/REP).
( 5 ) EFSA Panel on Contaminants in the Food Chain (CONTAM), EFSA
Panel on Dietetic Products, Nutrition and Allergies (NDA) and EFSA
( 1 ) OJ L 140, 30.5.2002, p. 10.
Panel on Plant Health (PLH); Scientific Opinion on the effect on
( 2 ) EFSA Panel on Contaminants in the Food Chain, Scientific Opinion
public or animal health or on the environment on the presence
on Nitrite as undesirable substances in animal feed, The EFSA
of seeds of Ambrosia spp. in animal feed. EFSA Journal 2010;
Journal (2009) 1017, 1-47. Available online: http://www.efsa.europa.
8(6):1566 [37 pp.]. doi:10.2903/j.efsa.2010.1566. Available online:
eu/en/scdocs/doc/1017.pdf
http://www.efsa.europa.eu/en/scdocs/doc/1566.pdf
L 159/8
EN
Official Journal of the European Union
17.6.2011
unground grains and seeds as low as reasonably
Commission Regulation (EC) No 124/2009 of
achievable (ALARA) by good agricultural practices and
10 February 2009 setting maximum levels for the
cleaning techniques.
presence of coccidiostats or histomonostats in food
resulting from the unavoidable carry-over of these
substances in non-target feed ( 1 ) should consequently be
(5) As
regards
coccidiostats
and
histomonostats,
transfer
amended.
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
(7) Annexes
I
and
II
to
Directive
2002/32/EC
had
already
produced subsequently by the presence of technically
been adapted substantially and many times in the past. It
unavoidable traces of such substances, referred to as
is therefore appropriate to consolidate those Annexes. To
unavoidable carry-over or cross-contamination, in feed
improve the clarity and readability of those Annexes, it is
for which coccidiostats and histomonostats are not au
appropriate to restructure them and to harmonise termi
thorised, referred to as non-target feed. Taking into
nology. Given that the provisions contained in the
account the application of good manufacturing practices,
Annexes have a direct application and are binding in
maximum levels of unavoidable carry-over of cocci
their entirety, it is appropriate to establish these
diostats or histomonostats in non-target feed should be
Annexes by a Regulation.
established following the ALARA (As Low As Reasonably
Achievable) principle. For the purpose of enabling the
feed manufacturer to manage unavoidable carry-over, a
(8) The
measures
provided
for
in
this
Regulation
are
in
carry-over rate of approximately 3 % of the authorised
accordance with the opinion of the Standing
maximum content should be considered acceptable as
Committee on the Food Chain and Animal Health and
regards feed for less sensitive non-target animal species
neither the European Parliament nor the Council has
while a carry-over rate of approximately 1 % of the au
opposed them,
thorised maximum content should be considered
acceptable for feed intended to sensitive non-target
animal species and feed used for the period before
HAS ADOPTED THIS REGULATION
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 histo
Article 1
monostats are added, and as regards non-target feed for
‘continuous food-producing animals’, such as dairy cows
Annexes I and II to Directive 2002/32/EC are replaced by the
or laying hens, where there is evidence of transfer from
text in the Annex to this Regulation.
feed to food of animal origin. Where feed materials are
fed directly to the animals or where complementary feed
ingstuffs are used, this should not lead to an exposure of
Article 2
the animals to a higher level of coccidiostats or histo
monostats than the corresponding maximum levels of
This Regulation shall enter into force on the 20th day following
exposure where only complete feedingstuffs are used in
its publication in the Official Journal of the European Union.
a daily ration.
It shall apply from 1 July 2011.
(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 modifi
The provisions as regards Ambrosia spp. shall apply from
cations of the authorisations of those substances and
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
( 1 ) OJ L 140, 11.2.2009, p. 7.
EN
17.6.2011 Official
Journal
of
the
European
Union L
159/9
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
Maximum content in
mg/kg (ppm) relative
Undesirable substance Products
intended
for
animal
feed
to a feed with a
moisture content of
12 %
1. Arsenic ( 1 ) Feed
materials
2
with the exception of:
— meal made from grass, from dried lucerne and from dried clover, and
4
dried sugar beet pulp and dried molasses sugar beet pulp,
— palm kernel expeller, 4
( 2 )
— phosphates and calcareous marine algae, 10
— calcium carbonate, 15
— magnesium oxide and magnesium carbonate, 20
— fish, other aquatic animals and products derived thereof, 25
( 2 )
— seaweed meal and feed materials derived from seaweed. 40
( 2 )
Iron particles used as tracer. 50
Feed additives belonging to the functional groups of compounds of trace
30
elements
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
( 2 )
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
10
elements
with the exception of:
— cupric oxide, manganous oxide, zinc oxide and manganous sulphate
30
monohydrate.
L 159/10
EN
Official Journal of the European Union
17.6.2011
Maximum content in
mg/kg (ppm) relative
Undesirable substance Products
intended
for
animal
feed
to a feed with a
moisture content of
12 %
Feed additives belonging to the functional groups of binders and anti-caking
2
agents.
Premixtures ( 6 ) 15
Complementary feed 0,5
with the exception of:
— mineral feed
- - containing < 7 % phosphorus ( 8 ),
5
- - containing ≥ 7 % phosphorus ( 8 ), 0,75
per
1
%
phos
phorus ( 8 ), 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
1
(except kids) and fish,
— complete feed for pet animals.
2
3. Fluorine ( 7 ) Feed
materials 150
with the exception of:
— feed materials of animal origin except marine crustaceans such as
500
marine krill,
— 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 % phosphorus ( 8 ), 500
— containing > 4 % phosphorus ( 8 ). 125
per
1
%
phos
phorus ( 8 )
Complete feed 150
with the exception of:
— complete feed for pigs, 100
— complete feed for poultry (except chicks) and fish, 350
EN
17.6.2011 Official
Journal
of
the
European
Union L
159/11
Maximum content in
mg/kg (ppm) relative
Undesirable substance Products
intended
for
animal
feed
to a feed with a
moisture content of
12 %
— 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 ( 3 ), 30
— phosphates and calcareous marine algae, 15
— calcium carbonate, 20
— yeasts.
5
Feed additives belonging to the functional group of compounds of trace
100
elements
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
30
agents
with the exception of:
— clinoptilolite of volcanic origin. 60
Premixtures ( 6 ). 200
Complementary feed 10
with the exception of:
— mineral feed. 15
Complete feed.
5
5. Mercury ( 4 ) 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
L 159/12
EN
Official Journal of the European Union
17.6.2011
Maximum content in
mg/kg (ppm) relative
Undesirable substance Products
intended
for
animal
feed
to a feed with a
moisture content of
12 %
6. Nitrite ( 5 ) 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 ( 9 ) Feed
2,5
with the exception of the feed additives:
— guanidino acetic acid (GAA),
—
— urea,
—
— biuret.
—
( 1 ) The maximum levels refer to total arsenic.
( 2 ) 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.
( 3 ) Forage includes products intended for animal feed such as hay, silage, fresh grass, etc.
( 4 ) The maximum levels refer to total mercury.
( 5 ) The maximum levels are expressed as sodium nitrite.
( 6 ) 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.
( 7 ) 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.
( 8 ) The % of phosphorus is relative to a feed with a moisture content of 12 %.
( 9 ) 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.
SECTION II: MYCOTOXINS
Maximum content in
mg/kg (ppm) relative
Undesirable substance Products
intended
for
animal
feed
to a feed with a
moisture content of
12 %
1. Aflatoxin B 1
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
0,005
goats and kids, piglets and young poultry animals,
EN
17.6.2011 Official
Journal
of
the
European
Union L
159/13
Maximum content in
mg/kg (ppm) relative
Undesirable substance Products
intended
for
animal
feed
to a feed with a
moisture content of
12 %
— compound feed for cattle (except dairy cattle and calves), sheep (except
0,02
dairy sheep and lambs), goats (except dairy goats and kids), pigs (except
piglets) and poultry (except young animals).
2. Rye ergot
Feed materials and compound feed containing unground cereals. 1
000
(Claviceps
purpurea)
SECTION III: INHERENT PLANT TOXINS
Maximum content in
mg/kg (ppm) relative
Undesirable substance Products
intended
for
animal
feed
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
L 159/14
EN
Official Journal of the European Union
17.6.2011
Maximum content in
mg/kg (ppm) relative
Undesirable substance Products
intended
for
animal
feed
to a feed with a
moisture content of
12 %
4. vinyl
thioo Complete feed for poultry 1
000
xazolidone (5-
vinyloxazolidine-
2-thione)
with the exception of:
— complete feed for laying hens. 500
5. Volatile mustard Feed materials 100
oil ( 1 )
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
1 000
(except kids),
— complete feed for pigs (except piglets) and poultry. 500
( 1 ) The maximum levels are expressed as allyl isothiocyanate.
SECTION IV: ORGANOCHLORINE COMPOUNDS (EXCEPT DIOXINS AND PCBs)
Maximum content in
mg/kg (ppm) relative
Undesirable substance Products
intended
for
animal
feed
to a feed with a
moisture content of
12 %
1. Aldrin ( 1 ) Feed
materials
and
compound
feed 0,01
( 2 )
2. Dieldrin ( 1 ) with
the
exception
of:
— fats and oils, 0,1
( 2 )
— compound feed for fish. 0,02
( 2 )
3. Camphechlor
Fish, other aquatic animals and products derived thereof 0,02
(toxaphene) – sum
of indicator
with the exception of
congeners CHB
26, 50 and 62 ( 3 ) — fish oil. 0,2
Complete feed for fish. 0,05
4. Chlordane (sum of Feed materials and compound feed 0,02
cis- and trans-
isomers and of with the exception of:
oxychlordane,
expressed as
— fats and oils. 0,05
chlordane)
5. DDT (sum of Feed materials and compound feed 0,05
DDT-, DDD- (or
TDE-) and DDE- with the exception of:
isomers, expressed
as DDT)
— fats and oils. 0,5
EN
17.6.2011 Official
Journal
of
the
European
Union L
159/15
Maximum content in
mg/kg (ppm) relative
Undesirable substance Products
intended
for
animal
feed
to a feed with a
moisture content of
12 %
6. Endosulfan (sum Feed materials and compound feed 0,1
of alpha- and
beta- isomers and with the exception of:
of endosulf
ansulphate
— maize and maize products derived from the processing thereof, 0,2
expressed as endo
sulfan)
— oilseeds and products derived from the processing thereof, except
0,5
crude vegetable oil,
— crude vegetable oil, 1,0
— complete feed for fish. 0,005
7. Endrin (sum of Feed materials and compound feed 0,01
endrin and of
delta-ketoi-endrin,
with the exception of:
expressed as
endrin)
— fats and oils. 0,05
8. Heptachlor (sum Feed materials and compound feed 0,01
of heptachlor and
of heptach with the exception of:
lorepoxide,
expressed as
— fats and oils. 0,2
heptachlor)
9. Hexachloro
Feed materials and compound feed 0,01
benzene (HCB)
with the exception of:
— fats and oils. 0,2
10. Hexachlorocyclo
hexane (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-
Feed materials and compound feed 0,2
isomers
with the exception of:
— fats and oils. 2,0
( 1 ) Singly or combined expressed as dieldrin.
( 2 ) Maximum level for aldrin and dieldrin, singly or combined, expressed as dieldrin.
( 3 ) 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.
L 159/16
EN
Official Journal of the European Union
17.6.2011
SECTION V: DIOXINS AND PCBs
Maximum content in
ng WHO-PCDD/F-
Undesirable substance Products
intended
for
animal
feed
TEQ/kg (ppt) ( ( 1 ), ( 2 ))
relative to a feed with
a moisture content of
12 %
1. Dioxins (sum of Feed materials of plant origin 0,75
polychlorinated
dibenzo-para-
with the exception of:
dioxins (PCDDs)
and polychlor — vegetable oils and their by-products 0,75
inated diben
zofurans
Feed materials of mineral origin 1,0
(PCDFs))
expressed in
Feed materials of animal origin:
World Health
Organisation
— Animal fat, including milk fat and egg fat 2,0
(WHO) toxic
equivalents,
— Other land animal products including milk and milk products and eggs
0,75
using the WHO
and egg products.
–TEFs (toxic
equivalency
— Fish oil 6,0
factors, 1997 ( 4 ))
— Fish, other aquatic animals and products derived thereof with the
1,25
exception of fish oil and fish protein hydrolysates containing more
than 20 % fat ( 3 )
— Fish protein hydrolysates containing more than 20 % fat. 2,25
The feed additives kaolinitic clay, calcium sulphate dihydrate, vermiculite,
0,75
natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedi
mentary origin belonging to the functional groups of binders and anti-
caking agents.
Feed additives belonging to the functional group of compounds of trace
1,0
elements.
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 Feed materials of plant origin 1,25
and dioxin-like
PCBs (sum of with the exception of:
polychlorinated
dibenzo-para-
— vegetable oils and their by-products. 1,5
dioxins (PCDDs),
polychlorinated
Feed materials of mineral origin 1,5
dibenzofurans
(PCDFs) and
Feed materials of animal origin:
polychlorinated
biphenyls (PCBs)) — Animal fat, including milk fat and egg fat, 3,0
expressed in
World Health
— Other land animal products including milk and milk products and eggs
1,25
Organisation
and egg products.
(WHO) toxic
equivalents,
— Fish oil 24,0
using the WHO-
TEFs (toxic
equivalency
— Fish, other aquatic animals and products derived thereof with the
4,5
factors, 1997 (
exception of fish oil and fish protein hydrolysates containing more
4 ))
than 20 % fat ( 3 )
— Fish protein hydrolysates containing more than 20 % fat. 11,0
EN
17.6.2011 Official
Journal
of
the
European
Union L
159/17
Maximum content in
ng WHO-PCDD/F-
Undesirable substance Products
intended
for
animal
feed
TEQ/kg (ppt) ( ( 1 ), ( 2 ))
relative to a feed with
a moisture content of
12 %
The feed additives kaolinitic clay, calcium sulphate dihydrate, vermiculite,
1,5
natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedi
mentary origin belonging to the functional groups of binders and anti-
caking agents.
Feed additives belonging to the functional group of compounds of trace
1,5
elements.
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.
—
( 1 ) 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.
( 2 ) The separate maximum level for dioxins (PCDD/F) remains applicable for a temporary period. The products intended for animal feed
mentioned in point 1 have to comply both with the maximum levels for dioxins and with the maximum levels for the sum of dioxins
and dioxin-like PCBs during that temporary period.
( 3 ) 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 4,0 ng WHO-PCDD/F-TEQ/kg product and 8,0 ng WHO-
PCDD/F-PCB-TEQ/kg product are applicable to fresh fish and 25,0 ng WHO-PCDD/F-PCB-TEQ/kg product 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.
( 4 ) WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation meeting in Stockholm, Sweden, 15-
18 June 1997 (Van den Berg et al., (1998) Toxic Equivalency Factors (TEFs) for PCBs, PCDDs, PCDFs for Humans and for Wildlife.
Environmental Health Perspectives, 106(12), 775).
Congener TEF
value
Congener TEF
value
Dibenzo-p-dioxins (“PCDDs”) and diben
“Dioxin-like” PCBs Non-ortho PCBs +
zofurans (PCDFs)
Mono-ortho PCBs
2,3,7,8-TCDD
1
1,2,3,7,8-PeCDD
1
Non-ortho PCBs
1,2,3,4,7,8-HxCDD 0,1
PCB 77 0,0001
1,2,3,6,7,8-HxCDD 0,1
PCB 81 0,0001
1,2,3,7,8,9-HxCDD 0,1
PCB 126 0,1
1,2,3,4,6,7,8-HpCDD 0,01
PCB 169 0,01
OCDD 0,0001
Mono-ortho PCBs
2,3,7,8-TCDF 0,1
PCB 105 0,0001
1,2,3,7,8-PeCDF 0,05
PCB 114 0,0005
2,3,4,7,8-PeCDF 0,5
PCB 118 0,0001
1,2,3,4,7,8-HxCDF 0,1
PCB 123 0,0001
1,2,3,6,7,8-HxCDF 0,1
PCB 156 0,0005
1,2,3,7,8,9-HxCDF 0,1
PCB 157 0,0005
2,3,4,6,7,8-HxCDF 0,1
PCB 167 0,00001
1,2,3,4,6,7,8-HpCDF 0,01
PCB 189 0,0001
1,2,3,4,7,8,9-HpCDF 0,01
OCDF 0,0001
Abbreviations used: “T” = tetra; “Pe” = penta; “Hx” = hexa; “Hp” = hepta; “O” = octa; “CDD” = chlorodibenzodioxin; “CDF” = chlorodibenzofuran; “CB” =
chlorobiphenyl.
L 159/18
EN
Official Journal of the European Union
17.6.2011
SECTION VI: HARMFUL BOTANICAL IMPURITIES
Maximum content in
mg/kg (ppm) relative
Undesirable substance
Products intended for
animal feed
to a feed with a
moisture content of
12 %
1. Weed seeds and unground and uncrushed fruits containing alkaloids, Feed materials and
3 000
glucosides or other toxic substances separately or in combination compound feed
including
— Datura sp.
1 000
2. Crotalaria spp. Feed
materials
and
100
compound feed
3. Seeds and husks from Ricinus communis L., Croton tiglium L. and Abrus Feed materials and
10 ( 2 )
precatorius L. as well as their processed derivatives ( 1 ), separately or in compound feed
combination
4. Unhusked beech mast – Fagus silvatica L.
Feed materials and Seeds and fruit of
5. Purghera – Jatropha curcas L.
compound feed
the plant species
6. Indian mustard – Brassica juncea (L.) Czern. And Coss. ssp. integrifolia
listed opposite as
(West.) Thell.
well as their
7. Sareptian mustard – Brassica juncea (L.) Czern. And Coss. ssp.juncea
processed
8. Chinese mustard – Brassica juncea (L.) Czern. And Coss. ssp. juncea var.
derivatives may
lutea Batalin
only be present in
9. Black mustard – Brassica nigra (L.) Koch
feed in trace
10. Ethiopian mustard – Brassica carinata A. Braun
amounts not
quantitatively deter
minable
11. Seeds from Ambrosia spp. Feed
materials 50
with the exception of:
— Millet (grains of
200
Panicum miliaceum
L.) and sorghum
(grains of
Sorghum bicolor
(L) Moench s.l.)
not directly fed
to animals.
Compound feed
50
containing unground
grains and seeds
( 1 ) In so far determinable by analytical microscopy.
( 2 ) Includes also seed husk fragments.
SECTION VII: AUTHORISED FEED ADDITIVES IN NON-TARGET FEED FOLLOWING UNAVOIDABLE CARRY-OVER
Maximum content in
mg/kg (ppm) relative
Coccidiostat Products
intended
for
animal
feed
( 1 )
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
0,4
use of decoquinate is prohibited (withdrawal feed),
EN
17.6.2011 Official
Journal
of
the
European
Union L
159/19
Maximum content in
mg/kg (ppm) relative
Coccidiostat Products
intended
for
animal
feed
( 1 )
to a feed with a
moisture content of
12 %
— other animal species. 1,2
Premixtures for use in feed in which the use of decoquinate is not
( 2 )
authorised.
2. Diclazuril Feed
materials 0,01
Compound feed for
— laying birds, chickens reared for laying (> 16 weeks) and turkeys for
0,01
fattening (> 12 weeks),
— rabbits for fattening and breeding for the period before slaughter in
0,01
which the use of diclazuril is prohibited (withdrawal feed),
— other animal species other than chickens reared for laying (< 16
0,03
weeks), chickens for fattening, guinea fowl and turkeys for
fattening (< 12 weeks).
Premixtures for use in feed in which the use of diclazuril is not auth
( 2 )
orised.
3. Halofuginone
Feed materials 0,03
hydrobromide
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
0,03
slaughter in which the use of halofuginone hydrobromide is
prohibited (withdrawal feed),
— other animal species. 0,09
Premixtures for use in feed in which the use of halofuginone hydro
( 2 )
bromide is not authorised.
4. Lasalocid sodium Feed
materials 1,25
Compound feed for
— dogs, calves, rabbits, equine species, dairy animals, laying birds,
1,25
turkeys (> 16 weeks) and chickens reared for laying (> 16 weeks),
— chickens for fattening, chickens reared for laying (< 16 weeks) and
1,25
turkeys (< 16 weeks) for the period before slaughter in which the use
of lasalocid sodium is prohibited (withdrawal feed),
— other animal species. 3,75
Premixtures for use in feed in which the use of lasalocid sodium is not
( 2 )
authorised
5. Maduramicin
Feed materials 0,05
ammonium alpha
L 159/20
EN
Official Journal of the European Union
17.6.2011
Maximum content in
mg/kg (ppm) relative
Coccidiostat Products
intended
for
animal
feed
( 1 )
to a feed with a
moisture content of
12 %
Compound feed for
— equine species, rabbits, turkeys (> 16 weeks), laying birds and
0,05
chickens reared for laying (> 16 weeks),
— chickens for fattening and turkeys (< 16 weeks) for the period before
0,05
slaughter in which the use of maduramicin ammonium alpha is
prohibited (withdrawal feed),
— other animal species. 0,15
Premixtures for use in feed in which the use of maduramicin ammonium
( 2 )
alpha is not authorised.
6. Monensin sodium Feed
materials 1,25
Compound feed for
— equine species, dogs, small ruminants (sheep and goat), ducks,
1,25
bovine, dairy cattle, laying birds, chickens reared for laying (> 16
weeks) and turkeys (> 16 weeks),
— chickens for fattening, chickens reared for laying (< 16 weeks) and
1,25
turkeys (< 16 weeks) for the period before slaughter in which the use
of monensin sodium is prohibited (withdrawal feed),
— other animal species. 3,75
Premixtures for use in feed in which the use of monensin sodium is not
( 2 )
authorised.
7. Narasin Feed
materials 0,7
Compound feed for
— turkeys, rabbits, equine species, laying birds and chickens reared for
0,7
laying (> 16 weeks),
— other animal species. 2,1
Premixtures for use in feed in which the use of narasin is not authorised.
( 2 )
8. Nicarbazin Feed
materials 1,25
Compound feed for
— equine species, laying birds and chickens reared for laying (> 16
1,25
weeks),
— other animal species. 3,75
EN
17.6.2011 Official
Journal
of
the
European
Union L
159/21
Maximum content in
mg/kg (ppm) relative
Coccidiostat Products
intended
for
animal
feed
( 1 )
to a feed with a
moisture content of
12 %
Premixtures for use in feed in which the use of nicarbazin (alone or in
( 2 )
combination with narasin) is not authorised.
9. Robenidine hydro Feed materials 0,7
chloride
Compound feed for
— laying birds and chickens reared for laying (> 16 weeks), 0,7
— chickens for fattening, rabbits for fattening and breeding and turkeys
0,7
for the period before slaughter in which the use of robenidine hydro
chloride is prohibited (withdrawal feed),
— other animal species. 2,1
Premixtures for use in feed in which the use of robenidine hydrochloride
( 2 )
is not authorised.
10. Salinomycin
Feed materials 0,7
sodium
Compound feed for
— equine species, turkeys, laying birds and chickens reared for laying
0,7
(> 12 weeks),
— chickens for fattening, chickens reared for laying (< 12 weeks) and
0,7
rabbits for fattening for the period before slaughter in which the use
of salinomycin sodium is prohibited (withdrawal feed),
— other animal species. 2,1
Premixtures for use in feed in which the use of salinomycin sodium is
( 2 )
not authorised
11. Semduramicin
Feed materials 0,25
sodium
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
0,25
use of semduramicin sodium is prohibited (withdrawal feed),
— other animal species. 0,75
Premixtures for use in feed in which the use of semduramicin sodium is
( 2 )
not authorised.
( 1 ) 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).
( 2 ) 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.
L 159/22
EN
Official Journal of the European Union
17.6.2011
ANNEX II
ACTION THRESHOLDS TRIGGERING INVESTIGATIONS BY MEMBER STATES, AS REFERRED TO IN
ARTICLE 4(2)
SECTION: DIOXINS AND PCBs
Action
threshold in ng Comments and
WHO-PCDD/F-
additional
Undesirable substances Products
intended
for
animal
feed
TEQ/kg
information (e.g.
(ppt) ( 2 ), ( 3 )
nature of inves
relative to a feed tigations to be
with a moisture
performed)
content of 12 %
1. Dioxins (sum of polychlorinated Feed materials of plant origin 0,5
( 4 )
dibenzo-para-dioxins (PCDDs), poly
chlorinated dibenzofurans (PCDFs))
expressed in World Health Organisation with the exception of:
(WHO) toxic equivalents, using the
WHO-TEFs (toxic equivalency factors,
1997 ( 1 ))
— vegetable oils and their by-products, 0,5
( 4 )
Feed materials of mineral origin 0,5
( 4 )
Feed materials of animal origin:
— Animal fat, including milk fat and egg
1,0
( 4 )
fat,
— Other land animal products including
0,5
( 4 )
milk and milk products and eggs and
egg products.
— Fish oil 5,0
( 5 )
— Fish, other aquatic animals, and
1,0
( 5 )
products and by-products with the
exception of fish oil and fish protein
hydrolysates containing more than
20 % fat ( 3 ).
— Fish protein hydrolysates containing
1,75
( 5 )
more than 20 % fat.
Feed additives belonging to the functional
0,5
( 5 )
groups of binders and anti-caking agents.
Feed additives belonging to the functional
0,5
( 4 )
group of compounds of trace elements
Premixtures 0,5
( 4 )
Compound feed 0,5
( 4 )
with the exception of:
EN
17.6.2011 Official
Journal
of
the
European
Union L
159/23
Action
threshold in ng Comments and
WHO-PCDD/F-
additional
Undesirable substances Products
intended
for
animal
feed
TEQ/kg
information (e.g.
(ppt) ( 2 ), ( 3 )
nature of inves
relative to a feed tigations to be
with a moisture
performed)
content of 12 %
— compound feed for pet animals and
1,75
( 5 )
fish,
— compound feed for fur animals.
—
2. Dioxin-like PCBs (sum of polychlor Feed materials of plant origin 0,35
( 4 )
inated biphenyls (PCBs)) expressed in
World Health Organisation (WHO)
toxic equivalents, using the WHO-TEFs with the exception of:
(toxic equivalency factors, 1997 ( 1 ))
— vegetable oils and their by-products, 0,5
( 4 )
Feed materials of mineral origin 0,35
( 4 )
Feed materials of animal origin:
— Animal fat, including milk fat and egg
0,75
( 4 )
fat,
— Other land animal products including
0,35
( 4 )
milk and milk products and eggs and
egg products.
— Fish oil 14,0
( 5 )
— Fish, other aquatic animals, and
2,5
( 5 )
products derived thereof with the
exception of fish oil and fish protein
hydrolysates containing more than
20 % fat ( 3 ),
— Fish protein hydrolysates containing
7,0
( 5 )
more than 20 % fat.
Feed additives belonging to the functional
0,5
( 4 )
groups of binders and anti-caking agents.
Feed additives belonging to the functional
0,35
( 4 )
group of compounds of trace elements.
Premixtures 0,35
( 4 )
Compound feed 0,5
( 4 )
with the exception of:
— compound feed for pet animals and
3,5
( 5 )
fish,
L 159/24
EN
Official Journal of the European Union
17.6.2011
Action
threshold in ng Comments and
WHO-PCDD/F-
additional
Undesirable substances Products
intended
for
animal
feed
TEQ/kg
information (e.g.
(ppt) ( 2 ), ( 3 )
nature of inves
relative to a feed tigations to be
with a moisture
performed)
content of 12 %
— compound feed for fur animals.
—
( 1 ) WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation meeting in Stockholm, Sweden, 15-
18 June 1997 (Van den Berg et al., (1998) Toxic Equivalency Factors (TEFs) for PCBs, PCDDs, PCDFs for Humans and for Wildlife.
Environmental Health Perspectives, 106(12), 775).
( 2 ) 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.
( 3 ) The Commission will review these action levels at the same time as it reviews the maximum levels for the sum of dioxins and dioxin-
like PCBs.
( 4 ) Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate
source of contamination.
( 5 ) 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 …, must be recorded with a view to future measures to manage the presence of dioxins and
dioxin-like compounds in these materials for animal nutrition.
Congener TEF
value
Congener TEF
value
Dibenzo-p-dioxins (“PCDDs”) and
“Dioxin-like” PCBs Non-ortho PCBs +
diobenzofurans (“PCDFs”)
Mono-ortho PCBs
2,3,7,8-TCDD
1
1,2,3,7,8-PeCDD
1
Non-ortho PCBs
1,2,3,4,7,8-HxCDD 0,1
PCB 77 0,0001
1,2,3,6,7,8-HxCDD 0,1
PCB 81 0,0001
1,2,3,7,8,9-HxCDD 0,1
PCB 126 0,1
1,2,3,4,6,7,8-HpCDD 0,01
PCB 169 0,01
OCDD 0,0001
Mono-ortho PCBs
2,3,7,8-TCDF 0,1
PCB 105 0,0001
1,2,3,7,8-PeCDF 0,05
PCB 114 0,0005
2,3,4,7,8-PeCDF 0,5
PCB 118 0,0001
1,2,3,4,7,8-HxCDF 0,1
PCB 123 0,0001
1,2,3,6,7,8-HxCDF 0,1
PCB 156 0,0005
1,2,3,7,8,9-HxCDF 0,1
PCB 157 0,0005
2,3,4,6,7,8-HxCDF 0,1
PCB 167 0,00001
1,2,3,4,6,7,8-HpCDF 0,01
PCB 189 0,0001
1,2,3,4,7,8,9-HpCDF 0,01
OCDF 0,0001
Abbreviations used: “T” = tetra; “Pe” = penta; “Hx” = hexa; “Hp” = hepta; “O” = octa; “CDD” = chlorodibenzodioxin; “CDF” = chlorodibenzofuran; “CB” =
chlorobiphenyl.’
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