MT
Undesirable Substances in Animal Feeds
Statutory Text (4 Articles)
L.N. 119 of 2007
VETERINARY SERVICES ACT
(CAP 437)
Undesirable Substances in Animal Feeds
(Amendment) (No. 2) Rules, 2007
IN exercise of the powers conferred by article 22(c) of the
Veterinary Services Act, 2001, the Minister for Rural Affairs and
the Environment has made the following rules:-
(1) The title of these rules is the Undesirable Substances
in Animal Feeds (Amendment No.2)Rules” 2007 and they shall be
read and construed as one with as Undesirable Substances in Animal
Feeds Rules, 2005, herinafter referred to as “the principal rules.
(2) The scope of these rules is to implement the
provisions found under Commission Directive 2006/13/EC of 3rd
February 2006 amending Annexes I and II to Directive 2002/32/EC
of the European Parliament and of the Council on undesirable
substances in animal feed as regards dioxins and dioxin-like PCBs’
For point 27 in Schedule I to the principal rules, there
shall be subsituted as follows:-
B
Undesirable substances
Products intended for animal feed
Maximum content relative to a
feedingstuff with a moisture
content of 12 %
(1)
(2)
(3)
0,75 ng WHO-PCDD/F-TEQ/kg (**)
27a.
Dioxins
(sum
of
(a) Feed materials of plant origin
(***)
polychlorinated
dibenzopara-
with the exception of vegetable
dioxins
(PCDDs)
and
oils and their byproducts
polychlorinateddibenzofurans
(PCDFs) expressed in World
Health Organisation (WHO) toxic
equivalents, using the WHO-
TEFs (toxicequivalency factors,
1997 (*)
(b) Vegetable oils and their by-products
0,75 ng WHO-PCDD/F-TEQ/kg (**)
(***)
(c) Feed materials of mineral origin
1,0 ng WHO-PCDD/F-TEQ/kg (**)
(***)
(d) Animal fat, including milk fat and
2,0 ng WHO-PCDD/F-TEQ/kg (**)
egg fat
(***)
(e) Other land animal products
0,75 ng WHO-PCDD/F-TEQ/kg (**)
including milk and milk products and
(***)
eggs and egg products
(f) Fish oil
6,0 ng WHO-PCDD/F-TEQ/kg (**)
(***)
(g) Fish, other aquatic animals, their
1,25 ng WHO-PCDD/F-TEQ/kg (**)
products and by-products with the
(***)
exception of fish oil and fish protein
hydrolysates containing more than 20
% fat
(h) Fish protein hydrolysates
2,25 ng WHO-PCDD/F-TEQ/kg (**)
containing more than 20 % fat
(***)
(i) The additives kaolinitic clay,
0,75 ng WHO-PCDD/F-TEQ/kg (**)
calcium sulphate dihydrate, vermiculite,
(***)
natrolitephonolite, synthetic calcium
aluminates and clinoptilolite of
sedimentary origin belonging to the
functional groups of binders and anti-
caking agents
(j) Additives belonging to the
1,0 ng WHO-PCDD/F-TEQ/kg (**)
functional group of compounds of trace
(***)
elements
1,0 ng WHO-PCDD/F-TEQ/kg (**)
(k) Premixtures
(***)
(l) Compound feedingstuffs, with the
0,75 ng WHO-PCDD/F-TEQ/kg (**)
exception of feed for fur animals, pet
(***)
foods and feed for fish
B
(m) Feed for fish.
2,25 ng WHO-PCDD/F-TEQ/kg (**)
Pet foods
(***)
27b. Sum of dioxins and dioxin-like PCBs
(a) Feed materials of plant origin with
1,25 ng WHO-PCDD/F-PCB-TEQ/kg
(sum of polychlorinated dibenzo-para-
the exception of vegetable oils and their
(**)
dioxins
(PCDDs),
polychlorinated
byproducts
dibenzofurans
(PCDFs)
and
polychlorinated
biphenyls
(PCBs)
expressed in World Health Organisation
(WHO) toxic equivalents, using the
WHO-TEFs (toxic equivalency factors,
1997 (*)
(b) Vegetable oils and their by-products
1,5 ng WHO-PCDD/F-PCB-TEQ/kg
(**)
(c) Feed materials of mineral origin
1,5 ng WHO-PCDD/F-PCB-TEQ/kg
(**)
(d) Animal fat, including milk fat and
3,0 ng WHO-PCDD/F-PCB-TEQ/kg
egg fat
(**)
(e) Other land animal products
1,25 ng WHO-PCDD/F-PCB-TEQ/kg
including milk and milk products and
(**)
eggs and egg products
(f) Fish oil
24,0 ng WHO-PCDD/F-PCB-TEQ/kg
(**)
(g) Fish, other aquatic animals, their
4,5 ng WHO-PCDD/F-PCB-TEQ/kg
products
(**)
and by-products with the exception of
fish oil and fish protein hydrolysates
containing more than 20 % fat
(h) Fish protein hydrolysates containing
11,0 ng WHO-PCDD/F-PCB-TEQ/kg
more
(**)
than 20 % fat
(i) Additives belonging to the
1,5 ng WHO-PCDD/F-PCB-TEQ/kg
functional
(**)
groups of binders and anti-caking
agents
(j) Additives belonging to the
1,5 ng WHO-PCDD/F-PCB-
functional group of compounds of trace
TEQ/kg(**)
elements
(k) Premixtures
1,5 ng WHO-PCDD/F-PCB-TEQ/kg
(**)
(l) Compound feedingstuffs, with the
1,5 ng WHO-PCDD/F-PCB-TEQ/kg
exception of feed for fur animals, pet
(**)
foods and feed for fish
(m) Feed for fish.
7,0 ng WHO-PCDD/F-PCB-TEQ/kg
Pet foods
(**)
(*) 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, and PCDFs for Humans and for Wildlife. Environmental Health
Perspectives, 106(12), 775).
B
Congener
TEF value
Congener
TEF value
Dibenzo-p-dioxins
“Dioxin-Like PCBs”
(PCDSS)
2-3-7-8 TCDD
0.0001
Non-ortho
0.0001
PCBs+Mono-ortho
1,2,3 7 8 PeCDD
0.1
Non-ortho PCBs
0.01
1,2,3,4,7, HxCDD
0,1
PCB 77
1,2,3,7,8 HxCDD
0,1
PCB 81
1,2,3,4,7,8 HxCDD
0.01
PCB 126
OCDD
0.0001
PCB 169
Dibenzofurans
Mono-ortho PCBs
(PCDFs)
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
1,2,3,4,7,8,9-HpCDF
0,01
PCB 189
OCDF
0,0001
0,0001
(**) 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.
(***) The separate maximum level for dioxins (PCDD/F) remains applicable for a temporary period. The products intended for animal feed
mentioned in point 27a 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.
(****) Fresh fish directly delivered and used without intermediate processing for the production of feed for fur animals is 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 used for the direct feeding of pet animals, zoo and circus animals. The products, 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.’
B
Amendment to Schedule II to the principal rules.
For Schedule II to the principal rules, shall be subsituted by the following
‘SCHEDULE II
‘Undesirable substances
Products intended for animal
Action threshold relative to a
Comments and additional
feed
feedingstuff with a moisture
information
content of 12 %
(e.g. nature of investigations to
be performed)
(1))
(2)
(3
(4)
1. Dioxins (sum of
a) Feed materials of plant()
0,5 ng WHO-PCDD/F-TEQ/
Identification of source of
polychlorinated
(origin with the exception of
kg
contamination. Once source
dibenzo-para-dioxins
vegetable oils and their
is identified,
(PCDDs),
byproducts
take appropriate measures,
polychlorinated PCDFs)
where
expressed in World
possible, to reduce or
Health Organisation (WHO
eliminate source of
dibenzofurans toxic
contamination
equivalents, using the WHO-
TEFs (toxic equivalency
factors, 1997 (*)
(b) Vegetable oils and their
0,5 ng WHO-PCDD/F-TEQ
Identification of source of
byproducts
contamination.
Once source is identified,
take appropriate measures,
where
possible, to reduce or
eliminate
source of contamination
(c) Feed materials of mineral
0,5 ng WHO-PCDD/F-TEQ/
Identification of source of
origin
kg
contamination.
Once source is identified,
take appropriate measures,
where possible, to reduce or
eliminate
source of contamination
(d) Animal fat, including
1,0 ng WHO-PCDD/F-TEQ/
Identification of source of
milk fat
kg
contamination.
and egg fat
Once source is identified,
take appropriate measures,
where possible, to reduce or
eliminate
source of contamination
(e) Other land animal
0,5 ng WHO-PCDD/F-TEQ/
Identification of source of
products
kg
contamination.
including milk and milk
Once source is identified,
products and eggs and egg
take appropriate measures,
products
where possible, to reduce or
eliminate
source of contamination
(f) Fish oil /
5,0 ng WHO-PCDD/F-TEQ
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
B
period, geographical origin,
fish species etc., should be
recorded with a view to
future measures to
manage the presence of
dioxins and dioxin-like
compounds in these
materials for animal
nutrition.
(g) Fish, other aquatic
0,5 ng WHO-PCDD/F-TEQ/
In many cases it might not
animals, their products and
kg
be necessary to perform an
.
byproducts
with
the
investigation into the source
,
exception of fish oil and fish
of contamination as the
protein
hydrolysates
background level in some
containing more than 20 %
areas is close to or above the
fat
action level. However, in
cases where the action level
is exceeded all information,
such as sampling period,
geographical origin, fish
species etc., should be
recorded with a view to
future measures to manage
the presence of dioxins and
dioxin-like compounds in
these materials for animal
nutrition.
h) Fish protein hydrolysates
1,75 ng WHO-PCDD/F-
In many cases it might not
containing more than 20 %
TEQ/ kg
be necessary to perform an
fat
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., should be
recorded with a view to
future measures to
manage the presence of
dioxins and dioxin-like
compounds in these
materials for animal
nutrition.
.
i) Additives belonging to the
0,5 ng WHO-PCDD/F-TEQ/
Identification of source of
functional groups of binders
kg
contamination.
and anti-caking agents
Once source is identified,
take appropriate measures,
where
possible, to reduce or
eliminate
source of contamination
B
j) Additives belonging to the
0,5 ng WHO-PCDD/F-TEQ/
Identification of source of
functional group of
kg
contamination. Once source
compounds
is identified, take appropriate
of trace elements
measures, where possible, to
reduce or eliminate source of
contamination
(k) Premixtures
0,5 ng WHO-PCDD/F-TEQ/
Identification of source of
.
kg
contamination. Once source
is identified, take appropriate
measures, where
possible, to reduce or
eliminate source of
contamination
(l) Compound feedingstuffs,
0,5 ng WHO-PCDD/F-TEQ/
Identification of source of
with the exception of
kg
contamination. Once source
feedingstuffs for fur animals,
is identified,
pet foods and feedingstuffs
take appropriate measures,
for fish
where possible, to reduce or
eliminate source of
contamination
(m) Feedingstuffs for fish.
1,75 ng WHO-PCDD/F-
In many cases it might not
Pet foods
TEQ/kg
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.
(.
B
2. Dioxin like PCBs (sum of
(a) Feed materials of plant
0,35 ng WHO-PCB-TEQ/
Identification of source of
polychlorinated
origin with the exception of
kg
contamination.
biphenyls (PCBs)
vegetable oils and their
Once source is identified,
expressed in World Health
byproducts
take appropriate measures,
Organisation (WHO) toxic
where possible, to reduce or
equivalents, using the
eliminate
WHOTEFs
source of contamination.
(toxic equivalency factors,
1997 (*)
b) Vegetable oils and their
0,5 ng WHO-PCB-TEQ/
Identification of source of
byproducts source of
kg
contamination.
contamination.
Once source is identified,
take appropriate measures,
where possible, to reduce or
eliminate
(c) Feed materials of mineral
0,35 ng WHO-PCB-TEQ/
Identification of source of
origin
kg
contamination.
Once source is identified,
take appropriate measures,
where possible, to reduce or
eliminate source of
contamination
(d) Animal fat, including
0,75 ng WHO-PCB-TEQ/
Identification of source of
milk fat
kg (**) (***)
contamination.
and egg fat
Once source is identified,
take appropriate measures,
where possible, to reduce or
eliminate source of
contamination
e) Other land animal
0,35 ng WHO-PCB-TEQ/
Identification of source of
products
kg (**) (***)
contamination.
including milk and milk
Once source is identified,
products and eggs and egg
take appropriate measures,
products
where possible, to reduce or
eliminate source of
contamination
f) Fish oil
14,0 ng WHO-PCB-TEQ/
In many cases it might not
kg (**) (***)
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.
B
(g) Fish, other aquatic
2,5 ng WHO-PCB-TEQ/
In many cases it might not
animals, their products and
kg
be necessary to perform an
byproducts
with
the
investigation into the source
exception of fish oil and fish
of contamination as the
protein
hydrolysates
background level in some
containing more than 20 %
areas is close to or above the
fat
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.
(h) Fish protein hydrolysates
7,0 ng WHO-PCB-TEQ/
In many cases it might not
containing more than 20 %
kg (**) (***)
be necessary to perform an
fat
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.
(i) Additives belonging to
0,5 ng WHO-PCB-TEQ/
Identification of source of
the
kg
contamination. Once source
functional groups of binders
is identified,take appropriate
and anti-caking agents
measures, where possible, to
reduce or eliminate source of
contamination
0,35 ng WHO-PCB-TEQ/
Identification of source of
kg
contamination. Once
(j) Additives belonging to
source is identified, take
the
appropriate measures, where
functional group of
possible, to reduce or
compounds
eliminate
source
of
of trace elements
contamination.
0,35 ng WHO-PCB-TEQ/
Identification of source of
kg
contamination.
(k) Premixtures
Once source is identified,
take appropriate measures,
where possible, to reduce or
eliminate source of
contamination
B
(l) Compound feedingstuffs,
0,5 ng WHO-PCB-TEQ/
Identification of source of
with the exception of
kg
contamination.
feedingstuffs for fur animals,
Once source is identified,
pet foods and feedingstuffs
take appropriate measures,
for fish
where possible, to reduce or
eliminatesource of
contamination
(m) Feedingstuffs for fish.
3,5 ng WHO-PCB-TEQ/
In many cases it might not
Pet foods
kg
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.
(*) 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).
B
Congener
TEF value
Congener
TEF value
Dibenzo-p-dioxins
“Dioxin-Like PCBs”
(PCDSS)
2-3-7-8 TCDD
Non-ortho
PCBs+Mono0ortho
1,2,3 7 8 PeCDD
Non-ortho PCBs
0.0001
1,2,3,4,7, HxCDD
0,1
PCB 77
0.1
PCB 81
1,2,3,7,8 HxCDD
0,1
0.01
1,2,3,4,7,8 HxCDD
0.01
PCB 126
0.0001
OCDD
0.0001
PCB 169
Dibenzofurans
Mono-ortho PCBs
(PCDFs)
2,3,7,8-TCDF
0,1
PCB 105
0,0001
PCB 114
0,0005
1,2,3,7,8-PeCDF
0,05
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
1,2,3,4,7,8,9-HpCDF
0,01
OCDF
0,0001
0,0001
(**) 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.
(***) The Commission will review these action levels by 31 December 2008 at the latest at the same time as it reviews the maximum levels the
sum of dioxins and dioxin-like PCBs.’
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