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7.1.2014 Official
Journal
of
the
European
Union
L
2/3
COMMISSION REGULATION (EU) No 5/2014
of 6 January 2014
amending Directive 2008/38/EC establishing a list of intended uses of animal feedingstuffs for
particular nutritional purposes
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4)
A specific way of feeding is the administration of a bolus.
In order to guarantee an appropriate and safe use of a
bolus as feed for particular nutritional purposes, general
requirements should be established for the conditions
associated with certain intended uses.
Having regard to the Treaty on the Functioning of the European
Union,
(5) The
Commission
made
all
applications,
including
the
Having regard to Regulation (EC) No 767/2009 of the European
dossiers, available to the Member States.
Parliament and of the Council of 13 July 2009 on the placing
on the market and use of feed, amending European Parliament
and Council Regulation (EC) No 1831/2003 and repealing
Council Directive 79/373/EEC, Commission Directive
80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC,
(6) The
dossiers
included
in
the
applications
demonstrate
93/74/EEC, 93/113/EC and 96/25/EC and Commission
that the specific composition of the respective feeds
Decision 2004/217/EC (
fulfil the particular intended nutritional purposes ‘Nutri

1 ), and in particular Article 10(5)
thereof,
tional restoration, convalescence‘ as regards dogs, ‘Stabili
sation of physiological digestion’ ‘Reduction of iodine
levels in feed in case of hyperthyroidism’ as regards
cats, ‘Support the preparation for and recovery from
sport effort’ as regards equidae, ‘Compensation for insuf
Whereas:
ficient iron availability after birth’ as regards suckling
piglets and calves, ‘Support the regeneration of hooves,
trotters and skin’ as regards horses, ruminants and pigs,
‘Support the preparation for oestrus and reproduction’ as
regards mammals and birds and ‘Long-term supply of
(1) In
accordance
with
Article
32(2)
of
Regulation
(EC)
No
767/2009, several applications for authorisation were
grazing animals with trace elements and/or vitamins’ as
submitted to the Commission before 1 September
regards ruminants with a functional rumen.
2010 for updating the list of intended uses as referred
to in Article 10 of that Regulation.
(7) Furthermore, the evaluation showed that the feeds
concerned have no adverse effects on animal health,
(2) Some
of
those
applications
concern
changes
of
the
human health, the environment or animal welfare. The
conditions associated with the particular nutritional
evaluation of the dossiers included verification that the
purposes ‘Nutritional restoration, convalescence’ as
characterisation ‘high level of a certain feed additive’
regards dogs and ‘Stabilisation of physiological digestion’
implies an important level of the respective additive
in respect of feed that may contain additives in concen
which is close to the relevant fixed maximum content
trations higher than 100 times the relevant fixed
in complete feed but not exceeding this content.
maximum content in complete feed as referred to in
Article 8(2) of Regulation (EC) No 767/2009. The
other applications concern new particular nutritional
purposes with respect to the requirement established in
Article 8(2) of Regulation (EC) No 767/2009.
(8) The
applications
are
therefore
valid
and
the
particular
nutritional purposes should be added to the list of
intended uses and the conditions associated with the
particular nutritional purposes ‘Nutritional restoration,
convalescence’ and ‘Stabilisation of physiological
(3) In
addition,
in
accordance
with
Article
10
of
Regulation
digestion’ should be changed.
(EC) No 767/2009, the Commission received an appli
cation to add the particular nutritional purpose
‘Reduction of iodine levels in feed in case of hyperthy
roidism’ as regards cats.
(9) Directive
2008/38/EC
should
therefore
be
amended
( 1 ) OJ L 229, 1.9.2009, p. 1.
accordingly.

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L 2/4
EN
Official Journal of the European Union
7.1.2014
(10) Since safety reasons do not require the immediate appli
Article 2
cation of the modifications for the feed currently legally
placed on the market, it is appropriate to allow a tran
Feed included in the Annex to this Regulation and referred to in
sitional period for interested parties to prepare them
Article 8(2) of Regulation (EC) No 767/2009 that have already
selves to meet the new requirements.
been legally placed on the market before 1 September 2010
which are produced and labelled before 27 July 2014 may
(11) The
measures
provided
for
in
this
Regulation
are
in
continue to be placed on the market and used until the
accordance with the opinion of the Standing
existing stocks are exhausted. In case this feed is intended for
Committee on the Food Chain and Animal Health and
pets, the date mentioned in the last sentence is 27 January
neither the European Parliament nor the Council has
2016.
opposed them,
HAS ADOPTED THIS REGULATION:
Article 3
Article 1
This Regulation shall enter into force on the twentieth day
Annex I to Directive 2008/38/EC is amended in accordance
following that of its publication in the Official Journal of the
with the Annex to this Regulation.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 January 2014.
For the Commission
The President
José Manuel BARROSO

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7.1.2014 Off
ANNEX
Annex I to Directive 2008/38/EC is amended as follows:
(1) In Part A, the following point is added:
‘10. When a feed intended for particular nutritional purposes is placed on the market in the form of a bolus, being a feed material or complementary feed intended for individual oral administration by
EN
forced feeding, the label of the feed shall, if applicable, mention the maximum period of continuously release of the bolus and the daily release rate for each additive for which a maximum content in

complete feed is fixed. At the request of the competent authority the feed business operator which is placing a bolus on the market shall provide proof that the daily available additive level in the
digestive tract will not exceed, if applicable, the maximum content of the additive established per kg complete feed during the whole feeding period (slow release effect). It is recommended that feed in
form of bolus is administered by a veterinarian or any other competent person.’
(2) Part B is amended as follows:
Particular nutritional purpose Essential
nutritional
characteristics
Species or category of
animal
Labelling declarations Recommended
length
of
time Other
provisions
(a) The following row is inserted between the row of the particular nutritional purpose ‘Regulation of lipid metabolism in the case of hyperlipidaemia’ and the row of the particular nutritional purpose
icial
‘Reduction of copper in the liver’:
Jour
‘Reduction of iodine levels in Restricted level of iodine: maximum Cats Total
iodine Initially
up
to
3
months Indicate
on
the
labelling:
“It
is
recom
nal
feed in case of hyperthy
0,26 mg/kg complete pet food with
mended that advice from a veterinarian
roidism
a moisture content of 12 %
be sought before use and before
of
extending the period of use” ’
the
European
(b) The row of the particular nutritional purpose ‘Nutritional restoration, convalescence’, species or category of animals: ‘dogs and cats’, is replaced by the following:
‘Nutritional restoration,
High energy density, high concen
Dogs and cats —
Highly
digestible
ingredients,
Until restoration is achieved In
the
case
of
feed
specially
presented
Union
convalescence (*)
trations of essential nutrients and
including their treatment if
to be given via tubing, indicate on the
highly digestible ingredients
appropriate
labelling: “Administration under
veterinary supervision.”
— Energy value
— Content of n-3 and n-6 fatty
acids (if added)
Enterococcus faecium DSM 10663 / Dogs Name
and
added
amount
of
the
10 to 15 days —
The
instructions
for
use
of
the
feed
NCIMB 10415 (E1707)
gut flora stabiliser
shall ensure that the legal maximum
content of the gut flora stabiliser for
The complementary feed may
complete feed is respected.
contain feed additives of the func
tional group of “gut flora stabilisers”
— Indicate on the labelling: “It is
in a concentration higher than 100
recommended that advice from a
times the relevant fixed maximum
veterinarian be sought before use
content in complete feed.
and before extending the period of
use.”
L
2/5
(*) The manufacturer may complete the particular nutritional purpose with a reference to “Feline hepatic lipidosis”.’

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L 2/6
(c) The row of the particular nutritional purpose ‘Stabilisation of physiological digestion’ is replaced by the following:
‘Stabilisation of physiological Low buffering capacity, and highly
Piglets —
Highly
digestible
ingredients
2 to 4 weeks Indicate
on
the
labelling:
digestion
digestible ingredients
including their treatment if
appropriate
“In case of risk of, during periods of, or
recovery from, digestive disturbance.”
— Buffering capacity
EN
— Source(s) of astringent

substances (if added)
— Source(s) of mucilaginous
substances (if added)
Highly digestible ingredients Pigs —
Highly
digestible
ingredients
including their treatment if
appropriate
— Source(s) of astringent
Off
substances (if added)
icial
— Source(s) of mucilaginous
Jour
substances (if added)
nal
of
Feed additives of the functional
Animal species for Name and added amount of the Up to 4 weeks
Indicate on the labelling of the feed:
group “Gut flora stabiliser” of the
which the gut flora gut flora stabiliser
the
category “zootechnical additives” as stabiliser is auth
(1) “In case of risk of, during periods
European
referred to in Annex I to Regulation orised
of, or recovery from digestive
(EC) No 1831/2003.
disturbance.”
The complementary feed may
(2) If applicable: “The feed contains a
Union
contain feed additives of the func
gut flora stabiliser in a concen
tional group of “gut flora stabilisers”
tration above 100 times the auth
in a concentration higher than 100
orised maximum content in
times the relevant fixed maximum
complete feed.”
content in complete feed.
The instructions for use of the feed
shall ensure that the legal maximum
content of the gut flora stabiliser for
complete feed is respected.’
(d) The following rows are inserted between the row of the particular nutritional purpose ‘Reduction of the risk of acidosis’ and the row for the particular nutritional purpose ‘Stabilisation of water and
electrolyte balance’:
‘Long-term supply of
High level of
Ruminants with a
— Names and total amounts of Up to 12 months —
Application
in
the
form
of
bolus
is
grazing animals with trace
functional rumen
each added trace element,
allowed. A bolus may contain up to
elements and/or vitamins
— Trace elements
vitamin, provitamin and
20 % iron in an inert, non-bioa
7.1.2014
chemically well-defined
vailable form, in order to increase
and/or
substance having similar
its density.
effects.

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7.1.2014 Off
— vitamins, provitamins and
— Daily release rate for each
— Indicate on the labelling of the feed:
chemically well-defined
trace element and/or vitamin
substances having similar effects.
if a bolus is used;
“— Simultaneous supplementation
of additives with a maximum
The complementary feed may
— Maximum period of
content from other sources to
contain feed additives in a concen
continuously release of the
those incorporated in a bolus, if
tration higher than 100 times the
trace element or vitamin if a
applicable, shall be avoided.
EN
relevant fixed maximum content in
bolus is used.

complete feed.
— Before using, it is recommended
to have advice from a
veterinarian or nutritionist
concerning:
(1) the balance of trace
elements in the daily ration;
icial
(2) the trace elements status of
Jour
the herd
nal
— The bolus contains x % inert
of
iron in order to increase its
the
density, if applicable.”
European
Compensation for insufficient High level of iron compounds auth Suckling piglets
Total iron content After
birth
up
to
3
weeks
The instructions for use for the feed
iron availability after birth
orised under the functional group
and calves
shall ensure that the legal maximum
Union
“compounds of trace elements” of
contents of iron for complete feed are
the category “nutritional additives” as
respected.
referred to in Annex I to Regulation
(EC) No 1831/2003.
The complementary feed may
contain iron in a concentration
higher than 100 times the relevant
fixed maximum content in complete
feed.
Support the regeneration of
High level of zinc.
Horses, ruminants Total amount of
Up to 8 weeks The
instructions
of
use
for
the
feed
hooves, trotters and skin
and pigs
shall ensure that the legal maximum
contents of zinc for complete feed are
The complementary feed may
— zinc
respected.
contain zinc in a concentration
higher than 100 times the relevant
fixed maximum content in complete
— methionine
L
feed.
2/7

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L 2/8
Support the preparation for
— High level of selenium and
Mammals Names
and
total
amounts
of
each
— Cows: 2 weeks before — The instructions of use for the feed
oestrus and reproduction
added trace element and vitamin.
the end of gestation
shall ensure that the respective legal
until the next gestation is
maximum contents for complete
a minimum content of vitamin E
confirmed.
feed are respected.
per kg complete feed with a
moisture content of 12 % for
pigs of 53 mg, rabbits of 35 mg,
— Sows: 7 days before until — Indicate on the labelling of the feed:
for dogs, cats, mink of 88 mg;
3 days after parturition
EN
and 7 days before until 3

days mating.
“Guidance on the situations in
a minimum content of vitamin E
which the use of the feed is appro
per animal and day for ovines of
priate.” ’
100 mg, cattle of 300 mg, horses
— Other female mammals:
of 1 100 mg
from the last part of
gestation until the next
gestation is confirmed.
or
— Males: during periods of
— High level(s) of vitamins A
reproductive activity.
Off
icial
and/or vitamin D and/or a
Jour
nal
minimum content of beta-
carotene of 300 mg per animal
of
and day.
the
European
The complementary feed may
contain selenium, vitamin A and D
in a concentration higher than 100
times the relevant fixed maximum
Union
content in complete feed.
— High level(s) of vitamin A and/or Birds Names
and
total
amounts
of
each
— For females: during
vitamin D
added trace element and vitamin.
oestrus
or
— For males: during periods
of reproductive activity
— High level(s) of selenium and/or
zinc and/or a minimum content
of vitamin E of 44 mg/kg
complete feed with a moisture
content of 12 %.
The complementary feed may
contain selenium, zinc, vitamin A
7.1.2014
and D in a concentration higher
than 100 times the relevant fixed
maximum content in complete feed.

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7.1.2014 Off
(e) The following row is inserted between the row of the particular nutritional purpose ‘Compensation of electrolyte loss in the cases of heavy sweating’ and the row of the particular nutritional purpose
‘Nutritional restoration, convalescence’, species or category of animals: ‘equidae’:
‘Support the preparation for High level of selenium and a
Equidae Total
amount
of
Up to 8 weeks before sport The instructions for use for the feed
and recovery from sport
minimum content of 50 mg vitamin
effort – Up to 4 weeks after shall ensure that the legal maximum
effort
E per kg complete feed with
sport effort
contents of selenium for complete feed
moisture content of 12 %.
— vitamin E
are respected.’
EN

The complementary feed may
— selenium.
contain compounds of selenium in a
concentration higher than 100 times
the relevant fixed maximum content
in complete feed.
icial
Jour
nal
of
the
European
Union
L
2/9

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