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L 53/120 EN Official Journal of the European Union 23.2.2018
COMMISSION IMPLEMENTING REGULATION (EU) 2018/248
of 15 February 2018
concerning the authorisation of 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-
3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxy
pyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline as feed additives
for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003
on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the
grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the
re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).
(2) The substances 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2-acetyl-3-ethylpyrazine, 2,3-diethyl-5-
methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3-methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline,
2-ethylpyrazine and 5-methylquinoxaline (‘substances concerned’) were authorised without a time limit by
Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the
Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC)
No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an
application was submitted for the re-evaluation of the substances concerned as feed additives for all animal
species. The applicant requested those additives be classified in the additive category ‘sensory additives’. That
application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC)
No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 December 2016 (3) that,
under the proposed conditions of use the substances concerned do not have adverse effects on animal health,
human health or the environment. These substances increase the food smell or palatability. The Authority has
concluded that since the substances concerned are used in food as flavourings and their function in feed is
essentially the same as in food, no further demonstration of efficacy is necessary. Therefore, that conclusion can
be extrapolated for feed. The applicant withdrew the application for use of the substances concerned in water for
drinking.
(5) The Authority further noted that for the substances concerned hazards for the skin, eye contact and respiratory
exposure are recognised. Most substances are classified as irritating to the respiratory system. Consequently,
appropriate protective measures should be taken. The Authority does not consider that there is a need for
specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed
additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6) The assessment of the substances concerned shows that the conditions for authorisation, as provided for in
Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be
authorised as specified in the Annex to this Regulation.
(7) The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal,
the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of
official controls along the food chain, certain labelling requirements should be provided for. In particular, where
the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of
premixtures and the labelling of feed materials and compound feed containing the substances concerned include
certain information including reference to the levels considered by the Authority.
(1) OJ L 268, 18.10.2003, p. 29.
(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3) EFSA Journal 2016;15(2):4671.23.2.2018 EN Official Journal of the European Union L 53/121
(8) The fact that the use of the substances concerned in water for drinking is not authorised does not preclude their
use in compound feed which is administered via water.
(9) Since safety reasons do not require the immediate application of the modifications to the conditions of authoris
ation for the substances concerned, it is appropriate to allow a transitional period for interested parties to
prepare themselves to meet the new requirements resulting from the authorisation.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Authorisation
The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group
‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that
Annex.
Article 2
Transitional measures
1. The substances specified in the Annex and premixtures containing those substances, which are produced and
labelled before 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be
placed on the market and used until the existing stocks are exhausted.
2. Feed materials and compound feed containing the substances as specified in the Annex which are produced and
labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 may continue to be
placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Feed materials and compound feed containing the substances as specified in the Annex which are produced and
labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 may continue to be
placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing
animals.
Article 3
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 February 2018.
For the Commission
The President
Jean-Claude JUNCKERANNEX
Minimum Maximum
Identifica content content
Name of End of
tion Species or
the holder Composition, chemical formula, Maximum period of
number of Additive category of mg of active substance/kg Other provisions
of author description, analytical method age authoris
the animal of complete feedingstuff isation ation
additive with a moisture content of
12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b14005 — 2,3- Additive composition All animal — — — 1. The additive shall be incorporated into the 15.3.2028
Diethyl species feed in the form of a premixture.
2,3-Diethylpyrazine
pyrazine
2. In the directions for use of the additive
Characterisation of the active sub
and premixtures, the storage and stability
stance
conditions shall be indicated.
2,3-Diethylpyrazine
3. On the label of the additive the following
Produced by chemical synthesis shall be indicated:
Purity: min. 97 % assay ‘Recommended maximum content of the
active substance of complete feedingstuff
Chemical formula: C H N
8 12 2 with a moisture content of 12 %:
CAS number: 15707-24-1
— 0,1 mg/kg for pigs and poultry.
FLAVIS No: 14.005
— 0,5 mg/kg for other species and cat
Method of analysis(1) egories’.
For the determination of 2,3- 4. The functional group, the identification
diethylpyrazine in the feed addi number, the name and the added amount
tive and in feed flavouring of the active substance shall be indicated
premixtures: on the label of the premixture where the
use levels suggested on the label of the
Gas chromatography mass spec
premixture would result in exceeding the
trometry with retention time lock
levels referred to in point 3.
ing GC-MS-RTL.
5. The functional group, the identification
number, the name and the added amount
of the active substance shall be indicated
in the labelling of feed materials and com
pound feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content of
12 % exceeds:
— 0,1 mg/kg for pigs and poultry.
— 0,5 mg/kg for other species and cat
egories
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Journal
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Union
23.2.2018Minimum Maximum
Identifica content content
Name of End of
tion Species or
the holder Composition, chemical formula, Maximum period of
number of Additive category of mg of active substance/kg Other provisions
of author description, analytical method age authoris
the animal of complete feedingstuff
isation ation
additive with a moisture content of
12 %
6. For users of the additive and premixtures,
feed business operators shall establish op
erational procedures and organisational
measures to address potential risks by in
halation, dermal contact or eyes contact.
Where those risks cannot be eliminated or
reduced to a minimum by such procedures
and measures, the additive and premix
tures shall be used with personal protective
equipment, including breathing protection,
safety glasses and gloves.
2b14025 — 2,5 or 6- Additive composition All animal — — — 1. The additive shall be incorporated into the 15.3.2028
Methoxy- species feed in the form of a premixture.
2,5 or 6-Methoxy-3-methylpyra
3-methyl
zine 2. In the directions for use of the additive
pyrazine
and premixtures, the storage and stability
Characterisation of the active sub
conditions shall be indicated.
stance
3. On the label of the additive the following
2,5 or 6-Methoxy-3-methylpyra
shall be indicated:
zine
‘Recommended maximum content of the
Produced by chemical synthesis
active substance of complete feedingstuff
Purity: min. 97 % assay with a moisture content of 12 %:
Chemical formula: C H ON — 0,1 mg/kg for pigs and poultry.
6 8 2
CAS number: 63450-30-6 — 0,5 mg/kg for other species and cat
egories’.
FLAVIS No: 14.025
4. The functional group, the identification
Method of analysis(1)
number, the name and the added amount
For the determination of 2,5 or of the active substance shall be indicated
6-methoxy-3-methylpyrazine in on the label of the premixture where the
the feed additive and in feed fla use levels suggested on the label of the
vouring premixtures: premixture would result in exceeding the
levels referred to in point 3.
Gas chromatography mass spec
trometry with retention time lock
ing GC-MS-RTL.
23.2.2018
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53/123Minimum Maximum
Identifica content content
Name of End of
tion Species or
the holder Composition, chemical formula, Maximum period of
number of Additive category of mg of active substance/kg Other provisions
of author description, analytical method age authoris
the animal of complete feedingstuff
isation ation
additive with a moisture content of
12 %
5. The functional group, the identification
number, the name and the added amount
of the active substance shall be indicated
in the labelling of feed materials and com
pound feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content of
12 % exceeds:
— 0,1 mg/kg for pigs and poultry.
— 0,5 mg/kg for other species and cat
egories
6. For users of the additive and premixtures,
feed business operators shall establish op
erational procedures and organisational
measures to address potential risks by in
halation, dermal contact or eyes contact.
Where those risks cannot be eliminated or
reduced to a minimum by such procedures
and measures, the additive and premix
tures shall be used with personal protective
equipment, including breathing protection,
safety glasses and gloves.
2b14049 — 2-Acetyl- Additive composition All animal — — — 1. The additive shall be incorporated into the 15.3.2028
3-ethylpyr species feed in the form of a premixture.
2-Acetyl-3-ethylpyrazine
azine
2. In the directions for use of the additive
Characterisation of the active sub
and premixtures, the storage and stability
stance
conditions shall be indicated.
2-Acetyl-3-ethylpyrazine
3. On the label of the additive the following
Produced by chemical synthesis shall be indicated:
Purity: min. 98 % assay ‘Recommended maximum content of the
active substance of complete feedingstuff
Chemical formula: C H ON
8 10 2 with a moisture content of 12 %:
CAS number: 32974-92-8 — 0,1 mg/kg for pigs and poultry.
FLAVIS No: 14.049 — 0,5 mg/kg for other species and cat
egories’.
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53/124
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Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
Identifica content content
Name of End of
tion Species or
the holder Composition, chemical formula, Maximum period of
number of Additive category of mg of active substance/kg Other provisions
of author description, analytical method age authoris
the animal of complete feedingstuff
isation ation
additive with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identification
number, the name and the added amount
For the determination of 2-acetyl-
of the active substance shall be indicated
3-ethylpyrazine in the feed addi
on the label of the premixture where the
tive and in feed flavouring
use levels suggested on the label of the
premixtures:
premixture would result in exceeding the
Gas chromatography mass spec levels referred to in point 3.
trometry with retention time lock
5. The functional group, the identification
ing GC-MS-RTL.
number, the name and the added amount
of the active substance shall be indicated
in the labelling of feed materials and com
pound feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content of
12 % exceeds:
— 0,1 mg/kg for pigs and poultry.
— 0,5 mg/kg for other species and cat
egories
6. For users of the additive and premixtures,
feed business operators shall establish op
erational procedures and organisational
measures to address potential risks by in
halation, dermal contact or eyes contact.
Where those risks cannot be eliminated or
reduced to a minimum by such procedures
and measures, the additive and premix
tures shall be used with personal protective
equipment, including breathing protection,
safety glasses and gloves.
2b14056 — 2,3- Additive composition All animal — — — 1. The additive shall be incorporated into the 15.3.2028
Diethyl-5- species feed in the form of a premixture.
2,3-Diethyl-5-methylpyrazine
methylpyr
2. In the directions for use of the additive
azine
and premixtures, the storage and stability
conditions shall be indicated.
23.2.2018
EN
Official
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53/125Minimum Maximum
Identifica content content
Name of End of
tion Species or
the holder Composition, chemical formula, Maximum period of
number of Additive category of mg of active substance/kg Other provisions
of author description, analytical method age authoris
the animal of complete feedingstuff
isation ation
additive with a moisture content of
12 %
Characterisation of the active sub 3. On the label of the additive the following
stance shall be indicated:
2,3-Diethyl-5-methylpyrazine ‘Recommended maximum content of the
active substance of complete feedingstuff
with a moisture content of 12 %:
Produced by chemical synthesis
— 0,1 mg/kg for pigs and poultry.
Purity: min. 98 % assay
— 0,5 mg/kg for other species and cat
Chemical formula: C H N
9 14 2 egories’.
CAS number: 18138-04-0
4. The functional group, the identification
number, the name and the added amount
FLAVIS No: 14.056 of the active substance shall be indicated
on the label of the premixture where the
use levels suggested on the label of the
Method of analysis(1)
premixture would result in exceeding the
levels referred to in point 3.
For the determination of 2,3-
diethyl-5-methylpyrazine alcohol
5. The functional group, the identification
in the feed additive and in feed
number, the name and the added amount
flavouring premixtures:
of the active substance shall be indicated
in the labelling of feed materials and com
Gas chromatography mass spec pound feedingstuffs where the content of
trometry with retention time lock the active substance in the complete
ing GC-MS-RTL. feedingstuff with a moisture content of
12 % exceeds:
— 0,1 mg/kg for pigs and poultry.
— 0,5 mg/kg for other species and cat
egories
L
53/126
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Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
Identifica content content
Name of End of
tion Species or
the holder Composition, chemical formula, Maximum period of
number of Additive category of mg of active substance/kg Other provisions
of author description, analytical method age authoris
the animal of complete feedingstuff
isation ation
additive with a moisture content of
12 %
6. For users of the additive and premixtures,
feed business operators shall establish op
erational procedures and organisational
measures to address potential risks by in
halation, dermal contact or eyes contact.
Where those risks cannot be eliminated or
reduced to a minimum by such procedures
and measures, the additive and premix
tures shall be used with personal protective
equipment, including breathing protection,
safety glasses and gloves.
2b14062 — 2-(sec-Bu Additive composition All animal — — — 1. The additive shall be incorporated into the 15.3.2028
tyl)-3- species feed in the form of a premixture.
2-(sec-Butyl)-3-methoxypyrazine
methoxy
2. In the directions for use of the additive
pyrazine Characterisation of the active sub
and premixtures, the storage and stability
stance
conditions shall be indicated.
2-(sec-Butyl)-3-methoxypyrazine
3. On the label of the additive the following
Produced by chemical synthesis shall be indicated:
Purity: min. 99 % assay ‘Recommended maximum content of the
active substance of complete feedingstuff
Chemical formula: C H ON
9 14 2 with a moisture content of 12 %:
CAS number: 24168-70-5
— 0,1 mg/kg for pigs and poultry.
FLAVIS No: 14.062
— 0,5 mg/kg for other species and cat
Method of analysis(1) egories’.
For the determination of 2-(sec- 4. The functional group, the identification
butyl)-3-methoxypyrazine in the number, the name and the added amount
feed additive and in feed flavour of the active substance shall be indicated
ing premixtures: on the label of the premixture where the
use levels suggested on the label of the
Gas chromatography mass spec
premixture would result in exceeding the
trometry with retention time lock
levels referred to in point 3.
ing GC-MS-RTL.
23.2.2018
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Official
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Union
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53/127Minimum Maximum
Identifica content content
Name of End of
tion Species or
the holder Composition, chemical formula, Maximum period of
number of Additive category of mg of active substance/kg Other provisions
of author description, analytical method age authoris
the animal of complete feedingstuff
isation ation
additive with a moisture content of
12 %
5. The functional group, the identification
number, the name and the added amount
of the active substance shall be indicated
in the labelling of feed materials and com
pound feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content of
12 % exceeds:
— 0,1 mg/kg for pigs and poultry.
— 0,5 mg/kg for other species and cat
egories
6. For users of the additive and premixtures,
feed business operators shall establish op
erational procedures and organisational
measures to address potential risks by in
halation, dermal contact or eyes contact.
Where those risks cannot be eliminated or
reduced to a minimum by such procedures
and measures, the additive and premix
tures shall be used with personal protective
equipment, including breathing protection,
safety glasses and gloves.
2b14112 — 2-Ethyl-3- Additive composition All animal — — — 1. The additive shall be incorporated into the 15.3.2028
methoxy species feed in the form of a premixture.
2-Ethyl-3-methoxypyrazine
pyrazine
2. In the directions for use of the additive
Characterisation of the active sub
and premixtures, the storage and stability
stance
conditions shall be indicated.
2-Ethyl-3-methoxypyrazine
3. On the label of the additive the following
Produced by chemical synthesis shall be indicated:
Purity: min. 99 % assay ‘Recommended maximum content of the
active substance of complete feedingstuff
Chemical formula: C H N O
7 10 2 with a moisture content of 12 %:
CAS number: 25680-58-4 — 0,1 mg/kg for pigs and poultry
FLAVIS No: 14.112 — 0,5 mg/kg for other species and cat
egories’.
L
53/128
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
Identifica content content
Name of End of
tion Species or
the holder Composition, chemical formula, Maximum period of
number of Additive category of mg of active substance/kg Other provisions
of author description, analytical method age authoris
the animal of complete feedingstuff
isation ation
additive with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identification
number, the name and the added amount
For the determination of 2-ethyl-
of the active substance shall be indicated
3-methoxypyrazine in the feed ad
on the label of the premixture where the
ditive and in feed flavouring
use levels suggested on the label of the
premixtures:
premixture would result in exceeding the
Gas chromatography mass spec levels referred to in point 3.
trometry with retention time lock
5. The functional group, the identification
ing GC-MS-RTL.
number, the name and the added amount
of the active substance shall be indicated
in the labelling of feed materials and com
pound feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content of
12 % exceeds:
— 0,1 mg/kg for pigs and poultry.
— 0,5 mg/kg for other species and cat
egories
6. For users of the additive and premixtures,
feed business operators shall establish op
erational procedures and organisational
measures to address potential risks by in
halation, dermal contact or eyes contact.
Where those risks cannot be eliminated or
reduced to a minimum by such procedures
and measures, the additive and premix
tures shall be used with personal protective
equipment, including breathing protection,
safety glasses and gloves.
2b14015 — 5,6,7,8- Additive composition All animal — — — 1. The additive shall be incorporated into the 15.3.2028
Tetrahy species feed in the form of a premixture.
5,6,7,8-Tetrahydroquinoxaline
droqui
2. In the directions for use of the additive
noxaline
and premixtures, the storage and stability
conditions shall be indicated.
23.2.2018
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53/129Minimum Maximum
Identifica content content
Name of End of
tion Species or
the holder Composition, chemical formula, Maximum period of
number of Additive category of mg of active substance/kg Other provisions
of author description, analytical method age authoris
the animal of complete feedingstuff
isation ation
additive with a moisture content of
12 %
Characterisation of the active sub 3. On the label of the additive the following
stance shall be indicated:
5,6,7,8-Tetrahydroquinoxaline
‘Recommended maximum content of the
Produced by chemical synthesis
active substance of complete feedingstuff
Purity: min. 98 % assay with a moisture content of 12 %:
Chemical formula: C H N
8 10 2
CAS number: 34413-35-9 — 0,1 mg/kg for pigs and poultry.
FLAVIS No: 14.015
— 0,5 mg/kg for other species and cat
Method of analysis(1) egories’.
For the determination of 5,6,7,8-
tetrahydroquinoxaline in the feed 4. The functional group, the identification
additive and in feed flavouring number, the name and the added amount
premixtures: of the active substance shall be indicated
Gas chromatography mass spec on the label of the premixture where the
trometry with retention time lock use levels suggested on the label of the
ing GC-MS-RTL. premixture would result in exceeding the
levels referred to in point 3.
5. The functional group, the identification
number, the name and the added amount
of the active substance shall be indicated
in the labelling of feed materials and com
pound feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content of
12 % exceeds:
— 0,1 mg/kg for pigs and poultry.
— 0,5 mg/kg for other species and cat
egories
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53/130
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Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
Identifica content content
Name of End of
tion Species or
the holder Composition, chemical formula, Maximum period of
number of Additive category of mg of active substance/kg Other provisions
of author description, analytical method age authoris
the animal of complete feedingstuff
isation ation
additive with a moisture content of
12 %
6. For users of the additive and premixtures,
feed business operators shall establish op
erational procedures and organisational
measures to address potential risks by in
halation, dermal contact or eyes contact.
Where those risks cannot be eliminated or
reduced to a minimum by such procedures
and measures, the additive and premix
tures shall be used with personal protective
equipment, including breathing protection,
safety glasses and gloves.
2b14022 — 2-Ethyl Additive composition All animal — — — 1. The additive shall be incorporated into the 15.3.2028
pyrazine species feed in the form of a premixture.
2-Ethylpyrazine
2. In the directions for use of the additive
Characterisation of the active sub
and premixtures, the storage and stability
stance
conditions shall be indicated.
2-Ethylpyrazine
3. On the label of the additive the following
Produced by chemical synthesis shall be indicated:
Purity: min. 98 % assay ‘Recommended maximum content of the
active substance of complete feedingstuff
Chemical formula: C H N
6 8 2 with a moisture content of 12 %:
CAS number: 13925-00-3
— 0,1 mg/kg for pigs and poultry.
FLAVIS No: 14.022
— 0,5 mg/kg for other species and cat
Method of analysis(1) egories’.
For the determination of 2-ethyl 4. The functional group, the identification
pyrazine in the feed additive and number, the name and the added amount
in feed flavouring premixtures: of the active substance shall be indicated
on the label of the premixture where the
Gas chromatography mass spec
use levels suggested on the label of the
trometry with retention time lock
premixture would result in exceeding the
ing GC-MS-RTL.
levels referred to in point 3.
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Official
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53/131Minimum Maximum
Identifica content content
Name of End of
tion Species or
the holder Composition, chemical formula, Maximum period of
number of Additive category of mg of active substance/kg Other provisions
of author description, analytical method age authoris
the animal of complete feedingstuff
isation ation
additive with a moisture content of
12 %
5. The functional group, the identification
number, the name and the added amount
of the active substance shall be indicated
in the labelling of feed materials and com
pound feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content of
12 % exceeds:
— 0,1 mg/kg for pigs and poultry.
— 0,5 mg/kg for other species and cat
egories
6. For users of the additive and premixtures,
feed business operators shall establish op
erational procedures and organisational
measures to address potential risks by in
halation, dermal contact or eyes contact.
Where those risks cannot be eliminated or
reduced to a minimum by such procedures
and measures, the additive and premix
tures shall be used with personal protective
equipment, including breathing protection,
safety glasses and gloves.
2b14028 — 5-Methyl Additive composition All animal — — — 1. The additive shall be incorporated into the 15.3.2028
quinoxa species feed in the form of a premixture.
5-Methylquinoxaline
line
2. In the directions for use of the additive
Characterisation of the active sub
and premixtures, the storage and stability
stance
conditions shall be indicated.
5-Methylquinoxaline
3. On the label of the additive the following
Produced by chemical synthesis shall be indicated:
Purity: min. 98 % assay ‘Recommended maximum content of the
active substance of complete feedingstuff
Chemical formula: C H N
9 8 2 with a moisture content of 12 %:
CAS number: 13708-12-8 — 0,05 mg/kg for pigs and poultry
FLAVIS No: 14.028 — 0,08 mg/kg for other species and cat
egories.’
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Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
Identifica content content
Name of End of
tion Species or
the holder Composition, chemical formula, Maximum period of
number of Additive category of mg of active substance/kg Other provisions
of author description, analytical method age authoris
the animal of complete feedingstuff
isation ation
additive with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identification
number, the name and the added amount
For the determination of 5-
of the active substance shall be indicated
methylquinoxaline in the feed
on the label of the premixture where the
additive and in feed flavouring
use levels suggested on the label of the
premixtures:
premixture would result in exceeding the
Gas chromatography mass spec levels referred to in point 3.
trometry with retention time lock
5. The functional group, the identification
ing GC-MS-RTL.
number, the name and the added amount
of the active substance shall be indicated
in the labelling of feed materials and com
pound feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content of
12 % exceeds:
— 0,05 mg/kg for pigs and poultry.
— 0,08 mg/kg for other species and cat
egories
6. For users of the additive and premixtures,
feed business operators shall establish op
erational procedures and organisational
measures to address potential risks by in
halation, dermal contact or eyes contact.
Where those risks cannot be eliminated or
reduced to a minimum by such procedures
and measures, the additive and premix
tures shall be used with personal protective
equipment, including breathing protection,
safety glasses and gloves.
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/133