Date: 2018-02-23Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2018/245 of 15 February 2018 concerning the authorisation of menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate as feed additives for all animal species (Text with EEA relevance. )
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2018/245 of February 15, 2018, authorises menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-pent-2-cisenylcyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate as sensory feed additives for all animal species. It establishes conditions for their use, labelling requirements, and monitoring, setting maximum content levels in animal feed. Transitional measures are in place, with deadlines in 2018, 2019 and 2020 for the use of products produced and labelled under previous regulations.
Key Points / Main Content:
Authorisation of Feed Additives:
* Menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-pent-2-cisenylcyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate are authorised as sensory feed additives for all animal species.
* These additives belong to the functional group of flavouring compounds.
Conditions of Use:
* The additives must be incorporated into feed in the form of a premix.
* Directions for use and storage/stability conditions must be indicated on the additive and premixture labels.
* Specific maximum content levels for each substance in complete feedingstuff (with 12% moisture content) are defined, varying by substance and animal category.
Labelling Requirements:
* Additive labels must include the functional group, identification number, name, and amount of active substance.
* Premixture labels must include the same information if the use level exceeds specified limits.
* Feed material and compound feedingstuff labels must include the same information if the content of the active substance exceeds specific limits.
Safety Measures:
* Feed business operators must establish operational procedures and measures to address potential inhalation, dermal contact, or eye contact risks.
* Personal protective equipment (breathing protection, safety glasses, and gloves) must be used if risks cannot be minimised.
Transitional Measures:
* Additives and premixtures produced and labelled before September 15, 2018, under previous rules, can be placed on the market and used until existing stocks are exhausted.
* Feed materials and compound feed for food-producing animals, containing these substances, produced and labelled before March 15, 2019, under previous rules, can be placed on the market and used until existing stocks are exhausted.
* Feed materials and compound feed for non-food-producing animals, containing these substances, produced and labelled before March 15, 2020, under previous rules, can be placed on the market and used until existing stocks are exhausted.
Impact Analysis:
Feed Additive Manufacturers:
* Impact: Can legally use the specified substances as sensory additives in animal feed, provided they meet the conditions outlined in the regulation, including labelling and safety requirements.
* Action Required: Ensure compliance with the maximum content levels, labelling requirements, and safety measures. Update production and labelling processes by the specified deadlines.
Feed Business Operators:
* Impact: Must implement operational procedures and organisational measures to minimise risks associated with using these additives.
* Action Required: Establish safety protocols for handling the additives, including the use of personal protective equipment where necessary. Comply with labelling requirements for feed materials and compound feedingstuffs.
Animal Feed Producers:
* Impact: Can use feed additives with the ingredients listed in the regulation.
* Action Required: Adhere to the prescribed maximum content levels when incorporating the additives into feed formulations.
EU Member States:
* Impact: Responsible for enforcing the regulation within their jurisdiction.
* Action Required: Ensure that national regulations align with this EU regulation and implement monitoring and control measures to ensure compliance.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation (EC) No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
Council Directive 70/524/EEC: A Council Directive concerning additives in feedingstuffs.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Standing Committee on Plants, Animals, Food and Feed: A committee that provides opinions on measures proposed by the European Commission related to food safety.
Brussels: The de facto capital city of the European Union, located in Belgium.
Menthol: A feed additive authorized for all animal species
23.2.2018 EN Official Journal of the European Union L 53/87
COMMISSION IMPLEMENTING REGULATION (EU) 2018/245
of 15 February 2018
concerning the authorisation of menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-
2-(pent-2(cis)-enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl
alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate 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 menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)-enyl)cyclopent-2-
en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate
and fenchyl acetate (‘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 20 April 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. The Authority has concluded that, since the substances concerned are efficacious
when 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 to feed. The applicant
withdrew the application for the use of the substances concerned in water for drinking.
(5) The Authority further noted that 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;14(6):4475.L 53/88 EN Official Journal of the European Union 23.2.2018
(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
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff the additive sation sation
with a moisture content of
12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b02015 — Menthol Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a premix
Menthol
ture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage and
Menthol stability conditions shall be indicated.
Produced by chemical synthesis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 95 % assay
‘Recommended maximum content of
Chemical formula: C H O
10 20 the active substance of complete fee
CAS number: 89-78-1 dingstuff with a moisture content of
FLAVIS No: 02.015 12 %: 25 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For the determination of menthol added amount of the active sub
in the feed additive and in feed fla stance shall be indicated on the label
vouring premixtures: of the premixture where the use level
Gas chromatography mass spectro suggested on the label of the premix
metry with retention time locking ture would result in exceeding the
GC-MS-RTL. level referred to in point 3
5. The functional group, the identifica
tion number, the name and the
added amount of the active sub
stance shall be indicated in the label
ling of feed materials and compound
feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content
of 12 % exceeds: 25 mg/kg
23.2.2018
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Journal
of
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Union
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53/89Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
6. For users of the additive and premix
tures, feed business operators shall
establish operational procedures and
organisational measures to address
potential risks by inhalation, dermal
contact or eyes contact. Where those
risks cannot be eliminated or re
duced to a minimum by such proce
dures and measures, the additive and
premixtures shall be used with per
sonal protective equipment, includ
ing breathing protection, safety
glasses and gloves.
2b07146 — d-Carvone Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a premix
d-Carvone
ture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage and
d-Carvone stability conditions shall be indicated.
Produced by chemical synthesis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 95 % assay
‘Recommended maximum content of
Chemical formula: C H O
10 14 the active substance of complete fee
CAS number: 2244-16-8 dingstuff with a moisture content of
FLAVIS No: 07.146 12 %: 5 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For the determination of d-carvone added amount of the active sub
in the feed additive and in feed fla stance shall be indicated on the label
vouring premixtures: of the premixture where the use level
Gas chromatography mass spectro suggested on the label of the premix
metry with retention time locking ture would result in exceeding the
GC-MS-RTL. level referred to in point 3
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53/90
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Journal
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Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
5. The functional group, the identifica
tion number, the name and the
added amount of the active sub
stance shall be indicated in the label
ling of feed materials and compound
feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content
of 12 % exceeds: 5 mg/kg
6. For users of the additive and premix
tures, feed business operators shall
establish operational procedures and
organisational measures to address
potential risks by inhalation, dermal
contact or eyes contact. Where those
risks cannot be eliminated or re
duced to a minimum by such proce
dures and measures, the additive and
premixtures shall be used with per
sonal protective equipment, includ
ing breathing protection, safety
glasses and gloves.
2b09016 — Menthyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
acetate species into the feed in the form of a premix
Menthyl acetate
ture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage and
Menthyl acetate stability conditions shall be indicated.
Produced by chemical synthesis
Purity: min. 97 % assay
Chemical formula: C H O
12 22 2
23.2.2018
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53/91Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
CAS number: 29066-34-0 3. On the label of the additive the fol
lowing shall be indicated:
FLAVIS No: 09.016
‘Recommended maximum content of
Method of analysis(1)
the active substance of complete fee
For the determination of menthyl dingstuff with a moisture content of
acetate in the feed additive and in 12 %: 5 mg/kg.’
feed flavouring premixtures:
4. The functional group, the identifica
Gas chromatography mass spectro tion number, the name and the
metry with retention time locking added amount of the active sub
GC-MS-RTL. stance shall be indicated on the label
of the premixture where the use level
suggested on the label of the premix
ture would result in exceeding the
level referred to in point 3
5. The functional group, the identifica
tion number, the name and the
added amount of the active sub
stance shall be indicated in the label
ling of feed materials and compound
feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content
of 12 % exceeds: 5 mg/kg
6. For users of the additive and premix
tures, feed business operators shall
establish operational procedures and
organisational measures to address
potential risks by inhalation, dermal
contact or eyes contact. Where those
risks cannot be eliminated or re
duced to a minimum by such proce
dures and measures, the additive and
premixtures shall be used with per
sonal protective equipment, includ
ing breathing protection, safety
glasses and gloves.
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53/92
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Journal
of
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European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
2b07078 — d,l-Iso Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
menthone species into the feed in the form of a premix
d,l-Isomenthone
ture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage and
d,l-Isomenthone stability conditions shall be indicated.
Produced by chemical synthesis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content of
Chemical formula: C H O
10 18 the active substance of complete fee
CAS number: 491-07-6 dingstuff with a moisture content of
FLAVIS No: 07.078 12 %:
— 0,3 mg/kg for pigs and poultry;
Method of analysis(1)
— 0,5 mg/kg for other species and
For the determination of d,l-iso
categories.’
menthone in the feed additive and
in feed flavouring premixtures: 4. The functional group, the identifica
tion number, the name and the
Gas chromatography mass spectro
added amount of the active sub
metry with retention time locking
stance shall be indicated on the label
GC-MS-RTL.
of the premixture where the use level
suggested on the label of the premix
ture would result in exceeding the le
vels referred to in point 3
5. The functional group, the identifica
tion number, the name and the
added amount of the active sub
stance shall be indicated in the label
ling of feed materials and compound
feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content
of 12 % exceeds:
— 0,3 mg/kg for pigs and poultry;
— 0,5 mg/kg for other species and
categories
23.2.2018
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53/93Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
6. For users of the additive and premix
tures, feed business operators shall
establish operational procedures and
organisational measures to address
potential risks by inhalation, dermal
contact or eyes contact. Where those
risks cannot be eliminated or re
duced to a minimum by such proce
dures and measures, the additive and
premixtures shall be used with per
sonal protective equipment, includ
ing breathing protection, safety
glasses and gloves.
2b07094 — 3-Methyl- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
2-(pent- species into the feed in the form of a premix
3-Methyl-2-(pent-2(cis)-enyl)cyclo
2(cis)-enyl) ture.
pent-2-en-1-one
cyclopent-2-
2. In the directions for use of the addi
en-1-one Characterisation of the active sub
tive and premixtures, the storage and
stance
stability conditions shall be indicated.
3-Methyl-2-(pent-2(cis)-enyl)cyclo
3. On the label of the additive the fol
pent-2-en-1-one
lowing shall be indicated:
Produced by chemical synthesis
‘Recommended maximum content of
Purity: min. 98 % assay the active substance of complete fee
dingstuff with a moisture content of
Chemical formula: C H O
11 16 12 %:
CAS number: 488-10-8 — 0,3 mg/kg for pigs and poultry;
FLAVIS No: 07.094 — 0,5 mg/kg for other species and
categories.’
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23.2.2018Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
Method of analysis(1) 4. The functional group, the identifica
tion number, the name and the
For the determination of 3-methyl-
added amount of the active sub
2-(pent-2(cis)-enyl)cyclopent-2-en-
stance shall be indicated on the label
1-one in the feed additive and in
of the premixture where the use level
feed flavouring premixtures:
suggested on the label of the premix
Gas chromatography mass spectro ture would result in exceeding the le
metry with retention time locking vels referred to in point 3
GC-MS-RTL.
5. The functional group, the identifica
tion number, the name and the
added amount of the active sub
stance shall be indicated in the label
ling of feed materials and compound
feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content
of 12 % exceeds:
— 0,3 mg/kg for pigs and poultry;
— 0,5 mg/kg for other species and
categories.
6. For users of the additive and premix
tures, feed business operators shall
establish operational procedures and
organisational measures to address
potential risks by inhalation, dermal
contact or eyes contact. Where those
risks cannot be eliminated or re
duced to a minimum by such proce
dures and measures, the additive and
premixtures shall be used with per
sonal protective equipment, includ
ing breathing protection, safety
glasses and gloves.
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53/95Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
2b07126 — 3,5,5-Tri Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
methylcyclo species into the feed in the form of a premix
3,5,5-Trimethylcyclohex-2-en-1-
hex-2-en-1- ture.
one
one
2. In the directions for use of the addi
Characterisation of the active sub
tive and premixtures, the storage and
stance
stability conditions shall be indicated.
3,5,5-Trimethylcyclohex-2-en-1-
3. On the label of the additive the fol
one
lowing shall be indicated:
Produced by chemical synthesis
‘Recommended maximum content of
Purity: min. 98 % assay the active substance of complete fee
dingstuff with a moisture content of
Chemical formula: C H O
9 14 12 %:
CAS number: 78-59-1
— 0,3 mg/kg for pigs and poultry;
FLAVIS No: 07.126
— 0,5 mg/kg for other species and
Method of analysis(1) categories.’
For the determination of 3,5,5-tri 4. The functional group, the identifica
methylcyclohex-2-en-1-one in the tion number, the name and the
feed additive and in feed flavouring added amount of the active sub
premixtures: stance shall be indicated on the label
of the premixture where the use level
Gas chromatography mass spectro
suggested on the label of the premix
metry with retention time locking
ture would result in exceeding the le
GC-MS-RTL.
vels referred to in point 3.
5. The functional group, the identifica
tion number, the name and the
added amount of the active sub
stance shall be indicated in the label
ling of feed materials and compound
feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content
of 12 % exceeds:
— 0,3 mg/kg for pigs and poultry;
— 0,5 mg/kg for other species and
categories
L
53/96
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
6. For users of the additive and premix
tures, feed business operators shall
establish operational procedures and
organisational measures to address
potential risks by inhalation, dermal
contact or eyes contact. Where those
risks cannot be eliminated or re
duced to a minimum by such proce
dures and measures, the additive and
premixtures shall be used with per
sonal protective equipment, includ
ing breathing protection, safety
glasses and glove.
2b07159 — d-Fenchone Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a premix
d-Fenchone
ture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage and
d-Fenchone stability conditions shall be indicated.
Produced by chemical synthesis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 97 % assay
‘Recommended maximum content of
Chemical formula: C H O
10 16 the active substance of complete fee
CAS number: 4695-62-9 dingstuff with a moisture content of
FLAVIS No: 07.159 12 %:
— 0,3 mg/kg for pigs and poultry;
Method of analysis(1)
— 0,5 mg/kg for other species and
For the determination of d-fench categories.’
one in the feed additive and in
feed flavouring premixtures:
Gas chromatography mass spectro
metry with retention time locking
GC-MS-RTL.
23.2.2018
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53/97Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
4. The functional group, the identifica
tion number, the name and the
added amount of the active sub
stance shall be indicated on the label
of the premixture where the use level
suggested on the label of the premix
ture would result in exceeding the le
vels referred to in point 3
5. The functional group, the identifica
tion number, the name and the
added amount of the active sub
stance shall be indicated in the label
ling of feed materials and compound
feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content
of 12 % exceeds:
— 0,3 mg/kg for pigs and poultry;
— 0,5 mg/kg for other species and
categories
6. For users of the additive and premix
tures, feed business operators shall
establish operational procedures and
organisational measures to address
potential risks by inhalation, dermal
contact or eyes contact. Where those
risks cannot be eliminated or re
duced to a minimum by such proce
dures and measures, the additive and
premixtures shall be used with per
sonal protective equipment, includ
ing breathing protection, safety
glasses and gloves
L
53/98
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
2b02038 — Fenchyl al Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
cohol species into the feed in the form of a premix
Fenchyl alcohol
ture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage and
Fenchyl alcohol stability conditions shall be indicated.
Produced by chemical synthesis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 97 % assay
‘Recommended maximum content of
Chemical formula: C H O
10 18 the active substance of complete fee
CAS number: 1632-73-1 dingstuff with a moisture content of
FLAVIS No: 02.038 12 %: 1 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For the determination of fenchyl added amount of the active sub
alcohol in the feed additive and in stance shall be indicated on the label
feed flavouring premixtures: of the premixture where the use level
Gas chromatography mass spectro suggested on the label of the premix
metry with retention time locking ture would result in exceeding the
GC-MS-RTL. level referred to in point 3
5. The functional group, the identifica
tion number, the name and the
added amount of the active sub
stance shall be indicated in the label
ling of feed materials and compound
feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content
of 12 % exceeds: 1 mg/kg
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/99Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
6. For users of the additive and premix
tures, feed business operators shall
establish operational procedures and
organisational measures to address
potential risks by inhalation, dermal
contact or eyes contact. Where those
risks cannot be eliminated or re
duced to a minimum by such proce
dures and measures, the additive and
premixtures shall be used with per
sonal protective equipment, includ
ing breathing protection, safety
glasses and gloves.
2b09215 — Carvyl acet Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
ate species into the feed in the form of a premix
Carvyl acetate
ture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage and
Carvyl acetate stability conditions shall be indicated.
Produced by chemical synthesis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content of
Chemical formula: C H O
12 18 2 the active substance of complete fee
CAS number: 97-42-7 dingstuff with a moisture content of
FLAVIS No: 09.215 12 %: 1 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For the determination of carvyl added amount of the active sub
acetate in the feed additive and in stance shall be indicated on the label
feed flavouring premixtures: of the premixture where the use level
Gas chromatography mass spectro suggested on the label of the premix
metry with retention time locking ture would result in exceeding the
GC-MS-RTL level referred to in point 3
L
53/100
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
5. The functional group, the identifica
tion number, the name and the
added amount of the active sub
stance shall be indicated in the label
ling of feed materials and compound
feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content
of 12 % exceeds: 1 mg/kg.
6. For users of the additive and premix
tures, feed business operators shall
establish operational procedures and
organisational measures to address
potential risks by inhalation, dermal
contact or eyes contact. Where those
risks cannot be eliminated or re
duced to a minimum by such proce
dures and measures, the additive and
premixtures shall be used with per
sonal protective equipment, includ
ing breathing protection, safety
glasses and gloves.
2b09216 — Dihydrocar Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
vyl acetate species into the feed in the form of a premix
Dihydrocarvyl acetate
ture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage and
Dihydrocarvyl acetate stability conditions shall be indicated.
Produced by chemical synthesis
Purity: min. 97 % assay
Chemical formula: C H O
12 20 2
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/101Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
CAS number: 20777-49-5 3. On the label of the additive the fol
lowing shall be indicated:
FLAVIS No: 09.216
‘Recommended maximum content of
Method of analysis(1)
the active substance of complete fee
For the determination of dihydro dingstuff with a moisture content of
carvyl acetate in the feed additive 12 %: 1 mg/kg.’
and in feed flavouring premixtures:
4. The functional group, the identifica
Gas chromatography mass spectro tion number, the name and the
metry with retention time locking added amount of the active sub
GC-MS-RTL stance shall be indicated on the label
of the premixture where the use level
suggested on the label of the premix
ture would result in exceeding the
level referred to in point 3
5. The functional group, the identifica
tion number, the name and the
added amount of the active sub
stance shall be indicated in the label
ling of feed materials and compound
feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content
of 12 % exceeds: 1 mg/kg
6. For users of the additive and premix
tures, feed business operators shall
establish operational procedures and
organisational measures to address
potential risks by inhalation, dermal
contact or eyes contact. Where those
risks cannot be eliminated or re
duced to a minimum by such proce
dures and measures, the additive and
premixtures shall be used with per
sonal protective equipment, includ
ing breathing protection, safety
glasses and gloves.
L
53/102
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
2b09269 — Fenchyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
acetate species into the feed in the form of a premix
Fenchyl acetate
ture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage and
Fenchyl acetate stability conditions shall be indicated.
Produced by chemical synthesis 3. On the label of the additive the fol
lowing shall be indicated:
Purity: min. 98 % assay
‘Recommended maximum content of
Chemical formula: C H O
12 20 2 the active substance of complete fee
CAS number: 13851-11-1 dingstuff with a moisture content of
FLAVIS No: 09.269 12 %: 1 mg/kg.’
4. The functional group, the identifica
Method of analysis(1)
tion number, the name and the
For the determination of fenchyl added amount of the active sub
acetate in the feed additive and in stance shall be indicated on the label
feed flavouring premixtures: of the premixture where the use level
Gas chromatography mass spectro suggested on the label of the premix
metry with retention time locking ture would result in exceeding the
GC-MS-RTL level referred to in point 3
5. The functional group, the identifica
tion number, the name and the
added amount of the active sub
stance shall be indicated in the label
ling of feed materials and compound
feedingstuffs where the content of
the active substance in the complete
feedingstuff with a moisture content
of 12 % exceeds: 1 mg/kg
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/103Minimum Maximum
content content
Identifica Name of End of pe
Species or
tion the holder Composition, chemical formula, Maximum riod
Additive category of mg of active substance/kg Other provisions
number of of authori description, analytical method age of authori
animal of complete feedingstuff
the additive sation sation
with a moisture content of
12 %
6. For users of the additive and premix
tures, feed business operators shall
establish operational procedures and
organisational measures to address
potential risks by inhalation, dermal
contact or eyes contact. Where those
risks cannot be eliminated or re
duced to a minimum by such proce
dures and measures, the additive and
premixtures shall be used with per
sonal protective equipment, includ
ing 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
L
53/104
EN
Official
Journal
of
the
European
Union
23.2.2018