Date: 2018-02-23Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2018/250 of 15 February 2018 concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl 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) 2018/250 authorises methyl 2-furoate, bis(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide, and furfuryl acetate as sensory feed additives for all animal species. The regulation includes transitional measures for products produced and labelled before specific dates in 2018, with deadlines in 2019 and 2020 for feed materials and compound feed. The regulation went into force on March 15, 2018.
Key Points / Main Content:
* **Authorisation of Feed Additives:**
* The specified substances are authorised as feed additives for all animal species, classified as sensory additives (flavouring compounds).
* The authorisation is subject to the conditions outlined in the Annex of the Regulation.
* The end date of authorisation for all listed substances is March 15, 2028.
* **Conditions of Use and Labelling Requirements:**
* The additives must be incorporated into feed in the form of a premixture.
* Storage and stability conditions must be indicated in the directions for use of the additive and premixtures.
* The label of the additive must include the recommended maximum content of the active substance in complete feedingstuff (12% moisture).
* For premixtures, if the suggested use level exceeds the Authority's considered safe levels, the label must indicate the functional group, identification number, name, and added amount of the active substance.
* For feed materials and compound feedingstuffs, the labelling must include the functional group, identification number, name, and added amount of the active substance if the content in the complete feedingstuff (12% moisture) exceeds the specified limit.
* **Safety Measures:**
* Feed business operators must establish operational procedures and organisational measures to address potential risks of inhalation, dermal contact, or eye contact for users of the additive and premixtures.
* Personal protective equipment, including breathing protection, safety glasses, and gloves, must be used if risks cannot be eliminated or minimised.
* **Transitional Measures:**
* Additives and premixtures produced and labelled before September 15, 2018, according to previous rules, can continue to be placed on the market and used until existing stocks are exhausted.
* Feed materials and compound feed for food-producing animals, containing the substances, produced and labelled before March 15, 2019, according to previous rules, can continue to be placed on the market and used until existing stocks are exhausted.
* Feed materials and compound feed for non-food-producing animals, containing the substances, produced and labelled before March 15, 2020, according to previous rules, can continue to be placed on the market and used until existing stocks are exhausted.
Impact Analysis:
* **Feed Additive Manufacturers:**
* *Impact:* Must comply with the new authorisation conditions, including labelling and safety requirements.
* *Action Required:* Adjust production and labelling processes to meet the specifications in the Annex and ensure safety measures are in place for users.
* **Feed Business Operators:**
* *Impact:* Need to implement operational procedures and organisational measures to mitigate risks associated with the use of these additives.
* *Action Required:* Establish and enforce safety protocols, including the use of personal protective equipment, and ensure proper labelling of premixtures, feed materials, and compound feedingstuffs.
* **Animal Feed Industry (including Premixture Producers):**
* *Impact:* Must adhere to the updated regulations regarding the composition and use of the specified feed additives.
* *Action Required:* Update formulations, labelling, and usage instructions to align with the new requirements and ensure compliance within the specified transitional periods.
* **Official Control Authorities:**
* *Impact:* Responsible for enforcing the regulation and ensuring compliance along the food chain.
* *Action Required:* Monitor and verify that feed additives, premixtures, feed materials, and compound feed comply with the new authorisation conditions and labelling requirements.
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, and managing the EU's day-to-day operations.
Treaty on the Functioning of the European Union: One of the primary treaties forming the constitutional basis of the European Union.
European Parliament: The directly elected parliamentary body of the European Union.
Council Directive 70524EEC: A directive concerning additives in feedingstuffs.
Regulation EC No 18312003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
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 and feed safety.
L 53/166 EN Official Journal of the European Union 23.2.2018
COMMISSION IMPLEMENTING REGULATION (EU) 2018/250
of 15 February 2018
concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl
alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide,
2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl
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 methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol,
S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl
disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate (‘substances concerned’) were authorised without
a time limit by Directive 70/524/EEC as feed additives for all animal species. Those products 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 that 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 26 January 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.
(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(2):4389.23.2.2018 EN Official Journal of the European Union L 53/167
(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.
(8) The fact that the use of the substance concerned in water for drinking is not authorised does not preclude its 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.L 53/168 EN Official Journal of the European Union 23.2.2018
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
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff the additive tion tion
with a moisture content of
12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b13002 — Methyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
2-furoate species into the feed in the form of a pre
Methyl 2-furoate
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Methyl 2-furoate and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. On the label of the additive the fol
Purity: min. 98 % assay
lowing shall be indicated:
Chemical formula: C H O
6 6 3 ‘Recommended maximum content
CAS number: 611-13-2 of the active substance of complete
FLAVIS No: 13.002 feedingstuff with a moisture content
of 12 %: 0,5 mg/kg.’
Method of analysis(1)
4. The functional group, the identifica
For the determination of methyl tion number, the name and the
2-furoate in the feed additive and added amount of the active sub
in feed flavouring premixtures: stance shall be indicated on the la
Gas chromatography mass spec bel of the premixtures where the use
trometry with retention time lock level suggested on the label of the
ing GC-MS-RTL premixture would result in exceed
ing 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 la
belling 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:
0,5 mg/kg.
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/169Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes contact.
Where those risks cannot be elimin
ated or reduced to a minimum by
such procedures and measures, the
additive and premixtures shall be
used with personal protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b13016 — Bis-(2-methyl- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
3-furyl) disul species into the feed in the form of a pre
Bis-(2-methyl-3-furyl) disulfide
fide mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Bis-(2-methyl-3-furyl) disulfide and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. On the label of the additive the fol
Purity: min. 98 % assay
lowing shall be indicated:
Chemical formula: C H O S
10 10 2 2 ‘Recommended maximum content
CAS number: 28588-75-2 of the active substance of complete
FLAVIS No: 13.016 feedingstuff with a moisture content
of 12 %: 0,05 mg/kg.’
Method of analysis(1)
4. The functional group, the identifica
For the determination of tion number, the name and the
bis-(2-methyl-3-furyl) disulfide in added amount of the active sub
the feed additive and in feed fla stance shall be indicated on the la
vouring premixtures: bel of the premixtures where the use
Gas chromatography mass spec level suggested on the label of the
trometry with retention time lock premixture would result in exceed
ing GC-MS-RTL ing the level referred to in point 3.
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Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
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 la
belling 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.
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes contact.
Where those risks cannot be elimin
ated or reduced to a minimum by
such procedures and measures, the
additive and premixtures shall be
used with personal protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b13018 — Furfural Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
species into the feed in the form of a pre
Furfural
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Furfural and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. On the label of the additive the fol
Purity: min. 95 % assay
lowing shall be indicated:
Chemical formula: C H O
5 4 2 ‘Recommended maximum content
CAS number: 98-01-1 of the active substance of complete
FLAVIS No: 13.018 feedingstuff with a moisture content
of 12 %: 5 mg/kg.’
23.2.2018
EN
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Journal
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the
European
Union
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53/171Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
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 furfural
added amount of the active sub
in the feed additive and in feed
stance shall be indicated on the la
flavouring premixtures:
bel of the premixtures where the use
Gas chromatography mass spec level suggested on the label of the
trometry with retention time lock premixture would result in exceed
ing GC-MS-RTL ing 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 la
belling 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:
5 mg/kg.
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes contact.
Where those risks cannot be elimin
ated or reduced to a minimum by
such procedures and measures, the
additive and premixtures shall be
used with personal protective equip
ment, including breathing protec
tion, safety glasses and gloves.
L
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Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
2b13019 — Furfuryl alco Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
hol species into the feed in the form of a pre
Furfuryl alcohol
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Furfuryl alcohol and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. On the label of the additive the fol
Purity: min. 97 % assay
lowing shall be indicated:
Chemical formula: C H O
5 6 2 ‘Recommended maximum content
CAS number: 98-00-0 of the active substance of complete
FLAVIS No: 13.019 feedingstuff with a moisture content
of 12 %: 5 mg/kg.’
Method of analysis(1)
4. The functional group, the identifica
For the determination of furfuryl tion number, the name and the
alcohol in the feed additive and in added amount of the active sub
feed flavouring premixtures: stance shall be indicated on the la
Gas chromatography mass spec bel of the premixtures where the use
trometry with retention time lock level suggested on the label of the
ing GC-MS-RTL premixture would result in exceed
ing 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 la
belling 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:
5 mg/kg.
23.2.2018
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Journal
of
the
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Union
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53/173Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes contact.
Where those risks cannot be elimin
ated or reduced to a minimum by
such procedures and measures, the
additive and premixtures shall be
used with personal protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b13026 — 2-Furan Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
methanethiol species into the feed in the form of a pre
2-Furanmethanethiol
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
2-Furanmethanethiol and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. On the label of the additive the fol
Purity: min. 97 % assay
lowing shall be indicated:
Chemical formula: C H OS
5 6 ‘Recommended maximum content
CAS number: 98-02-2 of the active substance of complete
FLAVIS No: 13.026 feedingstuff with a moisture content
of 12 %: 0,05 mg/kg.’
Method of analysis(1)
4. The functional group, the identifica
For the determination of 2-furan tion number, the name and the
methanethiol in the feed additive added amount of the active sub
and in feed flavouring premix stance shall be indicated on the la
tures: bel of the premixtures where the use
Gas chromatography mass spec level suggested on the label of the
trometry with retention time lock premixture would result in exceed
ing GC-MS-RTL ing the level referred to in point 3.
L
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Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
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 la
belling 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.
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes contact.
Where those risks cannot be elimin
ated or reduced to a minimum by
such procedures and measures, the
additive and premixtures shall be
used with personal protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b13033 — S-Furfuryl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
acetothioate species into the feed in the form of a pre
S-furfuryl acetothioate
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
S-furfuryl acetothioate and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. On the label of the additive the fol
Purity: min. 95 % assay
lowing shall be indicated:
Chemical formula: C H O S
7 8 2 ‘Recommended maximum content
CAS number: 13678-68-7 of the active substance of complete
FLAVIS No: 13.033 feedingstuff with a moisture content
of 12 %: 0,05 mg/kg.’
23.2.2018
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53/175Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
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 S-fur
added amount of the active sub
furyl acetothioate in the feed addi
stance shall be indicated on the la
tive and in feed flavouring pre
bel of the premixtures where the use
mixtures:
level suggested on the label of the
Gas chromatography mass spec premixture would result in exceed
trometry with retention time lock ing the level referred to in point 3.
ing 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 la
belling 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.
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes contact.
Where those risks cannot be elimin
ated or reduced to a minimum by
such procedures and measures, the
additive and premixtures shall be
used with personal protective equip
ment, including breathing protec
tion, safety glasses and gloves.
L
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Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
2b13050 — Difurfuryl di Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
sulfide species into the feed in the form of a pre
Difurfuryl disulfide
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Difurfuryl disulfide and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. On the label of the additive the fol
Purity: min. 96 % assay
lowing shall be indicated:
Chemical formula: C H O S
10 10 2 2 ‘Recommended maximum content
CAS number: 4437-20-1 of the active substance of complete
FLAVIS No: 13.050 feedingstuff with a moisture content
of 12 %: 0,05 mg/kg.’
Method of analysis(1)
4. The functional group, the identifica
For the determination of difur tion number, the name and the
furyl disulfide in the feed additive added amount of the active sub
and in feed flavouring premix stance shall be indicated on the la
tures: bel of the premixtures where the use
Gas chromatography mass spec level suggested on the label of the
trometry with retention time lock premixture would result in exceed
ing GC-MS-RTL. ing 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 la
belling 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.
23.2.2018
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Journal
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Union
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53/177Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes contact.
Where those risks cannot be elimin
ated or reduced to a minimum by
such procedures and measures, the
additive and premixtures shall be
used with personal protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b13053 — Methyl fur Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
furyl sulfide species into the feed in the form of a pre
Methyl furfuryl sulfide
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Methyl furfuryl sulfide and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. On the label of the additive the fol
Purity: min. 97 % assay
lowing shall be indicated:
Chemical formula: C H OS
6 8 ‘Recommended maximum content
CAS number: 1438-91-1 of the active substance of complete
FLAVIS No: 13.053 feedingstuff with a moisture content
of 12 %: 0,05 mg/kg.’
Method of analysis(1)
4. The functional group, the identifica
For the determination of methyl tion number, the name and the
furfuryl sulfide in the feed additive added amount of the active sub
and in feed flavouring premix stance shall be indicated on the la
tures: bel of the premixtures where the use
Gas chromatography mass spec level suggested on the label of the
trometry with retention time lock premixture would result in exceed
ing GC-MS-RTL. ing the level referred to in point 3.
L
53/178
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
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 la
belling 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.
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes contact.
Where those risks cannot be elimin
ated or reduced to a minimum by
such procedures and measures, the
additive and premixtures shall be
used with personal protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b13055 — 2-Methyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
furan-3-thiol species into the feed in the form of a pre
2-Methylfuran-3-thiol
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
2-Methylfuran-3-thiol and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. On the label of the additive the fol
Purity: min. 95 % assay
lowing shall be indicated:
Chemical formula: C H OS
5 6 ‘Recommended maximum content
CAS number: 28588-74-1 of the active substance of complete
FLAVIS No: 13.055 feedingstuff with a moisture content
of 12 %: 0,05 mg/kg.’
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/179Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
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
added amount of the active sub
2-methylfuran-3-thiol in the feed
stance shall be indicated on the la
additive and in feed flavouring
bel of the premixtures where the use
premixtures:
level suggested on the label of the
Gas chromatography mass spec premixture would result in exceed
trometry with retention time lock ing the level referred to in point 3.
ing 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 la
belling 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.
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes contact.
Where those risks cannot be elimin
ated or reduced to a minimum by
such procedures and measures, the
additive and premixtures shall be
used with personal protective equip
ment, including breathing protec
tion, safety glasses and gloves.
L
53/180
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
2b13064 — Methyl fur Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
furyl disulfide species into the feed in the form of a pre
Methyl furfuryl disulfide
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Methyl furfuryl disulfide and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. On the label of the additive the fol
Purity: min. 95 % assay
lowing shall be indicated:
Chemical formula: C H OS
6 8 2 ‘Recommended maximum content
CAS number: 57500-00-2 of the active substance of complete
FLAVIS No: 13.064 feedingstuff with a moisture content
of 12 %: 0,05 mg/kg.’
Method of analysis(1)
4. The functional group, the identifica
For the determination of methyl tion number, the name and the
furfuryl disulfide in the feed addi added amount of the active sub
tive and in feed flavouring pre stance shall be indicated on the la
mixtures: bel of the premixtures where the use
Gas chromatography mass spec level suggested on the label of the
trometry with retention time lock premixture would result in exceed
ing GC-MS-RTL. ing 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 la
belling 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.
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/181Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
with a moisture content of
12 %
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes contact.
Where those risks cannot be elimin
ated or reduced to a minimum by
such procedures and measures, the
additive and premixtures shall be
used with personal protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b13079 — Methyl 2- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
methyl-3-furyl species into the feed in the form of a pre
Methyl 2-methyl-3-furyl disulfide
disulfide mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Methyl 2-methyl-3-furyl disulfide and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. On the label of the additive the fol
Purity: min. 97 % assay
lowing shall be indicated:
Chemical formula: C H OS
6 8 2 ‘Recommended maximum content
CAS number: 65505-17-1 of the active substance of complete
FLAVIS No: 13.079 feedingstuff with a moisture content
of 12 %: 0,05 mg/kg.’
Method of analysis(1)
4. The functional group, the identifica
For the determination of methyl tion number, the name and the
2-methyl-3-furyl disulfide in the added amount of the active sub
feed additive and in feed flavour stance shall be indicated on the la
ing premixtures: bel of the premixtures where the use
Gas chromatography mass spec level suggested on the label of the
trometry with retention time lock premixture would result in exceed
ing GC-MS-RTL. ing the level referred to in point 3.
L
53/182
EN
Official
Journal
of
the
European
Union
23.2.2018Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
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 la
belling 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.
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes contact.
Where those risks cannot be elimin
ated or reduced to a minimum by
such procedures and measures, the
additive and premixtures shall be
used with personal protective equip
ment, including breathing protec
tion, safety glasses and gloves.
2b13128 — Furfuryl acet Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
ate species into the feed in the form of a pre
Furfuryl acetate
mixture.
Characterisation of the active sub
2. In the directions for use of the addi
stance
tive and premixtures, the storage
Furfuryl acetate and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. On the label of the additive the fol
Purity: min. 97 % assay
lowing shall be indicated:
Chemical formula: C H O
7 8 3 ‘Recommended maximum content
CAS number: 623-17-6 of the active substance of complete
FLAVIS No: 13.128 feedingstuff with a moisture content
of 12 %: 0,5 mg/kg.’
23.2.2018
EN
Official
Journal
of
the
European
Union
L
53/183Minimum Maximum
content content
Identifica Name of End of
Species or
tion the holder Composition, chemical formula, Maximum period
Additive category of mg of active substance/kg Other provisions
number of of authorisa description, analytical method age of authorisa
animal of complete feedingstuff
the additive tion tion
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 furfuryl
added amount of the active sub
acetate in the feed additive and in
stance shall be indicated on the la
feed flavouring premixtures:
bel of the premixtures where the use
Gas chromatography mass spec level suggested on the label of the
trometry with retention time lock premixture would result in exceed
ing GC-MS-RTL. ing 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 la
belling 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:
0,5 mg/kg.
6. For users of the additive and pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes contact.
Where those risks cannot be elimin
ated or reduced to a minimum by
such procedures and measures, the
additive and premixtures shall be
used with personal protective equip
ment, including breathing protec
tion, 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
53/184
EN
Official
Journal
of
the
European
Union
23.2.2018