Date: 2018-02-23Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2018/243 of 15 February 2018 concerning the authorisation of 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopentan-1,2-dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3-methylnona-2-,4-dione as feed additives for all animal species (Text with EEA relevance. )
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary:**
This Commission Implementing Regulation (EU) 2018/243 authorises the use of specific flavouring compounds as sensory feed additives for all animal species. It addresses the re-evaluation of these substances, initially authorised under Directive 70/524/EEC, and sets conditions for their use. The regulation includes transitional measures for products produced and labelled before specified dates in 2018, 2019 and 2020, and the authorisations expire on March 15, 2028.
**Key Points / Main Content:**
* **Authorisation of Feed Additives:**
* Authorises 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl-cyclopentan-1,2-dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3-methylnona-2,4-dione as sensory feed additives for all animal species.
* These additives are classified under the functional group "flavouring compounds."
* **Conditions of Use and Labelling:**
* The additives must be incorporated into feed as a premixture.
* The storage and stability conditions must be indicated in the directions for use.
* A recommended maximum content of the active substance in complete feeding stuff (with 12% moisture content) must be indicated on the label.
* If the content of the active substance exceeds the recommended maximum, the functional group, identification number, name, and added amount of the active substance must be indicated on the label of premixtures, feed materials and compound feedingstuffs.
* **Safety Measures:**
* Feed business operators must establish procedures to address potential risks from inhalation, dermal contact, or eye contact.
* Personal protective equipment (breathing protection, safety glasses, and gloves) should be used if risks cannot be eliminated or minimised.
* **Transitional Measures:**
* Substances and premixtures produced and labelled before September 15, 2018, under previous rules, may be placed on the market and used until existing stocks are exhausted.
* Feed materials and compound feed produced and labelled before March 15, 2019 (for food-producing animals) or March 15, 2020 (for non-food-producing animals) under previous rules, may be placed on the market and used until existing stocks are exhausted.
* **End of Authorisation Period:**
* The authorisation for each additive expires on March 15, 2028.
**Impact Analysis:**
**Feed Additive Producers/Suppliers:**
* *Impact:* Must comply with the new authorisation conditions, including proper labelling, ensuring the additives are incorporated as a premixture, and providing appropriate safety information.
* *Action Required:* Update labels to include recommended maximum content and other required information; implement operational procedures and safety measures.
**Feed Business Operators:**
* *Impact:* Responsible for ensuring the safe use of the additives, including establishing operational procedures to address potential risks.
* *Action Required:* Implement operational procedures and organisational measures to address potential inhalation, dermal, and eye contact risks; provide and ensure the use of personal protective equipment where necessary.
**Farmers/Animal Feeders:**
* *Impact:* Need to be aware of the authorised additives and their proper use to ensure animal health and safety.
* *Action Required:* Follow the updated labelling and usage instructions for feed containing these additives.
**Regulatory Bodies/Enforcement Agencies:**
* *Impact:* Responsible for monitoring and enforcing compliance with the new regulation.
* *Action Required:* Ensure that feed additives and feed products comply with the new labelling and usage requirements.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution 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: Regulation of the European Parliament and of the Council on additives for use in animal nutrition.
Council Directive 70/524/EEC: Council Directive concerning additives in feedingstuffs.
European Food Safety Authority: The Authority that concluded the substances do not have adverse effects on animal health, human health, or the environment.
Standing Committee on Plants, Animals, Food and Feed: The committee that provided the opinion in accordance to which the measures of the regulation are provided.
Brussels: The city where the regulation was adopted.
Jean-Claude Juncker: The President of the European Commission at the time of the regulation's adoption.
23.2.2018 EN Official Journal of the European Union L 53/69
COMMISSION IMPLEMENTING REGULATION (EU) 2018/243
of 15 February 2018
concerning the authorisation of 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopen
tan-1,2-dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione
and 3-methylnona-2-,4-dione 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 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopentan-1,2-dione, hexan-3,4-dione,
sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3-methylnona-2-,4-dione (‘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 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 19 October 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 was necessary. Therefore, that conclusion can be extrapolated to feed. The
applicant withdrew the application for water for drinking, however, it should be possible to use the substances
concerned within compound feeds which are subsequently administered via water.
(5) Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the
setting of a maximum content and taking into account the re-evaluation performed by the Authority,
a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain
information should be indicated on the label of premixtures, and on the labelling of feed materials and
compound feed.
(6) The Authority 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.
(7) 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(11):4618.L 53/70 EN Official Journal of the European Union 23.2.2018
(8) 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.
(9) 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 Name of content content End of pe
Species or
tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions riod
number of of authori description, analytical method animal age of complete feedingstuff of authori
the additive sation with a moisture content of sation
12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b07051 — 3-Hydroxybu Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
tan-2-one species into the feed in the form of a pre
3-Hydroxybutan-2-one
mixture.
Characterisation of the active sub
2. In the directions for use of the ad
stance
ditive and premixtures, the storage
3-Hydroxybutan-2-one and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. The recommended maximum con
Purity: min. 96 % assay
tent of the active substance shall be
Chemical formula: C H O 5 mg/kg of complete feedingstuff
4 8 2
CAS number: 513-86-0 with a moisture content of 12 %.
FLAVIS No: 07.051 4. On the label of the additive the fol
lowing shall be indicated:
Method of analysis(1)
‘Recommended maximum content
For the determination of 3-hydro of the active substance of complete
xybutan-2-one in the feed additive feedingstuff with a moisture con
and in feed flavouring premixtures: tent of 12 %: 5 mg/kg.’
Gas chromatography mass spectro 5. The functional group, the identifi
metry with retention time locking cation number, the name and the
GC-MS-RTL. added amount of the active sub
stance shall be indicated on the la
bel of the premixtures and on the
labelling of feed materials and com
pound feedingstuffs, if the content
of the active substance in complete
feedingstuff with a moisture con
tent of 12 % exceeds: 5 mg/kg.
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53/71Minimum Maximum
Identifica Name of content content End of pe
Species or
tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions riod
number of of authori description, analytical method animal age of complete feedingstuff of authori
the additive sation with a moisture content of sation
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 con
tact. Where those risks cannot be
eliminated or reduced to a mini
mum by such procedures and
measures, the additive and premix
tures shall be used with personal
protective equipment, including
breathing protection, safety glasses
and gloves.
2b07060 — Pentan-2,3- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
dione species into the feed in the form of a pre
Pentan-2,3-dione
mixture.
Characterisation of the active sub
2. In the directions for use of the ad
stance
ditive and premixtures, the storage
Pentan-2,3-dione and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. The recommended maximum con
Purity: min. 93 % assay
tent of the active substance shall be
Chemical formula: C H O 5 mg/kg of complete feedingstuff
5 8 2
CAS number: 600-14-6 with a moisture content of 12 %.
FLAVIS No: 07.060 4. On the label of the additive the fol
lowing shall be indicated:
Method of analysis(1)
‘Recommended maximum content
For the determination of pentan- of the active substance of complete
2,3-dione in the feed additive and feedingstuff with a moisture con
in feed flavouring premixtures: tent of 12 %: 5 mg/kg.’
Gas chromatography mass spectro
metry with retention time locking
GC-MS-RTL.
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tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions riod
number of of authori description, analytical method animal age of complete feedingstuff of authori
the additive sation with a moisture content of sation
12 %
5. The functional group, the identifi
cation number, the name and the
added amount of the active sub
stance shall be indicated on the la
bel of the premixtures and on the
labelling of feed materials and com
pound feedingstuffs, if the content
of the active substance in complete
feedingstuff with a moisture con
tent 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 con
tact. Where those risks cannot be
eliminated or reduced to a mini
mum by such procedures and
measures, the additive and premix
tures shall be used with personal
protective equipment, including
breathing protection, safety glasses
and gloves.
2b07076 — 3,5-Dimethyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
cyclopentan- species into the feed in the form of a pre
3,5-dimethyl cyclopentan-1,2-dio
1,2-dione mixture.
ne
2. In the directions for use of the ad
Characterisation of the active sub
ditive and premixtures, the storage
stance
and stability conditions shall be in
3,5-dimethyl cyclopentan-1,2-dio dicated.
ne
Produced by chemical synthesis
Purity: min. 97 % assay
Chemical formula: C H O
7 10 2
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53/73Minimum Maximum
Identifica Name of content content End of pe
Species or
tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions riod
number of of authori description, analytical method animal age of complete feedingstuff of authori
the additive sation with a moisture content of sation
12 %
CAS number: 13494-07-0 3. The recommended maximum con
tent of the active substance shall be
FLAVIS No: 07.076
0,5 mg/kg of complete feedingstuff
Method of analysis(1) with a moisture content of 12 %.
For the determination of 3,5-di 4. On the label of the additive the fol
methyl cyclopentan-1,2-dione in lowing shall be indicated:
the feed additive and in feed fla
‘Recommended maximum content
vouring premixtures:
of the active substance of complete
Gas chromatography mass spectro feedingstuff with a moisture con
metry with retention time locking tent of 12 %: 0,5 mg/kg.’
GC-MS-RTL.
5. The functional group, the identifi
cation number, the name and the
added amount of the active sub
stance shall be indicated on the la
bel of the premixtures and on the
labelling of feed materials and com
pound feedingstuffs, if the content
of the active substance in complete
feedingstuff with a moisture con
tent 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 con
tact. Where those risks cannot be
eliminated or reduced to a mini
mum by such procedures and
measures, the additive and premix
tures shall be used with personal
protective equipment, including
breathing protection, safety glasses
and gloves.
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tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions riod
number of of authori description, analytical method animal age of complete feedingstuff of authori
the additive sation with a moisture content of sation
12 %
2b07077 — Hexan-3,4- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
dione species into the feed in the form of a pre
Hexan-3,4-dione
mixture.
Characterisation of the active sub
2. In the directions for use of the ad
stance
ditive and premixtures, the storage
Hexan-3,4-dione and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. The recommended maximum con
Purity: min. 97 % assay
tent of the active substance shall be
Chemical formula: C H O 5 mg/kg of complete feedingstuff
6 10 2
CAS number: 4437-51-8 with a moisture content of 12 %.
FLAVIS No: 07.077 4. On the label of the additive the fol
lowing shall be indicated:
Method of analysis(1)
‘Recommended maximum content
For the determination of hexan- of the active substance of complete
3,4-dione in the feed additive and feedingstuff with a moisture con
in feed flavouring premixtures: tent of 12 %: 5 mg/kg.’
Gas chromatography mass spectro 5. The functional group, the identifi
metry with retention time locking cation number, the name and the
GC-MS-RTL. added amount of the active sub
stance shall be indicated on the la
bel of the premixtures and on the
labelling of feed materials and com
pound feedingstuffs, if the content
of the active substance in complete
feedingstuff with a moisture con
tent of 12 % exceeds: 5 mg/kg.
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53/75Minimum Maximum
Identifica Name of content content End of pe
Species or
tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions riod
number of of authori description, analytical method animal age of complete feedingstuff of authori
the additive sation with a moisture content of sation
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 con
tact. Where those risks cannot be
eliminated or reduced to a mini
mum by such procedures and
measures, the additive and premix
tures shall be used with personal
protective equipment, including
breathing protection, safety glasses
and gloves.
2b09186 — Sec-butan-3- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
onyl acetate species into the feed in the form of a pre
Sec-butan-3-onyl acetate
mixture.
Characterisation of the active sub
2. In the directions for use of the ad
stance
ditive and premixtures, the storage
Sec-butan-3-onyl acetate and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. The recommended maximum con
Purity: min. 98 % assay
tent of the active substance shall be
Chemical formula: C H O 5 mg/kg of complete feedingstuff
6 10 3
CAS number: 4906-24-5 with a moisture content of 12 %.
FLAVIS No: 09.186 4. On the label of the additive the fol
lowing shall be indicated:
Method of analysis(1)
‘Recommended maximum content
For the determination of sec-bu of the active substance of complete
tan-3-onyl acetate in the feed addi feedingstuff with a moisture con
tive and in feed flavouring premix tent of 12 %: 5 mg/kg.’
tures:
Gas chromatography mass spectro
metry with retention time locking
GC-MS-RTL.
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Identifica Name of content content End of pe
Species or
tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions riod
number of of authori description, analytical method animal age of complete feedingstuff of authori
the additive sation with a moisture content of sation
12 %
5. The functional group, the identifi
cation number, the name and the
added amount of the active sub
stance shall be indicated on the la
bel of the premixtures and on the
labelling of feed materials and com
pound feedingstuffs, if the content
of the active substance in complete
feedingstuff with a moisture con
tent 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 con
tact. Where those risks cannot be
eliminated or reduced to a mini
mum by such procedures and
measures, the additive and premix
tures shall be used with personal
protective equipment, including
breathing protection, safety glasses
and gloves.
2b07109 — 2,6,6-Tri Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
methylcyclo species into the feed in the form of a pre
2,6,6-Trimethylcyclohex-2-en-1,4-
hex-2-en-1,4- mixture.
dione
dione
2. In the directions for use of the ad
Characterisation of the active sub
ditive and premixtures, the storage
stance
and stability conditions shall be in
2,6,6-Trimethylcyclohex-2-en-1,4- dicated.
dione
Produced by chemical synthesis
Purity: min. 98 % assay
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53/77Minimum Maximum
Identifica Name of content content End of pe
Species or
tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions riod
number of of authori description, analytical method animal age of complete feedingstuff of authori
the additive sation with a moisture content of sation
12 %
Chemical formula: C H O 3. The recommended maximum con
9 12 2
tent of the active substance of com
CAS number: 1125-21-9 plete feedingstuff with a moisture
content of 12 % shall be:
FLAVIS No: 07.109
— 0,3 mg/kg for pigs and poultry;
Method of analysis(1)
— 0,5 mg/kg for other species and
categories.
For the determination of 2,6,6-tri
methylcyclohex-2-en-1,4-dione in
4. On the label of the additive the fol
the feed additive and in feed fla
lowing shall be indicated:
vouring premixtures:
‘Recommended maximum content
Gas chromatography mass spectro
of the active substance of complete
metry with retention time locking
feedingstuff with a moisture con
GC-MS-RTL.
tent of 12 %:
— 0,3 mg/kg for pigs and poultry;
— 0,5 mg/kg for other species and
categories’.
5. The functional group, the identifi
cation number, the name and the
added amount of the active sub
stance shall be indicated on the la
bel of the premixtures and on the
labelling of feed materials and com
pound feedingstuffs, if the content
of the active substance in complete
feedingstuff with a moisture con
tent of 12 % exceeds:
— 0,3 mg/kg for pigs and poultry;
— 0,5 mg/kg for other species and
categories.
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Identifica Name of content content End of pe
Species or
tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions riod
number of of authori description, analytical method animal age of complete feedingstuff of authori
the additive sation with a moisture content of sation
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 con
tact. Where those risks cannot be
eliminated or reduced to a mini
mum by such procedures and
measures, the additive and premix
tures shall be used with personal
protective equipment, including
breathing protection, safety glasses
and gloves.
2b07184 — 3-Methyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028
nona-2-,4- species into the feed in the form of a pre
3-Methylnona-2-,4-dione
dione mixture.
Characterisation of the active sub
2. In the directions for use of the ad
stance
ditive and premixtures, the storage
3-Methylnona-2-,4-dione and stability conditions shall be in
dicated.
Produced by chemical synthesis
3. The recommended maximum con
Purity: min. 97 % assay
tent of the active substance of com
Chemical formula: C H O plete feedingstuff with a moisture
10 18 2
CAS number: 113486-29-6 content of 12 % shall be:
FLAVIS No: 07.184 — 0,3 mg/kg for pigs and poultry;
— 0,5 mg/kg for other species and
Method of analysis(1)
categories.
For the determination of 3-methyl
4. On the label of the additive the fol
nona-2-,4-dione in the feed addi
lowing shall be indicated:
tive and in feed flavouring premix
tures: ‘Recommended maximum content
of the active substance of complete
Gas chromatography mass spectro
feedingstuff with a moisture con
metry with retention time locking
tent of 12 %:
GC-MS-RTL.
— 0,3 mg/kg for pigs and poultry;
— 0,5 mg/kg for other species and
categories’.
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53/79Minimum Maximum
Identifica Name of content content End of pe
Species or
tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions riod
number of of authori description, analytical method animal age of complete feedingstuff of authori
the additive sation with a moisture content of sation
12 %
5. The functional group, the identifi
cation number, the name and the
added amount of the active sub
stance shall be indicated on the la
bel of the premixtures and on the
labelling of feed materials and com
pound feedingstuffs, if the content
of the active substance in complete
feedingstuff with a moisture con
tent 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 pre
mixtures, feed business operators
shall establish operational proce
dures and organisational measures
to address potential risks by inhala
tion, dermal contact or eyes con
tact. Where those risks cannot be
eliminated or reduced to a mini
mum 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.
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