Commission Implementing Regulation (EU) 2022/385 of 7 March 2022 correcting Implementing Regulation (EU) 2021/421 concerning the authorisation of tincture derived from Artemisia vulgaris L. (mugwort tincture) as a feed additive for all animal species, Implementing Regulation (EU) 2021/485 concerning the authorisation as feed additives of ginger essential oil from Zingiber officinale Roscoe for all animal species, ginger oleoresin from Zingiber officinale Roscoe for chickens for fattening, laying hens, turkeys for fattening, piglets, pigs for fattening, sows, dairy cows, veal calves (milk replacers), cattle for fattening, sheep, goats, horses, rabbits, fish and pets and ginger tincture from Zingiber officinale Roscoe for horses and dogs and Implementing Regulation (EU) 2021/551 concerning the authorisation of turmeric extract, turmeric oil, turmeric oleoresin from Curcuma longa L. rhizome as feed additives for all animal species and turmeric tincture from Curcuma longa L. rhizome as a feed additive for horses and dogs (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/385
• Articles: 8

Article 1

The Annex to Implementing Regulation (EU) 2021/421 is replaced by Annex I to this Regulation.

Article 2

The Annex to Implementing Regulation (EU) 2021/485 is replaced by Annex II to this Regulation.

Article 3

The Annex to Implementing Regulation (EU) 2021/551 is replaced by Annex III to this Regulation.

Article 4

The substances specified in Annexes I, II and III and premixtures containing those substances, which are produced and labelled before 9 September 2022 in accordance with the rules applicable before 9 March 2022 may continue to be placed on the market until the existing stocks are exhausted.

Article 5

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX I

ANNEX I

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method.

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg active substance/kg of complete feed with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b72-t

-

Mugwort tincture

Additive composition

Tincture produced from the fragmented aerial parts of Artemisia vulgaris L.

Characterisation of the active substance

Tincture produced from the fragmented aerial parts of Artemisia vulgaris L by extended extraction with a water/ethanol mixture as defined by the Council of Europe  ( 1 ) .

The specifications of the active substance are:

Dry matter: 1,4-1,9 %

Ash: 0,2-0,5 %

Organic fraction: 1,13-1,65 %, of which

—

Total polyphenols:0,05-0,2 %

—

Phenolic acids 0,02-0,11 %

—

Chlorogenic acid: 0,0028-0,0136 %

—

α- and β-thujone: < 0,005 %

—

1,8-cineole: 0,005 %

—

Solvent (ethanol): 98,1-98,6 %

CoE number: 72

Liquid form

Analytical method

( 2 )

For the characterisation of the feed additive (Mugwort tincture):

—

gravimetric method for the determination of loss on drying and the ash content

—

spectrophotometric method for the determination of total polyphenols content

—

high performance thin layer chromatography (HPTLC) method for the determination of total phenolic acids, chlorogenic acid, alpha- and beta- thujones and eucalyptol.

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 400 mg/kg’.

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

30.3.2031

( 1 )   Natural sources of flavourings – Report No 2 (2007).

( 2 )   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

ANNEX II

ANNEX II

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method.

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg active substance/kg of complete feed with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b489-eo

-

Ginger essential oil

Additive composition

Essential oil derived by steam distillation from the dried rhizomes of Zingiber officinale Roscoe.

Characterisation of the active substance

Essential oil derived by steam distillation from the dried rhizomes of Zingiber officinale Roscoe as defined by the Council of Europe  ( 1 ) .

—

α-zingiberene: 29-40 %

—

β-sesquiphellandrene: 8-14 %

—

ar-curcumene: 5-12 %

—

α-farnesene: 4-10 %

—

camphene: 2-10 %

—

β-bisabolene: 2-9 %

CAS number: 8007-08-7

Einecs number: 283-634-2

FEMA number: 2522

CoE number: 489

Liquid form

Analytical method

( 2 )

For the quantification of alpha-zingiberene, beta-sesquiphellandrene and ar-curcumene in the feed additive:

—

Gas chromatography coupled to mass spectrometry (GC-MS) (full scan mode) using Retention Time Locking (RTL) methodology (or standard substances of the phytochemical markers) with (or without) gas chromatography coupled to flame ionisation detection (GC-FID) based on the ISO 11024 standard method.

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—

veal calves (milk replacer): 80 mg;

—

other species or categories of animals: 20 mg’.

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

5.

The mixture of ginger essential oil with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

12.4.2031

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method.

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg active substance/kg of complete feed with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b489-or

-

Ginger oleoresin

Additive composition

Ginger oleoresin obtained by steam distillation and solvent extraction of dried rhizomes of Zingiber officinale Roscoe.

Characterisation of the active substance

Ginger oleoresin obtained by steam distillation and solvent extraction of dried rhizomes of Zingiber officinale Roscoe as defined by the Council of Europe  ( 3 ) .

Essential oil: 25-30 (w/w)

Total gingerols: 0,5-8 % (w/w)

—

6-Gingerol

—

8-Gingerol

—

10-Gingerol

Total shogaols: 3-6 % (w/w)

—

6-Shogaol

—

8-Shogaol

Humidity and volatiles: 25-30 (w/w)

CoE number: 489

Liquid form

Analytical method

( 4 )

For the quantification of the phytochemical markers: total gingerols and total shogaols in the feed additive (ginger oleoresin):

—

High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – ISO 13685

Chickens for fattening

Laying hens

Turkeys for fattening

Piglets

Pigs for fattening

Sows

Dairy cows

Veal calves (milk replacers)

Cattle for fattening

Sheep and goats

Horses

Rabbits

Fish

Pets

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 % and for milk replacers with a moisture content of 5,5 %:

—

chickens for fattening: 5 mg;

—

laying hens and rabbits: 7 mg;

—

turkeys for fattening: 6 mg;

—

piglets: 8 mg;

—

pigs for fattening: 10 mg;

—

sows: 13 mg;

—

dairy cows: 12 mg;

—

veal calves (milk replacers): 21 mg;

—

cattle for fattening: 19 mg;

—

sheep, goats, horses and fish: 20 mg;

—

pets: 1 mg’.

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

5.

The mixture of ginger oleoresin with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

12.4.2031

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method.

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg active substance/kg of complete feed with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b489-t

-

Ginger tincture

Additive composition

Ginger tincture obtained by extraction of ground dried rhizomes of Zingiber officinale Roscoe using an ethanol/water mixture.

Characterisation of the active substance

Ginger tincture is obtained by extraction of ground dried rhizomes of Zingiber officinale Roscoe using an ethanol/water mixture as defined by the Council of Europe  ( 5 ) .

Solvent (ethanol/water, 90/10): 97-98 % (w/w)

Dry matter: 2-3 % (w/w)

Total gingerols: 0,14-0,11 % (w/w)

—

6-Gingerol

—

8-Gingerol

—

10-Gingerol

Total shogaols: 0,043-0,031 % (w/w)

—

6 Shogaol

—

8-Shogaol

Analytical method

( 6 )

For the quantification of the phytochemical markers: total gingerols and total shogaols in the feed additive (ginger tincture):

—

High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – ISO 13685

Horses

Dogs

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—

Horses 1,58 mL

—

Dogs 1,81 mL’.

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

5.

The mixture of ginger tincture with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

12.4.2031

( 1 )   Natural sources of flavourings – Report No 2 (2007).

( 2 )   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

( 3 )   Natural sources of flavourings – Report No 2 (2007).

( 4 )   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

( 5 )   Natural sources of flavourings – Report No 2 (2007).

( 6 )   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

ANNEX III

ANNEX III

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method.

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg active substance/kg of complete feed with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b163-eo

-

Turmeric essential oil

Additive composition

Essential oil derived by steam distillation from the dried rhizomes of Curcuma longa L.

Characterisation of the active substance

Essential oil derived by steam distillation from the dried rhizomes of Curcuma longa L. as defined by the Council of Europe  ( 1 ) :

—

ar-Turmerone: 40-60 %

—

ß-Turmerone (curlone): 5-15 %

—

ar-Curcumene: 3-6 %

—

ß-Sesquiphellandrene: 3-6 %

—

a-Zingiberene: 1-5 %

—

(E)-Atlantone: 2-4 %

CAS number: 8024-37-1  ( 2 )

Einecs number: 283-882-1 1

FEMA number: 3085 1

CoE number: 163

Liquid form

Analytical method

( 3 )

For the quantification of the phytochemical markers: ar-turmerone and beta-turmerone in the feed additive (turmeric oil):

—

Gas chromatography coupled to mass spectrometry (GC-MS) (full scan mode) using Retention Time Locking (RTL) methodology (or standard substances of the phytochemical markers) with (or without) gas chromatography coupled to flame ionisation detection (GC-FID) based on the ISO 11024 standard method

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 % or milk replacers with a moisture content of 5,5 %:

—

all animal species except veal calves: 20 mg

—

veal calves: 80 mg (milk replacers)’.

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture, if the content of the active substance in complete feedingstuff specified in point 3 is exceeded.

5.

The mixture of Turmeric essential oil with other authorised additives obtained from Curcuma longa L. shall be not be allowed in feedingstuffs.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

20.4.2031

2b163-or

-

Turmeric oleoresin

Additive composition

Oleoresin obtained by solvent extraction of dried rhizomes of Curcuma longa L.

Characterisation of the active substance

Oleoresin obtained by solvent extraction of dried rhizomes of Curcuma longa L. as defined by the Council of Europe  ( 4 ) .

Essential oil: 30-33 % (w/w)

Total curcuminoids: 20-35 % (w/w)

—

Curcumin (I): 16-21 % (w/w)

—

Desmethoxycurcumin (II): 4-6 % (w/w)

—

Bis-desmethoxycurcumin (III): 3-5 % (w/w).

Humidity: 12-30 % (w/w)

Analytical method

( 5 )

For the quantification of the phytochemical marker (total curcuminoids) in the feed additive (turmeric oleoresin):

—

Spectrophotometry – FAO JECFA Combined Compendium of Food Additive Specifications, ‘Turmeric Oleoresin’, monograph No 1 (2006)

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg complete feedingstuff with a moisture content of 12 %:

—

Chicken and laying hens: 30 mg

—

Other animal species: 5 mg’.

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture, if the content of the active substance in complete feedingstuff specified in point 3 is exceeded.

5.

The mixture of Turmeric oleoresin with other authorised additives obtained from Curcuma longa L. shall be not be allowed in feedingstuffs.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

20.4.2031

2b163-ex

-

Turmeric extract

Additive composition

Extract of dried rhizomes Curcuma longa L. using organic solvents.

Characterisation of the active substance

Extract of dried rhizomes Curcuma longa L. using organic solvents as defined by the Council of Europe  ( 6 ) .

Total curcuminoids: ≥ 90 % (w/w)

—

Curcumin (I): 74-79 % (w/w)

—

Desmethoxycurcumin (II): 15-19 % (w/w)

—

Bis-desmethoxycurcumin (III): 2-5 % (w/w)

Water: 0,30-1,7 % (w/w)

Einecs number: 283-882-1 4

FEMA number: 3086 4

CAS number: 8024-37-1 4

CoE number: 163

Solid form (powder)

Analytical method

( 7 )

For the quantification of the phytochemical marker (total curcuminoids) in the feed additive (turmeric extract):

—

Spectrophotometry – FAO JECFA Combined Compendium of Food Additive Specifications, ‘Curcumin’, monograph No 1 (2006)

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 % and milk replacers with a moisture content of 5,5 %: all species and veal calves (milk replacers): 15 mg’.

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture, if the content of the active substance in complete feedingstuff specified in point 3 is exceeded.

5.

The mixture of Turmeric extract with other authorised additives obtained from Curcuma longa L. shall be not be allowed in feedingstuffs.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

20.4.2031

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method.

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mL active substance/kg of complete feed with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b163-t

-

Turmeric tincture

Additive composition

Tincture produced by extraction of ground-dried rhizomes of Curcuma longa L. using a water/ethanol mixture (55/45 % v/v).

Characterisation of the active substance

Tincture produced by extraction of ground-dried rhizomes of Curcuma longa L. using a water/ethanol mixture (55/45 % v/v), as defined by the Council of Europe  ( 8 ) .

Phenols (as gallic acid equivalent):

1 000 -1 500 μg/mL

Total curcuminoids  ( 9 ) (as curcumin): 0,04 to 0,09 % (w/v)

Curcumin (I): 83-182 μg/mL Desmethoxycurcumin (II):

80-175 μg/mL

Bis-desmethoxycurcumin (III): 139-224 μg/mL

Essential oil: 1 176 -1 537 μg/mL

Dry matter: 2,62-3,18 % (w/w)

Solvent (water/ethanol, 55/45): 96-97,5 % (w/w)

CoE number:163

Liquid form

Analytical method

( 10 )

For the quantification of the phytochemical marker (total curcuminoids) in the feed additive

(turmeric tincture):

—

Spectrophotometry (based on European Pharmacopeia monograph ‘Turmeric Javanese’ (01/2008:1441))

Horses

Dogs

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

3.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—

horses: 0,75 mL;

—

dogs: 0,05 mL’.

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture, if the content of the active substance in complete feedingstuff specified in point 3 is exceeded.

5.

The mixture of Turmeric tincture with other authorised additives obtained from Curcuma longa L. shall be not be allowed in feedingstuffs.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

20.4.2031

( 1 )   Natural sources of flavourings – Report No 2 (2007).

( 2 )   The same identifier applies indiscriminately to different kinds of extracts and derivatives from Curcuma longa such as turmeric essential oil, turmeric extract and turmeric tincture.

( 3 )   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

( 4 )   Natural sources of flavourings – Report No 2 (2007).

( 5 )   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

( 6 )   Natural sources of flavourings – Report No 2 (2007).

( 7 )   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

( 8 )   Natural sources of flavourings – Report No 2 (2007).

( 9 )   Determined by spectrophotometry as dicinnamoyl methane derivatives.

( 10 )   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