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Document 02021R0551-20220309

    Consolidated text: Commission Implementing Regulation (EU) 2021/551 of 30 March 2021 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)Text with EEA relevance

    Access initial legal act
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    Legal status of the document In force

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    ELI: http://data.europa.eu/eli/reg_impl/2021/551/2022-03-09

    02021R0551 — EN — 09.03.2022 — 001.001

    This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

    ►B

    COMMISSION IMPLEMENTING REGULATION (EU) 2021/551

    of 30 March 2021

    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)

    (OJ L 111 31.3.2021, p. 3)

    Amended by:

     

     

    Official Journal

      No

    page

    date

    ►M1

    COMMISSION IMPLEMENTING REGULATION (EU) 2022/385 of 7 March 2022

      L 78

    21

    8.3.2022



    ▼B

    COMMISSION IMPLEMENTING REGULATION (EU) 2021/551

    of 30 March 2021

    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)



    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

    Use in water for drinking

    The authorised substances specified in the Annex shall not be used in water for drinking.

    Article 3

    Transitional measures

    1.  
    The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 20 October 2021 in accordance with the rules applicable before 20 April 2021 may continue to be placed on the market and used until the existing stocks are exhausted.
    2.  
    Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 20 April 2022 in accordance with the rules applicable before 20 April 2021 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.  
    Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 20 April 2023 in accordance with the rules applicable before 20 April 2021 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 4

    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.

    ▼M1



    ANNEX



    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: 283-882-11

    FEMA number: 30851

    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: 283-882-14

    FEMA number: 30864

    CAS number: 8024-37-14

    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
    (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



    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 (1).

    Phenols (as gallic acid equivalent):

    1 000 -1 500  μg/mL

    Total curcuminoids (2) (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 (3)

    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)   

    Determined by spectrophotometry as dicinnamoyl methane derivatives.

    (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
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