Commission Implementing Regulation (EU) 2020/1418 of 6 October 2020 concerning the authorisation of saponified paprika (Capsicum annuum) extract (capsanthin) as a feed additive for chickens for fattening, minor poultry species for fattening, laying hens and minor poultry species for laying (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1418
• Articles: 4

Article 1

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants: (ii) substances which, when fed to animals, add colours to food of animal origin’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

1.   The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 27 April 2021 in accordance with the rules applicable before 27 October 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 27 October 2021 in accordance with the rules applicable before 27 October 2020 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

Article 3

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

Schedules & Appendices

ANNEX

ANNEX

Identification number of the additive

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 of total carotenoids of the active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin

2a160c

Saponified paprika extract (capsanthin)

Additive composition:

Saponified extract from dried fruits of Capsicum annuum L. rich in capsanthin.

Benzene ≤ 2 mg/kg

Hexane ≤ 130 mg/kg

Capsaicin ≤ 250 mg/kg

Chickens for fattening

-

-

40

1.

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

2.

The total carotenoids content of the additive shall be indicated on the label of the additive and on the label of the premixtures.

3.

Saponified paprika extract (capsanthin) shall be placed on the market and used as an additive consisting of a preparation.

4.

The mixture of Saponified paprika extract (capsanthin) with other authorised carotenoids and/or xanthophylls shall not exceed a total carotenoids and/or xanthophylls content of 80 mg/kg of complete feed.

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. 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 eye and skin protection

27.10.2030

Minor poultry for fattening

-

-

40

Laying hens

-

-

40

Characterisation of the active substance:

Saponified extract of the dried fruits of C. annuum L.

Total carotenoids content: 25–90 g/kg

Capsanthin ≥ 35 % of total carotenoids.

CAS number capsanthin:465-42-9

Einecs Capsanthin: 207-364-1

Viscous paste

Minor poultry for laying.

-

-

40

Analytical method

( 1 )

For the determination of capsanthin in the feed additive, premixtures and feedingstuffs:

—

High Performance Liquid Chromatography with visible detection (HPLC-Vis)

For the determination of total carotenoids and xanthophylls in the feed additive:

—

Commission Regulation (EU) No 231/2012 referring to FAO JECFA monograph ‘paprika

extract’ monograph No 5 (2008), Combined Compendium for Food Additive Specifications

For the determination of total carotenoids and xanthophylls in premixtures and feedingstuffs:

—

Liquid chromatography with visible detection (LC-Vis) – AOAC official method

970.64

( 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