Commission Implementing Regulation (EU) 2020/376 of 5 March 2020 concerning the authorisation of Norbixin (annatto F) as a feed additive for cats and dogs (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/376
• Articles: 4

Article 1 Authorisation

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Transitional measures

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 26 September 2020 in accordance with the rules applicable before 26 March 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substance specified in the Annex which are produced and labelled before 26 March 2022 in accordance with the rules applicable before 26 March 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

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 .

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

Category: Sensory additives. Functional group: Colourants. (i) substances that add or restore colour in feedingstuffs

2a160b

Norbixin (annatto F)

Additive composition:

Liquid preparation of annatto F containing 2,3-2,7 % norbixin potassium salt

Characterisation of the active substance:

Alkali processed norbixin,acid precipitated (annatto F) is described as the potassium salt of norbixin (dipotassium 6,6’-diapo-psi,psi-carotenedioate);

It is a carotenoid derivative prepared by removal of the outer coating of the seeds of the annatto tree (Bixa orellana L ) and further chemical processing.

Solid form

Chemical formula: C24H26K2O4

CAS number 33261-80-2

Analytical method

( 1 )

For the quantification of norbixin potassium in the feed additive:

—

Spectrophotometry at 482 nm (JECFA monograph on Annatto extracts (alkali processed norbixin, acid-precipitated)

For the quantification of norbixin potassium in feedingstuffs:

—

Reversed phase high performance liquid chromatography coupled to diode array detection (RP-HPLC-DAD)

Cats

Dogs

-

-

13

16

1.

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

2.

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.

26.3.2030

( 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