Sunset Yellow FCF

In the current application an authorisation is sought under Article 10(2) for Sunset Yellow FCF under the category/functional group 2(a) "sensory additives"/"colourants", according to the classification system of Annex I of Regulation (EC) No 1831/2003. Specifically, the authorisation is sought for the use of the feed additive for cats and dogs, ornamental fish, grain-eating ornamental birds and small rodents. 

The feed additive is a synthetic orange-red powder or granules soluble in water, consisting of a minimum of 85 % (w/w) of "total colouring matters content" calculated as sodium salt of 6-hydroxy-5-[(sulfophenyl)azo]-2-naphthalene sulfonate (Sunset Yellow FCF). The Applicant states that the purity criteria for Sunset Yellow FCF as a food additive set in the Commission Directive 2008/128/EC (superseded by the Commission Regulation (EU) 2012/231) are applicable also for the current feed additive. 

Sunset Yellow FCF is intended to be incorporated directly in feedingstuffs or as a solution in water. The Applicant proposed a maximum content of 150 mg/kg complete feedingstuffs only for grain-eating ornamental birds and small rodents. 

For the determination of the "total colouring matters content" in the feed additive, the Applicant submitted the internationally recognised FAO JECFA monographs for food additives (recommended by Commission Regulation (EU) 2012/231), where the determination of the total colouring matters content of Sunset Yellow FCF is based on (i) spectrophotometry and (ii) titration with titanic chloride. 

The EURL recommends for official control the above mentioned methods recommended by Commission Regulation (EU) 2012/231 and described in the FAO JECFA monographs for the determination of Sunset Yellow FCF in the feed additive. 

For the determination of Sunset Yellow FCF in feedingstuffs the Applicant submitted a single-laboratory validated and further verified method based on high performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). 

The following performance characteristics were obtained in the frame of the validation and verification studies for the determination of Sunset Yellow FCF in feedingstuffs with the mass fractions ranging from 1 to 100 mg/kg: a relative standard deviation for repeatability (RSD_r) ranging from 2.0 to 7.6 %, a relative standard deviation for intermediate precision (RSD_ip) ranging from 2.8 to 16.4 %, a recovery rate (R_Rec) ranging from 83 to 101 % and a limit of quantification (LOQ) of 1 mg for Sunset Yellow FCF /kg feedingstuffs.

In addition, samples of a few commercial pet feed products (kibbles) have been analysed using the above mentioned method and acceptable precision was demonstrated. However, a significantly lower mass fraction of Sunset Yellow FCF compared to the expected value was measured in one of the samples. 

The Applicant has attributed the lower mass fraction observed in the sample to a lack of homogeneity of the samples and/or the adverse impact of specific production conditions of the kibbles. It is therefore recommended that additional measures are taken for checking the documentation related to the specific characteristics of the production process of the complete feedingstuffs in case when significantly lower mass fractions of the colourant in comparison to the ones indicated on the labels are obtained during the official control of pet feed samples. 

The Applicant did not provide to the EURL a method for the determination of the above mentioned colourant in premixtures, as the feed additives (in the form of powder or as the solutions in water) are supposed to be added directly into feedingstuffs. 

Based on the performance characteristics available the EURL recommends for official control a single laboratory validated and verified LC-MS/MS method for the determination of Sunset Yellow FCF in feedingstuffs. 

Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2023/1712

For the determination of the total colouring matters content of Sunset Yellow FCF in the feed additive:

• Spectrophotometry at 485 nm and titration with titanic chloride as specified and described in Commission Regulation (EU) No 231/2012(2) which refers to FAO JECFA Combined Compendium for Food Additive Specifications (Analytical methods Vol. 4) and the Monograph No 11 (2011) ‘Sunset Yellow FCF’

For the determination of Sunset Yellow FCF in compound feed:

• High performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)