# Assessment of the feed additive consisting of canthaxanthin (Carophyll® Red 10%) for breeder hens for the renewal of its authorisation (DSM Nutritional Products Ltd.)

## TL;DR

This paper evaluates the safety and authorization renewal of a canthaxanthin feed additive for breeder hens, noting potential risks to humans and animals.

## Contribution

The study provides a scientific assessment of canthaxanthin's safety and authorization renewal, including modifications to its formulation.

## Key findings

- The additive is safe for target species and consumers under current conditions.
- Current maximum residue limits may not be protective enough for combined exposure routes.
- The additive is irritant and a skin sensitiser, posing a risk with any exposure.

## Abstract

Following a request from the European Commission, the EFSA was asked to deliver a scientific opinion on the renewal of the feed additive consisting of canthaxanthin (Carophyll® Red 10%) for breeder hens and to modify the additive specifications by substituting ethoxyquin by 4.4% butylated hydroxytoluene (BHT) and increasing the limit for dichloromethane to 80 mg/kg. The additive complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) notes that the proposed modifications for the additive are considered to be of no concern. The Panel concluded that CAROPHYLL®Red 10% remains safe for the target species and the consumer under the current authorised conditions of use for CAROPHYLL® Red 10%. The Panel noted that the current maximum residue limits (MRLs) set in the different authorisations for canthaxanthin may not be protective enough for the consumer when considering combined exposure by all possible routes. CAROPHYLL® Red 10% should be considered to be irritant to skin and eyes and the respiratory tract and to be a skin sensitiser; any exposure is considered a risk. In the absence of data, the Panel could not conclude whether the additive CAROPHYLL® Red 10% remains safe for the environment under the current conditions of the authorisation. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.