Safety and efficacy of a feed additive consisting of l-isoleucine produced with Corynebacterium glutamicum CGMCC 20437 for all animal species (Eppen Europe SAS).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 as a nutritional feed additive for use in feed and in water for drinking for all animal species. The production strain is non-genetically modified, qualifies for the QPS approach to safety assessment when used for production purposes, is susceptible to the relevant antibiotics and contains no antimicrobial resistance genes of concern. No viable cells of the production strain were detected in the final product. The additive does not give rise to any safety concern regarding the production strain. l-Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered safe for the target species, the consumer and the environment. Regarding the use in water, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reiterates its concerns over the safety for the target species of l-isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. In the absence of data, the FEEDAP Panel is not in a position to conclude on the potential of l-isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 to be irritant to skin and/or eyes, or as a dermal sensitiser. Due to the high dusting potential, exposure by inhalation is likely. l-Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered as an efficacious source of the essential amino acid l-isoleucine for non-ruminant animal species. For the supplemental l-isoleucine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.

Safety of a feed additive consisting of indigo carmine for cats, dogs and ornamental fish (Sensient Colors Europe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of indigo carmine as a colourant feed additive for cats, dogs and ornamental fish. In its previous opinion, the FEEDAP Panel concluded that indigo carmine is safe for cats and dogs at levels up to 250 mg/kg complete feed and for ornamental fish up to 1000 mg/kg complete feed. These conclusions were limited to indigo carmine with a purity of at least 93% colouring matter. For the current assessment, the applicant submitted additional data on the characterisation and on the toxicological profile to support the safety of the additive with the purity of at least 85% colouring matter. Based on the new data submitted, the FEEDAP Panel concludes that indigo carmine (purity of at least 85% colouring matter) is safe for cats and dogs at levels up to 250 mg/kg complete feed and for ornamental fish up to 1000 mg/kg complete feed.

Assessment of the feed additive consisting of red carotenoid-rich Paracoccus carotinifaciens NITE SD 00017 for salmon and trout for the renewal of its authorisation (ENEOS Techno Materials Corporation).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on red carotenoid-rich Paracoccus carotinifaciens NITE SD 00017 for salmon and trout (category: sensory additives; functional group: colourants; substances which when fed to animals add colours to food of animal origin) for the renewal of its authorisation. The applicant provided evidence that the additive complies with the conditions of the authorisation. The Panel concludes that the use of the additive in salmon and trout remains safe for the target species, the consumer and the environment under the authorised conditions of use. When assessing consumer exposure to canthaxanthin and adonirubin at the level of the existing maximum residue limits (MRL) for poultry and the proposed MRL for trout/salmon (5 mg/kg muscle), the exposure of consumers exceeds the acceptable daily intake (ADI) in the population classes toddlers and other children. The Panel considers that there is no need to restrict the use of the additive to fish older than 6 months or of more than 50 g. Red carotenoid-rich Paracoccus carotinifaciens NITE SD 00017 is not irritant to the skin, but is irritant to the eyes. It is considered a dermal and respiratory sensitiser and any exposure via skin or the respiratory tract is a risk.

Integrated approach for the analysis of neonicotinoids in fruits and food matrices.

We searched for five neonicotenoids (namely acetamiprid, clothianidin, imidacloprid, thiacloprid and thiamethoxam) in 67 samples of fruits, leaves, pollen and honey via HPLC-MS by employing QueChERs for extraction and purification. Clothianidin was never detected, while imidacloprid was identified in apple (9.2 µg/kg) and pollen (18-28 µg/Kg), thiacloprid in peaches (21-35 µg/kg) and acetamiprid was identified in the hazel leaves (1266 µg/kg), honey (13-26 µg /Kg) and pollen (11-24 µg/kg). Since the levels found of acetamiprid in hazel, honey and pollen were concerning, we accomplished a study to identify and characterize the possible transformation products via a laboratory simulation. The methodology exploited the analysis by HPLC-HRMS and its application in all matrices. We identify twelve transformation products, whose formation involved dimerization, hydroxylation, oxidation, demethylation and cleavage of the molecule. Three of them were also detected in hazel leaves.