Cochineal, carminic acid, carmines (E 120) have been previously evaluated by JECFA and by the SCF. Both committees established an ADI of 5 mg/kg bw/day. The Panel noted that the title of the EC specifications for E 120 does not adequately correspond to the specified food additive and therefore, proposes to modify it to "E 120 cochineal extract, carminic acid and carmines", which would more accurately reflect the material used. The Panel also noted that the specifications need to be updated with regard to the maximum limits for certain toxic elements present as impurities, to ensure that E 120 will not be a significant source of exposure to these toxic elements in food. No ADME studies on cochineal extract, carminic acid or carmines were available for evaluation, but indirect evidence suggests that carmines are absorbed and distributed in the body. Acute, shortterm, subchronic, carcinogenicity, reproduction and developmental toxicity studies conducted in rats or mice did not show toxicological potential. Consideration of the available information regarding genotoxicity indicated that carminic acid is not genotoxic. The Panel concluded that the present dataset does not give reason to revise the ADI of 5 mg carmine (containing approximately 50 % carminic acid)/kg bw, allocated by the SCF in 1983. The Panel concluded that this ADI should be expressed as carminic acid content, which would correspond to 2.5 mg carminic acid/kg bw/day. The Panel considered that, since no threshold dose can be established for allergic reactions, it is advisable that exposure to the eliciting allergens, such as proteinaceous compounds, in E 120 is avoided by introducing appropriate purification steps in the manufacturing process. Refined exposure estimates show that exposure to E 120 for the non-brand-loyal scenario, is below the ADI of 2.5 mg carminic acid/kg bw/day for all population groups. for the preparatory work on this scientific opinion and EFSA staff members Petra Gergelova, Ana Maria Rincon and Stavroula Tasiopoulou for the support provided to this scientific opinion. The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output. Re-evaluation of cochineal, carminic acid, carmines (E 120) as a food additive EFSA Journal 2015;13(11):4288 2 SUMMARY Following a request from the European Commission (EC), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of cochineal, carminic acid, carmines (E 120) as a food additive. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the information available following public calls for data. The Panel noted that not all original studies on which previous evaluations were based were available for re-evaluation by the Panel. To assist in identifying any emerging issue or any information relevant for the...