EFSA Panel Determines That Patent Blue V Color is Not a Safety Concern
EFSA’s Scientific Panels have both concluded that the colour Patent Blue V (E 131) is not a safety concern for people or animals when used as a food or feed additive at current levels of use. Under EU legislation in the food and feed areas, EFSA is required to operate under different regulatory frameworks with separate data requirements.
3 Mar 2013 --- When assessing the safety of substances such as colours and other additives used both in food and feed, EFSA’s Panels will continue to ensure consistency in their risk assessment approaches including consideration of the available scientific information within these fields.
Experts on EFSA’s Panel on Food Additives and Nutrient Sources Added to Food (ANS Panel) have assessed the safety of Patent Blue V as a food colour and established a new Acceptable Daily Intake (ADI) of 5 milligrams per kilogram of body weight per day for its use as a food additive. The ADI is the amount of a substance that people can consume on a daily basis during their entire lifetime without any appreciable risk to health. At maximum ‘reported’ use levels in food, consumer exposure is estimated to be below the ADI for all population groups. However, at the maximum ‘permitted’ levels of use established by the EU, the estimated exposure of toddlers and children who are high consumers of food products containing this colour are above the ADI. Maximum permitted levels of use are set by risk managers to limit the amount of a substance used in food and feed products to protect consumers; reported levels of use refer to the actual amounts of such substances present in these products as reported by producers (and which may be lower than the maximum levels authorised).
In its assessment, the ANS Panel included data from studies that have also been used by the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In its opinion, the FEEDAP Panel assessed the safety and efficacy of this colour when used as a feed additive for non-food producing animals such as domestic pets. Therefore, its use as a feed additive is of no concern for consumer safety.
The data requirements in these areas differ due to the separate regulatory frameworks. For the safety and efficacy assessment of a feed additive a dossier submitted by an applicant (for example, the manufacturer or an intermediary) is used as well as publicly available information. For a currently authorised food additive no dossier is submitted for review and therefore all available scientific information may be gathered and considered.
