Two of 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. 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.
- EFSA’s FEEDAP Panel has a key role in providing independent scientific advice to support the authorisation process for feed additives as set down in Regulation EC 1831/2003. The Panel carries out an evaluation of each new additive submitted for authorisation. Manufacturers need to submit an application with information on the identity of the additive, its conditions of use, control methods and data demonstrating its efficacy and safety. The FEEDAP Panel reviews this information and examines the efficacy and safety of the additive in terms of animal and human health as well as the environment, including residues in products of animal origin (e.g. milk, meat, eggs) as well as in soil, ground water and surface water. If EFSA’s opinion is favourable, the European Commission and Member States may grant authorisation for specific animal species and/or conditions of use. Authorisation is limited to ten-year periods which may be renewed. See Applications for feed additives
- Under Regulations EC 1333/2008 and EU 257/2010, EFSA must re-evaluate by 2020 all food additives authorised for use in the EU prior to 20 January 2009 before they can be included on an EU list of approved food additives. In its re-evaluations of previously authorised food additives, EFSA’s ANS Panel is required to review all the relevant scientific literature including the original scientific evaluation, and may also publish a call for data. See ‘Re-evaluation of food additives’
- Authorisation of a new food additive or of proposed new uses of existing food additives requires submission of a formal request to the European Commission with an application dossier on the substance stating its intended uses and including scientific data concerning its safety. See Applications for regulated food ingredients