Scientists at EFSA further strengthen co-ordination of food and feed additive evaluations
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 Product intentionally added to animal feed to improve: i) the quality of the feeds ii) the quality of the food products obtained from animals; iii) animal performance and health. 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 A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. approaches including consideration of the available scientific information within these fields.
Experts on EFSA’s Panel on Food Additives and Nutrient An element or compound needed for normal growth, development and health maintenance. Essential nutrients cannot be made by the body and must, therefore, be consumed from food. 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 The amount of a substance (e.g. nutrient or chemical) that is ingested by a person or animal via the diet. ( ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs.) of 5 milligrams per kilogram of body weight per day for its use as a food additive A substance deliberately added to foods or beverages for beneficial technological reasons (e.g. to preserve, flavour, colour or ensure a particular texture). Food additives are not normally consumed by themselves nor used as typical ingredients in food.. The ADI The acceptable daily intake (ADI) is an estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. 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 Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. is estimated to be below the ADI for all population Community of humans, animals or plants from the same species. 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 How well something works in relation to predefined standards or expectations. 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 A subdivision of the genus, a species is a group of closely related and similar-looking organisms; for example, in the case of Homo sapiens (humans), the second part of the name (sapiens) represents the 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
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