The European Food Safety Authority (EFSA) is the agency of the European Union (EU) that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain. EFSA was established in February 2002, is based in Parma, Italy and had a budget for 2008 of €65.9 million.

The work of EFSA covers all matters with a direct or indirect impact on food and feed safety, including animal health and welfare, plant protection and plant health and nutrition. EFSA supports the European Commission, the European Parliament and EU member states in taking effective and timely risk management decisions that ensure the protection of the healthof European consumers and the safety of the food and feed chain. EFSA also communicates to the public in an open and transparent way on all matters within its remit.

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Published on: 12 June 2019

The European Food Safety Authority (EFSA) carried out a public consultation to receive input from interested parties on questions asked to health professionals in the fields of nephrology, mineral metabolism, cardiovascular and nutrition medicine relevant to the re-evaluation of phosphates (E 338-341, E 343, E 450-452) food additives. The written public consultation for this document was open from 1 June 2018 to 13 July 2018. EFSA received answers from five interested parties from public bodies. EFSA and its Panel on Food Additives and Flavourings (FAF) wish to thank all stakeholders for their contributions. The current report collects all answers received and concludes on how the answers were used. The EFSA FAF Panel in the preparation of the opinion on re-evaluation of phosphates as food additives considered all answers received. The related opinion on re-evaluating the safety of phosphates (E 338-341, E 343, E 450-452) as food additives was adopted at the FAF Plenary meeting on 27 March 2019.


© European Food Safety Authority, 2015

Outcome of the questions for health professionals in the fields of nephrology, mineral metabolism, cardiovascular and nutrition medicine on phosphates food additives re-evaluation


Published on: 12 June 2019

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel foods and Food Allergens (NDA) was asked to deliver an opinion on chia seeds (Salvia hispanica L.) powders as novel foods (NFs) pursuant to Regulation (EU) 2015/2283. The NFs are partially defatted chia seed powders, obtained by extrusion of whole seeds of S. hispanica L. with the main differences between two powders in particle sizes and the content of some macronutrients. The information provided on the production processes, composition, batch‐to‐batch variability, stability and specifications of the NFs is sufficient and does not raise safety concerns. The applicant proposed to market the NFs as food supplements and as ingredients in a variety of foods. The target population for the NFs is the general population. Noting that no hazard raising safety concerns (except for allergenicity) could be identified from the information available on the source (i.e. chia seeds), the production processes, composition, specifications and proposed uses of the NFs, irrespectively of the maximum use levels at the proposed uses, the Panel considers that intake estimates and additional toxicological data for the NFs are not needed for this assessment. The Panel concludes that the NFs, partially defatted powders of whole chia seeds, are safe under the assessed conditions of use.


© European Food Safety Authority, 2015

Safety and efficacy of Levucell SC® (Saccharomyces cerevisiae CNCM I‐1077) as a feed additive for calves and minor ruminant species and camelids at the same developmental stage


Published on: 12 June 2019

The Panel on Food Additives and Flavourings added to Food (FAF) provided a scientific opinion re-evaluating the safety of phosphates (E 338–341, E 343, E 450–452) as food additives. The Panel considered that adequate exposure and toxicity data were available. Phosphates are authorised food additives in the EU in accordance with Annex II and III to Regulation (EC) No 1333/2008. Exposure to phosphates from the whole diet was estimated using mainly analytical data. The values ranged from 251 mg P/person per day in infants to 1,625 mg P/person per day for adults, and the high exposure (95th percentile) from 331 mg P/person per day in infants to 2,728 mg P/person per day for adults. Phosphate is essential for all living organisms, is absorbed at 80–90% as free orthophosphate excreted via the kidney. The Panel considered phosphates to be of low acute oral toxicity and there is no concern with respect to genotoxicity and carcinogenicity. No effects were reported in developmental toxicity studies. The Panel derived a group acceptable daily intake (ADI) for phosphates expressed as phosphorus of 40 mg/kg body weight (bw) per day and concluded that this ADI is protective for the human population. The Panel noted that in the estimated exposure scenario based on analytical data exposure estimates exceeded the proposed ADI for infants, toddlers and other children at the mean level, and for infants, toddlers, children and adolescents at the 95th percentile. The Panel also noted that phosphates exposure by food supplements exceeds the proposed ADI. The Panel concluded that the available data did not give rise to safety concerns in infants below 16 weeks of age consuming formula and food for medical purposes.


© European Food Safety Authority, 2015

Re-evaluation of the safety of phosphates (E 338–341, E 343, E 450–452)


Published on: 12 June 2019

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel foods and Food Allergens (NDA) was asked to deliver an opinion on chia seeds (Salvia hispanica L.) powders as novel foods (NFs) pursuant to Regulation (EU) 2015/2283. The NFs are partially defatted chia seed powders, obtained by extrusion of whole seeds of S. hispanica L. with the main differences between two powders in particle sizes and the content of some macronutrients. The information provided on the production processes, composition, batch‐to‐batch variability, stability and specifications of the NFs is sufficient and does not raise safety concerns. The applicant proposed to market the NFs as food supplements and as ingredients in a variety of foods. The target population for the NFs is the general population. Noting that no hazard raising safety concerns (except for allergenicity) could be identified from the information available on the source (i.e. chia seeds), the production processes, composition, specifications and proposed uses of the NFs, irrespectively of the maximum use levels at the proposed uses, the Panel considers that intake estimates and additional toxicological data for the NFs are not needed for this assessment. The Panel concludes that the NFs, partially defatted powders of whole chia seeds, are safe under the assessed conditions of use.


© European Food Safety Authority, 2015

Safety of chia seeds (Salvia hispanica L.) powders, as novel foods, pursuant to Regulation (EU) 2015/2283


Published on: 11 June 2019

The additive (trade name Biomin®DC‐P) is a blend of five individual compounds (carvacrol, thymol, d‐carvone, methyl salicylate and l‐menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for various poultry species at a minimum concentration of 65 mg/kg complete feed and a recommended maximum level of 105 mg/kg complete feed. The results of a tolerance study show that Biomin® DC‐P is safe for chickens for fattening at the maximum recommended application rate of 105 mg/kg complete feed; this conclusion is extended to include chickens reared for laying and extrapolated to minor poultry species The active components of a previously evaluated additive (Biomin®DC‐C) were shown to be not genotoxic; owing to the similarity on composition, this conclusion can be also applied to Biomin®DC‐P. Notwithstanding the uncertainties identified in the residue study, after applying a worst‐case scenario to calculate potential exposure of consumers to menthol and carvone, and since that the components of the additive are considered safe for their use as food and feed flavourings, the FEEDAP Panel concludes that the use of the additive in animal nutrition is considered safe for consumers. The FEEDAP Panel considered that exposure of users by inhalation is unlikely, but cannot conclude on the effects of Biomin®DC‐P on skin and eyes. The use of Biomin®DC‐P is not expected to pose a risk for the environment. Biomin®DC‐P has a potential to increase the growth performance of chickens for fattening when incorporated into feed at a minimum application rate of 65 mg/kg complete feed; the conclusion can be extended to chickens reared for laying and extrapolated to minor poultry species reared up to the point of lay.


© European Food Safety Authority, 2015

Safety and efficacy of Biomin® DC‐P as a zootechnical feed additive for chickens for fattening, chickens reared for laying and minor avian species to the point of lay