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: 15 January 2021

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 water extract of Cistanche tubulosa stems as a novel food (NF) for its use in food supplements (FS) and foods for special medical purposes (FSMP). The target population is the general adult population excluding pregnant and lactating women. The applicant proposes a maximum daily intake of 2 g for FS and a maximum use level of 10% in FSMP. The characteristic components of the extract are phenylethanoid glycosides (at least 70% of the NF), in particular, echinacoside (25–45% of the NF). The NF has been authorised as a prescription drug in China in 2005 for the treatment of vascular dementia. The Panel notes that an integrated analysis of three studies covering 1,076 patients with vascular dementia treated with the proposed NF at a daily dose of 1,800 mg, reported that 12 adverse events (AEs) were classified to be ‘definitely’, ‘probably’ or ‘possibly related’ to the exposure to the NF. Two of these AE were classified as severe (cerebral haemorrhage and epilepsy). The Panel considers that the reported AEs raise safety concerns. The Panel also notes the limitations of the provided toxicological studies, in particular the non‐compliance with the EFSA approach on the genotoxicity testing strategy and the non‐compliance with good laboratory practice (GLP) and the respective OECD Guidance documents of the repeated dose toxicity studies. In view of the AEs in the human studies, the Panel considers that additional toxicological studies, following testing guidelines would not be able to overcome the concerns raised from the human studies. The Panel concludes that the safety of the NF has not been established.


© European Food Safety Authority, 2015

Safety of water extract of Cistanche tubulosa stems as a Novel food pursuant to Regulation (EU) 2015/2283


Published on: 13 January 2021

Following the submission of application EFSA-GMO-RX-016 under Regulation (EC) No 1829/2003 fromSyngenta the Panel on Genetically Modied Organisms of the European Food Safety Authority wasasked to deliver a scientic risk assessment on the data submitted in the context of the renewal ofauthorisation application for the insect-resistant and herbicide-tolerant genetically modied maize Bt11,for food and feed uses, excluding cultivation within the European Union. The data rece ived in thecontext of this renewal application contained post-market environmental monitoring reports, asystematic search and evalua tion of literature, updated bioinformatic analyses, and additionaldocuments or studies performed by or on behalf of the applicant. The GMO Panel assessed these datafor possible new hazards, modied exposure or new scientic uncertainties identied during theauthorisation period and not previously assessed in the context of the original application. Under theassumption that the DNA sequences of the event in maize Bt11 considered for renewal is identical tothe sequence of the originally assessed events, the GMO Panel concludes that there is no evidence inrenewal application EFSA-GMO-RX-016 for new hazards, modied exposure or scientic uncertaintiesthat would change the conclusions of the original risk assessment on maize Bt11.


© European Food Safety Authority, 2015

Assessment of genetically modified maize Bt11 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐016)


Published on: 7 January 2021

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain NZYM‐DB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The food enzyme is intended to be used in an immobilised form in the production of modified fats and oils by interesterification. Based on the estimated use levels recommended for interesterification of fats and oils and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.75 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level at the highest dose of 1,132 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1,500. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is likely to be low. Based on the data provided, the immobilisation of the food enzyme and the removal of total organic solids during fats and oils processing, the Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.


© European Food Safety Authority, 2015

Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus niger strain NZYM‐DB


Published on: 8 January 2021

This opinion deals with the re‐evaluation of polydextrose (E 1200) when used as a food additive. The Panel followed the conceptual framework for the risk assessment of certain additives and considered that: adequate exposure estimates were available; the margin of safety (MOS)/margin of exposure (MOE) for arsenic was between 0.5‐14 and 8.5 for lead; the exhaustions of the tolerable weekly intake (TWI) for cadmium would be 165%, 10% for mercury, whereas the exhaustion of the tolerable daily intake (TDI) for nickel would be 9%; the absorption is limited and part of polydextrose is fermented in the large intestine into short‐chain fatty acids (SCFA); adequate toxicity data were available; there is no concern with respect to genotoxicity; no adverse effects were reported in subchronic studies in rats, dogs or monkeys nor in chronic or carcinogenicity studies in mice and rats at the highest doses tested of up 12,500 mg/kg body weight (bw) per day and 15,000 mg/kg bw per day, respectively; the nephrocalcinosis in dogs given high doses of polydextrose was considered to be a treatment‐related but a secondary effect related to diarrhoea, and hence not relevant for the risk assessment; no adverse effects were reported in reproductive or developmental toxicity studies in rats administered up to 10,000 mg polydextrose/kg bw per day, or in a developmental toxicity study in rabbits up to 1,818 mg/kg bw per day (the highest dose tested). Therefore, the Panel concluded that there is no need for numerical acceptable daily intake (ADI) for polydextrose (E 1200), and that there is no safety concern for the reported uses and use levels of polydextrose as a food additive. The Panel recommended that European Commission considers to lower the maximum limit for lead and to introduce limits for arsenic, cadmium and mercury in the EU specifications for polydextrose (E 1200), and to verify that polydextrose‐N as a food additive (E 1200) is no longer marketed in the EU.


© European Food Safety Authority, 2015

Re‐evaluation of polydextrose (E 1200) as a food additive