Re‐evaluation of gellan gum (E 418) as food additive

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of gellan gum (E 418) as a food additive. Following the conceptual framework for the risk assessment of certain food additives re‐evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Based on the reported use levels, a refined exposure of up to 72.4 mg/kg body weight (bw) per day in toddlers at the 95th percentile was estimated. Gellan gum is unlikely to be absorbed intact and would not be fermented by human intestinal microbiota. There is no concern with respect to carcinogenicity and genotoxicity. No adverse effects were reported in chronic studies at the highest doses tested in mice and rats (3,627 and 1,460 mg gellan gum/kg bw per day, respectively). Repeated oral intake up to 200 mg/kg bw per day for 3 weeks had no adverse effects in humans. The Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for gellan gum (E 418), and that there is no safety concern at the refined exposure assessment for the reported uses and use levels of gellan gum (E 418) as a food additive. The Panel recommended to better define the specifications of gellan gum including the absence of viable cells of the microbial source and the presence of polyhydroxybutyrate (PHB), protein and residual bacterial enzymatic activities

Guidance on the scientific requirements for health claims related to muscle function and physical performance (Revision 1)

EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from a grant launched in 2014 which aimed at gathering information in relation to claimed effects, outcome variables and methods of measurement in the context of the scientific substantiation of health claims. The guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to muscle function and physical performance. The draft guidance was subject to public consultation from 16 July to 2 September 2018. This document supersedes the guidance on the scientific requirements for health claims related to physical performance published in 2012. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims

Estimation of costs for control of Salmonella in high-risk feed materials and compound feed

Introduction: Feed is a potential and major source for introducing Salmonella into the animal-derived food chain. This is given special attention in the European Union (EU) efforts to minimize human food-borne Salmonella infections from animal-derived food. The objective of this study was to estimate the total extra cost for preventing Salmonella contamination of feed above those measures required to produce commercial feed according to EU regulation (EC) No 183/2005. The study was carried out in Sweden, a country where Salmonella infections in food-producing animals from feed have largely been eliminated. Methods: On the initiative and leadership of the competent authority, the different steps of feed production associated with control of Salmonella contamination were identified. Representatives for the major feed producers operating in the Swedish market then independently estimated the annual mean costs during the years 2009 and 2010. The feed producers had no known incentives to underestimate the costs. Results and discussion: The total cost for achieving a Salmonella-safe compound feed, when such a control is established, was estimated at 1.8–2.3 € per tonne of feed. Of that cost, 25% relates to the prevention of Salmonella contaminated high-risk vegetable feed materials (mainly soybean meal and rapeseed meal) from entering feed mills, and 75% for measures within the feed mills. Based on the feed formulations applied, those costs in relation to the farmers’ 2012 price for compound feed were almost equal for broilers and dairy cows (0.7%). Due to less use of protein concentrate to fatten pigs, the costs were lower (0.6%). These limited costs suggest that previous recommendations to enforce a Salmonella-negative policy for animal feed are realistic and economically feasible to prevent a dissemination of the pathogen to animal herds, their environment, and potentially to human food products

Risks to human and animal health related to the presence of deoxynivalenol and its acetylated and modified forms in food and feed

Peer reviewedPublisher PD

Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources

Whenever new substances are proposed for use as sources of nutrients in food supplements, foods for the general population or foods for specific groups, EFSA is requested by the European Commission to perform an assessment of their safety and of the bioavailability of the nutrient from the proposed source. This guidance describes the scientific data required to allow an evaluation of the safety of the source within the established framework for risk assessment of food additives and novel food ingredients and the bioavailability of the nutrient from this source. This document is arranged in five main sections: one on technical data aimed at characterising the proposed source and at identifying potential hazards resulting from its manufacture and stability in food; one on existing authorisations and evaluation, providing an overview of previous assessments on the proposed source and their conclusions; one on proposed uses and exposure assessment section, allowing an estimate of the dietary exposure to the source and the nutrient based on the proposed uses and use levels; one on toxicological data, describing approaches which can be used to identify (in conjunction with data on manufacture and composition) and to characterise hazards of the source and any relevant breakdown products; the final section on bioavailability focuses on determining the extent to which the nutrient from the proposed source is available for use by the body in comparison with one or more forms of the same nutrient that are already permitted for use on the positive lists. This guidance document should replace the previous guidance issued by the Scientific Committee for Food and published in 2001

Risks for public health related to the presence of tetrodotoxin (TTX) and TTX analogues in marine bivalves and gastropods

Peer reviewedPublisher PD

Reasoned opinion on the modification of the existing MRLs for dimethomorph in several vegetable crops

<p>In accordance with Article 6 of Regulation (EC) No 396/2005, Germany received three applications from BASF SE to modify or set MRLs for the active substance dimethomorph. In order to accommodate for the intended uses of dimethomorph, Germany proposed to raise the existing MRL from the LOQ of 0.05 mg/kg to 3 mg/kg in leafy brassica, from 1 mg/kg to 5 mg/kg on scarole, whereas an amendment of the existing MRLs was not necessary for cress and land cress, and to set import tolerances at 4 mg/kg on flowering brassica, 15 mg/kg on lettuce and celery and 0.6 mg/kg on garlic, onions and shallots. Germany drafted three separate evaluation reports according to Article 8 of Regulation (EC) No 396/2005 which were submitted to the European Commission and forwarded to EFSA, which addressed these applications in a single reasoned opinion. According to EFSA the data are sufficient to derive MRL proposals of 3 mg/kg for leafy brassica, 6 mg/kg for scarole (outdoor use in Southern Europe), while the existing MRL of 10 mg/kg supports the intended indoor/outdoor uses on cress and land cress and no amendment is necessary. The following import tolerances are proposed: 0.6 mg/kg for onion, garlic and shallot, 15 mg/kg for lettuce and celery. The values of 7 mg/kg and 5 mg/kg for head cabbage and broccoli, respectively, are proposed assuming that the modification of the GAP authorised in the USA will be approved. Adequate analytical methods are available to monitor the residues of dimethomorph in the commodities under consideration at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concludes that the proposed uses under consideration (except the indoor use on scarole) will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern.</p&gt

Statement on the dietary risk assessment for proposed temporary maximum residue levels (t-MRLs) for fosetyl-Al in certain crops

In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to perform a dietary risk assessment of the proposed temporary MRLs for fosetyl-Al. These temporary MRLs should accommodate for residues found in different commodities which are according to food business operators most likely resulting from the use of foliar phosphorous fertilizers which could mimic the treatment with fosetyl-Al. The European Commission proposed to raise the existing MRLs as a proportionate risk management measure on a temporary basis to avoid market disruptions, provided that the proposed temporary MRLs do not pose a consumer heath risk. EFSA concludes that the overall dietary exposure to fosetyl-Al (sum of fosetyl and phosphonic acid and their salts expressed as fosetyl) linked to the proposed temporary MRLs for the crops under assessment and the existing MRLs for other commodities covered by the EU MRL legislation is not expected to result in a consumer exposure exceeding the toxicological reference values for fosetyl. Considering that the exposure assessment was performed with a conservative approach which is likely to overestimate the real exposure, EFSA concludes that the proposed temporary MRLs are unlikely to pose a consumer health risk. Since the source of the occurrence of the residues in the crops under consideration is not clarified, the conclusions of the risk assessment are restricted to the identified residues of phosphonic acid. EFSA derived several recommendations to be considered by risk managers to identify the source of the contamination aiming to reduce the uncertainties of the risk assessment

Scientific Opinion on the substantiation of a health claim related to Rosbacher drive^® and increased attention pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Hassia Mineralquellen GmbH & Co KG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Rosbacher drive® and increased attention. The Panel considers that Rosbacher drive®, which contains natural mineral water plus grape juice, lemon juice, pomegranate juice, elderberry juice, isomaltulose, sucrose, fructose syrup, caffeine, ascorbic acid and natural flavourings, is sufficiently characterised. The claimed effect, increased attention, is a beneficial physiological effect. The single study which was carried out with Rosbacher drive® was an open-label, non-randomised sequential study and the study did not report on any outcomes of attention. No conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of Rosbacher drive® and increased attention

Scientific Opinion on the safety and efficacy of <em>Lactobacillus paracasei</em> (NCIMB 30151) as a silage additive for all animal species

Lactobacillus paracasei is a technological additive intended to improve the ensiling process at a minimum proposed dose of 1.0 × 108 colony-forming units (CFU)/kg fresh material. The bacterial species L. paracasei is considered by the European Food Safety Authority to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and as no antibiotic resistance of concern was detected, the use of the strain in the production of silage is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive should be regarded as a skin and eye irritant and a potential skin and respiratory sensitiser, and treated accordingly. A total of seven studies with laboratory-scale silos were made using samples of forage of differing water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. The results showed that the additive has the potential to improve the production of silage from easy, moderately difficult and difficult to ensile forage species by reducing the pH and increasing the preservation of dry matter. This was most consistently shown at application rates of 5 × 107 and 1 × 108 CFU/kg forage