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 The draft guidance was subject to public consultation from 16 July to 2 September 2018.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

Assessment of genetically modified maize Bt11\ua0x\ua0MIR162\ua0x\ua01507\ua0x\ua0GA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No\ua01829/2003 (application EFSA-GMO-DE-2010-86)

In this opinion, the GMO Panel\ua0assessed the four-event stack maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21 and three of its subcombinations, independently of their origin. The GMO Panel\ua0previously assessed the four single events and seven of their combinations and did not identify safety concerns. No new data on the single events or the seven subcombinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events in the four-event stack maize did not give rise to food/feed safety issues.\ua0Based on the nutritional assessment of the compositional characteristics of maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21, foods and feeds derived from the genetically modified (GM) maize are expected to have the same nutritional impact as those derived from non-GM maize varieties. In the case of\ua0accidental release of viable grains of maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21 into the environment, this\ua0would not raise environmental safety concerns. The GMO Panel\ua0concludes that maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21 is nutritionally equivalent to and as safe as its non-GM comparator in the context of the scope of this application. For the three subcombinations included in the scope, for which no experimental data were provided, the GMO Panel\ua0assessed the likelihood of interactions among the single events and concluded that their combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and the four-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21 and its subcombinations. A minority opinion expressed by a GMO Panel\ua0member is appended to this opinion

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

Re‐evaluation of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) as food additives

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of calcium silicate (E 552), magnesium silicate (E 553a) and talc (E 553b) when used as food additives. In 1991, the Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) ‘not specified’ for silicon dioxide and silicates. The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) recently provided a scientific opinion re‐evaluating the safety of silicon dioxide (E 551) when used as a food additive. The Panel noted that the absorption of silicates and talc was very low; there was no indication for genotoxicity or developmental toxicity for calcium and magnesium silicate and talc; and no confirmed cases of kidney effects have been found in the EudraVigilance database despite the wide and long‐term use of high doses of magnesium trisilicate up to 4 g/person per day over decades. However, the Panel considered that accumulation of silicon from calcium silicate in the kidney and liver was reported in rats, and reliable data on subchronic and chronic toxicity, carcinogenicity and reproductive toxicity of silicates and talc were lacking. Therefore, the Panel concluded that the safety of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) when used as food additives cannot be assessed. The Panel considered that there is no mechanistic rationale for a group ADI for silicates and silicon dioxide and the group ADI established by the SCF is obsolete. Based on the food supplement scenario considered as the most representative for risk characterisation, exposure to silicates (E 552–553) for all population groups was below the maximum daily dose of magnesium trisilicate used as an antacid (4 g/person per day). The Panel noted that there were a number of approaches, which could decrease the uncertainties in the current toxicological database. These approaches include – but are not limited to – toxicological studies as recommended for a Tier 1 approach as described in the EFSA Guidance for the submission of food additives and conducted with an adequately characterised material. Some recommendations for the revision of the EU specifications were proposed by the Panel

Re‐evaluation of propane‐1,2‐diol alginate (E 405) as a food additive

The present opinion deals with the re‐evaluation of propane‐1,2‐diol alginate (E 405) when used as a food additive. The Panel noted that absorption, distribution, metabolism and excretion (ADME) data on propane‐1,2‐diol alginate gave evidence for the hydrolysis of this additive into propane‐1,2‐diol and alginic acid. These two compounds have been recently re‐evaluated for their safety of use as food additives (EFSA ANS Panel, 2017, 2018). Consequently, the Panel considered in this opinion the major toxicokinetic and toxicological data of these two hydrolytic derivatives. No adverse effects were reported in subacute and subchronic dietary studies with propane‐1,2‐diol alginate. The available data did not indicate a genotoxic concern for propane‐1,2‐diol alginate (E 405) when used as a food additive. Propane‐1,2‐diol alginate, alginic acid and propane‐1,2‐diol were not of concern with respect to carcinogenicity. The Panel considered that any adverse effect of propane‐1,2‐diol alginate would be due to propane‐1,2‐diol. Therefore, the acceptable daily intake (ADI) of the food additive E 405 is determined by the amount of free propane‐1,2‐diol and the propane‐1,2‐diol released from the food additive after hydrolysis. According to the EU specification, the concentration of free and bound propane‐1,2‐diol amounts to a maximum of 45% on a weight basis. On the worst‐case assumption that 100% of propane‐1,2‐diol would be systemically available and considering the ADI for propane‐1,2‐diol of 25 mg/kg body weight (bw) per day, the Panel allocated an ADI of 55 mg/kg bw per day for propane‐1,2‐diol alginate. The Panel concluded that exposure estimates did not exceed the ADI in any of the population groups from the use of propane‐1,2‐diol alginate (E 405) as a food additive. Therefore, the Panel concluded that there is no safety concern at the authorised use levels

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

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

Re‐evaluation of glycerol esters of wood rosin (E 445) as a food additive

The present opinion deals with the re‐evaluation of glycerol esters of wood rosin (GEWR, E 445) when used as a food additive. Regarding GEWR originating from Pinus palustris (longleaf pine) and Pinus elliottii (slash pine), based on the overall toxicity database, and given the absence of reproductive and developmental toxicity data, the Panel concluded that the current acceptable daily intake (ADI) of 12.5 mg/kg body weight (bw) per day for GEWR (E 445) as established by the Scientific Committee on Food (SCF) in 1994 should be temporary pending the provision of such data. This assessment is restricted to GEWR derived from P. palustris (longleaf pine) and P. elliottii (slash pine) and with a chemical composition in compliance with GEWR used in the toxicological testing. The Panel concluded that the mean and the high exposure levels (P95) of the brand‐loyal refined exposure scenario did not exceed the temporary ADI in any of the population groups from the use of GEWR (E 445) as a food additive at the reported use levels. For GEWR originating from Pinus halepensis and Pinus brutia, the Panel noted that concentrations of the fractions of ‘glycerol monoesters’, ‘free resin acids’ and ‘neutrals’, which are considered to be of particular toxicological relevance, are not known; therefore, the evaluation of chemical equivalence with GEWR originating from P. palustris (longleaf pine) and P. elliottii (slash pine) is not possible; no data on stability were available; no toxicological data were available. Therefore, the Panel concluded that a safety assessment of GEWR originating from P. halepensis and P. brutia could not be performed. The Panel recommended the European Commission to consider an update of the definition of GEWR (E 445) in the EU specifications. It should be indicated that GEWR (E 445) (i) contain, besides the mentioned glycerol di‐ and triesters, a residual fraction of glycerol monoesters, and (ii) contain residual free resin acids and neutrals (non‐acidic other saponifiable and unsaponifiable substances)

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

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