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 The draft guidance was subject to public consultation from 16 July to 2 September 2018.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

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

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)

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

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)

Maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 (six‐event stack maize) was produced by conventional crossing to combine six single events: Bt11, MIR162, MIR604, 1507, 5307 and GA21. The GMO Panel previously assessed the six single events and 22 of their combinations and did not identify safety concerns. No new data on the maize single events or their 22 combinations that could lead to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the six–event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the six‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 34 maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the six‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the six‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment