Current issue

Just Published: May, 2016

Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel

Safety of changes in specification for basic methacrylate copolymer (E 1205)

Food ingredients and packaging
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes
EFSA Journal 2016;14(5):4490 [13 pp.].
doi
10.2903/j.efsa.2016.4490
Abstract

Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver an opinion to amend the specifications regarding the ‘definition’ and the ‘particle size’ limits of basic methacrylate copolymer (BMC – E 1205) listed in Commission Regulation (EU) No 231/2012. The request resulted from the change of the manufacturing process from a bulk polymerisation process to a solution polymerisation process and that the specifications for the particle size of < 0.1 μm are set at limits of ‘between 5.1% and 5.5%’. These limits were never met and could be interpreted as requesting a defined percentage of nanoparticles in the powder. The specifications were amended as follows: at least 95% of the particles have a size below 50 μm; at least 50% have a size below 20 μm; not more than 10% have a size below 3 μm. Particles with a diameter of 0.1 μm (100 nm) or below were never observed in the batches analysed. A detailed description of the solution polymerisation process was provided together with data on residual solvents, residual monomers, stability and reaction and fate in food. No new or additional biological and toxicological data were submitted. The ANS Panel taking into account the available information and as BMC was recently evaluated by EFSA (EFSA ANS Panel, 2010), considered this conclusion would still be valid for BMC produced by the new manufacturing procedure and that the request for amending the specification can be accepted. Therefore, the Panel concluded that there is no safety concern from the proposed amendments in the specifications resulting from the changes in the manufacturing process for the food additive BMC.

Beetroot red (E 162): extension of use in FSMP for young children

Food ingredients and packaging
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes
EFSA Journal 2016;14(5):4487 [13 pp.].
doi
10.2903/ j.efsa.2016.4487
Abstract

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to provide a scientific opinion on the safety of the extension of use of the food colour beetroot red (E 162) when added to dietary food for special medical purposes (FSMP) intended for young children aged 1–3 years. Currently, the use of colours in foodstuffs is prohibited in any food for infants and young children, including FSMPs. According to the applicant, the use of food colours is required to ensure appealing and palatable foods for the dietary management of patients whose compliance with the dietary regime (prescribed by healthcare professionals) is a key factor to their health. The Panel considered that there was no higher risk of sensitivity or intolerance to beetroot red extract in the specific population of children with cow's milk allergy or other protein allergies. The exposure scenarios indicated that the total daily protein requirement (up to 3 g protein/kg bw) could be covered by the products containing beetroot red at the proposed use level of 20 mg/L (expressed as the colouring principle betanin) in the final diluted product as consumed without exceeding the amount of betanin likely to be ingested in the same age group from the use of beetroot red (E 162) as a food additive. Exposure in other scenarios based on different assumptions was always below the range of the high level intake of betanin in the same age group. The ANS Panel concluded that the proposed extension of use of beetroot red (E 162) at the proposed level of 20 mg/L in the final diluted FSMP in young children aged 1–3 years would not be of safety concern.

Re-evaluation of sucrose acetate isobutyrate (E 444) as a food additive

Food ingredients and packaging
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes
EFSA Journal 2016;14(5):4489 [39 pp.].
doi
10.2903/j.efsa.2016.4489
Abstract

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of sucrose acetate isobutyrate (SAIB, E 444) as a food additive. The SCF allocated an acceptable daily intake (ADI) of 10 mg/kg body weight (bw) per day in 1994. JECFA established an ADI of 20 mg/kg bw per day in 1997. Both the JECFA and the SCF concluded that the hepatic effects observed in the dog have little relevance to the safety evaluation in humans. The Panel agreed with this conclusion. Oral absorption is approximately 70% in rats, about 50% in dogs and ≥ 88% in humans. The Panel concluded that SAIB does not raise concern for genotoxicity. No treatment-related effects have been observed on clinical signs, haematology and clinical chemistry in humans at a dose of 20 mg/kg bw per day for 14 days. The Panel identified a no observed adverse effect level (NOAEL) of 2,000 mg/kg bw per day, the highest dose tested, from chronic toxicity, carcinogenicity and reproductive and developmental studies in rats. Applying an uncertainty factor of 100, an ADI of 20 mg/kg bw per day for SAIB can be established. Overall, the Panel concluded that the present data set on absorption, distribution, metabolism and excretion, genotoxicity, subchronic, developmental and long-term toxicity, and carcinogenicity give reason to revise the ADI of 10 mg/kg bw per day allocated by the SCF in 1994 to 20 mg/kg bw per day. Considering that the ADI is not exceeded in any population group, the Panel also concluded that the use of SAIB (E 444) as a food additive at the permitted or reported use and use levels would not be of safety concern.

Polydextrose and normal defecation

Nutrition
Jean-Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts
EFSA Journal 2016;14(5):4480 [12 pp.].
doi
10.2903/j.efsa.2016.4480
Abstract

Following an application from Tate & Lyle PLC submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, 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 polydextrose and maintenance of normal defecation. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food constituent that is the subject of the health claim is ‘polydextrose’. The Panel considers that polydextrose is sufficiently characterised. The claimed effect proposed by the applicant is ‘improved bowel function by increasing stool bulk’. The target population proposed by the applicant is ‘the general population’. The Panel considers that maintenance of normal defecation is a beneficial physiological effect. In weighing the evidence, the Panel took into account that, out of the three human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim, one study showed an effect at doses of 20 g/day when polydextrose was given for 10 days, whereas two studies in which polydextrose was administered at doses of 21 and 18 g/day for longer periods of time did not show an effect. The Panel also took into account that the evidence provided for the mechanisms by which polydextrose could contribute to the maintenance of normal defecation in vivo in humans is weak. The Panel concludes that a cause and effect relationship has not been established between the consumption of polydextrose and maintenance of normal defecation.

L-Lysine HCl produced by Escherichia coli for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(5):4471 [9 pp.].
doi
10.2903/j.efsa.2016.4471
Abstract

L-Lysine monohydrochloride is a feed additive produced by fermentation using a genetically modified strain of Escherichia coli (CGMCC 7.57). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of the EFSA, in its opinion on the safety and efficacy of the product, could not conclude on the safety of the product for target animals, consumers, users and the environment. The European Commission asked EFSA to deliver an opinion on the safety of L-lysine monohydrochloride as a nutritional additive for all animal species based on additional data submitted by the applicant on the characterisation of the additive. No recombinant antibiotic resistance genes are present in the production strain and therefore in the final product. The L-lysine monohydrochloride manufactured by fermentation using E. coli CGMCC 7.57 does not raise safety concerns for the target species, consumers, users and the environment with regard to the genetic modification of the production strain. The levels of endotoxins present in the product and its dusting potential indicate no health risk for the user.

L-Threonine produced by Escherichia coli for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(5):4470 [11 pp.].
doi
10.2903/j.efsa.2016.4470
Abstract

L-Threonine, technically pure, is a feed additive produced by fermentation using a genetically modified (GM) strain of Escherichia coli (CGMCC 7.58). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA issued an opinion on the safety and efficacy of the product, which concluded that the recipient strain and its genetic modification, including the presence or absence of an antibiotic resistance gene in the product under assessment, are insufficiently characterised. Consequently, the FEEDAP Panel could not make a conclusion on the safety of the product L-threonine produced by fermentation with this recombinant strain of E. coli for target animals, consumers, users and the environment. Furthermore, the level of endotoxins present in the product and its dusting potential represent a risk for the user by inhalation. The European Commission asked EFSA to deliver an opinion on the safety of L-threonine for all animal species based on additional data submitted by the applicant on the characterisation of the additive and of the genetic modification of the production strain. No recombinant antibiotic resistance genes are present in the production strain and therefore in the final product. L-Threonine technically pure, manufactured by fermentation using E. coli CGMCC 7.58, does not raise safety concerns for the target species, consumers, users and the environment with regard to the genetic modification of the production strain. A risk from exposure to endotoxins for people handling the additive is expected. Concerns remain about possible dermal sensitisation.

GM oilseed rape MS8 × RF3 × GT73 and specific subcombinations

GMO
Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Achim Gathmann, Mikolaj Antoni Gralak, Philippe Guerche, Huw Jones, Barbara Manachini, Antoine Messéan, Hanspeter Naegeli, Elsa Ebbesen Nielsen, Fabien Nogué, Christophe Robaglia, Nils Rostoks, Jeremy Sweet, Christoph Tebbe, Francesco Visioli and Jean-Michel Wal
EFSA Journal 2016;14(5):4466 [26 pp.].
doi
10.2903/j.efsa.2016.4466
Abstract

The EFSA Panel on Genetically Modified Organisms (GMO) previously assessed the three single events that are combined to produce the three-event stack oilseed rape (OSR) MS8 × RF3 × GT73. In this Scientific Opinion, the GMO Panel assessed the three-event stack OSR and subcombinations that have not been authorised previously (i.e. MS8 × GT73 and RF3 × GT73), independently of their origin, for food and feed uses, import and processing, with the exception of isolated seed protein for food. The combination of OSR events, MS8, RF3 and GT73, in the three-event stack OSR does not raise issues relating to molecular, agronomic/phenotypic or compositional characteristics requiring further investigations. In line with previous assessments and considering the scope of this application, the GMO Panel did not find indications of safety concern for food and feed with trace levels of glyphosate oxidoreductase (GOX)v247 protein derived from the three-event stack OSR; whereas, the GMO Panel cannot assess the safety of three-event stack OSR products rich in protein, such as rapeseed protein isolates in feed. As the risk assessment of the three-event stack OSR could not be completed for products rich in protein, such as rapeseed protein isolates, the GMO Panel is not in a position to complete the food and feed safety assessment of subcombinations within the scope of this application (i.e. MS8 × GT73 and RF3 × GT73). The two-event stack OSR MS8 × RF3 is outside the scope of this application. Considering the scope of this application, the mode of action of the introduced traits and the data available for the three-event and two-event stack OSR MS8 × RF3, the GMO Panel considered that different combinations of the events, MS8, RF3 and GT73, would not raise environmental concerns.

Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate)

Food ingredients and packaging
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu
EFSA Journal 2016;14(5):4464 [7 pp.].
doi
10.2903/j.efsa.2016.4464
Abstract

This opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate), Chemical Abstracts Service (CAS) No 147398-31-0 and food contact material (FCM) substance No 1059, to produce packaging for contact with fresh whole fruits and vegetables. This biodegradable (co)polymer is produced by fermentation of genetically modified microorganisms (Cupriavidus necator) using palm oil. Specific migration was not tested because it is currently not foreseen by Regulation (EU) No 10/2011 for FCM for these two food groups. Overall migration was lower than 1 mg/dm2. No genotoxicity data are required for Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) because of its high molecular weight. Its low molecular weight fraction below 1,000 Da is 0.5% and its migration is expected to be negligible. The polymer's major unit (89–99%), 3-hydroxybutyric acid, is an intermediate in fatty acid metabolism. Its minor unit (1–11%), 3-hydroxyhexanoic acid, was tested negative for bacterial gene mutations. Degradation products, which may be present in the (co)polymer, are crotonic acid and (E)-2-hexenoic acid. Crotonic acid is authorised for use in FCM with a specific migration limit (SML) of 0.05 mg/kg food; for (E)-2-hexenoic acid no indication for genotoxicity was identified by the EFSA CEF Panel in its 2010 group evaluation of flavouring substances in FGE.05Rev2. The CEF Panel concluded that the substance Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) is not of safety concern if used alone or in blends with other polymers for contact with unpeeled/uncut fruits and vegetables, according to food groups Ref. nos 04.01 and 04.04 as specified in Regulation (EU) No 10/2011. Migration of crotonic acid should not exceed 0.05 mg/kg food and if this SML is met, then migration of (E)-2-hexenoic acid will also not exceed 0.05 mg/kg food.

Manganese hydroxychloride for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(5):4474 [15 pp.].
doi
10.2903/j.efsa.2016.4474
Abstract

The additive under assessment, manganese hydroxychloride, contains ≥ 45% manganese (Mn). Manganese hydroxychloride is a safe source of manganese for all target species when used up to the maximum level of total manganese in complete feed authorised in the EU (Fish 100 (total) and Other species 150 (total) mg Mn/kg feedingstuffs). Manganese hydroxychloride would substitute for other manganese sources in feed. It does not differently affect tissue deposition compared to manganese sulphate. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the use of manganese hydroxychloride in animal nutrition is safe for the consumers, provided the maximum authorised manganese content in complete feed is respected. In the absence of specific data, the FEEDAP Panel cannot conclude on the safety for the user when handling the additive. The use of manganese hydroxychloride in animal nutrition for all animal species is not expected to pose a risk to the environment. Manganese hydroxychloride is considered a source of bioavailable manganese as indicated by a dose-dependent increase of manganese deposition in bone and liver based on two studies on chickens for fattening. The FEEDAP Panel concludes that the additive is efficacious in meeting the manganese requirements for all animal species/categories.

Polyacrylic acid, sodium salt, cross-linked

Food ingredients and packaging
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu
EFSA Journal 2016;14(5):4462 [7 pp.].
doi
10.2903/j.efsa.2016.4462
Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the polyacrylic acid, sodium salt, cross-linked, food contact material (FCM) substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods, such as meat, poultry, seafood, fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polyacrylic acid, sodium salt, cross-linked, is not in direct contact with the food but is placed in a pad and used under conditions where its absorption capacity is not exceeded, then no migration is to be expected and therefore no exposure from the consumption of the packed food is expected. The CEF Panel concluded that the use of this polyacrylic acid, sodium salt, cross-linked, does not raise a safety concern when used in absorbent pads in the packaging of fresh or frozen meat, poultry, fish, fruits and vegetables. The absorbent pads must be used only under conditions in which the absorption capacity of the active substance is not exceeded and direct contact between the substance and the food is excluded.

L-Tryptophan produced by Escherichia coli for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(5):4444 [9 pp.].
doi
10.2903/j.efsa.2016.4444
Abstract

L-Tryptophan is a feed additive produced by fermentation using a genetically modified strain of Escherichia coli. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) issued an opinion on the safety and efficacy of the product, which concluded that ‘The use of L-tryptophan produced by E. coli CGMCC 7.59 in feed is safe for non-ruminant target species when supplemented to diets in appropriate amounts. As the metabolites of L-tryptophan produced by ruminal bacteria may be toxic to the host animal, oral administration of unprotected L-tryptophan to ruminants should be avoided. The Panel on Additives and Products or substances used in Animal Feed (FEEDAP) has concerns about the safety of L-tryptophan for target species when administered via water for drinking. . . . . .In the absence of any data on sensitisation, the product should be considered a potential dermal sensitiser. The level of endotoxins present in the product and its dusting potential indicate a health risk for the user upon inhalation’. The European Commission asked EFSA to deliver an opinion on the safety of L-tryptophan, produced by an improved manufacturing process, as a nutritional additive for all animal species based on additional data submitted by the applicant on characterisation of the additive. The FEEDAP Panel reiterates its concern on the use of unprotected tryptophan to ruminants and on the safety of the amino acid L-tryptophan for target species when administered simultaneously via water for drinking. As the estimated maximum exposure to endotoxins by inhalation of the improved product is below the provisional occupational exposure limit, no risk from exposure to endotoxins for people handling the additive is expected. Concerns remain about possible dermal sensitisation.

Diarr-Stop S Plus® for pigs for fattening

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(5):4472 [15 pp.].
doi
10.2903/j.efsa.2016.4472
Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Diarr-Stop S Plus®, a mixture of sodium salt of ethylenediaminetetraacetic acid (Na2EDTA), a tannin-rich extract of Castanea sativa, thyme oil and oregano oil. The additive is intended for use with pigs for fattening at a recommended dose of 1,000 mg/kg feed to reduce the incidence of dysentery caused by Brachyspira hyodysenteriae and so improve performance. The additive is considered safe for pigs for fattening at the recommended dose of 1,000 mg/kg feed. None of the active constituents of Diarr-Stop S Plus® raised safety concerns for consumers when considered individually and at the concentrations delivered to feed using the recommended dose. As no interactions between constituents impacting on consumer safety are expected, the use of Diarr-Stop S Plus® in feed for pigs for fattening is considered safe for consumers without a withdrawal period. The additive should be considered as a skin and eye irritant, but the FEEDAP Panel could not conclude on the potential for dermal sensitisation. Because of the particle size, exposure of users by inhalation is considered unlikely. In the absence of appropriate data on the ecotoxicological effects of Na2EDTA, the assessment of risk for terrestrial and aquatic compartments cannot be completed. None of the submitted efficacy studies, all based on observations on commercial premises, comply with the minimum requirements for an experimental design for the demonstration of efficacy. Consequently, the FEEDAP Panel is unable to conclude on the efficacy of the additive Diarr-Stop S Plus® when used in feed for pigs for fattening.

Potassium metabisulfite

Food ingredients and packaging
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu
EFSA Journal 2016;14(5):4465 [8 pp.].
doi
10.2903/j.efsa.2016.4465
Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety assessment of the active substance potassium metabisulfite, food contact material (FCM) substances No 1056, intended to extend the shelf life of wine. The active substance is sulfur dioxide (SO2, E 220) which is generated in situ from potassium metabisulfite, E 224. Alternative precursors of SO2 are other authorised sulfites marketed as food preservatives. A gel of agar (E 406) is used as a physical support media for the E 224 and the E 220 generated from it. This mixture is contained within plastic containers that are closed with a membrane of polyethersulfone (PES). When the precursor comes in contact with water contained in the agar gel, sulfur dioxide is formed. The PES acts as a microporous membrane which ensures the controlled diffusion of SO2 from the active cap to the wine. Interactions and reactions between the active ingredients and the PES or the agar or the plastic caps, and any consequential release of reaction products into the wine, are not to be expected. The CEF Panel concluded that the substance potassium metabisulfite (E 224), as well as any of the other authorised ‘sulfites’ (E 221, E 222, E 223, E 226, E 227 and E 228) would not be a safety concern for the consumer if used as precursors for the release of sulfur dioxide (E 220) to wine under the conditions considered in the present opinion. The release of SO2should not cause an exceedance of the maximum permitted levels (MPLs) for total SO2 (free SO2 plus combined SO2) in wine given in Regulation (EC) No 606/2009 and Regulation (EC) No 203/2012. The conclusions and the recommendations of the EFSA Panel on Food Additives and Nutrient Sources Added to Food (ANS) Panel on the re-evaluation of sulfur dioxide and sulfites should be considered.

Safety of Lancer for weaned piglets

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(5):4477 [3 pp.].
doi
10.2903/j.efsa.2016.4477
Abstract

Lancer (lanthanide citrate) is a feed additive mainly consisting of two rare earth elements, lanthanum (La) and cerium (Ce), in their citrate forms. Lancer has not been previously authorised in the European Union. In 2013, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of Lancer as a zootechnical feed additive for weaned piglets. In its opinion the FEEDAP Panel could not conclude on the safety of the additive for the target species, on the safety for the consumer and on the safety for the environment. As a result of the additional information provided by the applicant, the FEEDAP Panel concluded that the additive Lancer is safe for weaned piglets when used at the maximum recommended dose of 250 mg/kg complete feed. In view of concerns over the possible developmental neurotoxicity of La, the many gaps in the available toxicological information on Ce and La, the absence of studies of long-term toxicity, carcinogenicity, reproductive toxicity and developmental toxicity of Lancer, and the absence of residue data in edible tissues, the FEEDAP Panel cannot conclude on the safety of Lancer for the consumer. In the absence of adequate data the FEEDAP Panel cannot conclude on the safety of Lancer for the environment.

MCPD and glycidyl esters in food

Chemical contaminants
Jan Alexander, Lars Barregard, Margherita Bignami, Sandra Ceccatelli, Bruce Cottrill, Michael Dinovi, Lutz Edler, Bettina Grasl-Kraupp, Christer Hogstrand, Laurentius (Ron) Hoogenboom, Helle Katrine Knutsen, Carlo Stefano Nebbia, Isabelle Oswald, Annette Petersen, Vera Maria Rogiers, Martin Rose, Alain-Claude Roudot, Tanja Schwerdtle, Christiane Vleminckx, Günter Vollmer and Heather Wallace
EFSA Journal 2016;14(5):4426 [159 pp.].
doi
10.2903/j.efsa.2016.4426
Abstract

EFSA was asked to deliver a scientific opinion on free and esterified 3- and 2-monochloropropane-1, 2-diol (MCPD) and glycidyl esters in food. Esters of 3- and 2-MCPD and glycidol are contaminants of processed vegetable oils; free MCPDs are formed in some processed foods. The Panel on Contaminants in the Food Chain (CONTAM Panel) evaluated 7,175 occurrence data. Esters of 3- and 2-MCPD and glycidyl esters were found at the highest levels in palm oil/fat, but most vegetable oil/fats contain substantial quantities. Mean middle bound (MB) dietary exposure values to total 3-MCPD, 2-MCPD and glycidol, respectively, across surveys and age groups in μg/kg body weight (bw) per day were 0.2–1.5, 0.1–0.7 and 0.1–0.9; high exposure (P95) values were 0.3–2.6, 0.2–1.2 and 0.2–2.1. Animal studies show extensive hydrolysis of esterified 3-MCPD and glycidol following oral administration; esterified and free forms were assumed to contribute equally to internal exposures. Nephrotoxicity was consistently observed in rats treated with 3-MCPD. Data on 2-MCPD toxicity were insufficient for dose–response assessments. Chronic treatment with glycidol increased the incidence of tumours in several tissues of rats and mice, likely via a genotoxic mode of action. The Panel selected a BMDL10 value for 3-MCPD of 0.077 mg/kg bw per day for induction of renal tubular hyperplasia in rats and derived a tolerable daily intake (TDI) of 0.8 μg/kg bw per day. The mean exposure to 3-MCPD was above the TDI for ‘Infants’, ‘Toddlers’ and ‘Other children’. For glycidol, the Panel selected a T25 value of 10.2 mg/kg bw per day for neoplastic effects in rats. The margins of exposure (MoEs) were 11,300–102,000 and 4,900–51,000 across surveys and age groups at mean and P95 exposures, respectively. An exposure scenario for infants receiving formula only resulted in MoEs of 5,500 (mean) and 2,100 (P95). MoEs of 25,000 or higher were considered of low health concern.

DHA and improvement of memory function

Nutrition
Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts
EFSA Journal 2016;14(5):4455 [19 pp.].
doi
10.2903/j.efsa.2016.4455
Abstract

Following an application from DSM Nutritional Products, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, 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 docosahexaenoic acid (DHA) and improvement of memory function. DHA is sufficiently characterised. An improvement of memory function is a beneficial physiological effect. In weighing the evidence, the Panel took into account that, out of the 11 human intervention studies from which conclusions can be drawn for the scientific substantiation of the claim, two studies showed a beneficial effect of DHA supplementation on memory function, one study showed inconsistent results, one study showed a negative effect of DHA on memory function and seven studies did not show an effect of DHA on memory outcomes. The Panel considers that the majority of the human intervention studies provided did not show an effect of DHA supplementation on memory, and that the conflicting results across studies cannot be explained by differences in the study design, the source of DHA, the DHA dose, the baseline characteristics of the subjects recruited, or the duration of the studies. The Panel also took into account that the meta-analyses of intervention studies submitted by the applicant do not provide evidence for an effect of DHA on memory function, and that the three observational studies from which conclusions could be drawn for the scientific substantiation of the claim do not provide evidence for an association between dietary DHA and memory function. The Panel concludes that a cause and effect relationship has not been established between the consumption of DHA and an improvement of memory function.

Scientific Opinions: Statements of the Scientific Committee/Scientific Panel

Analysis of the need for an update of the guidance documents

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(5):4473 [8 pp.].
doi
10.2903/j.efsa.2016.4473
Abstract

The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) adopted a series of guidance documents which complement the Regulations governing the authorisation of feed additives. These are intended to help applicants in their preparation of technical dossiers. Although most guidance documents prepared by the Panel have been updated at some point, experience has shown that some elements are in need of technical update. Consequently, the EFSA has asked the FEEDAP Panel to identify from the current guidance documents those that need to be updated. The FEEDAP Panel addressed this by considering the experience gained since the last major revision of the individual guidance documents. Each of the Standing Working Groups of the FEEDAP Panel were asked to identify issues which have arisen during additive assessments and which suggested the need for elements of the guidance to be reconsidered. In addition, consideration was given to the relevant overarching guidance documents produced by the EFSA Scientific Committee and to developments in assessment tools provided by EFSA and other international organisations. The analysis of the information collected indicated a number of broad areas in the existing guidance which need possible revision. In particular, since the existing guidance on environmental risk assessment is no longer aligned to other EFSA outputs, the Panel proposes that revision of this guidance should be given the highest priority. The Panel then proposes the revision of the three guidance documents concerned with safety (target animals, consumer and user) followed by the guidance on efficacy. In parallel, the data necessary to establish the characterisation of the additive should be reviewed and modified as necessary. The FEEDAP Panel considers it fundamental to involve industry, consumer associations and experts from Member States risk assessment bodies in the early stages of the guidance revision.

Guidance of EFSA

Reporting data on pesticide residues using SSD (2015 data collection)

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(5):4496 [33 pp.].
doi
10.2903/j.efsa.2016.4496
Abstract

According to Regulation (EC) No 396/2005 on maximum residue levels (MRLs) of pesticides in or on food and feed of plant and animal origin, Member States have to monitor pesticide residue levels in food samples and submit the monitoring results to EFSA and the European Commission. The Standard Sample Description (SSD) is the data model used for the reporting of data on analytical measurements of chemical substances occurring in food, feed and water to EFSA. In July 2015, EFSA issued a revised guidance document defining the appropriate SSD codes to describe the samples and the analytical results for the reporting of the 2014 pesticide residues monitoring data. In the current guidance document new coding provisions are provided for some specific SSD data elements for the reporting of the 2015 pesticide monitoring data; those provisions take into account the experience of both the previous reporting season and the new legislation relevant for the 2015 pesticide monitoring data collection. In addition, new explanatory examples on the appropriate coding for specific food samples are provided.

Conclusions on Pesticide Peer Review

Peer review of the pesticide risk assessment of the active substance 2,4-DB

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(5):4500 [25 pp.].
doi
10.2903/j.efsa.2016.4500
Abstract

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Belgium, and co-rapporteur Member State, Greece, for the pesticide active substance 4-(2,4-dichlorophenoxy)butyric acid (2,4-DB) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of 2,4-DB as a herbicide on winter and spring barley, wheat and oats, and on legumes (lucerne and clover). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance abamectin

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(5):4491 [24 pp.].
doi
10.2903/j.efsa.2016.4491
Abstract

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State (RMS) the Netherlands for the pesticide active substance abamectin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative uses of abamectin as a nematicide on tomato, aubergine, pepper, cucurbits (edible and non-edible peel) and green beans. The representative uses evaluated for the approval of abamectin comprised foliar spraying for the control of motile stages of mites, leaf miners on citrus, lettuce and tomatoes. The reliable endpoints appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Reasoned Opinions

Modification of existing MRL for mancozeb in persimmons

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(5):4495 [13 pp.].
doi
10.2903/j.efsa.2016.4495
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Spain, received an application from United Phosphorus Ltd. to modify the existing maximum residue level (MRL) for the active substance mancozeb in persimmons. To accommodate for the intended use of mancozeb, Spain proposed to raise the existing MRL from the limit of quantification of 0.05 to 0.2 mg/kg. Spain drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the data are sufficient to derive a MRL proposal of 0.2 mg/kg (expressed as carbon disulfide) for the proposed use on persimmons. Adequate analytical enforcement methods are available to control the residues of carbon disulfide on persimmons. Based on the risk assessment results, EFSA concludes that the proposed use of mancozeb on persimmons will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

Modification of existing MRL for fluazifop-P in pumpkin seeds

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(5):4486 [14 pp.].
doi
10.2903/j.efsa.2016.4486
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Austria, compiled an application to modify the existing maximum residue level (MRL) for the active substance fluazifop-P in pumpkins seeds. To accommodate for the intended use of fluazifop-P, Austria proposed to set the MRL for pumpkin seed at the value of 5 mg/kg. Austria drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the data are sufficient to derive the MRL proposal of 5 mg/kg for the proposed use on pumpkin seeds. Adequate analytical enforcement methods are available to control the residues of fluazifop-P on pumpkin seeds. Based on the risk assessment results, EFSA concludes that the proposed use of fluazifop-P on pumpkin seeds will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

Modification of existing MRLs for azoxystrobin in chervil, rhubarb, linseed, safflower and borage seeds

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(5):4459 [17 pp.].
doi
10.2903/j.efsa.2016.4459
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Greece, received an application from the company Syngenta Switzerland to modify the existing maximum residue level (MRL) for the active substance azoxystrobin in chervil, rhubarb, linseed, safflower and borage seeds. Greece drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the data are sufficient to derive an MRL proposal of 0.4 mg/kg for linseed, safflower and borage seeds supporting uses in northern and southern Europe. No change of the MRL was proposed for chervil as the submitted residue dataset results in a lower MRL proposal than the value currently in force in the EU legislation. An MRL is not proposed for rhubarb, as the submitted trials were not conducted according to the intended agricultural practices (GAP). Based on the risk assessment results, EFSA concludes that the proposed use of azoxystrobin in chervil, linseed, safflower and borage seeds will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.