Special Issue Item
Scientific opinions of Scientific/Scientific Panel
Opinion of the Scientific Committee/Scientific Panel
Statement of the Scientific Committee/Scientific Panel
Guidance of the Scientific Committee/Scientific Panel
Statement of EFSA
Guidance of EFSA
Conclusion on pesticides
Reasoned opinion on pesticide
Scientific report of EFSA
Animal health & welfare
Evidence Management (DATA)
Assessment and methodological support
The EFSA Journal is an open-access, online scientific journal that publishes the scientific outputs of the European Food Safety Authority. EFSA’s various output types are devoted to the field of risk assessment in relation to food and feed and include nutrition, animal health and welfare, plant health and plant protection.
Issue: 2 (February) 2015
Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel
Following an application from Lycotec Ltd, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to “L-tug lycopene” and reduction of blood low-density lipoprotein (LDL)-cholesterol. The food constituent that is the subject of the claim is L-tug lycopene (i.e. Lyc-O-Mato® embedded in fat-rich matrices by a manufacturing process claimed as proprietary and confidential by the applicant). The Panel considers that the food constituent, L-tug lycopene, which is the subject of the claim, is sufficiently characterised. The Panel considers that reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces the risk of CHD. The Panel notes that the unpublished studies submitted to support the claim were exploratory in nature and insufficient information was provided to allow the scientific evaluation of these studies. The Panel concludes that a cause and effect relationship has not been established between the consumption of L-tug lycopene and reduction of blood LDL-cholesterol.
Following applications from Dextro Energy GmbH & Co. KG, submitted for the authorisation of health claims 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 health claims related to glycaemic carbohydrates and maintenance of normal brain function. The scope of the applications was proposed to fall under health claims based on newly developed scientific evidence. The Panel considers that the food constituent, glycaemic carbohydrates, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effect. Maintenance of normal brain function is a beneficial physiological effect. A claim on glycaemic carbohydrates and maintenance of normal brain function has already been assessed by the Panel with a favourable outcome.
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on refined Buglossoides oil as a novel food ingredient (NFI) in the context of Regulation (EC) No 258/97. The NFI is produced from the seeds of Buglossoides arvensis (L.) I. M. Johnst, using processes conventionally used for edible oil production. The main fatty acids (FAs) contained in the NFI are alpha-linolenic acid (ALA), stearidonic acid (SDA) and linoleic acid, with smaller amounts of oleic acid, gamma-linolenic acid (GLA) and saturated FAs. With the exceptions of SDA and GLA, these FAs are widely present in common foods. The NFI is intended to be used in a range of foods and food supplements to provide approximately 200 mg of SDA per day. Upon digestion, FAs are used primarily as an energy source. ALA and SDA can be elongated and desaturated to produce eicosapentaenoic acid. In human studies using various sources of SDA, no increase or small increases in SDA were observed in blood cell membranes or in total plasma. The proposed specifications for pyrrolizidine alkaloids and erucic acid, which are undesirable substances,do not give rise to concern in view of the proposed conditions of use. The available information does not give concerns as regards other undesirable substances in the NFI. Available animal studies provide only limited information on the safety of the NFI. Human studies that investigated different plant oils or fatty acid ethyl esters as sources of SDA, GLA and ALA found no adverse effects with up to 4 200 mg SDA/day for 12 weeks, up to 1 700 mg GLA/day for 28 days and 9 100 mg ALA/day for four weeks. The Panel concludes that the NFI is safe for the proposed uses and use levels.
Following an application from Dextro Energy GmbH & Co. KG, submitted for the 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 glycaemic carbohydrates and contribution to normal cognitive function. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The Panel considers that the food constituent, glycaemic carbohydrates, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect. Contribution to normal cognitive function is a beneficial physiological effect. Glycaemic carbohydrates contribute to the maintenance of normal brain functions, including cognition. The Panel concludes that a cause and effect relationship has been established between the consumption of glycaemic carbohydrates and contribution to normal cognitive function. A daily intake of 130 g of glycaemic carbohydrates has been estimated to cover the glucose requirement of the brain. Such amounts can be consumed as part of a balanced diet. The target population is the general population.
L-Tryptophan, technically pure, is a feed additive produced by a genetically modified Escherichia coli strain (CGMCC 7.59). The additive does not give rise to safety concerns regarding the genetic modifications of the production strain. 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. The composition of edible tissues and products of animal origin will not be changed by the use of the product L-Tryptophan in animal nutrition when supplemented in appropriate amounts. No risks are expected for the consumer from the use of L-Tryptophan, produced by E. coli CGMCC 7.59 as a feed additive, considering the purity of the additive (≥ 99.1 % L-Tryptophan) and the low levels of 1,1′-ethylidene-bis-L-Tryptophan (EBT) and 1-methyl-1,2,3,4-tetrahydro-beta-carboline-3-carboxylic acid (MTCA) (< 10 mg/kg additive each). The product L-Tryptophan, technically pure, is considered to be non-irritant to skin and eyes. 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 product under assessment does not pose any risk to the environment when supplemented to feed. The product L-Tryptophan is regarded as an effective source of the amino acid L-Tryptophan for all non-ruminant species. For the supplemental L-Tryptophan to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen.
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of ethylene glycol dipalmitate (EGDP), CAS No 624-03-3, FCM substance No 01048, for use as a processing aid at concentrations of up to 2 % in various types of plastics, acting as a lubricant to improve injection moulding and to improve the distribution of additives in the polymer melt. Based on the modelled specific migration results, it cannot be ruled out that the overall migration limit may be exceeded. No toxicological data were provided for the substance EGDP. Toxicological data from similar ethylene and propylene glycol fatty acid esters were submitted for ‘read across’. Based on the genotoxicity data provided, the CEF Panel considered that there is no indication of genotoxic potential for the substance EGDP. Based on two 90-day oral toxicity studies on structural homologues, no sub-chronic toxicity of EGDP is expected at relevant doses (< 1 000 mg/kg bw/day). The CEF Panel concluded that the substance EGDP is not of safety concern for consumers if it is used in plastics intended for contact with all types of foodstuffs under all contact conditions, provided that the fatty acid precursor is obtained from edible fats or oils using conventionally applied procedures, and that any impurities in the ethylene glycol are under the control of the producer. The substance should be included in the group total specific migration limit (SML(T)) of 30 mg/kg expressed as ethylene glycol.
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of fatty acids, C16–18 saturated, hexaesters with dipentaerythritol (FADP), FCM substance No 01053, for use as a processing agent at up to 1.5 % in various types of plastics. Based on the modelled specific migration calculation results, it cannot be ruled out that the overall migration limit may be exceeded. No toxicological data were provided for the assessed substance. Toxicological data from similar pentaerythritol fatty acids were submitted for ‘read across’. Based on the genotoxicity data provided, the CEF Panel considered that there is no indication of mutagenic potential of the substance. The CEF Panel concluded that the substance FADP is not of safety concern for the consumer if used in polymers intended for contact with all types of foodstuffs at all time–temperature conditions, provided that the fatty acid precursors are obtained from edible fats or oils and that any impurities in the dipentaerythritol are under the control of the producer.
Hexamethylene tetramine (HMTA) is a technological additive intended to improve the ensiling process of forage for pigs, poultry, bovines, sheep, goats, rabbits and horses when used at a maximum concentration of 600 mg HMTA/kg of fresh forage. The residual concentration of HMTA plus formaldehyde, its degradation product, is significantly reduced in silage after three months’ ensiling. Considering that no data were provided on the qualitative and quantitative composition of the residues in silage, conclusions cannot be drawn on the safety of HMTA for the target species. The proposed use of HMTA as a silage additive would not increase consumer exposure to the parent compound, its major metabolite formaldehyde or N-nitrosodimethylamine to an extent that would pose an appreciably increased health risk to the consumer. HMTA is irritant to the skin, eyes and mucous membranes and it is a skin and respiratory sensitiser. Farmers may be exposed to ammonia and formaldehyde while opening the silo. Formaldehyde is a strong irritant, a potent skin and respiratory sensitiser and a proven human carcinogen by the respiratory route. Measures should be taken to ensure that the respiratory tract, skin and eyes of any person handling the product are not exposed to any dust, mist or vapour generated by the use of HMTA. Similar protective measures are needed for any person handling silage treated with this product. It is expected that the use of HMTA as a silage additive at the proposed concentration would not pose a risk to the environment. The combination of HMTA and sodium nitrite used in the efficacy studies has the potential to improve the ensiling of forage by reducing butyric acid production and proteolysis, pH and dry matter loss. However, with the limited data available, the Panel is unable to conclude on the efficacy of HMTA when used alone.
Cygro® 10G is a coccidiostat for turkeys for fattening containing 10 g of the polyether ionophore maduramicin ammonium-α (Maα)/kg additive. The maximum proposed dose (5 mg Maα/kg) is considered safe for turkeys with a margin of safety of 2.5. It is unlikely that there will be any measurable adverse effects of Maα on the overall gut flora. Maα is absorbed and excreted rapidly. O-demethylation is the main metabolic pathway in turkeys and rats. Maduramicin-α is the marker residue in the liver and skin/fat. Maα is not mutagenic or carcinogenic. The lowest no observed adverse effect level (NOAEL) of 0.1 mg/kg bw per day is found in chronic and multi-generation studies in rats. An acceptable daily intake (ADI) of 1 mg Maα/kg bw (60 μg per person) is derived, applying an uncertainty factor of 100. After a three-day withdrawal, human exposure to maduramicin residues complies with the ADI (17 %). Maximum residue limits (MRL) of 0.15 mg maduramicin/kg liver and skin/fat, 0.1 mg/kg kidney and 0.03 mg/kg muscle are proposed. Although Cygro® 10G is not an irritant to skin or eyes or a dermal sensitiser, any direct dermal contact should be avoided owing to the high systemic toxicity of Maα after dermal application. Inhalation of Cygro® 10G is considered a hazard; therefore a risk to persons handling the additive cannot be excluded. The use of Cygro® 10G is safe for the environment, with the exception of soils with pH values above 7.2, for which no data were available. This conclusion does not extend to effects on organisms living on manure which are not assessed under the current regulation. Based on the recent studies (floor pen studies, field studies and sensitivity studies), the efficacy of Cygro® 10G in turkeys for fattening has not been sufficiently demonstrated.
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 recycling processes ‘CLRrHDPE’ and ‘Biffa Polymers’. These processes are used to recycle post-consumer high-density polyethylene (HDPE) bottles which have been in contact with food, mainly milk, to produce recycled HDPE pellets. Post-consumer HDPE bottles are collected in the United Kingdom and processed by conventional recycling including manual sorting into washed and dried HDPE flakes containing no more than 1 % HDPE from non-food consumer applications. The washed and dried HDPE flakes are heated in two successive continuous reactors under vacuum before being extruded under vacuum into pellets. Recycled pellets are blended with virgin HDPE to produce bottles (both processes) and with virgin polypropylene to produce trays (Biffa Polymers). Bottles are intended for storage of milk and fruit juices. Trays are intended for storage of animal products and raw fruits, vegetables and mushrooms. Having examined the challenge tests provided, the Panel noted the limited decontamination efficiency under the conditions of testing and concluded that the processes do not satisfy criteria set for HDPE. Uncertainties and consequent conservatism of the selected criteria could allow the conclusion that a process is safe when these criteria are met but not when they are not met. Therefore, the CEF Panel considered that, for the manufacture of recycled bottles for milks and fruit juices and trays for animal products, additional data should be provided before it can conclude on the safety assessment. For the manufacture of recycled trays intended for contact with whole fruits and vegetables including mushrooms, at room temperature or below, the CEF Panel concluded that recycled HDPE obtained from the process Biffa Polymers is not considered of safety concern under the restriction given in the opinion.
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The substances are evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. FGE.65 concerns a group of 33 sulfur-substituted furan derivatives evaluated by the JECFA at their 59th meeting. The Panel concluded in FGE.65 that the evaluation could not be finalised for four of the 33 substances [FL-no: 13.056, 13.160, 13.193 and 13.194] due to lack of toxicity data. In the present revision of FGE.65, the toxicity data requested in FGE.65 for [FL-no: 13.160] have now become available. These toxicity data are also considered to cover the evaluation of [FL-no: 13.193 and 13.194], but not [FL-no: 13.056]. Based on the new data the Panel agrees with the JECFA conclusion, ‘No safety concern at estimated levels of intake as flavouring substances’ based on the MSDI approach for 32 of the furan derivatives. For one substance [FL-no: 13.056] a request for additional toxicity data still remains. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 33 substances, the information is adequate.
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 recycling processes Greentech, Alimpet and Polyrecycling (EU register numbers RECYC112, RECYC114 and RECYC119, respectively), all of which are based on the same EREMA Advanced technology. The input to these processes is washed and dried polyethylene terephthalate (PET) flakes originating from collected post-consumer PET containers, mainly bottles, containing no more than 5 % PET from non-food consumer applications. In this technology, washed and dried PET flakes are heated successively in two continuous reactors before being extruded into pellets. Having examined the results of the challenge test provided, the Panel concluded that the continuous reactor step (step 3) is the critical step that determines the decontamination efficiency of these processes. The operating parameters which control the performance of this step are well defined and are temperature, pressure and residence time. It was demonstrated that the recycling processes under evaluation are able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food, derived from the exposure scenario for infants, and 0.15 μg/kg food, derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from these processes is not of safety concern when used to manufacture articles intended for food contact materials applications if it is produced in compliance with the conditions specified in the conclusion of this opinion.
The additive XTRACT® Evolution-B, Code X60-6930, is a preparation of carvacrol, cinnamaldehyde and capsicum oleoresin and is intended to be used as a zootechnical feed additive for chickens for fattening. Based on a tolerance study in which chickens for fattening tolerated a 10-fold overdose of the additive, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that XTRACT is safe for chickens for fattening at the maximum proposed dose (100 mg/kg complete feed). No increase in the exposure of consumers to any of the active substances contained the additive is expected. Therefore, the Panel concludes that use of XTRACT in feed for chickens for fattening under the proposed conditions of use is safe for consumers. It would be prudent to consider the additive to be a skin, eye and respiratory tract irritant and a skin sensitiser. The use of XTRACT at the recommended levels is safe for the environment. XTRACT has the potential to be efficacious in chickens for fattening at the recommended dose of 100 mg/kg complete feed. The use of additive under the proposed conditions does not affect the sensory properties of meat products from chickens.
An application has been made for the authorisation of citric acid (anhydrous and monohydrate) when used as an acidity regulator in feed and in water for drinking for all animal species. Citric acid (anhydrous and monohydrate) is already authorised for use in food following the quantum satis principle. There is evidence from published studies that citric acid is safe for the target species when used up to 30 000 mg citric acid/kg complete feedingstuffs and the corresponding concentration in water for drinking (10 000 mg citric acid/L). The additive is consequently also safe for the target species at the proposed conditions of use of 15 000 mg citric acid/kg complete feedingstuffs and 5 000 mg citric acid/L in water for drinking. The quality of the available data does not allow a margin of safety to be derived. The use of citric acid in animal nutrition is safe for the consumer. It is prudent to regard citric acid as potentially hazardous to workers by exposure of the skin, eyes or mucous membranes or by inhalation. The use of citric acid in animal nutrition would not pose a risk for the environment. The addition of citric acid reduces the pH of aqueous suspensions of compound feedingstuffs and feed materials. However, the relevance of pH and buffer capacity measurements made with aqueous suspensions to the effects of citric acid in dry feed (< 12 % moisture) is open to question. Citric acid might have the potential to act as an acidity regulator in feedingstuffs.
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 additive (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform, FCM substance No 01016, intended to be used at up to 10 % w/w as an impact modifier in rigid non-plasticised polyvinylchloride and up to 15 % w/w in non-plasticised polylactic acid. The final materials are intended to be used for contact with all food types, at room temperature or below, for long-term storage. The monomers constituting the copolymer are listed in Regulation (EU) No 10/2011. The migration of the low-molecular-weight fraction of the additive below 1 000 Da was estimated to be about 0.008 mg/kg food from polyvinylchloride and about 0.007 mg/kg food from polylactic acid. Considering that these low-molecular-weight oligomers are made from authorised monomers, which by reaction are expected to lack the reactive functional groups, they do not give rise to safety concerns. The migration of the additive in nanoparticle form from the polyvinylchloride and polylactic acid was estimated, using conservative migration modelling, to be in the range 1 to 1.3 × 10–6 mg/kg food. The CEF Panel concluded that there is no safety concern for the consumer if the substance is used as an additive at up to 10 % (w/w) in rigid polyvinylchloride and up to 15 % (w/w) in non-plasticised polylactic acid, used in contact with all food types at ambient temperature or below for long-term storage.
DL-Methionyl-DL-methionine is intended to replace supplemental methionine in feed for aquatic animal species. This dipeptide differs from free DL-methionine, particularly in its solubility in water. In the organism, DL-methionyl-DL-methionine will be cleaved to produce methionine. Since supplementing appropriate quantities of methionine to meet requirements is safe for the target species, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) extends this conclusion to the safety of DL-methionyl-DL-methionine for fish and crustaceans. The amino acid L-methionine originating from the metabolism of DL-methionyl-DL-methionine in the body is incorporated into the tissue proteins of aquatic animal species, without affecting their amino acid composition. There is no concern for the safety of consumers from the use of the additive under application in aquatic species nutrition. The product DL-methionyl-DL-methionine is not regarded as an irritant to the eyes and the results of an in vitro study indicated that it is unlikely to be an irritant to the skin. It is also considered likely not to be a sensitiser by the dermal route. Since there is no evidence of acute toxicity by the inhalation route it is not regarded as hazardous for the user. The use of DL-methionyl-DL-methionine as an additive to feed for aquatic animal species does not represent a risk to the environment. Based on in vitro and in vivo studies with rainbow trout, carp, tilapia and shrimp, the FEEDAP Panel concludes that the product, DL-methionyl-DL-methionine, is an efficacious source of the essential amino acid L-methionine for fish and crustaceans.
An application has been made for the re-authorisation of citric acid (anhydrous and monohydrate) when used as a preservative in feed and also for the new use in water for drinking for all animal species. Citric acid (anhydrous and monohydrate) is already authorised for use in food and feed as a preservative following the quantum satis principle. There is evidence from published studies that citric acid is safe for the target species when used up to 30 000 mg citric acid/kg complete feedingstuffs and the corresponding concentration in water for drinking (10 000 mg citric acid/L). The additive is, consequently, also safe for the target species at the proposed conditions of use of 15 000 mg citric acid/kg complete feedingstuffs and 5 000 mg citric acid/L in water for drinking. The quality of available data does not allow a margin of safety to be derived. The use of citric acid in animal nutrition is safe for the consumer. It is prudent to regard citric acid as potentially hazardous to workers by exposure of the skin, eyes or mucous membranes or by inhalation. The use of citric acid in animal nutrition would not pose a risk to the environment. Although citric acid is a well-recognised preservative in food, based on data provided the effectiveness of citric acid as a preservative in feedingstuffs and water for drinking was not sufficiently demonstrated. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has reservations about the effectiveness of organic acids as preservatives in feedingstuffs with a typical moisture content of ≤ 12 %.
The EFSA Panel on Animal Health and Welfare (AHAW Panel) was asked by the European Commission to deliver a scientific opinion on three studies evaluating electrical parameters for the stunning of lambs and kid goats. The Commission received the studies from the Spanish authorities. One study was in the form of a manuscript entitled ‘Electrical stunning effectiveness with current levels lower than 1 A in lambs and kid goats’. The second study consisted of a summary in English entitled ‘Effect of the electrical stunning with inferior intensities of current to 1 Ampere on the carcass quality in Pascuales lambs’, and the third study consisted of a summary in English entitled ‘Effect of electrical stunning with inferior intensities to 1 Ampere on the induction to the unconsciousness in lambs’. Reported outcomes for different animal categories were inconsistent and contradictory, indicating a need to validate if the stunning equipment delivered the intended current levels to the animals. The head-only stunning and slaughter intervention failed to achieve and/or maintain unconsciousness during bleeding and the head-to-body stunning and slaughter intervention failed to achieve cardiac ventricular fibrillation in all of the animals, as evidenced by the presence of corneal reflex and rhythmic breathing. No evidence of absence of pain and suffering is presented in the studies. The submitted studies are not considered adequate for a full welfare assessment of the alternative stunning method because they do not fulfil the eligibility criteria and the reporting quality criteria defined in the EFSA guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions or the EFSA opinion on monitoring welfare at slaughter of small ruminants.
The EFSA Panel on Animal Health and Welfare (AHAW Panel) was asked by the European Commission to deliver a scientific opinion on two studies concerned with the use of carbon dioxide for stunning rabbits. The European Commission had received from the Spanish authorities a report of a study entitled ‘Carbon dioxide stunning of rabbits’ and another study entitled ‘Stunning of rabbits with carbon dioxide’, provided as a complement to the first study. The latter was undertaken in a commercial abattoir where a commercial carbon dioxide stunner was installed. The results of electrocardiography and animal-based measures (nasal discomfort and vocalisation) produced in the experimental slaughterhouse study clearly indicated that the rabbits were subjected to pain and suffering prior to the loss of consciousness. The data presented do not describe stable, controlled or repeatable experimental conditions. The statistical tests used to analyse the data were not appropriate. The study in the commercial abattoir was not based on sound scientific conclusions resulting from the experimental slaughterhouse study. For all of these reasons, the submitted studies did not meet the minimum criteria for eligibility in the EFSA guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions. Therefore, they were not further assessed.
Following a request from the European Food Safety Authority, the Panel on Plant Protection Products and their Residues developed an opinion on the science to support the development of a risk assessment scheme of plant protection products for non-target arthropods. The current risk assessment scheme is reviewed, taking into consideration recent workshops and progress in science. Proposals are made for specific protection goals which aim to protect important ecosystem services such as food web support, pest control and biodiversity. In order to address recovery and source–sink population dynamics, conducting a landscape-level risk assessment is suggested. A new risk assessment scheme is suggested which integrates modelling approaches. The main exposure routes for non-target arthropods are identified and proposals are made on how to integrate them in the risk assessment. The appropriateness of the currently used vegetation distribution factor was investigated. It is proposed that new tests be included in order to address exposure via oral uptake of residues and uncertainties related to differences in species sensitivity.
EFSA received a request from the Hellenic Food Authority (EFET) for a scientific opinion on the risk to human health from the presence of nickel (Ni) in food, particularly in vegetables. The EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) decided to extend the risk assessment also to drinking water. The reproductive and developmental toxicity in experimental animals was selected as the critical effect for the assessment of chronic effects of Ni. A tolerable daily intake of 2.8 µg Ni/kg body weight (b.w.) per day was derived from a lower 95 % confidence limit for a benchmark dose at 10 % extra risk (BMDL10) of 0.28 mg/kg b.w. for post-implantation fetal loss in rats. The current dietary exposure to Ni raises concern when considering the mean and 95th percentile chronic exposure levels for all different age groups. The systemic contact dermatitis (SCD) elicited in Ni-sensitive humans after oral exposure to Ni was selected as the critical effect suitable for the assessment of acute effects of Ni. A lowest BMDL10 of 1.1 µg Ni/kg b.w. was derived for the incidence of SCD following oral exposure to Ni of human volunteers. The CONTAM Panel applied a margin of exposure (MOE) approach and considered an MOE of 10 to be indicative of a low health concern. The MOEs calculated considering the estimated mean and the 95th percentile acute exposure levels were considerably below 10 for all age groups. Overall, the CONTAM Panel concluded that, at the current levels of acute dietary exposure to Ni, there is a concern that Ni-sensitized individuals may develop eczematous flare-up skin reactions. The CONTAM Panel noted the need for mechanistic studies to assess the human relevance of the effects on reproduction and development observed in experimental animals and for additional studies on human absorption of nickel from food, for example in combination with duplicate diet studies.
Statements of EFSA
Dietary exposure is an essential element of a risk assessment of genetically modified (GM) foods. This is primarily used following the identification and characterisation of a hazard, or for the assessment of the nutritional consequences after consumption of GM foods with altered nutritional profile and then for the full risk characterisations. A crude estimate of dietary exposure may also be used during hazard identification/characterisation to support the choice of dose regimes. Implementing Regulation (EU) No 503/2013 requires that a dietary exposure assessment is carried out on the basis of representative consumption data, and that it should consider also particular consumer groups. The EFSA Comprehensive European Food Consumption Database is currently the only available single source of consumption data in Europe, its use is encouraged for all GM applications. This statement provides technical advice on the use of the EFSA Comprehensive database for the dietary exposure assessment of GM foods
Following a self-tasking request, the European Food Safety Authority (EFSA) carried out a refined exposure assessment for Allura Red AC (E 129) taking into account additional information on its use in foods. In 2009, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Allura Red AC (E 129) used as a food additive. In that opinion, the Panel concluded that, at the high level, under both scenarios, that is using either the maximum permitted levels (MPLs) or the reported use levels provided by industry, intake estimates for 1- to 10-year old children can be above the Acceptable Daily Intake (ADI) of 7 mg/kg body weight (bw) per day. Following this conclusion, EFSA performed a refined exposure assessment for this food colour, using new usage data from industry, as well as analytical data submitted to EFSA by Member States and the EFSA Comprehensive European Food Consumption Database. Usage data from industry were provided to EFSA for six out of the 51 food categories in which Allura Red AC (E 129) is authorised as a food additive; while analytical data from Member States were provided to EFSA for 35 food categories. Using MPLs and these new data, none of the exposure estimates exceeded the ADI of 7 mg/kg bw per day in any population.
Conclusions on Pesticide Peer Review
The conclusions of the European Food Safety Authority (EFSA), following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance tricyclazole, 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 representative use of tricyclazole as a fungicide on rice. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
The conclusions of the European Food Safety Authority (EFSA), following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance rescalure, and the considerations as regards the application to include rescalure in Annex IV of Regulation (EC) No 396/2005, 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 representative use of rescalure as an insecticide by mating disruption on citrus. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed.
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands for the pesticide active substance flupyradifurone and the assessment of applications for maximum residue levels 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 representative uses of flupyradifurone as an insecticide on hops and field and glasshouse lettuce. Maximum residue levels were assessed in pome fruits, grapes, fruity vegetables watermelon, lettuce and cucurbits. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, and the proposed maximum residue levels are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands, for the pesticide active substance pyraflufen-ethyl are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of pyraflufen-ethyl as a herbicide on potato and grape vines. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance diethofencarb. In order to assess the occurrence of diethofencarb residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers.
Scientific Reports of EFSA
This report provides an analysis and critical assessment of the sampling strategy, the data collected, and the detection methods used in the Norwegian 2012–2013 E. multilocularis surveillance campaigns and reported in the context of Regulation (EU) No 1152/2011 regarding preventive health measures for the control of E. multilocularis infection in dogs. The surveillance aims at detecting the parasite, if present, in mainland Norway. The Norwegian surveillance reports were assessed by checking the description of the surveillance system for completeness against the relevant elements that need to be addressed in assessing the quality of E. multilocularis surveillance reports in the context of Regulation (EU) No 1152/2011. The data reported on individual samples were assessed using the raw data submitted by Norway via the EFSA Data Collection Framework (DCF). Descriptive statistics were calculated to check whether the requirements of Regulation (EU) No 1152/2011 had been fulfilled. The E. multilocularis-specific surveillance programme aimed at detecting the parasite, if present in mainland Norway, has not detected E. multilocularis through the surveillance activities performed in 2012 and 2013. Under the assumption of unbiased representative sampling and considering the sensitivity of the tests applied, Norway has fulfilled the requirement of Regulation (EU) No 1152/2011 to the effect that the surveillance activities should detect a prevalence of E. multilocularis of 1 % or less at a confidence level of at least 0.95 in 2012, but not in 2013.
The antimicrobial resistance data on zoonotic and indicator bacteria in 2013, submitted by 28 EU MSs, were jointly analysed by EFSA and ECDC. Resistance in zoonotic Salmonella and Campylobacter species from humans, animals and food, and resistance in indicator Escherichia coli and enterococci,as well as data on meticillin-resistant Staphylococcus aureus, in animals and food were addressed. ‘Microbiological’ resistance was assessed using epidemiological cut-off (ECOFF) values in animal and food isolates and, where possible, in human isolates. For human isolates interpreted based on clinical breakpoints, the ‘clinically’ resistant and ‘intermediate’ resistant categories were combined into a ‘non-susceptible’ group, resulting in close correspondence with the ECOFF-defined ‘microbiological’ resistance for most antimicrobials. In Salmonella from humans, high proportions of isolates were resistant to ampicillin, sulfonamides and tetracyclines, while proportions of isolates resistant to third-generation cephalosporins and clinically non-susceptible to fluoroquinolones generally remained low. In Salmonella and Escherichia coli isolates from fowl, pigs, cattle and meat thereof, resistance to ampicillin, tetracyclines and sulfonamides was commonly detected, while resistance to third-generation cephalosporins was generally uncommon. High to very high resistance to (fluoro)quinolones was observed in Salmonella from turkeys, fowl and broiler meat. In Campylobacter from humans, a high to very high proportion of isolates were resistant to ciprofloxacin and tetracyclines, while resistance to erythromycin was low to moderate. The resistance to fluoroquinolones in some MSs was extremely high; in such settings, the effective treatment option for human enteric Campylobacter infection may be significantly reduced. High to extremely high resistance to ciprofloxacin, nalidixic acid and tetracyclines was observed in Campylobacter isolates from fowl, broiler meat, pigs and cattle, whereas much lower levels were observed for erythromycin and gentamicin. Increasing trends in ciprofloxacin resistance were observed in Campylobacter from broilers and/or pigs in several MSs. Multi-resistance and co-resistance to critically important antimicrobials in both human and animal isolates were uncommon. A minority of isolates from animals belonging to a few Salmonella serovars (notably Kentucky and Infantis) had a high level of resistance to ciprofloxacin.
The objective of the EU-coordinated Multi Annual Pesticide Control Program (MACP) is the assessment of MRL exceedance (above 1%) in food items available for consumption in the EU market as well as consumer exposure. The 30 food items currently included in the survey represent 70% of the consumption of adults and around 74% of consumption by children. Probability based sampling methods minimize selection bias, since every element in the population of food items has a non-zero probability of being selected. Using a stratified sampling framework based on food consumption, MRL-exceedance could be estimated with a margin of error of 0.0075 (in terms of raw proportion) by selecting 683 sample units for 32 different food items. The participating countries can be considered to constitute strata since sampling is organized within the countries themselves, for each food item the 683 sample units can be proportionally allocated either on the basis of the resident population or the food item consumption, producing different allocations, the latter being the recommended option. A sample size of 683 is also sufficient to ensure that assessment of consumer exposure is achieved with the same margin of error and confidence. Based on a review of the characteristics of the EU-coordinated multiannual control programme and the use of probability based sampling methods 21,856 samples would need to be taken. This could be split over a three year period. A survey sample design approach requires high quality food consumption data at the level of individual food items for all reporting countries. Food consumption data for individual food items covering all reporting countries should be collected and assessment related to the selection of food items should be revised as well as the allocation of samples per Member States according to the new consumption figures.
In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing maximum residue levels (MRLs) for the active substance fenhexamid in cranberries, blueberries, gooseberries and azarole (kiwiberry). In order to accommodate for the uses of fenhexamid under greenhouse conditions, Belgium proposed to raise the MRLs proposed during the review of the existing MRLs under Article 12 of the Regulation (EC) No 396/2005, to 15 mg/kg. Belgium drafted an evaluation report, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to extrapolate the MRL of 15 mg/kg set on currants to azarole (kiwiberry). In contrast, the extrapolation to cranberries, blueberries and gooseberries is not recommended, since the maximum application rate of 1000 g/ha proposed on these crops, is not covered by the trials conducted on currants at a dose rate of 750 g/ha. Adequate analytical enforcement methods are available to control the residues of fenhexamid in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of fenhexamid on azarole (kiwiberry) will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.Erratum/Corrigendum
The Reasoned Opinion was amended due to an error in the original version which indicated that the extrapolation of the MRL of 15 mg/kg from currants to cranberries, blueberries and gooseberries was considered not acceptable because the application rate was not within the ±25% tolerance rule. The original Reasoned Opinion is available on request as is a copy showing all the changes that were made.
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State United Kingdom, for the pesticide active substance fenhexamid are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of fenhexamid as a fungicide on grapes, strawberry and tomato. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
This opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) deals with the setting of Dietary Reference Values (DRVs) for protein. The Panel concludes that a Population Reference Intake (PRI) can be derived from nitrogen balance studies. Several health outcomes possibly associated with protein intake were also considered but data were found to be insufficient to establish DRVs. For healthy adults of both sexes, the average requirement (AR) is 0.66 g protein/kg body weight per day based on nitrogen balance data. Considering the 97.5th percentile of the distribution of the requirement and assuming an efficiency of utilisation of dietary protein for maintenance of 47 %, the PRI for adults of all ages was estimated to be 0.83 g protein/kg body weight per day and is applicable both to high quality protein and to protein in mixed diets. For children from six months onwards, age-dependent requirements for growth estimated from average daily rates of protein deposition and adjusted by a protein efficiency for growth of 58 % were added to the requirement for maintenance of 0.66 g/kg body weight per day. The PRI was estimated based on the average requirement plus 1.96 SD using a combined SD for growth and maintenance. For pregnancy, an intake of 1, 9 and 28 g/d in the first, second and third trimesters, respectively, is proposed in addition to the PRI for non-pregnant women. For lactation, a protein intake of 19 g/d during the first six months, and of 13 g/d after six months, is proposed in addition to the PRI for non-lactating women. Data are insufficient to establish a Tolerable Upper Intake Level (UL) for protein. Intakes up to twice the PRI are regularly consumed from mixed diets by some physically active and healthy adults in Europe and are considered safe.