Published on:

23 May 2013

This document provides guidance for the environmental risk assessment (ERA) of living genetically modified (GM) animals, namely fish, insects and mammals and birds, to be placed on the European Union (EU) market in accordance with Regulation (EC) No 1829/2003 or Directive 2001/18/EC. It provides guidance for assessing potential effects of GM animals on animal and human health and the environment and the rationales for data requirements for a comprehensive ERA. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six sequential steps for the ERA of GM animals, as indicated in Directive 2001/18/EC: (1) problem formulation including hazard and exposure identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority follows Annex II of Directive 2001/18/EC, considering specific areas of risk to be addressed by applicants and risk assessors during the ERA of GM fish, GM insects and GM mammals and birds. Each specific area of risk is considered in a structured and systematic way following the aforementioned six steps. In addition, this Guidance Document describes several generic cross-cutting considerations (e.g. choice of comparators, use of non-GM surrogates, experimental design and statistics, long-term effects, uncertainty analysis) that need to be accounted for throughout the whole ERA.

© European Food Safety Authority, 2013

Guidance on the environmental risk assessment of genetically modified animals

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Guidance on the environmental risk assessment of genetically modified animals

Published on:

21 May 2013

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 ethoxyquin. Although this active substance is no longer authorised within the European Union, an MRL was established by the Codex Alimentarius Commission (CXL). Based on the assessment of the available data, EFSA assessed the CXL, and a consumer risk assessment was carried out. The CXL was found not to be adequately supported by data and a possible risk to consumers was identified. Hence, further consideration by risk managers is needed.

© European Food Safety Authority, 2013

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for ethoxyquin according to Article 12 of Regulation (EC) No 396/2005

Published on:

17 May 2013

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 asulam. Considering that this active substance is no longer authorised within the European Union, that no MRLs are established by the Codex Alimentarius Commission, and that no import tolerances were notified to EFSA, residues of asulam are not expected to occur in any plant or animal commodity. Available data were also not sufficient to derive a residue definition or an LOQ for enforcement against potential illegal uses.

© European Food Safety Authority, 2013

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for asulam according to Article 12 of Regulation (EC) No 396/2005

Published on:

17 May 2013

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 flupyrsulfuron-methyl. In order to assess the occurrence of flupyrsulfuron-methyl residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC European authorisations reported by Member States (incl. 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.

© European Food Safety Authority, 2013

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for flupyrsulfuron-methyl according to Article 12 of Regulation (EC) No 396/2005

Published on:

17 May 2013

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of one flavouring substance, 2,6-dimethyl-2,5,7-octatriene-1-ol acetate [FL-no: 09.931], from subgroup 1.1.2 of FGE.19, which is considered to be representative for four substances, 12-beta-santalen-14-ol [FL-no: 02.216], 12-alpha-santalen-14-ol [FL-no: 02.217], santalyl acetate [FL-no: 09.034] and santalyl phenylacetate [FL-no: 09.712], from subgroup 2.1 of FGE.19. The Flavour Industry has provided genotoxicity studies for the representative substance 2,6-dimethyl-2,5,7-octatriene-1-ol acetate [FL-no: 09.931] and these data are considered by EFSA to be representative for the four substances [FL-no: 02.216, 02.217, 09.034 and 09.712]. Based on the new data, the Panel concluded that 2,6-dimethyl-2,5,7-octatriene-1-ol acetate [FL-no: 09.931] from FGE.19 subgroup 1.1.2 does not give rise to concern with respect to genotoxicity and can accordingly be evaluated using the Procedure. This conclusion can also be applied to the four substances 12-beta-santalen-14-ol [FL-no: 02.216], 12-alpha-santalen-14-ol [FL-no: 02.217], santalyl acetate [FL-no: 09.034] and santalyl phenylacetate [FL-no: 09.712] from FGE.19 subgroup 2.1 for which 2,6-dimethyl-2,5,7-octatriene-1-ol acetate [FL-no: 09.931] is representative.

© European Food Safety Authority, 2013

Scientific Opinion on Flavouring Group Evaluation 207 (FGE.207): Consideration of genotoxic potential for one branched-chain aliphatic acyclic α,β-unsaturated 2-alkylated aldehyde with additional double-bonds, from subgroup 1.1.2 of FGE.19 and four alicyclic aldehydes with the α,β-unsaturation in a side-chain, from subgroup 2.1 of FGE.19, which are considered to be covered by the one substance of subgroup 1.1.2, by EFSA

Published on:

Scientific Opinion on Flavouring Group Evaluation 207 (FGE.207): Consideration of genotoxic potential for one branched-chain aliphatic acyclic α,β-unsaturated 2-alkylated aldehyde with additional double-bonds, from subgroup 1.1.2 of FGE.19 and four alicyclic aldehydes with the α,β-unsaturation in a side-chain, from subgroup 2.1 of FGE.19, which are considered to be covered by the one substance of subgroup 1.1.2, by EFSA

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Scientific Opinion on re-evaluation of one flavouring substance 3-acetyl-2,5-dimethylthiophene [FL-no 15.024] from FGE.19 subgroup 5.2

Published on:

16 May 2013

The 26th Plenary meeting of the AFC Panel on 27-29 November 2007 discussed the flavouring group evaluation 19 (FGE.19) which included alpha, beta-unsaturated aldehydes or ketones considered to be a structural alert for genotoxicity. The flavour industry was requested to submit data on genotoxicity of 3-acetyl-2,5-dimethylthiophene [FL-no 15.024] (subgroup 5.2 in the FGE.19; the other substances of this subgroup were evaluated in FGE.224). An in vitro bacterial mutation assay was positive in Salmonella typhimurium strains TA98, TA100 and TA102 in the presence of rat liver metabolic activation system (S9-mix), and an in vivo study on mutant frequency in Muta™Mice was positive in liver after exposure to 3-acetyl-2,5-dimethylthiophene. Based on this outcome the CEF Panel considered 3-acetyl-2,5-dimethylthiophene as mutagenic in vitro and in vivo and concluded that its use as flavouring substance raises a safety concern.

© European Food Safety Authority, 2013

Scientific Opinion on re-evaluation of one flavouring substance 3-acetyl-2,5-dimethylthiophene [FL-no 15.024] from FGE.19 subgroup 5.2

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The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2011

Published on:

16 May 2013

The antimicrobial resistance data among zoonotic and indicator bacteria in 2011, submitted by 26 European Union Member States, were jointly analysed by the European Food Safety Authority and the European Centre for Disease Prevention and Control. Data covered resistance in zoonotic Salmonella and Campylobacter isolates from humans, food and animals, and in indicator Escherichia coli and enterococci isolates from animals and food. Data on methicillin-resistant Staphylococcus aureus in animals and food were also presented. Resistance in isolates from humans were mainly interpreted using clinical breakpoints, while animal and food isolate resistance was interpreted using epidemiological cut-off values. Resistance was commonly found in isolates from humans, animals and food, although disparities in resistance were frequently observed between Member States. High resistance levels were recorded to ampicillin, tetracyclines and sulfonamides in Salmonella isolates from humans, while resistance to third-generation cephalosporins and fluoroquinolones remained low. In Salmonella and indicator Escherichia coli isolates from fowl, pigs, cattle and meat thereof, resistance to ampicillin, tetracyclines and sulfonamides was also commonly detected, while resistance to third-generation cephalosporins was low. Moderate to high resistance to (fluoro)quinolones was observed in Salmonella isolates from turkeys, fowl and broiler meat. In Campylobacter isolates from human cases, resistance to ampicillin, ciprofloxacin, nalidixic acid and tetracyclines was high, while resistance to erythromycin was low to moderate. 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. Among the indicator enterococci isolates from animals and food, resistance to tetracyclines and erythromycin was commonly detected. The report also presents for the first time results on multi-resistance and co-resistance to critically important antimicrobials in both human and animal isolates. Very few isolates from animals were co-resistant to critically important antimicrobials.

? European Food Safety Authority, European Centre for Disease Prevention and Control, 2013

The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2011

Published on:

14 May 2013

Glycine betaine (betaine) acts as a methyl group donor in transmethylation reactions in organisms. Betaine occurs in numerous vertebrate tissues as an osmolyte, ensuring osmoprotection. Betaine is safe for piglets at the maximum supplementation rate of 2 000 mg/kg complete feed with a margin of safety below 5. This conclusion is extended to all pigs and extrapolated to all animal species and categories. The use of betaine anhydrous and betaine hydrochloride as feed additives up to a supplementation rate of 2 000 mg betaine/kg complete feed is unlikely to pose concerns for consumer safety. In the absence of data, betaine anhydrous and betaine hydrochloride should be considered hazardous by inhalation, as irritant to skin, eyes and mucous membranes, and skin sensitisers. The supplementation of feed with betaine anhydrous and betaine hydrochloride does not pose a risk to the environment. Betaine has the potential to become efficacious in all animal species and categories when administered via feed or water for drinking. Betaine anhydrous and betaine hydrochloride are considered as nutritionally equivalent sources of betaine. The FEEDAP Panel made some recommendations on (i) introduction of a maximum content for supplemental betaine in complete feed and water for drinking; (ii) avoidance of simultaneous use of betaine in feed and water for drinking; (iii) avoidance of simultaneous inclusion of betaine and choline chloride in premixtures; and (iv) protection of users when handling the additives.

© European Food Safety Authority, 2013

Scientific Opinion on the safety and efficacy of betaine (betaine anhydrous and betaine hydrochloride) as a feed additive for all animal species based on a dossier submitted by VITAC EEIG

Published on:

14 May 2013

Glycine betaine (betaine) acts as a methyl group donor in transmethylation reactions in organisms. Betaine occurs in numerous vertebrate tissues as an osmolyte, ensuring osmoprotection. Betaine is safe for piglets at the maximum supplementation rate of 2 000 mg/kg complete feed with a margin of safety below 5. This conclusion is extended to all pigs and extrapolated to all animal species and categories. The use of betaine as a feed additive up to a supplementation of 2 000 mg/kg complete feed is unlikely to pose concerns for consumer safety. In the absence of data, betaine anhydrous should be considered hazardous by inhalation, irritant to skin, eyes and mucous membranes and a skin sensitiser. The supplementation of feed with betaine anhydrous does not pose a risk to the environment. Betaine has the potential to become efficacious in all animal species and categories when administered via feed or water for drinking. The FEEDAP Panel made some recommendations on (i) introduction of a maximum content for supplemental betaine in complete feed and water for drinking; (ii) avoidance of simultaneous use of betaine in feed and water for drinking; and (iii) avoidance of simultaneous inclusion of betaine and choline chloride in premixtures.

© European Food Safety Authority, 2013

Scientific Opinion on the safety and efficacy of betaine anhydrous as a feed additive for all animal species based on a dossier submitted by Trouw Nutritional International B.V.

Published on:

13 May 2013

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State Germany, received an application from Isagro SpA to modify the existing MRLs for the active substance tetraconazole in various plant and animal commodities. Before lowering the existing MRLs on pome fruits from 0.3 mg/kg to 0.2 mg/kg, grapes from 0.5 mg/kg to 0.07 mg/kg and wheat from 0.1 mg/kg to and 0.04 mg/kg, Germany suggested awaiting the finalisation of the ongoing review of the existing MRLs of tetraconazole, whereas they proposed to raise the existing MRLs in the liver of swine and ruminants from 1 mg/kg to 1.5 mg/kg and 2 mg/kg, respectively. Germany 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 on apples, 0.07 mg/kg on grapes and 0.02 mg/kg (LOQ) on wheat. Before the MRLs are lowered it should be confirmed that no more critical GAPs are currently authorised at EU level for these crops. Taking into account the intended and the existing uses of tetraconazole, EFSA proposes to raise to 1.5 mg/kg and 3 mg/kg the existing MRLs for swine and ruminant liver, respectively. The data also support the lowering of the existing MRLs in swine, bovine, sheep and goats meat, fat and kidney and in ruminant milk. Adequate analytical enforcement methods are available to control the residues of tetraconazole in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of tetraconazole on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values for tetraconazole and therefore is unlikely to pose a consumer health risk.

© European Food Safety Authority, 2013

Reasoned opinion on the modification of the existing MRLs for tetraconazole in commodities of plant and animal origin

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Scientific Opinion on the re-evaluation of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) as food additives

Published on:

13 May 2013

Following a request by the European Commission, the Panel of Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the safety of sodium stearoyl-2-lactylate (E 481, SSL) and calcium stearoyl-2-lactylate (E 482, CSL) when used as food additives. SSL and CSL are used as emulsifiers and stabilizers. An Acceptable Daily Intake (ADI) of 20 mg/kg bw/day for SSL and CSL (either singly or in combination) was established in 1974 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The Scientific Committee on Food (SCF) endorsed this ADI of 20 mg/kg bw/day in 1978. The biological fate of CSL is comparable in rodent and non-rodent species. The acute oral toxicity in rats is low. Subacute and subchronic oral toxicity studies with SSL and CSL in rats and dogs revealed a NOAEL of 5 % in the diet. Neither SSL and CSL nor their breakdown products stearic and lactic acid raise concern for genotoxicity. The NOAEL in a one-year oral toxicity study with SSL in rats was 2214 mg/kg bw/day for males and 2641 mg/kg bw/day for females. No data on reproductive toxicity and carcinogenicity were available. However, no reproductive or carcinogenic effects are expected since the products of hydrolysis, stearic and lactic acid are constituents of natural food and part of endogenous metabolism in mammals. The Panel concluded that based on the NOAEL of 2200 mg/kg bw/day derived from the one-year toxicity study in rats and an uncertainty factor of 100, an ADI of 22 mg/kg bw/day for sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) either singly or in combination can be established. The estimated exposure to SSL and CSL occurs mainly via the consumption of flavoured fermented milk products including heat treated products, bread and rolls and fine bakery wares and is below the ADI of 22 mg/kg bw/day for all the adult population including the elderly, but exceeds the ADI for other groups of the population at mean level and for all groups of the population at high level.

© European Food Safety Authority, 2013

Scientific Opinion on the re-evaluation of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) as food additives

Published on:

13 May 2013

In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, hereafter referred to as the evaluating Member State (EMS), received an application from the company Probelte to modify the existing MRL for the active substance 8-hydroxyquinoline in tomatoes. In order to accommodate for the intended indoor use of 8-hydroxyquinoline, Spain proposed to raise the existing MRL in tomatoes to 0.1 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 submitted data are sufficient to derive a MRL proposal of 0.1 mg/kg for 8-hydroxyquinoline in tomatoes which reflects the analytical LOQ of the method used to analyse residue trial samples. Based on the risk assessment results, EFSA concludes that the intended indoor use of 8-hydroxyquinoline on tomatoes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health risk.

© European Food Safety Authority, 2013

Reasoned opinion on the modification of the existing MRL for 8-hydroxyquinoline in tomatoes

Published on:

13 May 2013

Glycine betaine (betaine) acts as a methyl group donor in transmethylation reactions in organisms. Betaine occurs in numerous vertebrate tissues as an osmolyte, ensuring osmoprotection. Betaine is safe for piglets at the maximum supplementation rate of 2 000 mg/kg complete feed with a margin of safety below 5. This conclusion is extended to all pigs and extrapolated to all animal species and categories. The use of betaine as a feed additive up to a supplementation rate of 2 000 mg/kg complete feed is unlikely to pose concerns for consumer safety. Users’ inhalation exposure to betaine is expected to be minimal. Betaine anhydrous should be considered irritant to skin, eyes and mucous membranes and a skin sensitiser. It is likely to cause skin sensitisation. The supplementation of feed with betaine anhydrous does not pose a risk to the environment. Betaine has the potential to become efficacious in all animal species and categories when administered via feed or water for drinking. The FEEDAP Panel made some recommendations on (i) introduction of a maximum content for supplemental betaine in complete feed and water for drinking; (ii) avoidance of simultaneous use of betaine in feed and water for drinking; and (iii) avoidance of simultaneous inclusion of betaine and choline chloride in premixtures.

© European Food Safety Authority, 2013

Scientific Opinion on the safety and efficacy of betaine anhydrous as a feed additive for all animal species based on a dossier submitted by Danisco Animal Nutrition

Published on:

13 May 2013

Chemical group 20 consists of aliphatic and aromatic mono- and di-thiols and mono-, di-, tri-, and polysulphides with or without additional oxygenated functional groups, of which 31 are currently authorised for use as flavours in food. The FEEDAP Panel was unable to perform an assessment of six compounds (methanethiol, methyl propyl disulphide, dipropyl trisulphide, 3-mercaptobutan-2-one, 3-(methylthio)butanal and 3-methyl-1,2,4-trithiane) because of issues related to the purity of the compounds. The FEEDAP Panel concludes that the following 25 compounds are safe for the target species at the proposed maximum dose level (0.05 mg/kg complete feed): 3-(methylthio)propionaldehyde, methyl 3-(methylthio)propionate, allylthiol, dimethyl sulphide, dibutyl sulphide, diallyl disulphide, diallyl trisulphide, dimethyl trisulphide, dipropyl disulphide, allyl isothiocyanate, dimethyl disulphide, 2-methylbenzene-1-thiol, S-methyl butanethioate, allyl methyl disulphide, 3-(methylthio)propan-1-ol, 3-(methylthio)hexan-1-ol, 1-propane-1-thiol, diallyl sulphide, 2,4-dithiapentane, 2-methyl-2-(methyldithio)propanal, 2-methylpropane-1-thiol, methylsulfinylmethane, propane-2-thiol, 3,5-dimethyl-1,2,4-trithiolane and 2-methyl-4-propyl-1,3-oxathiane. No safety concern for the consumer would arise from the use of these 25 compounds of CG 20 up to the highest safe level in feedingstuffs for all animal species, with the exception of allyl isothiocyanate. Although additional exposure to this substance through its low use level in animal feeds would not substantially increase consumer exposure, the FEEDAP Panel notes that the estimated exposure of consumers is already higher than the acceptable daily intake (ADI). All compounds should be considered irritant to skin, eyes and respiratory tract and as skin sensitisers. The proposed concentration of 0.05 mg flavour/kg feed is not expected to cause detrimental effects to the environment, except for 2-methylpropane-1-thiol, for which 0.04 mg/kg is expected to be safe. Since all 25 compounds are used in food as flavourings and their function is essentially the same as that in food, no further demonstration of efficacy is necessary.

© European Food Safety Authority, 2013

Scientific Opinion on the safety and efficacy of aliphatic and aromatic mono- and di-thiols and mono-, di-, tri-, and polysulphides with or without additional oxygenated functional groups (chemical group 20) when used as flavourings for all animal species

Published on:

8 May 2013

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 United Kingdom, for the pesticide active substance carbon dioxide are reported. The context of the peer review was that required by Commission Regulation (EC) No 2229/2004 as amended by Commission Regulation (EC) No 1095/2007. The conclusions were reached on the basis of the evaluation of the representative uses of carbon dioxide as an insecticide on stored cereal grains, fatty seeds, medicinal plants, spices, tobacco, tea and dried fruits. 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.

© European Food Safety Authority, 2013

Conclusion on the peer review of the pesticide risk assessment of the active substance carbon dioxide

Published on:

8 May 2013

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 picolinafen. In order to assess the occurrence of picolinafen 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 (incl. 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.

© European Food Safety Authority, 2013

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for picolinafen according to Article 12 of Regulation (EC) No 396/2005

Published on:

8 May 2013

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 United Kingdom, for the pesticide active substance spinetoram are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of spinetoram as an insecticide on grapes. 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.

© European Food Safety Authority, 2013

Conclusion on the peer review of the pesticide risk assessment of the active substance spinetoram

Published on:

7 May 2013

The strain of Lactobacillus plantarum is intended to improve the ensiling process at proposed doses ranging from 1 x 10⁸ to 1 x 10⁹ CFU/kg fresh material. This speciesis considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been established and as no antibiotic resistance of concern was detected, the use of the strain in the production of silage is presumed safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The active agent is not an eye or skin irritant or a skin sensitiser. Given the proteinaceous nature of the active agent and the high dusting potential of the product tested, the FEEDAP Panel considers it prudent to treat this additive as a respiratory sensitiser. A total of 20 laboratory-scale ensiling studies were conducted with L. plantarum applied at 1 x 10⁹ or 1 x 10⁸ CFU/kg forage. In all the studies, forage containing the additive was compared with untreated control materials, and the duration of the studies was at least 90 days. L. plantarum has the potential to improve the production of silage by increasing lactic acid content and the preservation of dry matter, by reducing the pH and protein degradation. This was demonstrated in a range of easy and moderately difficult to ensile forage materials at a minimum concentration of 1 x 10⁸ CFU/kg fresh material and also in difficult to ensile forage materials when added at a concentration of 1 x 10⁹ CFU/kg fresh material.

© European Food Safety Authority, 2013

Scientific Opinion on the safety and efficacy of Lactobacillus plantarum (NCIMB 40027) as a silage additive for all animal species

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Scientific Opinion on the safety and efficacy of Lactobacillus plantarum (NCIMB 40027) as a silage additive for all animal species

Published on:

7 May 2013

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 1,3-dichloropropene. Considering that this active substance is no longer authorised within the European Union, that no MRLs are established by the Codex Alimentarius Commission, and that no import tolerances were notified to EFSA, residues of 1,3-dichloropropene are not expected to occur in any plant or animal commodity. Available data were also not sufficient to derive an LOQ for enforcement against potential illegal uses.

© European Food Safety Authority, 2013

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for 1,3-dichloropropene according to Article 12 of Regulation (EC) No 396/2005

Published on:

6 May 2013

The additive, based on a single bacterial strain (DSM 11798), is intended for use in feeds for pig to reduce the epoxide group of contaminating trichothecene mycotoxins to a less toxic metabolite. To establish an identity for the strain a phylogenetic analysis was made based on the genomic sequence of the strain and 24 genome sequences available for the family Coriobacteriaceae. The three approaches used consistently suggested an assignment to a new taxonomic unit within the family Coriobacteriaceae. The Panel accepts that a new species and/or genus may have to be established. In the interim the deposition of the bacterium in a European culture collection is sufficient to ensure that any authorisation would apply only to the additive under application. Based on the results of a tolerance study the additive is considered safe for piglets and pigs for fattening at the maximum dose proposed. The live organism is not expected to present a hazard for consumers and the negative findings in a series of genotoxicity and oral toxicity tests indicates that toxic metabolites are not produced. Since the additive is expected to act only by the biotransformation of trichothecene mycotoxins to less toxic forms, no hazards for consumers would arise from the use of the additive in animal production. The additive was non-irritant to eyes and skin and was not a skin sensitiser, but the potential for respiratory sensitization cannot be excluded. As the strain has a very limited capability to survive in aerobic conditions, its use in animal production is unlikely to introduce an environmental concern. The evidence presented in ex vivo and in vivo studies with deoxynivalenol confirms that the capacity to transform trichothecenes can be realised in pigs when the additive is incorporated into diets at a minimum dose of 1.7 x 10⁸ CFU/kg complete feed.

© European Food Safety Authority, 2013

Scientific Opinion on the safety and efficacy of micro-organism DSM 11798 when used as a technological feed additive for pigs

Published on:

3 May 2013

The additive Lenziaren is a polynuclear Fe(III) starch/saccharose complex intended to be used in food for adult cats to reduce phosphate absorption in the gastrointestinal tract in order to prevent chronic kidney disease. The recommended minimum and maximum levels are 0.25 g and 1.0 g per cat per day, equivalent to 5 000 and 20 000 mg/kg feed, respectively. The FEEDAP Panel considers that Lenziaren is safe for adult cats at the maximum recommended dose. However, the consequences of chronic exposure have not been investigated. The additive is not genotoxic. No adverse effects were seen in a repeat-dose toxicity study in mice. Lenziaren had no adverse effects on reproduction and development at dose levels that were not toxic to the mother. A no observed adverse effect level (NOAEL) of 500 mg/kg body weight (bw) per day was identified for Lenziaren on the basis of maternal toxicity (diarrhoea and reduced body weight gain), which was seen in rabbits at an oral dose of 1 000 mg/kg bw per day or greater. Similar effects were seen in rats, dogs and monkeys at higher doses in repeat-dose toxicity studies. No NOAELs were identified in these studies. Lenziaren is not regarded as an irritant to skin or eyes or as a skin sensitiser. Although some inhalation exposure is possible, it is not expected to be harmful to those exposed as a result of handling the additive. Based on the results of three in vivo efficacy studies, the FEEDAP Panel concludes that Lenziaren has the potential to be efficacious in cats at the highest recommended dose of 1 g/cat per day (equivalent to 20 000 mg/kg feed). However, the FEEDAP Panel has some reservations regarding the value of its long-term use in healthy cats. The Panel concludes that there is a need for a post-market monitoring plan.

© European Food Safety Authority, 2013

Scientific Opinion on the safety and efficacy of Lenziaren (iron, aqua carbonate hydroxyl oxo starch sucrose complex) as a feed additive for cats

Published on:

3 May 2013

Lancer is a feed additive mainly consisting of two rare earth elements, lanthanum (La) and cerium (Ce), in their citrate forms. In the absence of an adequate tolerance study in weaned piglets, the FEEDAP Panel cannot conclude on the safety of the additive for the target species. Lancer is not genotoxic. Although one study suggests that La and Ce are not deposited in tissues in piglets, this is apparently not consistent with data found in other species (cattle and rats). Consequently, the Panel is reluctant to conclude that there is no potential for consumer exposure. In addition, in the absence of a no observed adverse effect level, the Panel is unable to relate any possible exposure to evidence of a safe dose. Lancer is not irritant to skin and eyes and does not induce skin sensitisation. The high proportion of particles of diameter less than 10 μm and the high dusting potential suggest that the material can be inhaled deep into the lungs of workers. Although the acute respiratory toxicity data indicate that the dust is of low toxicity, prolonged/repeated exposure should be avoided. The use of Lancer as a feed additive will probably increase the levels of La and Ce above those naturally occurring in the environment. Lanthanum is potentially toxic to environmental relevant species, but its toxicity is highly dependent on speciation. Because of the low solubility of La and Ce, in most situations the additive would probably not give rise to concern for the aquatic environment. There are no data on toxicity of the additive to terrestrial organisms. In the absence of such data, a full environmental assessment cannot be completed. Based on three studies in which growth of piglets was positively affected, the Panel considers that Lancer has the potential to be efficacious.

© European Food Safety Authority, 2013

Scientific Opinion on the safety and efficacy of Lancer (lanthanide citrate) as feed additive for weaned piglets

Published on:

2 May 2013

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received an application from BASF to modify the existing MRLs for pendimethalin in various crops. In order to accommodate for the intended uses Germany proposed to raise the existing MRLs to 0.2 mg/kg on salsify, to 0.5 mg/kg for the group of herbal infusions (roots) and to 0.3 mg/kg on spices (seeds) and on caraway, whereas the intended uses on swedes, turnips, celeriac and celery were not sufficiently supported by data and no amendment of the MRLs was proposed. Germany 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 propose a MRL of 0.2 mg/kg on salsify, 0.5 mg/kg on herbal infusions (roots) and 0.05 mg/kg (LOQ) on spices (seeds) and on caraway. The intended uses on swedes, turnips, celeriac and celery are not adequately supported by residue data and no MRL proposals can be therefore derived. Analytical enforcement methods are available to control the residues of pendimethalin in the crops under consideration, which are fully validated on salsify matrices; further validation data would be desirable on herbal infusions and spices. Based on the risk assessment results, EFSA concludes that the proposed use of pendimethalin on salsify, herbal infusions (roots), spices (seeds) and caraway will not result in a exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

© European Food Safety Authority, 2013

Reasoned opinion on the modification of the existing MRLs for pendimethalin in various crops

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30 April 2013

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 United Kingdom, for the pesticide active substance pyroxsulam are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of pyroxsulam as a herbicide on winter wheat, rye and triticale. 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.

© European Food Safety Authority, 2013

Conclusion on the peer review of the pesticide risk assessment of the active substance pyroxsulam

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30 April 2013

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 dimethenamid-P. In order to assess the occurrence of dimethenamid-P residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (incl. 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 some MRL proposals derived by EFSA still require further consideration by risk managers.

© European Food Safety Authority, 2013

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for dimethenamid-P according to Article 12 of Regulation (EC) No 396/2005

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26 April 2013

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 propamocarb. In order to assess the occurrence of propamocarb residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

© European Food Safety Authority, 2013

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for propamocarb according to Article 12 of Regulation (EC) No 396/2005

The present document has been produced and adopted by the bodies identified above as authors. This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the authors, awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.

Published on:

26 April 2013

Outbreaks of RVF often occur linked to periodical abundance peaks of Aedes and Culex species. Abundance data is therefore critical but needs a specific approach. A novel methodology was developed to model spatial abundance patterns for two potential vectors (Aedes vexans and Culex pipiens) of Rift Valley Fever in Europe and the Mediterranean Basin. For those two species, abundance data was extracted from the compiled papers and subdivided into three categories; low, medium and high abundances. Only geocoded records could be used in the modelling approach. The categories were based on a log-transformation where the low class are sites with 1-10 specimen per trap, medium class sites with 10-1000 specimens and high all sites with more than 1000 specimen per trap. Models were created using Random Classification Forests for each of the classes separately and then combined with a maximum value compositing procedure. In a final step, the abundance map was combined with the probability map. Abundance models could only be created for Cx pipiens as detailed abundance data was lacking for Aedes vexans. Although it has some drawbacks, the proposed methodology has proven to be a useful approach when only scattered literature data is available. © 2013 Avia-GIS.

Abundance of Rift Valley Fever vectors in Europe and the Mediterranean Basin Ducheyne E., Versteirt V. & Hendrickx G.

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Systematic literature review on the geographic distribution of rift valley fever vectors in Europe and the neighbouring countries of the Mediterranean Basin

The present document has been produced and adopted by the bodies identified above as authors. This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the authors, awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.

Published on:

26 April 2013

Although Rift Valley Fever (RVF) is mainly affecting large parts of sub-Saharan Africa, there is an increased concern that this vector-borne disease could be introduced into the Europe. Transmission of this viral zoonosis can occur through various pathways of which infected mosquitoes are one of the most important. Several species have been suspected as putative vector, mainly of the genus Aedes and Culex. The possible occurrence and/or distribution of at least nine of these species in the Mediterranean Basin are not fully clarified though crucial for the development of a risk assessment for the Europe. To acquire this information a stepwise approach was adopted. Firstly, a systematic literature review was initiated to compile all existing presence/absence data of these eight species in the proposed countries from different data sources. Relevant environmental and eco-climatic data needed to model the distribution and potential areas of spread were also extracted. All information was used to generate predicted presence maps using Random Classification Forest. Outputs were validated using accuracy assessment and compared to existing maps. For six of the nine species sufficient data was obtained from a large range of publications, for Culex tritaenorhynchus and Culex antennatus only few publications and/or scattered data was available. Despite lacking data, predicted presence maps were created for all species with an adequately high accuracy with Area Under the Receiver Operating Curve (AUC) values ranging from 0.905 to 0.995. The created maps highlight however specific regions in Europe and countries around the Mediterranean Basin that seems to be highly suitable for the occurrence of putative vectors of RVF. With these maps, one of the first prerequisite to advance the restricted knowledge on vector ecology and distribution is fulfilled. © 2013 Avia-GIS.

Systematic literature review on the geographic distribution of rift valley fever vectors in Europe and the neighbouring countries of the Mediterranean Basin

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Scientific Opinion on Rift Valley fever

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26 April 2013

Based on a comprehensive review of literature and OIE (World Animal Health Organisation) outbreak reports, this scientific opinion reports, first, that there is no evidence that Rift Valley fever (RVF) has spread to previously uninfected countries during the past 10 years. Nevertheless, RVF has moved north within Mauritania, in a desert area. Secondly, maps of Europe and the southern Mediterranean Basin are provided, displaying the geographic distribution of the reported presence of nine potentially competent Rift Valley fever virus (RVFV) vectors of the region, based on a systematic literature review. From environmental and eco-climatic data, predicted presence maps were generated that suggest the suitability of several parts of Europe and the southern Mediterranean Basin for these potentially competent RVFV vectors. Thirdly, to assess the risk of introduction of RVFV into some designated countries in the southern Mediterranean Basin (hereafter defined as the region concerned, RC), especially through the movements of live animals and vectors, a quantitative model was constructed and model parameters were derived based on expert knowledge elicitation (EKE). The EKE model indicates that some hundreds of RVFV-infected animals will be moved into the RC when an epidemic in the source areas occurs. The risk of RVFV entering the RC through the movement of vectors is expected to be small in comparison with the risk of entry through infected animals. Because of a lack of quantitative information on the seasonality of vector abundance and vertical transmission of RVFV within local vector species, the risk of endemicity could not be assessed. However, based on the abundance of the vector Culex pipiens, the livestock densities and the temperature in the region, there is a potential for the occurrence of RVF spread in the coastal areas of the RC.

© European Food Safety Authority, 2013

Scientific Opinion on Rift Valley fever

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Abundance of Rift Valley Fever vectors in Europe and the Mediterranean Basin Ducheyne E., Versteirt V. & Hendrickx G.

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25 April 2013

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 bifenox. In order to assess the occurrence of bifenox 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 (incl. 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 some MRL proposals derived by EFSA still require further consideration by risk managers.

© European Food Safety Authority, 2013

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for bifenox according to Article 12 of Regulation (EC) No 396/2005

Published on:

25 April 2013

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 L-ascorbic acid are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of L-ascorbic acid as a fungicide on potato, glasshouse tomato and field and glasshouse flower bulbs. 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.

© European Food Safety Authority, 2013

Conclusion on the peer review of the pesticide risk assessment of the active substance L-ascorbic acid

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Scientific Opinion on the re-evaluation of anthocyanins (E 163) as a food additive

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Scientific Opinion on the re-evaluation of anthocyanins (E 163) as a food additive

Published on:

23 April 2013

Following a request from the European Commission to the European Food Safety Authority (EFSA), the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to provide a scientific opinion re-evaluating the safety of anthocyanins (E 163). The Panel concluded that the currently available toxicological database was inadequate to establish a numerical ADI for anthocyanins. For anthocyanins extracted from edible fruits and vegetables by aqueous processes, changes in composition would not be expected. The Panel concluded that provided exposure from use as a food additive was comparable to that from the diet the underlying conclusion in the 1975 SCF opinion that such food additives derived from natural sources would still apply. The majority of data are on aqueous grape skin extract (GSKE) and blackcurrant extracts and the Panel considers that exposures estimated from current uses and use levels these extracts are unlikely to be of safety concern. The Panel recommends that the specifications for E 163 should be modified to reflect this conclusion. For anthocyanins extracted from other sources and/or using non-aqueous extraction methods the absence of characterisation does not allow verification that this conclusion in the 1975 SCF opinion could be applied. The Panel noted that for some extracts it had proven possible to assess a group based on toxicological and compositional data on representative samples across the range of extracts. The Panel concluded that refined exposure estimates of anthocyanins used as a food additive were much higher than dietary intakes and that these did not include intakes from colouring foods. Therefore the Panel would recommend that appropriate characterisation and toxicological data should be required to permit a further re-evaluation of anthocyanins including comparative data on anthocyanins (E 163) produced by aqueous extraction.

© European Food Safety Authority, 2013

Scientific Opinion on the re-evaluation of anthocyanins (E 163) as a food additive

Published on:

19 April 2013

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the Evaluating Member State (EMS), received an application from the Landwirtschaftskammer Nordrhein-Westfalen to modify the existing MRL for trifloxystrobin in beans with pods. In order to accommodate for the intended use of trifloxystrobin Germany proposed to raise the existing MRL on beans (with pods) from the value of 0.5 mg/kg to 1 mg/kg. Germany 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 1.0 mg/kg for the intended use on beans with pods. Adequate analytical enforcement methods are available to control the residues of trifloxystrobin in the commodity under consideration. Based on the provisional risk assessment results, EFSA concludes that the intended use of trifloxystrobin on beans with pods will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

© European Food Safety Authority, 2013

Reasoned opinion on the modification of the existing MRL for trifloxystrobin in beans with pods

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18 April 2013

In accordance with Article 6 of Regulation (EC) No 396/2005, Italy, herewith referred to as the evaluating Member State (EMS), received an application from Dow AgroScience to set an import tolerance for tricyclazole in rice to accommodate the authorized use in Brazil. Tricyclazole is a non-included active substance and no EU uses are currently authorized. Thus, the existing EU MRL of 1 mg/kg in rice should be lowered to the LOQ. The applicant requested to maintain the existing EU MRL to allow the import of rice treated with tricyclazole from third countries. The EMS confirmed that the MRL should be set provisionally at the level 1 mg/kg to accommodate the Brazilian GAP. EFSA is of the opinion that on the basis of the currently available studies, the toxicological reference values for tricyclazole cannot be set, since the genotoxic potential of tricyclazole could not be totally disregarded. In addition, uncertainties regarding the carcinogenic potential of tricyclazole were identified by EFSA. The submitted residue trials data were found to be insufficient to derive an MRL proposal which accommodates the use of tricyclazole on rice in Brazil. EFSA concludes that the import tolerance request for tricyclazole in rice is not sufficiently supported by data which would justify maintaining the existing EU MRL of 1 mg/kg in rice.

© European Food Safety Authority, 2013

Reasoned opinion on the modification of the existing MRL for tricyclazole in rice

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Guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non-allowed pharmacologically active substances present in food of animal origin

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17 April 2013

EFSA was asked by the European Commission to deliver a Scientific Opinion on guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non-allowed pharmacologically active substances in food of animal origin. This guidance document presents a simple and pragmatic approach which takes into account both analytical and toxicological considerations. The aim is to define an analytical concentration for a non-allowed pharmacologically active substance that can be determined by official control laboratories and is low enough to adequately protect the consumers of food commodities that contain that substance. The proposed step-wise approach considers factors such as analytical capability, toxic potential and pharmacological activity of the substance in question, and includes the identification of the Reasonably Achievable Lowest Limit of Quantification (RALLOQ), the establishment of a Toxicological Screening Value (TSV) and the derivation of a Toxicologically Based Limit of Quantification (TBLOQ). The TBLOQ is compared with the RALLOQ for the respective substance. If the TBLOQ is equal to or higher than the RALLOQ, then the latter can be accepted as the RPA. If the TBLOQ is lower than the RALLOQ, then the sensitivity of the analytical method needs to be improved. In the case where no further analytical improvements are feasible, a substance-specific risk assessment should be considered. The CONTAM Panel concluded that RPAs should be matrix independent. The CONTAM Panel noted that sometimes non-edible matrices are monitored to identify the administration of non-allowed pharmacologically active substances. In these cases, RPAs cannot be applied. The CONTAM Panel also proposed several criteria where the European Commission might consider it appropriate to consult EFSA for a substance-specific risk assessment.

© European Food Safety Authority, 2013

Guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non-allowed pharmacologically active substances present in food of animal origin

Published on:

16 April 2013

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 substances mecoprop and mecoprop-p. In order to assess the occurrence of mecoprop and mecoprop-p 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 (incl. 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 some MRL proposals derived by EFSA still require further consideration by risk managers.

© European Food Safety Authority, 2013

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for mecoprop and mecoprop-p according to Article 12 of Regulation (EC) No 396/2005

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16 April 2013

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 prohexadione. In order to assess the occurrence of prohexadione 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 import tolerances and European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. No information required by the regulatory framework was found to be missing and no risk to consumers was identified.

© European Food Safety Authority, 2013

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for prohexadione according to Article 12 of Regulation (EC) No 396/2005

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Scientific Opinion on application (EFSA-GMO-UK-2008-53) for the placing on the market of herbicide tolerant genetically modified maize 98140 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Pioneer Overseas Corporation