Archive for the ‘EFSA’ Category

Technical specifications for the analysis and reporting of data on antimicrobial resistance (AMR) in the European Union Summary Report

Wednesday, February 22nd, 2012

Published on:

22 February 2012

In this report, proposals to improve the analysis and reporting of data in the European Union Summary Reports on antimicrobial resistance in animals and food collected from the Member States have been elaborated. A logistic regression modelling approach is recommended to assess significance of temporal trends in occurrence of resistance. Temporal trends in full scale minimum inhibitory concentration distributions should be also explored to increase the early detection of decreased susceptibility. The recommendations for the reporting of quantitative resistance data obtained through standardised dilution methods and the interpretation of resistance using epidemiological cut-off values are reinforced. A further harmonisation of national monitoring designs would facilitate data interpretation at European Union level, where weighted indicators of resistance should be designed, accounting for prevalence of bacteria, occurrence of resistance and monitoring design at national level. It is also proposed to complement the harmonised panel of antimicrobials used for susceptibility testing and to emphasize the monitoring of resistance in indicator bacteria. It is considered essential that resistance data should be reported at isolate level in order to address the multi-resistance phenomenon. For this purpose, a definition and an analysis approach of the multi-resistance as well as a list of important co-resistance patterns have been put forward. The reporting of isolate-based data should facilitate obtaining more detailed data on the animal population/food category sampled, the number and the origin of samples, the bacterial subtypes and the antimicrobial concentration ranges tested. This would enable more in depth analyses to be conducted as regards the identification of factors associated with resistance and the geographical diffusion of the multi-resistance. Finally, recommendations are given on the comparison between new emerging resistance types in healthy humans and animals/food.

© European Food Safety Authority, 2012

Technical specifications for the analysis and reporting of data on antimicrobial resistance (AMR) in the European Union Summary Report


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Scientific opinion on the safety of smoke flavouring Primary Product AM 01 – 2012 Update

Wednesday, February 22nd, 2012

Published on:

22 February 2012

The EFSA CEF Panel updated the safety assessment of the smoke flavouring Primary Product AM 01. After the opinion of 2010 the Panel received new data i.e. new use levels, chemical data and a new in vivo Comet assay. In 2010, the Panel concluded that the genotoxic potential of this Primary Product could not be ruled out given the limitations in the data set. Also the margins of safety for this Primary Product were considered insufficient and the proposed use levels were considered of safety concern.

In the new in vivo Comet assay the Primary Product did not induce statistically significant increases in DNA strand breaks at any of the tested doses in the liver or in the duodenum cells. The Panel concluded that based on the available data there is no concern with respect to genotoxicity for the Primary Product.

The chemical data provided demonstrate that the material tested in the Comet assay is representative of the Primary Product evaluated by EFSA in 2010. No additional data were provided in order to mitigate the issue associated with the large degree of batch-to-batch variability and chemical stability during shelf life described for the Primary Product in the opinion of 2010.

Based on newly submitted use levels, the margins of safety are 104-114 (total dietary exposure) and 109-179 (use in traditionally smoke foods only) depending on the exposure scenario used. Given that these margins of safety are based on a 90-day toxicity study, and given the absence of data on reproduction, developmental toxicity and of long term studies, it is concluded that the uses and use levels of Primary Product would require a larger margin of safety. The Panel concluded that the proposed use of the Primary Product at the uses and use levels specified is of safety concern.

© European Food Safety Authority, 2012

Scientific opinion on the safety of smoke flavouring Primary Product AM 01 – 2012 Update


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Setting of new MRLs for saflufenacil in a wide range of food commodities

Tuesday, February 21st, 2012

Published on:

21 February 2012

Setting of new MRLs for saflufenacil in a wide range of food commodities


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Report of the Quality Manager 2011

Monday, February 20th, 2012

Published on:

20 February 2012

Report of the Quality Manager 2011


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Outcome of the Public Consultation on the Draft Scientific Opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations of plant protection products in soil

Friday, February 17th, 2012

Published on:

17 February 2012

Outcome of the Public Consultation on the Draft Scientific Opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations of plant protection products in soil


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Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis

Thursday, February 16th, 2012

Published on:

16 February 2012

The European Commission requested that the EFSA Panel on Genetically Modified Organisms deliver a scientific opinion related to risk assessment of cisgenic and intragenic plants. The EFSA GMO Panel considers that the Guidance for risk assessment of food and feed from genetically modified plants and the Guidance on the environmental risk assessment of genetically modified plants are applicable for the evaluation of food and feed products derived from cisgenic and intragenic plants and for performing an environmental risk assessment and do not need to be developed further. It can be envisaged that on a case-by-case basis lesser amounts of event-specific data are needed for the risk assessment. The EFSA GMO Panel compared the hazards associated with plants produced by cisgenesis and intragenesis with those obtained either by conventional plant breeding techniques or by transgenesis. The Panel concludes that similar hazards can be associated with cisgenic and conventionally bred plants, while novel hazards can be associated with intragenic and transgenic plants. The Panel is of the opinion that all of these breeding methods can produce variable frequencies and severities of unintended effects. The frequency of unintended changes may differ between breeding techniques and their occurrence cannot be predicted and needs to be assessed case by case. Independent of the breeding method, undesirable phenotypes are generally removed during selection and testing programmes by breeders. The risks to human and animal health and the environment will depend on exposure factors such as the extent to which the plant is cultivated and consumed.

© European Food Safety Authority, 2012

Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis


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Scientific Opinion on the safety and efficacy of Carmoisine (E 122) in feed for cats and dogs

Thursday, February 16th, 2012

Published on:

16 February 2012

Carmoisine is intended to be used as a colourant in feedingstuffs for cats and dogs without quantitative limitations. Since the additive is only applied for non-food producing animals, the assessment of safety is limited to the target species and the user. Carmoisine is safe in complete feed for cats and dogs at up to about 200 mg/kg dry matter. In the absence of any information, the substance should be considered as potentially harmful by skin, eye, or inhalation exposure. Carmoisine is intended to serve the same function in feed as in food. The intended concentrations in feedingstuffs are similar to those permitted for wide range of foodstuffs. The colouring efficacy of Carmoisine in a typical complementary feed for dogs was demonstrated at a minimum dose of 50 mg/kg. Carmoisine is considered efficacious in adding colour to feed of cats and dogs.

© European Food Safety Authority, 2012

Scientific Opinion on the safety and efficacy of Carmoisine (E 122) in feed for cats and dogs


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Review of the existing maximum residue levels (MRLs) for diniconazole-M according to Article 12 of Regulation (EC) No 396/2005

Thursday, February 16th, 2012

Published on:

16 February 2012

Review of the existing maximum residue levels (MRLs) for diniconazole-M according to Article 12 of Regulation (EC) No 396/2005


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Modification of the existing MRLs for sulfuryl fluoride and fluoride ion in chestnuts

Thursday, February 16th, 2012

Published on:

16 February 2012

Modification of the existing MRLs for sulfuryl fluoride and fluoride ion in chestnuts


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Scientific opinion on application (EFSA-GMO-NL-2009-73) for the placing on the market of insect-resistant and herbicide-tolerant genetically modified soybean MON 87701 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

Wednesday, February 15th, 2012

Published on:

15 February 2012

This scientific opinion is an evaluation of a risk assessment for placing on the market the genetically modified (GM) insect-resistant and herbicide-tolerant soybean MON 87701 × MON 89788 for food and feed uses, import and processing. Soybean MON 87701 × MON 89788 was produced by conventional crossing methods, and the F1 plant is hemizygous for all newly introduced traits. The soybean contains the Cry1Ac and CP4 epsps genes conferring resistance against certain lepidopteran target pests and tolerance to glyphosate-based herbicides. No biologically relevant differences were identified in the composition or agronomic and phenotypic characteristics of soybean MON 87701 × MON 89788, as compared with its comparator, except that it expresses the Cry1Ac and CP4 EPSPS proteins. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of soybean MON 87701 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering its intended use as food and feed, environmental risks associated with an unlikely but theoretically possible horizontal gene transfer from soybean MON 87701 × MON 89788 to bacteria have not been identified. Potential interactions of soybean MON 87701 × MON 89788 with the biotic and abiotic environment were not considered to be an issue owing to the low level of exposure. The monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87701 × MON 89788. In conclusion, the EFSA GMO Panel considers that the information available for soybean MON 87701 × MON 89788 addresses the scientific comments raised by Member States and that the soybean MON 87701 × MON 89788, as described in this application, is as safe as its comparator with respect to potential effects on human and animal health and the environment, in the context of its intended uses.

© European Food Safety Authority, 2012

Scientific opinion on application (EFSA-GMO-NL-2009-73) for the placing on the market of insect-resistant and herbicide-tolerant genetically modified soybean MON 87701 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto


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Scientific Opinion on the safety and efficacy of phenol derivatives containing ring-alkyl, ring-alkoxy and side-chains with an oxygenated functional group (chemical group 25) when used as flavourings for all species

Wednesday, February 15th, 2012

Published on:

15 February 2012

Chemical Group 25 (CG 25) consist of phenol derivatives containing ring-alkyl, ring-alkoxy and side-chains with an oxygenated functional group, of which 16 are currently authorised for use as flavours in food. The flavouring compounds are calculated to be safe for all animal species at a maximum level of 5 mg/kg complete feed. This value supports the highest proposed use level for 13 of the 16 compounds with the margin of safety of approximately 1 to 5 for pigs and poultry, the most sensitive species. This safe level is substantially below the maximum proposed use level for all species for thymol and carvacrol (125 mg/kg complete feed) and for 3-methoxyphenol (25 mg/kg complete feed). The Panel concludes that the use of any of the 16 compounds included in CG 25 at the maximum proposed use level in animal feed would not raise safety concerns for consumers of animal products. No new data on the safety for the user was provided. However, potential hazards for skin and eye contact and respiratory exposure of various severities are recognised for all of the compounds included in CG 25. The Panel expects that at the use level safe for all target species (5 mg/kg feed), the 16 compounds included in CG 25 do not pose a risk for the environment. Since all 16 compounds include in CG 25 are used in food as flavourings and their function in feed is essentially the same as that in food, no further demonstration of efficacy was considered necessary.

© European Food Safety Authority, 2012

Scientific Opinion on the safety and efficacy of phenol derivatives containing ring-alkyl, ring-alkoxy and side-chains with an oxygenated functional group (chemical group 25) when used as flavourings for all species


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Review of the existing maximum residue levels (MRLs) for S-metolachlor according to Article 12 of Regulation (EC) No 396/2005

Wednesday, February 15th, 2012

Published on:

15 February 2012

Review of the existing maximum residue levels (MRLs) for S-metolachlor according to Article 12 of Regulation (EC) No 396/2005


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Review of the existing maximum residue levels (MRLs) for chlorpropham according to Article 12 of Regulation (EC) No 396/2005

Wednesday, February 15th, 2012

Published on:

15 February 2012

Review of the existing maximum residue levels (MRLs) for chlorpropham according to Article 12 of Regulation (EC) No 396/2005


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Review of the existing maximum residue levels (MRLs) for beflubutamid according to Article 12 of Regulation (EC) No 396/2005

Wednesday, February 15th, 2012

Published on:

15 February 2012

Review of the existing maximum residue levels (MRLs) for beflubutamid according to Article 12 of Regulation (EC) No 396/2005


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EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed

Wednesday, February 15th, 2012

Published on:

15 February 2012

EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed


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Scientific Opinion on the safety and efficacy of acetic acid, sodium diacetate and calcium acetate as preservatives for feed for all animal species

Tuesday, February 14th, 2012

Published on:

14 February 2012

Acetic acid, calcium acetate and sodium diacetate are listed in the EU Register of Feed Additives as preservatives for use with feed for all animal species without restrictions. There is now an application for the re-authorisation of acetic acid and these salts as preservatives in feed and for a new use of acetic acid as preservative in water for drinking. They may be used alone or in combination with other organic acids typically in a concentration 200 to 2,500 mg acetate/kg complete feedingstuffs. Acetic acid and its salts are considered equivalent when compared on a molar basis. Based on the comparison between consumer and target animals exposure to acetic acid and the limited experimental data available for chickens and the dogs fed diets containing acetate, a maximum concentration of 2,500 mg acetic acid/kg complete feed (or 1000 mg/L water for drinking) is considered safe for poultry, pigs and pet animals. The tolerance of ruminants is considerably higher. No data is available for salmonids. Given the complete and rapid metabolism of acetate, the use of acetate in animal nutrition is not expected to contribute to human exposure. Acetic acid and its salts are bulk industrial chemicals and the hazards for those handling these substances are well known and documented. Acetates are normal components of the diet of humans and animals and are produced in molar quantities in the gastrointestinal tract. They are fully metabolised and so do not pose a risk to the environment. Acetic and its salts have the potential to act as preservatives in feedingstuffs and water for drinking.

© European Food Safety Authority, 2012

Scientific Opinion on the safety and efficacy of acetic acid, sodium diacetate and calcium acetate as preservatives for feed for all animal species


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Scientific Opinion on ammonium chloride (Amoklor) for lambs for fattening

Tuesday, February 14th, 2012

Published on:

14 February 2012

Ammonium chloride when used in feedingstuffs reduces the urinary pH and the formation of urinary calculi of target animals. Amoklor contains 99  % ammonium chloride. Ammonium chloride in complete diet for lambs for fattening at the maximum dose of 1  % is considered safe for a limited period of feeding (approximately three months), the margin of safety being small (≤1.5). No residues of the parent compound and its ions are expected in organs and tissues of the target animal when fed ammonium chloride. A withdrawal period is not necessary. In the absence of data and taking into account the limited information from the material safety data sheet, ammonium chloride should be considered as an irritant to skin, eyes, the digestive and respiratory tracts and as a dermal and respiratory sensitiser. The use of ammonium chloride at the maximum level of 1  % in feedingstuffs for lambs for fattening does not pose a risk for the environment. The FEEDAP Panel concluded that the effective dose for lambs for fattening is 1  % in complete feedingstuffs. The FEEDAP Panel recommended restricting the use of the additive to a maximum period of three months.

© European Food Safety Authority, 2012

Scientific Opinion on ammonium chloride (Amoklor) for lambs for fattening


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Conclusion on the peer review of the pesticide risk assessment of the active substance hydrolysed proteins

Monday, February 13th, 2012

Published on:

13 February 2012

Conclusion on the peer review of the pesticide risk assessment of the active substance hydrolysed proteins


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Conclusion on the peer review of the pesticide risk assessment of the active substance extract from tea tree

Monday, February 13th, 2012

Published on:

13 February 2012

Conclusion on the peer review of the pesticide risk assessment of the active substance extract from tea tree


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Reasoned opinion of EFSA: Modification of the existing MRLs for phosmet in various crops

Monday, February 13th, 2012

Published on:

13 February 2012

Reasoned opinion of EFSA: Modification of the existing MRLs for phosmet in various crops


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Scientific Opinion on Lactiferm® (Enterococcus faecium) as a feed additive for weaned piglets and calves

Friday, February 10th, 2012

Published on:

10 February 2012

Lactiferm® is a feed additive containing viable cells of Enterococcus faecium. It is currently authorised for use in piglets and calves and provisionally authorised for its use in chickens for fattening in powder and coated forms. The applicant is requesting the authorisation of a new water-miscible form of the product, and the renewal of the powder form and the withdrawal of the coated form. Lactiferm® is intended for use at a range of 5 x 108 – 2 x 1010 CFU/kg feedstuffs. It is also intended to be used in water for drinking for piglets in the range of 2 x 108 to 8 x 109 CFU/L water. E. faecium NCIMB 11181 does not contain marker genes typical of hospital associated isolates responsible for clinical infections and does not harbour acquired genes coding for antibiotic resistance. Lactiferm® is safe for weaned piglets and calves at the recommended dose range. Since neither the active agent nor the other components of the additive give rise to concerns, the FEEDAP Panel considers the use of the additive safe for consumers. Given the lack of specific information and its proteinaceous nature and the high dusting potential, in particular of the water soluble form, Lactiferm® should be considered to have the potential to be an irritant to eye and skin and a skin/respiratory sensitiser. E. faecium is a natural component of gut microbiota and its use as Lactiferm® in animal feeding would not be expected to pose any additional risk for the environment. Lactiferm® is efficacious in improving zootechnical performance of piglets and calves. The minimum effective dose for piglets is in the order of 1 x 1010 CFU/kg feed and for calves in the region of 2 x 109 CFU/kg milk replacer. The FEEDAP Panel considers evidence of efficacy to be independent of route of delivery provided that the same dose is given.

© European Food Safety Authority, 2012

Scientific Opinion on Lactiferm® (Enterococcus faecium) as a feed additive for weaned piglets and calves


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Scientific Opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations of plant protection products in soil

Friday, February 10th, 2012

Published on:

10 February 2012

Based on consultation with Member States, EFSA asked the Panel to prepare a revision of the Guidance Document on the persistence of plant protection products in soil (SANCO/9188VI/1997 of 12 July 2000) as scientific knowledge in this field has evolved in recent years. Therefore the Panel developed a revised methodology for the assessment of exposure of soil organisms to such products. Based on a previous Opinion of the Panel, this methodology has been developed both for the concentration in total soil and the concentration in the soil pore water. The goal of the exposure assessment has been chosen to be the 90th percentile of the exposure concentration in the intended area of use in each of the three regulatory geographical zones (North, Centre, South). The exposure-assessment methodology is restricted to spray applications to annual crops under conventional or reduced tillage (excluding tillage systems with ridges and furrows). The Panel proposes a tiered approach. Tier 1 is based on a simple analytical model. Tier 2A is based on simulations with numerical models. To keep the approach as simple as possible, the Panel based Tiers 1 and 2A for each regulatory zone on only one scenario each for the concentration in total soil and for that in pore water. These scenarios are to be used for all these annual crops and for all plant protection products in each regulatory zone. Tiers 2B and 2C are also based on the simple analytical model but in these tiers a specific crop or crop group and an individual plant protection product are considered. Tier 3 is based on simulations with numerical models but, as in Tiers 2B and 2C, a specific crop or crop group and a specific plant protection product are considered. All tiers aim to assess the same exposure assessment goal. Given the complexity of the calculations in the different tiers, efficient use of this tiered approach in the regulatory process is impossible without software tools. Therefore the Panel recommends developing user-friendly software tools for the calculation of the exposure concentrations in the different tiers.

© European Food Safety Authority, 2012

Scientific Opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations of plant protection products in soil


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Reasoned opinion of EFSA: Modification of the existing MRLs for bifenazate in currants (red, black and white), blackberries and raspberries

Thursday, February 9th, 2012

Published on:

9 February 2012

Reasoned opinion of EFSA: Modification of the existing MRLs for bifenazate in currants (red, black and white), blackberries and raspberries


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Report on the safety analysis of oilseed rape GT73 pollen in food or as food

Wednesday, February 8th, 2012

Published on:

8 February 2012

Report on the safety analysis of oilseed rape GT73 pollen in food or as food


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Report on the safety analysis of oilseed rape Ms8 x Rf3 pollen in food or as food

Wednesday, February 8th, 2012

Published on:

8 February 2012

Report on the safety analysis of oilseed rape Ms8 x Rf3 pollen in food or as food


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"Schmallenberg" virus: likely epidemiological scenarios and data needs

Wednesday, February 8th, 2012

Published on:

8 February 2012

Following a request from the European Commission, the European Food Safety Authority (EFSA) issued a technical report on likely epidemiological scenarios in Europe in relation to a recently detected virus provisionally named "Schmallenberg" (SBV) virus (Simbu serogroup, Bunyaviridae family, genus Orthobunyavirus), found in ruminants. Clinical signs in adults are mainly mild or non-existent, but transient fever, loss of appetite, a reduction in milk yield and diarrhoea have been observed in association with the infection. The major clinical sign of SBV is congenital malformations in newborn animals similar to those observed in infections by Akabane virus. Germany, the Netherlands, Belgium, France and United Kingdom have reported confirmed cases. Due to limited information on the epidemiology of SBV, EFSA used a bluetongue virus (BTV8) model to assess whether SBV can spread into susceptible populations. BTV8 was chosen because: i) other Simbu serogroup viruses are primarily vector transmissible diseases as is BTV8, ii) BTV8 and SBV are circulating in the ruminant population iii) information is available regarding BTV8 in Europe whereas there has only been one case report for viruses of the Simbu serogroup in European Member States. The scenarios illustrate that whenever the number of vectors per host and the temperature are above a specific threshold, there is a possibility of disease epidemic in a susceptible population. In order to assess the situation in Europe and to refine the possible spread scenarios, knowledge of putative risk factors relevant for the disease transmission is necessary (including the immune status of the EU animal populations). EFSA proposes a coordinated data collection in all Member States in 2012 on the incidence and prevalence of the disease, number of malformed foetuses, as well as the presence of the virus in dams. Current knowledge suggests that it is unlikely that SBV can cause disease in humans; EFSA and ECDC are closely monitoring the situation in order to address public health concerns should these arise. EFSA will provide an overall assessment of the impact of SBV infection on animal health and welfare once further data become available from Member States.

© European Food Safety Authority, 2012

"Schmallenberg" virus: likely epidemiological scenarios and data needs


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Implementation of Electronic Transmission of Chemical Occurrence Data (CFP/EFSA/DATEX/2010/01) in Latvia

Monday, February 6th, 2012

This external report is the output from a scientific or technical project that EFSA has funded to support its work in accordance with Article 36 of EFSA?s Founding Regulation. It was produced by the beneficiaries of an EFSA grant following a call for proposal published on the EFSA website. For more information on this procedure see Article 36 cooperation. It is published complying with the transparency principle to which EFSA is subject and cannot be considered as an output adopted by EFSA. EFSA reserves its rights, view and position as regards the issues addressed and conclusions reached in the present document, without prejudice to the rights of the authors.

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6 February 2012

The present report describes the results, resources used, benefits gained and challenges met in restructuring the chemical occurrence data system of Food and Veterinary Service of Latvia that forms national data bank for chemical contaminants and pesticides in order to implement and test an electronic system for the transmission of chemical occurrence data to European Food Safety Agency according to standards.

Implementation of Electronic Transmission of Chemical Occurrence Data (CFP/EFSA/DATEX/2010/01) in Latvia


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Electronic Transmission of Chemical Occurrence Data in Romania

Monday, February 6th, 2012

This external report is the output from a scientific or technical project that EFSA has funded to support its work in accordance with Article 36 of EFSA?s Founding Regulation. It was produced by the beneficiaries of an EFSA grant following a call for proposal published on the EFSA website. For more information on this procedure see Article 36 cooperation. It is published complying with the transparency principle to which EFSA is subject and cannot be considered as an output adopted by EFSA. EFSA reserves its rights, view and position as regards the issues addressed and conclusions reached in the present document, without prejudice to the rights of the authors.

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6 February 2012

The present report describes the solution proposed by the team of the Dunarea de Jos University of Galati, Romania, to the National Sanitary Veterinary and Food Safety Authority to address the collection and transmission to EFSA of the contaminants occurrence data. The specialized software for data recording is explained and the procedure to collect data at national level is described; the transmission system of the data to EFSA is also presented. All these products were developed under the grant offered by EFSA, and are now in function, after having been tested successfully.

Electronic Transmission of Chemical Occurrence Data in Romania


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Reasoned opinion of EFSA: Modification of the existing MRLs for oxadixyl in parsley, celery and leek

Friday, February 3rd, 2012

Published on:

3 February 2012

Reasoned opinion of EFSA: Modification of the existing MRLs for oxadixyl in parsley, celery and leek


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Scientific Opinion on Flavouring Group Evaluation 21, Revision 3 (FGE.21Rev3): Thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

Thursday, February 2nd, 2012

Published on:

2 February 2012

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 59 flavouring substances in the Flavouring Group Evaluation 21, including an additional three substances in this Revision 3, using the Procedure in Commission Regulation (EC) No 1565/2000. Since the publication of the last revision of this FGE, the EFSA has been requested to evaluate three additional substances [FL-no: 15.057, 15.079 and 15.135], which have been included in the present revision of FGE.21. Seven of the substances [FL-no: 15.060, 15.086, 15.090, 15.099, 15.114, 15.119 and 15.133] were considered to have genotoxic potential. The remaining 52 substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that 26 substances [FL-no: 15.038, 15.039, 15.044, 15.050, 15.051, 15.052, 15.058, 15.061, 15.062, 15.063, 15.067, 15.068, 15.069, 15.071, 15.078, 15.080, 15.082, 15.084, 15.085, 15.087, 15.089, 15.098, 15.108, 15.115, 15.116 and 15.118] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For the remaining 26 candidate substances [FL-no: 15.037, 15.040, 15.042, 15.043, 15.045, 15.054, 15.055, 15.057, 15.064, 15.070, 15.072, 15.074, 15.076, 15.077, 15.079, 15.088, 15.091, 15.092, 15.093, 15.094, 15.096, 15.097, 15.106, 15.107, 15.129 and 15.135] evaluated through the Procedure, no appropriate NOAEL was available and additional data are required. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. For one substance [FL-no: 15.129], evaluated using the Procedure, an identity test is lacking and for four substances [FL-no: 15.042, 15.057, 15.079 and 15.135] the stereoisomeric composition has not been specified sufficiently.

© European Food Safety Authority, 2012

Scientific Opinion on Flavouring Group Evaluation 21, Revision 3 (FGE.21Rev3): Thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30


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Scientific Opinion on Flavouring Group Evaluation 08, Revision 4 (FGE.08Rev4): Aliphatic and alicyclic mono-, di-, tri-, and polysulphides with or without additional oxygenated functional groups from chemical groups 20 and 30

Thursday, February 2nd, 2012

Published on:

2 February 2012

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 80 flavouring substances in the Flavouring Group Evaluation 08, Revision 4, using the Procedure in Commission Regulation (EC) No 1565/2000. Since the publication of the last revision of this FGE, the EFSA has been requested to evaluate 10 additional substances, which have been included in the present revision of FGE.08. For the substances methyl methanethiosulphonate [FL-no: 12.159], 2-methylbutane-2-thiol [FL-no: 12.172], 2-methylpropane-2-thiol [FL-no: 12.174], ethyl-2-mercapto-2-methyl propanoate [FL-no: 12.304] and 2,4,4-trimethyl-1,3-oxathiane [FL-no: 16.057] there is an indication of a genotoxic potential in vitro. Therefore, in the absence of further genotoxicity data, the Panel concluded that the Procedure could not be applied to these five substances. For four substances, 3-mercaptooctanal [FL-no: 12.268], 3-mercaptodecanal [FL-no: 12.269], methanedithiol diacetate [FL-no: 12.271] and 3,5-dimethyl-1,2-dithiolane-4-one [FL-no: 12.295] no data on use as flavouring substances in Europe are available. Therefore, no intakes in Europe can be estimated and accordingly the Panel concluded that the Procedure could not be applied to these four substances either. The remaining 71 substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that 57 substances do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For the remaining fourteen substances [FL-no: 12.093, 12.094, 12.097, 12.100, 12.112, 12.116, 12.120, 12.164, 12.167, 12.199, 15.007, 15.102 and 15.125 and 15.134], evaluated through the Procedure, no appropriate NOAEL was available and additional data are required. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and for 21 substances, evaluated through the Procedure, information on the stereoisomeric/positional composition and/or the specifications is lacking.

© European Food Safety Authority, 2012

Scientific Opinion on Flavouring Group Evaluation 08, Revision 4 (FGE.08Rev4): Aliphatic and alicyclic mono-, di-, tri-, and polysulphides with or without additional oxygenated functional groups from chemical groups 20 and 30


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Technical report on the use of Excel/XML files for submission of data to the Zoonoses system

Wednesday, February 1st, 2012

Published on:

1 February 2012

This report summarises the technical aspects and the requirements to be considered in future implementation of XML and Excel submission to EFSA of data on zoonoses, antimicrobial resistance, animal population and food-borne outbreaks in accordance to Directive 2003/99/EC. It applies to aggregated and sample-based data, and defines the practical support expected by the Member States in this exercise. In order to move to ‘one-single’ reporting system maintained by EFSA, it suggests to use the EFSA’s Data Collection Framework tool and to adopt the exchange protocols as defined in the “EFSA’s Guidance on Data Exchange”. It highlights the need to keep and maintain the Zoonoses Web Reporting Application until full automatic transmission is in place in all the Member States and summarises the outcomes of the pilot on AMR isolate-based data submission run in 2011 including some suggestion on how to extend the ‘EFSA Standard Sample Description (SSD)’ model to support the collection of AMR isolate-based data.

© European Food Safety Authority, 2012

Technical report on the use of Excel/XML files for submission of data to the Zoonoses system


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A pilot with volunteering reporting countries on submission of antimicrobial resistance isolate-based data in Excel and XML formats using the Data Collection Framework

Wednesday, February 1st, 2012

Published on:

1 February 2012

A pilot with volunteering reporting countries on submission of antimicrobial resistance isolate-based data in Excel and XML formats using the Data Collection Framework


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