eval_next_word_efsa.json

[{"prefix":"and ‘ food enzyme preparation ’ . ‘ Food","next-word":"enzyme"},{"prefix":"QPS Qualified presumption of safety SDS – PAGE sodium dodecyl sulfate – polyacrylamide gel electrophoresis TOS Total Organic Solids WHO World Health","next-word":"Organization"},{"prefix":"food for a technological purpose at any stage of the manufacturing , processing , preparation , treatment , packaging","next-word":","},{"prefix":"Organization of the United Nations GMO genetically modified organism IUBMB International Union of Biochemistry and Molecular Biology JECFA Joint FAO/WHO Expert Committee on Food Additives LOD limit of detection MIC","next-word":"minimum"},{"prefix":"European Union market and intended to remain on that market , as well as all new food enzymes , shall be subjected to a safety evaluation by the European Food Safety","next-word":"Authority"},{"prefix":"‘ Food enzyme preparation ’ means a formulation consisting of one or more food enzymes in which substances such as food additives and/or other food ingredients","next-word":"are"},{"prefix":"European Union ( EU ) procedures for the safety assessment and the authorisation procedure","next-word":"of"},{"prefix":"Nations GMO genetically modified organism IUBMB International Union of Biochemistry and Molecular Biology JECFA Joint FAO/WHO Expert Committee on Food Additives LOD limit of detection MIC minimum inhibitory concentration PCR polymerase chain reaction","next-word":"RAU"},{"prefix":"‐ 2EINECS No : 232 ‐ 565 ‐ 6.α ‐ Amylase catalyses the hydrolysis of 1,4 ‐ α ‐ glucosidic linkages in starch ( amylose and amylopectin ) , glycogen and related polysaccharides and oligosaccharides , resulting in the generation of soluble dextrins and other malto","next-word":"‐"},{"prefix":"biochemical reaction ; and ( ii ) added to food for a technological purpose at any stage of the manufacturing , processing , preparation , treatment ,","next-word":"packaging"},{"prefix":"use does not mislead the consumer . All food enzymes currently on the European Union market and intended to remain on that market , as well as all new food enzymes , shall be subjected to a safety evaluation by the European","next-word":"Food"},{"prefix":"ingredients are incorporated to facilitate their storage , sale , standardisation , dilution or dissolution.Before January 2009 , food enzymes other than those used as food additives were not regulated","next-word":"or"},{"prefix":"on Food Contact Materials , Enzymes and Processing Aids DNA Deoxyribonucleic acid DSMZ Deutsche Sammlung von","next-word":"Mikroorganismen"},{"prefix":"the legislation of the Member States. On 20 January 2009 , Regulation ( EC ) No 1332/2008 on food enzymes came into force. This Regulation applies to enzymes that are added to food to perform a technological function","next-word":"in"},{"prefix":"six glucosyl units.The food enzyme contains DNA from the production strain , which harbours genes conferring resistance to two highly important antimicrobials for human and veterinary medicine in a self ‐ replicating multicopy plasmid. Therefore , the enzyme α ‐ cyclodextrin","next-word":"glucanotransferase"},{"prefix":"intended to be used in starch processing for the production of α ‐ cyclodextrin , which consists of six glucosyl units.The food enzyme contains DNA from the production","next-word":"strain"},{"prefix":"5EINECS No. : 618 ‐ 522 ‐ 8The α ‐ cyclodextrin glucanotransferase catalyses the transglycosylation of glucans by the formation of a ( 1 → 4 ) ‐ α ‐ d ‐ glucosidic bond , resulting in","next-word":"the"},{"prefix":"Materials , Enzymes and Processing Aids DNA Deoxyribonucleic acid DSMZ Deutsche Sammlung von Mikroorganismen und Zellkulturen GMbH EINECS European Inventory of Existing Commercial Chemical Substances FAO Food and Agricultural Organization of the United Nations GLP Good Laboratory Practice GMO Genetically modified organism","next-word":"IUBMB"},{"prefix":"proprietary enzyme is not for sale to third parties . Technical dossier ‘ Alpha ‐ cyclodextrin glucanotransferase ’ . March 2015 , submitted by Bioresco","next-word":"Ltd"},{"prefix":"enzyme contains DNA from the production strain , which harbours genes conferring resistance to two highly","next-word":"important"},{"prefix":", which were included in the challenge test , are critical for the decontamination efficiency.The Panel considered that the recycling process Somoplast ‐ Riachi &","next-word":"Co"},{"prefix":"Processing Aids Cmod modelled concentration in PET Cres residual concentrations","next-word":"in"},{"prefix":"( ethylene terephthalate ) SSP solid ‐ state","next-word":"polycondensation"},{"prefix":"PET are not intended to be used in microwave and conventional ovens and such","next-word":"uses"},{"prefix":"recommended periodic verification that the input material to be recycled originates from materials and articles that have been manufactured in accordance with the EU legislation","next-word":"on"},{"prefix":"that the recycling process Somoplast ‐ Riachi & Co is able to reduce foreseeable accidental contamination of post ‐ consumer food contact PET to a concentration that does not give rise to concern for a risk to human health if : it is operated under conditions that","next-word":"are"},{"prefix":"in the challenge test used to measure the decontamination efficiency of the process ; the input material of the process is washed and dried post ‐ consumer PET flakes originating from materials and articles that have been","next-word":"manufactured"},{"prefix":"legislation on food contact materials and contain no more than 5 % of PET from non ‐ food consumer applications . the recycled PET obtained from the process Somoplast ‐ Riachi & Co is used at up to 100 % for the manufacture of","next-word":"materials"},{"prefix":"decontamination efficiency of the process ; the input material of the process is washed and dried post ‐ consumer PET flakes originating from materials and articles that have been","next-word":"manufactured"},{"prefix":"documentation should be available on how it is ensured that the critical steps are operated under conditions at least as severe as those in the challenge test used to measure","next-word":"the"},{"prefix":"is used at up to 100 % for the manufacture of materials and articles for contact with all types of foodstuffs for long ‐ term storage at room temperature , with or without hotfill . The final articles made of this","next-word":"recycled"},{"prefix":"‐ consumer PET flakes originating from materials andb articles that have been manufactured in accordance with the EU legislation on food contact materials and contain no","next-word":"more"},{"prefix":"articles for contact with all types of foodstuffs for long ‐ term storage at room temperature , with or without hotfill . The final articles made of this recycled PET are not intended","next-word":"to"},{"prefix":"evaluation.The Panel recommended periodic verification that the input material","next-word":"to"},{"prefix":"Hagner ’ . March 2020. Submitted on behalf of sicht ‐ pack Hagner GmbH , Germany . Bw body weight CEF Panel Panel on Food Contact Materials , Enzymes , Flavourings and Processing Aids CEP Panel Panel on Food Contact Materials","next-word":","},{"prefix":"recycled PET are not intended to be used in microwave","next-word":"and"},{"prefix":"step 3 ) , which were included in the challenge test , are critical for","next-word":"the"},{"prefix":"Aids Cmod modelled concentration in PET Cres residual concentrations in PET PET poly ( ethylene terephthalate ) PVC poly ( vinyl chloride ) rPET recycled poly ( ethylene","next-word":"terephthalate"},{"prefix":"human health if : it is operated under conditions that are at least as severe as those applied in the challenge test used to measure the decontamination efficiency of the process ; the input material","next-word":"of"},{"prefix":"decontamination efficiency.The Panel considered that the recycling process sicht ‐ pack Hagner is able to reduce foreseeable accidental contamination of post ‐ consumer food contact PET to a concentration that does not","next-word":"give"},{"prefix":"( RMS ) , Denmark , and co ‐ rapporteur Member State ( co ‐ RMS ) , the","next-word":"Netherlands"},{"prefix":"two Cry ‐ like proteins and one vegetative insecticidal protein ( VIP 3Aa10 ) . Furthermore , Bacillus thuringiensis subsp. kurstaki strain SA ‐","next-word":"12"},{"prefix":"the intended uses. However , it is noted that a validated enumeration method in high water commodities","next-word":"("},{"prefix":"SA ‐ 12 during its development , manufacture , preparation or field application have been documented or reported. The results of allergenicity observations indicate","next-word":"that"},{"prefix":"not provided. The applicant chose to address the representative use on protected","next-word":"tomato"},{"prefix":"be expected to meet the approval criteria provided for in Article 4 of Regulation ( EC ) No 1107/2009 within 5 months from the end of the period provided for the submission of written comments , subject to an extension","next-word":"of"},{"prefix":"to 2.2 × 107 CFU/g ) considering representative uses demonstrate that counts at harvest exceed this threshold. Since samples in the lettuce study were stored at ‐ 18 ° C prior to analysis , a storage stability of Bacillus thuringiensis subsp. kurstaki strain","next-word":"SA"},{"prefix":"( issue not finalised ) while the use of respiratory protective equipment is recommended for operators and workers.Bacillus","next-word":"thuringiensis"},{"prefix":"the lettuce study were stored at ‐ 18 ° C prior to analysis , a storage stability of Bacillus thuringiensis subsp. kurstaki strain SA ‐ 12 in high ‐ water commodities is still","next-word":"required"},{"prefix":"without prejudice to the provisions of Article 56 of Regulation ( EC ) No 1107/2009 concerning information on potentially harmful effects ) . Further assessment of potential health effects","next-word":"after"},{"prefix":"represented 7 % of the acceptable daily intake ( ADI ) for the diets DE child","next-word":"and"},{"prefix":"currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues ( European Commission , 1997a , b , c d , e , f , g , 2000 , 2010a , b , 2017b ; OECD , 2008 , 2011 ,","next-word":"2013"},{"prefix":"provisions , EFSA shall base its reasoned opinion in particular on the relevant assessment report prepared under Directive 91/414/EEC repealed by Regulation ( EC ) No 1107/2009. It should be noted , however , that , in","next-word":"the"},{"prefix":"report ( DAR ) prepared under Council Directive 91/414/EEC ( Spain , 2006 ) ; the final addendum of the additional","next-word":"report"},{"prefix":"DAR draft assessment report DAT days after treatment DB dietary burden DM dry","next-word":"matter"},{"prefix":"in the framework of this review was calculated using revision 3.1 of the EFSA PRIMo. For globe artichoke where data were insufficient to","next-word":"derive"},{"prefix":"EURLs for commenting via a written procedure. All comments received by 4 August 2020 were considered by EFSA during the finalisation of the reasoned opinion.The evaluation","next-word":"report"},{"prefix":"and its main metabolite is reported in Appendix F.The approval of oxyfluorfen is restricted to uses as herbicide for banded applications close to ground from autumn to early spring , at a rate not exceeding 150 g a.s./ha per year","next-word":"("},{"prefix":"exposure calculations for all crops reported in the framework of this review performed using the EFSA Pesticide Residues Intake","next-word":"Model"},{"prefix":"for the diets DE child and NL toddler ; the highest acute exposure amounted to 0.5 % of the ARfD for pears. Although uncertainties remain due to the data gap identified , the indicative exposure calculation did not indicate a risk to","next-word":"consumer's"},{"prefix":"initial commenting phase to the conclusion. The peer review report comprises the following documents , in which all views expressed during the course of the peer review , including minority views , where applicable , can be found : the comments received","next-word":"on"},{"prefix":"for consultation and comments on 8 August 2019. EFSA also provided comments. In addition , EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments","next-word":"received"},{"prefix":"the end of the comment evaluation phase and which required further consideration , including those issues to be considered in an expert consultation , were compiled by EFSA in the format of an evaluation table.The conclusions arising from the consideration by EFSA , and as","next-word":"appropriate"},{"prefix":"batches complies with the requirements of SANCO/12116/2012 rev.0 ( European Commission , 2012 ) .The optimum temperature of growth of Metarhizium brunneum BIPESCO 5/F52 ranged from 27 ° C to 30 ° C. Growth was limited at","next-word":"34"},{"prefix":"BIPESCO 5/F52 is unlikely to interfere with the methodologies routinely used for such determinations.Being a mitotic asexual fungus ( no sexual recombination or meiosis having been observed in its life","next-word":"cycle"},{"prefix":"to respond to the comments in column 3 of the reporting table. The comments and the applicants ’ response were evaluated by the RMS in column 3.The need for expert consultation and the necessity for additional information to be submitted by the applicants in accordance","next-word":"with"},{"prefix":"renewal of approval of the active substance Metarhizium brunneum BIPESCO 5/F52. Complying with Article 8 of the Regulation , the RMS checked","next-word":"the"},{"prefix":"sufficient insecticidal and acaricidal efficacy against the target organisms.The assessment of the data package revealed no issues that need to be included as critical areas of concern with respect to the identity","next-word":"of"},{"prefix":"consumer exposure to viable residues of Metarhizium brunneum BIPESCO 5/F52 is not necessary.However ,","next-word":"due"},{"prefix":"no issues that need to be included as critical areas of concern with respect to the identity of the active substance , physical and technical properties of the representative formulations ; however , data","next-word":"gaps"},{"prefix":"is considered a risk to persons handling the additive. Since the lack of genotoxic potential","next-word":"of"},{"prefix":"FEEDAP Panel was not able to conclude on the safety of STENOROL ® for chickens and turkeys for fattening at the highest proposed use level of 3 mg halofuginone HBr/kg complete feed. No incompatibilities or interactions with feedingstuffs , carriers , other approved additives or","next-word":"medicinal"},{"prefix":"EC50 median effective concentration ErC50 median effective concentration which results in 50","next-word":"%"},{"prefix":"line with Article 8 ( 1 ) ( 2 ) of Regulation ( EC ) No 1831/2003. Issues : Characterisation ,","next-word":"Safety"},{"prefix":"as active substance when used as a coccidiostat feed additive in chickens for fattening and turkeys.The FEEDAP Panel is not able to conclude on the safety of STENOROL ® for chickens and turkeys for fattening at the highest proposed use level of 3","next-word":"mg"},{"prefix":"the applicant – Methods of analysis 29/07/2015 Reception of the Evaluation report of the European Union Reference Laboratory for Feed Additives 19/08/2016 Reception of supplementary","next-word":"information"},{"prefix":"and efficacy studies 27/01/2020 Reception of reply to clarification request including additional information 01/07/2020 Opinion adopted by the FEEDAP Panel. End of the Scientific assessment 30/09/2020 Opinion withdrawn by the FEEDAP Panel. Amended","next-word":"opinion"},{"prefix":"Halofuginone HBr does not have antimicrobial activity at the highest dose proposed ; it is not expected to exert adverse effects on chicken","next-word":"gut"},{"prefix":"weight DT50 disappearance time 50 ( the time within","next-word":"which"},{"prefix":"and ocular routes and is very irritant to both the eye and the","next-word":"skin."},{"prefix":"by the identified hazards should be put in place.Finally , outcome tables linking all the elements ( welfare hazards , origin of hazards , preventive and corrective measures , welfare consequences and related","next-word":"ABMs"},{"prefix":"and produced a list containing the possible welfare hazards of each process related to the slaughter of cattle. To address the ToRs , experts identified the origin of each hazard ( ToR ‐ 1 ) and related preventive and corrective measures ( ToR ‐ 3 )","next-word":","},{"prefix":"Opinion.To spare cattle from severe welfare consequences , a standard operating procedure ( SOP ) should include identification of hazards and related welfare consequences , using relevant","next-word":"ABMs"},{"prefix":"EFSA AHAW Panel , 2013 ) .In parallel , since 2005 , the World Organisation for Animal Health ( OIE ) has developed two chapters in its Terrestrial Animal Health Code : i ) Slaughter of animals ( Chapter 7.5 ) , and ii ) Killing","next-word":"of"},{"prefix":"to assess qualitatively or quantitatively these welfare consequences. Lists and","next-word":"definitions"},{"prefix":"Code : i ) Slaughter of animals ( Chapter 7.5 ) , and ii ) Killing","next-word":"of"},{"prefix":"World Organisation for Animal Health ( OIE ) has developed two chapters in its Terrestrial Animal Health Code : i ) Slaughter of animals ( Chapter 7.5 ) , and ii ) Killing","next-word":"of"},{"prefix":"‐ negative ( existing but not ‐ included ) hazards.As this Opinion will be used by the European Commission to address the OIE standards , more methods for","next-word":"slaughter"},{"prefix":"welfare aspects. It has to be noted that methods , procedures or practices cannot be subjected to a risk assessment procedure if there is no published scientific evidence related to them. Chapter 7.5.10 of the OIE Terrestrial Animal Health Code includes a","next-word":"list"},{"prefix":"for assessing the welfare consequences have been provided in this Opinion. ABMs for the assessment of all the welfare consequences have been identified","next-word":","},{"prefix":"conditions of authorisation.The identity of the active agent has been established as Bacillus velezensis ATCC PTA ‐ 6737 and the strain does not show acquired antimicrobial resistance determinants for antibiotics of human and veterinary interest. Following the QPS approach to","next-word":"safety"},{"prefix":"the stain 19/03/2020 Reception of supplementary information from the applicant ‐ Scientific assessment re ‐ started 30/09/2020 Opinion adopted by the FEEDAP Panel. End of the Scientific assessment ATCC American Type Culture Collection EURL European Union Reference","next-word":"Laboratory"},{"prefix":"the QPS approach to safety assessment , the use of the strain as zootechnical additive is considered safe for the target species , consumers and the environment.","next-word":"The"},{"prefix":"minor poultry species ( except for laying purposes ) . The applicant is asking for the renewal of this authorisation , the extension of use to ornamental , sporting and game birds and a modification of the concentration of the product – after standardisation","next-word":"–"},{"prefix":"supplementary information from the applicant ‐ Scientific assessment re ‐ started 18/02/2020 Request of supplementary information to the applicant in line with Article 8 ( 1 ) ( 2 ) of Regulation ( EC ) No 1831/2003 – Scientific assessment suspended. Issues : Characterisation of the stain 19/03/2020","next-word":"Reception"},{"prefix":"stain 19/03/2020 Reception of supplementary information from the applicant ‐","next-word":"Scientific"},{"prefix":"the additive at minimum inclusion level of 1 × 107 CFU/kg feed has the potential to be efficacious in ornamental , sporting and game birds . Date Event 28/02/2019 Dossier received by EFSA. Bacillus subtilis PB6. Submitted by Kemin Europa N.V 06/05/2019 Reception mandate from","next-word":"the"},{"prefix":"the European Commission 05/09/2019 Application validated by EFSA – Start of the scientific assessment 31/10/2017 Request of supplementary information to the applicant in line with Article 8 ( 1 ) ( 2 ) of Regulation ( EC ) No 1831/2003 – Scientific assessment suspended. Issues","next-word":":"},{"prefix":"1 × 107 CFU/kg feed has the potential to be efficacious in ornamental , sporting and game birds . Date Event 28/02/2019 Dossier received by EFSA. Bacillus subtilis PB6. Submitted by Kemin Europa N.V 06/05/2019 Reception mandate from the European","next-word":"Commission"},{"prefix":"‐ 6737 and the strain does not show acquired antimicrobial resistance determinants for antibiotics of human and veterinary interest. Following the QPS approach to safety assessment , the use of","next-word":"the"}]