欧盟-NO618-1新型食品和新型食品配料和编制的初步评估报告根据法规VIP专享VIP免费

第1页共36页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第1页共36页COMMISSIONRECOMMENDATIONof29July1997concerningthescientificaspectsandthepresentationofinformationnecessarytosupportapplicationsfortheplacingonthemarketofnovelfoodsandnovelfoodingredientsandthepreparationofinitialassessmentreportsunderRegulation(EC)No258/97oftheEuropeanParliamentandoftheCouncil(TextwithEEArelevance)(97/618/EC)THECOMMISSIONOFTHEEUROPEANCOMMUNITIES,HavingregardtotheTreatyestablishingtheEuropeanCommunity,HavingregardtoRegulation(EC)No258/97oftheEuropeanParliamentandoftheCouncilof27January1997concerningnovelfoodsandnovelfoodingredients(1),andinparticularArticle4(4)thereof,Whereas,inordertoprotectpublichealth,itisnecessarythatnovelfoodsandnovelfoodingredientsaresubjecttoasinglesafetyassessmentthroughaCommunityprocedurebeforetheyareplacedonthemarketwithintheCommunity;Whereasrecommendationsconcerningthescientificaspectsoftheinformationnecessarytosupportanapplicationfortheplacingonthemarketofanovelfoodoranovelfoodingredientwillfacilitatethetaskofeconomicoperatorsinpreparingsuchanapplication;whereasrecommendationsconcerningthepresentationofsuchinformationandconcerningthepreparationofinitialassessmentreportsbythecompetentfoodassessmentbodiesoftheMemberStateswillfacilitatetheevaluationofsuchapplications;WhereastheScientificCommitteeforFoodhasmaderecommendationsontheinformationnecessarytosupportsuchapplications,thepresentationofthatinformationandthepreparationofinitialassessmentreportsonthoseapplications;Whereasexperienceintheassessmentofnovelfoodsandnovelfoodingredientsisatpresentlimited;whereasthereforeanyrecommendationsinthisareamustbekeptunderconstantreviewtotakeaccountofnewscientificinformationandtheworkoftherelevantinternationalorganizations;WhereastheMemberStateshavebeenconsultedonthisRecommendationwithintheframeworkoftheStandingCommitteeforFoodstuffs,第2页共36页第1页共36页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第2页共36页HEREBYRECOMMENDSTHAT:1.Whenpreparingapplicationsfortheplacingonthemarketofnovelfoodsandnovelfoodingredients,economicoperatorsshouldfollowtherecommendationsconcerningthescientificaspectsoftheinformationnecessarytosupportsuchapplicationssetoutintheAnnex,PartI.附錄Part1，當準備進軍NF、NF成分到市場，經濟經營者(企業)應遵循科學方面提供必要的資料，以支持這些應用2.Economicoperatorsshouldensurethattheinformationnecessarytosupportapplicationsreferredtoinpoint1ispresentedinaccordancewiththerecommendationssetoutintheAnnex,PartII.附錄Part2，說明依第一點，企業要保證支持申請文件的資料3.MemberStatesshouldensurethattheinitialassessmentreportsdrawnupbytheircompetentfoodassessmentbodiespursuanttoArticle6(2)ofRegulation(EC)No258/97arepreparedinaccordancewiththerecommendationssetoutintheAnnex,PartIII.附錄Part3，會員國的主管單位依Article6(2)ofRegulation(EC)No258/97來要求各項最初的評估報告。DoneatBrussels,29July1997.FortheCommissionMartinBANGEMANNMemberoftheCommission(1)OJL43,14.2.1997,p.1.第3页共36页第2页共36页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第3页共36页ANNEX附件PARTIRECOMMENDATIONSCONCERNINGTHESCIENTIFICASPECTSOFINFORMATIONNECESSARYTOSUPPORTAPPLICATIONSFORTHEPLACINGONTHEMARKETOFNOVELFOODSANDNOVELFOODINGREDIENTS附錄Part1，關於支持新食物及其成份的市場所需的科學資料建議。TABLEOFCONTENTSPage1.Introduction.42.Categoriesofnovelfoodsandnovel...