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...