![Page 1: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/1.jpg)
!"#$%&'()*+,-./012345'(6789:New Plant Breeding Techniques;<1=>4
?@AB:CDEFGHIJK)!"#LMNOPQ;
)!"#$%&'()*+:*+RS(,TU;1VWXYZ[A\]1^_`a:bcPdefgh1i1jklmno=>;)NBT1pq1rs[EUltu.vwxEUyzQ{1|})2011~9�l_��O������NBT�Q�^���)��ltu.=>t��EUltu.=>
)��1��)�r��
![Page 2: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/2.jpg)
!"#$ !"#$!"%$
&'()*+,-.&'()*+/01234567
89:;<1=>?@ABCDE%$F:GHIJHKLMN
OPQR6OPQR6OSQR6
$%&��,*������1�1VWX��
!"#$%&*+ *+RS(1VWX��
![Page 3: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/3.jpg)
¡¢ltu.!"#$%&G(£:LMO;1VWXYZ1�¤1¥$¦)j§
¨©ªF« ¬®¯« °G±²« ³´¯µ« IJ«
IJ¶·��:¸¹7º»;
��¼½�1º» ¯µº»:¬®¯;��VWX
¯µº»:*+¾*+RS(¾¿À+£;
¯µº»:Áµº»;
ÂÃÄÅ��»��xÆÇ1º»)ÈÉ
*+xÆÇ1º»)ÈÉ$%&ÊG(£l�ËÇÌÍ���*+RS(xÆÇ1º»)ÈÉ
ÎÏФÑÒ,ÆÓÔÕµ½º»
Õµ½º»)Ö×ÈÉ
ØÙÚLMO1ÛÜ)ÄÅ£1ÝÞ*+ßGfgJASfl�.}à
ØÙÚLMO1áâPãOä:ÛÜå;:Ö×ÈÉå;
��VWfæç«
LMO,º»Æ�ècéQc1ÌÍ
êëìí
bcPdef
bcPdef
*+ßGf
bcPdef
Àîf
ècéQcîµf
bcPdef
*+VWm¢f
bcPdefbcPdef
*+VWïðñ
bcPdef�òIJ¶·��,óô
![Page 4: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/4.jpg)
NABATA1A³AAõ
)EU�ò¾2007~ö÷¾NBTløù.pq,ú¤¾2011~¾JRC-IPTSxJRC-
IHCP1ûü�¾ýþÿ:New plant breeding techniques : State-of-the-art
and prospects for commercial development;,|}!
)h1"#�ò¾$%&�r}��ÇÔ.q¨g'(,)�.xx*l¾�rñ+<1,-./)0£,óËÇ-�!)1123ò¾451�g67�89�-.*1�òÓo¾$%�pqù.:;<=.x1>qxÓË�!)'?1�1ø@ìlABËÇ*÷Ô¾ªF½pq1¦,ù.:j§h1*1løù.pqòÆÓÔ;1xxÓË�!)¡¢l=ÆÇò¾JRCö÷¾¡¢ö÷1CSì1DEFG<=/¾?@xH@
<CSù.1xxÓË�!)23,IJø@ìlKLƾMp,Æ�N�¾?@xH@<_��O1NOãè�������Q�^���:2011~9�;lCSÆ�!
AAAAAAJRC (the European Commission’s Joint Research Center)
AAAAAAIPTS (Institute for Prospective Technological Studies)
AAAAAAIHCP (Institute for Health and Consumer Prospection)
![Page 5: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/5.jpg)
PQýþÿl=.RSTUVWXYZU[\SS]^Y_U`SabY^cdSe
:¹;f^YaUg^Y_S\UYdaWSXeSUZSabYhWh_i:jkalA;AAAA:mo¾nÁo�yèQpnÁo�yèQpxÆÇ=>;:qmrs,tu��.;AA¹;fvRwx:yz»rs,{Ü�|¾fvR!"#1¦,{Üù.×};AA~;fvRw�:yz»rsxfvR!"#,{Üƾ�qmÒ%ù.×};AA�;fvRw�:���1qmrs,TUyz»rsxfvR!"#,AAAA{Üƾ���1qmrs<©�'�½l{Ü��.×};:~;�W^_hYdaWShZ^]SU]^\SaZS]U�dZX_SYSe^e:���;:fvRw�gfvRw�x��;:�;�^e_SYSe^ex�YZ\X_SYSe^eAAAA:ü7)!"#�%��7�]!"#1¦,{Üù.;AA¹;�^e_SYSe^e:��áQPgPQ��QP£*t�ÆÓÔ;AA~;�YZ\X_SYSe^e:��áQPgPQ��QP£,$¦}��Çt�ù.;:�;�R�w]S�SY]SYZU�R�U�SZbiWXZ^hY:�]��;:��jkalA;AAAA:qmrs,tu��|¾�R�1��cu2�1¦,tu��.;: ;: ;$%&¡,»Ô�¢£¤$%&¡,»Ô�¢£¤:_\XgZ^Y_UhYU¥�U\hhZeZha¦;:§;:§;�S¨S\eSU[\SS]^Y_�S¨S\eSU[\SS]^Y_:Ã]!"#l�ËÇ©ª¡«¬ü$%&£,§Æ�N�¾AAAA®¯Å°£l�ËǼ½!"#,±á�²5³¡,´µù.×}£;
AAAAA:67,¶·u��.<¾6¸Æ�+7&l¾Ã]!"#,¹�ÓÔ;:º;�_\hw^Yg^WZ\XZ^hYAA¹;X_\hw^Yg^WZ\XZ^hYU»eSYedUeZ\^aZh»:¡¼½$¾�¿À½lÁÂÃXÄÅ,{Ü;AA~;~;X_\hw^YhadWXZ^hYX_\hw^YhadWXZ^hY::X_\hw^YgSaZ^hYX_\hw^YgSaZ^hY;;U:¡¼½$¾lÆÇc_£,{Ü;AA�;gWh\XWU]^�:!"#$%&'()#*+,1¢7;:È$É�$%&¡,´µ;:Ê;ËiYZbSZ^aU¥SYh�^ae
![Page 6: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/6.jpg)
ñp��Ìl¾Í�ìö÷ýþ,Τ÷�ÇÔ�îÏ
)Ð�1j§1ÑyQa�Q�)ÒÓ:GMO=.Ôòevent£;1?Ô
)ÕåÖ�1NBTl=ù.vw23
)��1×ØÙÚ:ÛÜÝQÞQCS;
_��O1NOãè�2011~9�l�����NBT�Q�^���
![Page 7: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/7.jpg)
¢£¤
ߤ[GM
:àáâãäåX£;
æ¤[çèéê+7:non-GM;
7#,ëÔÇ6Ç��ÉìòGM¾non-GMí
GMxnon-GM1¢£¤l�.ìG¯
îïG¯g+7ðêltu../ñÔí
ÓËÇÔ.îLòGM¾non-GMí
òARNAgPOó�ô<õ�
³¡W¡xÆÇò��ö'(xÆÇGMñÔ
Ã]!"#÷Æ
Ã]!"#÷Æ
øùÆ�LòGM¾non-GMí
¢£¤
![Page 8: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/8.jpg)
(a) (b)
pi
se
pest
ovuova
(c) B
TUVW7?XY?Q(3Z[?\]P^_W
`a.bcGde?,BfgNhi1jJ?T
UV1kQlmE7\^_noppNh
FT&'(Bqr9Es<3tuvN>?3Z
SwxnoWcGdbjJ?kQlm1yz{
|G}~9E�b:N>��uKLMNh
Construction of ALSV vector
FT!"#FT&'(Bqr9Es<3tuvNi>W
dMjc1c�BR�L��uv?���w
x[E7�X1,G:�?���1Q(=>
Kjh���W7)*+���y7��uK
:Mh=���?TUV����E��&'
(7��uK:Mh
Þöªîï671úûüu: ý~, 4¹ý~lþ;
�r�É'(òGM¾non-GMí
ÆÇc_,»Ô�!"#{Ü
Ã]!"#÷Æ
X_\hw^YhadWXZ^hY
![Page 9: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/9.jpg)
nÁo�yèQp,»Ô�jkalA
![Page 10: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/10.jpg)
!"DNA
#$
%&'()*+,-(.
/0123
456789:
GM
GM
non-GM;
!"DNA<=678>?@/01236AB8#$/01DNACDE)F.
)GHIJKLMNO.
>?@P/0123CQRSTUCDEVWXCYZC[\]^8_-)`abaDcde]^fg8.VL+0hi&\]^8_-)i&j6e78\k`abaDcde]^fg8.V>?@6lmPnMo5pqrstu6<=v8_-)!"wxyJz\{|v8m}kGMO6~�v8.
/0123�!6�k!"������P�
![Page 11: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/11.jpg)
#$
non-GM;
!"DNA<=678>?@/01236AB8#$/01DNACDE)�.
!"DNA /0123
456789:
GM
GM
GM
%&'()*+,-(.
!"DNAC��\�P_
�6=�UT��m_-
/0123�!k!"���e!"�����e
��P�
/0123�!6k!"�����q��
)GHIJKLMNO.
WX5pYZL+0hi&
![Page 12: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/12.jpg)
!"DNA
#$ ��
������
�
45
����������(C� @¡¢Oq£¤6v8���)¥@67�U¡¦.
§ ¨ © ª § ¨ © ª§ ¨ © ª
!"���q«mP��(q¡¢
§ ¨ © ª
§ ¨ © ª
¬6®¯U°±²45
¥@C³´(µ¶q«·�(q¡¢
Reverse¸¨¹ºº»¼�½678¾�¿�
ÀÁÂÃÁ���¸)F1Ä���C
� @ÅÆ.
ÇÈÉÊÁ���)����C�ÈE.
ËÌ%&'ÍÎ���)ÏÐ�(C� @�¶.
Ñ�E����ÒÊ���)ÓÔP�(dÕ��vÖkÊqmÖÔ×ØBÔÙ8.
![Page 13: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/13.jpg)
^CÚCÛÜÝ\�ÞF���ß6àáÔâm
JRC Scientific and Technical Reports
ãComparative regulatory approaches for
new plant breeding techniques
(Proceedings of September 2011 workshop)ä
)åæSçèC{áéê�JRC (Joint Research Center.CHP.
ëìv8íî�>ïO\èðñòó6ôõSàáÔâU�8Nature Biotechnology, Vol. 30, No. 3, March 2012
Agnostic about agriculture
Existing agbiotech traits continue global march
Confronting the Gordian knot
Agbiotech 2.0
Tiptoeing around transgenics
Deployment of new biotechnologies in plant breeding
![Page 14: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/14.jpg)
öèC÷ø
Vù±úûSP�U�8üòdýþâmjÿC!"#$6·�UkX%@6&ÎCúûd�P�SC'�\(6PÔâU�8))^C*6·�U�k2012�+ßköèC,-.�/\"0TmÚ
61,23Tm.
ÿ4567\É{Tmüò)EXZACTTM4GHIJKLMNCF�.
dýþâm¾�O
8C9C:ÿ��;q<=http://www.aphis.usda.gov/biotechnology/reg_loi.shtml
![Page 15: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/15.jpg)
EUCEFSA)European Food Safety Authority.Cï>
Scientific opinion addressing the safety assessment of plants developed
through cisgenesis and intragenesis. EFSA J., 2012; 10(2):2561
VX%@P?'@STUkintragenesisd�¶TmeCSÌAkcisgenesisd�¶Tme
CeEU&ÎCB"C&ÎCDoEDxdú®£¤kÔþP8&Î�Â
VF�GHDFMGd�I8\kDJxKrc@LÛ�MPÖUe��NOg)VcisgenesisSPQC��CeC�̯RSModI8)T@kintragenesis�PQC
%&'S̯7g6lmPRSMo\Ifg8)VmNTk�UâCüòdI�UeVÈÙWXY\If'k8CZ[�\[�D]Tg8eCdI8)T^@6k��_\dk`�TÖP�az�b²â8)cdCZ[))T^@PeGJfgC?'@qhi¸eGJC\[jRSMoC\[Xcdk.
!"#$%&#'#"()*#%#)%(+,,-$..#%/(&0$(.+'$&1(+..$..2$%&()'(*3+%&.,$4$3)*$,(5.#%/(6#%"(7#%/$-(85"3$+.$(9(+%,()&0$-(!#&$:;#-$"&$,
85"3$+.$.(<#&0(.#2#3+-('5%"&#)%=7!>(?@A(BCDBE(DCFDCGHBIJ9
VX%@P?'@STUkEU&ÎCB"C&ÎCDoEDxdú®£¤kÔþP
8&Î�ÂSTU�8)
![Page 16: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/16.jpg)
le$Pí*
V”Detection”S”Identification”qm�TUnív8)
¸¸VopdqP�eC�;¸¸Vop�dq8\NBT678eCdI8^SqÌsdqP�
¸¸¸eC)baDcSm�\dqP�eC.�;
ùrCstVÉ{]u
V®iVviEstw²fdPÖkXxstdCüòÉ{Vyi\z{6|×d�8)VÔþ6lT�üòÉ{S8Cyi\}{ETU�8)V|~k�èdeëìüòq��ml¾��¶\z���d|}þâU�8�A)V!"w²fdPÖk]"deGHIJKLMNq��mv�#$C�¶�yi\z{6|×d�8)
![Page 17: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/17.jpg)
TALENüòq��U�¶Ôâm
��iN�E�����)�\=�U�8.öèEPA67�Uk���%&'Å
"STUC&Îq�BP�eCSTU3sÔâk��ÔâU�8
�CN�E�����#$S���%&'#$)GloFish.)���STU(6�
�ÔâU�8.C4567�U�þâm��iN�E�����%#$eöèd��ÔâU�8
![Page 18: 0123 · 2018-06-10 · EUCEFSA)European Food Safety Authority.Cï> Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA](https://reader033.vdocuments.mx/reader033/viewer/2022060512/5f2af50d24cab525864f2bb5/html5/thumbnails/18.jpg)
Cisgenesis
Intragenesis
Grafting
Agro-infiltration
>?@P��/0123
�
�
>?@P/0123
�
�
9:��dC!"���
�
�
�
�
�
�
�
�
�
�
�sÔâ8'�
GM
GM
GM
GM
???
???
???
!"���<=Å"Cr�6AB8ÒAPDES8C9:
non-GM
ëìv8(�üòVËÌ%&'qyiTm/01¿DVRNAi678�~���C{|ÍÎ
V`abaDcC6��G,�)��6��G.V`a�³6��GC�����C<=)6��G Á.
RdDM
GHIJKLMN
ODM
Reverse Breeding/0123S��