d•basf dr. hans kast basf plant the chemical company

D•BASF The Chemical Company

BASF Plan! Sdarn:e GmbH Cari-Bosch-Str. 38 87056 ludwigshafen

European Commission Commissioner Stavros Dimas DG Environment Rue de la Loi 200

B-1 049 Brussels (Belgium)

BASF Plant Science Dr. Hans Kast President & CEO

Attrib.

_ 1 -02- 2007 N ~':(~

Limburgerhof, January 30th, 2007

Dear Commissioner Dimas,

BASF's application for the genetically modified starch potato Amflora was voted on in the Regulatory Committee on December 4th, 2006. The potato and the starch derived from it, is intended solely for industrial purposes - such as in the paper, textile and adhesive industry. Application and use of this specialty starch enables optimizing production processes resulting in a lower consumption of energy and resources.

Following the regulatory procedure {Council Decision 1999/468/EC), we understand that the Commission is obliged to submit the draft decision without delay to the Council in order to enable a vote. In no case shall the time from the date of referral by the Commission to the vote in Council exceed three months, therefore we anticipate our application to be on the agenda of the next meeting of the Council"" on February 201

h,

2007.

We appreciate the support you have given to the Amflora dossier during the approval process so far, and for this reason we are surprised to recognize that the regulatory procedure was not followed and the Amflora dossier has not yet been forwarded to the Council.

BASF Plant Science GmbH Tel&lon (0621} 60-0 {Vennittlung) Telafax (0621) 8()...42525 (Zanlrale)

Bankverblndung: Wlntershall Bank GmbH, 3411 g Kassel, Konto: 40093Q (BLZ 520 200 00) SWJFTWINBDE52XXX Sitz der Geaellach.tt: 67056 LudWiQ$hsfen, Deulschland Reglatergerlcht Amtsgericht Ludwigshafen. Eintragungsnummer: HRB 4525Lu Urnsalzstel$r-ldeni·Nr. DE812838522

Gaschlttafllhrer: HCWlal<ad Reiner ErTVich JOr;en SclliWiden

a•BASF The Chemical Company

page 2


January 301h, 2007

We assume that the reason for the delay may be the antibiotic resistance marker gene nptll that is present in our product. lt is our understanding that a WHO report of 2005 is being used to re-evaluate the previous safety assessment of the antibiotic resistance marker and that this report is put forward to justify a re-examination of the dossier.

After an approval process that has already lasted more than 10 years, we consider a re-examination as an additional and unwarranted delay since the evaluation and confirmation of safety of the nptll ene in Amflora potato was already part of the approva proce ure. e sa ety of the selectable marker gene was fully assessed by the Rapporteur, by the Member States, by EFSA and the assessment process included a public consultation period. Moreover, the use of the nptll gene as a selectable marker gene in Amflora has no implications on the spread of microbial resistance to antibiotics. This is supported by the Commission's funded ENTRANSFOOD study stating that the nptll gene is without any risk of compromising the use of important clinically used antibiotics.

Therefore, we do not see any reason applying the precautionary principle in this case. On the contrary, this would constitute an undue delay.

We are aware of the fact that approval of GMO products in Europe is a politically highly sensitive issue. However, we do not understand your hesitation in forwarding the draft decision to the Council. The safety of Amflora potato has been demonstrated through extensive food, feed and environmental safety studies. Results of these studies have been reviewed by numerous scientific experts who collectively concluded that Amflora potato is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed uses. Furthermore, Amflora strengthens the Commission's overall policy as well as the numerous policy initiatives such as the Lisbon Strategy, the Biotechnology Strategy, the Strategy on Sustainable Use of Resources, the Environmental Technology Action Plan, the Biomass Action Plan and the EU-Strategy for Biofuels. The product can help increase European qompetitiveness in global markets, creating new income opportunities for European farmers, and contributing to environmental sustalnability.

Therefore, we count on your support to enable a vote in the Environment Council on February 20th, 2007. BASF has committed significant investment and resources to the development and safety assessments of the Amflora potato in order to provide potato growers, processors and the starch industry access to the benefits of this technology.

BASF Plant Science GmbH Teleton (o&21) 60.0 (Vermlltlung) Tetefax (0621) 81)..42525 (Zentrale)

Bankverblndung: WlntetshaJt Bsnk GmbH, 34119 Kassel, l<onto: 400939 (Bl.Z 520 200 00) SWIFT WIN.BOE52XXX Sll:r. der Gesellachaft: 67056 U!dwlgsha!en, Deutschland Regletergerk;ht: Amtsgericht Ludwlgshafen, Elntr~ungsnummer: HRB <1525Lu UmsBtzsteuer-ldent-Nr. DE812$S6522

Oeschattstohr~~r: Ham> Ka$! Reiner Ernric:tl JOrgen &:hweden


page 3


January 301\ 2007

The schedule of voting in the Environmental Council is absolutely critical. Any further delays to the Regulatory approval process will continue to deny these stakehotders access to this technology and will seriously compromise the commercial cultivation of Amflora in 2007.

Yours sincerely,

cc. President Jose Manuel Barroso Commissioner Markos Kyprianou Commissioner GOnther Verheugen Commissioner Janez Potocnik Commissioner Mariann Fischer Boel Commissioner Peter Mandelson Secretary General Catherine Day Director General Mogens Peter Carl Director General Robert Madelin

8ASF Plant Science GmbH Telefon (0$21) 60-0 (Vermlttlung) Telefax (0621) 60-42525 (Zentrale)

Banknrtllndung: Wintetshall Bank GmbH, 34119 Kassel, Konto: 400939 (BLZ 520 200 00) SWIFT WINBOE52XXX Sitz der GeHIIschaft: &7058 Ludwigahafen, Deubchland Regtsterger1cht Amtsgerlcht LudWigshafen. Elntragungsnummer. HRB 4525Lu UITIII8tzsteuer-Jdent-Nr DE812838522

Geschlft8f0hrer: HansKast Reiner Emrlch JOrgen Sellweden


BASf Plant Scienca GmbH • Cari-Bosch-5tr. 64 · 67117Umburgamof


European Commission Commissioner Stavros Dimas DG Environment

Attrib .

Rue de la Loi 200

8-1049 Brussels (Belgium)

Cl) Q) > :E

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ALL

1 4 -05- 2007 AJ 1 / 1{8()

May ath 2007

Re: C/SE/96/3501 - Vote in Council of Ministers on the Commission's decision for Amylopectin potato Amflora

Dear Commissioner Dim as,

As the notifier of the genetically modified Amylopectin potato EH92-527 -1 , Am flora, we are approaching you with respect to the ongoing authorisation procedure under Directive 2001/18/EC.

On 4th December 2006, in the Regulatory Committee, member states voted with a simple majority in favour of the Amflora potato. Given the t imelines set forward by the Commission for the remaining steps of the approval process, we expected the approval in time for the potato planting period in spring 2007.

The discussion about the safety of the use of the nptll gene brought the approval process to a halt. However, on 13th April 2007, EFSA confirmed that the use of the nptll gene as selectable marker in GM plants does not pose a risk to human or animal health or to the environment EFSA also confirmed its eartier safety assessments of GM plants and derived food/feed products, comprising the nptll gene (e.g. Ainflora).

Therefore, from our point of view, all requirements have been met to continue the approval process without any delay. This was also confirmed by DG Environment.

BASF Plant Science GmbH Telefon (oe21) 6G-O (Vetmittlung) Teletax (0621) 80-42625 {Zentrale)

Ban kverblnd ungJ Winterahal Bank G!OOH, 341 111 Kuael, Konto: -400939 (BlZ 520 200 00) SWIFT WINBDE52XXX Sitz der Geaelbn:haft: B705B Ludwlg$hafen, Oeut&chland Reglatergerlcht Amlagericht LudwlgshJfen, Elntragungsnummer: HRB 4526Lu Umsatnteuer-ldeni-Nr. DE812838!!22

Oeal:hllftsfOhrer: Han& Ka$t Reiner Emtlch JOrgan Sthweclen

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·a•BASF The Chemical Company


Please may I also remind you that the approval process for Amflora has now been running for more than 10 years and any further delay will have a significant negative economic impact on our product. ·

Moreover, further delays would contradict the Commission's overall policy as well as the numerous policy initiatives - such as the Lisbon Strategy, the Biotechnology Strategy, the Strategy on Sustainable Use of Resources, the Environmental Technology Action Plan, the Biomass Action Plan and the EU Strategy for Biofuels -since our product developed in Europe for Europe can create new income opportunities for European farmers, contribute to environmental sustainability and increase European competitiveness in global markets.

Therefore, we kindly ask you to pursue the authorization procedure as quickly as possible and to ensure that a vote is held on Amflora at the next meeting of the appropriate Council of Ministers such as the Environment Council in June 2007.

Yours sincerely,

cc. President Jose Manuel Barroso Commissioner Markos Kyprianou Commissioner GOnther Verheugen Commissioner Janez Potocnik Commissioner Mariann Fischer Boel Commissioner Peter Mandelson Secretary General Catherine Day Director General Robert Madelin Diirector General Mogens Peter Carl

BASF Plant Science GmbH Telefon (0821) 8().() (VermiWung) Telefax (0621) 60-42626 (Zentrale)

Banberblndung: Wmt«illall Bank GmbH, 34119 Kassel, Konlo: 400939 (BLZ 620 200 00) SWIFT W1NBDE52XXX Sitz der GesetJschaft: · 67056 Ludwigshsfen, Oeutschland Reglstbrgertcht Aml4gericht ludwigshafen. Elntragung&nummer. HR.B 4525Lu Um$atzsteuer-fdent·Nr OES12838522

Guehlift$ftlhrer. Hans Kast Relner Emrich Jurgen Schweden


BASF Plant Sdenc& OmbH • Cart-Sosch-Stt. 38 · 67058 Ludllltgshaten


European Commission L---.g~~sr,;~~-~19. November 2007 Commissioner Stavros D ~ib. elefon +49 621 60 27011 DG Environment ax + 49 621 60 28117 Rue de la Loi 200 2 3 -1i-' 2007

Re: CISE/96/3501 - Adoption of the proposed implementing act concerning the placing on the market of a potato pr-oduct.(Solanum tuberosum L. line EH92-527-1) genetically modified for enhanced content of the amylopectin component of starch


We are contacting you in expectation of a final decision regarding the BASF product Amflora, our genetically modified starch potato with enhanced amylopectin content. Since all procedural requirements for the cultivation notification according to Directive 2001/18/EC are fulfilled, we are surprised that the final decision is still pending.

After an approval process lasting more than ten years the Commission's decision proposal for cultivation of Amflora was voted on in the Council of Agricultural Ministers on 16 July 2007. According to the Commitology procedure 1999/46/EC Art. 5 it is now up to the Commission to adopt the proposed implementing act. Therefore, we would like to ask you to adopt timely the decision.

The fact that the Commission so far did not adopt the proposed implementation act is all the more difficult to understand as the GMO potato Amflora and the starch derived from are intended solely for industrial purposes - such as for use in the paper, textile and adhesive industry. The potato will be produced in a tightly controlled identity preservation system by farmers who do the planting under a contract agreement with a starch factory. This is important from a business point of view since we have to maintain the unique quality of our amylopectin speciality starch. Furthermore, potato as a crop is easy to cultivate in co-existence with any other potato farming practice, be it conventional or organic.

We are aware of the fact that there have been discussions in the public media about the use of an antibiotic resistance gene nptll as a selection marker conferring resistance against kanamycin and neomycin in our amylopectin potato. However, these concerns are unjustified as you have stated also in your response to the written question P-4070/07 by MEP Mrs. Hiltrud Breyer and as underlined manifold by EFSA, EMEA and the

BASI" Plent Science GmbH Telefon (0621) 60..0 (Vermltllung) Telefax (0821)8D-42525 (Zentrale)

Bankverblndung: WlntBnlhall Bank GmbH, 3411g Kassel, Konto: 400939 (BLZ 620 200 00) SWIFT WINBOE!I2XXX Sitz der Ge .. ll.ehaft: 67058 Ludwigahafert, Oeutachland Reglatergerlcht Amtsgaricht Ludwigahalen, Elntragung.snummer: HRB 4525Lu Umsatutauer.fdent-Nr. DEB12838522

GeachlftsfQh.-.r: Hans Kast Relnar Emrich JOrgen Schweden


page 2


competent authorities of different European member states. Therefore the use of nptll is also fully in line with all legal requirements resulting from directive 2001/18 (Art. 4) or other legal documents.

We acknowledge that in general approvals of GM products in Europe are a politically highly sensitive issue. But, we wish to emphasize that the safety of Amflora potato has been demonstrated through extensive food, feed and environmental safety studies. The results of these studies have been reviewed by independent scientific experts who collectively concluded that Amflora potato is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed uses.

Amflora can help to increase the competitiveness of European farmers in global markets, creating new income opportunities, and contributing to environmental sustainability. Any further delays to the Regulatory approval process will continue to deny these stakeholders access to this technology and will seriously compromise the commercial cultivation of Amflora in 2008. Only an adoption and publication of the decision still within 2007 will enable the rapporteur country Sweden to issue the consent prior to February 2008, which allows the farmers to prepare for cultivation in 2008 (e.g. announcement of planting in the national GMO registers, ordering seed potatoes).

We are looking forward to the Commission's adoption of the proposed implementing act concerning Amflora. ·

Yours sincerely,

cc. President Jose Manuel Barroso Commissioner Markos Kyprianou Commissioner GOnther Verheugen Commissioner Janez Potocnik Commissioner Mariann Fischer Boel Secretary General Catherine Day

The Chemical Company

Commissioner Stavros Dimas European Commission DG Environment Rue de la Loi 200

B-1 049 Brussels BELGIUM

Re~ Genetically modified potato "Amffora"


Dr. Stefan Marclnowski Board of Executive Directors BASF SE

March 181h,· 2008

Attrib.

1 9 -03- 2008

Attached is the formal request to the European Commission of BASF SE's affiliate, BASF

Plant Science GmbH ("BPS"), for which I have responsibility in BASF SE's Board of

Managing Directors, to adopt the implementing act regarding the placing on the market of

BPS' genetically modified starch potato ~Amflora".

1 would have preferred to hand over this request to you in person, and explain to you in

more detail why the growing and marketing of the "Amflorau pot~to is unobjectionable and

safe under environmental, health and all other relevant aspects, that BPS has complied

with all legal requirements, and is, therefore, entitled to the requested·decision.

Unfortunately and to my regret, my numerous attempts, commencing in January of th is

year, to arrange an appointme·nt with you had been unsuccessful.

BASFSE Re6SOrt VII- E 100 67056 Ludwlgsharen Germany

Phone +4S 621 61!·43130 Fax +411 621 S0-<48978 E·MaD ilefan,rniii'[email protected] Internet v/W\v.basr.CQm

D 11 BASF The Chemical Company

Page 2

Nevertheless, Dr. JOrgen Hambrecht, the Chairman of BASF SE's Board of Managing

Directors and I would still be happy to meet and discuss with you all aspects related to

BPS' request. I am confident that we could convince you on the safety of the "Amflora•

-----1P*O~ta:HtG-aAd its benefit for both, the agrieultl:lr~e-tf\e s.tareh inoostfy-ifH:ttreft1pe~.--"Y'(-(o~utrr--

proposals for a date and time of a meeting would be highly appreciated.

Nei'fher BASF SE, nor BPS intend to make the attached formal request public at this point

in time and I am assuming that the Commission would also make no public

announcement until the decision has been made ·and communicated to BPS.

Attachment

cc. President Jose Manual Barroso Vice President GOnter Vemeugen Commissioner Androllfa Vassilou Commissioner Peter Mandelson Commlssioner Janez Potocrlik Commissioner Mariann Ascher Boel Secretary General Cathertne Day

:D·•8ASF

Ell r.opeirfi ·cam.r.ii rsstcm , Commissioner ~ta~rAs QJm~s dei Ehvironmer:1t -~-u~ -d_e t~ ~ ;~·0.0-·

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·a~mmt ~edsfbiJ' tn~ p~e~---?§.gri~~ :,f'! ~.tf:l:r$'. 'Pf'O~t.Jdf .~"!~ if[ tfi~· feed an~ /ii!:JrJ. chatm~' ·<r.t:FJb~ -Cammlsslon> has-- Eonven.ed· ~-eV.$.~ w,qf/tirtg< :gfQJ:iP' · lt1,e~t1Qg$· Wlf!J 't{!re· tri,eV,{':.IJ,~ ;na'tlon:at ·camp-etent: <JYfhlldiJ:t$j ··~rtd the :maj~ty. ·o'f.·Memb"eif States t~n:ciJt(ed :Wlth me OP.It'I(Ot,f· 'd.f5!Er$A,, b;;}' Ma.rea_v.er,~ -f)J ·tiJi1.¥it9:1;i~':oiftn.~ lo.f:qr,hJ!ftroF.J. {)~liJea br__EMEA.c.Ooi:t!r.nfnf/:! the l.iS.~:of kani!tn.f..CJri: ~n-&. n~t1tnY.dn ~n 'hQmd.n. and- .v.eteon~uy. ~m~i:i/21rji!,, •'f;JJ.~ :~F$.~: GM.() :J?.~tJ..e! pf.!}Jitsfred .. ·~· stat~ment;.li:t 'Ma.kd#. ;:200.1~, i:eite.liiti/Jg: .'lt'$ eaidl.etipnJPJ.:Jskitl's.~ tft.atd(le u.~l!f;pf;~ ~P.~l:fff?l'l.e':JJ'!; SW~ta,p~. ma.ri<~~n iSM:pr8nts· ramU/i!dvea f®'f.J.,(jr feed): .q~ ·~o.t _'PO'Se !a. ff$ :m: :bqrnan iit<~mrfmr(! 'bealtb. &r ·to· t?ffl- ~gf(frorurrtmt. the: :GMO. -P.'r!ael -atso Gf!r:ilfrms 'earii"er ·sa'/ety :assessdfeljt!;t ttf'-:(;M fllatit:S ·B/fd Cf~'fiie<$ fti..rii!/fei!d coropi'Jsfng .th,e ·n{f.t1t gene: l.t [en}'(l~~§.~ ¥.~f~ed-J ·

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3

16/04/2008 13:11 16-APR- 2008 14:29

+49 621 6045976 BASF AG RESSORT U I I

a~BASF The Chemical Company

Commissioner Stavros Dlmas European Commission DG Environment Rue de la Loi 200

8 w1049 Brussels BELGIUM

Dear Commissioner Dimas.

+49 621 6045976 8.01

BASF Plant s·den~e GmbH

April 16, 2008

Cab. FISCHER BOEL

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FlUng Coda/Other Ref.:

Thank you for taking time to meet us on April 15th to discuss Amflor~·: BASF's genetically

optimised starch potato.

Amflora is tor industrial use - developed In Europe for the European st~rch indus.try-. The potato produces pure amylopectin , a starch for uSQ in technical proces~es such· as. pap~r ma~ltig._. lt !s a

renewable raw material that helps in saving energy and water. · ·.

Leading starch producers confirm that amylopectin potatoes such ·as Amflo.i'a are -estlm.ated to

create an added value of at least €100 million per year for the· European s~arch industry ~nd farmers. Industry and farmers now want to see Amtlora cultivate·d: . · . . . ·. ·. . ·

Genetically modified crops are already reality, being grown by 12 million·farmers around the wqrld

on more than 114 million hectares, although. on only 0.1 million hectares in Europe. In the future,

the Importance of genetically modified crops will· further grow. To rell}~in com,pstltlve on the _world

market, European farmers must be granted access to safe, innoVative technology now!

. . EU experts at the European Food Safety Authority (EFSA) have repeatedly stated that Amflora Is

as safe as conventional potatoes. Theil' conclusion is based on extensive sCientific studies · on

Amflora. All scientific evidence supports the safety of Amflora. · You, Commissioner Dimes,

confirmed Amflora's safety to the European Parliament on September 21:. 2007, stating that it

does not pose a risk to human or animal health or to the environment .

BASF SE Re~!IOrt VJI- E 100 67056 Ludwi~Mten Germany

Phone +49 621 00~130 FOJ( .. 49 !121 !ID-46976 E-Mall [email protected] fn"-rnat www.basf.com

16- APR-2008 14 =30 BASF AG RESSI:RT V I I

a ~~ BASF The Chemical Company

Page 2

. +49 621 6045976 . . .

BASF Pfanf Scien~e GmbH .. . ..

5 . 02

Th.e arguments you raised yesterday do not include any new ~vidence . that would .challenge the previous position. Therefore , we do not understand why the · ~ppro"~i . ·of AJ:nfl~ra . is further

delayed: Amflora is a safe, environmentally friendly product. that brin~s. cotnj)etltlve advantages to

farmers and industry lh Europe.

Amflora was submitted to the E( J for approval· years ago BASE_ has adhered to all El J pmcesse_s · . .. . . . that have been agreed upon between. EU countries, and ha~ subm~ed aJI requir_e_d data: We_ we_re

encouraged to see that you Initiated the appro.val process by reco~meridln~ _' the approval of.

Am flora in your own "positive d raft decision" in 2006. ·

•,.

Now, although all political and admini~trative steps have been taken, the final decision by. the EU

Commission has been pending since July 2007. We believe that a failure to implement EU

legislation questions the credibility of the EU approval processes. In addition, the approval delay

has a negative impact on BASF's business and that of our customers. We call once· again on.you

to follow EU processes immediately and allow Amflora to be cultivate~ co~m~rcial~y _in Europe.

Yours sincerer'~

~~-> Stefan Marcinowskl Board of Bcecutlve Directors, BASF SE

Cc: President Jose Manuel Barroso Commissioner Androulla Vassiliou Commissioner GUnther Verheugen Commissioner Janez Potocnik Commissioner Mariann Flscher Boel Commissioner Peter Mandelson Secretary General Catherine Day Director General Robert Madelin Director General Peter Mogens Cerl

ans Kast President and CEO. BASF _Plant Science GmqH

GESAMTSE ITEN 02

I:I•BASF The Chemical Company

Dr. Stefan Marcinowski Board of Executive Directors BASFSE

Cab. FISCHER 80EL COM1 PSC /KDS I LN I DB I I

European Commission President Jose Manuel Barroso Rue de la Loi, 200

Attrlb. JWF I JM I TS I MP I PF l KW J

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l 11 ·u L 9 n7 700R ~ 1 049 Brussels

BELGIUM coMI PSC I KOB I LN Vos L I Copy JWF 1 JM 1 rs 1 MP r PF 1 Kw 1,

r=mn2 Code/Orher Rei.: 23 July, 2008

Notification C/SE/96/3501 - Adoption of the proposed implementing act concerning the placfng on the market of a potato product (Solanum · tuberosum L line EH92-527-1) genetically modified for enhanced content of the amylopectin component of starch

Dear President Barroso,

On 17 March, 2008, BASF Plant Science has formally called upon the Commission to adopt a decision In accordance with Article 18(1) of Directive 2001/18/EC and with Article 5 of Council Decision 1999/468/EC. Although the approval process for Amflora has been lasting for 12 years, approval has still not been granted. The process was even stopped several times for Incomprehensible reasons. And since the final vote in the Council in July 2007 we are waiting for the adoption of the decision by the EU commission.

As a result of the orientation debate on GMOs on 7 May, 2008, the Commission asked EFSA to prepare a consolidated scientiflc opinion on the safety of antibiotic resistance marker (ARM) genes when used as marker genes in genetically modified {GM) plants. This Includes nptll , the ARM gene of Amflora, BASF's genetically modified starch potato for industrial applications.

However, the question of safety of nptll is not new. Indeed, EFSA has already evaluated Amflora three times including the nptll marker, and EFSA repeatedly stated that the use of nptll as selectable marker gene in plants does not pose a risk to human or animal health or to the environment. Even the Directorate-General Environment clearly expressed (reply of 12 October, 2007) - based on the same scientific rationale that has led to the third EFSA re-evaluation - that the antibiotic resistance marker gene nptll and GM plants· that contain the nptll gene are safe.

After the above-mentioned orientation debate, the Commission announced to adopt the approval of Amflora if and when EFSA has confirmed the safety of nptll. However, we do not see the need for this additional process since no new scientific evidence questions the safe use of nptJI. All the more we deplore that the deadline for completion of the EFSA re-assessment has been postponed until 15 December, 2008.

9ASF8E R&SSOrtVII- E 100 87058 luctwlgshafen Genllanv

Phone· +49 621110-43130 Fax +.o19 SZ1 e0-45Q78 E-MaJI atsf8n.marclnow&kl®ba&f.com lrrtsmet www.b1111f.com

D•BASF The Chemical ·cd"mpany

Page 2

Based on all circumstances BASF Plant Science has now decided to bring an action for failure to act according to Art. 232 EC to the EC Court of First Instance. By doing so we aim at ensuring that the approval process will then be completed in a timely manner. Please understand that for us the point of time when an approval is granted is critical, as we might loose another planting season. Only an approval by the Commission in January 2009 will allow us to start commercial cultivation of Amflora in April 2009.

We welcome that the Commission - as stated during its orientation debate -will base its decisions on science and confirmed its confidence in the high standard of scientific advice provided by EFSA. Therefore, we expect that European fanners and the· European potato starch industry will finally get access to Amflora which will bring them an added value of more than €1 00 million per year.

Siyo~

Stefan Marcinowski

cc. Vice President Gunter Verheugen Commissioner Stavros Dimas

~ommissioner Mariann Fischer Boel · Commissioner Peter Mandelson Commissioner Janez Potocnik Commissioner Androula Vassiliou Secretary General Catherine Day

ll•BASF The Chemical Company

European Commission President Jose Manue! Barroso Rue de la Loi, 200 1 049 Brussels BELGIUM

Approval Process· of Amflora


Dr. Stefan Marcinowski Board of Executive Directors BASF SE

December 1, 2008 Cab. f iSCHER BOEL coMwsc /Kos1 LN J os I 1 ~ ·w

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In Mr. Vale [)e A lmeida's letter dated October 9, 2008 sent on your be~alf you refer to the

Commission's request to the European Food Safety Authority to analyze further scie.ntific

evidence on GMO's, such as Amflora, which contain antibiotic resistance marker genes.

In May the Commission asked for EFSA's opinion by September 30, 2008, nevertheless

the deadline has been extended to December 15, 2008:

Since the Amflora dossier has been reviewed intensively by EFSA with the conclusion that it is as safe as any conventional potato and, according to our knowledge there is no

new scientific evidence presented, the extended timeline is for us difficult to understand. We expect that EFSA will deliver its opinion latest by December 15 based on science as

required by legis_lation. We advocate the clear commitment of the Commission in the orientation debate that ythe Commission will adopt pending decisions if and when EFSA

has confirmed the safety of the products".

Let me point out that any further delays to the regulatory approval process will continue to

deny stakeholders access to this technology and will seriously compromise the

commercial cultivation. of Amflora in 2009. Only an adoption and publication of the decision in January 2009 will enable the rapporteur country Sweden to issue the consent

in February 2009, which will allow farmers to prepare for cultivation in 2009.

BASF SE Ressort VII - E 100 67056 l udwigshafen

Phone • 49 621 60-43130 Fax +49 621 60-45976 E-Mail [email protected]


Page 2

Dear President Barroso, we believe that, after being in the European approval process for more than 12 years, the decision on our genetically modified potato Amflora with enhanced amylopectin content is more than overdue.

Sincerely yours.

cc. Vice President GOnter Verheugen Commissioner Stavros Dimas Commissioner Mariann Fischer Boel Commissioner Cathedne Ashton Commissioner Janez Potocnik Commissioner Androula Vassiliou Secretary General Catherine Day

• · -· .. · ···-;----.. -· :-""1 · -···- · ··· -~ ·- . .. .. - · ___ ... - . ···--·--·· ......

-

16/06/2009 09: 18 +49 621 6028685 16- JLIN- 2009 10! 39 BASF PLANT SCIENCE GMBH +49 &21 6028685 5 . 01

D•BASF BASF ~lant Science

The Chemlcal Company

fiJTV~ tvfn·l TELEFAX Cab. FISCHER BOEL -

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CA-v-· oJ ·. ~ .S? 16.06.2009 -~ 1 6 -06- 2009 . AIA~~~1 49 621 ~60-281 83 £ ~

< 8 coMIKoel LN l oo !JWF1 Jia> 49 621·60·28685

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no. of pages 2 FlUng Code!Oiher Rei. ~ ·m~il1n· eate. [email protected]

From Beate von Borcke, BASF Plant Science GmbH, Carf-Bosch Stra$Se 64,

BPS -li439,

611 17 Umburgerhof, Germany

To Commissioner Androu/a Vassiliou

0032 2 298 1 098

Dear Commissioner Vassiliou,

please find attached the fetter of Dr. Stefan Marcinowski and Dr. Hans Kast from the 1511; of

June 2009. The original you will receive via TNT tomorrow.

Sincerely,

BASF Plant Science GmbH Cari-Bosch-Strasse 64 BPS-LI439 67117 Llmburgerhof Germany

eASF Pfanl S<iene& GmbH Telefon (01121) 8()..() (VotmittJung) Tels hsx ~21) 0042525 (Ze"ltalu)

••mkwrllind"ng: Winlet5haii iS3 nk GmbH, 34119 KaiSCI, Konto: -4QD~II {SLZ 520 200 00) SWII'T WINBDE52XXX Sit.t der Geu!ltehaft: G70:i6 ~udwiiJShalen. Deulscl'll;)"<f Reglltergori~ht Amte9el'lel\l Ludwigshalen, Eintr11gungsnummor: HRB 4525Lv Um~;atnleuer-ldcn\-N(, OE8126~22

Go$ehl!ftsflil1r~r: Hlli\S l<a$1 Reinsr Errvicll JOrgell SctJwRden

16- JUI'-1-2009 10:39 BASF PLANT SC fE~~ GMBH -t49 621 6028685 5 . 02

----~~~~~~~1

BASF' SI!. 6?'0:!6 Ludwipsh~fen. Germany

Mr. Jose Manuel Barroso President European Commission Rue de la Loi 200 (BREY 12/1 00)

BE - 1 049 Brussels

l s -06- 2009

Notification C/SE/96/3501 - Adoption of the proposed implementing act concerning th~ placement on the market of the genetically modified starch potato Am flora


In relation to the above mentioned authorisation procedure, the EU Commission has requested the European Food Safety Authority (EFSA) on 14 May 2008 to deliver a further scientific opinion on the use of antibiotic resistance genes as· marker genes in genetically mOdified (GM) plants.

On 11 June 2009, EFSA published the results of its further evaluation of the use of antibiotic resistance marker (ARM) geryes in GM plants entitled "Consolidated presentation of the joint Scientific Opinion of the GMO and BIOHAZ Panels on the "Use of Antibiotic Resistance Genes as Marker Genes in Genetically Modified Plants" and the Scientific Opinion of the GMO Panel on aconsequences of the Opinion on the Use of Antibiotic Resistance Genes as Marker Genes in Genetically Modified ·Plants on Previous EFSA Assesments of Individual GM Plants"". This statement confirms agai"n the safety of our GM potato Amflora. In detail, EFSA states that " ... n.o new scientific evidence has become available that would prompt the Panel to change its previous opinions." Two minority opinions were expressed and" ... have already beeh extensively considered during the preparation of the joint Scientific Opinion; .. " and ''... further clarification of this Scientific Opinion is not required, nor is further scientific work needed at this time."

Based on such previous EFSA opinions stating that the use of the nptll gene in GM plants does not pose a risk to human or animal health or to the environment DG Environment in the past already submitted a positive draft decision authorising Amftora to 1he Regula1or)t Committee as well as to the Council.

S,t.SFSE 61058 Ludwigshaten, Gerrn!lny

Pnone· •4!1 621 oo.o Few: +49 571 60-A252S E·rna1J; gtooet 111to@ba$f.com 11\leltlet: www.l'la&r.com

E.uro Bltnlc dtttlls: Comme~bank Alltiti'IOI!Uli$Chaft Account No.: Ol101000700, Sort cooe s.;s 4CO 33 !BAN OE2tl ~S4 0033 0201 OOD? 00 SW!f'l' COBAOEFF"$43

Oeutacht BanK A!(1leng!sl:fi$CM" ACCOUnl No.: 0013302500, S041 code 54S 700 94

~egl.slerro Office: 67056ludwi9~hafen IBAN 0~72 5457 OOIM 0013 3025 00 Regi&lra llon Court: Anltsgeric.hllUOwl!l$hafen, SWIFT DEtnOESMS<~!. oa .. , ...... ui.-- J..'- . ,.ulA cMn

Chalrlnan of the SupeM~ory Bollr!l; EgSJert Vosthereu

Bo~td of Executlvc Olreoton:: Jvergen Hambfecnt. Chaifll'IM; Kurt Sock. Martin SrvctermuGIJer. HaM-Ulr&ch Engtl, John FeldmBM. .Andreas Krelmeyer. Sl«fon Marcinow~k•. Haralct Schwager


page 2

tn the.le~ter dated 25 August 2008 addressed to Dr. Marcinowski as well as in the pre·ss release dated 7 May 2008. summarizing the College's orientation debate on GMOs, the EU Coml'l!ission confirmed that the approval of the potato Amflora will b~ granted if and when EFSA reconfirms the safety of our product

Since now the preconditions are· fulfilled we expect the adoption of the Implementing act in accordance with Article 18 (1) of Dire.ctive 2001/18/EC and with Article 5 (6} third paragra.pli of Council Decision 1999/468/EC and kindly ask for a fast decision process.

As you know, any. further delay to the authorisation will delay the necessary preparation for the next . pfahting . season. This will .result in significant negative financial consequences for BASF SE, BASF Plant Science and our partners in the European starch industry. ·

We would appreciate lf you could acknowledge receiving this letter and inform us on the timing of the next steps of the EU Commission concerning the approval of Amflora.

Yours sincerely,

Dr. Hans Kast President·& ·.CEO

Dr. Stefan Marcinowski Board of·Executive, Dlreqtors BASF SE BASF Plant Science GmbH

cc: GOntherVerheugen, Vice President, Commissioner for Enterprise & Industry Stavros Dim as, Commissioner for Environment Janez Potocnik, Commissioner tor Science & Research Androulla Vassil!ou, Commissioner for Health Mariann Flscher ·aoel, Commissioner for Agriculture & Rural Development Catherine Ashton, Commissioner for Trade Catherine Day, Secretary General, European Commission

GESAf'JTSEITEH 03

Ai..L.

The Chemical Company z 9 -09~ 2009

BASF SE, 67056 Ludwigshafen. Gennany

Mr. Jose Manuel Barroso President

25 September 2009

European Commission Rue de la Loi 200 (BREY 12/1 00)

BE- 1049 Brussels

Notification C/SE/96/3501 -Adoption of the proposed implementing act concerning the placement on the market of tho genetically modified starch potato Am flora

Dear President,

First of all we would like to congratulate you on your renewed appointment as President of the European Commission.

On the other hand we are writing in relation to the above mentioned authorisation procedure and our attached letter of 15 June 2009, concerning the same matter (to which we have not yet received any reply).

On 11 June 2009 EFSA published its scientific op1mon on the use of antibiotic resistance genes as marker genes in genetically modified plants, which once again confirmed the safety of the Amflora potato.

In the letter dated 25 August 2008 addressed to Dr. Marcinowski as well as in the press release dated 7 May 2008 the Commission confirmed that it would approve Amflora potato if EFSA gave a positive opinion. Although over three months have now elapsed since EFSA's positive opinion was published, the Commission has so far failed to indicate what it has, is or intends to do in order to bring the Amflora approval procedure to a satisfactory conclusion.

Further delay to the authorisation will delay the necessary preparation for the next planting season. This will result in significant financial consequences for BASF SE, BASF Plant s·cience and our partners ·in the European starch industry.

Given that the Amflora approval procedure has now lasted-for over 13 years, and given that it has been over three months since the publication of the EFSA opinion, you will

BASF SE 61056 Ludwigshalen, Germany

Phone: +49 621 60·0 Fax: +49 621 60-42525 E-mail: [email protected] lntemet: www.besf.com

Euro Bank details: Commerzbank Aktiengesellschalt Account No.: 0201000700, Sort code 545 400 33 IBAN OE26 5454 0033 0201 0007 00 SWIFT COBAOEFFS45

Oeutsche Bank Aktiengesellsehaft Account No.: 0013302500, Sort code 545 700 94

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Chairman of the Suparvi11ory Board: Eggert Vo&cherau

Board of Executive Directors: Juergen Hambrecht, Chalnnan; Kvrt Sock, Martin Brudermuelle1', Hans-Uirich Engel. John Feldmann, Andreas Krelmeyer, Stetan Marcinowski, Harold Schwager


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hopefully understand that BASF would appreciate if you could acknowledge receiving this letter and inform us on the timing of the next steps of the Commission concerning the approval. of Amflora.

Yours sincerely,

~~ Dr. Stefan Marcinowski Board of Executive Directors BASF SE

cc.

Dr. Peter Eckes President & CEO BASF Plant Science Company GmbH

GUnther Verheugen, Vice President, Commissioner for Enterprise & Industry Stavros Dim as, Commissioner for Environment Janez Potocnik, Commissioner for Science & Research Androulia Vassiliou, Commissioner for Health Mariann Fischer Beef, Commissioner for Agricu lture & Rural Development Catherine Ashton, Commissioner for Trade Catherine Day, Secretary General, European Commission

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