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Commission Decision
Deċiżjoni tal-Kummissjoni
of 8 September 2008
tat- 8 ta’ Settembru 2008
authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean A2704-12 (ACS-GMØØ5-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
li tawtorizza t-tqegħid fis-suq ta’ prodotti li fihom, li huma magħmula, jew li ġejjin mis-sojja modifikata ġenetikament A2704-12 (ACS-GMØØ5-3) skond ir-Regolament (KE) Nru 1829/2003 tal-Parlament Ewropew u tal-Kunsill
(notified under document number C(2008) 4735)
(notifikata taħt id-dokument numru C(2008) 4735)
(Only the German text is authentic)
(It-test Ġermaniż biss huwa awtentiku)
(Text with EEA relevance)
(Test b’relevanza għaż-ŻEE)
(2008/730/EC)
(2008/730/KE)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
IL-KUMMISSJONI TAL-KOMUNITAJIET EWROPEJ,
Having regard to the Treaty establishing the European Community,
Wara li kkunsidrat it-Trattat li jistabbilixxi l-Komunità Ewropea,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [1], and in particular Articles 7(3) and 19(3) thereof,
Wara li kkunsidrat ir-Regolament (KE) Nru 1829/2003 tal-Parlament Ewropew u tal-Kunsill tat- 22 ta’ Settembru 2003 dwar ikel u għalf modifikati ġenetikament [1], u b’mod partikolari l-Artikoli 7(3) u 19(3) tiegħu,
Whereas:
Billi:
(1) On 1 July 2005, Bayer CropScience AG submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from A2704-12 soybean ("the application").
(1) Fl- 1 ta’ Lulju 2005, Bayer CropScience AG ippreżentat applikazzjoni lill-awtorità kompetenti tal-Olanda, skont l-Artikoli 5 u 17 tar-Regolament (KE) Nru 1829/2003, għat-tqegħid fis-suq tal-ikel, ingredjenti tal-ikel u għalf li fihom, li huma magħmula jew li ġejjin mis-sojja A2704-12 ("l-applikazzjoni").
(2) The application also covers the placing on the market of other products containing or consisting of A2704-12 soybean for the same uses as any other soybean with the exception of cultivation. Therefore, in accordance with the provisions of Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, it includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC [2] and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC.
(2) L-applikazzjoni tkopri wkoll it-tqegħid fis-suq ta’ prodotti oħrajn li fihom jew li huma magħmula mis-sojja A2704-12 għall-istess użi bħal kull sojja oħra bl-eċċezzjoni tal-kultivazzjoni. Għalhekk, skond id-dispożizzjonijiet tal-Artikoli 5(5) u 17(5) tar-Regolament (KE) Nru 1829/2003, din tinkludi d-dejta u t-tagħrif meħtieġ mill-Annessi III u IV tad-Direttiva 2001/18/KE tal-Parlament Ewropew u tal-Kunsill tat- 12 ta’ Marzu 2001 dwar ir-rilaxx intenzjonat fl-ambjent ta’ organiżmi modifikati ġenetikament u tħassar id-Direttiva tal-Kunsill 90/220/KEE [2] u tagħrif u konklużjonijiet dwar il-valutazzjoni ta’ riskju mwettqa skond il-prinċipji stipulati f’Anness II tad-Direttiva 2001/18/KE.
(3) On 10 August 2007, the European Food Safety Authority (EFSA) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 and concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from A2704-12 soybean as described in the application ("the products") will have any adverse effects on human or animal health or the environment in the context of their intended uses [3]. In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation.
(3) Fl- 10 t’Awwissu 2007, l-Awtorità Ewropea dwar is-Sigurtà fl-Ikel (l-"EFSA"), tat opinjoni favorevoli skond l-Artikoli 6 u 18 tar-Regolament (KE) Nru 1829/2003 u kkonkludiet li mhux probabbli li t-tqegħid fis-suq tal-prodotti li fihom, li huma magħmula, jew li ġejjin mis-sojja A2704-12 kif deskritti fl-applikazzjoni ("il-prodotti"), jkollu xi effetti negattivi fuq il-bniedem jew is-saħħa tal-annimali jew l-ambjent fil-kuntest tal-użi li huma maħsuba għalihom [3] Fl-opinjoni tagħha, l-EFSA qieset il-mistoqsijiet speċifiċi kollha u t-tħassib imqajjem mill-Istati Membri fil-kuntest tal-konsultazzjoni tal-awtoritajiet kompetenti nazzjonali kif previst fl-Artikoli 6(4) u 18(4) ta’ dan ir-Regolament.
(4) In particular, EFSA concluded that after considering all the data available in the application on the molecular characterisation, compositional analysis and agronomic performance, A2704-12 soybean is equivalent to its non-genetically modified counterpart and, as a consequence, that no further animal safety studies with the whole food/feed (e.g. a 90-day toxicity study in rats) are needed.
(4) B’mod partikolari, l-EFSA kkonkludiet li wara li qieset id-dejta kollha disponibbli fl-applikazzjoni dwar il-karatterizzazzjoni molekolari, l-analiżi ta’ kompożizzjoni u l-osservanza agronomika, is-sojja A2704-12 hi ekwivalenti għal kontroparti mhux ġenetikament modifikata tagħha u, bħala konsegwenza, li m’hemmx bżonn aktar studji dwar is-sikurezza tal-annimali bl-ikel/l-għalf kollu (eż. studju ta’ tossiċità fil-firien għal 90 ġurnata).
(5) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended use of the products.
(5) Fl-opinjoni tagħha, l-EFSA kkonkludiet ukoll li l-pjan ta’ monitoraġġ tal-ambjent, li jikkonsisti fi pjan ta’ sorveljanza ġenerali, li kien ippreżentat mill-applikant, huwa konformi ma’ l-użu intenzjonat tal-prodotti.
(6) Taking into account those considerations, authorisation should be granted for the products.
(6) Wara li jitqiesu dawn il-kunsiderazzjonijiet, għandha tingħata l-awtorizzazzjoni għall-prodotti.
(7) A unique identifier should be assigned to each genetically modified organism (GMO) as provided for in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms [4].
(7) Għandu jiġi assenjat identifikatur uniku għal kull OMĠ kif previst fir-Regolament tal-Kummissjoni (KE) Nru 65/2004 tal- 14 ta’ Jannar 2004 li jistabbilixxi sistema għall-iżvilupp u l-assenjazzjoni ta’ identifikaturi uniċi għall-organiżmi modifikati ġenetikament [4].
(8) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for the foods, food ingredients and feed containing, consisting of, or produced from A2704-12 soybean. However, in order to ensure the use of the products within the limits of the authorisation provided by this Decision, the labelling of feed containing or consisting of the GMO and other products than food and feed containing or consisting of the GMO for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.
(8) Fuq il-bażi tal-opinjoni mogħtija mill-EFSA, l-ebda rekwiżiti tat-tikkettjar speċifiċi għajr dawk stipulati fl-Artikolu 13(1) u 25(2) tar-Regolament (KE) Nru 1829/2003 ma jidhru meħtieġa għall-ikel, l-ingredjenti tal-ikel u l-għalf li fihom, li huma magħmula minn, jew li ġejjin mis-sojja A2704-12. Madankollu, sabiex ikun żgurat l-użu tal-prodotti fil-limiti tal-awtorizzazzjoni prevista b’din id-Deċiżjoni, l-ittikkettjar ta’ għalf li fih jew li hu magħmul minn OMĠ u prodotti oħra għajr ikel u għalf li fih jew li hu magħmul mill-OMĠ li għalih intalbet awtorizzazzjoni għandu jkun ikkomplementat b’indikazzjoni ċara li l-prodotti meqjusa ma għandhomx jintużaw għall-kultivazzjoni.
(9) Similarly, the EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Articles 6(5) and 18(5) of Regulation (EC) No 1829/2003.
(9) Bl-istess mod, l-opinjoni tal-EFSA ma tiġġustifikax l-impożizzjoni ta’ kundizzjonijiet jew restrizzjonijiet speċifiċi għat-tqegħid fis-suq u/jew kundizzjonijiet jew restrizzjonijiet speċifiċi għall-użu u l-ġarr, inklużi r-rekwiżiti ta’ superviżjoni ta’ wara t-tqegħid fis-suq, jew ta’ kundizzjonijiet speċifiċi għall-ħarsien ta’ ekosistemi/ambjent u/jew żoni ġeografiċi partikolari, kif stipulat fil-punt (e) tal-Artikoli 6(5) u 18(5) tar-Regolament (KE) Nru 1829/2003.
(10) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(10) It-tagħrif rilevanti kollu dwar l-awtorizzazzjoni tal-prodotti għandu jiddaħħal fir-reġistru Komunitarju tal-ikel u l-għalf modifikat ġenetikament, kif previst fir-Regolament (KE) Nru 1829/2003.
(11) Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [5], lays down labelling requirements for products consisting or containing GMOs.
(11) L-Artikolu 4(6) tar-Regolament (KE) Nru 1830/2003 tal-Parlament Ewropew u tal-Kunsill tat- 22 ta’ Settembru 2003 dwar it-traċċabilità u tal-ittikkettjar ta’ organiżmi modifikati ġenetikament u t-traċċabilità ta’ prodotti tal-ikel u tal-għalf prodotti minn organiżmi modifikati ġenetikament u li jemenda d-Direttiva 2001/18/KE [5], jistipula rekwiżiti ta’ tqegħid ta’ tikketti għal prodotti li huma magħmula minn jew li fihom OMĠ.
(12) This decision is to be notified through the Biosafety Clearing House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c), of Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms [6].
(12) Din id-deċiżjoni għandha tiġi notifikata permezz tal-Clearing House dwar il-Bijosigurtà lill-Partijiet fil-Protokoll ta’ Cartagena dwar il-Bijosigurtà tal-Konvenzjoni dwar id-Diversità Bijoloġika, skont l-Artikoli 9(1) u 15(2)(c), tar-Regolament (KE) Nru 1946/2003 tal-Parlament Ewropew u tal-Kunsill tal- 15 ta’ Lulju 2003 dwar il-movimenti transkonfinali ta’ organiżmi modifikati ġenetikament [6].
(13) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman; the Commission has therefore submitted a proposal to the Council on 28 April 2008 in accordance with Article 5 of the Council Decision 1999/468/EC [7], the Council being required to act within three months.
(13) Il-Kumitat Permanenti dwar il-Katina Alimentari u s-Saħħa tal-Annimali ma tax opinjoni fil-limitu taż-żmien stabbilit mill-President tiegħu. Il-Kummissjoni għalhekk ippreżentat proposta lill-Kunsill fit- 28 ta’ April 2008 skond l-Artikolu 5 tar-Regolament (KE) Nru 1999/468/KE [7], bil-Kunsill mitlub jaġixxi fi żmien tliet xhur.
(14) However, the Council has not acted within the required time limit; a Decision should now be adopted by the Commission,
(14) Madankollu, il-Kunsill ma aġixxiex fil-limiti taż-żmien mitluba; issa għandha tiġi adottata Deċiżjoni mill-Kummissjoni,
HAS ADOPTED THIS DECISION:
ADOTTAT DIN ID-DEĊIŻJONI:
Article 1
Artikolu 1
Genetically modified organism and unique identifier
Organiżmu modifikat ġenetikament u identifikatur uniku
Genetically modified soybean (Glycine max) A2704-12, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier ACS-GMØØ5-3, as provided for in Regulation (EC) No 65/2004.
Is-Sojja modifikata ġenetikament (Glycine max) A2704-12, kif inhu speċifikat fil-punt (b) tal-Anness ma’ din id-Deċiżjoni, hi assenjata l-identifikatur uniku ACS-GHØØ5-3, kif previst fir-Regolament (KE) Nru 65/2004.
Article 2
Artikolu 2
Authorisation
Awtorizzazzjoni
The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
Il-prodotti li ġejjin huma awtorizzati għall-finijiet tal-Artikoli 4(2) u 16(2) tar-Regolament (KE) Nru 1829/2003, skond il-kundizzjonijiet stipulati f’din id-Deċiżjoni:
(a) foods and food ingredients containing, consisting of, or produced from ACS-GMØØ5-3 soybean;
(a) ikel u ingredjenti tal-ikel li fihom, li huma magħmula, jew li ġejjin mis-sojja ACS-GHØØ5-3;
(b) feed containing, consisting of, or produced from ACS-GMØØ5-3 soybean;
(b) ikel li fih, li hu magħmul, jew li ġej mis-sojja ACS-GHØØ5-3;
(c) products other than food and feed containing or consisting of ACS-GMØØ5-3 soybean for the same uses as any other soybean with the exception of cultivation.
(c) prodotti għajr ikel u għalf li fihom jew li huma magħmulin mis-sojja ACS-GHØØ5-3 għall-istess użi bħal kwalunkwe sojja oħra ħlief għall-kultivazzjoni.
Article 3
Artikolu 3
Labelling
It-tikkettjar
1. For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the "name of the organism" shall be "soybean".
1. Għall-finijiet tar-rekwiżiti tal-ittikkettjar stipulati fl-Artikoli 13(1) u 25(2) tar-Regolament (KE) Nru 1829/2003 u fl-Artikolu 4(6) tar-Regolament (KE) Nru 1830/2003, l-"isem tal-organiżmu" għandu jkun "sojja".
2. The words "not for cultivation" shall appear on the label of and in documents accompanying products containing or consisting of ACS-GMØØ5-3 soybean referred to in Article 2(b) and (c).
2. Il-kelmiet "mhux għall-kultivazzjoni" għandhom jidhru fuq it-tikketta ta’, u fid-dokumenti li jakkumpanjaw, il-prodotti li fihom jew li huma magħmula mis-sojja ACS-GHØØ5-3 li jissemmew fl-Artikolu 2(b) u (c).
Article 4
Artikolu 4
Monitoring for environmental effects
Il-Monitoraġġ għal effetti ambjentali
1. The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in the point (h) of the Annex, is put in place and implemented.
1. Id-detentur tal-awtorizzazzjoni għandu jiżgura li l-pjan ta’ sorveljanza għal effetti ambjentali, kif speċifikat fil-punt (h) tal-Anness, jiddaħħal fis-seħħ u jiġi implimentat.
2. The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring activities.
2. Id-detentur tal-awtorizzazzjoni għandu jibgħat lill-Kummissjoni rapporti annwali dwar l-implimentazzjoni u r-riżultati tal-attivitajiet imfassla fil-pjan ta’ monitoraġġ.
Article 5
Artikolu 5
Community register
Reġistru Komunitarju
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.
It-tagħrif stabbilit fl-Anness ta’ din id-Deċiżjoni għandu jiddaħħal fir-reġistru Komunitarju tal-ikel u l-għalf modifikati ġenetikament, kif stipulat fl-Artikolu 28 tar-Regolament (KE) Nru 1829/2003.
Article 6
Artikolu 6
Authorisation holder
Detentur tal-awtorizzazzjoni
The authorisation holder shall be Bayer CropScience AG.
Id-detentur tal-awtorizzazzjoni għandu jkun Bayer Cropscience AG.
Article 7
Artikolu 7
Validity
Validità
This Decision shall apply for a period of 10 years from the date of its notification.
Din id-Deċiżjoni għandha tapplika għal perjodu ta’ 10 snin mid-data tan-notifika tagħha.
Article 8
Artikolu 8
Addressee
Destinatarju
This Decision is addressed to Bayer CropScience AG, Alfred-Nobel-Straße 50, D-40789 Monheim am Rhein, Germany.
Din id-Deċiżjoni hija indirizzata lil Bayer CropScience AG, Alfred-Nobel-Strasse 50, D - 40789 Monheim am Rhein - il-Ġermanja,
Done at Brussels, 8 September 2008.
Magħmula fi Brussell, 8 ta’ Settembru 2008.
For the Commission
Għall-Kummissjoni
Androulla Vassiliou
Androulla Vassiliou
Member of the Commission
Membru tal-Kummissjoni
[1] OJ L 268, 18.10.2003, p 1.
[1] ĠU L 268, 18.10.2003, p. 1.
[2] OJ L 106, 17.4.2001, p. 1.
[2] ĠU L 106, 17.4.2001, p. 1.
[3] http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620785771.htm
[3] http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620785771.htm
[4] OJ L 10, 16.1.2004, p. 5.
[4] ĠU L 10, 16.1.2004, p. 5.
[5] OJ L 268, 18.10.2003, p. 24.
[5] ĠU L 268, 18.10.2003, p. 24.
[6] OJ L 287, 5.11.2003, p. 1.
[6] ĠU L 287, 5.11.2003, p. 1.
[7] OJ L 184, 17.7.1999, p 23.
[7] ĠU L 184, 17.7.1999, p. 23.
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ANNEX
ANNESS
(a) Applicant and authorisation holder:
(a) L-applikant u d-detentur tal-Awtorizzazzjoni:
Name : Bayer CropScience AG.
Isem : Bayer CropScience AG
Address : Alfred-Nobel-Strasse 50, D-40789 Monheim am Rhein, Germany.
Indirizz : Alfred-Nobel-Strasse 50, D - 40789 Monheim am Rhein – Il-Ġermanja
(b) Designation and specification of the products:
(b) Isem u speċifikazzjoni tal-prodotti:
1. Foods and food ingredients containing, consisting of, or produced from ACS-GMØØ5-3 soybean.
(1) Ikel u ingredjenti tal-ikel li fihom, li huma magħmula, jew li ġejjin mis-sojja ACS-GHØØ5-3;
2. Feed containing, consisting of, or produced from ACS-GMØØ5-3 soybean.
(2) Għalf li fih, li hu magħmul, jew li ġej mis-sojja ACS-GHØØ5-3;
3. Products other than food and feed containing or consisting of ACS-GMØØ5-3 soybean for the same uses as any other soybean with the exception of cultivation.
(3) Prodotti għajr ikel u għalf li fihom jew li huma magħmula mis-sojja ACS-GHØØ5-3 għall-istess użi bħal kwalunkwe sojja oħra ħlief għall-kultivazzjoni.
The genetically modified ACS-GMØØ5-3 soybean, as described in the application, expresses the PAT protein which confers tolerance to the glufosinate-ammonium herbicide.
Is-sojja ACS-GHØØ5-3 modifikata ġenetikament, kif deskritt fl-applikazzjoni, tesprimi l-proteina PAT li tagħti t-tolleranza lill-erbiċida glufosinat-ammonju.
(c) Labelling:
(c) L-ittikkettjar:
1. For the purposes of the specific labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the "name of the organism" shall be "soybean".
(1) Għall-finijiet tar-rekwiżiti speċifiċi tal-ittikkettjar stipulati fl-Artikoli 13(1) u 25(2) tar-Regolament (KE) Nru 1829/2003 u fl-Artikolu 4(6) tar-Regolament (KE) Nru 1830/2003, "isem l-organiżmu" għandu jkun "sojja".
2. The words "not for cultivation" shall appear on the label of and in documents accompanying products containing or consisting of ACS-GMØØ5-3 soybean referred to in Article 2(b) and (c) of this Decision.
(2) Il-kelmiet "mhux għall-kultivazzjoni" għandhom jidhru fuq it-tikketta ta’, u fid-dokumenti li jakkumpanjaw, il-prodotti li fihom jew li huma magħmula mis-sojja ACS-GHØØ5-3 li jissemmew fl-Artikolu 2(b) u (c) ta’ din id-Deċiżjoni.
(d) Method for detection:
(d) Metodu ta’ investigazzjoni:
- event specific real-time PCR-based method for the quantification of ACS-GMØØ5-3 soybean,
- Metodu fil-ħin reali speċifiku għall-avveniment ibbażat fuq il-PCR għall-kwantifikazzjoni tas-sojja ACS-GHØØ5-3
- validated on seeds by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.it/statusofdoss.htm
- Ivvalidat fuq iż-żrieragħ mil-laboratorju ta’ referenza Komunitarju stabbilit skont ir-Regolament (KE) Nru 1829/2003, ippubblikat fuq http://gmo-crl.jrc.it/statusofdoss.htm
- reference material: AOCS 0707-A, AOCS 0707-B and AOCS 0707-C accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm/bayer_soy.cfm
- Materjal ta’ Referenza: AOCS 0707-A, AOCS 0707-B u AOCS 0707-C aċċessibbli permezz l-American Oil Chemists Society f’http://www.aocs.org/tech/crm/bayer_soy.cfm
(e) Unique identifier:
(e) Identifikatur uniku:
ACS-GMØØ5-3.
ACS-GMØØ5-3
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
(f) Tagħrif mitlub skond l-Anness II tal-Protokoll ta’ Cartagena dwar il-Bijosigurtà mal-Konvenzjoni dwar id-Diversità Bijoloġika:
Biosafety Clearing House, Record ID: see [to be completed when notified].
Clearing House tal-Bijosikurezza, Rekord ID: ara [għandu jitlesta meta notifikat]
(g) Conditions or restrictions on the placing on the market, use or handling of the products:
(g) Kundizzjonijiet jew restrizzjonijiet rigward it-tqegħid fis-suq, l-użu jew il-ġarr tal-prodotti:
Not required.
Mhux meħtieġa.
(h) Monitoring plan:
(h) Il-pjan ta’ monitoraġġ
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
Il-pjan ta’ monitoraġġ għal effetti ambjentali li jikkonforma ma’ l-Anness VII tad-Direttiva 2001/18/KE
[Link: plan published on the Internet]
[Link: pjan ippubblikat fuq l-Internet]
(i) Post-market monitoring requirements for the use of the food for human consumption:
(i) Rekwiżiti ta’ monitoraġġ wara t-tqegħid fis-suq għall-użu tal-ikel għal konsum mill-bniedem
Not required.
Mhux meħtieġa.
Note: Links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.
Nota: il-links għal dokumenti rilevanti jista’ jkollhom bżonn jiġu emendati minn żmien għall-ieħor. Dawk il-modifiki se jkunu disponibbli għall-pubbliku permezz tal-aġġornament tar-reġistru Komunitarju tal-ikel u l-għalf modifikati ġenetikament.
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