natgillin/translations-raw huggingface dataset:
PORTUGAL
AUSTRIJA
ROMANIA
POLJSKA
SLOVENIA
RUMUNJSKA
SLOVAKIA
SLOVENIJA
renewing the authorisation for the placing on the market of genetically modified maize MON 810 (MON-ØØ81Ø-6) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
o obnovi odobrenja za stavljanje na tržište proizvoda od genetski modificiranog kukuruza MON 810 (MON-ØØ81Ø-6) na temelju Uredbe (EZ) br. 1829/2003 Europskog parlamenta i Vijeća
(notified under document C(2017) 4453)
(priopćeno pod brojem dokumenta C(2017) 4453)
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 11(3) and 23(3) thereof,
uzimajući u obzir Uredbu (EZ) br. 1829/2003 Europskog parlamenta i Vijeća od 22. rujna 2003. o genetski modificiranoj hrani i hrani za životinje [1], a posebno njezin članak 11. stavak 3. i članak 23. stavak 3.,
On 11 and 18 April 2007, Monsanto Europe SA submitted to the Commission three applications, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of the authorisation of existing foods, food ingredients and feed produced from maize MON 810, of the authorisation of feed containing and consisting of maize MON 810 and of the authorisation of maize MON 810 in products consisting of it or containing it for other uses than food and feed, as any other maize, including cultivation.
Dana 11. i 18. travnja 2007. trgovačko društvo Monsanto Europe S.A. podnijelo je Komisiji tri zahtjeva, u skladu s člancima 11. i 23.
After the date of the entry into force of Regulation (EC) No 1829/2003, those products were notified to the Commission pursuant to Article 8(1)(a) and (b) and Article 20(1)(b) of that Regulation and included in the Community Register of genetically modified food and feed.
Uredbe (EZ) br. 1829/2003 za obnovu odobrenja postojeće hrane, sastojaka hrane i hrane za životinje proizvedenih od kukuruza MON 810, odobrenja hrane za životinje koja sadržava kukuruz MON 810 i sastoji se od njega te odobrenje kukuruza MON 810 u proizvodima koji ga sadržavaju ili se od njega sastoje te se koriste za druge namjene od hrane i hrane za životinje, kao i ostali kukuruz, uključujući uzgoj.
On 9 March 2016, Monsanto Europe SA sent a letter to the Commission requesting that the part of the application concerning cultivation be considered separately from the rest of the application.
Nakon datuma stupanja na snagu Uredbe (EZ) br. 1829/2003 ti su proizvodi prijavljeni Europskoj komisiji u skladu s člankom 8. stavkom 1. točkama (a) i (b) i člankom 20. stavkom 1. točkom (b) te Uredbe i uvršteni u registar Zajednice genetski modificirane hrane i hrane za životinje.
Therefore, this Decision does not cover the use of maize MON 810 seeds for cultivation.
Dana 9. ožujka 2016.
The placing on the market of pollen produced from maize MON 810 was authorised by Commission Implementing Decision 2013/649/EU [2] and is therefore not covered by this Decision.
Monsanto Europe S.A. poslao je Komisiji pismo u kojem zahtijeva da se dio zahtjeva za uzgoj razmatra zasebno od ostatka zahtjeva.
On 30 June 2009, the European Food Safety Authority (‘EFSA’) issued a favourable opinion (updated on 30 July 2009) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003.
Stoga ova Odluka ne obuhvaća uporabu sjemena kukuruza MON 810 za uzgoj.
It concluded that genetically modified maize MON 810, as described in the application, is as safe as its conventional counterpart with respect to potential adverse effects on human and animal health and is unlikely to have adverse effects on the environment taking into account its intended uses [3].
Stavljanje na tržište peludi proizvedene od kukuruza MON 810 odobreno je Provedbenom odlukom Komisije 2013/649/EU [2] i stoga nije obuhvaćeno ovom odlukom.
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 Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.
Europska agencija za sigurnost hrane („EFSA”) dala je 30. lipnja 2009. pozitivno mišljenje (ažurirano 30. srpnja 2009.) u skladu s člancima 6. i 18.
Taking into account those considerations, the authorisation should be renewed for food and food ingredients produced from maize MON 810, with the exception of pollen, for feed containing or consisting of, or produced from maize MON 810 and for maize MON 810 in products consisting of it or containing it for other uses than food or feed, with the exception of cultivation.
Uredbe (EZ) br. 1829/2003.
A unique identifier has been assigned to genetically modified maize MON 810 in accordance with Commission Regulation (EC) No 65/2004 [4], in the context of the initial authorisation of maize MON 810.
Agencija je zaključila da je genetski modificirani kukuruz MON 810, kako je opisano u zahtjevu, jednako siguran kao njegov konvencionalni dvojnik u pogledu mogućih štetnih učinaka na zdravlje ljudi i životinja te da vjerojatno neće imati negativne učinke na okoliš uzimajući u obzir planiranu uporabu [3].
That unique identifier should continue to be used.
EFSA je u svojem mišljenju razmotrila sva specifična pitanja i dvojbe država članica koji su izneseni u okviru savjetovanja s nacionalnim nadležnim tijelima, kako je predviđeno člankom 6. stavkom 4. i člankom 18. stavkom 4.
On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for food and food ingredients produced from maize MON 810 and for feed containing, consisting of, or produced from maize MON 810.
Uredbe (EZ) br. 1829/2003.
The authorisation holder should submit annual reports on the implementation and the results of the activities set out in in this monitoring plan.
Uzimajući u obzir navedeno, potrebno je obnoviti odobrenje za hranu i sastojke hrane koji su proizvedeni od kukuruza MON 810, s iznimkom peludi, za hranu za životinje koja sadržava ili se sastoji od ili je proizvedena od kukuruza MON 810 i za kukuruz MON 810 u proizvodima koji se od njega sastoje ili ga sadržavaju te se koriste za druge namjene od hrane ili hrane za životinje, osim uzgoja.
Those results should be presented in accordance with Commission Decision 2009/770/EC [5].
Genetski modificiranom kukuruzu MON 810 dodijeljen je jedinstveni identifikacijski kod u skladu s Uredbom Komisije (EZ) br. 65/2004 [4], u kontekstu početnog odobrenja kukuruza MON 810.
The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or for the use and handling of the food and feed, including post-market monitoring requirements.
Taj se jedinstveni identifikacijski kod treba nastaviti koristiti.
All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed referred to in Regulation (EC) No 1829/2003.
Na temelju mišljenja EFSA-e čini se da nisu potrebni posebni zahtjevi za označivanje hrane i sastojaka hrane proizvedenih od kukuruza MON 810 te hrane za životinje koja sadržava genetski modificirani kukuruz MON 810 te se sastoji ili je proizvedena od kukuruza MON 810, osim onih predviđenih člankom 13. stavkom 1. i člankom 25. stavkom 2.
The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman.
Uredbe (EZ) br. 1829/2003.
An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation.
Nositelj odobrenja trebao bi podnositi godišnja izvješća o provedbi i rezultatima aktivnosti utvrđenih ovim planom praćenja.
The appeal committee did not deliver an opinion,
Te bi rezultate trebalo dostaviti u skladu s Odlukom Komisije 2009/770/EZ [5].
HAS ADOPTED THIS DECISION:
Mišljenje EFSA-e ne opravdava uvođenje posebnih uvjeta ili ograničenja za stavljanje na tržište i/ili za uporabu hrane i hrane za životinje i rukovanje njima, uključujući zahtjeve za nadzor nakon stavljanja na tržište.
Article 1
Sve relevantne informacije o odobrenju proizvoda trebalo bi upisati u registar Zajednice genetski modificirane hrane i hrane za životinje, kako je predviđeno Uredbom (EZ) br. 1829/2003.
Genetically modified organism and unique identifier
Stalni odbor za bilje, životinje, hranu i hranu za životinje nije dostavio mišljenje u roku koji je odredio njegov predsjednik.
Genetically modified maize (Zea mays L.)
Ocijenilo se da je potrebno donijeti provedbeni akt te je predsjednik odbora odboru za žalbe podnio nacrt provedbenog akta na daljnje razmatranje.
MON 810, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØ81Ø-6, in accordance with Regulation (EC) No 65/2004.
Odbor za žalbe nije dostavio mišljenje,
Renewal of the authorisation
Članak 1.
The authorisation of the following products is renewed in accordance with the conditions set out in this Decision:
Genetski modificirani organizam i jedinstveni identifikacijski kod
foods and food ingredients produced from MON-ØØ81Ø-6 maize, with the exception of pollen;
Genetski modificiranom kukuruzu (Zea maysL.)
feed containing, consisting of or produced from MON-ØØ81Ø-6 maize;
MON 810, kako je utvrđeno točkom (b) Priloga ovoj odluci, dodjeljuje se jedinstveni identifikacijski kod MON-ØØ81Ø-6, u skladu s Uredbom (EZ) br. 65/2004.
MON-ØØ81Ø-6 maize in products containing it or consisting of it for any other use than food or feed, with the exception of cultivation.
Članak 2.
Article 3
Obnova odobrenja
Labelling
U skladu s uvjetima iz ove odluke obnavlja se odobrenje sljedećih proizvoda:
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council [6], the ‘name of the organism’ shall be ‘maize’.
hrana i sastojci hrane su proizvedeni od kukuruza MON-ØØ81Ø-6, osim peludi;
Article 4
hrana za životinje koja sadržava kukuruz MON-ØØ81Ø-6, sastoji se ili je proizvedena od njega;
Monitoring for environmental effects
kukuruz MON-ØØ81Ø-6 u proizvodima koji ga sadržavaju ili se sastoje od njega te se koriste za druge namjene od hrane ili hrane za životinje, osim uzgoja.
The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex to this Decision, is put in place and implemented.
Članak 3.
The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with the format set out in Decision 2009/770/EC.
Označivanje
Article 5
Za potrebe zahtjeva označivanja iz članka 13. stavka 1. i članka 25. stavka 2.
Community register
Uredbe (EZ) br. 1829/2003 te članka 4. stavka 6.
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed referred to in Article 28 of Regulation (EC) No 1829/2003.
Uredbe (EZ) br. 1830/2003 Europskog parlamenta i Vijeća [6]„naziv organizma” je „kukuruz”.
Authorisation holder
Praćenje učinaka na okoliš
The authorisation holder shall be Monsanto Europe SA, Belgium, representing Monsanto Company, United States of America.
Nositelj odobrenja jamči uspostavu i provedbu plana praćenja učinaka na okoliš, kako je utvrđeno u točki (h) Priloga ovoj odluci.
Article 7
Nositelj odobrenja Komisiji podnosi godišnja izvješća o provedbi i rezultatima aktivnosti utvrđenih planom praćenja u skladu s formatom utvrđenim Odlukom 2009/770/EZ.
Validity
Članak 5.
This Decision shall apply for a period of 10 years from the date of its notification.
Registar Zajednice
Article 8
Informacije iz Priloga ovoj odluci upisuju se u registar Zajednice genetski modificirane hrane i hrane za životinje, kako je predviđeno člankom 28.
Addressee
Uredbe (EZ) br. 1829/2003.
This Decision is addressed to Monsanto Europe SA, Avenue de Tervuren 270-272, B-1150 Brussels, Belgium
Članak 6.
Done at Brussels, 4 July 2017.
Nositelj odobrenja
For the Commission
Nositelj odobrenja je Monsanto Europe S. A., Belgija, koji zastupa Monsanto Company, Sjedinjene Američke Države.
Member of the Commission
Članak 7.
OJ L 268, 18.10.2003, p. 1.
Valjanost
Commission Implementing Decision 2013/649/EU of 6 November 2013 authorising the placing on the market of pollen produced from maize MON 810 (MON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 302, 13.11.2013, p. 44).
Ova se odluka primjenjuje u razdoblju od 10 godina od dana objave.
Scientific Opinion of the Panel on Genetically Modified Organisms on applications (EFSA-GMORX-MON810) for the renewal of authorisation for the continued marketing of (1) existing food and food ingredients produced from genetically modified insect resistant maize MON810; (2) feed consisting of and/or containing maize MON810, including the use of seed for cultivation; and of (3) food and feed additives, and feed materials produced from maize MON810, all under Regulation (EC) No 1829/2003 from Monsanto.
Članak 8.
EFSA Journal (2009) 1149, pp. 1-84.
Adresat
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 (OJ L 10, 16.1.2004, p. 5).
Ova je odluka upućena trgovačkom društvu Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 Bruxelles, Belgija
Commission Decision 2009/770/EC of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (OJ L 275, 21.10.2009, p. 9).
Sastavljeno u Bruxellesu 4. srpnja 2017.
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 (OJ L 268, 18.10.2003, p.
Za Komisiju
24)
Član Komisije
ANNEX
SL L 268, 18.10.2003., str. 1.
Applicant and authorisation holder:
Provedbena odluka Komisije 2013/649/EU оd 6. studenoga 2013. o odobravanju stavljanja na tržište peluda proizvedenog od kukuruza MON 810 (MON-ØØ81Ø-6) na temelju Uredbe (EZ) br. 1829/2003 Europskog parlamenta i Vijeća (SL L 302, 13.11.2013., str. 44.).
Name Monsanto Europe SA
Znanstveno mišljenje panela o genetski modificiranim organizmima o Monsantovim zahtjevima (EFSA-GMORX-MON810) za obnovu odobrenja za daljnje stavljanje na tržište (1) postojeće hrane i sastojaka hrane proizvedenih od genetski modificiranog kukuruza otpornog na insekte MON810; (2) hrane za životinje koja se sastoji od kukuruza MON810 i/ili ga sadržava, uključujući uporabu sjemena za uzgoj; i (3) hrane i dodataka hrani za životinje te krmiva proizvedenih od kukuruza MON810, sve u skladu s Uredbom (EZ) br. 1829/2003.
Address Avenue de Tervuren 270-272, B-1150 Brussels — Belgium
EFSA Journal (2009.) 1149, 1–84.
On behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America
Uredba Komisije (EZ) br. 65/2004 od 14. siječnja 2004. o uspostavi sustava za određivanje i dodjelu jedinstvenih identifikacijskih kodova za genetski modificirane organizme (SL L 10, 16.1.2004., str. 5.).
Designation and specification of the products:
Odluka Komisije 2009/770/EZ od 13. listopada 2009. o utvrđivanju standardnih obrazaca za izvješćivanje o rezultatima praćenja namjernog uvođenja genetski modificiranih organizama u okoliš, kao proizvoda ili u sastavu proizvoda, za potrebe stavljanja na tržište, u skladu s Direktivom 2001/18/EZ Europskog parlamenta i Vijeća (SL L 275, 21.10.2009., str. 9.).
feed containing, consisting of, or produced from MON-ØØ81Ø-6 maize;
Uredba (EZ) br.
The genetically modified MON-ØØ81Ø-6 maize as described in the applications expresses the Cry1Ab protein, derived from Bacillus thuringiensis subsp. kurstaki, which confers protection against predation by certain lepidopteran insect pests, including the European corn borer (Ostrinia nubilalis) and pink borers (Sesamia spp.).
1830/2003 Europskog parlamenta i Vijeća od 22. rujna 2003. o sljedivosti i označivanju genetski modificiranih organizama te sljedivosti hrane i hrane za životinje proizvedene od genetski modificiranih organizama i izmjeni Direktive 2001/18/EZ (SL L 268, 18.10.2003., str.
Labelling:
24.).
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 ‘maize’;
PRILOG
Method for detection:
Podnositelj zahtjeva i nositelj odobrenja:
Event-specific real-time PCR-based method for the quantification of MON-ØØ81Ø-6 maize;
Naziv Monsanto Europe S.A.
Validated by the Federal Institute for Risk assessment (BfR) in collaboration with the Joint Research Centre of the European Commission and other parties, and verified by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from maize seeds, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
Adresa Avenue de Tervuren 270-272, B-1150 Bruxelles, Belgija
Reference Material: ERM-BF413 and ERM-AD413 accessible via the Institute for Reference Materials and Measurements (IRMM) of the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/
U ime trgovačkog društva Monsanto Company – 800 N. Lindbergh Boulevard – St. Louis, Missouri 63167, Sjedinjene Američke Države
Unique identifier:
Opis i specifikacija proizvoda:
Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
hrana za životinje koja sadržava kukuruz MON-ØØ81Ø-6, sastoji se ili je proizvedena od njega;
(Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified).
Genetski modificirani kukuruz MON-ØØ81Ø-6, kako je opisano u zahtjevima, eksprimira protein Cry1Ab, dobiven iz Bacillus thuringiensis podvrste kurstaki, koji pruža zaštitu od određenih insekata nametnika iz reda Lepidoptera, uključujući kukuruznog moljca (Ostrinia nubilalis) i kukuruznu sovicu (Sesamia spp.).
Conditions or restrictions on the placing on the market, use or handling of the products:
Označivanje:
Not required.
Za potrebe zahtjeva označivanja iz članka 13. stavka 1. i članka 25. stavka 2.
Monitoring plan for environmental effects:
Uredbe (EZ) br. 1829/2003 te članka 4. stavka 6.
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
Uredbe (EZ) br. 1830/2003 „naziv organizma” je „kukuruz”;
(Link: plan published in the Community register of genetically modified food and feed)
Metoda otkrivanja:
Post-market monitoring requirements for the use of the food for human consumption:
Specifična kvantitativna metoda za otkrivanje kukuruza MON-ØØ81Ø-6 na temelju lančane reakcije s polimerazom (PCR), u stvarnom vremenu.
Note: links to relevant documents may need to be modified over the time.
Potvrđena od strane Saveznog instituta za procjenu rizika (BfR) u suradnji sa Zajedničkim istraživačkim centrom Europske komisije i drugim strankama te provjerena u referentnom laboratorija EU-a osnovanom na temelju Uredbe (EZ) br. 1829/2003 o genomskom DNK-u ekstrahiranom iz sjemenja kukuruza, objavljeno na http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx;
authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB119 (BCS-GHØØ5-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed
o odobravanju stavljanja na tržište proizvoda koji sadržavaju genetski modificirani pamuk GHB119 (BCS-GHØØ5-8) ili se sastoje ili su proizvedeni od njega, na temelju Uredbe (EZ) br. 1829/2003 Europskog parlamenta i Vijeća o genetski modificiranoj hrani i hrani za životinje
(notified under document C(2017) 4457)
(priopćeno pod brojem dokumenta C(2017) 4457)
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,
uzimajući u obzir Uredbu (EZ) br. 1829/2003 Europskog parlamenta i Vijeća od 22. rujna 2003. o genetski modificiranoj hrani i hrani za životinje [1], a posebno njezin članak 7. stavak 3. i članak 19. stavak 3.,
On 25 March 2011, Bayer 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 GHB119 cotton (‘the application’).
U skladu s člancima 5. i 17.
The application also covered the placing on the market of genetically modified cotton GHB119 in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation.
Uredbe (EZ) br. 1829/2003 društvo Bayer 25. ožujka 2011. podnijelo je nadležnom tijelu Nizozemske zahtjev za stavljanje na tržište hrane, sastojaka hrane i hrane za životinje koji sadržavaju pamuk GHB119 ili se sastoje ili su proizvedeni od njega („zahtjev”).
In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council [2] and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to that Directive.
Zahtjev obuhvaća i stavljanje na tržište genetski modificiranog pamuka GHB119 u proizvodima koji se sastoje od njega ili ga sadržavaju za druge namjene, osim kao hrana i hrana za životinje, koje su odobrene za druge vrste pamuka, osim za uzgoj.
It also included a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
U skladu s člankom 5. stavkom 5. i člankom 17. stavkom 5.
On 21 October 2016, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 [3].
Uredbe (EZ) br. 1829/2003 zahtjev je uključivao podatke i informacije koji se zahtijevaju na temelju priloga III. i IV.
It concluded that genetically modified cotton GHB119, as described in the application, is as safe and as nutritious as its conventional counterpart as regards the potential effects on human and animal health and the environment in the context of the scope of the application.
Direktivi 2001/18/EZ Europskog parlamenta i Vijeća [2] te informacije i zaključke o procjeni rizika provedenoj u skladu s načelima utvrđenima u Prilogu II. toj direktivi.
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 Article 18(4) of Regulation (EC) No 1829/2003.
Zahtjev je sadržavao i plan praćenja učinaka na okoliš u skladu s Prilogom VII.
EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant, is in line with the intended uses of the products.
Direktivi 2001/18/EZ.
Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified cotton GHB119.
Europska agencija za sigurnost hrane („EFSA”) 21. listopada 2016. dala je pozitivno mišljenje u skladu s člancima 6. i 18.
A unique identifier should be assigned to cotton GHB119, in accordance with Commission Regulation (EC) No 65/2004 [4].
Uredbe (EZ) br. 1829/2003 [3].