natgillin/translations-raw huggingface dataset:
The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.
Na temelju mišljenja EFSA-e, kojim se potvrđuje da je sastav masnih kiselina sjemena soje 305423 × 40-3-2 i dobivenog ulja izmijenjen u odnosu na njezin konvencionalni ekvivalent, potrebna je posebna oznaka u skladu s člankom 13. stavkom 2. točkom (a) i člankom 25. stavkom 2. točkom (c) Uredbe (EZ) br. 1829/2003.
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.
Na temelju mišljenja EFSA-e čini se da za proizvode obuhvaćene ovom Odlukom nisu potrebni posebni zahtjevi za označivanje, osim onih utvrđenih u članku 13. stavku 1. i članku 25. stavku 2.
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 Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council [7].
Uredbe (EZ) br. 1829/2003 te u članku 4. stavku 6.
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. 1830/2003 Europskog parlamenta i Vijeća [5].
This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation.
Međutim, kako bi se zajamčila uporaba proizvoda u okviru granica odobrenja predviđenog ovom Odlukom, pri označivanju proizvoda koji sadržavaju genetski modificirani organizam za koji je zatraženo odobrenje ili se sastoje od njega, osim prehrambenih proizvoda, trebalo bi jasno istaknuti da se predmetni proizvodi ne smiju upotrebljavati za uzgoj.
The appeal committee did not deliver an opinion,
Nositelji odobrenja trebali bi podnositi godišnja izvješća o provedbi i rezultatima aktivnosti utvrđenih u planu praćenja učinaka na okoliš.
HAS ADOPTED THIS DECISION:
Te bi rezultate trebalo dostaviti u skladu sa zahtjevima standardnog obrasca za izvješćivanje utvrđenima u Odluci Komisije 2009/770/EZ [6].
Article 1
Uzimajući u obzir mišljenje EFSA-e, nije opravdano uvođenje posebnih uvjeta za zaštitu posebnih ekosustava/okoliša ili geografskih područja, kako je predviđeno u članku 6. stavku 5. točki (e) i članku 18. stavku 5. točki (e) Uredbe (EZ) br. 1829/2003.
Genetically modified organism and unique identifier
Nositelj odobrenja trebao bi podnositi i godišnja izvješća o provedbi i rezultatima aktivnosti utvrđenih u planu praćenja nakon stavljanja na tržište.
Genetically modified soybean (Glycine max (L.)
Sve relevantne informacije o odobrenju proizvoda trebalo bi upisati u registar Zajednice genetski modificirane hrane i hrane za životinje, kako je predviđeno u Uredbi (EZ) br. 1829/2003.
Merr.) 305423 × 40-3-2, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DP-3Ø5423-1 × MON-Ø4Ø32-6, as provided for in Regulation (EC) No 65/2004.
O ovoj je Odluci potrebno obavijestiti stranke Kartagenskog protokola o biološkoj sigurnosti uz Konvenciju o biološkoj raznolikosti mehanizmom za razmjenu obavijesti o biološkoj sigurnosti, u skladu s člankom 9. stavkom 1. i člankom 15. stavkom 2. točkom (c) Uredbe (EZ) br. 1946/2003 Europskog parlamenta i Vijeća [7].
Authorisation
Ovaj se provedbeni akt smatrao potrebnim i predsjednik odbora podnio ga je žalbenom odboru na daljnje razmatranje.
The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
Žalbeni odbor nije dostavio mišljenje,
foods and food ingredients containing, consisting of, or produced from DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean;
DONIJELA JE OVU ODLUKU:
feed containing, consisting of, or produced from DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean;
Članak 1.
DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.
Genetski modificirani organizam i jedinstveni identifikacijski kôd
Article 3
Genetski modificiranoj soji (Glycine max (L.)
Labelling
Merr.) 305423 × 40-3-2, kako je utvrđena u točki (b) Priloga ovoj Odluci, dodjeljuje se jedinstveni identifikacijski kôd DP-3Ø5423-1 × MON-Ø4Ø32-6, kako je predviđeno u Uredbi (EZ) br. 65/2004.
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and Article 4(6) of Regulation (EC) No 1830/2003 the ‘name of the organism’ shall be ‘soybean’.
Članak 2.
For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.
Odobrenje
The words ‘not for cultivation’ shall appear on the label of the product and in the documents accompanying products containing or consisting of DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean, with the exception of products referred to in point (a) of Article 2.
Za potrebe članka 4. stavka 2. i članka 16. stavka 2.
Article 4
Uredbe (EZ) br. 1829/2003 i u skladu s uvjetima utvrđenima u ovoj Odluci odobravaju se sljedeći proizvodi:
Monitoring plan for environmental effects
hrana i sastojci hrane koji sadržavaju soju DP-3Ø5423-1 × MON-Ø4Ø32-6, sastoje se ili su proizvedeni od nje;
The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.
hrana za životinje koja sadržava soju DP-3Ø5423-1 × MON-Ø4Ø32-6, sastoji se ili je proizvedena od nje;
The authorisation holder shall submit annual reports on the implementation and the results of the activities set out in the monitoring plan to the Commission in accordance with Decision 2009/770/EC.
soja DP-3Ø5423-1 × MON-Ø4Ø32-6 u proizvodima koji je sadržavaju ili se sastoje od nje za sve druge namjene osim onih iz točaka (a) i (b), osim za uzgoj.
Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003
Označivanje
The authorisation holder shall ensure that the post-market monitoring plan of the DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean oil, as set out in point (g) of the Annex, is put in place and implemented.
Za potrebe zahtjeva za označivanje utvrđenih u članku 13. stavku 1. i članku 25. stavku 2.
The authorisation holder shall submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan to the Commission for the duration of the authorisation.
Uredbe (EZ) br. 1829/2003 te u članku 4. stavku 6.
Article 6
Uredbe (EZ) br. 1830/2003, „naziv organizma” jest „soja”.
Community register
Za potrebe zahtjeva za označivanje utvrđenih u članku 13. stavku 2. točki (a) i članku 25. stavku 2. točki (c) Uredbe (EZ) br. 1829/2003, riječi „s povećim udjelom jednostruko nezasićenih masnoća i smanjenim udjelom višestruko nezasićenih masnoća” navode se iza naziva organizma na oznaci ili, prema potrebi, u popratnim dokumentima proizvoda.
The information set out in the Annex 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.
Riječi „nije za uzgoj” navode se na oznaci proizvoda i u popratnim dokumentima proizvoda koji sadržavaju soju DP-3Ø5423-1 × MON-Ø4Ø32-6 ili se sastoje od nje, osim proizvoda iz članka 2. točke (a).
Authorisation holder
Plan praćenja učinaka na okoliš
The authorisation holder shall be Pioneer Overseas Corporation, representing Pioneer Hi-Bred International, Inc., United States.
Nositelji odobrenja osiguravaju uspostavu i provedbu plana praćenja učinaka na okoliš, kako je utvrđeno u točki (h) Priloga.
Article 8
Nositelj odobrenja dužan je Komisiji podnositi godišnja izvješća o provedbi i rezultatima aktivnosti utvrđenih u planu praćenja u skladu s Odlukom 2009/770/EZ.
This Decision shall apply for a period of 10 years from the date of its notification.
Praćenje nakon stavljanja na tržište u skladu s člankom 6. stavkom 5. točkom (e) Uredbe (EZ) br. 1829/2003
Article 9
Nositelj odobrenja osigurava uspostavu i provedbu plana praćenja nakon stavljanja na tržište ulja od soje DP-3Ø5423-1 × MON-Ø4Ø32-6, kako je utvrđeno u točki (g) Priloga.
Addressee
Tijekom trajanja odobrenja nositelj odobrenja Komisiji podnosi godišnja izvješća o provedbi i rezultatima aktivnosti utvrđenih u planu praćenja nakon stavljanja na tržište.
This Decision is addressed to Pioneer Overseas Corporation, Avenue des Arts 44, B-1040 Brussels – Belgium
Članak 6.
Done at Brussels, 21 December 2017.
Registar Zajednice
For the Commission
Informacije iz Priloga upisuju se u registar Zajednice genetski modificirane hrane i hrane za životinje, kako je predviđeno u članku 28.
Member of the Commission
Uredbe (EZ) br. 1829/2003.
OJ L 268, 18.10.2003, p.
Članak 7.
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 (OJ L 106, 17.4.2001, p.
Nositelj odobrenja je Pioneer Overseas Corporation, koji zastupa Pioneer Hi-Bred International, Inc., Sjedinjene Američke Države.
1).
Članak 8.
EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2016.
Valjanost
Scientific Opinion on an application by Pioneer (EFSA-GMO-NL-2007-47) for the placing on the market of the herbicide-tolerant, high-oleic acid, genetically modified soybean 305423 9 40-3-2 for food and feed uses, import and processing under Regulation (EC) No 1829/2003.
Ova se Odluka primjenjuje u razdoblju od 10 godina od dana objave.
EFSA Journal 2016; 14(8):4566, 31 pp. doi:10.2903/j.efsa.2016.4566.
Članak 9.
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.
Adresat
5).
Ova je Odluka upućena društvu Pioneer Overseas Corporation, Avenue des Arts 44, B-1040 Bruxelles, Belgija
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.
Sastavljeno u Bruxellesu 21. prosinca 2017.
24).
Za Komisiju
9).
SL L 268, 18.10.2003., str.
Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (OJ L 287, 5.11.2003, p.
1.
1).
Direktiva 2001/18/EZ Europskog parlamenta i Vijeća od 12. ožujka 2001. o namjernom uvođenju u okoliš genetski modificiranih organizama i o stavljanju izvan snage Direktive Vijeća 90/220/EEZ (SL L 106, 17.4.2001., str. 1.).
ANNEX
EFSA Journal 2016.; 14(8):4566, 31 str. doi:10.2903/j.efsa.2016.4566.
Applicant and Authorisation holder:
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.).
Name Pioneer Overseas Corporation
Uredba (EZ) br. 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. 24.).
Address Avenue des Arts 44, 1040 Brussels - Belgium
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.).
On behalf of Pioneer Hi-Bred International, Inc. – 7100 NW 62nd Avenue – P.O. Box 1014 – Johnston, IA 50131-1014 - United States of America
Uredba (EZ) br. 1946/2003 Europskog parlamenta i Vijeća od 15. srpnja 2003. o prekograničnom prijenosu genetski modificiranih organizama (SL L 287, 5.11.2003., str. 1.).
Designation and specification of the products:
PRILOG
DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean in products containing it or consisting of it for any other use than those provided in points (1) and (2), with the exception of cultivation.
Podnositelj zahtjeva i nositelj odobrenja:
The genetically modified DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean, as described in the application, has a reduced expression of the soybean enzyme omega-6 desaturase, which results in a high oleic acid and reduced linoleic acid profile, expresses an optimised Glycine max-hra gene, which confers tolerance to acetolactate synthase-inhibiting herbicides and expresses the CP4 EPSPS protein which confers tolerance to glyphosate herbicides.
Naziv Pioneer Overseas Corporation
Labelling:
Adresa Avenue des Arts 44, B-1040 Bruxelles, Belgija
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, the ‘name of the organism’ shall be ‘soybean’;
Opis i specifikacija proizvoda:
For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products;
soja DP-3Ø5423-1 × MON-Ø4Ø32-6 u proizvodima koji je sadržavaju ili se sastoje od nje za sve druge namjene osim onih iz točaka 1. i 2., osim za uzgoj.
The words ‘not for cultivation’ shall appear on the label of and in the accompanying documents of the products containing or consisting of DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean with the exception of products referred to in point (a) of Article 2.
Kako je opisano u zahtjevu, genetski modificirana soja DP-3Ø5423-1 × MON-Ø4Ø32-6 ima smanjenu ekspresiju enzima soje omega-6 desaturaze, što ima za posljedicu povećanje udjela oleinske kiseline i smanjenje udjela linolne kiseline, eksprimira optimizirani gen Glycine max-hra koji omogućuje toleranciju na herbicid koji inhibira acetolaktat sintazu i eksprimira protein CP4 EPSPS koji omogućuje otpornost na herbicid glifosat.
Method for detection:
Označivanje:
Event specific real-time quantitative PCR based methods for DP-3Ø5423-1 and MON-Ø4Ø32-6 soybeans; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean;
za potrebe zahtjeva za označivanje utvrđenih u članku 13. stavku 1. i članku 25. stavku 2.
Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
Uredbe (EZ) br. 1829/2003 te u članku 4. stavku 6.
Reference Material: ERM-BF426 (for DP-3Ø5423-1) and ERM-BF410 (for MON-Ø4Ø32-6) are accessible via the Joint Research Centre (JRC) of the European Commission at https://ec.europa.eu/jrc/en/reference-materials/catalogue
Uredbe (EZ) br. 1830/2003, „naziv organizma” je „soja”;
Unique identifier:
za potrebe zahtjeva označivanja utvrđenih u članku 13. stavku 2. točki (a) i članku 25. stavku 2. točki (c) Uredbe (EZ) br. 1829/2003, riječi „s povećanim udjelom jednostruko nezasićenim masnoća i smanjenim udjelom višestruko nezasićenih masnoća” navode se iza naziva organizma na oznaci ili, prema potrebi, u popratnim dokumentima proizvoda;
Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
Na etiketi proizvoda i u popratnim dokumentima proizvoda koji sadržavaju soju DP-3Ø5423-1 × MON-Ø4Ø32-6 ili se sastoje od nje, osim proizvoda iz članka 2. točke (a), navodi se „nije za uzgoj”.
[Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified].
Metoda detekcije:
Conditions or restrictions on the placing on the market, use or handling of the products:
specifične kvantitativne metode za detekciju soje DP-3Ø5423-1 i MON-Ø4Ø32-6 na temelju lančane reakcije s polimerazom (PCR) u stvarnom vremenu; metode detekcije potvrđene su na pojedinačnim promjenama i provjerene na genomskom DNK-u dobivenom iz sjemena soje DP-3Ø5423-1 × MON-Ø4Ø32-6;
The authorisation holder shall collect the following information:
potvrdio referentni laboratorij Europske unije osnovan na temelju Uredbe (EZ) br. 1829/2003, objavljeno na: http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
Quantities of DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean oil and DP-3Ø5423-1 × MON-Ø4Ø32-6 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food.
referentni materijal: ERM-BF426 (za DP-3Ø5423-1) i ERM-BF410 (za MON-Ø4Ø32-6) dostupan preko Zajedničkog istraživačkog centra (ZIC) Europske komisije, na https://ec.europa.eu/jrc/en/reference-materials/catalogue
In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.
Jedinstveni identifikacijski kôd:
The authorisation holder shall, based on the information collected and reported, review the nutritional assessment conducted as part of the risk assessment.
Informacije koje se zahtijevaju na temelju Priloga II.
Commission Implementing Decision (EU) 2017/2449
Provedbena odluka Komisije (EU) 2017/2449
authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-68416-4, 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 modificiranu soju DAS-68416-4 ili se sastoje ili su proizvedeni od nje, na temelju Uredbe (EZ) br. 1829/2003 Europskog parlamenta i Vijeća o genetski modificiranoj hrani i hrani za životinje
(notified under document C(2017) 9041)
(priopćeno pod brojem dokumenta C(2017) 9041)
Regulation (EC) No 1829/2003 lays down authorisation procedures for genetically modified food and feed.
Uredbom (EZ) br. 1829/2003 utvrđuju se postupci odobravanja genetski modificirane hrane i hrane za životinje.
On 25 January 2011, Dow AgroSciences Europe submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified DAS-68416-4 soybean to the national competent authority of the Netherlands in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003.
U skladu s člancima 5. i 17.
The application also covered the placing on the market of genetically modified soybean DAS-68416-4 in products consisting of it or containing it for other uses than food and feed as any other soybean, with the exception of cultivation.
Uredbe (EZ) br. 1829/2003 društvo Dow AgroSciences Europe 25. siječnja 2011. podnijelo je nacionalnom nadležnom tijelu Nizozemske zahtjev za stavljanje na tržište hrane, sastojaka hrane i hrane za životinje koji sadržavaju genetski modificiranu soju DAS-68416-4 ili se sastoje ili su proizvedeni od nje.
In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council [2] and the data and information required by Annexes III and IV to that Directive.
Zahtjev je obuhvaćao i stavljanje na tržište genetski modificirane soje DAS-68416-4 u proizvodima koji se sastoje od nje ili je sadržavaju za namjene koje ne uključuju hranu i hranu za životinje kao i svake druge soje, osim za uzgoj.
On 17 March 2017, 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 informacije i zaključke o procjeni rizika provedenoj u skladu s načelima utvrđenima u Prilogu II.
EFSA concluded that genetically modified soybean DAS-68416-4, as described in the application, is as safe and as nutritious as its conventional counterpart and non-genetically modified commercial varieties with regard to potential effects on human and animal health and the environment.
Direktivi 2001/18/EZ Europskog parlamenta i Vijeća [2] te podatke i informacije koji se zahtijevaju na temelju priloga III. i IV. 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 Article 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.
In addition, EFSA 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 soybean DAS-68416-4.
Europska agencija za sigurnost hrane („EFSA”) 17. ožujka 2017. dala je pozitivno mišljenje u skladu s člancima 6. i 18.
A unique identifier should be assigned to genetically modified soybean DAS-68416-4 in accordance with Commission Regulation (EC) No 65/2004 [4].
Uredbe (EZ) br. 1829/2003 [3].
On the basis of the EFSA opinion, no specific labelling requirements, other than those 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 [5], appear to be necessary for the products covered by this Decision.
EFSA je zaključila da je genetski modificirana soja DAS-68416-4, kako je opisana u zahtjevu, jednako sigurna i hranjiva kao konvencionalna soja i genetski nemodificirane komercijalne sorte kad je riječ o mogućim učincima na zdravlje ljudi i životinja te na okoliš.
However, in order to ensure the use of those products within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of soybean DAS-68416-4, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.
EFSA je u svojemu mišljenju uzela u obzir sva specifična pitanja i dvojbe država članica koji su izneseni u okviru savjetovanja s nacionalnim nadležnim tijelima, kako je predviđeno u članku 6. stavku 4. i članku 18. stavku 4.
The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects.
Uredbe (EZ) br. 1829/2003.
Those results should be presented in accordance with the standard reporting format requirements laid down in Commission Decision 2009/770/EC [6].
Osim toga, EFSA je zaključila da je plan praćenja učinaka na okoliš, koji je dostavio podnositelj zahtjeva i koji se sastoji od općeg plana nadzora, u skladu s predviđenim namjenama proizvodâ.
The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environments and geographical areas, as provided for in Article 6(5)(e) and Article 18(5) of Regulation (EC) No 1829/2003.
Uzimajući u obzir navedeno, trebalo bi odobriti proizvode koji sadržavaju genetski modificiranu soju DAS-68416-4, sastoje se ili su proizvedeni od nje.