natgillin/translations-raw huggingface dataset:
Consequently, it was not possible to conclude on the basis of the information available that beta-cypermethrin meets the criteria for inclusion in Annex I to Directive 91/414/EEC.
Osim toga, procjena rizika za organizme koji žive u tlu i vodene organizme te ocjena izloženosti podzemnih voda nije se mogla dovršiti jer nije dostavljeno dovoljno informacija o zadržavanju i ponašanju ciklopropilne skupine prstena beta-cipermetrina.
The Commission invited the applicant to submit its comments on the conclusion of the Authority.
Nadalje, nisu dostavljene informacije o metabolizmu stoke, koje su potrebne da bi se potvrdila definicija ostatka za proizvode životinjskog podrijetla, niti informacije o toksičnosti metabolita PBA i njegovoj važnosti za procjenu rizika za potrošače.
Furthermore, in accordance with Article 9 of Commission Regulation (EU) No 188/2011 [5], the Commission invited the applicant to submit comments on the draft review report.
Stoga na temelju raspoloživih informacija nije bilo moguće utvrditi da beta-cipermetrin ispunjava kriterije za uvrštenje u Prilog I. Direktivi 91/414/EEZ.
The applicant submitted its comments, which have been carefully examined.
Komisija je pozvala podnositelja zahtjeva da podnese svoje primjedbe na zaključak Agencije.
Despite the arguments put forward by the applicant, the concerns referred to in recital 4 could not be eliminated.
Nadalje, u skladu s člankom 9.
Consequently, it has not been demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing beta-cypermethrin satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.
Uredbe Komisije (EU) br. 188/2011 [5] Komisija je pozvala podnositelja zahtjeva da podnese primjedbe na nacrt izvješća o pregledu.
Beta-cypermethrin should therefore not be approved in accordance with Article 13(2) of Regulation (EC) No 1107/2009.
Podnositelj zahtjeva podnio je primjedbe, koje su detaljno pregledane.
This Regulation does not prevent the applicant from submitting a further application for beta-cypermethrin in accordance with Article 7 of Regulation (EC) No 1107/2009.
Unatoč argumentima koje je iznio podnositelj zahtjeva, bojazni u pogledu tvari iz uvodne izjave 4. nisu se mogle ukloniti.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Dakle, nije dokazano da se može očekivati da, u predloženim uvjetima uporabe, sredstva za zaštitu bilja koja sadržavaju beta-cipermetrin u načelu ispunjavaju zahtjeve iz članka 5. stavka 1. točaka (a) i (b) Direktive 91/414/EEZ.
HAS ADOPTED THIS REGULATION:
Beta-cipermetrin stoga ne bi trebalo odobriti u skladu s člankom 13. stavkom 2.
Article 1
Uredbe (EZ) br. 1107/2009.
Non-approval of active substance
Ovom se Uredbom podnositelja zahtjeva ne sprječava da ponovno podnese zahtjev za beta-cipermetrin u skladu s člankom 7.
The active substance beta-cypermethrin is not approved.
Uredbe (EZ) br. 1107/2009.
Entry into force
DONIJELA JE OVU UREDBU:
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Neodobrenje aktivne tvari
Done at Brussels, 6 September 2017.
Aktivna tvar beta-cipermetrin ne odobrava se.
OJ L 309, 24.11.2009, p. 1.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
Commission Implementing Decision 2011/266/EU of 2 May 2011 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of beta-cypermethrin, eugenol, geraniol and thymol in Annex I to Council Directive 91/414/EEC (OJ L 114, 4.5.2011, p. 3).
Sastavljeno u Bruxellesu 6. rujna 2017.
EFSA (European Food Safety Authority), 2014, Conclusion on the peer review of the pesticide risk assessment of the active substance beta-cypermethrin.
Za Komisiju
EFSA Journal 2014;12(6):3717, 90 pp. doi:10.2903/j.efsa.2014.3717.
Predsjednik
Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).
SL L 309, 24.11.2009., str. 1.
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances cyflufenamid, fluopicolide, heptamaloxyloglucan and malathion
o izmjeni Provedbene uredbe (EU) br. 540/2011 u pogledu produljenja roka valjanosti odobrenja aktivnih tvari ciflufenamid, fluopikolid, heptamaloksiloglukan i malation
Applications for the renewal of the approval of the active substances included in this Regulation were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 [3].
Zahtjevi za produljenje odobrenja aktivnih tvari obuhvaćenih ovom Uredbom podneseni su u skladu s Provedbenom uredbom Komisije (EU) br. 844/2012 [3].
It is therefore necessary to extend their approval periods in accordance with Article 17 of Regulation (EC) No 1107/2009.
Stoga je potrebno produljiti rok valjanosti tih odobrenja u skladu s člankom 17.
In view of the time and resources necessary for completing the assessment of applications for the renewal of approvals of the large number of active substances the approvals of which are expiring between 2019 and 2021, Commission Implementing Decision C(2016) 6104 [4] established a work programme grouping together similar active substances and setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009.
Uredbe (EZ) br. 1107/2009.
The presumed low risk substances should be prioritised in accordance with Implementing Decision C(2016) 6104.
S obzirom na vrijeme i sredstva potrebna za dovršenje procjene zahtjevâ za produljenje odobrenja velikog broja aktivnih tvari za koje odobrenja istječu između 2019. i 2021., Provedbenom odlukom Komisije C(2016) 6104 [4] utvrđen je program rada u kojemu se grupiraju slične aktivne tvari i određuju prioriteti na temelju pitanjâ sigurnosti za zdravlje ljudi i životinja ili za okoliš, kako je predviđeno člankom 18.
The approval of those substances should therefore be extended by a period as short as possible.
Uredbe (EZ) br. 1107/2009.
Taking into account the distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and decision-making, that period should be of one year for the active substance heptamaloxyloglucan.
Tvarima za koje se smatra da su manjeg rizika treba dati prioritet u skladu s Provedbenom odlukom C(2016) 6104.
For active substances which do not fall in the prioritised categories in Implementing Decision C(2016)6104, the approval period should be extended by either two or three years, taking into account the current date of expiry, the fact that in accordance with Article 6(3) of Implementing Regulation (EU) No 844/2012 the supplementary dossier for an active substance is to be submitted no later than 30 months before expiry of the approval, the need to ensure a balanced distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and decision-making.
Stoga bi odobrenje za te tvari trebalo produljiti za najkraće moguće razdoblje.
It is therefore appropriate to extend the approval period for active substance malathion by two years, and to extend the approval periods of active substances cyflufenamid and fluopicolide by three years.
Uzimajući u obzir raspodjelu odgovornosti i rada među državama članicama koje djeluju kao izvjestiteljice i suizvjestiteljice te dostupne resurse potrebne za procjenu i donošenje odluke, to bi razdoblje za aktivnu tvar heptamaloksiloglukan trebalo trajati jednu godinu.
In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.
Za aktivne tvari koje nisu obuhvaćene prioritetnim kategorijama u Provedbenoj odluci C(2016) 6104 rok valjanosti odobrenja trebalo bi produljiti za dvije ili tri godine, uzimajući u obzir postojeći datum prestanka odobrenja, činjenicu da se u skladu s člankom 6. stavkom 3.
In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later.
Provedbene uredbe (EU) br. 844/2012 treba dostaviti dopunsku dokumentaciju za aktivnu tvar najkasnije 30 mjeseci prije isteka odobrenja, potrebu da se osigura ujednačena raspodjela odgovornosti i rada među državama članicama koje djeluju kao izvjestiteljice i suizvjestiteljice te raspoložive resurse potrebne za procjenu i donošenje odluke.
As regards cases where the Commission will adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.
Stoga je primjereno produljiti rok valjanosti odobrenja aktivne tvari malation za dvije godine te rok valjanosti odobrenja aktivnih tvari ciflufenamid i fluopikolid za tri godine.
Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
S obzirom na cilj članka 17. prvog stavka Uredbe (EZ) br. 1107/2009, ako se dopunska dokumentacija ne dostavi u skladu s Provedbenom uredbom (EU) br. 844/2012 najkasnije 30 mjeseci prije datuma prestanka odobrenja utvrđenog u Prilogu toj uredbi, Komisija će kao datum prestanka odobrenja odrediti isti datum koji je vrijedio prije donošenja ove Uredbe ili najraniji mogući datum nakon tog datuma.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
S obzirom na cilj članka 17. prvog stavka Uredbe (EZ) br. 1107/2009 ako Komisija donese uredbu kojom se predviđa da se odobrenje aktivne tvari iz Priloga ovoj Uredbi ne produljuje jer nisu ispunjena mjerila za odobravanje, Komisija će kao datum isteka odrediti isti datum koji je vrijedio prije donošenja ove Uredbe ili datum stupanja na snagu uredbe kojom se predviđa da se odobrenje aktivne tvari ne produljuje, ovisno o tome koji je datum kasniji.
HAS ADOPTED THIS REGULATION:
Ako Komisija donese uredbu kojom se predviđa produljenje odobrenja aktivne tvari iz Priloga ovoj Uredbi, Komisija će nastojati, u skladu s okolnostima, odrediti najraniji mogući datum primjene.
Article 1
Provedbenu uredbu (EU) br. 540/2011 trebalo bi stoga na odgovarajući način izmijeniti,
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Prilog Provedbenoj uredbi (EU) br. 540/2011 mijenja se u skladu s Prilogom ovoj Uredbi.
Done at Brussels, 6 September 2017.
Članak 2.
OJ L 309, 24.11.2009, p. 1.
Sastavljeno u Bruxellesu 6. rujna 2017.
OJ L 153, 11.6.2011, p. 1.
Za Komisiju
Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).
Predsjednik
Commission Implementing Decision of 28 September 2016 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2019, 2020 and 2021 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (OJ C 357, 29.9.2016, p. 9).
SL L 309, 24.11.2009., str. 1.
ANNEX
SL L 153, 11.6.2011., str. 1.
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
Provedbena uredba Komisije (EU) br. 844/2012 od 18. rujna 2012. o određivanju odredaba potrebnih za provedbu postupka obnavljanja odobrenja za aktivne tvari, kako je predviđeno Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja (SL L 252, 19.9.2012., str. 26.).
in the sixth column, expiration of approval, of row 296, Cyflufenamid, the date is replaced by ‘31 March 2023’;
Provedbena odluka Komisije оd 28. rujna 2016. o uspostavi programa rada za procjenu zahtjevâ za produljenje odobrenja aktivnih tvari koja istječu u 2019., 2020. i 2021. u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća (SL C 357, 29.9.2016., str. 9.).
in the sixth column, expiration of approval, of row 297, Fluopicolide, the date is replaced by ‘31 May 2023’;
PRILOG
in the sixth column, expiration of approval, of row 298, Heptamaloxyloglucan, the date is replaced by ‘31 May 2021’;
Dio A Priloga Provedbenoj uredbi (EU) br. 540/2011 mijenja se kako slijedi:
in the sixth column, expiration of approval, of row 300, Malathion, the date is replaced by ‘30 April 2022’.
u šestom stupcu, prestanak odobrenja, u retku 296., ciflufenamid, datum se zamjenjuje datumom „31. ožujka 2023.”;
approving the basic substance sodium chloride in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
o odobravanju osnovne tvari natrijev klorid u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja te o izmjeni Priloga Provedbenoj uredbi Komisije (EU) br. 540/2011
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC [1], and in particular Article 23(5) in conjunction with Article 13(2) thereof,
uzimajući u obzir Uredbu (EZ) br. 1107/2009 Europskog parlamenta i Vijeća od 21. listopada 2009. o stavljanju na tržište sredstava za zaštitu bilja i stavljanju izvan snage direktiva Vijeća 79/117/EEZ i 91/414/EEZ [1], a posebno njezin članak 23. stavak 5. u vezi s člankom 13. stavkom 2.,
In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 7 June 2016 an application from the Agriculture and Horticulture Development Board (UK) and the Institut Technique de l'Agriculture Biologique (ITAB) for the approval of salt as a basic substance for use as a fungicide in mushrooms.
U skladu s člankom 23. stavkom 3.
In addition, the Commission received on 21 July 2016 an application from ITAB for the approval of sea salt as basic substance for use as a fungicide and insecticide in grapes.
Uredbe (EZ) br. 1107/2009 Komisija je 7. lipnja 2016. od subjekata Agriculture and Horticulture Development Board (UK) i Institut Technique de l'Agriculture Biologique (ITAB) primila zahtjev za odobrenje soli kao osnovne tvari za uporabu kao fungicid na gljivama.
Since both applications concern the substance sodium chloride of food-grade quality, the applications were merged.
Uz to, Komisija je 21. srpnja 2016. od ITAB-a primila zahtjev za odobrenje morske soli kao osnovne tvari za uporabu kao fungicid i insekticid na grožđu.
The applications were accompanied by the information required by the second subparagraph of Article 23(3) of Regulation (EC) No 1107/2009.
Budući da se oba zahtjeva odnose na tvar natrijev klorid prehrambene kvalitete, zahtjevi su objedinjeni.
The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance.
Uz navedene zahtjeve priložene su tražene informacije iz članka 23. stavka 3. drugog podstavka Uredbe (EZ) br. 1107/2009.
The Authority presented to the Commission a Technical Report on sodium chloride on 20 January 2017 [2].
Komisija je od Europske agencije za sigurnost hrane (dalje u tekstu: „Agencija”) zatražila znanstvenu pomoć.
The Commission presented the review report [3] and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 23 March 2017 and finalised them for the meeting of that Committee on 20 July 2017.
Agencija je 20. siječnja 2017.
The documentation provided by the applicant shows that sodium chloride fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council [4].
Komisiji dostavila tehničko izvješće o natrijevu kloridu [2].
Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water.
Komisija je 23. ožujka 2017.
Consequently, it is to be considered as a basic substance.
Stalnom odboru za bilje, životinje, hranu i hranu za životinje dostavila izvješće o pregledu [3] i nacrt ove Uredbe te pripremila njihove završne verzije za sastanak tog odbora održan 20. srpnja 2017.
It has appeared from the examinations made that sodium chloride may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report.
Dokumentacija koju je dostavio podnositelj zahtjeva pokazuje da natrijev klorid ispunjava kriterije za hranu iz članka 2.
It is therefore appropriate to approve sodium chloride as a basic substance.
Uredbe (EZ) br. 178/2002 Europskog parlamenta i Vijeća [4].
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions.
Osim toga, predmetna tvar nije prvenstveno namijenjena zaštiti bilja, ali je korisna za tu namjenu u sredstvu koje se sastoji od te tvari i vode.
In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 [5] should be amended accordingly.
Stoga je treba smatrati osnovnom tvari.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Provedena ispitivanja pokazala su kako se za natrijev klorid može očekivati da načelno ispunjava zahtjeve utvrđene člankom 23.
HAS ADOPTED THIS REGULATION:
Uredbe (EZ) br. 1107/2009, posebno u pogledu uporaba koje su ispitane i navedene u Komisijinu izvješću o pregledu.
Article 1
Stoga je primjereno odobriti natrijev klorid kao osnovnu tvar.
Approval of a basic substance
U skladu s člankom 13. stavkom 2.
The substance sodium chloride is approved as a basic substance as laid down in Annex I.
Uredbe (EZ) br. 1107/2009 u vezi s njezinim člankom 6. te s obzirom na postojeća znanstvena i tehnička saznanja, potrebno je, međutim, utvrditi određene uvjete i ograničenja.
Amendments to Implementing Regulation (EU) No 540/2011
Uredbe (EZ) br. 1107/2009 trebalo bi na odgovarajući način izmijeniti Prilog Provedbenoj uredbi Komisije (EU) br. 540/2011 [5].
Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Odobravanje osnovne tvari
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Tvar natrijev klorid, kako je navedena u Prilogu I., odobrava se kao osnovna tvar.
Done at Brussels, 7 September 2017.
Članak 2.
The President
Provedbena uredba (EU) br. 540/2011 mijenja se u skladu s Prilogom II. ovoj Uredbi.
European Food Safety Authority, 2016; Outcome of the consultation with Member States and EFSA on the basic substance application for sodium chloride for use in plant protection as fungicide and bactericide in seed treatment and for disinfecting cutting tools.
Stupanje na snagu
EFSA supporting publication 2016:EN-1091.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
39 pp.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN
Sastavljeno u Bruxellesu 7. rujna 2017.
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
Za Komisiju
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).
Predsjednik
Common Name, Identification Numbers
Europska agencija za sigurnost hrane, 2016.; Outcome of the consultation with Member States and EFSA on the basic substance application for sodium chloride for use in plant protection as fungicide and bactericide in seed treatment and for disinfecting cutting tools (Rezultati savjetovanja s državama članicama i EFSA-om o zahtjevu za odobrenje natrijeva klorida kao osnovne tvari za uporabu u sredstvima za zaštitu bilja kao fungicid i baktericid za tretiranje sjemena te za dezinfekciju alata za rezanje).
IUPAC Name
EFSA, povezana publikacija 2016:EN-1091.
Purity [1]
39 str.
Date of approval
http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN.
Specific provisions
Uredba (EZ) br. 178/2002 Europskog parlamenta i Vijeća od 28. siječnja 2002. o utvrđivanju općih načela i uvjeta zakona o hrani, osnivanju Europske agencije za sigurnost hrane te utvrđivanju postupaka u područjima sigurnosti hrane (SL L 31, 1.2.2002., str. 1.)
Sodium chloride
Provedbena uredba Komisije (EU) br. 540/2011 od 25. svibnja 2011. o provedbi Uredbe (EZ) br. 1107/2009 Europskog parlamenta i Vijeća u pogledu popisa odobrenih aktivnih tvari (SL L 153, 11.6.2011., str. 1.).
CAS No 7647-14-5
PRILOG I.
Food grade
Uobičajeni naziv, identifikacijski brojevi
28 September 2017
Kemijski naziv prema IUPAC-u
Only uses as basic substance being a fungicide and insecticide are approved.
Čistoća [1]
Sodium chloride shall be used in accordance with the specific conditions included in the conclusions of the review report on sodium chloride (SANTE/10383/2017) and in particular Appendices I and II thereof.
Datum odobrenja
Further details on identity, specification and manner of use of basic substance are provided in the review report.
Posebne odredbe
ANNEX II
Natrijev klorid
In Part C of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
CAS br. 7647-14-5
Number
Prehrambena kvaliteta
Sodium chloride shall be used in accordance with the specific conditions included in the conclusions of the review report on sodium chloride (SANTE/10383/2017) and in particular Appendices I and II thereof.’
28. rujna 2017.
970 g/kg
Natrijev klorid mora se upotrebljavati u skladu s posebnim uvjetima navedenima u zaključcima izvješća o pregledu za natrijev klorid (SANTE/10383/2017), a posebno njegovim dodacima I. i II.