natgillin/translations-raw huggingface dataset:
In conjunction with the establishment of restrictions for varnishes and coatings, it is also necessary to define rules for verification of compliance with the restrictions.
Komisija je ovlaštena poduzeti preventivne mjere u pogledu uporabe BPA-a na temelju načela predostrožnosti koje se primjenjuje ako postoji znanstvena nesigurnost, čak i ako rizik, osobito za ljudsko zdravlje, još uvijek nije dokazan.
In particular, rules for migration testing and rules for expression of migration testing results should be established.
Kako bi se to postiglo, BPA se ne bi trebao upotrebljavati za proizvodnju polikarbonatnih šalica ili boca koje su namijenjene za dojenčad i malu djecu, kako je definirano u Uredbi (EU) br.
Therefore it is appropriate to establish such rules for checking compliance with the restrictions for varnishes and coatings applied to materials and articles where those varnishes or coatings have been produced using BPA.
609/2013 Europskog parlamenta i Vijeća.
Regulation (EU) No 10/2011 establishes a comprehensive framework for verifying compliance of plastic food contact materials with defined restrictions, including rules on the expression of migration test results.
Osim uporabe u plastičnim materijalima koji dolaze u dodir s hranom BPA se u velikoj mjeri upotrebljava u epoksidnim smolama za lakove i premaze, osobito one koji se nanose na unutrašnjost konzervi za hranu.
As the varnishes and coatings applied to materials and articles do not have specific characteristics that would require the establishment of different or more specific provisions, it is appropriate to extend the application of the rules laid down in Regulation (EU) No 10/2011 to the verification of compliance of varnishes and coatings applied to materials and articles with the established restrictions.
Iako su člankom 5.
Article 16(1) of Regulation (EC) No 1935/2004 provides that materials and articles covered by specific measures be accompanied by a written declaration of compliance stating that they comply with the rules applicable to them.
Uredbe (EZ) br.
On production of the varnished or coated material or article, the responsible business operator should document compliance with the applicable rules in a declaration of compliance which is made available to their customers.
1935/2004 donesene posebne mjere za BPA u plastičnim materijalima i predmetima, na razini Unije nisu donesene slične mjere za BPA u lakovima i premazima.
In order to ensure that the declaration provides sufficient information to enable verification of compliance, it is appropriate to specify the information that must be included in the declaration.
Stoga su u skladu s člankom 6. te Uredbe države članice mogle zadržati postojeće ili donijeti nove nacionalne mjere u pogledu BPA-a u lakovima ili premazima uz uvjet da su te mjere u skladu s pravilima iz Ugovorâ.
In addition, competent authorities should be able to verify compliance with the applicable rules.
S obzirom na to da su države članice uvele različite nacionalne mjere koje se primjenjuju na BPA u materijalima koji dolaze u dodir s hranom i da je industrija prijavila tehničke i praktične poteškoće koje proizlaze iz toga te uzimajući u obzir da je u mišljenju Agencije iz 2014. navedeno da izloženosti BPA-u iz prehrambenih izvora pridonosi i konzervirana hrana te da se BPA u velikoj mjeri upotrebljava u epoksidnim smolama za lakove i premaze koji se nanose na konzerve za hranu, primjereno je utvrditi i ograničenja za BPA koji se upotrebljava u lakovima i premazima.
Business operators should therefore be required to make available for the competent authorities appropriate supporting documentation, substantiating the declaration of compliance.
Ista pretpostavka o izloženosti BPA-u iz plastičnih materijala i predmeta može se primijeniti i na lakove i premaze.
In order to ensure that the business operators have sufficient time to adjust their manufacturing processes to comply with the restrictions and to reduce the administrative and financial burden that such adjustment may entail, it is appropriate to defer the application of this Regulation and to permit materials and articles which have been lawfully placed on the market before the date of application of this Regulation to remain on the market until the exhaustion of stocks.
Kako bi se osiguralo učinkovito funkcioniranje unutarnjeg tržišta i visoka razina zaštite zdravlja ljudi, SML koji je utvrđen za BPA iz plastičnih materijala i predmeta trebalo bi primjenjivati i na lakove i premaze koji se nanose na materijale i predmete, ako je pri proizvodnji laka odnosno premaza upotrijebljen BPA.
Regulation (EU) No 10/2011 should therefore be amended accordingly.
S obzirom na to da se BPA može upotrebljavati u prehrambenoj ambalaži koja sadržava hranu za dojenčad i malu djecu, BPA ne bi smio migrirati iz lakova i premaza koji se nanose na materijale ili predmete koji su posebno namijenjeni da dolaze u dodir s hranom namijenjenom za dojenčad i malu djecu kako je navedena u Uredbi (EU) br.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
609/2013, odnosno početna hrana za dojenčad, prijelazna hrana za dojenčad, prerađena hrana na bazi žitarica, hrana za bebe, hrana za posebne medicinske potrebe koja je razvijena s ciljem zadovoljavanja prehrambenih potreba dojenčadi i male djece ili napitci na bazi mlijeka i slični proizvodi posebno namijenjeni maloj djeci.
HAS ADOPTED THIS REGULATION:
Uz utvrđivanje ograničenja za lakove i premaze potrebno je utvrditi i pravila za provjeru sukladnosti s tim ograničenjima.
Article 1
Osobito je potrebno utvrditi pravila za ispitivanje migracije i pravila za izražavanje rezultata ispitivanja migracije.
For the purposes of this Regulation, the following definitions shall apply:
Stoga je primjereno utvrditi pravila za provjeru sukladnosti s ograničenjima za lakove i premaze koji se nanose na materijale i predmete ako je pri proizvodnji tih lakova ili premaza upotrijebljen BPA.
‘specific migration limit’ (SML) means the maximum permitted amount of a given substance released from a material or article into food or food simulants;
Uredbom (EU) br.
‘materials and articles’ means any materials or articles which fall within one of the categories laid down in Article 1(2) of Regulation (EC) No 1935/2004;
10/2011 utvrđen je sveobuhvatni okvir za provjeru sukladnosti plastičnih materijala koji dolaze u dodir s hranom s utvrđenim ograničenjima, uključujući pravila o izražavanju rezultata ispitivanja migracije.
‘varnishes’ or ‘coatings’ means materials or articles composed of one or more non-self-supporting layer or layers manufactured using 2,2-bis(4-hydroxyphenyl)propane (‘BPA’), applied on a material or article in order to impart special properties on it or to improve its technical performance.
Budući da lakovi i premazi koji se nanose na materijale i predmete nemaju posebna svojstva za koja bi bilo potrebno utvrditi različite ili dodatne posebne mjere, primjereno je proširiti primjenu pravila iz Uredbe (EU) br.
Article 2
10/2011 na provjeru sukladnosti lakova i premaza koji se nanose na materijale i predmete s utvrđenim ograničenjima.
The migration into or onto food of 2,2-bis(4-hydroxyphenyl)propane (‘BPA’) (CAS No 0000080-05-7) from varnishes or coatings applied to materials and articles shall not exceed a specific migration limit of 0,05 mg of BPA per kg of food (mg/kg).
Člankom 16. stavkom 1.
By derogation from paragraph 1, no migration of BPA shall be permitted from varnishes or coatings applied to materials and articles specifically intended to come into contact with infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children, as referred to in Regulation (EU) No 609/2013.
Uredbe (EZ) br.
Article 3
1935/2004 predviđeno je da uz materijale i predmete obuhvaćene posebnim mjerama treba priložiti pismenu izjavu o sukladnosti, u kojoj se navodi da su u skladu s pravilima koja se na njih primjenjuju.
In order to verify compliance with Article 2 of this Regulation, rules laid down in Article 11(4), in paragraphs 1, 2, 3, 6 and 7 of Article 18, in Annex III and in Chapters 1, 2 and 4 of Annex V to Regulation (EU) No 10/2011 shall apply.
Pri proizvodnji lakiranog odnosno premazanog materijala ili predmeta nadležni subjekt u poslovanju trebao bi dokumentirati sukladnost s primjenjivim pravilima u obliku izjave o sukladnosti, koju bi trebao staviti na raspolaganje kupcima.
Test results obtained as part of the verification procedure referred to in paragraph 1 shall be expressed in accordance with the rules laid down in paragraphs 1 to 3 of Article 17 of Regulation (EU) No 10/2011.
Kako bi se osiguralo da izjava sadržava dostatne informacije kojima se omogućuje provjera sukladnosti, primjereno je utvrditi informacije koje moraju biti obuhvaćene izjavom.
Article 4
Osim toga, nadležnim tijelima trebalo bi omogućiti da provjere sukladnost s primjenjivim pravilima.
In accordance with Article 16(1) of Regulation (EC) No 1935/2004, business operators shall ensure that varnished or coated materials and articles are accompanied by a written declaration of compliance containing the information laid down in Annex I to this Regulation.
Od poslovnih subjekta bi stoga trebalo zahtijevati da nadležnim tijelima stave na raspolaganje odgovarajuću popratnu dokumentaciju, kojom se potkrepljuje izjava o sukladnosti.
The declaration shall be available at all stages of manufacture, processing and distribution other than the retail stage.
Kako bi se osiguralo da poslovni subjekti imaju dovoljno vremena da prilagode postupak proizvodnje radi usklađenosti s utvrđenim ograničenjima te smanjilo administrativno i financijsko opterećenje koje ta prilagodba može uključivati, primjereno je odgoditi primjenu ove Uredbe i dopustiti da materijali i predmeti koji su zakonito stavljeni na tržište prije datuma primjene ove Uredbe ostanu na tržištu do iscrpljenja zaliha.
The written declaration shall permit an easy identification of the varnished or coated materials and articles to which it applies.
Uredbu (EU) br.
It shall be renewed to reflect any changes in migration levels from the varnish or coating that has been applied to materials and articles.
10/2011 stoga bi trebalo na odgovarajući način izmijeniti.
Business operators shall, upon request of a national competent authority, make available appropriate supporting documentation to demonstrate compliance with the written declaration referred to in paragraph 1.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
Such supporting documentation shall be provided without delay and in any event not later than 10 days following receipt of the request.
DONIJELA JE OVU UREDBU:
The documentation shall contain the conditions and results of the testing, calculations, including modelling, other analysis and evidence on the safety or reasoning demonstrating compliance.
Članak 1.
Article 5
Za potrebe ove Uredbe primjenjuju se sljedeće definicije:
Annex I to Regulation (EU) No 10/2011 is amended in accordance with Annex II to this Regulation.
„granica specifične migracije” (SML) znači maksimalno dopuštena količina pojedine tvari koja se otpušta iz materijala ili predmeta u hranu ili modelnu otopinu;
Article 6
„materijali i predmeti” znači bilo koji materijali ili predmeti koji pripadaju jednoj od kategorija iz članka 1. stavka 2.
Varnished or coated materials and articles and plastic materials and articles that were lawfully placed on the market before 6 September 2018 may remain on the market until exhaustion of stocks.
Uredbe (EZ) br.
Article 7
1935/2004;
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
„lakovi” ili „premazi” znači materijali ili predmeti koji se sastoje od jednog sloja ili više slojeva koji nisu samonosivi proizvedeni od 2,2-bis(4-hidroksifenil)propana („BPA”), naneseni na materijal ili predmet kako bi mu se dala posebna svojstva ili poboljšala njegova tehnička svojstva.
It shall apply from 6 September 2018.
Članak 2.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Migracija 2,2-bis(4-hidroksifenil)propana („BPA”) (CAS br.
Done at Brussels, 12 February 2018.
0000080-05-7) na ili u hranu s lakova ili premaza koji se nanose na materijale ili predmete ne smije prijeći granicu specifične migracije od 0,05 mg BPA-a po kilogramu hrane (mg/kg).
For the Commission
Odstupajući od stavka 1., nije dopuštena migracija BPA-a iz lakova ili premaza koji se nanose na materijale i predmete posebno namijenjene da dolaze u dodir s početnom hranom za dojenčad, prijelaznom hranom za dojenčad, prerađenom hranom na bazi žitarica, hranom za bebe, hranom za posebne medicinske potrebe koja je razvijena s ciljem zadovoljavanja prehrambenih potreba dojenčadi i male djece ili pićima na bazi mlijeka i sličnim proizvodima namijenjenima maloj djeci, kako je navedeno u Uredbi (EU) br.
The President
609/2013.
OJ L 338, 13.11.2004, p.
Članak 3.
4.
Kako bi se potvrdila usklađenost s člankom 2. ove Uredbe, primjenjuju se pravila iz članka 11. stavaka 4., članka 18. stavaka 1., 2., 3., 6. i 7.
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p.
Uredbe (EU) br.
1).
10/2011 te Priloga III. i poglavlja 1., 2. i 4.
Opinion of the Scientific Committee on Food on Bisphenol A (SCF/CS/PM/3936 Final).
Priloga V. toj Uredbi.
The EFSA Journal (2006) 428, 1.
Rezultati dobiveni u okviru postupka provjere iz stavka 1. izražavaju se u skladu s pravilima iz članka 17. stavaka od 1. do 3.
The EFSA Journal (2008) 759, 1.
Uredbe (EU) br.
The EFSA Journal 2010;8(9):1829.
10/2011.
The EFSA Journal 2011;9(12):2475.
Članak 4.
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.
U skladu s člankom 16. stavkom 1.
The EFSA Journal 2015;13(1):3978.
1935/2004 poslovni subjekti osiguravaju da je uz lakirane ili premazane materijale i predmete priložena pismena izjava o sukladnosti koja sadržava informacije utvrđene u Prilogu I. ovoj Uredbi.
EFSA Journal 2016;14(10):4580.
Izjava mora biti dostupna tijekom svih faza proizvodnje, prerade i distribucije, osim maloprodaje.
Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p.
Pismena izjava omogućuje laku identifikaciju lakiranih ili premazanih materijala i predmeta na koje se odnosi.
35).
Obnavlja se kako bi se uzele u obzir promjene razina migracije s laka ili premaza nanesenog na materijale i predmete.
ANNEX I
Poslovni subjekti na zahtjev nacionalnog nadležnog tijela moraju staviti na raspolaganje odgovarajuću popratnu dokumentaciju kako bi dokazali sukladnost s pismenom izjavom iz stavka 1.
The written declaration referred to in Article 4 shall contain the following information:
Ta se popratna dokumentacija mora dostaviti bez odgode i u svakom slučaju u roku od 10 dana nakon primitka zahtjeva.
the identity and address of the business operator issuing the declaration of compliance;
Dokumentacija sadržava uvjete i rezultate ispitivanja, izračune, uključujući modele izračuna, druge analize i dokaze o sigurnosti ili obrazloženje kojim se dokazuje sukladnost.
the identity and address of the business operator which manufactures or imports the coated material or article;
Članak 5.
the identity of the varnished or coated material or article;
Prilog I.
the date of the declaration;
Uredbi (EU) br.
confirmation that the varnish or coating applied to the material or article meets the restrictions laid down in Article 2 of this Regulation and the requirements set out in Articles 3, 15 and 17 of Regulation (EC) No 1935/2004;
10/2011 mijenja se u skladu s Prilogom II. ovoj Uredbi.
specifications on the use of the coated material or article, such as:
Članak 6.
the type or types of food with which it is intended to be put into contact;
Lakirani ili premazani materijali i predmeti te plastični materijali i predmeti koji su zakonito stavljeni na tržište prije 6. rujna 2018. mogu ostati na tržištu do iscrpljenja zaliha.
the time and temperature of treatment and storage in contact with food;
Članak 7.
the highest food contact surface area to volume ratio for which compliance has been verified in accordance with Articles 17 and 18 of Regulation (EU) No 10/2011 or equivalent information.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
ANNEX II
Primjenjuje se od 6. rujna 2018.
In Table 1 of Annex I to Regulation (EU) No 10/2011, the entry concerning substance No 151 is replaced by the following:
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
2,2-bis(4-hydroxyphenyl)propane
Sastavljeno u Bruxellesu 12. veljače 2018.
Not to be used for the manufacture of polycarbonate infant feeding bottles.
Za Komisiju
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007, and in particular Article 99 thereof,
uzimajući u obzir Uredbu (EU) br.
The Commission has examined the application for the approval of an amendment to the specification for the Protected Designation of Origin ‘Pla i Llevant’, sent by Spain in accordance with Article 105 of Regulation (EU) No 1308/2013.
922/72, (EEZ) br.
The Commission has published the application for the approval of an amendment to the specification in the Official Journal of the European Union, as required by Article 97(3) of Regulation (EU) No 1308/2013.
234/79, (EZ) br.
No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.
1037/2001 i (EZ) br.
The amendment to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013.
1234/2007, a posebno njezin članak 99.,
The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,
budući da:
HAS ADOPTED THIS REGULATION:
Komisija je ispitala zahtjev za odobrenje izmjene specifikacije za zaštićenu oznaku zemljopisnog podrijetla „Pla i Llevant”, koji je podnijela Španjolska u skladu s člankom 105.
The amendment to the specification published in the Official Journal of the European Union regarding the name ‘Pla i Llevant’ (PDO) is hereby approved.
1308/2013.
Article 2
Komisija je zahtjev za odobrenje izmjene specifikacije objavila u Službenom listu Europske unije u skladu s člankom 97. stavkom 3.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
1308/2013.
Done at Brussels, 13 February 2018.
Komisiji nije dostavljen ni jedan prigovor u smislu članka 98.
For the Commission
Uredbe (EU) br.
The President
1308/2013.
OJ L 347, 20.12.2013, p.
Stoga je primjereno odobriti izmjenu specifikacije u skladu s člankom 99.
671.
Uredbe (EU) br.
conferring protection under Article 99 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council on the name ‘Mergelland’ (PDO)
o zaštiti naziva „Mergelland” (ZOI) u skladu s člankom 99.
Having regard to the Treaty on the Functioning of the European Union,
1308/2013 Europskog parlamenta i Vijeća
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007, and in particular Article 99 thereof,
EUROPSKA KOMISIJA,
In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘Mergelland’ sent by the Netherlands and has published it in the Official Journal of the European Union.
uzimajući u obzir Uredbu (EU) br.
No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.
1308/2013 Europskog parlamenta i Vijeća od 17. prosinca 2013. o uspostavljanju zajedničke organizacije tržišta poljoprivrednih proizvoda i stavljanju izvan snage uredbi Vijeća (EEZ) br.
In accordance with Article 99 of Regulation (EU) No 1308/2013, the name ‘Mergelland’ should be protected and entered in the register referred to in Article 104 of that Regulation.
922/72, (EEZ) br.
The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,
234/79, (EZ) br.
HAS ADOPTED THIS REGULATION:
1037/2001 i (EZ) br.
Article 1
1234/2007, a posebno njezin članak 99.,
The name ‘Mergelland’ (PDO) is hereby protected.
budući da:
Article 2
U skladu s člankom 97. stavcima 2. i 3.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
1308/2013, Komisija je ispitala zahtjev Nizozemske za upis naziva „Mergelland” te ga objavila u Službenom listu Europske unije.
Done at Brussels, 13 February 2018.
Komisiji nije dostavljen nijedan prigovor na temelju članka 98.
OJ L 347, 20.12.2013, p.
U skladu s člankom 99.
amending Annexes V and IX to Regulation (EU) No 978/2012 of the European Parliament and of the Council applying a scheme of generalised tariff preferences
o izmjeni priloga V. i IX.
Having regard to Regulation (EU) No 978/2012 of the European Parliament and of the Council of 25 October 2012 applying a scheme of generalised tariff preferences and repealing Council Regulation (EC) No 732/2008, and in particular Article 6(2) and Article 11(2) thereof,
EUROPSKA KOMISIJA,
Article 6(1) of Regulation (EU) No 978/2012, provides that the products to which tariff preferences are to be applied under the general arrangement of the Generalised Scheme of Preferences referred to in Article 1(2)(a) of Regulation (EU) No 978/2012 are listed in Annex V.
uzimajući u obzir Uredbu (EU) br.
Article 11(1) of Regulation (EU) No 978/2012 provides that the products to which tariff preferences are to be applied under the special incentive arrangement for sustainable development and good governance referred to in Article 1(2)(b) of Regulation (EU) No 978/2012 are listed in Annex IX.
978/2012 Europskog parlamenta i Vijeća od 25. listopada 2012. o primjeni sustava općih carinskih povlastica i stavljanju izvan snage Uredbe Vijeća (EZ) br.
The Combined Nomenclature (‘CN’) established by Council Regulation (EEC) No 2658/87 has been amended by Commission Implementing Regulation (EU) 2016/1821, which entered into force on 1 January 2017.
732/2008, a posebno njezin članak 6. stavak 2. i članak 11. stavak 2.,
In order to incorporate changes made necessary by those amendments to the CN and ensure consistency with the CN product list, Annexes V and IX to Regulation (EU) No 978/2012 should therefore be amended accordingly,
budući da:
HAS ADOPTED THIS REGULATION:
Člankom 6. stavkom 1.
Amendments to Regulation (EU) No 978/2012
978/2012 predviđeno je da su proizvodi na koje se primjenjuju carinske povlastice u okviru općeg dogovora Općeg sustava povlastica iz članka 1. stavka 2. točke (a) Uredbe (EU) br.
Regulation (EU) No 978/2012 is amended as follows:
978/2012 navedeni u Prilogu V.
Annex V is replaced by the text in Annex I to this Regulation.
Člankom 11. stavkom 1.
Annex IX is replaced by the text in Annex II to this Regulation.
Uredbe (EU) br.