1. Naziv propisa Evropske unije : Odluka Evropskog parlamenta i Saveta br. 768/2008/EZ od 9. jula 2008. godine o zajedničkom okviru za trgovanje proizvodima, i ukidanju Odluke Saveta 93/465/EEZDecision of the European Parliament and of the Council No 768/2008/EC of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC 2. „CELEX” oznaka EU propisa32008D0768 3. Organ državne uprave, odnosno drugi ovlašćeni predlagač propisa: Vlada Obrađivač – Ministarstvo privrede Republike Srbije Ministry of Economy of the Republic of Serbia 4. Datum izrade tabele: 1.1.2018. 5. Naziv (Nacrta, predloga) propisa čije odredbe su predmet analize usklađenosti sa propisom Evropske unije:Predlog zakona o tehničkim zahtevima za proizvode i ocenjivanje usaglašenostiDraft Law on Technical Requirements for Products and Conformity Assesssment 6. Brojčane oznake (šifre) planiranih propisa iz baze NPAA:2016-405 7. Usklađenost odredbi propisa sa odredbama propisa EU:
a) |a1) |b) |b1) |v) |g) |d) | |Odredba propisa EU |Sadržina odredbe |Odredbe propisa R. Srbije |Sadržina odredbe |Usklađenost |Razlozi za delimičnu usklađenost, neusklađenost ili neprenosivost |Napomena o usklađenosti | |1.1. |General principles
Products placed on the Community market shall comply with all applicable legislation. |23.1 |Usaglašenost proizvoda
Proizvod koji se isporučuje na tržištu, odnosno stavlja u upotrebu, mora da ispunjava zahteve svih tehničkih propisa koji se odnose na taj proizvod |PU | | | |1.2. |When placing products on the Community market, economic operators shall, in relation to their respective roles in the supply chain, be responsible for the compliance of their products with all applicable legislation. |23.2 |Isporučilac je odgovoran za usaglašenost proizvoda koje isporučuje na tržište u zavisnosti od svoje uloge u lancu isporuke, u skladu sa ovim zakonom. |PU | | | |1.3 |Economic operators shall be responsible for ensuring that all information they provide with regard to their products is accurate, complete and in compliance with Community rules applicable |23.3 |Isporučilac je odgovoran za tačnost i potpunost podataka koje pruža o proizvodima koje isporučuje na tržištu i obezbeđuje da su ti podaci u skladu sa zahtevima primenjivih propisa. |PU | | | |2.1 |Subject matter and scope
This Decision sets out the common framework of general principles and reference provisions for the drawing up of Community legislation harmonising the conditions for the marketing of products (Community harmonisation legislation).
|1 |Predmet
Ovim zakonom uređuje se način propisivanja tehničkih zahteva za proizvode, način ocenjivanja usaglašenosti proizvoda sa zahtevima tehničkih propisa, obaveze isporučilaca i vlasnika proizvoda, pretpostavka usaglašenosti, zaštitna klauzula i klauzula o uzajamnom priznavanju, važenje inostranih isprava o usaglašenosti, obaveštavanje o tehničkim propisima i postupcima ocenjivanja usaglašenosti, zahtevi za imenovanje i obaveze imenovanih tela, notifikacija tela za ocenjivanje usaglašenosti i tehničkih propisa, vođenje registara i vršenje nadzora nad sprovođenjem ovog zakona i propisa donetih na osnovu ovog zakona. |DU |Predlog zakona ima šire područje primene od Odluke 768/2008/EZ, tj. odnosi se i na harmonizovanu i neharmonizovanu oblast. | | |2.2 |Community harmonisation legislation shall have recourse to the general principles set out in this Decision and to the relevant reference provisions of Annexes I, II and III. However, Community legislation may depart from those general principles and reference provisions if that is appropriate on account of the specificities of the sector concerned, especially if comprehensive legal systems are already in place.
|2 |Ovaj zakon primenjuje se na sve proizvode, osim na proizvode za koje su tehnički zahtevi uređeni posebnim zakonima i propisima donetim na osnovu tih zakona.
Ako posebnim zakonima i propisima iz stava 1. ovog člana nisu uređena pojedina pitanja koja uređuje ovaj zakon, na ta pitanja se primenjuju odredbe ovog zakona.
Odredbe ovog zakona kojima se uređuje način donošenja tehničkih propisa, vođenje registara, klauzula o uzajamnom priznavanju, Srpski znak usaglašenosti, postupak i način imenovanja tela za ocenjivanje usaglašenosti, postupak i način notifikacije tela za ocenjivanje usaglašenosti, postupak i način nadzora nad imenovanim i notifikovanim telima i notifikacija tehničkih propisa, primenjuju se i na proizvode za koje su tehnički zahtevi uređeni posebnim zakonima i propisima donetim na osnovu tih zakona. |DU |Predlog zakona ima šire područje primene od Odluke 768/2008/EZ, tj. odnosi se i na harmonizovanu i neharmonizovanu oblast. |
| |3.1.
|Level of protection of public interests
As regards the protection of public interests, Community harmonisation legislation shall restrict itself to setting out the essential requirements determining the level of such protection and shall express those requirements in terms of the results to be achieved.
Where recourse to essential requirements is not possible or not appropriate, in view of the objective of ensuring the adequate protection of consumers, public health and the environment or other aspects of public interest protection, detailed specifications may be set out in the Community harmonisation legislation concerned. |6.1 |Način propisivanja tehničkih zahteva
Zaštita javnog interesa u tehničkom propisu obezbeđuje se propisivanjem bitnih zahteva kojima se utvrđuje nivo te zaštite, tako što se ti zahtevi propisuju u vidu ciljeva koje treba postići (u daljem tekstu: bitni zahtevi) ili, gde to nije moguće ili nije odgovarajuće u cilju obezbeđivanja zaštite potrošača, javnog zdravlja, životne sredine ili drugog javnog interesa, u vidu detaljnih specifikacija. |PU | | | |3.2 |Where Community harmonisation legislation sets out essential requirements, it shall provide for recourse to be had to harmonised standards, adopted in accordance with Directive 98/34/EC, which shall express those requirements in technical terms and which shall, alone or in conjunction with other harmonised standards, provide for the presumption of conformity with those requirements, while maintaining the possibility of setting the level of protection by other means. |6.3 |Ukoliko se tehničkim propisom preuzimaju bitni zahtevi harmonizovanog zakonodavstva EU, tim propisom se vrši pozivanje na odgovarajuće srpske standarde kojima su preuzeti harmonizovani standardi i koji obezbeđuju pretpostavku usaglašenosti sa takvim bitnim zahtevima, s tim da se nivo zaštite javnog interesa u tehničkom propisu može utvrditi na drugi način. |PU | | | |4.1 |Conformity assessment procedures
1. Where Community harmonisation legislation requires conformity assessment to be performed in respect of a particular product, the procedures which are to be used shall be chosen from among the modules set out and specified in Annex II, in accordance with the following criteria:
(a) whether the module concerned is appropriate to the type of product;
(b) the nature of the risks entailed by the product and the extent to which conformity assessment corresponds to the type and degree of risk;
(c) where third party involvement is mandatory, the need for the manufacturer to have a choice between quality assurance and product certification modules set out in Annex II;
(d) the need to avoid imposing modules which would be too burdensome in relation to the risks covered by the legislation concerned. |10.1 |Moduli za određeni proizvod, odnosno grupe proizvoda, koji se propisuju tehničkim propisom utvrđuju se u skladu sa sledećim principima:
1) da modul bude odgovarajući za određeni proizvod, odnosno grupu proizvoda;
2) da modul bude odgovarajući u odnosu na vrstu, prirodu i stepen rizika koji predstavlja, odnosno može predstavljati proizvod;
3) ako je obavezno učešće nezavisne treće strane, proizvođaču se omogućuje izbor između modula ocenjivanja usaglašenosti kojima se obezbeđuje garancija kvaliteta i modula sertifikacije proizvoda;
4) izbegavati module kojima se nameće preveliko opterećenje u odnosu na rizike na koje se odnosi propis. |PU | | | |4.2 |2. Where a product is subject to several Community acts within the scope of this Decision, consistency among conformity assessment procedures shall be ensured by the legislator. |10.3 |Ako se na određeni proizvod primenjuje više tehničkih propisa, neophodno je obezbediti međusobnu usklađenost i konzistentnost postupaka ocenjivanja usaglašenosti. |PU | | | |4.3 |3. The modules referred to in paragraph 1 shall be applied as appropriate to the product concerned and in accordance with the instructions set out in those modules. |10.2 |Moduli iz stava 1. ovog člana se primenjuju na proizvod koji je predmet ocenjivanja usaglašenosti, a u skladu sa zahtevima navedenim u tim modulima iz tehničkog propisa. |PU | | | |4.4 |4. For custom-made products and small series production, the technical and administrative conditions relating to conformity assessment procedures shall be alleviated. |10.4 |U slučaju neserijskih proizvoda i proizvodnje malih serija, tehnički i netehnički zahtevi koji se odnose na postupke ocenjivanja usaglašenosti propisuju se na način da omogućavaju olakšanu primenu u odnosu na takvu proizvodnju. |PU | | | |4.5 |5. When applying the modules referred to in paragraph 1, and wherever applicable and relevant, the legislative instrument may:
(a) regarding technical documentation, require information additional to that which is already stipulated in the modules;
(b) regarding the time for which the manufacturer and/or notified body are obliged to keep any kind of documentation, alter the period stipulated in the modules;
(c) specify the manufacturer’s choice as to whether the tests are carried out either by an accredited in-house body or under the responsibility of a notified body chosen by the manufacturer;
(d) where product verification is performed, specify the manufacturer’s choice as to whether the examinations and tests to check the conformity of the products with the appropriate requirements will be carried out, by examination and testing of every product, or by examination and testing of the products on a statistical basis;
(e) provide for the EC-type examination certificate to have a period of validity;
(f) regarding the EC-type examination certificate, specify relevant information relating to conformity assessment and in-service control to be included in it or its annexes;
(g) provide for different arrangements regarding the obligations of the notified body to inform its notifying authorities;
(h) if the notified body carries out periodic audits, specify their frequency. |10.5 |Pri propisivanju modula iz stava 1. ovog člana, u meri u kojoj je to odgovarajuće, tehnički propis:
1) u pogledu tehničke dokumentacije, može da sadrži zahtev za dodatnim informacijama u odnosu na module;
2) može da definiše odgovarajući vremenski period u kome su proizvođač, odnosno telo za ocenjivanje usaglašenosti dužni da čuvaju dokumentaciju, s tim da taj period može biti različit u odnosu na module;
3) može propisati da proizvođač ima izbor da li će ispitivanja sprovoditi akreditovano telo u njegovom sastavu ili pod odgovornošću imenovanog, odnosno notifikovanog tela koje je odabrao proizvođač.
4) ako se sprovodi postupak verifikacije proizvoda, propisuje da li proizvođač obezbeđuje da se pregledi i ispitivanja proizvoda vrše pregledanjem, odnosno ispitivanjem svakog pojedinačnog proizvoda ili pregledanjem, odnosno ispitivanjem proizvoda na statističkoj osnovi;
5) obezbeđuje da sertifikat o pregledu tipa ima propisan rok važenja;
6) u pogledu sertifikata o pregledu tipa, sadrži relevantne informacije u vezi sa ocenjivanjem usaglašenosti i pregledima tokom veka upotrebe koje će biti sadržane u sertifikatu ili njegovim prilozima;
7) sadrži rešenja u vezi sa obavezama imenovanog, odnosno notifikovanog tela da obaveštava organe koji vrše imenovanje, odnosno notifikaciju;
8) ako imenovano, odnosno notifikovano telo vrši periodične provere, sadrži odredbe o tome koliko često to radi. | | | | |4.6 |6. When applying the modules referred to in paragraph 1, and wherever applicable and relevant, the legislative instrument shall:
(a) where product checks and/or verification are performed, determine the products concerned, the appropriate tests, the adequate sampling schemes, the operational characteristics of the statistical method to be applied and the corresponding action to be taken by the notified body and/or the manufacturer;
(b) where EC-type examination is performed, determine the appropriate manner (design type, production type, design and production type) and the specimens required. |10.6 |Pri primeni modula i u drugim slučajevima gde je to odgovarajuće, tehničkim propisom se:
1) ako se vrše provere, odnosno verifikacije proizvoda, propisuje koji su proizvodi za koje se vrše takve provere, koja su odgovarajuća ispitivanja, koje su odgovarajuće šeme uzimanja uzoraka i operativne karakteristike statističkog metoda koji se primenjuje, kao i radnje koje će preduzeti imenovano, odnosno notifikovano telo, ili proizvođač;
2) ako se vrši pregled tipa, propisuje koji je odgovarajući način za to (tip projekta, tip proizvodnje, tip projekta i proizvodnje) i potrebni uzorci. |PU | | | |4.7 |7. An appeal procedure against decisions of the notified body shall be available. |10.7 |Tehničkim propisom se mora obezbediti mogućnost podnošenja primedbe na odluke imenovanog, odnosno notifikovanog tela. |PU | | | |5. |EC declaration of conformity
Where Community harmonisation legislation requires a statement by the manufacturer that fulfilment of the requirements relating to a product has been demonstrated (EC declaration of conformity), the legislation shall provide that a single declaration shall be drawn up in respect of all Community acts applicable to the product containing all information required for the identification of Community harmonisation legislation to which the declaration relates, and giving the publication references of the acts concerned.
|3.1.17 |17) deklaracija o usaglašenosti je izjava kojom proizvođač potvrđuje da su ispunjeni zahtevi za proizvod iz tehničkog propisa kojim je propisano sačinjavanje takve izjave; |DU |PU se obezbeđuje tehničkim propisom kojim se transponuje sektorsko harmonizovano zakonodavstvo EU, a podzakonskim aktom na osnovu ovog zakona propisaće se opšta načela za sačinjavanje deklaracije o usaglašenosti, kao opšti strukturni model deklaracije o usaglašenosti iz Aneksa III Odluke 768/2008/EZ. | | |6.1
|Conformity assessment
Where Community harmonisation legislation requires conformity assessment, it may provide for that assessment to be carried out by public authorities, manufacturers or notified bodies.
|8.1
8.2 |Propisivanje ocenjivanja usaglašenosti
Zahtevi za ocenjivanje usaglašenosti utvrđuju se tehničkim propisom.
Kada se tehničkim propisom utvrđuju zahtevi za ocenjivanje usaglašenosti, tim propisom se može propisati da u postupku ocenjivanja usaglašenosti učestvuju proizvođač, imenovano, odnosno notifikovano telo i/ili organ državne uprave. |PU | | | |6.2 |Where Community harmonisation legislation provides for conformity assessment to be carried out by public authorities, the legislation shall provide that the conformity assessment bodies on which those authorities rely for technical assessments must comply with the same criteria as those set out in this Decision for notified bodies. |13.2
15.2 |Kada je posebnim zakonom ili tehničkim propisom utvrđeno da ocenjivanje usaglašenosti sprovodi organ državne uprave, tim propisom se može propisati da za potrebe tog organa određene aktivnosti ocenjivanja usaglašenosti sprovodi ovlašćeno, odobreno ili drugo telo za ocenjivanje usaglašenosti, kome je taj organ odobrio da sprovodi aktivnosti ocenjivanja usaglašenosti.
Zahtevi iz stava 1. ovog člana shodno se primenjuju i na tela za ocenjivanje usaglašenosti iz člana 13. stav 2. ovog zakona. |PU | | | |7 |Reference provisions
The reference provisions for Community harmonisation legislation for products shall be as set out in Annex I. |/ |/ |NP | | | |8 |Repeal
Decision 93/465/EEC is hereby repealed.
References to the repealed Decision shall be construed as references to this Decision |/ |/ |NP | | | |Annex I
(aI) |REFERENCE PROVISIONS FOR COMMUNITY HARMONISATION LEGISLATION FOR PRODUCTS
DEFINITIONS |/ |/ |PU |Predlog zakona ima šire područje primene od Odluke 768/2008/EZ, tj. odnosi se i na harmonizovanu i neharmonizovanu oblast.
PU u harmonizovanoj oblasti se obezbeđuje podzakonskim aktima. | | |Chapter R1 |Definitions |3 |Značenje pojedinih izraza |PU | | | |aI.R1.1 |Definitions
For the purposes of this … [act] the following definitions shall apply:
1. „making available on the market“ shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge; |3.1.2 |2) isporuka na tržištu je svako činjenje dostupnim proizvoda na tržištu Republike Srbije radi distribucije, potrošnje ili upotrebe, u okviru privredne delatnosti, sa ili bez naknade; |PU |PU je obezbeđena prelaznom odredbom 52.1 Predloga zakona. | | |aI.R1.2 |2. „placing on the market“ shall mean the first making available of a product on the Community market;
|3.1.3 |3) stavljanje na tržište je prva isporuka proizvoda na tržištu Republike Srbije; |PU |PU je obezbeđena prelaznom odredbom 52.1 Predloga zakona. | | |aI.R1.3 |3. „manufacturer“ shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark; |3.1.4 |4) proizvođač je pravno lice ili preduzetnik koje izrađuje proizvod ili za koga se proizvod projektuje i izrađuje, i koji stavlja taj proizvod na tržište pod svojim imenom ili trgovačkim znakom; |PU | | | |aI.R1.4 |4. „authorised representative“ shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks; |3.1.5 |5) zastupnik je pravno lice ili preduzetnik registrovan u Republici Srbiji, koje ima pisano ovlašćenje proizvođača da u njegovo ime preduzima određene radnje; |PU |PU je obezbeđena prelaznom odredbom 52.1 Predloga zakona. | | |aI.R1.5 |5. „importer“ shall mean any natural or legal person established within the Community who places a product from a third country on the Community market; |3.1.6 |6) uvoznik je pravno lice ili preduzetnik registrovan u Republici Srbiji, koje stavlja na tržište proizvod iz drugih država; |PU |PU je obezbeđena prelaznom odredbom 52.1 Predloga zakona. | | |aI.R1.6 |6. „distributor“ shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market; |3.1.7 |7) distributer je pravno lice ili preduzetnik registrovan u Republici Srbiji, koje je uključeno u lanac isporuke, a nije proizvođač ili uvoznik; |PU |PU je obezbeđena prelaznom odredbom 52.1 Predloga zakona. | | |aI.R1.7 |7. „economic operators“ shall mean the manufacturer, the authorised representative, the importer and the distributor; |3.1.8 |8) isporučilac je proizvođač, zastupnik, uvoznik ili distributer; |PU | | | |aI.R1.8 |8. „technical specification“ shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service; |3.1.18 |18) tehnička specifikacija je dokument kojim se utvrđuju tehnički zahtevi koje treba da ispuni proizvod, proces ili usluga; |PU | | | |aI.R1.9 |9. „harmonised standard“ shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC on the basis of a request made by the Commission in accordance with Article 6 of that Directive; |3.1.23 |23) harmonizovani standard je evropski standard koji je donet na osnovu zahteva Evropske komisije za primenu u harmonizovanom zakonodavstvu Evropske unije; |PU |Ova definicija je usklađena sa Uredbom (EU) 1025/2012 i sektorskim harmonizovanim zakonodavstvom EU | | |aI.R1.10 |10. „accreditation“ shall have the meaning assigned to it by Regulation (EC) No 765/2008; |ZoA 2.1.1 |akreditacija je utvrđivanje od strane nacionalnog tela za akreditaciju da li telo za ocenjivanje usaglašenosti ispunjava zahteve odgovarajućih srpskih, odnosno međunarodnih i evropskih standarda, i kada je primenljivo, sve dodatne zahteve definisane za pojedine oblasti, kako bi se vršili određeni poslovi ocenjivanja usaglašenosti |PU | | | |aI.R1.11 |11. „national accreditation body“ shall have the meaning assigned to it by Regulation (EC) No 765/2008; |ZoA 5.1 |Akreditaciono telo Srbije (u daljem tekstu: ATS) je jedino u Republici Srbiji kome se ovim zakonom poverava obavljanje poslova akreditacije iz čl. 3. i 8. ovog zakona |PU | | | |aI.R1.12 |12. „conformity assessment“ shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled; |3.1.9 |9) ocenjivanje usaglašenosti je postupak kojim se utvrđuje da li su ispunjeni zahtevi određeni za proizvod, proces, uslugu, sistem, lice ili telo; |PU | | | |aI.R1.13 |13. „conformity assessment body“ shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection; |3.1.10 |10) telo za ocenjivanje usaglašenosti je pravno lice koje sprovodi aktivnosti ocenjivanja usaglašenosti, što uključuje etaloniranje, ispitivanje, sertifikaciju i/ili kontrolisanje; |PU | | | |aI.R1.14 |14. „recall“ shall mean any measure aimed at achieving the return of a product that has already been made available to the end user; |3.1.22 |22) opoziv je svaka mera koja ima za cilj povraćaj proizvoda koji je već isporučen krajnjem korisniku |PU | | | |aI.R1.15 |15. „withdrawal“ shall mean any measure aimed at preventing a product in the supply chain from being made available on the market; |3.1.21 |21) povlačenje je svaka mera koja ima za cilj da spreči da se proizvod u lancu isporuke isporuči na tržištu |PU | | | |aI.R1.16 |16. „CE marking“ shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing; |3.1.25 |23) SE znak je oznaka kojom proizvođač potvrđuje da je proizvod usaglašen sa primenjivim zahtevima harmonizovanog zakonodavstva EU kojim je propisano stavljanje tog znaka; |PU | | | |aI.R1.17 |17. „Community harmonisation legislation“ shall mean any Community legislation harmonising the conditions for the marketing of products. |3.1.24 |22) harmonizovano zakonodavstvo EU su propisi Evropske unije kojima se usklađuju uslovi za trgovanje proizvodima; |PU | | | |Chapter R2 |Obligations of economic operators |Glava V. |OBAVEZE ISPORUČIOCA I VLASNIKA PROIZVODA U UPOTREBI |PU |PU u pogledu detaljnih aktivnosti isporučilaca se, na osnovu ovlašćenja iz odredaba 4.2 u vezi sa 24.12, 26.12 i 27.8, obezbeđuje tehničkim propisom kojim se preuzima sektorsko harmonizovano zakonodavstvo EU. | | |aI.R2.1 |Obligations of manufacturers
When placing their products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in … [reference to the relevant part of the legislation]. |24.1.1 |Obaveze proizvođača
Proizvođač je dužan da:
1) obezbedi da je proizvod koji stavlja na tržište projektovan i izrađen u skladu sa propisanim zahtevima; |PU | | | |aI.R2.2 |Manufacturers shall draw up the required technical documentation and carry out the conformity assessment procedure applicable or have it
carried out.
Where compliance of a product with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EC
declaration of conformity and affix the conformity marking. |24.1.2
24.1.3 |2) kada je propisano tehničkim propisom, sačini potrebnu tehničku dokumentaciju i čuva je u propisanom roku;
3) obezbedi sprovođenje propisanog postupka ocenjivanja usaglašenosti i, ako je primenom tog postupka potvrđena usaglašenost proizvoda sa primenjivim zahtevima, sačini propisanu ispravu o usaglašenosti i čuva je u propisanom roku, kao i da stavi na proizvod propisani znak usaglašenosti, odnosno druge propisane oznake; |PU | | | |aI.R2.3 |Manufacturers shall keep the technical documentation and the EC declaration of conformity for … [period to be specified in proportion to the lifecycle of the product and the level of risk] after the product hasbeen placed on the market. |24.1.2
24.1.3 |2) kada je propisano tehničkim propisom, sačini potrebnu tehničku dokumentaciju i čuva je u propisanom roku;
3) … sačini propisanu ispravu o usaglašenosti i čuva je u propisanom roku… |PU | | | |aI.R2.4 |Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in technical
specifications by reference to which conformity of a product is declared shall be adequately taken into account.
When deemed appropriate with regard to the risks presented by a product, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of any such monitoring. |24.1.4
24.1.5 |4) obezbedi primenu postupaka kojima se osigurava održavanje usaglašenosti proizvoda u slučaju serijske proizvodnje, uzimajući u obzir izmene projekta i karakteristika proizvoda ili izmene u primenjenim standardima ili drugim tehničkim specifikacijama;
5) kada je propisano tehničkim propisom i kada je to odgovarajuće u odnosu na rizik koji proizvod predstavlja, u cilju zaštite zdravlja i bezbednosti potrošača, vrši ispitivanje uzoraka proizvoda na tržištu, obrađuje informacije i, po potrebi, vodi evidencije reklamacija, kao i neusaglašenih i opozvanih proizvoda, i o tome obaveštava distributere; |PU | | | |aI.R2.5 |Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product. |24.1.6 |6) kada je propisano tehničkim propisom, obezbedi da je proizvod označen brojem tipa, partije, serijskim brojem ili drugim podatkom za identifikaciju proizvoda ili, ako to nije moguće, obezbedi da su ovi podaci navedeni na ambalaži proizvoda ili dokumentu koji prati proizvod; |PU | | | |aI.R2.6 |Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a
document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted. |24.1.7 |7) kada je propisano tehničkim propisom, navede na proizvodu svoje poslovno ime, registrovano trgovačko ime ili registrovani trgovački znak, kao i adresu na kojoj ga je moguće kontaktirati, ili ako to nije moguće, da navede ove podatke na ambalaži proizvoda ili dokumentu koji prati proizvod; |PU | | | |aI.R2.7 |Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the
Member State concerned. |24.1.8 |8) obezbedi da proizvod prate propisana uputstva i informacije na srpskom jeziku , odnosno druga propisana dokumentacija; |PU |PU u pogledu jezika drugih država članica je obezbeđena prelaznom odredbom 52.1. | | |aI.R2.8 |Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Community harmonisation legislation shall immediately take the necessary corrective measures to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the noncompliance and of any corrective measures taken. |24.1.9
24.1.10 |9) ako smatra ili ima razloga da sumnja da proizvod koji je stavio na tržište nije usaglašen sa tehničkim propisom, bez odlaganja preduzima potrebne korektivne radnje kako bi taj proizvod usaglasio sa tehničkim propisom ili, ako je odgovarajuće, kako bi ga povukao ili opozvao;
10) kada je propisano, dostavlja nadležnom organu propisane informacije, odnosno dokumentaciju, uključujući i informacije organu tržišnog nadzora, a koje su neophodne za potvrđivanje usaglašenosti proizvoda, na obrazložen zahtev, na jeziku koji taj organ razume; |PU | | | |aI.R2.9 |Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market. |24.1.10
24.1.11 |10) kada je propisano, dostavlja nadležnom organu propisane informacije, odnosno dokumentaciju, uključujući i informacije organu tržišnog nadzora, a koje su neophodne za potvrđivanje usaglašenosti proizvoda, na obrazložen zahtev, na jeziku koji taj organ razume;
11) sarađuje sa nadležnim organima, na njihov zahtev, u svim radnjama preduzetim u cilju izbegavanja rizika koje predstavlja proizvod koji je stavio na tržište. |PU | | | |aI.R3.1 |Authorised representatives
A manufacturer may, by a written mandate, appoint an authorised representative.
The obligations laid down in Article [R2(1)] and the drawing up of technical documentation shall not form part of the authorised representative’s mandate. |25.1
25.2 |Ovlašćeni zastupnik
Proizvođač može da ovlasti zastupnika da izvršava pojedine njegove obaveze dajući mu pisano ovlašćenje, …
Proizvođač ne može da ovlasti zastupnika za izvršavanje obaveze iz člana 24. stav 1. tačka 1) ovog zakona, kao ni za sačinjavanje tehničke dokumentacije. |PU | | | |aI.R3.2 |An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the
authorised representative to do at least the following:
(a) keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for … [period to be specified in proportion to the lifecycle of the product and the level of risk];
(b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product;
(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate. |25.1 |… koje zastupniku mora da omogući najmanje da:
1) stavlja na raspolaganje nadležnim organima tržišnog nadzora propisanu ispravu o usaglašenosti i tehničku dokumentaciju tokom propisanog vremenskog perioda;
2) dostavlja nadležnim organima, na obrazložen zahtev, sve informacije i dokumentaciju neophodnu za dokazivanje usaglašenosti proizvoda;
3) sarađuje sa nadležnim organima, na zahtev, u svim radnjama preduzetim u cilju izbegavanja rizika koje predstavlja proizvod obuhvaćen ovlašćenjem proizvođača. |PU | | | |aI.R4.1 |Obligations of importers
Importers shall place only compliant products on the Community market. |26.1.1 |Obaveze uvoznika
Uvoznik je dužan da:
1) stavlja na tržište samo proizvode koji su usaglašeni sa propisanim zahtevima; |PU | | | |aI.R4.2 |Before placing a product on the market importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn
up the technical documentation, that the product bears the required conformity marking or markings and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article [R2(5) and (6)].
Where an importer considers or has reason to believe that a product is not in conformity with … [reference to the relevant part of the legislation], he shall not place the product on the market until it has been
brought into conformity. Furthermore, where the product presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect. |26.1.2
26.1.3 |2) obezbedi, pre stavljanja proizvoda na tržište:
(1) da je sproveden propisani postupak ocenjivanja usaglašenosti i da je proizvođač sačinio potrebnu tehničku dokumentaciju;
(2) da je proizvod označen propisanim znakom usaglašenosti, odnosno drugim propisanim oznakama, kao i da ga prati propisana dokumentacija;
(3) da je proizvođač ispunio svoje obaveze u pogledu obeležavanja proizvoda propisanim podacima;
3) ako smatra ili ima razloga da veruje da proizvod nije usaglašen sa propisanim zahtevima, stavi proizvod na tržište tek nakon što bude usaglašen sa tim zahtevima i, ako taj proizvod predstavlja rizik, o tome obavesti proizvođača i nadležni organ tržišnog nadzora; |PU | | | |aI.R4.3 |Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. |26.1.4 |4) kada je propisano, navede na proizvodu svoje poslovno ime, registrovano trgovačko ime ili registrovani trgovački znak, kao i adresu na kojoj ga je moguće kontaktirati, ili ako to nije moguće, da navede ove podatke na ambalaži proizvoda ili dokumentu koji prati proizvod; |PU | | | |aI.R4.4 |Importers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. |26.1.5 |5) obezbedi da proizvod prate propisana uputstva i informacije na srpskom jeziku, odnosno druga propisana dokumentacija; |PU |PU u pogledu jezika drugih država članica je obezbeđena prelaznom odredbom 52.1. | | |aI.R4.5 |Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in … [reference to the relevant part of the legislation]. |26.1.6 |6) obezbedi da, dok je proizvod pod njegovom odgovornošću, uslovi skladištenja ili prevoza ne ugroze usaglašenost proizvoda sa propisanim zahtevima; |PU | | | |aI.R4.6 |When deemed appropriate with regard to the risks presented by a product, importers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if
necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of such monitoring. |26.1.7 |7) kada je propisano tehničkim propisom i kada je to odgovarajuće u odnosu na rizik koji proizvod predstavlja, u cilju zaštite zdravlja i bezbednosti potrošača, vrši ispitivanje uzoraka proizvoda na tržištu, obrađuje informacije i, po potrebi, vodi evidencije reklamacija, kao i neusaglašenih i opozvanih proizvoda, i o tome obaveštava distributere; |PU | | | |aI.R4.7 |Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the Community harmonisation legislation applicable shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the noncompliance and of any corrective measures taken. |26.1.8 |8) ako smatra ili ima razloga da veruje da proizvod koji je stavio na tržište nije usaglašen sa tehničkim propisom, bez odlaganja preduzima potrebne korektivne radnje kako bi taj proizvod bio usaglašen sa tehničkim propisom ili, ako je odgovarajuće, kako bi ga povukao ili opozvao; |PU | | | |aI.R4.8 |Importers shall, for … [period to be specified in proportion to the lifecycle of the product and the level of risk], keep a copy of the EC declaration of conformity at the disposal of the market surveillance
authorities and ensure that the technical documentation can be made available to those authorities, upon request. |26.1.9 |9) u propisanom roku čuva propisanu ispravu o usaglašenosti i obezbeđuje dostupnost tehničke dokumentacije nadležnim organima |PU | | | |aI.R4.9 |Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product in a language
which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market. |26.1.10 |10) kada je propisano tehničkim propisom, dostavlja nadležnom organu propisane informacije, odnosno dokumentaciju, uključujući i informacije organu tržišnog nadzora, a koje su neophodne za potvrđivanje usaglašenosti proizvoda, na obrazložen zahtev, na jeziku koji taj organ razume;
11) sarađuje sa nadležnim organima, na njihov zahtev, u svim radnjama preduzetim u cilju izbegavanja rizika koje predstavlja proizvod koji je stavio na tržište. |PU | | | |aI.R5.1 |Obligations of distributors
When making a product available on the market distributors shall act with due care in relation to the requirements applicable. |27.1.1 |Obaveze distributera
Distributer je dužan da:
1) kada isporučuje proizvod na tržištu, postupa savesno u vezi sa propisanim zahtevima; |PU | | | |aI.R5.2 |Before making a product available on the market distributors shall verify that the product bears the required conformity marking or markings, that it is accompanied by the required documents and by
instructions and safety information in a language which can be easily understood by consumers and other end-users in the Member State in which the product is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article [R2(5) and (6)] and Article [R4(3)].
Where a distributor considers or has reason to believe that a product is not in conformity with … [reference to the relevant part of the legislation], he shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities. |27.1.2
27.1.3 |2) proveri, pre isporuke proizvoda na tržištu, da je proizvod označen propisanim znakom usaglašenosti, odnosno drugim propisanim oznakama i podacima, kao i da ga prate propisana uputstva i informacije na srpskom jeziku, odnosno druga propisana dokumentacija;
3) ako smatra ili ima razloga da veruje da proizvod nije usaglašen sa propisanim zahtevima, isporuči proizvod na tržištu tek nakon što je usaglašen sa tim zahtevima i, ako taj proizvod predstavlja rizik, o tome obavesti proizvođača ili uvoznika i nadležni organ tržišnog nadzora; |PU | | | |aI.R5.3 |Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in … [reference to the relevant part of the legislation]. |27.1.4 |4) obezbedi da, dok je proizvod pod njegovom odgovornošću, uslovi skladištenja ili prevoza ne ugroze usaglašenost proizvoda sa propisanim zahtevima; |PU | | | |aI.R5.4 |Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with the Community harmonisation legislation applicable shall make sure that the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the product presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. |27.1.5
27.1.6 |5) ako smatra ili ima razloga da verujeda proizvod koji je isporučio na tržištu nije usaglašen sa tehničkim propisom, bez odlaganja obezbedi preduzimanje potrebnih korektivnih radnji kako bi taj proizvod bio usaglašen sa tehničkim propisom ili, ako je odgovarajuće, kako bi bio povučen ili opozvan;
6) kada je propisano tehničkim propisom, dostavlja nadležnom organu propisane informacije, odnosno dokumentaciju, uključujući i informacije organu tržišnog nadzora, a koje su neophodne za potvrđivanje usaglašenosti proizvoda, na obrazložen zahtev, na jeziku koji taj organ razume; |PU | | | |aI.R5.5 |Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product. They shall
cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have made available on the market. |27.1.6
27.1.7 |6) kada je propisano tehničkim propisom, dostavlja nadležnom organu propisane informacije, odnosno dokumentaciju, uključujući i informacije organu tržišnog nadzora, a koje su neophodne za potvrđivanje usaglašenosti proizvoda, na obrazložen zahtev, na jeziku koji taj organ razume;
7) sarađuje sa nadležnim organima, na njihov zahtev, u svim radnjama preduzetim u cilju izbegavanja rizika koje predstavlja proizvod koji je stavio na tržište. |PU | | | |aI.R6 |Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered a manufacturer for the purposes of this … [act] and he shall be subject to the obligations of the manufacturer under Article [R2], where he places a product on the
market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected. |28
29 |Posebne obaveze uvoznika i distributera
Uvoznik ili distributer koji stavlja na tržište proizvod pod svojim imenom ili trgovačkim znakom, smatra se proizvođačem i preuzima obaveze proizvođača u vezi sa stavljanjem proizvoda na tržište, s tim da tehnička dokumentacija za taj proizvod ne mora da glasi na ime uvoznika, odnosno distributera.
Uvoznik, distributer ili drugo lice koje izmeni proizvod, koji je već stavljen na tržište, u meri koja utiče na usaglašenost sa zahtevima iz tehničkih propisa, smatra se proizvođačem i preuzima obaveze proizvođača u vezi sa stavljanjem proizvoda na tržište, s tim da tehnička dokumentacija koja se odnosi na izmene proizvoda mora da glasi na ime uvoznika, distributera ili drugog lica koje je izmenilo proizvod. |PU | | | |aI.R7 |Identification of economic operators
Economic operators shall, on request, identify the following to the market surveillance authorities, for … [period to be specified in proportion to the lifecycle of the product and the level of risk]:
(a) any economic operator who has supplied them with a product;
(b) any economic operator to whom they have supplied a product. |30 |Identifikacija isporučioca
Isporučilac je dužan da čuva i da, na zahtev nadležnog inspektora, dostavi podatke o isporučiocu od koga je nabavio proizvod, kao i podatke o isporučiocu kome je isporučio proizvod.
Period čuvanja podataka iz stava 1. utvrđuje se tehničkim propisom. Za proizvode za koje tehničkim propisom nije utvrđen period čuvanja i dostavljanja ovih podataka, taj period je 10 godina od datuma isporuke. |PU | | | |Chapter R3 |Conformity of the product |/ |/ | | | | |aI.R8.1 |Presumption of conformity
Products which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the requirements covered by those standards or parts thereof, set out in … [reference to the relevant part of the legislation]. |7.1 |Pretpostavka usaglašenosti
Tehničkim propisom može se propisati da se pretpostavlja da je proizvod usaglašen sa propisanim tehničkim zahtevima ako je usaglašen sa odgovarajućim srpskim standardima kojima su preuzeti harmonizovani standardi, ili, ukoliko nema takvih standarda u određenoj oblasti, drugim relevantnim standardima ili tehničkim specifikacijama za tu oblast. |PU | | | |aI.R9 |Formal objection to a harmonised standard
When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements which it covers and which are set out in … [reference to the relevant part of the legislation], the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, giving its arguments. The Committee shall, having consulted the relevant European standardisation bodies, deliver its opinion without delay.
In the light of the Committee’s opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in or from the Official Journal of the European Union.
The Commission shall inform the European standardisation body concerned and, if necessary, request the revision of the harmonised standards concerned. |/ |/ |NU |PU će se obezbediti direktnom primenom člana 11. Uredbe (EU) br. 1025/2012 od dana pristupanja Republike Srbije Evropskoj uniji.
Potrebne izmene Zakona o standardizaciji u cilju implementacije člana 11. Uredbe (EU) br. 1025/2012 – određivanje da prigovor podnosi ministarstvo nadležno za poslove standardizacije. | | |aI.R10 |EC declaration of conformity
The EC declaration of conformity shall state that the fulfilment of requirements specified in … [reference to relevant part of the legislation] has been demonstrated.
The EC declaration of conformity shall have the model structure set out in Annex III of Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, shall contain the elements specified in the relevant modules set out in Annex II of that Decision and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which market the product is placed or made available.
By drawing up the EC declaration of conformity, the manufacturer shall assume responsibility for the compliance of the product. |3.1.17 |17) deklaracija o usaglašenosti je izjava kojom proizvođač potvrđuje da su ispunjeni zahtevi za proizvod iz tehničkog propisa kojim je propisano sačinjavanje takve izjave; |DU |PU se obezbeđuje tehničkim propisom kojim se transponuje sektorsko harmonizovano zakonodavstvo EU, a podzakonskim aktom na osnovu ovog zakona propisaće se opšta načela za sačinjavanje deklaracije o usaglašenosti, kao opšti strukturni model deklaracije o usaglašenosti iz Aneksa III Odluke 768/2008/EZ. | | |aI.R11 |General principles of the CE marking
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. |14 |Srpski znak usaglašenosti
Proizvod koji je usaglašen sa tehničkim propisom označava se Srpskim znakom usaglašenosti, ako je to utvrđeno tehničkim propisom.
Ukoliko je tehničkim propisom preuzeto harmonizovano zakonodavstvo kojim se propisuje stavljanje „SE“ znaka, tim propisom se utvrđuje obaveza označavanja proizvoda Srpskim znakom usaglašenosti.
Proizvod koji nije usaglašen sa tehničkim propisom, odnosno proizvod za koji nije propisano označavanje Srpskim znakom usaglašenosti, zabranjeno je označiti tim znakom.
Zabranjeno je proizvod označiti drugim znakom koji nije Srpski znak usaglašenosti već na njega samo podseća svojim sadržajem ili oblikom čime bi kod potrošača ili drugog korisnika mogao da stvori zabludu da se radi o Srpskom znaku usaglašenosti ili ako bi označavanje proizvoda drugim znakom smanjilo vidljivost, odnosno čitljivost Srpskog znaka usaglašenosti.
Oblik, izgled, sadržaj i način stavljanja znaka usaglašenosti uređuje se propisom koji donosi Vlada. |DU |Principi SE označavanja se primenjuju na stavljanje Srpskog znaka usaglašenosti, u skladu sa članom 14. Predloga.
PU u smislu primene SE označavanja, obezbeđuje se prelaznim odredbama tehničkog propisa u skladu sa odredbama 53.1 i 53.2 Predloga. | | |aI.R12.1
aI.R12.2
aI.R12.3
|Rules and conditions for affixing the CE marking
The CE marking shall be affixed visibly, legibly and indelibly to the product or to its data plate. Where that is not possible or not warranted on account of the nature of the product, it shall be affixed to the packaging and to the accompanying documents, where the legislation concerned provides for such documents.
The CE marking shall be affixed before the product is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.
The CE marking shall be followed by the identification number of the notified body, where that body is involved in the production control phase.
The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative. |/ |/ |NU |Pravila i uslovi za stavljanje Srpskog znaka usaglašenosti, u skladu sa pravilima i uslovima SE označavanja, propisuju se podzakonskim aktom iz 14.5, kao i tehničkim propisom, na osnovu ovlašćenja iz 4.1.6 i podzakonskog akta iz 14.5.
PU u smislu primene SE označavanja, obezbeđuje se prelaznim odredbama tehničkog propisa u skladu sa odredbama 53.1 i 53.2 Predloga. | | |aI.R12.4 |Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use. |/ |/ |PU |PU je obezbeđena odredbama člana 41. Predloga koje se odnose na formalne neusaglašenosti u vezi sa stavljanjem znaka usaglašenosti i kaznenim odredbama iz člana 46. Predloga.
SE označavanje se obezbeđuje u skladu sa prelaznom odredbom 53.1 i 53.2. | | |Chapter R4 |Notification of conformity assessment bodies |21 |Notifikacija tela za ocenjivanje usaglašenosti | | | | |aI.R13 |Notification
Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this … [act]. |3.1.12
3.1.13 |12) imenovano telo je pravno lice koje obavlja poslove ocenjivanja usaglašenosti ili druge poslove u skladu sa zahtevima tehničkog propisa i koje ima odobrenje nadležnog ministra za obavljanje tih poslova;
13) notifikovano telo je imenovano telo za ocenjivanje usaglašenosti koje je prijavljeno Evropskoj komisiji i državama članicama EU kao nezavisna treća strana za obavljanje poslova ocenjivanja usaglašenosti za određenu oblast i upisano u odgovarajući registar tih tela koji vodi Evropska komisija („NANDO baza”); |PU | | | |aI.R14.1 |Notifying authorities
Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with the provisions of Article [R20]. |21.1
21.2 |Notifikacija tela za ocenjivanje usaglašenosti
Ministarstvo je organ nadležan za notifikaciju tela za ocenjivanje usaglašenosti Evropskoj komisiji i državama članicama Evropske unije i može notifikovati isključivo imenovana tela za ocenjivanje usaglašenosti.
Ministarstvo je odgovorno za uspostavljanje i sprovođenje neophodnih postupaka za ocenjivanje i notifikaciju tela za ocenjivanje usaglašenosti, kao i nadzor nad radom ovih tela, uključujući i usklađenost sa odredbama iz člana 16. ovog zakona koje se odnose na podizvođača ili povezano pravno lice. |PU |Napomena: «Ministarstvo» je Ministarstvo privrede koje je nadležno za poslove tehničkih propisa, standardizacije, akreditacije, mera i dragocenih metala. | | |aI.R14.2 |Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008. |17.3 |Pri donošenju rešenja o imenovanju, uzima se u obzir sertifikat o akreditaciji koji je izdalo Akreditaciono telo Srbije (u daljem tekstu: ATS), u meri u kojoj su propisani postupci ocenjivanja usaglašenosti obuhvaćeni obimom akreditacije. |NP |Diskreciona odredba. Zakonodavac ovim zakonom predviđa isključivu odgovornost nadležnih ministarstava za ocenjivanje i nadzor nad radom imenovanih/notifikovanih tela, s tim da se u postupku imenovanja uzima u obzir sertifikat o akreditaciji izdat od strane nacionalnog akreditacionog tela (Akreditaciono telo Srbije je članica EA). | | |aI.R14.3 |Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article [R15(1) to (6)]. In addition it shall have arrangements to cover liabilities arising out of its activities. |21.5 |Nadležno ministarstvo utvrđuje ispunjenost propisanih zahteva za notifikaciju u cilju sprovođenja nadzora nad radom notifikovanih tela i o tome obaveštava Ministarstvo radi informisanja Evropske komisije. |NP |Diskreciona odredba. Zakonodavac ovim zakonom predviđa isključivu odgovornost nadležnih ministarstava za utvrđivanje ispunjenosti propisanih zahteva za imenovana/notifikovana tela, kao i za notifikaciju i nadzor.
Napomena: «Nadležno ministarstvo» je ministarstvo koje je nadležno za donošenje sektorskog tehničkog propisa. | | |aI.R14.4 |The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3. |/ |/ |NP |Diskreciona odredba. Ovim zakonom zakonodavac nije predvideo mogućnost poveravanja poslova telu koje nije organ državne uprave. | | |aI.R15.1 |Requirements relating to notifying authorities
A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs. |22.1.1 |Posebni zahtevi za organ nadležan za notifikaciju
Ministarstvo je dužno da obezbedi:
1) da ne dolazi do sukoba interesa u odnosu na telo za ocenjivanje usaglašenosti; |PU | | | |aI.R15.2 |A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities. |22.1.2 |2) da je organizovano i da radi na takav način da njegova objektivnost i nepristrasnost bude garantovana; |PU | | | |aI.R15.3 |A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment. |22.1.3 |3) da sve odluke koje se odnose na notifikaciju tela za ocenjivanje usaglašenosti donose kompetentna lica koja nisu učestvovala u ocenjivanju tela za ocenjivanje usaglašenosti; |PU | | | |aI.R15.4 |A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis. |22.1.4 |4) da ne nudi niti obavlja aktivnosti koje obavljaju tela za ocenjivanje usaglašenosti, niti da pruža konsultantske usluge na komercijalnoj ili konkurentskoj osnovi; |PU | | | |aI.R15.5 |A notifying authority shall safeguard the confidentiality of the information it obtains. |22.1.5 |5) poverljivost podataka i informacija do kojih dolazi u obavljanju svojih poslova; |PU | | | |aI.R15.6 |A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks. |22.1.6 |6) dovoljan broj kompetentnih lica za obavljanje svojih poslova. |PU | | | |aI.R16.1 |Information obligation on notifying authorities
Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto. |21.3 |Ministarstvo je dužno da obavesti Evropsku komisiju o postupcima iz stava 2. ovog člana, kao i o svim njihovim promenama. |PU | | | |aI.R16.2 |The Commission shall make that information publicly available. |/ |/ |NP |Obaveza EK. | | |aI.R17.1 |Requirements relating to notified bodies
For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11. |15.1 |Zahtevi za imenovanje
Kada je tehničkim propisom utvrđeno da ocenjivanje usaglašenosti sprovodi imenovano telo za ocenjivanje usaglašenosti, tim propisom se utvrđuju i zahtevi koje to telo mora da ispuni, naročito u pogledu: |DU |PU u pogledu detaljnih zakteva za imenovana/notifikovana tela obezbeđuju se tehničkim propisom kojim se preuzima sektorsko harmonizovano zakonodavstvo EU, na osnovu ovlašćenja iz odredbe 4.1.7. Predloga i u skladu sa podzakonskim aktom koji će se doneti na osnovu odredbe 21.7. Predloga. | | |aI.R17.2 |A conformity assessment body shall be established under national law and have legal personality. |15.1.1 |1) pravnog statusa tog tela; |DU |Napomena: Videti komentar za odredbu 15.1 Predloga. | | |aI.R17.3 |A conformity assessment body shall be a third-party body independent of the organisation or the product it assesses.
A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body. |15.1.3 |4) nezavisnosti, nepristrasnosti i odsustva sukoba interesa u odnosu na isporučioca proizvoda koji je predmet ocenjivanja usaglašenosti; |DU |Napomena: Videti komentar za odredbu 15.1 Predloga. | | |aI.R17.4 |A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assess, nor the authorised representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities. |15.1.3
15.1.7 |4) nezavisnosti, nepristrasnosti i odsustva sukoba interesa u odnosu na isporučioca proizvoda koji je predmet ocenjivanja usaglašenosti;
7) zahteva koji se odnose na odgovornost za aktivnosti podizvođača; |DU |Napomena: Videti komentar za odredbu 15.1 Predloga. | | |aI.R17.5 |Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities. |15.1.2 |2) stručne osposobljenosti zaposlenih i drugih angažovanih lica; |DU |Napomena: Videti komentar za odredbu 15.1 Predloga. | | |aI.R17.6 |A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by … [reference to relevant part of the legislation] and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.
At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:
(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;
(c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
It shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities. |15.1.2
15.1.3
15.1.5 |2) stručne osposobljenosti zaposlenih i drugih angažovanih lica;
3) opreme;
5) postupanja sa prigovorima na njegov rad i donete odluke; |DU |Napomena: Videti komentar za odredbu 15.1 Predloga. | | |aI.R17.7 |The personnel responsible for carrying out conformity assessment activities shall have the following:
(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
(c) appropriate knowledge and understanding of the essential requirements, of the applicable harmonised standards and of the relevant provisions of Community harmonisation legislation and of its implementing regulations;
(d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out. |15.1.2 |2) stručne osposobljenosti zaposlenih i drugih angažovanih lica; |DU |Napomena: Videti komentar za odredbu 15.1 Predloga. | | |aI.R17.8 |The impartiality of the conformity assessment bodies, their top level management and of the assessment personnel shall be guaranteed.
The remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments. |15.1.4 |4) nezavisnosti, nepristrasnosti i odsustva sukoba interesa u odnosu na isporučioca proizvoda koji je predmet ocenjivanja usaglašenosti; |DU |Napomena: Videti komentar za odredbu 15.1 Predloga. | | |aI.R17.9 |Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment. |15.1.8 |8) osiguranja od odgovornosti za štetu. |DU |Napomena: Videti komentar za odredbu 15.1 Predloga. | | |aI.R17.10 |The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under … [reference to the relevant part of the legislation] or any provision of national law giving effect to it, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected. |15.1.6 |6) čuvanja poslovne tajne; |DU |Napomena: Videti komentar za odredbu 15.1 Predloga. | | |aI.R17.11 |Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under the relevant Community harmonisation legislation and apply as general guidance the administrative decisions and documents produced as a result of the work of that group. |/ |/ |DU |Napomena: Videti komentar za odredbu 15.1 Predloga. | | |aI.R18.1 |Presumption of conformity
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union it shall be presumed to comply with the requirements set out in Article [R17] in so far as the applicable harmonised standards cover those requirements. |17.4 |Pri ocenjivanju ispunjavanja propisanih zahteva, uzima se u obzir i ispunjenost zahteva srpskih standarda kojima su preuzeti relevantni harmonizovani standardi koji sadrže zahteve za tela za ocenjivanje usaglašenosti, u meri u kojoj su ti zahtevi obuhvaćeni navedenim standardima. |DU |PU se obezbeđuje podzakonskim aktom iz odredbe 21.7 Predloga. | | |aI.R19 |Formal objection to a harmonised standard
Where a Member State or the Commission has a formal objection to the harmonised standards referred to in Article [R18], the provisions of Article [R9] shall apply. |/ |/ |NU |PU se obezbeđuje direktnom primenom člana 11. Uredbe (EU) br. 1025/2012 od dana pristupanja Republike Srbije Evropskoj uniji | | |aI.R20.1 |Subsidiaries of and subcontracting by notified bodies
Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article [R17] and shall inform the notifying authority accordingly. |16.1
18.1.4 |Obaveze imenovanog tela u vezi sa angažovanjem podizvođača
Imenovano telo može da, uz saglasnost podnosioca zahteva za ocenjivanje usaglašenosti, podugovori podizvođača ili povezano pravno lice u smislu odredaba zakona kojim se uređuju privredna društva, da sprovede određene poslove u vezi sa ocenjivanjem usaglašenosti ako podizvođač ili povezano pravno lice ispunjava opšte zahteve iz člana 15. ovog zakona.
Imenovano telo dužno je da ispunjava zahteve utvrđene rešenjem o imenovanju, kao i da obavesti nadležnog ministra o:
4) poveravanju poslova podizvođaču iz člana 16. ovog zakona. |PU | | | |aI.R20.2 |Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established. |16.2 |Imenovano telo može da podugovori podizvođača ili povezano pravno lice iz stava 1. ovog člana samo za obavljanje poslova za koje je imenovano. Imenovano telo zadržava odgovornost za poslove koje obavlja podizvođač ili povezano pravno lice. |PU | | | |aI.R20.3 |Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client. |16.1 |… uz saglasnost podnosioca zahteva,… |PU | | | |aI.R20.4 |Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under … [reference to the relevant part of the legislation]. |16.3 |Imenovano telo je dužno da organu nadležnom za imenovanje stavi na raspolaganje relevantnu dokumentaciju koja se odnosi na kompetentnost podizvođača ili povezanog pravnog lica za poslove iz st. 1. i 2. ovog člana. |PU | | | |aI.R21 |Accredited in-house bodies
1. An accredited in-house body may be used to carry out conformity assessment activities for the undertaking of which it forms a part for the purpose of implementing the procedures set out in [Annex II — modules A1, A2, C1 or C2]. That body shall constitute a separate and distinct part of the undertaking and shall not participate in the design, production, supply, installation, use or maintenance of the products it assesses.
2. An accredited in-house body shall meet the following requirements:
(a) it shall be accredited in accordance with Regulation (EC) No 765/2008;
(b) the body and its personnel shall be organisationally identifiable and have reporting methods within the undertaking of which they form a part which ensure their impartiality and demonstrate it to the relevant national accreditation body;
(c) neither the body nor its personnel shall be responsible for the design, manufacture, supply, installation, operation or maintenance of the products they assess nor shall they engage in any activity that might conflict with their independence of judgment or integrity in relation to their assessment activities;
(d) the body shall supply its services exclusively to the undertaking of which it forms a part.
3. An accredited in-house body shall not be notified to the Member States or the Commission, but information concerning its accreditation shall be given by the undertaking of which it forms a part or by the national accreditation body to the notifying authority at the request of that authority. |11.3 |Ukoliko je u tehničkom propisu kojim je preuzeto harmonizovano zakonodavstvo EU propisano da u postupku ocenjivanja usaglašenosti može učestvovati akreditovano telo u sastavu proizvođača, to telo mora da bude organizovano kao zasebna organizaciona jedinica koja ne sme da učestvuje u izradi, isporuci, montaži, korišćenju ili održavanju proizvoda čiju usaglašenost ocenjuje i može da pruža usluge isključivo proizvođaču u čijem se sastavu nalazi. |DU |PU će se obezbediti podzakonskim aktom iz 11.4 i tehničkim propisom kojim se transponuje sektorsko harmonizovano zakonodavstvo EU. | | |aI.R22.1 |Application for notification
A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established. |21.4 |Ministarstvo vrši notifikaciju na zahtev imenovanog tela za ocenjivanje usaglašenosti koji se dostavlja preko nadležnog ministarstva. |PU | | | |aI.R22.2 |That application shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the product or products for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article [R17] of this … [act]. |/ |/ |NU |Princip je preuzet podzakonskim aktom kojim se uređuje način imenovanja.
PU u smislu notifikacije će se obezbediti podzakonskim aktom iz odredbe 21.7 Predloga. | | |aI.R22.3 |Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article [R17]. |/ |/ |NU |Princip je preuzet podzakonskim aktom kojim se uređuje način imenovanja.
PU u smislu notifikacije će se obezbediti podzakonskim aktom iz odredbe 21.7 Predloga. | | |aI.R23.1 |Notification procedure
Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article [R17]. |/ |/ |NU |PU će se obezbediti podzakonskim aktom iz odredbe 21.7 Predloga. | | |aI.R23.2 |They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission. |/ |/ |NU |PU će se obezbediti podzakonskim aktom iz odredbe 21.7 Predloga. | | |aI.R23.3 |The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and product or products concerned and the relevant attestation of competence. |/ |/ |NU |PU će se obezbediti podzakonskim aktom iz odredbe 21.7 Predloga. | | |aI.R23.4 |Where a notification is not based on an accreditation certificate as referred to in Article [R22(2)], the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body’s competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article [R17]. |/ |/ |NU |PU će se obezbediti podzakonskim aktom iz odredbe 21.7 Predloga. | | |aI.R23.5 |The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Only such a body shall be considered a notified body for the purposes of this … [act]. |/ |/ |NU |PU će se obezbediti podzakonskim aktom iz odredbe 21.7 Predloga. | | |aI.R23.6 |The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification. |/ |/ |NU |PU će se obezbediti podzakonskim aktom iz odredbe 21.7 Predloga. | | |aI.R24.1 |Identification numbers and lists of notified bodies
The Commission shall assign an identification number to a notified body.
It shall assign a single such number even where the body is notified under several Community acts. |/ |/ |NP |Obaveza EK | | |aI.R24.2 |The Commission shall make publicly available the list of the bodies notified under this … [act], including the identification numbers that have been allocated to them and the activities for which they have been notified.
The Commission shall ensure that that list is kept up to date. |/ |/ |NP |Obaveza EK | | |aI.R25.1 |Changes to notifications
Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article [R17], or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly. |20.1
20.2
21.5 |Ako nadležni ministar utvrdi da imenovano telo više ne ispunjava zahteve za imenovana tela propisane ovim zakonom i tehničkim propisom na osnovu kojeg je doneto rešenje o imenovanju, ili da ne izvršava svoje obaveze, odnosno da izvršava obaveze na način koji nije u skladu sa odredbama ovog zakona i tehničkog propisa na osnovu kojeg je doneto rešenje o imenovanju, donosi rešenje o suspenziji ili oduzimanju imenovanja, u skladu sa zakonom kojim se uređuje opšti upravni postupak i u skladu sa propisom iz člana 15. stav 3. ovog zakona.
Suspenzija ili oduzimanje imenovanja može biti delimična u odnosu na rešenje o imenovanju. Maksimalan period trajanja suspenzije je šest meseci od dana pravnosnažnosti rešenja o suspenziji.
Nadležno ministarstvo utvrđuje ispunjenost propisanih zahteva za notifikaciju u cilju sprovođenja nadzora nad radom notifikovanih tela i o tome obaveštava Ministarstvo radi informisanja Evropske komisije. |PU | | | |aI.R25.2 |In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request. |20.5 |U slučaju donošenja rešenja o oduzimanju ili suspenziji imenovanja ili u slučaju da imenovano telo prestane sa radom, nadležni ministar nalaže tom telu da izvrši prenos dokumentacije u vezi sa ocenjivanjem usaglašenosti drugom imenovanom telu ili da omogući dostupnost te dokumentacije nadležnim organima. |PU | | | |aI.R26.1 |Challenge of the competence of notified bodies
The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject. |/ |/ |NP |Obaveza EK | | |aI.R26.2 |The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the body concerned. |21.5 |Nadležno ministarstvo utvrđuje ispunjenost propisanih zahteva za notifikaciju u cilju sprovođenja nadzora nad radom notifikovanih tela i o tome obaveštava Ministarstvo radi informisanja Evropske komisije. |PU | | | |aI.R26.3 |The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially. |/ |/ |NP |Obaveza EK | | |aI.R26.4 |Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including de-notification if necessary. |/ |/ |NU |PU će se obezbediti podzakonskim aktom iz odredbe 21.7 Predloga. | | |aI.R27.1 |Operational obligations of notified bodies
Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in … [the relevant part of the legislation]. |12.1 |Ocenjivanje usaglašenosti koje sprovodi imenovano telo
Imenovano telo sprovodi ocenjivanje usaglašenosti u skladu sa postupkom ocenjivanja usaglašenosti koji je utvrđen tehničkim propisom. |PU |PU za notifikovana tela je obezbeđena odredbom 21.6 Predloga. | | |aI.R27.2 |Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the product with the provisions of this … [act]. |12.2
12.3 |Imenovano telo sprovodi ocenjivanje usaglašenosti samo u obimu koji je potreban u skladu sa tehničkim propisom, bez dodatnih zahteva prema podnosiocu zahteva za ocenjivanje usaglašenosti, u skladu sa propisom iz člana 8. stav 5. ovog zakona.
Imenovano telo za ocenjivanje usaglašenosti obavlja svoje aktivnosti posebno uzimajući u obzir veličinu i strukturu preduzeća, sektor u kome posluje, stepen složenosti tehnologije proizvodnje predmetnog proizvoda, kao i masovnu ili serijsku prirodu proizvodnog procesa, u skladu sa propisom iz člana 8. stav 5. ovog zakona, pri čemu imenovano telo za ocenjivanje usaglašenosti poštuje nivo strogosti i stepen zaštite koji se zahteva za proizvode da bi bili u skladu sa primenjivim tehničkim propisom. |PU |PU za notifikovana tela je obezbeđena odredbom 21.6 Predloga. | | |aI.R27.3 |Where a notified body finds that requirements laid down in … [the relevant part of the legislation] or corresponding harmonised standards or technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a conformity certificate. |12.7 |Ukoliko imenovano telo utvrdi da nisu ispunjeni propisani zahtevi, odnosno zahtevi odgovarajućih standarda ili tehničkih specifikacija, ne izdaje ispravu o usaglašenosti i zahteva da proizvođač, odnosno drugi podnosilac zahteva za ocenjivanje usaglašenosti preduzme odgovarajuće korektivne radnje. |PU |PU za notifikovana tela je obezbeđena odredbom 21.6 Predloga. | | |aI.R27.4 |Where, in the course of the monitoring of conformity following the issue of a certificate, a notified body finds that a product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary. |12.8 |Ako imenovano telo, prilikom provere usaglašenosti, posle izdavanja isprave, utvrdi da više nisu ispunjeni propisani zahtevi, tražiće od proizvođača, odnosno drugog lica na čije ime je izdata takva isprava, da preduzme odgovarajuće korektivne radnje i po potrebi može, privremeno ili trajno, da oduzme ispravu o usaglašenosti ili da ograniči važenje te isprave. |PU |PU za notifikovana tela je obezbeđena odredbom 21.6 Predloga. | | |aI.R27.5 |Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates, as appropriate. |12.9 |Ako se ne preduzmu korektivne radnje iz stava 8. ovog člana ili ako one nemaju očekivani rezultat, imenovano telo ograničava, privremeno ili trajno oduzima ispravu o usaglašenosti. |PU |PU za notifikovana tela je obezbeđena odredbom 21.6 Predloga. | | |aI.R28.1 |Information obligation on notified bodies
Notified bodies shall inform the notifying authority of the following: |18.1 |Obaveštenja koja dostavlja imenovano telo
Imenovano telo dužno je da ispunjava zahteve utvrđene rešenjem o imenovanju, kao i da obavesti nadležnog ministra o: |PU |PU za notifikovana tela je obezbeđena odredbom 21.6 Predloga. | | |aI.R28.1.a |(a) any refusal, restriction, suspension or withdrawal of a certificate; |18.1.1 |1) odbijanju izdavanja, ograničavanju, privremenom ili trajnom oduzimanju isprave o usaglašenosti; |PU |PU za notifikovana tela je obezbeđena odredbom 21.6 Predloga. | | |aI.R28.1.b |(b) any circumstances affecting the scope of and conditions for notification; |18.1.2 |2) izmenjenim okolnostima koje mogu da utiču na obim i uslove imenovanja; |PU |PU za notifikovana tela je obezbeđena odredbom 21.6 Predloga. | | |aI.R28.1.c |(c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities; |18.1.3 |3) zahtevu nadležnog inspektora u vezi sa ocenjivanjem usaglašenosti; |PU |PU za notifikovana tela je obezbeđena odredbom 21.6 Predloga. | | |aI.R28.1.4 |(d) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting. |18.2 |Pored obaveštenja iz stava 1. ovog člana na zahtev nadležnog ministarstva imenovano telo dostavlja i obaveštenja o:
1) izvršenom ocenjivanju usaglašenosti iz obima svog imenovanja u Republici Srbiji i inostranstvu;
2) drugim aktivnostima u vezi sa ocenjivanjem usaglašenosti. |PU |PU za notifikovana tela je obezbeđena odredbom 21.6 Predloga. | | |aI.R28.2 |Notified bodies shall provide the other bodies notified under this … [act] carrying out similar conformity assessment activities covering the same products with relevant information on issues relating to negative and, on request, positive conformity assessment results. |18.3 |Kada je to predviđeno tehničkim propisom, imenovano telo je dužno da obaveštava druga imenovana tela koja za iste proizvode obavljaju poslove ocenjivanja usaglašenosti iz tog tehničkog propisa, o negativnim i, na zahtev, pozitivnim rezultatima ocenjivanja usaglašenosti. |PU |PU za notifikovana tela je obezbeđena odredbom 21.6 Predloga. | | |aI.R29 |Exchange of experience
The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities responsible for notification policy. |/ |/ |NP |Obaveza EK | | |aI.R30.1 |Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooperation between bodies notified under … [the relevant act or other Community legislation] are put in place and properly operated in the form of a … [sectoral or cross sectoral] group or groups of notified bodies. |/ |/ |NP |Obaveza EK | | |aI.R30.2 |Member States shall ensure that the bodies notified by them participate in the work of that or those group or groups, directly or by means of designated representatives. |/ |/ |NU |PU će se obezbediti podzakonskim aktom iz odredbe 21.7 Predloga | | |Chapter R5 |Safeguard procedures |Glava VIII. |TRŽIŠNI NADZOR | | | | |aI.R31.1 |Procedure for dealing with products presenting a risk at national level
Where the market surveillance authorities of one Member State have taken action pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have sufficient reason to believe that a product covered by this … [act] presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this … [act], they shall carry out an evaluation in relation to the product concerned covering all the requirements laid down in this … [act]. The relevant economic operators shall cooperate as necessary with the market surveillance authorities.
Where, in the course of that evaluation, the market surveillance authorities find that the product does not comply with the requirements laid down in this … [act], they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the product into compliance with those requirements, to withdraw the product from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.
The market surveillance authorities shall inform the relevant notified body accordingly.
Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph. |39.1
39.2
39.3
39.4
|Postupanje sa proizvodima koji predstavljaju rizik
Nadležni organ tržišnog nadzora, ukoliko ima dovoljno razloga da veruje da proizvod predstavlja rizik za zdravlje i bezbednost ljudi ili za drugi aspekt zaštite javnog interesa, proverava da li proizvod ispunjava primenjive zahteve tehničkog propisa.
Isporučilac je dužan da sarađuje sa organom iz stava 1. ovog člana.
Nadležni inspektor, ako u vršenju provera iz stava 1. ovog člana utvrdi da proizvod nije usaglašen sa propisanim zahtevima, bez odlaganja nalaže isporučiocu da preduzme odgovarajuće korektivne radnje kako bi proizvod bio usaglašen sa tim zahtevima, povučen ili opozvan u razumnom roku, o čemu odlučuje srazmerno riziku koji proizvod predstavlja.
O utvrđenoj neusaglašenosti iz stava 3. ovog člana nadležni inspektor obaveštava imenovano telo koje je izdalo ispravu o usaglašenosti za taj proizvod, odnosno, kada je to primenjivo, nadležni organ koji je izdao ili priznao ispravu o usaglašenosti.
|PU | | | |aI.R31.2 |Where the market surveillance authorities consider that noncompliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take. |49.1 |O rezultatima izvršenih provera i preduzetim merama iz člana 39. stav 3. ovog zakona, ako je to utvrđeno tehničkim propisom, obaveštavaju se Evropska komisija i države članice Evropske unije, u skladu sa zakonom kojim se uređuje tržišni nadzor, ako nadležni organ tržišnog nadzora smatra da utvrđena neusaglašenost proizvoda može da ima posledice i izvan teritorije Republike Srbije. |PU | | | |aI.R31.3 |The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Community. |49.5 |Isporučilac obezbeđuje preduzimanje korektivnih radnji iz stava 3. ovog člana za sve proizvode koje je isporučio na tržištu, za koje je utvrđeno da predstavljaju rizik. |PU | | | |aI.R31.4 |Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the product’s being made available on their national market, to withdraw the product from that market or to recall it.
They shall inform the Commission and the other Member States, without delay, of those measures. |49.6
49.2 |Nadležni inspektor preduzima mere za zabranu ili ograničavanje isporuke proizvoda, odnosno povlačenje ili opoziv proizvoda, ukoliko isporučilac ne preduzme korektivne radnje u roku iz stava 3. ovog člana.
O preduzetim merama člana 39. stav 6. i člana 40. stav 1. ovog zakona, bez odlaganja se obaveštavaju Evropska komisija i države članice Evropske unije u skladu sa zakonom kojim se uređuje tržišni nadzor. |PU |
| | |aI.R31.5 |The information referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the noncompliant product, the origin of the product, the nature of the noncompliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either: |49.3 |Obaveštenje o preduzetim merama iz člana 39. stav 6. sadrži sve raspoložive detaljne informacije, uključujući podatke neophodne za identifikaciju neusaglašenog proizvoda, podatke o poreklu proizvoda, prirodi neusaglašenosti i povezanih rizika, vrsti i trajanju preduzetih mera, izjašnjenjima i argumentaciji koje je dostavio isporučilac, a naročito zaključke organa tržišnog nadzora o tome da li je neusaglašenost proizvoda nastala kao posledica: |PU | | | |aI.R31.5.a |failure of the product to meet requirements relating to the health or safety of persons or to other aspects of public interest protection laid down in this … [act]; or |49.3.1 |1) neispunjenja propisanih zahteva za zaštitu zdravlja i bezbednosti ili zaštitu drugog aspekta javnog interesa obuhvaćenog tehničkim propisom; ili |PU | | | |aI.R31.5.b |shortcomings in the harmonised standards referred to in … [reference to the relevant part of the legislation] conferring a presumption of conformity. |49.3.2 |2) nedostataka u standardima koji pružaju pretpostavku usaglašenosti u skladu sa odredbama tehničkog propisa. |PU | | | |aI.R31.6 |Member States other than the Member State initiating the procedure shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the product concerned, and, in the event of disagreement with the notified national measure, of their objections. |49.4 |Kada je to predviđeno tehničkim propisom, ukoliko su nadležni organi tržišnog nadzora obavešteni da je u nekoj državi članici Evropske unije preduzeta mera iz člana 39. stav 6. ovog zakona, obaveštavaju Evropsku komisiju i države članice Evropske unije, u skladu sa zakonom kojim se uređuje tržišni nadzor, o svim merama koje su preduzeli, kao i svim dodatnim informacijama kojima raspolažu u vezi sa neusaglašenošću predmetnog proizvoda, a u slučaju neslaganja sa preduzetom nacionalnom merom u državi članici Evropske unije, mogu dostaviti i prigovore. |PU | | | |aI.R31.7 |Where, within …. [period to be specified] of receipt of the information referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified. |49.5 |Ako, u roku utvrđenom u tehničkom propisu, Evropska komisija ili države članice Evropske unije nisu podnele prigovore na nacionalnu meru preduzetu u skladu sa članom 39. stav 6. ovog zakona, ta mera se smatra opravdanom, a u suprotnom se sprovodi zaštitni postupak Evropske unije čiji je rezultat odluka Evropske komisije o opravdanosti preduzete nacionalne mere. |PU | | | |aI.R31.8 |Member States shall ensure that appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from their market, without delay. |49.6 |Ukoliko se nacionalna mera preduzeta u drugoj državi članici Evropske unije smatra opravdanom u skladu sa stavom 5. ovog člana, nadležni organi tržišnog nadzora bez odlaganja preduzimaju odgovarajuće restriktivne mere, kao što je povlačenje predmetnog proizvoda sa tržišta Republike Srbije. |PU | | | |aI.R32.1 |Community safeguard procedure
Where, on completion of the procedure set out in Article [R31(3) and (4)], objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Community legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not.
The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators. | | |NP |Obaveza EK | | |aI.R32.2 |If the national measure is considered justified, all Member States shall take the measures necessary to ensure that the non-compliant product is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw the measure. |49.6
49.7 |Ukoliko se nacionalna mera preduzeta u drugoj državi članici Evropske unije smatra opravdanom u skladu sa stavom 5. ovog člana, nadležni organi tržišnog nadzora preduzimaju odgovarajuće restriktivne mere, kao što je povlačenje predmetnog proizvoda sa tržišta Republike Srbije.
U slučaju da je, nakon sprovođenja zaštitnog postupka Evropske unije, Evropska komisija odlučila da je mera koju je preduzeo nadležni organ tržišnog nadzora u skladu sa članom 36. stav 6. ovog zakona neopravdana, taj organ je dužan da povuče takvu meru. |PU | | | |aI.R32.3 |Where the national measure is considered justified and the noncompliance of the product is attributed to shortcomings in the harmonised standards referred to in [Article R31(5)(b)], the Commission shall inform the relevant European standardisation body or bodies and shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC. That Committee shall consult the relevant European standardisation body or bodies and deliver its opinion without delay. |/ |/ |NP |Obaveza EK i komitologija | | |aI.R33.1 |Compliant products which present a risk to health and safety
Where, having performed an evaluation under Article [R31(1)], a Member State finds that although a product is in compliance with this … [act], it presents a risk to the health or safety of persons or to other aspects of public interest protection, it shall require the relevant economic operator to take all appropriate measures to ensure that the product concerned, when placed on the market, no longer presents that risk, to withdraw the product from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe. |40.1 |Postupanje sa usaglašenim proizvodima koji predstavljaju rizik
Ako, nakon sprovedenih provera iz člana 39. stav 1. ovog zakona, nadležni inspektor utvrdi da proizvod, iako je usaglašen sa tehničkim propisom, predstavlja rizik za zdravlje i bezbednost ljudi ili za drugi aspekt zaštite javnog interesa, nalaže isporučiocu da preduzme odgovarajuće korektivne radnje kako bi obezbedio da proizvod, prilikom stavljanja na tržište, više ne predstavlja rizik ili da bude povučen ili opozovan u razumnom roku, o čemu odlučuje srazmerno riziku koji taj proizvod predstavlja. |PU | | | |aI.R33.2 |The economic operator shall ensure that corrective action is taken in respect of all the products oncerned that he has made available on the market throughout the Community. |40.2 |Isporučilac obezbeđuje preduzimanje korektivnih radnji iz stava 1. ovog člana za sve proizvode koje je isporučio na tržištu, za koje je utvrđeno da predstavljaju rizik. |PU | | | |aI.R33.3 |The Member State shall immediately inform the Commission and the other Member States. That information shall include all available details, in articular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken. |49.9 |Obaveštenje o preduzetim merama iz člana 40. stav 1. sadrži sve raspoložive detaljne informacije, a naročito podatke neophodne za identifikaciju proizvoda, podatke o poreklu i lancu isporuke proizvoda, prirodi rizika koje proizvod predstavlja, kao i vrsti i trajanju preduzetih mera. |PU | | | |aI.R33.4 |The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide whether the measure is justified or not, and where necessary, propose appropriate measures. |/ |/ |NP |Obaveza EK | | |aI.R33.5 |The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators. |/ |/ |NP |Obaveza EK | | |aI.R34.1 |Formal non-compliance
Without prejudice to Article [R31], where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned: |41.1
41.2 |Formalna neusaglašenost proizvoda
Ukoliko nadležni inspektor utvrdi jednu od formalnih neusaglašenosti, nalaže isporučiocu, u skladu sa propisanim obavezama, otklanjanje neusaglašenosti u određenom roku.
Formalna neusaglašenost iz stava 1. ovog člana može biti: |PU | | | |aI.R34.1.a |the conformity marking has been affixed in violation of Article [R11] or of Article [R12]; |41.2.2 |2) stavljanje znaka usaglašenosti suprotno odredbama ovog zakona i posebnih proisa donetih na osnovu ovog zakona; |PU | | | |aI.R34.1.b |the conformity marking has not been affixed; |41.2.1 |1) odsustvo znaka usaglašenosti; |PU | | | |aI.R34.1.c |the EC declaration of conformity has not been drawn up; |41.2.3 |3) nesačinjavanje deklaracije o usaglašenosti, odnosno druge isprave o usaglašenosti u skladu sa zahtevima tehničkog propisa; |PU | | | |aI.R34.1.d |the EC declaration of conformity has not been drawn up correctly; |41.2.4 |4) neispravno sačinjavanje deklaracije ili druge isprave o usaglašenosti koju izdaje isporučilac; |PU | | | |aI.R34.1.e |technical documentation is either not available or not complete. |41.2.5 |5) nedostupnost ili nekompletnost tehničke dokumentacije; |PU | | | |aI.R34.2 |Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is recalled or withdrawn from the market. |41.3 |U slučaju da isporučilac ne otkloni formalnu neusaglašenost u određenom roku, nadležni inspektor preduzima odgovarajuće mere za ograničavanje ili zabranu isporuke proizvoda na tržištu ili za povlačenje ili opoziv proizvoda sa tržišta, u skladu sa zakonom kojim se uređuje tržišni nadzor. |PU | | | |Annex II |CONFORMITY ASSESSMENT PROCEDURES |/ |/ |NU |Moduli i njihove varijante će se propisati podzakonskim aktom na osnovu ovog zakona | | |Annex III |EC DECLARATION OF CONFORMITY |/ |/ |NU |Podzakonskim aktom na osnovu ovog zakona propisaće se opšta načela za sačinjavanje deklaracije o usaglašenosti, kao opšti strukturni model deklaracije o usaglašenosti iz Aneksa III Odluke 768/2008/EZ. | | |