1. Naziv propisa Evropske unije : Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food (Text with EEA relevance) OJ L 384, 29.12.2006, p. 75–78 as last amended by Commission Regulation (EC) No 282/2008 of 27 March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006 (Text with EEA relevance) OJ L 86, 28.3.2008, p. 9–18 CELEX code of EU legislation 32006R2023 2. „CELEX” oznaka EU propisa32006R2023 3. Organ državne uprave, odnosno drugi ovlašćeni predlagač propisa: 4. Datum izrade tabele: 07.09.2018. Ministarstvo zdravlja 5. Naziv (nacrta, predloga) propisa čije odredbe su predmet analize usklađenosti sa propisom Evropske unije:01.Zakon o predmetima opšte upotrebe02.Pravilnik o materijalima i predmetima koji dolaze u kontakt sa hranom 6. Brojčane oznake (šifre) planiranih propisa iz baze NPAA:01. 2017-60302. 2017-693 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
|Subject matter
This Regulation lays down the rules on good manufacturing practice (GMP) for the groups of materials and articles intended to come into contact with food (hereafter referred to as materials and articles) listed in Annex I to Regulation (EC) No 1935/2004 and combinations of those materials and articles or recycled materials and articles used in those materials and articles. |01.
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7 |Pravila dobre proizvođačke prakse se primenjuju na grupe materijala i predmeta koji dolaze u kontakt sa hranom, za njihovu kombinaciju, kao i za reciklirane materijale i predmete koji su upotrebljeni u proizvodnji istih.
Detaljna pravila dobre proizvođačke prakse navedena u Prilogu III (Prilog III je odštampan uz pravilnik i čini njegov sastavni deo) se primenjuju na grupe materijala i predmeta koji dolaze u kontakt sa hranom, za kombinaciju ovih materijala i predmeta, kao i za reciklirane materijale i predmete koji su upotrebljeni u proizvodnji istih.
Detaljna pravila dobre proizvođačke prakse se, prema potrebi primenjuju na postupke upotrebe štamparskih boja i materijala koji se nanosi na površinu koja ne dolazi u kontakt sa hranom u proizvodnji materijala i predmeta koji su u kontaktu sa hranom. Ovi postupci su navedeni u Prilogu III. |PU | | | |2 |Scope
This Regulation shall apply to all sectors and to all stages of manufacture, processing and distribution of materials and articles, up to but excluding the production of starting substances.
The detailed rules set out in the Annex shall apply to the relevant individually mentioned processes, as appropriate. |01.
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/ |Pravila dobre proizvođačke prakse se moraju primenjivati na sve sektore i sve faze proizvodnje, prerade i distribucije materijala i predmeta koji dolaze u kontakt sa hranom, izuzev proizvodnje polaznih sirovina.
Detaljna pravila dobre proizvođačke prakse se, prema potrebi, primenjuju na postupke upotrebe štamparskih boja, na upotrebu reciklirane plastike i materijala koji se nanosi na površinu koja ne dolazi u kontakt sa hranom u proizvodnji materijala i predmeta koji su u kontaktu sa hranom, u skladu sa podzakonskim aktom koji uređuje oblast materijala i predmeta u kontaktu sa hranom. |PU | | | |3 |Definitions
For the purpose of this Regulation, the following definitions shall apply:
(a) ‘good manufacturing practice (GMP)’ means those aspects of quality assurance which ensure that materials and articles are consistently produced and controlled to ensure conformity with the rules
applicable to them and with the quality standards appropriate to their intended use by not endangering human health or causing an unacceptable change in the composition of the food or causing a deterioration in the organoleptic characteristics thereof;
(b) ‘quality assurance system’ means the total sum of the organised and documented arrangements made with the purpose of ensuring that materials and articles are of the quality required to ensure conformity with the rules applicable to them and the quality
standards necessary for their intended use;
(c) ‘quality control system’ means the systematic application of measures established within the quality assurance system that ensure compliance of starting materials and intermediate and finished materials and articles with the specification determined in the quality assurance system;
(d) ‘non-food-contact side’ means the surface of the material or article that is not directly in contact with food;
(e) ‘food-contact side’ means the surface of a material or article that is directly in contact with the food. |01.
6. 21)-25)
02. |21)dobra proizvođačka praksa jesu oni aspekti obezbeđenja kvaliteta kojima se osigurava da se materijali i predmeti koji dolaze u kontakt sa hranom i predmetima opšte upotrebe, ujednačeno proizvode i kontrolišu radi usaglašenosti sa pravilima koja se na njih odnose, kao i sa odgovarajućim standardima kvaliteta za predviđenu namenu, ne ugrožavajući pri tome zdravlje ljudi ili ne uzrokujući neprihvatljive promene u sastavu hrane i predmeta opšte upotrebe, odnosno ne dovodeći do pogoršanja senzorskih svojstava hrane i predmeta opšte upotrebe;
22)sistem obezbeđenja kvaliteta jeste zbir organizovanih i dokumentovanih postupaka, preduzetih kako bi materijali i predmeti koji dolaze u kontakt sa hranom i predmetima opšte upotrebe posedovali neophodan kvalitet za postizanje usaglašenosti sa pravilima koja se na njih odnose, kao i sa standardima kvaliteta neophodnih za predviđenu namenu;
23)sistem kontrole kvaliteta jeste sistematska primena mera (ustanovljenih u okviru sistema obezbeđenja kvaliteta) kojima se osigurava usaglašenost početnih sirovina, polugotovih i gotovih materijala i predmeta koji dolaze u kontakt sa hranom i predmetima opšte upotrebe, sa specifikacijama utvrđenim u sistemu obezbeđenja kvaliteta;
24)strana u kontaktu sa hranom jeste površina materijala ili predmeta koja je u neposrednom kontaktu sa hranom;
25)strana koja nije u kontaktu sa hranom jeste površina materijala ili predmeta koja nije u neposrednom kontaktu sa hranom;
|PU | | | |4. |Conformity with good manufacturing practice
The business operator shall ensure that manufacturing operations are carried out in accordance with:
(a) the general rules on GMP as provided for in Article 5, 6, and 7,
(b) the detailed rules on GMP as set out in the Annex. |01.
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02. |Subjekat u poslovanju je u obavezi da obezbedi da su proizvodne operacije sprovedene u skladu sa:
Opštim pravilima dobre proizvođačke prakse definisane: Sistemom obezbeđenja kvaliteta, Sistemom kontrole kvaliteta i pravilnim uspostavljanjem i održavanjem odgovarajuće dokumentacije i
Detaljnim pravilima dobre proizvođačke prakse propisanim podzakonskm aktom koji uređuje oblast materijala i predmeta u kontaktu sa hranom u delu korišćenja štamparskih boja, recikliranih materijala ili drugih materijala. |PU | | | |5 |Quality assurance system
1. The business operator shall establish, implement and ensure adherence to an effective and documented quality assurance system.
That system shall:
(a) take account of the adequacy of personnel, their knowledge and skills, and the organisation of the premises and equipment such as is necessary to ensure that finished materials and articles comply with the rules applicable to them;
(b) be applied taking into account the size of the business run by the operator, so as not to be an excessive burden on the business.
2. Starting materials shall be selected and comply with pre-established specifications that shall ensure compliance of the material or article with the rules applicable to it.
3. The different operations shall be carried out in accordance with pre-established instructions and procedures. |01
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02 |Subjekat u poslovanju uspostavlja, primenjuje i održava efikasan i dokumentovan sistem obezbeđenja kvaliteta. Ovaj sistem mora da:
uzme u obzir osposobljenost osoblja, njihova znanja i veštine i organizaciju prostora i opreme, koji su neophodni kako bi se obezbedila usaglašenost gotovih predmeta i materijala sa pravilima koja se na njih odnose;
bude primenjen u skladu sa obimom poslovanja subjekta, kako ne bi bio opterećujući za njega.
Polazne sirovine biraju se na osnovu prethodno ustanovljenih specifikacija, kojima se obezbeđuje usaglašenost materijala i predmeta koji dolaze u kontakt sa hranom, sa zahtevima koja se na njih odnose.
Supstance koje se koriste za pravljenje plastičnih slojeva kod plastičnih materijala i predmeta moraju imati tehnički kvalitet i čistoću pogodnu za namensku i predvidivu upotrebu tih materijala ili predmeta.
Sastav mora biti poznat proizvođaču supstance i dostupan nadležnom organu na njegov zahtev.
Različiti proizvodni procesi odvijaju se u skladu sa prethodno ustanovljenim uputstvima i procedurama. |PU | | | |6 |Quality control system
1. The business operator shall establish and maintain an effective quality control system.
2. The quality control system shall include monitoring of the implementation and achievement of GMP and identify measures to correct any failure to achieve GMP. Such corrective measures shall be implemented
without delay and made available to the competent authorities for inspections. |01
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02 |Subjekat u poslovanju uspostavlja i održava efikasan sistem kontrole kvaliteta.
Sistem kontrole kvaliteta obuhvata nadzor nad primenom i postizanjem ciljeva dobre proizvođačke prakse i utvrđuje korektivne mere ukoliko se ti ciljevi ne dostignu. Navedene korektivne mere primenjuju se bez odlaganja i dostupne su na uvid sanitarnom inspektoru. |PU | | | |7 |Documentation
1. The business operator shall establish and maintain appropriate documentation in paper or electronic format with respect to specifications, manufacturing formulae and processing which are relevant to compliance and safety of the finished material or article.
2. The business operator shall establish and maintain appropriate documentation in paper or electronic format with respect to records
covering the various manufacturing operations performed which are relevant to compliance and safety of the finished material or article and with respect to the results of the quality control system.
3. The documentation shall be made available by the business operator to the competent authorities at their request. |01
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02 |Subjekat u poslovanju priprema i čuva odgovarajuću dokumentaciju u papirnom ili elektronskom obliku a koja se odnosi na specifikacije, proizvodne formule i obradu koji su značajni za usklađenost i bezbednost gotovog materijala ili predmeta.
Subjekat u poslovanju priprema i čuva odgovarajuću dokumentaciju u papirnom ili elektronskom obliku. Ova dokumentacija obuhvata beleženje različitih proizvodnih postupaka koji se sprovode i koji su bitni za usaglašenost sa propisanim zahtevima i bezbednost gotovog materijala i predmeta, uz poštovanje rezultata sistema kontrole kvaliteta.
Subjekat u poslovanju daje na uvid pomenutu dokumentaciju sanitarnom inspektoru na njegov zahtev. | | | | |8 |Entry into force
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 August 2008.
This Regulation shall be binding in its entirety and directly applicable in all Member States. |01 /
02 / | |NP | | | |ANNEX |Detailed rules on good manufacturing practice
Printing inks
Processes involving the application of printing inks to the non-food contact side of a material or article
1. Printing inks applied to the non food-contact side of materials and articles shall be formulated and/or applied in such a manner that substances from the printed surface are not transferred to the food-contact side:
(a) through the substrate or;
(b) by set-off in the stack or the reel, in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004.
2. Printed materials and articles shall be handled and stored in their finished and
semi-finished states in such a manner that substances from the printed surface are not transferred to the food-contact side:
(a) through the substrate or;
(b) by set-off in the stack or reel, in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004.
3. The printed surfaces shall not come into direct contact with food.
B. Quality assurance system for plastic recycling processes covered by Regulation (EC) No 282/2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation
(EC) No 2023/2006
1. The quality assurance system implemented by the recycler must give adequate confidence in the capability of the recycling process to ensure the recycled plastic meets the requirements in the authorisation.
2. All the elements, requirements and provisions adopted by the recycler for his
quality assurance system must be documented in a systematic and orderly
manner in the form of written policy statements and procedures.
That quality system documentation must permit uniform interpretation of the quality policy and procedures, such as quality programmes, plans, manuals, records and measures taken to ensure traceability.
It must include, in particular:
(a) a quality policy manual, containing a clear definition of the recycler’s quality objectives, the organisation of the business and in particular the organisational structures, the responsibilities of the managerial staff and
their organisational authority where manufacture of the recycled plastic is concerned;
(b) the quality control plans, including those for input and recycled plastic characterisation, suppliers’ qualification, sorting processes, washing processes, deep cleansing processes, heating processes, or any other part of the process relevant for the quality of the recycled plastic including the choice of points which are critical for the quality control of the recycled plastics;
(c) the managing and operative procedures implemented to monitor and control the whole recycling process, including the inspection and quality assurance techniques at all the manufacturing stages, especially
the establishment of critical limits at the points which are critical for the quality of the recycled plastics;
(d) the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired recycled plastic quality, including control of products which fail to conform;
(e) the tests and analytical protocols or any other scientific evidence applied before, during and after recycled plastic production, the frequency with which they will take place, and the test equipment used; it must be
adequately possible to trace back the calibration of the test equipment;
(f) the recording documents adopted. |01
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Annex 3 |Prilog 3. Detaljna pravila dobre proizvođačke prakse
A. Šta mparske boje
B. Sistem obezbeđenja kvaliteta procesa reciklaže plastičnih materijala obuhvaćen ovim pravilnikom – deo o recikliranim plastičnim materijalima i predmetima namenjenih da dođu u kontakt sa hranom |PU | | | |