natgillin/translations-raw huggingface dataset:
the general rules on GMP as provided for in Article 5, 6, and 7,
splošnimi pravili dobre proizvodne prakse iz členov 5, 6 in 7,
the detailed rules on GMP as set out in the Annex.
podrobnimi pravili dobre proizvodne prakse iz priloge.
Quality assurance system
Sistem zagotavljanja kakovosti
The business operator shall establish, implement and ensure adherence to an effective and documented quality assurance system.
Nosilec dejavnosti vzpostavi in izvaja učinkovit in dokumentiran sistem zagotavljanja kakovosti ter zagotovi njegovo spoštovanje.
That system shall:
Sistem:
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;
upošteva ustreznost osebja, njegovega znanja in spretnosti ter organizacije prostorov in opreme, kot je potrebno za zagotavljanje skladnosti končnih materialov in izdelkov s pravili, ki se zanje uporabljajo;
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.
se uporablja ob upoštevanju velikosti podjetja, ki ga vodi nosilec dejavnosti, da tako ne predstavlja prekomerne obremenitve za podjetje.
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.
Vhodni materiali se izberejo na podlagi predhodno določenih specifikacij, ki zagotavljajo skladnost materialov ali izdelkov s pravili, ki se zanje uporabljajo.
The different operations shall be carried out in accordance with pre-established instructions and procedures.
Različni proizvodni procesi se izvajajo v skladu s predhodno določenimi navodili in postopki.
Quality control system
Sistem za nadzor kakovosti
The business operator shall establish and maintain an effective quality control system.
Nosilec dejavnosti vzpostavi in vzdržuje učinkovit sistem za nadzor kakovosti.
The quality control system shall include monitoring of the implementation and achievement of GMP and identify measures to correct any failure to achieve GMP.
Sistem za nadzor kakovosti vključuje spremljanje izvajanja in doseganja dobre proizvodne prakse ter določitev popravnih ukrepov v primeru nedoseganja dobre proizvodne prakse.
Such corrective measures shall be implemented without delay and made available to the competent authorities for inspections.
Takšni popravljalni ukrepi se izvedejo pravočasno, pristojnim organom pa so na voljo za inšpekcijske preglede.
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.
Nosilec dejavnosti pripravi in hrani ustrezno dokumentacijo v papirni ali elektronski obliki v zvezi s specifikacijami, sestavo proizvoda in predelavo, ki so pomembne za skladnost in varnost končnega materiala ali izdelka.
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.
Nosilec dejavnosti pripravi in hrani ustrezno dokumentacijo v papirni ali elektronski obliki v zvezi z evidence o različnih izvedenih proizvodnih postopkih, ki so pomembni za skladnost in varnost končnega materiala ali izdelka, in o izsledkih sistema za nadzor kakovosti.
The documentation shall be made available by the business operator to the competent authorities at their request.
Nosilec dejavnosti pristojnim organom na njihovo zahtevo omogoči vpogled v dokumentacijo.
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
Ta uredba začne veljati 20. dan po objavi v Uradnem listu Evropske unije.
It shall apply from 1 August 2008.
Uporabljati se začne 1. avgusta 2008.
Detailed rules on good manufacturing practice
Podrobna pravila o dobri proizvodni praksi
Processes involving the application of printing inks to the non-food contact side of a material or article
Postopki, ki vključujejo uporabo tiskarskih barv na površini materiala ali izdelka, ki ni v stiku z živilom
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:
Tiskarske barve, uporabljene na površini materialov in izdelkov, ki ni v stiku z živilom, se pripravijo in/ali uporabijo tako, da snovi s potiskane površine ne prehajajo v površino, ki je v stiku z živilom:
through the substrate or;
skozi medij ali
by set-off in the stack or the reel,
preko barvnega odtisa v skladovnicah ali na zvitku,
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.
v koncentracijah, ki privedejo do takšnih vsebnosti snovi v živilu, ki niso v skladu z zahtevami člena 3 Uredbe (ES) št. 1935/2004, na enak način pa se jih tudi skladišči.
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:
S potiskanimi materiali ter končnimi izdelki in polizdelki se ravna tako, da snovi s potiskane površine ne prehajajo v površino, ki je v stiku z živilom:
by set-off in the stack or reel,
preko barvnega odtisa v skladovnicah ali na zvitku,
The printed surfaces shall not come into direct contact with food.
Potiskane površine ne smejo priti v neposreden stik z živili.
Commission Regulation (EC) No 2024/2006
Uredba Komisije (ES) št. 2024/2006
laying down transitional measures derogating from Regulation (EC) No 2076/2002 and Decisions 98/270/EC, 2002/928/EC, 2003/308/EC, 2004/129/EC, 2004/141/EC, 2004/247/EC, 2004/248/EC, 2005/303/EC and 2005/864/EC as regards the continued use of plant protection products containing certain active substances not included in Annex I to Directive 91/414/EEC by reason of the accession of Romania
o uvedbi prehodnih ukrepov za odstopanje od Uredbe (ES) št. 2076/2002 in odločb 98/270/ES, 2002/928/ES, 2003/308/ES, 2004/129/ES, 2004/141/ES, 2004/247/ES, 2004/248/ES, 2005/303/ES in 2005/864/ES glede nadaljnje uporabe fitofarmacevtskih sredstev, ki vsebujejo nekatere aktivne snovi, ki niso vključene v Prilogo I k Direktivi 91/414/EGS, zaradi pristopa Romunije
Having regard to the Treaty of Accession of Bulgaria and Romania, and in particular Article 4(3) thereof,
ob upoštevanju Pogodbe o pristopu Bolgarije in Romunije, in zlasti člena 4(3) Pogodbe,
Having regard to the Act of Accession of Bulgaria and Romania, and in particular Article 42 thereof,
ob upoštevanju Akta o pristopu Bolgarije in Romunije, in zlasti člena 42 Akta,
Commission Regulation (EC) No 2076/2002 [1] and Decisions 98/270/EC [2], 2002/928/EC [3], 2003/308/EC [4], 2004/129/EC [5], 2004/141/EC [6], 2004/247/EC [7], 2004/248/EC [8], 2005/303/EC [9] and 2005/864/EC [10] contain provisions for the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC [11] and for the withdrawal by Member States of all authorizations for plant protection products containing those active substances.
Uredba Komisije (ES) št. 2076/2002 [1] in odločbe 98/270/ES [2], 2002/928/ES [3], 2003/308/ES [4], 2004/129/ES [5], 2004/141/ES [6], 2004/247/ES [7], 2004/248/ES [8], 2005/303/ES [9] in 2005/864/ES [10] vsebujejo določbe za nevključitev nekaterih aktivnih snovi v Prilogo I k Direktivi Sveta 91/414/EGS [11] in za odvzem vseh registracij, ki jih opravijo države članice za fitofarmacevtska sredstva, ki vsebujejo te snovi.
Since existing authorisations have to be withdrawn in Romania by 31 December 2006, Romania applied for transitional measures permitting it to grant a grace period for some of those active substances to allow existing stocks to be used up.
Ker mora Romunija do 31. decembra 2006 odvzeti obstoječe registracije, je zaprosila za odobritev prehodnih ukrepov, ki ji dovoljujejo podaljšanje roka za nekatere od navedenih aktivnih snovi, da se porabijo obstoječe zaloge.
Romania should take the appropriate measures to ensure that the continued uses have neither harmful effect on human or animal health nor unacceptable influence on the environment and that all necessary risk mitigation measures are taken.
Romunija mora sprejeti ustrezne ukrepe za zagotovitev, da nadaljnje uporabe ne bodo imele škodljivih vplivov na zdravje ljudi ali živali ali nepričakovanih vplivov na okolje, in da se sprejmejo vsi ustrezni ukrepi za zmanjšanje tveganja.
By way of derogation from Article 1 of Commission Decision 98/270/EC, any period of grace granted by Romania, in accordance with Article 4(6) of Directive 91/414/EEC, for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the active substance fenvalerate, shall be as short as possible and shall expire not later than 30 June 2008.
Z odstopanjem od člena 1 Odločbe Komisije 98/270/ES je vsako podaljšanje roka, ki ga Romunija odobri v skladu s členom 4(6) Direktive 91/414/EGS za odstranitev, skladiščenje, dajanje v promet ter uporabo obstoječih zalog fitofarmacevtskih sredstev z vsebnostjo aktivne snovi fenvalerat, čim krajše in se izteče najpozneje 30. junija 2008.
By way of derogation from Article 3 of Commission Decision 2002/928/EC, any period of grace granted by Romania, in accordance with Article 4(6) of Directive 91/414/EEC, for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the active substance benomyl shall be as short as possible and shall expire not later than 31 December 2007.
Z odstopanjem od člena 3 Odločbe Komisije 2002/928/ES je vsako podaljšanje roka, ki ga Romunija odobri v skladu s členom 4(6) Direktive 91/414/EGS za odstranitev, skladiščenje, dajanje v promet ter uporabo obstoječih zalog fitofarmacevtskih sredstev z vsebnostjo aktivne snovi benomil, čim krajše in se izteče najpozneje 31. decembra 2007.
By way of derogation from Article 3 of Commission Regulation (EC) No 2076/2002, any period of grace granted by Romania, in accordance with Article 4(6) of Directive 91/414/EEC, for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the active substances acifluorfen, bensultap, bromopropylate, fenpropathrin, fomesafen, imazapyr, nonylphenol ethoxylate, oxadixyl, prometryne, quinalphos, terbufos or triforine shall be as short as possible and shall expire not later than 30 June 2008.
Z odstopanjem od člena 3 Uredbe Komisije (ES) št. 2076/2002 je vsako podaljšanje roka, ki ga Romunija odobri v skladu s členom 4(6) Direktive 91/414/EGS za odstranitev, skladiščenje, dajanje v promet ter uporabo obstoječih zalog fitofarmacevtskih sredstev z vsebnostjo aktivnih snovi acifluorfen, bensultap, bromopropilat, fenpropatrin, fomesafen, imazapir, nonilfenol etoksilat, oksadiksil, prometrin, kvinalfos, terbufos ali triforin, čim krajše in se izteče najpozneje 30. junija 2008.
By way of derogation from Article 3 of Commission Decision 2003/308/EC, any period of grace granted by Romania, in accordance with Article 4(6) of Directive 91/414/EEC, for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the active substance metalaxyl shall be as short as possible and shall expire not later than 30 June 2008.
Z odstopanjem od člena 3 Odločbe Komisije 2003/308/ES je vsako podaljšanje roka, ki ga Romunija odobri v skladu s členom 4(6) Direktive 91/414/EGS za odstranitev, skladiščenje, dajanje v promet ter uporabo obstoječih zalog fitofarmacevtskih sredstev z vsebnostjo aktivne snovi metalaksil, čim krajše in se izteče najpozneje 30. junija 2008.
By way of derogation from Article 3 of Commission Decision 2004/129/EC, any period of grace granted by Romania, in accordance with Article 4(6) of Directive 91/414/EEC, for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the active substances boric acid, imazethapyr, methidathion or triadimefon shall be as short as possible and shall expire not later than 30 June 2008.
Z odstopanjem od člena 3 Odločbe Komisije 2004/129/ES je vsako podaljšanje roka, ki ga Romunija odobri v skladu s členom 4(6) Direktive 91/414/EGS za odstranitev, skladiščenje, dajanje v promet ter uporabo obstoječih zalog fitofarmacevtskih sredstev z vsebnostjo aktivnih snovi borova kislina, imazetapir, metidation ali triadimefon, čim krajše in se izteče najpozneje 30. junija 2008.
By way of derogation from Article 3 of Commission Decision 2004/141/EC, any period of grace granted by Romania, in accordance with Article 4(6) of Directive 91/414/EEC, for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the active substance amitraz shall be as short as possible and shall expire not later than 31 December 2007.
Z odstopanjem od člena 3 Odločbe Komisije 2004/141/ES je vsako podaljšanje roka, ki ga Romunija odobri v skladu s členom 4(6) Direktive 91/414/EGS za odstranitev, skladiščenje, dajanje v promet ter uporabo obstoječih zalog fitofarmacevtskih sredstev z vsebnostjo aktivne snovi amitraz, čim krajše in se izteče najpozneje 31. decembra 2007.
By way of derogation from Article 3 of Commission Decision 2004/247/EC, any period of grace granted by Romania, in accordance with Article 4(6) of Directive 91/414/EEC, for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the active substance simazine shall be as short as possible and shall expire not later than 31 December 2007.
Z odstopanjem od člena 3 Odločbe Komisije 2004/247/ES je vsako podaljšanje roka, ki ga Romunija odobri v skladu s členom 4(6) Direktive 91/414/EGS za odstranitev, skladiščenje, dajanje v promet ter uporabo obstoječih zalog fitofarmacevtskih sredstev z vsebnostjo aktivne snovi simazin, čim krajše in se izteče najpozneje 31. decembra 2007.
By way of derogation from Article 3 of Commission Decision 2004/248/EC, any period of grace granted by Romania, in accordance with Article 4(6) of Directive 91/414/EEC, for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the active substance atrazine shall be as short as possible and shall expire not later than 31 December 2007.
Z odstopanjem od člena 3 Odločbe Komisije 2004/248/ES je vsako podaljšanje roka, ki ga Romunija odobri v skladu s členom 4(6) Direktive 91/414/EGS za odstranitev, skladiščenje, dajanje v promet ter uporabo obstoječih zalog fitofarmacevtskih sredstev z vsebnostjo aktivne snovi atrazin, čim krajše in se izteče najpozneje 31. decembra 2007.
By way of derogation from Article 3 of Commission Decision 2005/303/EC, any period of grace granted by Romania, in accordance with Article 4(6) of Directive 91/414/EEC, for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the active substance kasugamycin shall be as short as possible and shall expire not later than 31 December 2007.
Z odstopanjem od člena 3 Odločbe 2005/303/ES je vsako podaljšanje roka, ki ga Romunija odobri v skladu s členom 4(6) Direktive 91/414/EGS za odstranitev, skladiščenje, dajanje v promet ter uporabo obstoječih zalog fitofarmacevtskih sredstev z vsebnostjo aktivne snovi kasugamicin, čim krajše in se izteče najpozneje 31. decembra 2007.
By way of derogation from Article 3 of Commission Decision 2005/864/EC, any period of grace granted by Romania, in accordance with Article 4(6) of Directive 91/414/EEC, for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the active substance endosulfan shall be as short as possible and shall expire not later than 31 December 2007.
Z odstopanjem od člena 3 Odločbe 2005/864/ES je vsako podaljšanje roka, ki ga Romunija odobri v skladu s členom 4(6) Direktive 91/414/EGS za odstranitev, skladiščenje, dajanje v promet ter uporabo obstoječih zalog fitofarmacevtskih sredstev z vsebnostjo aktivne snovi endosulfan, čim krajše in se izteče najpozneje 31. decembra 2007.
Romania shall ensure that the continued uses referred to in Articles 1 to 10 have neither harmful effect on human or animal health nor unacceptable influence on the environment.
Romunija zagotovi, da nadaljnje uporabe iz členov 1 do 11 ne bodo imele škodljivih vplivov na zdravje ljudi ali živali ali nepričakovanih vplivov na okolje.
Romania shall ensure that all necessary risk mitigation measures are taken.
Romunija zagotovi, da se sprejmejo vsi ustrezni ukrepi za zmanjšanje tveganja.
Where a plant protection product contains several active substances, and Articles 1 to 10 lay down different dates for in relation to those substances, the earlier date shall apply.
Če fitofarmacevtsko sredstvo vsebuje več aktivnih snovi in členi 1 do 11 določajo različne datume v zvezi z navedenimi snovmi, se uporabi zgodnejši datum.
OJ L 117, 21.4.1998, p. 15.
UL L 117, 21.4.1998, str. 15.
OJ L 113, 7.5.2003, p. 8.
UL L 113, 7.5.2003, str. 8.
OJ L 46, 17.2.2004, p. 35.
UL L 46, 17.2.2004, str. 35.
OJ L 78, 16.3.2004, p. 53.
UL L 78, 16.3.2004, str. 53.
Decision as last amended by Regulation (EC) No 835/2005 (OJ L 127, 29.4.2004, p. 43).
Odločba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 835/2005 (UL L 127, 29.4.2004, str. 43).
Directive as last amended by Commission Directive (EC) 2006/75/EC (OJ L 248, 12.9.2006, p. 3).
Direktiva, kakor je bila nazadnje spremenjena z Direktivo Komisije 2006/75/ES (UL L 248, 12.9.2006, str. 3).
Commission Regulation (EC) No 2025/2006
Uredba Komisije (ES) št. 2025/2006
amending Regulation (EC) No 796/2004 laying down detailed rules for the implementation of cross-compliance, modulation and the integrated administration and control system provided for in Council Regulation (EC) No 1782/2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers
o spremembi Uredbe (ES) št. 796/2004 o podrobnih pravilih za izvajanje navzkrižne skladnosti, modulacije in integriranega administrativnega in kontrolnega sistema, predvidenih z Uredbo Sveta (ES) št. 1782/2003 o skupnih pravilih za sheme neposrednih podpor v okviru skupne kmetijske politike in o uvedbi nekaterih shem podpor za kmete
Having regard to Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers and amending Regulations (EEC) No 2019/93, (EC) No 1452/2001, (EC) No 1453/2001, (EC) No 1454/2001, (EC) No 1868/94, (EC) No 1251/1999, (EC) No 1254/1999, (EC) No 1673/2000, (EEC) No 2358/71 and (EC) No 2529/2001 [1], and in particular Article 145(c) and (n) thereof,
ob upoštevanju Uredbe Sveta (ES) št. 1782/2003 z dne 29. septembra 2003 o skupnih pravilih za sheme neposrednih podpor v okviru skupne kmetijske politike in o uvedbi nekaterih shem podpor za kmete ter o spremembi uredb (EGS) št. 2019/93, (ES) št. 1452/2001, (ES) št. 1453/2001, (ES) št. 1454/2001, (ES) št. 1868/94, (ES) št. 1251/1999, (ES) št. 1254/1999, (ES) št. 1673/2000, (EGS) št. 2358/71 in (ES) št. 2529/2001 [1] ter zlasti člena 145(c) in (n) Uredbe,
Following the amendments of the rules of eligibility of hemp under the single payment scheme introduced by Article 2 of Council Regulation (EC) No 953/2006 [2], Commission Regulation (EC) No 796/2004 [3] needs to be amended with regard to the application procedure.
Zaradi spremenjenih pravil glede upravičenosti konoplje v okviru sheme enotnega plačila iz člena 2 Uredbe Sveta (ES) št. 953/2006 [2], Uredbe Komisije (ES) št. 796/2004 [3] je treba spremeniti uredbo glede postopka za vložitev zahtevkov.
Moreover, experience has shown that certain provisions of that Regulation need to be simplified or clarified.
Poleg tega so izkušnje pokazale, da je treba nekatere določbe navedene uredbe poenostaviti ali pojasniti.
From 2007 onwards, hemp produced for other uses than fibre will, pursuant to Chapter 4 of Title III of Regulation (EC) No 1782/2003, be allowed as a land use under the single payment scheme.
Od leta 2007 se lahko zemljišča v okviru sheme enotnega plačila v skladu s poglavjem 4 naslova III Uredbe (ES) št. 1782/2003 uporablja za konopljo, ki se goji za vlakna.
In this respect a contract or commitment for the hemp produced is no longer required.
Zato pogodba ali zaveza za proizvedeno konopljo ni več potrebna.
As a consequence, Article 13 of Regulation (EC) No 796/2004 should be adapted accordingly.
Člen 13 Uredbe (ES) št. 796/2004 je zato treba ustrezno spremeniti.
The aid to sugar beet and cane producers provided for in Chapter 10f of Title IV of Regulation (EC) No 1782/2003 is, due to its nature, not related to agricultural area.
Pomoč proizvajalcem pesnega in trsnega sladkorja iz poglavja 10f naslova IV Uredbe (ES) št. 1782/2003 se zaradi njenega namena ne nanaša na kmetijsko površino.
The provisions concerning the single application under Regulation (EC) No 796/2004 should therefore not apply to that aid scheme.
Določbe glede enotnega zahtevka v okviru Uredbe (ES) št. 796/2004 se zato ne uporabljajo za navedeno shemo pomoči.
Provisions should subsequently be made for an appropriate application procedure.
Zato je treba sprejeti določbe za primeren postopek za vložitev zahtevkov.
Moreover, since farmers are not bound anymore to declare separately the areas used for sugar beet or cane production, the provisions to draw an additional control sample from the farmers applying for the aid to sugar and cane producers should be abolished.
Ker kmetje poleg tega niso več zavezani, da ločeno prijavljajo območja, ki se uporabljajo za pridelavo sladkorne pese ali trsnega sladkorja, se odpravijo zahteve za jemanje kontrolnih vzorcev pri kmetih, ki zaprosijo za pomoč za proizvajalce pesnega in trsnega sladkorja.
In order to harmonise the rules under the area-related aid schemes and to simplify the administration and the controls of the applications for aid, features referred to in acts listed in Annex III to Regulation (EC) No 1782/2003, or which may form part of the good agricultural and environmental condition as referred to in Article 5 of that Regulation and Annex IV thereto, shall be eligible not only for the single payment scheme but for all area-related aid schemes.
Da bi uskladili pravila v okviru shem pomoči, vezanih na površino, in da bi poenostavili upravljanje in nadzor zahtevkov pomoči, so značilnosti, navedene v aktih iz Priloge III k Uredbi (ES) št. 1782/2003, ali tiste, ki so del dobrih kmetijskih in okoljskih pogojev iz člena 5 navedene Uredbe in Priloge IV, upravičene ne samo v okviru sheme enotnega plačila, temveč tudi pri shemah pomoči na površino.
Article 54(6) of Regulation (EC) No 1782/2003 requires that set-aside entitlements are to be claimed before any other entitlements.
Člen 54(6) Uredbe (ES) št. 1782/2003 določa, da se pravice za praho uveljavljajo pred vsemi drugimi pravicami.
In order to ensure equal treatment of farmers who do not have all the required set-aside area available to claim for all their set-aside entitlements, the provisions set out in Article 50(4) of Regulation (EC) No 796/2004 should be clarified.
Da bi zagotovili enake pogoje kmetom, ki ne razpolagajo s celotno zahtevano praho, da bi lahko uveljavljali vse svoje pravice za praho, je treba pojasniti zahteve, določene v členu 50(4) Uredbe (ES) št. 796/2004.