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101–150/338
metoda preverjanja
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ker bodo v naslednjih direktivah, ki jih bo treba sprejeti v skladu s postopkom, predvidenim v členu 10 Direktive 76/893/EGS, opredeljene analizne metode za preverjanje tovrstne migracije;
whereas further directives, to be adopted in accordance with the procedure laid down in Article 10 of Directive 76/893/EEC, will establish the methods of analysis necessary for the verification of such migration;
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Postopek opisuje metodo za preverjanje delovanja vgrajenih naprav za diagnostiko na vozilu (OBD) s simuliranjem napak v ustreznih sistemih za upravljanje motorja ali v sistemu za nadzor emisij.
The procedure describes a method for checking the function of the on-board diagnostic (OBD) system installed on the vehicle by failure simulation of relevant systems in the engine management or emission control system.
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ČETRTA DIREKTIVA KOMISIJE z dne 11. oktobra 1985 o približevanju zakonodaj držav članic v zvezi z analiznimi metodami, ki so potrebne za preverjanje sestave kozmetičnih izdelkov (85/490/EGS)
Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products
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TRETJA DIREKTIVA KOMISIJE z dne 27. septembra 1983 o približevanju zakonodaj držav članic v zvezi z analiznimi metodami, ki so potrebni za preverjanje sestave kozmetičnih izdelkov (83/514/EGS)
Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products
105 Pravna redakcija
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Prva direktiva Komisije 79/796 EGS z dne 26. julija 1979 o določitvi analiznih metod Skupnosti za preverjanje nekaterih sladkorjev, namenjenih za prehrano ljudi (UL št. L 239, 22.9.1979, str. 24).
First Commission Directive 79/796/EEC of 26 July 1979 laying down Community methods of analysis for testing certain sugars intended for human consumption (OJ No L 239, 22.9.1979, p. 24).
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promet
CELEX: 22003D0025
Odloeba Komisije 2002/8/ES z dne 28. decembra 2001 o doloeitvi metod za preverjanje porekla eistopasemskega plemenskega goveda in o spremembi odloeb 88/124/EGS in 96/80/ES fn, se vključi v Sporazum.
Commission Decision 2002/8/EC of 28 December 2001 laying down the methods for the genetic identification of pure-bred breeding animals of the bovine species and amending Decisions 88/124/EEC and 96/80/EC fn is to be incorporated into the Agreement.
107 Pravna redakcija
promet
CELEX: 22003D0025
Odloeba Komisije 2002/8/ES z dne 28. decembra 2001 o doloeitvi metod za preverjanje porekla eistopasemskega plemenskega goveda in o spremembi odloeb 88/124/EGS in 96/80/ES (UL L 3, 5.1.2002, str. 53).`
Commission Decision 2002/8/EC of 28 December 2001 laying down the methods for the genetic identification of pure-bred breeding animals of the bovine species and amending Decisions 88/124/EEC and 96/80/EC (OJ L 3, 5.1.2002, p. 53).`
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V vseh primerih, ko so ti standardi preseženi, je treba pregledati izvajanje metod za spremljanje in preverjanje kritičnih točk, ki se uporabljajo v obratu za predelavo v skladu s členom 14 te direktive.
In all cases where these standards are exceeded there must be a review of the implementation of the methods for monitoring and checking critical points applied in the processing establishment pursuant to Article 14 of this Directive.
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Prva direktiva Komisije 81/712 EGS z dne 28. julija 1981 o določitvi analiznih metod Skupnosti za preverjanje, da nekateri aditivi za živila izpolnjujejo merila čistosti (UL št. L 257, 10.9.1981, str. 1).
First Commission Directive 81/712/EEC of 28 July 1981 laying down Community methods of analysis for verifying that certain additives used in foodstuffs satisfy criteria of purity (OJ No L 257, 10.9.1981, p. 1).
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DIREKTIVA KOMISIJE z dne 10. februarja 1987 o spremembah Prve direktive 80/1335/EGS o približevanju zakonov držav članic glede analitskih metod, potrebnih za preverjanje sestave kozmetičnih izdelkov (87/143/EGS)
Commission Directive 87/143/EEC of 10 February 1987 amending the first Directive 80/1335/EEC on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products
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gospodarstvo
CELEX: 32003L0126
(1) Na podlagi Direktive 70/373/EGS se zaradi preverjanja skladnosti z zahtevami zakonov in drugih predpisov, ki urejajo kakovost in sestavo krme uradni nadzor krme izvaja z uporabo metod vzorčenja in analiz Skupnosti.
(1) Pursuant to Directive 70/373/EEC, official controls of feedingstuffs, for the purpose of checking compliance with the requirements of the laws, regulations and administrative provisions governing their quality and composition, are to be carried out using Community sampling and analysis methods.
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za razvrščanje blaga pod tarifni podštevilki 1902 19 10 in 1902 19 90 kombinirane nomenklature se za preverjanje prisotnosti moke in zdroba iz navadne pšenice v testeninah uporablja metoda iz Priloge III k tej uredbi;
For the purposes of classifying goods falling within subheadings 1902 19 10 and 1902 19 90 of the combined nomenclature, the method set out in Annex III to this Regulation shall be used to test for the presence of common wheat flours and semolinas in pasta;
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obramba
CELEX: 32004D0156
- sestavi načrt preverjanja, ki je sorazmeren s to analizo tveganja in obsegom ter zapletenostjo upravljavčeve dejavnosti in virov in opredeli metode vzorčenja, ki naj se uporabljajo v zvezi z napravami tega upravljavca,
- draw up a verification plan which is commensurate with this risk analysis and the scope and complexity of the operator's activities and sources, and which defines the sampling methods to be used with respect to that operator's installations,
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DIREKTIVA KOMISIJE z dne 4. aprila 1990 o spremembah Druge direktive 82/434/EGS o približevanju zakonodaj držav članic v zvezi z analiznimi metodami, ki so potrebne za preverjanje sestave kozmetičnih izdelkov (90/207/EGS)
Commission Directive 90/207/EEC of 4 April 1990 amending the Second Directive 82/434/EEC on the approximation of the laws of the Member State relating to methods of analysis necessary for checking the composition of cosmetic products
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Ta poenostavljen način izvajanja je treba dopolniti z metodo količinskega vrednotenja, kar bo omogočalo pristojnemu organu da bo preverjanje skladnosti zdravila s specifikacijo potem, ko je bilo zdravilo že dano v promet.
This simplified technique shall be supplemented by a method of quantitative evaluation, enabling the competent authority to have the conformity of the medicinal product with its specification verified after it has been placed on the market.
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promet
Četrta direktiva Komisije 85/490/EGS z dne 11. oktobra 1985 o približevanju zakonodaj držav članic v zvezi z analiznimi metodami, ki so potrebne za preverjanje sestave kozmetičnih izdelkov (UL L 295, 7.11.1985, str. 30).
Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 295, 7.11.1985, p. 30).
117 Pravna redakcija
obramba
CELEX: 32004D0156
Med postopkom preverjanja preveritelj preveri pravilno uporabo odobrene metodologije spremljanja in oceni upravljanje in zmanjševanje negotovosti s postopki, ki jih uporablja upravljavec za zagotavljanje in nadzor kakovosti.
During the verification process, the verifier shall check the correct application of the approved monitoring methodology, and shall assess the management and reduction of remaining uncertainties via the operator's quality assurance and control procedures.
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Poleg tega so spodaj naštete ustanove odgovorne za preverjanje kakovosti metode ELISA v vsaki državi članici, zlasti še za proizvodnjo in standardizacijo državnih referenčnih serumov glede na referenčni serum Skupnosti.
The institutes listed below will, in addition, be responsible for checking the quality of the ELISA method in each Member State, and in particular for producing and standardising national reference sera according to the Community reference sera.
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Ta standard zlasti ne izpolnjuje obvezne zahteve po minimalnem številu premikov ali rotacij v normalno predvidljivih pogojih uporabe ali definira metodologijo testiranja za preverjanje minimalnega števila premikov ali rotacij.
In particular, this standard does not cover the mandated requirement for a minimum number of trips or rotations in normally predictable conditions of use, or define a test method for checking this minimum number of trips or rotations.
120 Pravna redakcija
finance
CELEX: 32003R2003
Preverjanje, analiza in preskušanje enostavnih gnojil iz amonijevega nitrata z visoko vsebnostjo dušika zaradi uradnega nadzora, ki ga predvideva to poglavje, se izvajajo v skladu z metodami, opisanimi v oddelku 3 Priloge III.
The checking, analysis and testing for official controls of straight ammonium nitrate fertilisers of high nitrogen content provided for by this chapter shall be carried out in accordance with the methods described in section 3 of Annex III.
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Prva direktiva Komisije z dne 22. decembra 1980 o približevanju zakonov držav članic glede analitskih metod, potrebnih za preverjanje sestave kozmetičnih izdelkov, (UL L 383, 31.12.1980, str. 27), kakor je bila spremenjena z:
First Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 383, 31.12.1980, p. 27), as amended by:
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Četrta direktiva Komisije 85/490/EGS z dne 11. oktobra 1985 o približevanju zakonodaj držav članic v zvezi z analiznimi metodami, ki so potrebne za preverjanje sestave kozmetičnih izdelkov (UL št. L 295, 7. 11. 1985, str. 30).
Fourth Commission Directive 85/490/EEC of 11 October on the approximation of laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ No L 295, 7.11.1985, p. 30).
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Tretja direktiva Komisije 83/514/EGS z dne 27. septembra 1983 o približevanju zakonodaj držav članic v zvezi z analiznimi metodami, ki so potrebne za preverjanje sestave kozmetičnih izdelkov (UL št. L 291, 24. 10. 1983, str. 9).
Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ No L 291, 24.10.1983, p. 9).
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Kjer ni določena preskusna metoda, ali je zapisano, da se uporablja za preverjanje ali nadzor, naj bi se pristojni organi po potrebi opirali na deklaracije in dokumentacijo, ki jo predloži vlagatelj in/ali na neodvisna preverjanja.
Where no testing method is specified, or is mentioned as being for use in verification or monitoring, competent bodies should rely, as appropriate, on declarations and documentation provided by the applicant and/or independent verifications.
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Kjer ni določena preskusna metoda, ali je zapisano, da se uporablja za preverjanje ali nadzor, naj bi se pristojni organi po potrebi opirali na deklaracije in dokumentacijo, ki jo predloži vlagatelj, in/ali na neodvisna preverjanja.
Where no test method is specified, or is mentioned as being for use in verification or monitoring, competent bodies should rely as appropriate on declarations and documentation provided by the applicant and/or independent verifications.
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Podrobna pravila za izvajanje tega člena, zlasti pravila o preprečevanju navzkrižne kontaminacije ter o metodah vzorčenja in analize, potrebna za preverjanje skladnosti s tem členom, se sprejmejo v skladu s postopkom iz člena 24(2).
Detailed rules for the implementation of this Article, in particular rules on the prevention of cross-contamination and on the methods of sampling and analysis required to check compliance with this Article, shall be adopted in accordance with the procedure referred to in Article 24(2).
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Za enotno uporabo te direktive je v skladu s postopkom iz člena 12 iz te direktive treba določiti programe vzorčenja ter metode in dovoljena analitična odstopanja, ki se uporabljajo za preverjanje skladnosti z zahtevami iz tega poglavja.
For the uniform application of this Directive sampling plans as well as the methods and analytical tolerances to be applied in order to check compliance with the requirements of this Chapter must be established in accordance with the procedure laid down in Article 12 of this Directive.
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Če rezultati preverjanj iz odstavka 8 presegajo dovoljene meje, lahko imetnik zadevne serije zahteva ponovno analizo v enem od referenčnih laboratorijev iz seznama v Prilogi VIII po enaki metodi, kot je bila uporabljena pri prvotnem preskusu.
If the result of the checks referred to in paragraph 8 is in excess of the admissible limits, the holder of the batch concerned may request that a counter-analysis be carried out in one of the reference laboratories listed in Annex VIII, using the same method as for the initial test.
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Druga direktiva Komisije 82/434/EGS z dne 14. maja 1982 o približevanju zakonodaje držav članic v zvezi z analiznimi metodami, potrebnimi za preverjanje sestave kozmetičnih izdelkov (UL L 185, 30.6.1982, str. 1), kakor je bila spremenjena z:
Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 185, 30.6.1982, p. 1), as amended by:
130 Pravna redakcija
DRUGO
Prva direktiva Komisije 80/1335/EGS z dne 22. decembra 1980 o približevanju zakonov držav članic glede analitskih metod, potrebnih za preverjanje sestave kozmetičnih izdelkov (UL št. L 383, 31. 12. 1980, str. 27), kakor je bila spremenjena z:
First Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ No L 383, 31.12.1980, p. 27), as amended by:
131 Pravna redakcija
DRUGO
Ta poenostavljen način je treba dopolniti z metodo količinskega vrednotenja, ki pristojnemu organu omogoči, da preverjanje skladnosti imunološkega zdravilo za uporabo v veterinarski medicini s specifikacijo potem, ko je že bilo dano v promet.
This simplified technique shall be supplemented by a method of quantitative evaluation, enabling the competent authority to verify that the immunological veterinary medicinal product is in accordance with its formula after it has been placed on the market.
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Potem, ko je že bilo izdano dovoljenje za promet z zdravilom, mora imetnik, glede metod izdelave ter kontrolnih metod, ki jih določa člen 12(3)(d) ter (i), upoštevati dosežke na področju znanosti in tehnologije ter uvesti morebitne spremembe, ki so potrebne, da bi omogočile izdelavo in preverjanje zdravila s splošno veljavnimi znanstvenimi metodami.
After a marketing authorization has been issued, the holder must, in respect of the manufacturing methods and control methods provided for in Article 12(3)(d) and (i), take account of scientific and technical progress and introduce any changes that may be required to enable that veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.
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DRUGO
Druga direktiva Komisije 82/434/EGS z dne 14. maja 1982 o približevanju zakonodaje držav članic v zvezi z analiznimi metodami, potrebnimi za preverjanje sestave kozmetičnih izdelkov (UL št. L 185, 30. 6. 1982, str. 1), kakor je bila spremenjena z:
Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ No L 185, 30.6.1982, p. 1), as amended by:
134 Pravna redakcija
promet
Tretja direktiva Komisije 83/514/EGS z dne 27. septembra 1983 o približevanju zakonodaj držav članic v zvezi z analiznimi metodami, ki so potrebni za preverjanje sestave kozmetičnih izdelkov (UL L 291, 24.10.1983, str. 9), kakor je bila spremenjena z:
Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 291, 24.10.1983, p. 9).
135 Pravna redakcija
DRUGO
ODLOČBA KOMISIJE z dne 28. decembra 2001 o določitvi metod za preverjanje porekla čistopasemskega plemenskega goveda in o spremembi odločb 88/124/EGS in 96/80/ES (notificirano pod dokumentarno številko K(2001) 4709) (Besedilo velja za EGP) (2002/8/ES)
Commission Decision of 28 December 2001 laying down the methods for the genetic identification of pure-bred breeding animals of the bovine species and amending Decisions 88/124/EEC and 96/80/EC (Text with EEA relevance) (notified under document number C(2001) 4709)
136 Pravna redakcija
DRUGO
Ta navaja, da ima EACCE potrebno osebje, opremo in objekte za preverjanje, da uporablja metode, ki so enakovredne tistim iz člena 9 Uredbe (ES) št. 1148/2001, in da sadje in zelenjava, ki se izvažata iz Maroka v Skupnost, ustrezata standardom trženja Skupnosti.
This states that the EACCE has the necessary staff, equipment and facilities to carry out checks, that it uses methods equivalent to those referred to in Article 9 of Regulation (EC) No 1148/2001 and that the fresh fruit and vegetables exported from Morocco to the Community meet the Community marketing standards.
137 Pravna redakcija
DRUGO
Procenti tehnično neizbežne absorbirane vode, ki se ne sme preseči med pripravo svežih, zamrznjenih in hitro zamrznjenih klavnih trupov in njihovih kosov kakor tudi enotne metode preverjanja usklajenosti s postopkom, določenim v členu 17 Uredbe (EGS) št. 2777/75` .
The percentages of water absorption which are technically unavoidable and which shall not be exceeded during the preparation of fresh, frozen and quick-frozen carcases and cuts thereof as well as the uniform methods of verifying compliance therewith shall be determined in accordance with the procedure laid down in Article 17 of Regulation (EEC) No 2777/ 75'.
138 Pravna redakcija
DRUGO
Te lastnosti so take, da jih ni mogoče doseči, razen s posebno pazljivostjo pri izdelavi in vročem valjanju ter s stalnim preverjanjem med proizvodnjo, ki ne more biti dosledno zagotovljena s splošnimi metodami proizvodnje, uporabljenimi za fundamentalno in kakovostno jeklo.
These characteristics are such that they cannot be achieved except by special care in manufacture and hot rolling and by constant checking during production, which cannot be consistently guaranteed by the general method of production used for basis steels and quality steels.
139 Pravna redakcija
DRUGO
Ta navaja, da ima PPIS potrebno osebje, opremo in objekte za opravljanje preverjanj, da uporablja metode, ki so enakovredne tistim iz člena 9 Uredbe (ES) št. 1148/2001, in da sveže sadje in zelenjava, izvožena iz Izraela v Skupnost, izpolnjujeta standarde trženja Skupnosti.
This states that the PPIS has the necessary staff, equipment and facilities to carry out checks, that it uses methods equivalent to those referred to in Article 9 of Regulation (EC) No 1148/2001 and that the fresh fruit and vegetables exported from Israel to the Community meet the Community marketing standards.
140 Pravna redakcija
DRUGO
ker Druga direktiva Komisije 82/434/EGS z dne 14. maja 1982 o približevanju zakonodaj držav članic v zvezi z analiznimi metodami za preverjanje sestave kozmetičnih izdelkov( fn ) predpisuje enotno analizno metodo za kvalitativno in kvantitativno določanje prostega formaldehida;
Whereas Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the laws of the Member States relating to methods of analysis for checking the composition of cosmetic products (1) lays down a common method of analysis for the identification and determination of free formaladehyde;
141 Pravna redakcija
gospodarstvo
CELEX: 32003D0422
4. PCR se lahko izvede v enem delovnem dnevu. Metoda zahteva ustrezno laboratorijsko opremo, ločene prostore in usposobljeno osebje. Prednost metode je v tem, da pomnoževanje virusa v laboratoriju ni potrebno. Metoda je izredno občutljiva, vendar lahko zaradi velike možnosti kontaminacije zlahka pride do lažno pozitivnih rezultatov. Zato so bistvenega pomena strogi postopki preverjanja kakovosti izvajanja postopka.
The PCR can be performed within a working day. It requires appropriate laboratory equipment, separated facilities and skilled staff. An advantage is that the infectious virus need not be replicated in the laboratory. The PCR is highly sensitive, but contamination may easily occur, which leads to false positive results. Therefore stringent quality control procedures are essential.
142 Pravna redakcija
DRUGO
Podrobna pravila za uporabo tega člena, zlasti za določanje števila vzorcev, ki naj se jemljejo, teže ali volumna rib v vsakem vzorcu in metode za ocenjevanje razvrščanja in preverjanje teže šarž, ki se dajo v prodajo, se sprejmejo skladno s postopkom, določenem v členu 32 osnovne uredbe.
Detailed rules for the application of this Article, in particular for determining the number of samples to be taken, the weight or volume of fish in each sample, and the methods for assessing the grading and verifying the weight of lots offered for sale shall be adopted in accordance with the procedure laid down in Article 32 of the basic Regulation.
143 Pravna redakcija
DRUGO
Če za proizvod ni tehničnih specifikacij, opredeljenih v členu 4, namembna država članica, na zahtevo v posamičnih primerih, šteje, da je proizvod skladen z veljavnimi nacionalnimi določbami, če so to potrdili preskusi in preverjanje, ki jih je odobreni organ v državi članici proizvajalki izvedel v skladu z veljavnimi metodami namembne države članice ali z metodami, ki jih ta država članica priznava za enakovredne.
In the absence of technical specifications, as defined in Article 4, for any given product, the Member State of destination shall, on request in individual cases, consider the product to be in conformity with the national provisions in force if they have satisfied tests and inspections carried out by an approved body in the producing Member State according to the methods in force in the Member State of destination or recognized as equivalent by that Member State.
144 Pravna redakcija
promet
CELEX: 31992D0097
Tehnične specifikacije in metode preizkušanja, preverjanja, prevzema in izračuna vsake naročila se lahko opredelijo v prednostnem vrstnem redu s sklicevanjem na skupne standarde, sprejete s strani EGS in zadevne ČDO ali države članice, ali katere koli druge standarde, vključujoč mednarodne standarde.
The technical specifications and methods of testing, checking, acceptance and calculation in each contract, may be defined in order of precedence, by reference to the common standards accepted by the EEC and the OCT concerned, or the standards of the OCT concerned, or of a Member State, or any other standard, including international standards.
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DRUGO
Države članice sprejmejo potrebne ukrepe za zagotovitev, da se metode preverjanja, analize in preskušanja za uradno kontrolo enojnih gnojil iz amonijevega nitrata z visoko vsebnostjo dušika, ki so predvideni v Direktivi 80/876/EGS, izvajajo v skladu z metodami, opisanimi v Prilogah II in III k tej direktivi.
Member States shall take the necessary measures to ensure that the methods of checking, analysis and test for official controls of straight ammonium nitrate fertilizers of high nitrogen content provided for by Directive 80/876/EEC are carried out in accordance with the methods described in Annexes II and III to this Directive.
146 Pravna redakcija
finance
CELEX: 32003L0063
Ti preskusi so pomembni za preverjanje skladnosti zdravila s sestavo, če vlagatelj izjemoma predlaga analizno metodo za preskušanje končnega izdelka, ki ne vključuje določanja vsebnosti vseh zdravilnih učinkovin (ali vseh sestavin pomožnih snovi ob upoštevanju enakih zahtev kot za zdravilne učinkovine).
These tests are essential for checking the conformity of the medicinal product with the formula when, exceptionally, an applicant proposes an analytical method for testing the finished product which does not include the assay of all the active substances (or of all the excipient constituents subject to the same requirements as the active substances).
147 Pravna redakcija
gospodarstvo
CELEX: 32003R2295
(4) Da bi jamčili sledljivost jajc in zagotavljali možnost preverjanja porekla in proizvodne metode, je treba vsako jajce označiti tudi z identifikacijsko številko proizvodnega obrata v skladu z Direktivo Komisije 2002/4/ES že na mestu prireje (na kmetiji) ali najkasneje v prvem pakirnem centru, kamor so jajca poslana.
(4) In order to guarantee the traceability of eggs and ensure that their origin and production method can be verified, each egg should also be marked with the distinguishing number of the production establishment, in accordance with Commission Directive 2002/4/EC, at the production site (on the farm) or, at the latest, at the first packing centre to which the eggs are sent.
148 Pravna redakcija
DRUGO
Potrdilo, ki ga izda odobrena NA, ne vključuje samo ustreznih informacij, potrebnih za identifikacijo zadevnega blaga in pošiljke ter podrobnosti o prevoznem sredstvu, datumu prispetja in iztovarjanja, ampak naj zajema tudi opis kontrol in metod, ki so se uporabljale med preverjanjem identitete in teže potrjenih proizvodov.
Certification issued by approved SAs shall include not only the appropriate information necessary to identify the goods and consignment in question as well as details of means of transport, dates of arrival and unloading, but also a description of the controls and methods applied to verify the identity and weight of the certified products.
149 Pravna redakcija
DRUGO
Ti preskusi so ključnega pomena za preverjanje skladnosti zdravila s sestavo, če izjemoma predlagatelj predlaga analitsko metodo za preskušanje končnega proizvoda, ki ne vključuje določanja vsebnosti vseh zdravilnih učinkovin (ali vseh sestavin pomožnih snovi, za katere veljajo iste zahteve kot za zdravilne učinkovine).
These tests are essential for checking the conformity of the medicinal product with the formula when, exceptionally, an applicant proposes an analytical method for testing the finished product which does not include the assay of all the active substances (or of all the excipient components subject to the same requirements as the active substances).
150 Pravna redakcija
DRUGO
Pogodbenici primerjata metode, ki jih uporabljata pri preverjanju, če organi ustrezajo splošnim načelom glede imenovanja iz Priloge 2, ob upoštevanju določb ustreznega Oddelka IV v Prilogi 1. Za namen tovrstnih primerjav se lahko uporabijo sistemi za akreditacijo organov za ugotavljanje skladnosti, ki pri pogodbenicah že obstajajo.
The Parties shall compare methods used to verify conformity of the bodies with the general principles of designation outlined in Annex 2, subject to the provisions of the respective section IV in Annex 1. Existing systems for the accreditation of conformity assessment bodies in the Parties may be used for the purpose of such comparisons.
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101–150/338
metoda preverjanja