natgillin/translations-raw huggingface dataset:
The specifications provided for in this Regulation draw on a comparison of available technologies performed in the framework of the cost-benefit analysis, as well as on its suggestions for the appropriate structure of the codes used for the identification of marine equipment.
Specifikacije, določene s to uredbo, temeljijo na primerjavi razpoložljivih tehnologij, opravljeni v okviru analize stroškov in koristi, ter na predlogih iz te analize za ustrezno strukturo kod, ki se uporabljajo za identifikacijo pomorske opreme.
The comparison of existing data carriers and data exchange architectures in the framework of the cost-benefit analysis resulted in the recommendation to use data matrix codes and radio-frequency identification (‘RFID’) as the most appropriate technologies.
Iz primerjave obstoječih nosilcev podatkov in arhitektur za izmenjavo podatkov v okviru analize stroškov in koristi je sledilo priporočilo glede uporabe podatkovno-matričnih kod in radiofrekvenčne identifikacije (RFID) kot najustreznejših tehnologij.
The cost-benefit analysis also indicated that the limited data storage capacity on the electronic tag implies that the information on the electronic tag has to provide a link to databases where more detailed information can be found.
Analiza stroškov in koristi je tudi pokazala, da omejena zmogljivost shranjevanja podatkov na elektronsko oznako pomeni, da morajo informacije na elektronski oznaki zagotoviti povezavo do podatkovnih zbirk, v katerih so navedene podrobnejše informacije.
The data matrix codes and radio frequency identification (‘RFID’) specified by this Regulation contain the key information able to provide for such a link.
Podatkovno-matrične kode in radiofrekvenčna identifikacija iz te uredbe vsebujejo ključne informacije za zagotovitev takšne povezave.
Consequently, a unique identification of marine equipment, based on a standardised code structure independent from the electronic tag type should be used.
Zato bi bilo treba uporabiti edinstveno identifikacijo pomorske opreme, ki bi temeljila na standardizirani strukturi kode, neodvisni od vrste elektronske oznake.
Such an identification should be flexible enough to enable the direct access of users to the most relevant databases for marine equipment.
Takšna identifikacija bi morala biti dovolj prožna, da bi uporabnikom omogočala neposreden dostop do najustreznejših podatkovnih baz za pomorsko opremo.
The format of encoding the required information on the data carrier should be based on ISO standards.
Oblika kodiranja zahtevanih podatkov na nosilcu podatkov bi morala temeljiti na standardih ISO.
The format should also allow for the possibility to encode additional information for the use of the manufacturers, in particular as manufacturers should be able to embed into the data carrier additional security features in order to better identify counterfeited products.
Oblika bi morala proizvajalcem omogočati tudi vnos dodatnih informacij, zlasti zato, ker bi morali imeti možnost, da v nosilec podatkov vključijo dodatne varnostne elemente za boljše prepoznavanje ponarejenih proizvodov.
In order to be easily retrievable by visual inspection, marine equipment with electronic tags which replace the wheel mark should display an appropriate symbol.
Da bi omogočili enostaven dostop z vizualnim pregledom, bi morala biti pomorska oprema z elektronskimi oznakami, ki nadomeščajo znak krmila, označena s primernim simbolom.
The measures provided for in this Regulation are in accordance with the opinion of the Committee on Safe Seas and the Prevention of Pollution from Ships (‘COSS’),
Ukrepi iz te uredbe so v skladu z mnenjem Odbora za varnost na morju in preprečevanje onesnaževanja z ladij (COSS) –
‘electronic tag’ means a marker with radio frequency identification (‘RFID’) or with a data matrix code;
„elektronska oznaka“ pomeni označevalec z radiofrekvenčno identifikacijo (RFID) ali podatkovno-matrično oznako;
‘application identifier’ means a numeric prefix used to define the meaning and format of encoded data elements.
„identifikator aplikacije“ pomeni številčno predpono, ki se uporablja za opredelitev pomena in oblike vnesenih podatkovnih elementov.
Manufacturers of marine equipment may use the following electronic tags as specified in the Annex:
Proizvajalci pomorske opreme lahko uporabljajo naslednje elektronske oznake, kakor je določeno v Prilogi:
RFID tags affixed permanently on a marine equipment item;
oznake za radiofrekvenčno identifikacijo, trajno pritrjene na kos pomorske opreme;
optically readable tags containing data matrix codes affixed permanently on a marine equipment item; or
optično berljive oznake, ki vsebujejo podatkovno-matrične kode, trajno pritrjene na kos pomorske opreme; ali
optically readable tags containing data matrix codes permanently marked on a marine equipment item.
optično berljive oznake, ki vsebujejo podatkovno-matrične kode, trajno označene na kosu pomorske opreme.
RFID electronic tags which replace the wheel mark shall visibly, legibly and indelibly display the symbol set out in points 3.1 or 3.2 of the Annex, either on the tags themselves or adjacent to them.
Na elektronskih oznakah za radiofrekvenčno identifikacijo, ki nadomeščajo znak krmila, je vidno, berljivo in neizbrisno prikazan simbol iz točke 3.1 ali 3.2 Priloge, bodisi na oznakah samih ali v njihovi bližini.
Marine equipment with optically readable tags containing data matrix codes which replace the wheel mark shall visibly, legibly and indelibly display the symbol set out in point 3.3 of the Annex, either on the tags themselves or adjacent to them.
Na pomorski opremi z optično berljivimi oznakami, ki vsebujejo podatkovno-matrične kode, ki nadomeščajo znak krmila, je vidno, berljivo in neizbrisno prikazan simbol iz točke 3.3 Priloge, bodisi na oznakah samih ali v njihovi bližini.
‘The possible introduction of an electronic tag as a supplement or a replacement of the wheel mark in marine equipment’, Call for Tenders No MOVE/D2/2015-372 V1.0 of the European Commission DG Mobility and Transport.
„Možnost uvedbe elektronske oznake, ki dopolnjuje ali nadomešča znak krmila na pomorski opremi“, javni razpis št.
ANNEX
MOVE/D2/2015–372 V1.0 Evropske komisije, GD za mobilnost in promet.
Identification of marine equipment
PRILOGA
Electronic tags for marine equipment shall comprise an electronically readable identification in radio frequency identification (‘RFID’) or optically readable data matrix code containing the following information:
Identifikacija pomorske opreme
an appropriate application identifier in accordance with ISO/IEC 15434:2006 and ISO/IEC 15418:2016, using either an ASC MH10 Data Identifier or a GS1 Application Identifier;
Elektronske oznake za pomorsko opremo vsebujejo elektronsko berljivo identifikacijo v radiofrekvenčni identifikaciji ali optično berljivo podatkovno-matrično kodo, ki vsebuje naslednje informacije:
the type of conformity assessment module(s) set out in Annex II to Directive 2014/90/EU used for the conformity assessment [one digit alphabetical];
ustrezen identifikator aplikacije v skladu z ISO/IEC 15434: 2006 in ISO/IEC 15418:2016, bodisi z uporabo podatkovnega identifikatorja ASC MH10 ali identifikatorja aplikacije GS1;
the notified body identification number assigned by the Commission in accordance with point 3.1 of Annex IV to Directive 2014/90/EU [4 digits];
tip modulov za ugotavljanje skladnosti iz Priloge II k Direktivi 2014/90/EU, ki se uporabljajo za ugotavljanje skladnosti [ena črka];
the number(s) of the unit verification (Module G) or EC type examination and conformity to type certificates (Module B and D, E or F) [maximum 20 alpha-numeric digits].
identifikacijsko številko priglašenega organa, ki jo dodeli Komisija v skladu s točko 3.1 Priloge IV k Direktivi 2014/90/EU [4 števke];
In addition to the information provided pursuant to point 1.1, electronic tags may also contain information relating to the production site number, a product code, the lot or batch number and/or additional information designed by the manufacturer in accordance with ISO/IEC 15434:2006 [using either ASC MH10 Data Identifiers or GS1 Application Identifiers].
številke preverjanja enote (modul G) ali ES-pregleda tipa in potrdil o skladnosti s tipom (modul B in D, E ali F)] [največ 20 alfanumeričnih znakov].
Examples:
Poleg informacij, zagotovljenih v skladu s točko 1.1, lahko elektronske oznake vsebujejo tudi informacije o številki proizvodnega obrata, kodo izdelka, serijsko številko ali številko lota in/ali dodatne informacije, ki jih določi proizvajalec v skladu s standardom ISO/IEC 15434:2006 [bodisi z uporabo podatkovnih identifikatorjev ASC MH10 ali identifikatorjev aplikacije GS1].
Modules B+D: [see point 1.2.] + ([appropriate identifier]) B 0575 40123 + D 0038 040124
Primeri:
Modules B+E: [see point 1.2.] + ([appropriate identifier]) B 0575 40123 + E 0038 040125
Modula B + D: [glej točko 1.2] + ([ustrezen identifikator]) B 0575 40123 + D 0038 040124
Modules B+F: [see point 1.2.] + ([appropriate identifier]) B 0575 40123 + F 0038 040126
Modula B + E: [glej točko 1.2] + ([ustrezen identifikator]) B 0575 40123 + E 0038 040125
Module G: [see point 1.2.] + ([appropriate identifier]) G 0575 040126.
Modula B + F: [glej točko 1.2] + ([ustrezen identifikator]) B 0575 40123 + F 0038 040126
Electronic tags
Modul G: [glej točko 1.2] + ([ustrezen identifikator]) G 0575 040126.
RFID tags
Elektronske oznake
RFID transponders shall operate in the frequency range of 860 MHz to 960 MHz in accordance to ISO/IEC 18000-6:2004 Type C.
Oznake za radiofrekvenčno identifikacijo
The electronic tag shall be firmly affixed to the marine equipment concerned in a durable way and so as to ensure that the electronic tag will be able to be read as intended for the expected lifetime of the marine equipment.
Transponderji za radiofrekvenčno identifikacijo delujejo v frekvenčnem območju od 860 MHz do 960 MHz v skladu s standardom ISO/IEC 18000-6:2004 tip C.
Data matrix codes
Elektronska oznaka se trdno pritrdi na zadevno pomorsko opremo na trajen način in tako, da se zagotovi, da jo bo mogoče pravilno prebrati v celotni pričakovani življenjski dobi pomorske opreme.
Data matrix codes shall be in accordance with ISO/IEC 16022:2006.
Podatkovno-matrične kode
The electronic tag shall be marked on or firmly affixed to the marine equipment concerned in a durable way and so as to ensure that the electronic tag will be able to be read as intended for the expected lifetime of the marine equipment.
Podatkovno-matrične kode so v skladu z ISO/IEC 16022:2006.
Symbols
Elektronska oznaka mora biti označena na zadevni pomorski opremi ali trdno pritrjena nanjo na trajen način in tako, da se zagotovi, da jo bo mogoče pravilno prebrati v celotni pričakovani življenjski dobi pomorske opreme.
Commission Implementing Regulation (EU) 2018/609
Izvedbena uredba Komisije (EU) 2018/609
on the maximum buying-in price for skimmed milk powder for the second individual invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2018/154
o določitvi najvišje odkupne cene za posneto mleko v prahu za drugi posamični razpis v okviru razpisnega postopka, odprtega z Izvedbeno uredbo (EU) 2018/154
In the light of the tenders received for the second individual invitation to tender, a maximum buying-in price should not be fixed.
Glede na ponudbe, prejete v okviru drugega posamičnega razpisa, ni treba določiti najvišje odkupne cene.
For the second individual invitation to tender for the buying-in of skimmed milk powder within the tendering procedure opened by Implementing Regulation (EU) 2018/154, in respect of which the time limit for the submission of tenders expired on 17 April 2018, no maximum buying-in price shall be fixed.
Za drugi posamični razpis za odkup posnetega mleka v prahu v okviru razpisnega postopka, odprtega z Izvedbeno uredbo (EU) 2018/154, katerega rok za vložitev ponudb je potekel 17. aprila 2018, se najvišja odkupna cena ne določi.
Commission Implementing Regulation (EU) 2018/610
Izvedbena uredba Komisije (EU) 2018/610
on the minimum selling price for skimmed milk powder for the 19th partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080
o določitvi najnižje prodajne cene za posneto mleko v prahu za devetnajsti delni razpis v okviru razpisnega postopka, odprtega z Izvedbeno uredbo (EU) 2016/2080
In the light of the tenders received for the 19th partial invitation to tender, a minimum selling price should be fixed.
Glede na ponudbe, predložene za devetnajsti delni razpis, je treba določiti najnižjo prodajno ceno.
The Committee for the Common Organisation of the Agricultural Markets has not delivered an opinion within the time limit laid down by its Chair,
Upravljalni odbor za skupno ureditev kmetijskih trgov ni podal mnenja v roku, ki ga je določil njegov predsednik –
For the 19th partial invitation to tender for the selling of skimmed milk powder within the tendering procedure opened by Implementing Regulation (EU) 2016/2080, in respect of which the period during which tenders were to be submitted ended on 17 April 2018, the minimum selling price shall be 105,10 EUR/100 kg.
Za devetnajsti delni razpis za prodajo posnetega mleka v prahu v okviru razpisnega postopka, odprtega z Izvedbeno uredbo (EU) 2016/2080, katerega rok za predložitev ponudb je potekel 17. aprila 2018, znaša najnižja prodajna cena 105,10 EUR/100 kg.
Directorate-General for Agriculture and Rural Development
Generalni direktorat za kmetijstvo in razvoj odeželja
Commission Implementing Regulation (EU) 2018/613
Izvedbena uredba Komisije (EU) 2018/613
approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4
o odobritvi PHMB (1415; 4.7) kot obstoječe aktivne snovi za uporabo v biocidnih proizvodih 2. in 4. vrste proizvodov
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, and in particular the third subparagraph of Article 89(1) thereof,
ob upoštevanju Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta z dne 22. maja 2012 o dostopnosti na trgu in uporabi biocidnih proizvodov ter zlasti tretjega pododstavka člena 89(1) Uredbe,
That list includes PHMB (1415; 4.7).
Navedeni seznam vključuje PHMB (1415; 4.7).
PHMB (1415; 4.7) has been evaluated for use in products of product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, and product-type 4, food and feed area, as described in Annex V to Regulation (EU) No 528/2012.
PHMB (1415; 4.7) je bil ocenjen za uporabo v proizvodih 2. vrste proizvodov (razkužila in algicidi, ki niso namenjeni neposredni uporabi na ljudeh ali živalih) in 4. vrste proizvodov (za območja s hrano in krmo), kot sta opredeljeni v Prilogi V k Uredbi (EU) št. 528/2012.
France was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 13 December 2016.
Francija, ki je bila imenovana za ocenjevalni pristojni organ, je 13. decembra 2016 predložila poročila o oceni skupaj s svojimi priporočili.
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 4 October 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
V skladu s členom 7(2) Delegirane uredbe (EU) št. 1062/2014 je Odbor za biocidne pripravke ob upoštevanju ugotovitev pristojnega ocenjevalnega organa 4. oktobra 2017 oblikoval mnenja Evropske agencije za kemikalije.
According to those opinions, biocidal products of product-types 2 and 4 containing PHMB (1415; 4.7) may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.
Glede na navedena mnenja je za biocidne proizvode 2. in 4. vrste proizvodov, ki vsebujejo PHMB (1415; 4.7), mogoče pričakovati, da izpolnjujejo merila iz člena 19(1)(b) Uredbe (EU) št. 528/2012, če so izpolnjene nekatere specifikacije in pogoji glede njihove uporabe.
It is therefore appropriate to approve PHMB (1415; 4.7) for use in biocidal products of product-types 2 and 4, subject to compliance with certain specifications and conditions.
Zato je primerno PHMB (1415; 4.7) odobriti za uporabo v biocidnih proizvodih 2. in 4. vrste proizvodov, če je ta v skladu z nekaterimi specifikacijami in pogoji.
The opinions conclude that PHMB (1415; 4.7) meets the criteria for being a very persistent (vP) and toxic (T) substance in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council.
Iz mnenj je razvidno, da PHMB (1415; 4.7) izpolnjuje kriterije za razvrstitev kot zelo obstojna (vP) in strupena (T) snov v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006 Evropskega parlamenta in Sveta.
PHMB (1415; 4.7) therefore meets the conditions set out in point (d) of Article 10(1) of Regulation (EU) No 528/2012 and should be considered a candidate for substitution.
PHMB (1415; 4.7) zato izpolnjuje pogoje, določene v točki (d) člena 10(1) Uredbe (EU) št. 528/2012, in bi ga bilo zato treba obravnavati kot možno snov za zamenjavo.
Pursuant to Article 10(4) of that Regulation, the approval of an active substance that is considered as a candidate for substitution should be for a period not exceeding 7 years.
V skladu s členom 10(4) navedene uredbe je treba odobritev aktivne snovi, ki se šteje kot možna snov za zamenjavo, podati za obdobje največ sedem let.
For the use in product-type 4, the evaluation did not address the incorporation of biocidal products containing PHMB (1415; 4.7) in materials and articles intended to come into contact directly or indirectly with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council.
Glede uporabe v 4. vrsti proizvodov v oceni ni bila obravnavana vključitev biocidnih proizvodov, ki vsebujejo PHMB (1415; 4.7), v materiale in izdelke, namenjene za neposreden ali posreden stik z živili v smislu člena 1(1) Uredbe Evropskega parlamenta in Sveta (ES) št. 1935/2004.
Such materials may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of Regulation (EC) No 1935/2004.
Za takšne materiale je lahko potrebna določitev posebnih mejnih vrednosti za migracijo v živila, kot je določeno v členu 5(1)(e) Uredbe (ES) št. 1935/2004.
Since PHMB (1415; 4.7) meets the criteria for being very persistent (vP) according to Annex XIII to Regulation (EC) No 1907/2006, treated articles treated with or incorporating PHMB (1415; 4.7) should be appropriately labelled when placed on the market.
Ker PHMB (1415; 4.7) izpolnjuje kriterije za lastnost „zelo obstojen“ (vP – very persistent) v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006, bi bilo treba izdelke, ki so tretirani z PHMB (1415; 4.7) ali ga vsebujejo, ob dajanju na trg ustrezno označiti.
PHMB (1415; 4.7) is approved as an active substance for use in biocidal products of product-types 2 and 4, subject to the specifications and conditions set out in the Annex.
PHMB (1415; 4.7) se odobri kot aktivna snov za uporabo v biocidnih proizvodih 2. in 4. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).
Delegirana uredba Komisije (EU) št. 1062/2014 z dne 4. avgusta 2014 o delovnem programu za sistematično preverjanje vseh obstoječih aktivnih snovi, ki jih vsebujejo biocidni proizvodi, iz Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta (UL L 294, 10.10.2014, str. 1).
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
Uredba Evropskega parlamenta in Sveta (ES) št. 1935/2004 z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili, in o razveljavitvi direktiv 80/590/EGS in 89/109/EGS (UL L 338, 13.11.2004, str. 4).
Minimum degree of purity of the active substance
Minimalna stopnja čistosti aktivne snovi
PHMB (1415; 4.7) (polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1415 and a mean polydispersity (PDI) of 4.7)
PHMB (1415; 4.7) (poliheksametilen bigvanid hidroklorid s srednjo povprečno molekulsko maso (Mn) 1415 in srednjo polidisperznostjo (PDI) 4.7)
CoPoly(bisiminoimidocarbonyl, hexamethylene hydrochloride),(iminoimidocarbonyl, hexamethylene hydrochloride)
CoPoly (bisiminoimidokarbonil, heksametilen hidroklorid), (iminoimidokarbonil, heksametilen hidroklorid)
CAS No: 32289-58-0 and 1802181-67-4
ES: ni na voljo
943g/kg (calculated dry weight specification).
Št.
The active substance as manufactured is an aqueous solution of 20 % w/w of PHMB (1415; 4.7)
CAS: 32289-58-0 in 1802181-67-4
1 November 2019
943 g/kg (izračunana specifikacija suhe snovi)
31 October 2026
Aktivna snov, kot se proizvaja, je vodna raztopina z 20 mas. % PHMB (1415; 4.7)
PHMB (1415; 4.7) is considered a candidate for substitution in accordance with point (d) of Article 10(1) Regulation (EU) No 528/2012.
1. november 2019
The authorisations of biocidal products are subject to the following conditions:
31. oktober 2026
the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance;
PHMB (1415; 4.7) se šteje kot možna snov za zamenjavo v skladu s točko (d) člena 10(1) Uredbe (EU) št. 528/2012.
non-professional users;
zaradi ugotovljenih tveganj v zvezi z ocenjenimi uporabami se pri oceni proizvoda posebna pozornost nameni:
secondary exposure of the general public and toddlers;
poklicnim uporabnikom;
environment: surface water, sediment and soil.
nepoklicnim uporabnikom;
The placing on the market of treated articles is subject to the following condition:
sekundarni izpostavljenosti splošne javnosti in majhnih otrok;
The person responsible for the placing on the market of a treated article treated with or incorporating PHMB (1415; 4.7) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
okolju: površinski vodi, usedlinam in tlom.
PHMB (1415; 4.7) is considered a candidate for substitution in accordance with point (d) of Article 10(1) Regulation (EU) No 528/2012.
Za dajanje tretiranih izdelkov na trg velja naslednji pogoj:
secondary exposure of the general public;
Oseba, odgovorna za dajanje na trg proizvoda, ki je bil tretiran s PHMB (1415; 4.7) ali pa ga vsebuje, zagotovi, da so na oznaki tretiranega izdelka navedene informacije iz drugega pododstavka člena 58(3) Uredbe (EU) št. 528/2012.
environment: surface water, sediment and soil;
PHMB (1415; 4.7) se šteje kot možna snov za zamenjavo v skladu s točko (d) člena 10(1) Uredbe (EU) št. 528/2012.
for products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded;
sekundarni izpostavljenosti splošne javnosti;
products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of PHMB (1415; 4.7) into food or it has been established pursuant to that Regulation that such limits are not necessary.
okolju: površinski vodi, usedlinam in tlom.