natgillin/translations-raw huggingface dataset:
(b) biocidna lastnost tretiranega izdelka ali snovi , kjer je potrebno ;
(b) where relevant, the biocidal property attributed to treated articles or materials;
(b) biocidna lastnost tretiranega izdelka ali snovi, če pride biocidni pripravek, ki ga vsebujejo, v neposreden stik s človekom ali okoljem ;
(b) the biocidal property attributed to treated articles or materials , if the biocidal product contained therein will come i nto direct contact with people and the environment ;
Za pojasnitev, da veljajo za tretirane snovi in izdelke z zunanjim delovanjem strožje določbe o označevanju.
To clarify the fact that treated materials and articles which have external effects are subject to stricter labelling requirements.
Člen 47 – odstavek 2 – pododstavek 1 – točka c
Article 47 – paragraph 2 – subparagraph 1 – point c
c) številke dovoljenj vseh biocidnih pripravkov, ki so bili uporabljeni za tretiranje ali so vključeni v izdelke ali snovi.
c) the authorisation number of all biocidal products that were used for the treatment or were incorporated in the articles or materials;
Vključitev številke dovoljenja ne prinaša nobene koristi za varstvo potrošnikov.
The inclusion of the authorisation number does not have any consumer safety benefits.
Ravno nasprotno, imeli bi dolge sezname teh številk, saj ni nič neobičajnega, da je za eno samo aktivno snov več dobaviteljev.
On the contrary, a long list of authorisation numbers would arise as it is not uncommon to have multiple suppliers of one active substance.
To lahko potrošnike zmede.
This would create confusion among consumer.
Pristojni organi lahko za izvajanje te uredbe številko dovoljenja pridobijo kako drugače.
For the purposes of enforcement by competent authorities, the authorisation number can be obtained through other means.
Člen 47 – odstavek 2 – pododstavek 1 – točka d
Article 47 – paragraph 2 – subparagraph 1 – point d
(d) stavki o nevarnosti ali previdnostni stavki, navedeni v dovoljenju za biocidni pripravek.
(d) any hazard statement or precautionary statement set out in the authorisation for the biocidal product.
(d) stavki o nevarnosti ali previdnostni stavki, navedeni v dovoljenju za biocidni pripravek , če se biocidni pripravek sprosti ob običajnih ali predvidljivih pogojih uporabe .
(d) any hazard statement or precautionary statement set out in the authorisation for the biocidal product if the biocidal product is intended to be released under normal or reasonably foreseeable conditions of use .
Za izdelke z zunanjim biocidnim delovanjem bi morala veljati strožja pravila.
More stringent rules should apply to products which have an external biocidal effect.
V zvezi s tem je potrebna natančnejša ubeseditev člena 47.
In this respect the wording of Article 47 needs to be clarified.
Člen 47 – odstavek 2 – pododstavek 2 in 3
Article 47 – paragraph 2 – subparagraphs 2 and 3
Označba mora biti jasno vidna, čitljiva in primerno obstojna.
The labelling shall be clearly visible, easily legible and appropriately durable .
Označba mora biti jasno vidna, čitljiva , primerno obstojna ter se natisne na izdelek ali snov, embalažo na navodila za uporabo ali na garancijski list tretiranega izdelka ali snovi v nacionalnem jeziku ali jezikih države članice, na katere trg se daje tretirani izdelek ali snov .
The labelling shall be clearly visible, easily legible , appropriately durable and printed on the article or material, on the packaging, on the instructions for use or on the warranty of the treated article or material in the national language or languages of the Member State on whose market the treated article or material is to be placed .
Kjer je to potrebno zaradi velikosti ali funkcije tretiranega izdelka ali snovi, se označba natisne na embalažo, na navodila za uporabo ali na garancijski list tretiranega izdelka ali snovi.
Where this is necessary because of the size or the function of the treated article or material, the labelling shall be printed on the packaging, on the instructions for use or on the warranty of the treated article or material.
Pri tretiranih snoveh ali izdelkih, ki niso načrtovani in proizvedeni serijsko, temveč na podlagi posebnega naročila, se lahko proizvajalec s stranko dogovori o drugih načinih zagotavljanja informacij.
In the case of treated materials or articles which are not produced as part of a series, but rather designed and manufactured to meet a specific order, the manufacturer may agree other methods of providing the relevant information with the customer.
Jasno je treba zapisati, da morajo biti tretirani izdelki in snovi, tako kot drugi pripravki, označeni v nacionalnem jeziku oziroma jezikih države članice, v kateri bodo dani na trg.
It should be clarified that treated articles and materials, as with other products, should always be labelled in the national language or languages of the Member State on whose market the product is placed.
(Pripravljavec mnenja je svoj predlog spremembe 37 spremenil upoštevaje države članice, ki imajo več nacionalnih jezikov.)
(The rapporteur has amended his proposed Amendment 37 of his draft opinion to take account of Member States with more than one national language.)
Člen 47 – odstavek 2 – pododstavek 3 a (novo)
Article 47 – paragraph 2 – subparagraph 3 a (new)
Ta odstavek se uporabi, razen če druga zakonodaja Unije že ne predpisuje zahtev o tovrstnem označevanju.
This paragraph shall apply unless such labelling requirements already exist under other Union legislation.
(a) poznejši predlagatelj je od prvega predlagatelja pridobil pisni dogovor v obliki izjave o dostopnosti , v katerem mu dovoljuje uporabo navedenih informacij;
(a) the subsequent applicant has written agreement in the form of a letter of access from the first applicant that he can use that information,
(a) poznejši predlagatelj je pridobil pisni dogovor v obliki izjave o dostopu v skladu s členom 50 , v katerem mu je dovoljena uporaba navedenih informacij;
(a) the subsequent applicant has written agreement in the form of a letter of access in accordance with Article 50 that he can use that information,
Prvi predlagatelj ni nujno lastnik podatkov.
The first applicant is not necessarily the owner of the information.
Poleg tega bi bilo treba dovoliti možnost, da bi bil lastnik podatkov drug predlagatelj ali podjetje ali bi to postal zaradi delitve ali skupnega razvoja podatkov.
Moreover, the option of a second applicant or a second company owning or being able to acquire the information as the result of information sharing or joint information development should be permitted.
Udeležencem, ki so povezani z vključitvijo v Prilogo I in so že pridobili pravice, da se lahko seznanijo s podatki v dokumentaciji, ne bi bilo treba vsakokrat dokazovati, da so oziroma niso lastniki podatkov.
The participants involved with the inclusion of substances in Annex I, who are already entitled to refer to information contained in applications, should thus not be required to prove each time whether or not they are the actual data owners.
Člen 48 – odstavek 1 – točka b a (novo)
Article 48 – paragraph 1 – point b a (new)
(ba) poznejši predlagatelj je tudi lastnik podatkov.
(ba) the subsequent applicant is also an owner of the information.
Člen 48 – odstavek 4
Article 48 – paragraph 4
Seznam iz odstavka 2 agencija vnese v register za izmenjavo podatkov o biocidih.
The list referred to in paragraph 2 shall be entered by the Agency in the Biocides Data Sharing Register.
Agencija vse podatke na seznamu iz odstavka 2 označi z enkratno kodo in jih z vsemi podrobnostmi vnese v register za izmenjavo podatkov o biocidih , skupaj z identiteto prvega predlagatelja in lastnika podatkov .
Each item of information in the list referred to in paragraph 2 shall be identified by a unique code and entered by the Agency – with all relevant details and linked to the identity of the initial applicant and the information owner – in the Biocides Data Sharing Register.
Register mora vsebovati vse podatke ali dokumente iz seznama.
All the items of information or documents that are on the list must be contained in the register.
Numerično identificiranje posameznih dokumentov, ki so bili vloženi, je koristno zaradi preprečevanja nesporazumov glede podobnih naslovov ali sprememb študij ali neobdelanih podatkov v zvezi s študijami.
Giving each document submitted an identification number is a useful means of avoiding misunderstandings in relation to similar titles, changes in studies or unedited information on studies.
Povezava z lastnikom podatkov in predlagateljem zagotavlja varstvo lastninskih pravic.
Linking the items of information to the information owners and applicants will ensure that property rights are recognised.
Člen 49 – odstavek 1 – pododstavek 2
Article 49 – paragraph 1 – subparagraph 2
Informacije, varovane v skladu z Direktivo 98/8/ES ali tem členom ali za katere obdobje varovanja poteče v skladu z Direktivo 98/8/ES ali tem členom , se ponovno ne zavarujejo.
Information protected under Directive 98/8/EC or under this Article or for which the protection period expired under Directive 98/8/EC or under this Article shall not be protected again.
Informacije, varovane v skladu z Direktivo 98/8/ES, za katere obdobje varovanja poteče v skladu z Direktivo 98/8/ES ali informacije, varovane po tem členu , se na zahtevo ponovno zavarujejo.
Information protected under Directive 98/8/EC for which the protection period expired under Directive 98/8/EC or information protected under this Article shall , on application, be protected again.
Varstvo podatkov v skladu z direktivo 98/8/ES ni bilo nikoli jasno določeno.
The principle of data protection under Directive 98/8/EC has never been unequivocally established.
Datum predložitve dokumentacije bi lahko bil tudi datum vnosa večine podatkov, vendar bi bili zaradi poznejših predložitev in drugih dejanj datumi predložitve različni.
The date on which an application is submitted ought also to be the date of entry of most of the items of information but later submissions and other activities will result in a number of submission dates.
Vnos datumov predložitve za posamezne dokumente bi odražal dejanski položaj.
Entering a submission date for each individual document will reflect this situation accurately.
Določiti varstvo podatkov za vsak njihov element je upravičeno, saj je vsakemu elementu sledila naložba lastnika.
Establishing that each item of information is covered by data protection is justifiable because each item has entailed an investment on the information owner’s part.
Člen 49 – odstavek 1 – pododstavek 2 a (novo)
Article 49 – paragraph 1 – subparagraph 2 a (new)
Za vsak dokument, ki je prejel enkratno kodo skladno s členom 48(4), se posebej določi datum vnosa.
An entry date shall be individually established for each document that has been given a unique code in accordance with Article 48(4).
(4) Ne glede na prvi pododstavek odstavka 2 se obdobje varovanja informacij, predloženih državi članici v okviru nacionalnih sistemov ali praks za odobritev biocidnih pripravkov, preden so bile predložene za namene Direktive 98/8/ES ali te uredbe, konča ob izteku preostalega obdobja, predpisanega z nacionalnimi predpisi, ali 14. maja 2014, če to nastopi prej, razen če so bile te informacije pridobljene pred 14. majem 2000.
(4) By way of derogation from the first subparagraph of paragraph 2, the protection period for information submitted to a Member State under national systems or practices for the approval of biocidal products, before it was submitted for the purposes of Directive 98/8/EC or of this Regulation, shall end at the expiry of any remaining period provided for under national rules or on 14 May 2014, whichever is the earlier, unless this information has been generated after 14 May 2000.
Razlikovanje med novimi in obstoječimi podatki ni utemeljeno.
There is no justification for making a distinction between new and existing information.
Da se preprečijo preskusi na živalih, se preskusi na vretenčarjih za namene te uredbe opravijo samo v skrajni sili.
In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort.
Preskusi na vretenčarjih se za namene te uredbe ne ponavljajo.
Testing on vertebrate animals shall not be repeated for the purposes of this Regulation.
Ker je treba preprečiti preskuse na živalih, se preskusi na vretenčarjih za namene te uredbe opravijo samo v skrajni sili in če ni alternativnih rešitev, ki ne vplivajo na ljudi in živali .
Given that animal testing should be avoided , testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort where no alternative solution can be employed without producing an impact on humans or animals .
Uredba je usmerjena v trajnostni pristop z varnostjo biocidnih pripravkov, združljivih s človekom, živalmi in okoljem.
The regulation is aiming for a sustainable approach emphasising product safety and compatibility in terms of human and animal health and the environment.
Člen 51 – odstavek 2 – pododstavek 2
Article 51 - paragraph 2 - subparagraph 2
Če so bili navedeni preskusi ali študije že predloženi v povezavi s prejšnjo vlogo, pristojni organ ali agencija bodočemu predlagatelju nemudoma sporoči ime in kontaktne podatke latnika podatkov.
Where those tests or studies have already been submitted in connection with a previous application, the competent authority or the Agency shall without delay communicate the name and contact details of the owner of the information to the prospective applicant.
Če so bili navedeni preskusi ali študije že predloženi v povezavi s prejšnjo vlogo, pristojni organ ali agencija nemudoma oceni tehnično enakovrednost primerjalnega vira.
Where those tests or studies have already been submitted in connection with a previous application, the competent authority or the Agency shall , without delay , assess technical equivalence in relation to the comparison source.
Če je ocena tehnične enakovrednosti pozitivna, pristojni organ ali agencija bodočemu predlagatelju nemudoma sporoči ime in kontaktne podatke lastnika podatkov.
If the technical equivalence assessment is positive, the competent authority or the Agency shall without delay communicate the name and contact details of the owner of the information to the prospective applicant.
Tehnično enakovrednost je treba ustrezno določiti, preden postanejo študije aktualne v okviru izmenjave podatkov.
Before the studies become the subject of a data exchange, technical equivalence must be ascertained.
V nasprotnem primeru ni mogoče določiti, ali so razpoložljivi podatki uporabni pri testnem izdelku poznejšega predlagatelja.
Otherwise it is not possible to ascertain whether the data available are applicable to the subsequent applicant's article for testing.
Člen 53 – odstavek 1 – pododstavek 1
Article 53 - paragraph 1 - subparagraph 1
Za biocidni pripravek, za katerega je že bilo izdano dovoljenje v skladu s členom 15, 25 ali 28, in za katerega so potekla vsa obdobja varovanja informacij v skladu s členom 49, lahko pristojni organ prejemnik ali agencija soglaša, da se poznejši predlagatelj za izdajo dovoljenja sklicuje na podatke, ki jih je dal prvi predlagatelj, če poznejši predlagatelj dokaže, da gre za podoben biocidni pripravek in da so njegove aktivne snovi tehnično enakovredne kot pri pripravku, za katerega je že bilo izdano dovoljenje, vključno s stopnjo čistote in vrsto nečistot.
In the case of a biocidal product which has already been authorised in accordance with Articles 15, 25 or 28, and where all periods of protection of information according to Article 49 have expired, the receiving competent authority or the Agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant in so far as the subsequent applicant can provide evidence that the biocidal product is similar to and its active substances are technically equivalent to the one formerly authorised, including degree of purity and nature of impurities.
Za biocidni pripravek, za katerega je že bilo izdano dovoljenje v skladu s členom 15, 25 ali 28, in za katerega so potekla vsa obdobja varovanja informacij v skladu s členom 49, lahko pristojni organ prejemnik ali agencija soglaša, da se poznejši predlagatelj za izdajo dovoljenja sklicuje na podatke, ki jih je dal prvi predlagatelj ; če obdobja varovanja informacij v skladu s členom 49 še niso potekla, lahko pristojni organ prejemnik ali agencija soglaša, da se poznejši predlagatelj v skladu s členom 52 v obeh primerih sklicuje na podatke, ki jih je dal prvi predlagatelj, če poznejši predlagatelj dokaže, da gre za podoben biocidni pripravek in da so njegove aktivne snovi tehnično enakovredne kot pri pripravku, za katerega je že bilo izdano dovoljenje, vključno s stopnjo čistote in vrsto nečistot.
In the case of a biocidal product which has already been authorised in accordance with Articles 15, 25 or 28, and where all periods of protection of information according to Article 49 have expired, the receiving competent authority or the Agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant , and if the periods of protection of information according to Article 49 have not expired, the receiving competent authority or the Agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant pursuant to Article 52, in both cases in so far as the subsequent applicant can provide evidence that the biocidal product is similar to and its active substances are technically equivalent to the one formerly authorised, including degree of purity and nature of impurities.
Dokazati je treba tehnično podobnost in enakost, tudi če varovanje podatkov ni končano, naslednji predlagatelj pa želi uporabiti podatke.
Similarity and technical equivalence must also be demonstrated where the protection of information has not yet expired but a subsequent applicant wishes to share data.
Člen 54 – odstavek -1 (novo)
Article 54 - paragraph -1 (new)
Pristojni organi izvajajo uradne preglede, da bi zagotovili, da so proizvajalci aktivnih snovi, ki so na trgu za uporabo v biocidnih pripravkih, Komisiji predložili informacije o aktivnih snoveh iz Priloge II ali da imajo izjavo o dostopu do dokumentacije, ki izpolnjuje pogoje iz Priloge II.
C ompetent authorities shall perform official controls in order to ensure that manufacturers of active substances which are placed on the market for use in biocidal products have submitted to the Commission the information about the active substance s referred to in Annex II or are in the possession of a letter of access to a dossier which complies with the requirements of Annex II.
Nadzor trga bi moral zajemati tudi aktivne snovi, ki se dajejo v promet za uporabo v biocidnih pripravkih.
Market surveillance should also apply to active substances which are placed on the market for use in biocidal products.
V skladu s to uredbo morajo proizvajalci upoštevati mnoga pravila, da dosežejo spoštovanje, ki ga je treba zagotoviti na nacionalni ravni.
Under the regulation, manufacturers are required to comply with many rules in order to attain the level of respect which must be guaranteed at national level.
Vsaka tri leta , z začetkom leta 2013, pristojni organi predložijo Komisiji poročilo o izvajanju te uredbe na njihovem ozemlju.
Every three years , starting in 2013, competent authorities shall submit to the Commission a report on the implementation of this Regulation in their respective territories.
Poročilo vključuje:
The report shall include:
Vsako leto , začenši leta 2013, pristojni organi predložijo Komisiji poročilo o izvajanju te uredbe na njihovem ozemlju.
Every year , starting in 2013, competent authorities shall submit to the Commission a report on the implementation of this Regulation in their respective territories.
Poročila o izvajanju se letno objavljajo na ustreznem spletnem mestu Komisije.
The implementation reports shall be published annually on the relevant website of the Commission.
Člen 54 – odstavek 3 – točka b
Article 54 – paragraph 3 – point b
b) informacije o zastrupitvah z biocidnimi pripravki.
b) information on any poisonings involving biocidal products.
b) informacije o zastrupitvah z biocidnimi pripravki , zlasti glede ranljivih skupin, in o sprejetih ukrepih za zmanjšanje nevarnosti prihodnjih primerov .
b) information on any poisonings involving biocidal products , , especially regarding vulnerable groups , and the actions undertaken to lower the risk of future cases .
Države članice bi bilo treba obveščati o najboljših praksah.
Best practices should be disseminated among member states.
Člen 54 – odstavek 3 – točka b a (novo)
Article 54 – paragraph 3 – point b a (new)
(ba) podatke o vplivih na okolje.
(ba) information on the impact on the environment.
Komisija bo do 1. januarja 2023 pripravila poročilo o izvajanju te uredbe ali predvsem o delovanju postopka Skupnosti za izdajo dovoljenj in medsebojnega priznavanja.
The Commission shall draw up a report on the implementation of this Regulation and, in particular, on the functioning of the Community authorisation procedure and mutual recognition, by 1 January 2023 .
Komisija to poročilo predloži Evropskemu parlamentu in Svetu.
The Commission shall submit the report to the European Parliament and the Council.
Komisija do 1. januarja 2016 pripravi poročilo o izvajanju te uredbe in predvsem o delovanju postopka Unije za izdajo dovoljenj in medsebojnega priznavanja.
The Commission shall draw up a report on the implementation of this Regulation and, in particular, on the functioning of the Union authorisation procedure and mutual recognition, by 1 January 2016 .
Člen 54 – odstavek 4 a (novo)
Article 54 – paragraph 4 a (new)
Komisija najkasneje dve leti po začetku veljavnosti te uredbe predloži Evropskemu parlamentu in Svetu poročilo o oceni tveganja glede uporabe nanomaterialov v biocidnih pripravkih za zdravje ljudi in okolje ter o posebnih ukrepih, ki bi jih bilo treba sprejeti v zvezi z njimi.
At the latest t wo yearsafter the entry into force of this Regulation, the Commission shall submit to the European Parliament and Council a report on the assessment of the risks to human health and the environment presented by the use of nanomaterials in biocidal products and on specific measures to be taken with regard to them.
Snovi, ki vsebujejo nanomateriale, spadajo v področje uporabe uredbe.
Substances incorporating nanomaterials fall within the scope of the Regulation.
Vseeno pa je njihov vpliv na zdravje in okolje še zelo slabo raziskan.
However, the impact of these substances on health and the environment is largely unknown at present.
Nujno in zelo hitro je treba začeti študije za oceno tega vpliva, da bi lahko razmislili o potrebnih ukrepih.
It is imperative to initiate without delay research to asses their impact in order to be able to consider specific measures if appropriate.
Komisija najkasneje v petih letih po začetku veljavnosti te uredbe pripravi poročilo o vplivu sproščanja biocidov v okolje.
Not later than five years after the entry into force of this Regulation, the Commission shall draw up a report on the impact of the spread of biocidal products in the environment.
Poročilo predloži Evropskemu parlamentu in Svetu.
The Commission shall submit the report to the European Parliament and the Council.
Številni biocidi se ne uporabljajo v zaprtih sistemih, temveč se sproščajo v okolje, na primer v odpadne vode.
Many biocidal products are not used in closed systems but released into the environment, for example in effluent.
Podatki, ki so na voljo na tem področju, so pomanjkljivi.
Insufficient data are available in this field.
Izvesti je treba poglobljeno presojo vpliva na okolje.
A thorough study of their environmental impact is needed.
Člen 55 – odstavek 2 – točke d a - d d (novo)
Article 55 – paragraph 2 – points d a - d d (new)
(da) imena in naslovi proizvajalcev aktivnih snovi, vključno s krajem proizvodnih obratov;
(da) Names and addresses of manufacturers of the active substances , including location of manufacturing sites;
(db) kraj, kjer so proizvodni obrati biocidnega pripravka;
(db) the location of a biocidal product’s manufacturing site;
(dc) datum izdaje dovoljenja in datum, ko poteče;
(dc) the date of issue of an authorisation and the expiry date;