natgillin/translations-raw huggingface dataset:
Spremembo vira aktivne sestavine, ki se uporablja v biocidnih pripravkih, je treba sporočiti, saj bi lahko vplivala na varnost pripravka.
Notification of any change in the origin of an active substance used in a biocidal product is being requested as this can have an impact on the safety of the product.
Člen 39 – odstavek 3 a (novo)
Article 39 - paragraph 3 a (new)
Preklic ali sprememba prvega dovoljenja velja za dvojnike in dodatna dovoljenja, ki temeljijo na njem.
The cancellation or amendment of a primary authorisation shall apply to duplicate and additional authorisations based on that authorisation.
Pristojni organ, ki je izdal nacionalno dovoljenje, ali, v primeru dovoljenja Skupnosti, Komisija prekliče dovoljenje na zahtevo njegovega imetnika, ki navede razloge za takšno zahtevo.
The competent authority that has granted the national authorisation or in case of Community authorisation, the Commission, shall cancel the authorisation at the request of its holder, who shall state the reasons for such request.
Če takšna zahteva zadeva dovoljenje Skupnosti, se vloži pri agenciji.
If such a request concerns a Community authorisation, it shall be submitted to the Agency.
Pristojni organ, ki je izdal dovoljenje, ga prekliče na zahtevo njegovega imetnika, ki navede razloge za takšno zahtevo.
The competent authority that has granted an authorisation shall cancel the authorisation at the request of its holder, who shall state the reasons for such request.
Če takšna zahteva zadeva dvojnik dovoljenja ali dodatno dovoljenje Skupnosti, se vloži pri agenciji.
If such a request concerns a duplicate or additional Community authorisation, it shall be submitted to the Agency.
Člen 41 – odstavek 2 a (novo)
Article 41 - paragraph 2 a (new)
Sprememba prvega dovoljenja na zahtevo imetnika velja tudi za dvojnike in dodatna dovoljenja, ki temeljijo na prvem dovoljenju.
The amendment of a primary authorisation at the request of the holder of the primary authorisation shall apply to duplicate and additional authorisations based on that authorisation.
Člen 41 – odstavek 2 b (novo)
Article 41 – paragraph 2 b (new)
Sprememba obstoječega dovoljenja v skladu s členom 3 pomeni:
An amendment to an existing authorisation shall, in accordance with Article 3, constitute either:
a) upravno spremembo,
a) an administrative change;
b) manjšo spremembo ali
b) a minor change; or
c) večjo spremembo.
c) a major change .
V zakonodajnem besedilu bi morala biti jasno izražena glavna načela, ki se bodo uporabljala pri spremembi dovoljenja, podrobnosti glede postopka pa je mogoče določiti v izvedbenih ukrepih.
The legislative text should clearly outline the main principles which shall be applied when amending authorisations, although the details of the procedures can be specified in the implementing measures.
Merila in postopki iz odstavka 1 tega člena temeljijo, vendar ne izključno, na naslednjih načelih, za katere se zahteva poenostavljeni postopek priglasitve:
The criteria and procedures referred to in the first paragraph of this article shall be based, non ‑exclusively, on the following principles for which a simplified notification procedure has been requested:
(a) upravne spremembe dovoljenj;
(a) administrative changes to the authorisation;
(b) spremembe biocidnega pripravka znotraj dovoljenih sprememb, v skladu z obstoječo dovoljeno okvirno formulacijo;
(b) changes to the biocidal product within the range permitted under an existing authorised frame formulation;
(c) dajanje novega biocidnega pripravka, ki ustreza obstoječi dovoljeni okvirni formulaciji, na trg;
(c) placing on the market of a new biocidal product within the limits of an existing authorised frame formulation;
(d) spremembe biocidnih pripravkov, ki ne vplivajo negativno na stopnjo tveganja ali na učinkovitost pripravka.
(d) changes in a biocidal product which do not adversely alter the level of the risk or efficacy of the product.
Člen 44 – odstavek 1 – pododstavek 3
Article 44 – paragraph 1 – subparagraph 3
Vlogi se priložijo vse informacije, ki so potrebne, da se dokaže, da je biocidni pripravek zelo podoben referenčnemu biocidnemu pripravku, kot je določeno v odstavku 3.
The application shall be accompanied by all the information necessary to demonstrate that the biocidal product is substantially identical to the reference product as defined in paragraph 3.
Vlogi se priložijo vse informacije, ki so potrebne, da se dokaže, da je biocidni pripravek identičen referenčnemu biocidnemu pripravku, kot je določeno v odstavku 3.
The application shall be accompanied by all the information necessary to demonstrate that the biocidal product is identical to the reference product as defined in paragraph 3.
Biocidni pripravek šteje za identičnega referenčnemu biocidnemu pripravku, če so izpolnjeni vsi naslednji pogoji :
A biocidal product shall be considered as identical to the reference product if all the following conditions are met:
a) vir aktivnih snovi, ki jih vsebuje, je isti, kar zadeva proizvajalca in lokacijo proizvodnega obrata;
a) the source of the active substances it contains is the same in terms of manufacturer and location of the production plant ;
a) je bil izdelan v istem podjetju ali povezani družbi ali po licenci, pri čemer je bil uporabljen enak postopek izdelave;
a) it has been manufactured by the same company or one of its associate companies or under licence, following the same production process ;
b) je enak ali podoben , kar zadeva vsebnost neaktivnih snovi in vrsto formulacije;
b) it is either the same or similar with regard to the non- active substances present and the type of formulation;
b) je enak, kar zadeva tehnične specifikacije, vsebnost aktivnih snovi in vrsto formulacije;
b) it is the same with regard to the specifications, the active substances present and the type of formulation;
c) je enak ali enakovreden v smislu možnega neželenega učinka na varnost pripravka, kar zadeva zdravje ljudi ali živali ali okolje.
c) it is either the same or equivalent in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
c) je enak ali enakovreden v smislu vsebnosti pomožnih snovi v formulaciji, formata, materiala in oblike pakiranja, možnega neželenega učinka na varnost pripravka, kar zadeva zdravje ljudi ali živali ali okolje.
c) it is either the same or equivalent , as regards the co ‑formulants it contains and the format, materials and form of its packaging, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
aa) številka vključitve aktivnih snovi, ki jih vsebuje pripravek, in izjava o dostopu v skladu s členom 50, ki jo predloži predlagatelj v skladu s Poglavjem II te uredbe;
aa) the registration number s of the active substances contained in the product and a letter of access in accordance with Article 50 from the relevant applicant under Chapter II of this Regulation;
Člen 44 – odstavek 4 – točka (c)
Article 44 – paragraph 4 – point c
c) ime in naslov imetnika dovoljenja za biocidni pripravek v državi članici porekla;
c) name and address of the authorisation holder in the Member State of origin;
c) ime in naslov imetnika dovoljenja za biocidni pripravek v državi članici porekla in izjavo o dostopu v skladu s členom 50, ki jo predloži predlagatelj ;
c) name and address of the authorisation holder in the Member State of origin and a letter of access in accordance with Article 50 from the holder of the authorisation ;
Ne glede na člen 15 se lahko poskus ali preskus, namenjen za razvoj ali raziskave, vključno z raziskovalno in razvojno dejavnostjo, osredotočeno na pripravke in postopke, ki vključujejo dajanje še nedovoljenega biocidnega pripravka v promet, ali dajanje aktivne snovi v promet, ki je namenjena izključno za uporabo v biocidnem pripravku, izvedejo le, če gre za znanstveni razvoj in raziskave ali v pripravek in proces usmerjene raziskave in razvoj ter pod pogoji iz drugega in tretjega pododstavka.
By way of derogation from Article 15, an experiment or a test for the purposes of research or development , including product ‑ and process ‑oriented research and development activities, involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product may only take place in the case of scientific research and development or in the case of product and process-oriented research and development, and under the conditions laid down in the second and third subparagraphs.
Oseba sestavi in hrani pisno evidenco, ki vsebuje podroben opis biocidnega pripravka ali aktivne snovi, podatke o označevanju , dobavljene količine ter imena in naslove prejemnikov biocidnega pripravka ali aktivne snovi , ter zbere dokumentacijo, ki vsebuje vse razpoložljive podatke o možnih učinkih na zdravje človeka ali živali, ali vplivu na okolje.
The person shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data , quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance , and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment.
V primeru znanstvenega razvoja in raziskav , vključno z raziskavami in razvojem v zvezi s proizvodi ali postopki, oseba, ki namerava izvesti poskus ali preskus, pred začetkom izvajanja o tem obvesti pristojni organ.
In the case of scientific research and development, including product and process-oriented research and development , the person who intends to carry out the experiment or the test shall notify the competent authority prior to the start.
Člen 46 – odstavek 1 – pododstavek 2
Article 46 – paragraph 1 – subparagraph 2
V skladu s predlogom je pri nedovoljenih biocidnih pripravkih pred izvedbo poskusa oziroma preskusa za namene raziskav in razvoja potrebno nacionalno dovoljenje, če obstaja tveganje za sprostitev pripravka v okolje.
According to the proposal, in order to proceed with an experiment or test for the purposes of R&D, an unauthorised biocidal product which may involve release of the product into the environment requires a national authorisation before the test/experiment can be done.
To je jasna ovira inovacijam, saj pomeni izjemno dolgo čakalno dobo, preden se test lahko izvede.
This clearly constitutes a significant barrier to innovation, as it implies a very long waiting period before the test can be carried out.
Zato se določi 30-dnevno obdobje, v katerem se oceni, ali predlagani poskus oziroma preskus sproža pomisleke, obenem pa se ohrani potreba, da pristojni organ izvede predhodno oceno.
Thus, whilst maintaining the need for a prior evaluation by the competent authority, a 30 day period should be set to assess if the proposed test/experiment raises any concerns.
Člen 46 – odstavek 3 – pododstavek 1
Article 46 – paragraph 3 - subparagraph 1
Predlagatelj mora te podatke na zahtevo dati na voljo pristojnemu organu.
The applicant shall, if requested, make this information available to the competent authority .
Pravila za izvajanje poskusov oziroma preskusov v državi članici, ki ni država članica, na ozemlju katere bo biocidni pripravek dan na trg, morajo biti enaka kot pravila iz prvega odstavka istega člena.
The rules on conducting tests/experiments on the territory of a Member State, other than the one on whose market the biocidal products shall be placed, should be same as those in paragraph one of the same article.
Člen 47 – odstavek 2 – pododstavek 1
Article 47 – paragraph 2 - subparagraph 1
(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, kjer je potrebno;
(b) where relevant, the biocidal property attributed to treated articles;
(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.
(c) izjave o nevarnosti ali previdnostne izjave , navedene v dovoljenju za biocidni pripravek , če je ustrezno, ter za aktivne snovi, ki jih tretirani izdelki ali snovi izpustijo ob običajnih in predvidljivih pogojih uporabe ;
( c ) only for treated articles and where relevant, any hazard statement or precautionary statement set out in the authorisation for the biocidal product where relevant, and for all active substances intended to be released by the article or material treated in normal or foreseeable conditions of use .
Določbe o označevanju tretiranih izdelkov in snovi se ne bi smele prekrivati z obstoječimi zahtevami v sektorski zakonodaji.
The labelling provisions for treated articles and materials should not overlap with existing requirements under sectoral legislation.
Člen 47 – odstavek 2 – pododstavka 2 in 3
Article 47 – paragraph 2 – subparagraphs 2 and 3
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 tretirani izdelek ali snov daje .
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 .
Oseba, odgovorna za dajanje tretiranih izdelkov ali snovi v promet, mora imeti izjavo o certifikaciji, ki jo izda imetnik dovoljenja, za vse biocidne pripravke, ki so bili uporabljeni za tretiranje ali so bili izdelkom ali snovem dodani.
The person responsible for placing treated articles or materials on the market shall have a letter of certification issued by the holder of the authorisation in respect of all biocidal products that have been used for the treatment or that have been inserted into the articles or materials.
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 v skladu s členom 50 pridobil pisni dogovor v obliki izjave o dostopnosti;
a) the subsequent applicant has written agreement in the form of a letter of access in accordance with the requirements of Article 50 ,
Prvi predlagatelj ni nujno lastnik podatkov.
The first applicant is not necessarily the data owner.
Dovoliti je treba možnost, da zaradi delitve ali skupnega razvoja podatkov njihov solastnik postane drug predlagatelj oziroma podjetje.
Provision should also be made for cases in which a second applicant or company is or becomes joint owner of data as a result of the sharing or joint compilation of the data.
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 data.
Vse elemente podatkov s seznama iz odstavka 2 , označene z enotno kodo, agencija vnese v register za izmenjavo podatkov o biocidih skupaj z vsemi identifikacijskimi podrobnostmi in s povezavo z identiteto prvega predlagatelja in lastnika/lastnikov podatkov .
Every element of information in the list referred to in paragraph 2 , identified by a unique code, shall be entered by the Agency in the Biocides Data Sharing Register , including all the identifying details and linked to the identity of the first applicant and data owner(s) .
Register mora vsebovati vse elemente podatkov in dokumentov s seznama.
The Register should contain every element of information and documents in the list.
Numerično identificiranje posameznih dokumentov, ki so bili vloženi, je koristno za preprečitev nesporazumov glede podobnih naslovov ali sprememb študij.
A numerical identification is preferable for every document sent in order to avoid any confusion wherever titles or corrections of studies with similar names are sent.
Povezava z lastnikom podatkov in predlagateljem zagotavlja varstvo lastninskih pravic.
There should also be a link to the data owner to ensure that ownership rights are respected.
Vsak dokument, ki je prejel enkratno kodo skladno s členom 48(4), je treba posebej opremiti z datumom vnosa.
An individual date of submission shall be assigned to each document, as identified by the unique code under Article 48(4).
Direktiva št. 98/8/ES ne določa jasnih pogojev glede varstva podatkov.
Directive 98/8/EC did not clearly lay down data protection requirements.
Datum predložitve dokumentacije se ne ujema nujno z datumom predložitve vseh podatkov.
The date of submission of the dossier may not be the date of submission of all the information.
Zato je treba vsako predložitev podatkov opremiti z datumom.
This is why each submission should be assigned a date.
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 nemudoma oceni tehnično enakovrednost glede na referenčni vir .
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 whether they are technically equivalent in the light of the reference source.
Če je ocena pozitivna, pristojni organ ali agencija bodočemu predlagatelju nemudoma sporoči ime in kontaktne podatke lastnika podatkov.
If the assessment confirms the fact, the competent authority of the Agency shall communicate the name and contact details of the owner of the information to the prospective applicant.
Preden postanejo študije aktualne v okviru izmenjave podatkov, je treba ustrezno preveriti tehnično enakovrednost.
Before studies give rise to the sharing of data, appropriate checks should be carried out on technical equivalence.
V nasprotnem primeru ni mogoče določiti, ali so razpoložljivi podatki uporabni pri poznejšem predlagatelju.
Otherwise, there is no way of establishing whether the data available are applicable to the subsequent applicant.
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, in če obdobja varovanja informacij v skladu s členom 49 še niso potekla, lahko pristojni organ prejemnik ali agencija soglaša, da lahko poznejši predlagatelj v skladu s členom 52 uporablja 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 information protection periods under Article 49 have not ended, the competent authority or the Agency may agree that a subsequent applicant for authorisation may share the data provided by the first applicant in accordance with Article 52, 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.
Podobnost in tehnično enakovrednost je treba dokazati tudi v primeru, da rok za varstvo podatkov še ni potekel, poznejši predlagatelj pa bi želel izmenjati podatke.
If an applicant wishes to share data, the similarity and technical equivalence must be demonstrated even if the data protection period has not ended.
Komisija bo do 1. januarja 2016 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 2016 .
Člen 55 – odstavek 2 – pododstavek 1
Article 55 – paragraph 2 – subparagraph 1
Za razkritje naslednjih informacij običajno velja, da ogroža zaščito poslovnih interesov zadevne osebe:
Disclosure of the following information shall be deemed to undermine the protection of the commercial interests of the concerned person:
Za razkritje naslednjih informacij običajno velja, da ogroža zaščito poslovnih interesov zadevne osebe in se ne smejo razkriti javnosti :
Disclosure of the following information shall be deemed to undermine the protection of the commercial interests of the concerned person and may not be disclosed publicly :
a) podrobni podatki o celotni sestavi biocidnega pripravka;
a) details of the full composition of a biocidal product;
b) točna uporaba ali funkcija snovi ali mešanice;
b) the precise use, function or application of a substance or mixture;
c) natančna tonaža snovi ali mešanice, ki se proizvede ali da v promet;
c) the precise tonnage of the substance or mixture manufactured or placed on the market;
d) povezave med proizvajalcem aktivne snovi in osebo, odgovorno za dajanje biocidnega pripravka v promet, ali povezave med osebo, odgovorno za dajanje biocidnega pripravka v promet, in distributerji pripravka.
d) links between a manufacturer of an active substance and the person responsible for the placing of a biocidal product on the market or between the person responsible for the placing of a biocidal product on the market and the distributors of the product.
d) povezave med proizvajalcem aktivne snovi in osebo, odgovorno za dajanje biocidnega pripravka v promet, ali povezave med osebo, odgovorno za dajanje biocidnega pripravka v promet, in distributerji pripravka ;
d) links between a manufacturer of an active substance and the person responsible for the placing of a biocidal product on the market or between the person responsible for the placing of a biocidal product on the market and the distributors of the product ;
(da) proizvajalci aktivnih snovi (imena in naslovi, vključno s krajem proizvodnih obratov);
(da) manufacturers of the active substances (names and addresses including location of manufacturing sites);
(db) kraj proizvodnih obratov biocidnega pripravka;
(db) the location of a biocidal product's manufacturing site;
(dd) doziranje in navodila za uporabo .
(dd) doses and instructions for use .
Podatkom, ki jih je treba šteti za zaupne, ker so s poslovnega vidika občutljivi, je treba dodati še datum izdaje dovoljenja in njegov rok zapadlosti, doziranje in navodila za uporabo, pa še lokacijo proizvodnega obrata, kjer se izdeluje biocidni pripravek ali aktivna sestavina.
(dc) Information to be considered confidential because it is commercially sensitive should also include the date of issue of an authorisation and the expiry date, doses, instructions for use and the location of the manufacturing site of a biocidal product or active substance.
Člen se mora nanašati tudi na biocidnih pripravke, ne le na aktivne snovi.
This article should apply not just to active substances but also to biocidal products.
Člen 56 – odstavek 2 – točka (e)
Article 56 – paragraph 2 – point e
e) ob upoštevanju člena 24 Uredbe (ES) št. 1272/2008 ime po nomenklaturi IUPAC za aktivne snovi iz odstavka 1(a) tega člena, ki se uporabljajo samo za enega ali več naslednjih namenov:
e) subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for active substances referred to in paragraph 1(a) of this Article that are only used as one or more of the following:
i) pri znanstvenih raziskavah in razvoju;
i) in scientific research and development;