natgillin/translations-raw huggingface dataset:
Agencija v dveh mesecih od prejema obvestila o nesprejetju dogovora bodočemu predlagatelju dovoli uporabo preskusov ali študij, ki vključujejo preskuse na vretenčarjih.
Within two months of being informed about the failure to reach an agreement, the Agency shall give the prospective applicant the right to refer to the tests or studies involving tests on vertebrate animals.
Nacionalna sodišča odločijo o sorazmernem deležu stroškov, ki jih mora bodoči predlagatelj plačati lastniku podatkov.
National courts shall decide on the proportionate share of the cost that the prospective applicant shall pay to the data owner.
Če se dogovor ne sprejme v dveh mesecih po vložitvi zahtevka v skladu s členom 51(2), lastnik podatkov in bodoči predlagatelj o tem nemudoma obvestita agencijo.
Where no such agreement is reached two months after the request was made according to Article 51(2), both the data owner and the prospective applicant shall without delay inform the Agency thereof.
Razsodišče agencije odloči o sorazmernem deležu vseh stroškov , povezanih s pridobivanjem in uporabo informacij , ki jih mora bodoči predlagatelj plačati lastniku podatkov.
An arbitration body within the Agency shall decide on the proportionate share of all costs associated with the production and use of the information that the prospective applicant shall pay to the data owner.
V primeru, da ni možno doseči sporazuma med stranema, obe strani to sporočita agenciji, saj sta obe odgovorni za nedosego sporazuma.
If it is not possible to reach agreement between the two parties, both parties should inform the Agency, as both are responsible for the failure to agree.
Da bi se zagotovilo, da je obvezna širitev podatkov opravljena usklajeno na ravni EU, mora Komisija ustanoviti skupno razsodišče.
In order to ensure that the compulsory sharing of information proceeds in a harmonised manner at EU level, the Commission should establish an arbitration body for the Union.
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; 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 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 share the 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.
Treba je dokazati 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.
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 dostopnosti podatkov do dokumentacije, ki izpolnjuje pogoje iz Priloge II.
The competent 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 substances referred to in Annex II or are in possession of a letter of access to a dossier which complies with the requirements of Annex II.
Spoštovanje določb uredbe je treba zagotoviti z uradnimi pregledi pristojnih nacionalnih organov.
Compliance with the provisions of the Regulation must be guaranteed by official controls by the national competent authorities.
Vsako leto , z začetkom 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.
(b) informacije o zastrupitvah z biocidnimi pripravki.
(b) information on any poisonings involving biocidal products.
(b) informacije o zastrupitvah z biocidnimi pripravki ter morebitnih posledicah za zdravje občutljivih posameznikov, kot so otroci, nosečnice ali bolniki ;
(b) information on any poisonings involving biocidal products and the possible health implications for vulnerable groups, such as children, pregnant women or the sick;
Komisija bo do 1. januarja 2019 in nato vsaka tri leta 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 2019 and every three years thereafter .
Komisija na osnovi tega poročila oceni možnosti za predlaganje sprememb te uredbe.
On the basis of the report, the Commission shall assess the desirability of proposing amendments to this Regulation.
Poročilo Komisije mora biti temelj za postopek revizije, ki ima za namen čim bolj zmanjšati glavne težave.
The Commission report should be the basis for a process of revision with the aim of remedying as much as possible the main difficulties identified.
Člen 55 – odstavek 2 – točka d a (novo)
Article 55 – paragraph 2 – point d a (new)
(da) proizvajalci aktivnih snovi (imena in naslovi, vključno s krajem proizvodnih obratov);
(da) manufacturers of active substances (names and addresses including location of manufacturing sites);
Kraji proizvodnih obratov so informacije o trženju in konkurenci, zato niso za objavo.
Production sites are commercial information with implications for competition and should not be published.
Predlagatelj ima pravico zahtevati dovoljenje za številne končne uporabe proizvoda, ki morda niso že izkoriščene, zato je treba nekatere imeti v pripravljenosti za prihodnost.
Applicants have the right to seek authorisation for many final uses of a product, which however are not necessarily all used, so some of these must be reserved for future use.
Člen 55 – odstavek 2 – točka d b (novo)
Article 55 – paragraph 2 – point d b (new)
(db) kraj proizvodnih obratov biocidnega pripravka;
(db) the location of the site where a biocidal product is manufactured;
Člen 55 – odstavek 2 – točka d c (novo)
Article 55 – paragraph 2 – point d c (new)
(dc) datum dovoljenja in datum izteka dovoljenja;
(dc) date of the authorisation and its date of expiry;
Bistveno je, da nekatere informacije o predlagatelju, ki so v dovoljenju, ostanejo zaupne.
It is essential that some information contained in authorisations concerning the applicant should be treated in confidence.
Tudi datum izdaje in poteka dovoljenja sta občutljiva podatka, ki ju je treba varovati.
The date of the authorisation and its date of expiry are also sensitive information and should be protected.
Člen 55 – odstavek 2 – točka d d (novo)
Article 55 – paragraph 2 – point d d (new)
Doziranje in navodila za uporabo so odvisni od načina uporabe in od lastnosti, združenih z drugimi sestavinami, zato je nujno zagotoviti njihovo ustrezno varovanje.
Doses and instructions depend on the type of use, as well as on the intrinsic properties of the product and of the co-formulants, and it is therefore necessary to protect them adequately.
Člen 58 – odstavek 2 – prvi pododstavek – uvodni del
Article 58 – paragraph 2 – first subparagraph – introductory part
Oznaka ne sme biti zavajajoča in ne sme v nobenem primeru vsebovati navedb „biocidni pripravek z manjšim tveganjem“, „nestrupen“, „neškodljiv“ ali podobno.
Labels shall not be misleading and, in any case, shall not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or similar indications.
Poleg tega je treba na oznaki jasno in neizbrisno navesti:
In addition, the label must show clearly and indelibly the following information:
Oznaka ne sme biti zavajajoča in ne sme v nobenem primeru vsebovati navedb „nestrupen“, „neškodljiv“ ali podobno.
Labels shall not be misleading and, in any case, shall not mention the indications ‘non-toxic’, ‘harmless’ or similar indications.
Proizvajalce, ki dajejo na trg proizvode z manjšim tveganjem, je treba spodbujati in jim omogočiti, da to lahko ustrezno označijo.
Those who place low-risk products on the market should be encouraged and allowed to publicise them appropriately.
(e) navodila za uporabo in razmerje odmerka, izraženo v merskih enotah in/ali na potrošniku jasen in razumljiv način , za vsako uporabo, določeno v skladu s pogoji iz dovoljenja;
(e) directions for use and the dose rate, expressed in metric units and/or in a manner which is meaningful and comprehensible to the user , for each use provided for under the terms of the authorisation;
Člen 58 – odstavek 3 a (novo)
Article 58 – paragraph 3 a (new)
Ponuditi je treba možnost, da lahko vsi uporabniki pridobijo natančne in pravočasne informacije zaradi dopolnjevanja informacij ali da bi se jim omogočilo, da dobijo ustrezna navodila za uporabo, hranjenje in ravnanje s proizvodom.
It must be possible for all users to obtain detailed and timely information, in the interests of completeness of the information and to enable consumers to obtain the correct information about the prescribed conditions of use, keeping and treatment of the product.
Informacije na spletnem mestu dopolnijo in nudijo podrobnosti za navedbe na označbi, da uporabnikom, ki potrebujejo posebne podatke, ki se običajno pridobijo z dodatnimi zdravstvenimi nasveti, zagotovijo lahek dostop do njih.
The information on the website should supplement and add detail to the indications on the labelling, so as to ensure that users who require specific information, which can normally be obtained through additional medical consultation, can easily obtain it.
V skladu z zahtevanimi informacijami o proizvajalcih aktivnih snovi morajo tudi varnostni listi, ki so priloženi biocidnim pripravkom, vsebovati informacije, ki bodo nadzornim in pristojnim organom pomagale, da nadzorujejo poreklo snovi v proizvodih na trgu.
Consistently with the information requested concerning manufacturers of active substances, safety data sheets accompanying biocidal products too should contain such information to help the supervisory authorities and competent authorities to check the origin of the substances in products placed on the market.
Oglasi za biocidne pripravke ne predstavljajo pripravka na način, ki je zavajajoč, kar zadeva tveganje, ki ga pripravek predstavlja za zdravje ljudi ali okolje.
Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health or the environment.
V nobenem primeru oglasi za biocidni pripravek ne smejo vsebovati navedb „biocidni pripravek z manjšim tveganjem“, „nestrupen“, „neškodljiv“, ali katero drugo podobno oznako.
In any case, the advertising of a biocidal product shall not mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or any similar indication.
V nobenem primeru oglasi za biocidni pripravek ne smejo vsebovati navedb „nestrupen“, „neškodljiv“, ali katero drugo podobno oznako.
In any case, the advertising of a biocidal product shall not mention ‘non-toxic’, ‘harmless’ or any similar indication.
(d) letno pristojbino plačajo tisti, ki dajo biocidne pripravke v promet, ter
(d) an annual fee shall be paid by persons placing biocidal products on the market ; and
(d) pristojbina se naloži samo, ko je dejansko potrebna, ter
(d) the fee shall apply only when it is genuinely necessary ; and
Pristojbine se morajo nanašati na zahtevano delo in zato morajo biti sorazmerne z njim.
Fees should relate to the work requested and therefore be proportionate to it.
Člen 77 – odstavek 1– pododstavek 3
Article 77 – paragraph 1 – subparagraph 3
V odločitvi je naveden datum začetka veljavnosti vključitve v Prilogo I , in sicer dve leti po sprejetju odločitve .
The decision shall specify the date on which the inclusion in Annex I becomes effective , which shall be two years after the adoption of the decision .
V zakonodajnem besedilu bi morale biti jasno navedene ustrezne časovnice.
The legislative text should clearly state the timelines applicable.
Pristojni organi so se predhodno dogovorili o dveh letih.
Two years have previously been agreed upon by the Competent Authorities.
Člen 77 – odstavek 3– pododstavek 3
Article 77 – paragraph 3 – subparagraph 3
Biocidni pripravki, za katere vloga za dovoljenje za pripravek ni bila vložena v skladu z drugim pododstavkom, se ne dajejo več v promet, in sicer šest mesecev od datuma , ko začne veljati vključitev.
Biocidal products, for which an application for a product authorisation has not been submitted in accordance with the second subparagraph, shall no longer be placed on the market with effect from six months after the date on which the inclusion becomes effective.
S to spremembo želimo skrajšati obdobje za izključitev s trga, saj morajo uporabniki biocidnega pripravka poznati svoje obveznosti in stanje pri revizijah aktivnih snovi.
This amendment lays down shorter periods for exclusion from the market, as downstream users of the biocidal product must be informed of their obligations and of the state of revision of active substances.
Člen 77 – odstavek 4 – pododstavek 1 a (novo)
Article 77 – paragraph 4 – subparagraph 1 a (new)
Odlaganje, shranjevanje in uporaba obstoječih zalog biocidnih pripravkov, za katere je pristojni organ države članice zavrnil vlogo za dovoljenje, predloženo v skladu z odstavkom 3, ali se je odločil, da ne bo izdal dovoljenja, so dovoljeni do poteka 18 mesecev od take zavrnitve ali odločitve.
Disposal, storage and use of existing stocks of biocidal products for which the competent authority of the Member State has rejected an application for authorisation submitted under paragraph 3 or has decided not to grant authorisation are allowed until 18 months after such a rejection or a decision.
Ne glede na člen 47 se lahko tretirani izdelki in snovi, ki vsebujejo biocidne pripravke, ki niso dovoljeni v Skupnosti ali vsaj v eni državi članici in ki so bili na voljo v prometu dne ...
By way of derogation from Article 47, treated articles and materials that incorporate biocidal products which are not authorised in the Community or in at least one Member State and which were available on the market on ...
Člen 81 – odstavek 1 a (novo)
Article 81 – paragraph 1 a (new)
Odstranitev, skladiščenje in uporaba obstoječih zalog biocidnih pripravkov, ki jih pristojni organi ali Komisija niso dovolili za zadevno uporabo, so dovoljeni do poteka 12 mesecev od datuma odločitve iz prvega pododstavka člena 80(2) ali 12 mesecev od datuma iz drugega pododstavka člena 80(2), kar je pozneje.
Disposal, storage and use of existing stocks of biocidal products which are not authorised for the relevant use by the competent authority or the Commission are allowed until 12 months after the date of the decision referred to in the first subparagraph of Article 80(2) or 12 months after the date referred to in the second subparagraph of Article 80(2), whichever is the later.
Prehodni ukrepi v zvezi s snovmi, ki so v stiku z živili
Transitional measures concerning food contact materials
Vloge za izdajo dovoljenja za biocidne pripravke, ki so snovi v stiku z živili in ki so bili na voljo v prometu [UL: vstavite datum iz prvega pododstavka člena 85],
Applications for the authorisation of biocidal products which are food contact materials and which were available on the market on [OJ: insert the date referred to in the first subparagraph of Article 85] shall be submitted at the latest 1 January 2017.
Snovi, ki so v stiku z živili, ki so bile v prometu dne [UL: vstavite datum iz prvega pododstavka člena 85], za katere je bila vložena vloga v skladu z odstavkom 1, se lahko še naprej dajejo v promet do dne, ko se dovoljenje podeli ali zavrne.
Food contact materials which were available on the market on [OJ: insert the date referred to in the first subparagraph of Article 85] for which an application was submitted in accordance with paragraph 1 may continue to be placed on the market until the date of the decision granting the authorisation or refusing to grant the authorisation.
Če se dovoljenje za dajanje takšnega biocidnega pripravka v promet zavrne, se takšen biocidni pripravek preneha dajati v promet v šestih mesecih po sprejetju te odločitve.
In case of a refusal to grant an authorisation to place such biocidal product on the market, such biocidal product shall no longer be placed on the market within six months after such decision.
Snovi, ki so v stiku z živili, ki so bile na voljo v prometu dne [UL: vstavite datum iz prvega pododstavka člena 85] in za katere vloga ni bila vložena v skladu z odstavkom 1, se lahko še naprej dajejo v promet do dne šest mesecev po datumu iz odstavka 1.
Food contact materials which were available on the market on [OJ: insert the date referred to in the first subparagraph of Article 85] for which an application was not submitted in accordance with paragraph 1 may continue to be placed on the market until six months after the date referred to in paragraph 1.
Odstranitev, skladiščenje in uporaba obstoječih zalog biocidnih pripravkov, ki jih pristojni organi ali Komisija niso dovolili za zadevno uporabo, se lahko izvajajo dvanajst mesecev po datumu odločitve iz drugega pododstavka odstavka 1 ali dvanajst mesecev po datumu iz tretjega pododstavka odstavka 1, odvisno kateri datum je poznejši.
Disposal, storage and use of existing stocks of biocidal products which are not authorised for the relevant use by the competent authority or the Commission is allowed until twelve months after the date of the decision referred to in the second subparagraph of paragraph 1 or twelve months after the date referred to in the third subparagraph of paragraph 1, whichever is the later.
Člen 83 – odstavek -1 (novo)
Article 83 – paragraph -1 (new)
Samo proizvajalci, ki prispevajo sistemu, bi morali imeti možnost proizvajati in prodajati aktivne snovi, ki se uporabljajo v biocidnih pripravkih.
Only manufacturers who contribute to the system should be allowed to manufacture and market active substances intended for use in biocidal products.
To je najboljši način za soočanje s koristoljubjem (free-riding) prek ustreznega nadzora trga z aktivnimi snovmi.
This is the best way of overcoming the 'free rider' problem, by means of appropriate checks on the market for active substances.
Člen 83 – odstavek 3 a (novo)
Article 83 – paragraph 3 a (new)
Pristojni organi sprejmejo ustrezne ukrepe v skladu s členom 54(2).
The competent authorities shall adopt the necessary measures as required by Article 54(2).
Države morajo imeti obvezo, da določijo, kateri biocidni pripravki obstajajo na njihovem trgu, če je proizvajalec aktivne snovi vložili dokumentacijo za Prilogo I, in ustrezno ukrepati.
Member States should be required to establish which biocidal products exist on their market and whether the manufacturer of the active substance has submitted a dossier for Annex I, and proceed accordingly.
Člen 83 a (novo)
Article 83 a (new)
Člen 83 a
Article 83 a
Komisija Evropskemu parlamentu in Svetu v roku …* predloži poročilo o ustreznih ukrepih za spodbujanje trajnostne uporabe različnih vrst biocidnih pripravkov.
By ...*, the Commission shall submit report to the European Parliament and the Council regarding adequate measures to promote the sustainable use of biocidal products across the different product types.
Komisija na podlagi tega poročila po potrebi predstavi zakonodajne predloge.
On the basis of this report, the Commission shall present, where appropriate, legislative proposals.
*dveh let po začetku veljavnosti te uredbe.
* Two years from the entry into force of this Regulation.
Priloga III – naslov 1 – točka 3.7 – podtočka 1 a (novo)
Annex III – Title 1 - point 3.7 – subpoint 1 a (new)
Priloga V – glavna skupina 4
Annex V – Main group 4
vrsta pripravkov: -
Product-type 20: -
vrsta pripravkov: dezinfekcijska sredstva za hrano in krmo
Product-type 20: Food and feed disinfectants
Pripravki, ki se uporabljajo za dezinfekcijo hrane ali krme z nadzorom škodljivih organizmov.
Products used for disinfecting food or feedstocks by the control of harmful organisms.
Trg biocidnih pripravkov in pravna ureditev
Biocidal Products Market and Legal Regulation
Vrednost trga biocidnih pripravkov v Evropi je ocenjena na približno 890 milijonov EUR na leto, kar predstavlja približno 27 % vrednosti svetovnega trga.
The biocidal products market in Europe is estimated at c. €890m per year, comprising around 27% of the global market.
Direktiva 98/8/ES, ki zdaj ureja ta sektor, je imela dvojni namen – izboljšati varstvo okolja in zdravja.
Directive 98/8/EC, which currently regulates the sector, had the dual aim of improving environmental and health protection.
Določala je tudi sistem vzajemnega priznavanja nacionalnih postopkov odobritve ter tako omogočila promet z biocidnimi pripravki na notranjem trgu.
It also provided for a system of mutual recognition of national authorisation procedures in order to allow biocidal products to move across the internal market.
Vendar so številne težave v njeni 10-letni zgodovini (npr. čezmerni stroški, omejujoče zahteve, zamude pri odobritvah, časovna neskladja pri ocenjevanju vlog v različnih državah članicah) privedle do odobritve le ene učinkovine v veljavnem zakonodajnem okviru, v bližnji prihodnosti pa ni mogoče pričakovati izboljšanja.
However, a range of problems in its 10-year history (such as excessive cost, prohibitive requirements, authorisation time delays, time disparities in evaluations of applications in the different Member States) has led to only one active substance being approved under the current legislative framework with no better expectation in the foreseeable future.
Evropska komisija predlaga novo uredbo za poenostavitev postopkov in izboljšanje delovanja trga.
The European Commission proposes a new regulation to streamline procedures and enhance the functioning of the market.
Glavne točke vključujejo med drugim: neobvezen centralizirani postopek odobritve za biocidne pripravke z nizkim tveganjem, izboljšan postopek vzajemnega priznavanja, usklajeno strukturo pristojbin za nacionalne odobritve ter predpise za izdelke, obdelane z biocidnimi pripravki.
The main points include among others: an optional centralised authorisation procedure for "low risk" biocidal products, an improved mutual recognition procedure, a harmonised fee structure for national authorisations and regulation for articles treated with biocidal products.
Pripravljavec mnenja na splošno pozdravlja predloge Komisije in močno podpira predlagane ukrepe, zlasti poudarek na poenostavitvi postopka odobritve.
Your draftsman broadly welcomes the Commission's proposals and widely supports the proposed measures, particularly the emphasis on reducing the burden of the authorisation process.