natgillin/translations-raw huggingface dataset:
acknowledge receipt of the application in writing to the applicant within 14 days of its receipt.
v 14 dneh od prejema vlagatelju pisno potrdi prejem njegove vloge.
The acknowledgement shall state the date of receipt of the application;
V potrditvi navede datum prejema vloge,
inform the Authority without delay;
nemudoma obvesti Agencijo
make the application and any supplementary information supplied by the applicant available to the Authority;
poskrbi, da so vloga in vsi dodatni podatki, ki jih posreduje vlagatelj, na voljo Agenciji;
the Authority shall without delay inform the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them.
Agencija nemudoma obvesti druge države članice in Komisijo o vlogi in poskrbi, da so jim vloga in vsi dodatni podatki, ki jih posreduje vlagatelj, na voljo.
The Authority shall publish detailed guidelines concerning the preparation and the submission of the application [11].
Agencija objavi smernice s podrobnostmi glede priprave in predložitve vloge [11].
Opinion of the Authority
Mnenje Agencije
The Authority shall give an opinion within six months of the receipt of a valid application, as to whether, under the intended conditions of use of the material or article in which it is used, the substance complies with the safety criteria laid down in Article 3 and, where they apply, Article 4.
Agencija v šestih mesecih od prejema veljavne vloge posreduje mnenje o tem, ali je v predvidenih okoliščinah uporabe materiala ali izdelka, v katerem se uporablja, snov skladna z varnostnimi merili, določenimi v členu 3 in, kjer se uporablja, 4.
The Authority may extend the said period by a maximum period of a further six months.
Agencija lahko navedeno obdobje podaljša za največ šest mesecev.
In such a case it shall provide an explanation for the delay to the applicant, the Commission and the Member States.
V tem primeru vlagatelju, Komisiji in državam članicam obrazloži odlog.
The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a time limit specified by the Authority.
Če je to primerno, lahko Agencija od vlagatelja zahteva, da dopolni podrobnosti, priložene k vlogi, do roka, ki ga določi sama.
Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until that information has been provided.
Če Agencija zahteva dodatne informacije, se rok, določen v odstavku 1, začasno ustavi, dokler se te informacije ne posredujejo.
Similarly, the time limit shall be suspended for the time allowed the applicant to prepare oral or written explanations.
Prav tako se rok začasno ustavi za čas, ki se vlagatelju odobri za pripravo ustnih in pisnih pojasnil.
In order to prepare its opinion, the Authority shall:
Da bi oblikovala svoje mnenje, Agencija:
verify that the information and documents submitted by the applicant are in accordance with Article 9(1)(a), in which case the application shall be regarded as valid, and examine whether the substance complies with the safety criteria laid down in Article 3 and, where they apply, Article 4;
preveri, ali so informacije in dokumenti, ki jih je predložil vlagatelj, v skladu s členom 9(1)(a) in v tem primeru se vloga šteje za veljavno, in preveri, ali je snov v skladu z varnostnimi merili, določenimi v členu 3 in, kjer se uporablja, 4;
inform the applicant, the Commission and the Member States if an application is not valid.
če vloga ni veljavna, obvesti vlagatelja, Komisijo in države članice.
In the event of an opinion in favour of authorising the evaluated substance, the opinion shall include:
Če je mnenje za odobritev ocenjene snovi pozitivno, vsebuje:
the designation of the substance including its specifications;
oznako snovi, vključno z njenimi specifikacijami
where appropriate, recommendations for any conditions or restrictions of use for the evaluated substance and/or the material or article in which it is used;
kjer je to primerno, priporočila za katere koli pogoje ali omejitve uporabe ocenjene snovi in/ali materiala ali izdelka, kjer je uporabljen
an assessment as to whether the analytical method proposed is appropriate for the intended control purposes.
oceno o tem, ali je predlagana analitična metoda ustrezna za predvidene namene nadzora.
The Authority shall forward its opinion to the Commission, the Member States and the applicant.
Agencija svoje mnenje posreduje Komisiji, državam članicam in vlagatelju.
The Authority shall make its opinion public, after deletion of any information identified as confidential, in accordance with Article 20.
Agencija svoje mnenje objavi po izbrisu vseh informacij, ki so v skladu s členom 20 opredeljene kot zaupne.
Community authorisation
Dovoljenje Skupnosti
The Community authorisation of a substance or substances shall take place in the form of the adoption of a specific measure.
Dovoljenje Skupnosti za eno ali več snovi poteka v obliki sprejetja posebnih ukrepov.
The Commission shall, where appropriate, prepare a draft of a specific measure, as referred to in Article 5, to authorise the substance or substances evaluated by the Authority and specify or change the conditions of its or their use.
Komisija pripravi, kjer je to primerno, osnutek posebnega ukrepa iz člena 5 za odobritev ene ali več snovi, ki jih oceni Agencija, in opredeli ali spremeni pogoje za njeno oziroma njihovo uporabo.
The draft specific measure shall take into account the opinion of the Authority, relevant provisions of Community law and other legitimate factors relevant to the matter under consideration.
Osnutek posebnega ukrepa upošteva mnenje Agencije, ustrezne določbe iz prava Skupnosti in druge legitimne dejavnike, vezane na zadevo, ki se obravnava.
Where the draft specific measure is not in accordance with the opinion of the Authority, the Commission shall provide without delay an explanation for the reasons for the differences.
Če osnutek posebnega ukrepa ni usklajen z mnenjem Agencije, Komisija nemudoma predloži obrazložitev o razlogih za odstopanja.
If the Commission does not intend to prepare a draft specific measure after a favourable opinion by the Authority, it shall inform the applicant without delay and provide the applicant with an explanation.
Če po pozitivnem mnenju Agencije Komisija ne namerava pripraviti osnutka posebnega ukrepa, mora nemudoma o tem obvestiti vlagatelja in mu predložiti ustrezno obrazložitev.
Community authorisation in the form of a specific measure, as referred to in paragraph 1, shall be adopted in accordance with the procedure referred to in Article 23(2).
Odobritev Skupnosti v obliki posebnega ukrepa iz odstavka 1 se sprejme v skladu s postopkom iz člena 23(2).
After the authorisation of a substance in accordance with this Regulation, any business operator using the authorised substance or materials or articles containing the authorised substance shall comply with any condition or restriction attached to such authorisation.
Po odobritvi snovi v skladu s to uredbo mora kateri koli nosilec dejavnosti, ki uporablja odobreno snov oziroma materiale ali izdelke, ki vsebujejo odobreno snov, izpolnjevati vse pogoje ali omejitve, vezane na dovoljenje.
The applicant or any business operator using the authorised substance or materials or articles containing the authorised substance shall immediately inform the Commission of any new scientific or technical information, which might affect the safety assessment of the authorised substance in relation to human health.
Vlagatelj ali kateri koli nosilec dejavnosti, ki uporablja odobreno snov oziroma materiale ali izdelke, ki vsebujejo odobreno snov, Komisijo takoj obvesti o morebitnih novih znanstvenih ali tehničnih podatkih, ki bi utegnili vplivati na ocenitev varnosti odobrene snovi v zvezi z zdravjem ljudi.
If necessary, the Authority shall then review the assessment.
Če je to potrebno, Agencija nato ponovno preuči prvotno oceno.
The granting of an authorisation shall not affect the general civil and criminal liability of any business operator in respect of the authorised substance, the material or article containing the authorised substance, and the food that is in contact with such material or article.
Izdaja dovoljenja ne vpliva na splošno civilno in kazensko odgovornost katerega koli nosilca dejavnosti v zvezi z odobreno snovjo oziroma materiali ali izdelki, ki vsebujejo odobreno snov, in živili, ki so v stiku s takimi materiali ali izdelki.
Modification, suspension and revocation of authorisation
Sprememba, prekinitev in preklic dovoljenja
The applicant or any business operator using the authorised substance or materials or articles containing the authorised substance may, in accordance with the procedure laid down in Article 9(1), apply for modification of the existing authorisation.
Vlagatelj ali kateri koli nosilec dejavnosti, ki uporablja odobreno snov oziroma materiale ali izdelke, ki vsebujejo odobreno snov, lahko v skladu s postopkom iz člena 9(1) zaprosi za spremembo veljavnega dovoljenja.
The application shall be accompanied by the following:
Vlogi se priloži naslednje:
a reference to the original application;
sklicevanje na izvirno vlogo;
a technical dossier containing the new information in accordance with the guidelines referred to in Article 9(2);
tehnična dokumentacija z novimi podatki v skladu s smernicami iz člena 9(2);
a new complete summary of the technical dossier in a standardised form.
nov celoten povzetek tehnične dokumentacije v standardizirani obliki.
On its own initiative or following a request from a Member State or the Commission, the Authority shall evaluate whether the opinion or the authorisation is still in accordance with this Regulation, in accordance with the procedure laid down in Article 10, where applicable.
Na lastno pobudo ali v odgovor na zahtevo katere izmed držav članic ali Komisije Agencija v skladu s postopkom iz člena 10, kjer se uporablja, oceni, ali sta mnenje ali odobritev še vedno usklajena s to uredbo.
The Authority may, where necessary, consult the applicant.
Agencija se lahko, če je potrebno, posvetuje z vlagateljem.
The Commission shall examine the opinion of the Authority without delay and prepare a draft specific measure to be taken.
Komisija nemudoma pregleda mnenje Agencije in pripravi osnutek posebnega ukrepa, ki naj se sprejme.
A draft specific measure modifying an authorisation shall specify any necessary changes in the conditions of use and, if any, in the restrictions attached to that authorisation.
Osnutek posebnega ukrepa, ki spremeni dovoljenje, mora podrobno opredeliti vse potrebne spremembe v pogojih za uporabo in v morebitnih omejitvah, vezanih na dovoljenje.
A final specific measure on the modification, suspension or revocation of the authorisation shall be adopted in accordance with the procedure referred to in Article 23(2).
V skladu s postopkom iz člena 23(2) se sprejme dokončni posebni ukrep o spremembi, prekinitvi ali preklicu dovoljenja.
Competent authorities of Member States
Pristojni organi držav članic
Each Member State shall notify to the Commission and to the Authority the name and address, as well as a contact point, of the national competent authority or authorities designated to be responsible in its territory for receiving the application for authorisation referred to in Articles 9 to 12.
Vsaka država članica Komisiji in Agenciji sporoči ime in naslov ter točko za stik pristojnega organa oziroma pristojnih organov, ki so znotraj njenega ozemlja določeni kot odgovorni za sprejem vloge za odobritev iz členov 9 do 12.
The Commission shall publish the name and address of the national competent authorities as well as the contact points notified in accordance with this Article.
V skladu s tem členom Komisija objavi ime in naslov pristojnih nacionalnih organov in točke za stik.
Administrative review
Upravno preverjanje
Any act adopted under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.
Komisija lahko na lastno pobudo ali v odgovor na zahtevo katere izmed držav članic oziroma katere koli neposredno in posamično prizadete osebe preveri kateri koli akt, sprejet na podlagi pooblastil, ki jih ima Agencija po tej uredbi, oziroma preveri neizvajanje teh pooblastil.
To this effect a request shall be submitted to the Commission within two months from the day on which the party concerned became aware of the act or omission in question.
Prizadeta stranka za to predloži Komisiji zahtevek v roku dveh mesecev od dneva, ko je zvedela za tak akt oziroma opustitev.
The Commission shall take a decision within two months requiring, if appropriate, the Authority to undo its act or to remedy its failure to act.
Komisija odloči v roku dveh mesecev in, kadar je to primerno, od Agencije zahteva, da odpravi svoj akt ali popravi opustitev.
Without prejudice to the specific measures referred to in Article 5, materials and articles, which are not yet in contact with food when placed on the market, shall be accompanied by:
Brez poseganja v posebne ukrepe iz člena 5 morajo biti materiali in izdelki, ki še niso v stiku z živili in kadar se dajejo v promet, opremljeni:
the words ‘for food contact’, or a specific indication as to their use, such as coffee machine, wine bottle, soup spoon, or the symbol reproduced in Annex II;
z besedilom „za stik s živili“ ali s posebno oznako, kar zadeva njihovo uporabo, kakršen je avtomat za kavo, steklenica za vino, jušna žlica ali znak, ki je ponatisnjen v Prilogi II,
if necessary, special instructions to be observed for safe and appropriate use;
če je to potrebno, s posebnimi navodili, ki jih je treba upoštevati za varno in ustrezno uporabo,
the name or trade name and, in either case, the address or registered office of the manufacturer, processor, or seller responsible for placing on the market established within the Community;
z imenom ali blagovno znamko in, v obeh primerih, naslovom ali sedežem proizvajalca, predelovalca ali prodajalca, odgovornega za dajanje v promet, ki ima sedež v Skupnosti,
adequate labelling or identification to ensure traceability of the material or article, as described in Article 17;
ustrezno etiketo ali identifikacijsko oznako, ki bo omogočala slediti materialu ali izdelku iz člena 17,
in the case of active materials and articles, information on the permitted use or uses and other relevant information such as the name and quantity of the substances released by the active component so as to enable food business operators who use these materials and articles to comply with any other relevant Community provisions or, in their absence, national provisions applicable to food, including the provisions on food labelling.
pri aktivnih materialih ali izdelkih s podatki o dovoljeni uporabi ali uporabah in drugimi pomembnimi informacijami, kot na primer ime in količina snovi, ki jih sprosti sestavina aktivnega materiala, ki bodo omogočile nosilcem živilske dejavnosti, ki uporabljajo te materiale in izdelke, izpolnjevanje vseh drugih ustreznih predpisov Skupnosti oziroma, če teh ni, nacionalnih predpisov, ki se uporabljajo za živila, vključno z določbami o označevanju živil.
The information referred to in paragraph 1(a) shall not, however, be obligatory for any articles which, because of their characteristics, are clearly intended to come into contact with food.
Podatki iz odstavka 1(a) niso obvezni za vse izdelke, ki so zaradi svojih značilnosti nedvoumno namenjeni stiku z živili.
The information required by paragraph 1 shall be conspicuous, clearly legible and indelible.
Podatki, ki jih predpisuje odstavek 1, morajo biti dobro vidni, razločno čitljivi in neizbrisni.
Retail trade in materials and articles shall be prohibited if the information required under paragraph (1)(a), (b) and (e) is not given in a language easily understood by purchasers.
Trgovina na drobno z materiali in izdelki je prepovedana, če podatki, ki jih določa odstavek (1)(a), (b) in (e) niso navedeni v jeziku, ki ga kupci lahko razumejo.
Within its own territory, the Member State in which the material or article is marketed may, in accordance with the rules of the Treaty, stipulate that those labelling particulars shall be given in one or more languages which it shall determine from among the official languages of the Community.
V skladu s določbami Pogodbe lahko država članica, kjer se material ali izdelek trži, za svoje ozemlje določi, da bodo podatki na oznaki navedeni v enem ali več jezikih, ki jih bo izbrala med uradnimi jeziki Skupnosti.
Paragraphs 4 and 5 shall not preclude the labelling particulars from being indicated in several languages.
Odstavka 4 in 5 ne izključujeta možnosti, da se podatki na oznakah navedejo v več jezikih.
At the retail stage, the information required under paragraph 1 shall be displayed on:
Pri prodaji na drobno morajo biti podatki iz odstavka 1 prikazani na:
the materials and articles or on their packaging;
materialih in izdelkih ali njihovi ovojnini;
labels affixed to the materials and articles or to their packaging;
oznakah, pritrjenih na materialih in izdelkih ali na njihovi ovojnini;
a notice in the immediate vicinity of the materials and articles and clearly visible to purchasers; for the information referred to in paragraph 1(c), however, this option shall be open only if, for technical reasons, that information or a label bearing it cannot be affixed to the materials and articles at either the manufacturing or the marketing stage.
obvestilu v neposredni bližini materialov in izdelkov, ki ga kupci jasno vidijo; pri podatkih iz odstavka 1(c) se sme ta možnost uporabiti samo, kadar teh podatkov ali oznak, na katerih so navedeni, iz tehničnih razlogov v fazi izdelave ali trženja ni mogoče pritrditi na materiale in izdelke.
At the marketing stages other than the retail stage, the information required by paragraph 1 shall be displayed on:
V fazah trženja, razen v fazi prodaje na drobno, morajo biti podatki iz odstavka 1 prikazani na:
the accompanying documents;
spremnih dokumentih;
the labels or packaging;
oznakah ali ovojnini;
the materials and articles themselves.
samih materialih in izdelkih.
The information provided for in paragraph 1(a), (b) and (e) shall be confined to materials and articles which comply with:
Podatki iz odstavka 1(a), (b) in (e) so omejeni na materiale in izdelke, ki so v skladu:
the criteria laid down in Article 3 and, where they apply, Article 4;
z merili, ki jih določa člen 3, in kjer se uporablja, člen 4,
the specific measures referred to in Article 5 or, in their absence, with any national provisions applicable to these materials and articles.
s posebnimi ukrepi iz člena 5 ali, če teh ni, z vsemi nacionalnimi predpisi, ki se uporabljajo za te materiale in izdelke.
Declaration of compliance
Izjava o skladnosti
The specific measures referred to in Article 5 shall require that materials and articles covered by those measures be accompanied by a written declaration stating that they comply with the rules applicable to them.
Posebni ukrepi iz člena 5 zahtevajo, da se materialom in izdelkom, ki jih ti ukrepi zajemajo, priloži pisna izjava, da so skladni s predpisi, ki se zanje uporabljajo.
Appropriate documentation shall be available to demonstrate such compliance.
Za ocenjevanje skladnosti je na voljo ustrezna dokumentacija.
That documentation shall be made available to the competent authorities on demand.
Ta dokumentacija je dana na voljo pristojnim organom na njihovo zahtevo.
In the absence of specific measures, this Regulation shall not prevent Member States from retaining or adopting national provisions for declarations of compliance for materials and articles.
Ob odsotnosti posebnih ukrepov ta uredba ne preprečuje državam članicam ohraniti ali sprejeti nacionalne predpise za izjave o skladnosti za materiale in izdelke.
Traceability
Sledljivost
The traceability of materials and articles shall be ensured at all stages in order to facilitate control, the recall of defective products, consumer information and the attribution of responsibility.
Sledenje materialov in izdelkov je v vseh fazah zagotovljeno zaradi lažjega nadzora, umika neustreznih izdelkov, obveščanja potrošnikov in določanja odgovornosti.
With due regard to technological feasibility, business operators shall have in place systems and procedures to allow identification of the businesses from which and to which materials or articles and, where appropriate, substances or products covered by this Regulation and its implementing measures used in their manufacture are supplied.
Ob upoštevanju tehnološke izvedljivosti morajo nosilci dejavnosti vzpostaviti sisteme in postopke za določitev dejavnosti, iz katerih in za katere so bili dostavljeni materiali ali izdelki in, kjer je to primerno, snovi oziroma proizvodi, zajeti s to uredbo in z njenimi izvedbenimi ukrepi, ki so bili uporabljeni za njihovo proizvodnjo.
That information shall be made available to the competent authorities on demand.
Ti podatki so na voljo pristojnim organom na njihovo zahtevo.
The materials and articles which are placed on the market in the Community shall be identifiable by an appropriate system which allows their traceability by means of labelling or relevant documentation or information.
Materiali in izdelki, ki so dani v promet znotraj Skupnosti, so prepoznavni z ustreznim sistemom, ki omogoča, da se sledijo na podlagi označevanja ali ustrezne dokumentacije oziroma ustreznih informacij.
When a Member State, as a result of new information or a reassessment of existing information has detailed grounds for concluding that the use of a material or article endangers human health, although it complies with the relevant specific measures, it may temporarily suspend or restrict application of the provisions in question within its territory.
Kadar država članica kot posledico novih podatkov ali ponovne presoje obstoječih podatkov podrobno utemelji, da uporaba materiala ali izdelka, čeprav je v skladu z ustreznimi posebnimi ukrepi, ogroža zdravje ljudi, lahko na svojem ozemlju začasno prekine ali omeji uporabo teh določb.
It shall immediately inform the other Member States and the Commission and give reasons for the suspension or restriction.
O tem takoj obvesti druge države članice in Komisijo ter navede vzroke za prekinitev ali omejitev.
The Commission shall examine as soon as possible, where appropriate after obtaining an opinion from the Authority, within the Committee referred to in Article 23(1) the grounds adduced by the Member State referred to in paragraph 1 and shall deliver its opinion without delay and take appropriate measures.
Komisija v okviru odbora iz člena 23(1) in, kjer je to potrebno, po pridobitvi mnenja Agencije čim prej preuči utemeljitve, opredeljene v odstavku 1 tega člena, ki jih je navedla država članica, ter brez odloga da svoje mnenje in sprejme primerne ukrepe.
If the Commission considers that amendments to the relevant specific measures are necessary in order to remedy the difficulties referred to in paragraph 1 and to ensure the protection of human health, those amendments shall be adopted in accordance with the procedure referred to in Article 23(2).
Če Komisija meni, da so potrebne spremembe posebnih ukrepov za odpravo težav iz odstavka 1 in zagotovitev varovanja zdravja ljudi, navedene spremembe sprejme v skladu s postopkom iz člena 23(2).
The Member State referred to in paragraph 1 may retain the suspension or restriction until the amendments referred to in paragraph 3 have been adopted or the Commission has declined to adopt such amendments.
Država članica iz odstavka 1 lahko ohrani prekinitev ali omejitev, dokler spremembe iz odstavka 3 niso sprejete ali do odločitve Komisije o zavrnitvi sprejema teh sprememb.
Applications for authorisation, supplementary information from applicants and opinions from the Authority, excluding confidential information, shall be made accessible to the public in accordance with Articles 38, 39 and 41 of Regulation (EC) No 178/2002.
Vloge za odobritev, dodatne informacije vlagateljev in mnenja Agencije, razen zaupnih informacij, so dostopne javnosti v skladu s členi 38, 39 in 41 Uredbe (ES) št. 178/2002.