natgillin/translations-raw huggingface dataset:
Če predlagatelj zahtevanih informacij ne predloži v roku, agencija vlogo zavrne in o tem obvesti predlagatelja.
The Agency shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant thereof.
Na podlagi člena 68 se lahko proti odločitvam agencije na podlagi tretjega pododstavka odstavka 4 vloži pritožba.
An appeal may be brought, in accordance with Article 68, against Agency decisions under the third subparagraph of paragraph 4.
Če agencija na podlagi validacije, opravljene v skladu z odstavkom 3, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja in ocenjevalni pristojni organ.
If the Agency considers, on basis of the validation made pursuant to paragraph 3, that the application is complete, it shall without delay inform the applicant and the evaluating competent authority thereof.
Na podlagi razpoložljivih informacij in potrebe po pregledu ugotovitev prvotne ocene vloge za vključitev v Prilogo I, ocenjevalni pristojni organ, ki je opravil prvotno oceno vloge za vključitev v Prilogo I, v enem mesecu po validaciji iz člena 11 odloči, ali je potrebna popolna ocena vloge za obnovitev.
On the basis of the available information and the need to review the conclusions of the initial evaluation of the application for inclusion in Annex I, the evaluating competent authority that carried out the initial evaluation shall, within one month after the validation referred to in Article 11, decide whether a full evaluation of the application for renewal is necessary.
Če se ocenjevalni pristojni organ, odloči, da je potrebna popolna ocena vloge, se ocenjevanje opravi v skladu z odstavki 1 do 4 člena 8.
If the evaluating competent authority decides that a full evaluation of the application is necessary, the evaluation shall be carried out in accordance with paragraphs 1 to 4 of Article 8.
Odločitev o vlogi se sprejme v skladu z odstavki 5, 6 in 7 tega člena.
The decision on the application shall be adopted in accordance with paragraphs 5, 6 and 7 of this Article.
Če ocenjevalni pristojni organ, ki je opravil prvotno oceno vloge, odloči, da popolna ocena vloge ni potrebna, v šestih mesecih po validaciji pripravi in predloži agenciji priporočilo za obnovitev vključitve aktivne snovi v Prilogo I.
If the evaluating competent authority decides that a full evaluation of the application is not necessary, it shall, within six months, prepare and submit to the Agency a recommendation on the renewal of the inclusion of the active substance in Annex I.
Pred predložitvijo priporočila agenciji da ocenjevalni pristojni organ predlagatelju možnost, da v enem mesecu pisno ali ustno predloži opombe k priporočilu.
Prior to submitting the recommendation to the Agency, the evaluating competent authority shall provide the applicant with an opportunity to provide written or oral comments on the recommendation within one month.
Ocenjevalni pristojni organ te opombe ustrezno upošteva pri zaključevanju svojega priporočila.
The evaluating competent authority shall take due account of these comments when finalising its recommendation.
Ko agencija prejme priporočilo s strani ocenjevalnega pristojnega organa, ga da na voljo Komisiji, pristojnim organom drugih držav članic in predlagatelju ter jim da na voljo tri mesece za predložitev pisnih opomb.
On receipt of the recommendation from the evaluating competent authority, the Agency shall make it available to the Commission, the competent authorities of other Member States and the applicant and allow a period of three months during which they may submit written comments to it.
Komisija lahko zaprosi agencijo za mnenje o znanstvenih ali tehničnih vprašanjih, ki jih postavi pristojni organ, ki ugovarja priporočilu iz odstavka 2.
The Commission may ask the Agency for an opinion on scientific or technical matters raised by a competent authority objecting to the recommendation referred to in paragraph 2.
Agencija poda mnenje v šestih mesecih od datuma, ko je prejela vprašanje.
The Agency shall issue an opinion within six months from the date on which the matter was referred to it.
Komisija ob koncu obdobja iz odstavka 3 ali ob prejemu mnenja agencije
at the end of the period referred to in paragraph 3 or on receipt of the opinion of the Agency, the Commission shall adopt
z delegiranimi akti v skladu s členom 73 in pod pogoji iz členov 74 in 75
, by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75,
sprejme odločitev glede obnovitve vključitve aktivne snovi v Prilogo I. ▌
a decision concerning the renewal of the inclusion of the active substance in Annex I. ▌
Če je verjetno, da se bo vključitev aktivne snovi v Prilogo I zaradi razlogov, na katere predlagatelj nima vpliva, iztekla, preden bo sprejeta odločitev o njeni obnovitvi, sprejme Komisija skladno s postopkom iz člena 76(2) odločitev o odložitvi datuma poteka vključitve za čas, ki je potreben za preučitev vloge.
Where, for reasons beyond the control of the applicant, the inclusion of the active substance in Annex I is likely to expire before a decision has been taken on its renewal, the Commission shall, in accordance with the procedure referred to in Article 76(2), adopt a decision postponing the expiry date of inclusion for a period sufficient to enable it to examine the application.
Če Komisija odloči, da vključitve aktivne snovi v Prilogo I ne obnovi, lahko odobri prehodno obdobje za odstranitev, skladiščenje, dajanje v promet in uporabo obstoječih zalog biocidnih pripravkov, ki vsebujejo navedeno aktivno snov.
Where the Commission decides not to renew the inclusion of an active substance in Annex I, it may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks of biocidal products containing that active substance.
Prehodno obdobje ne sme presegati šest mesecev za dajanje v promet in dodatnih največ dvanajst mesecev za odstranitev, skladiščenje in uporabo obstoječih zalog biocidnih pripravkov, ki vsebujejo navedeno aktivno snov.
The period of grace shall not exceed six months for the placing on the market and an additional maximum of twelve months for the disposal, storage, and use of existing stocks of the biocidal products containing that active substance.
Če se ti znaki potrdijo, Komisija
Where those indications are confirmed, the Commission shall adopt
sprejme odločitev o spremembi vključitve aktivne snovi v Prilogo I ali pa jo iz navedene priloge odstrani.
a decision amending the entry of an active substance in Annex I or removing it from that Annex.
Če Komisija aktivno snov odstrani iz Priloge I, lahko odobri prehodno obdobje za odstranitev, skladiščenje, dajanje v promet in uporabo obstoječih zalog biocidnih pripravkov, ki vsebujejo navedeno aktivno snov.
Where the Commission removes the entry of an active substance from Annex I, it may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks of biocidal products containing that active substance.
Za zagotovitev nemotenega delovanja postopkov za obnovo ali podaljšanje
In order to ensure the smooth functioning of the renewal and review procedures,
podrobne ukrepe
detailed measures
z delegiranimi akti v skladu s členom 73 in pod pogoji iz členov 74 in 75
by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75
Biocidni pripravki se ne smejo dati v promet ali uporabljati, če jim ni bilo izdano dovoljenje v skladu s to uredbo.
No biocidal product may be placed on the market or used unless an authorisation has been issued for that biocidal product in accordance with this Regulation.
imetnik dovoljenja,
the authorisation holder.
odgovorna za dajanje biocidnega pripravka v promet v določeni državi članici oziroma v Uniji.
responsible for the placing on the market of a biocidal product in a particular Member State or in the Union.
Vloga za dovoljenje ▌se vloži pri Agenciji.
Application for ▌authorisation shall be submitted to the Agency.
Ko predlagatelj vloži vlogo za nacionalno dovoljenje, v dogovoru z zadevno državo članico, na ozemlju katere bo veljalo to dovoljenje, v vlogi, kot je določeno v členu 22, navede organ, pristojen za ocenjevanje in odločanje o vlogi (v nadaljevanju: sprejemni pristojni organ).
When an applicant submits an application for national authorisation, that applicant shall, with the agreement of the Member State concerned on whose territory the national authorisation would be applicable, identify in the application itself, as laid down in Article 22, the competent authority of the Member State of his choice which shall be responsible for the evaluation of, and decision on, the application (hereinafter the ‘receiving competent authority’).
Imetnik dovoljenja ima stalno poslovalnico v Uniji.
Authorisation holders shall have a permanent office within the Union.
Dovoljenje se lahko izda za enotno formulacijo pripravka ali pa za okvirno formulacijo.
An authorisation may be granted for a unique product formulation or for a frame formulation.
Dovoljenje se izda za največ deset let.
An authorisation shall be granted for a maximum period of 10 years.
Biocidni pripravki se uporabljajo pravilno.
Biocidal products shall be used properly.
Pravilna uporaba vključuje skladnost s pogoji izdaje dovoljenja, določenimi v členu 16, in z zahtevami za označevanje iz člena 58.
Proper use shall include compliance with the conditions for granting an authorisation established in Article 16 and labelling requirements laid down in Article 58.
Pravilna uporaba vključuje tudi racionalno uporabo kombinacije fizikalnih, bioloških, kemijskih ali drugih ukrepov, kakor je primerno, pri čemer je uporaba biocidnih pripravkov omejena na najmanjšo potrebno mero.
Proper use shall also involve the rational application of a combination of physical, biological, chemical or other measures as appropriate, whereby the use of biocidal products is limited to the minimum necessary.
Napad škodljivih organizmov je treba preprečiti z ustreznimi odvračilnimi ukrepi, da se ti organizmi izkoreninijo ali odženejo.
Infestation with harmful organisms shall be avoided by suitable measures of deterrence to banish or repel such organisms.
Poleg tega je treba sprejeti druge varnostne ukrepe, na primer ustrezno skladiščenje blaga, upoštevanje higienskih standardov in takojšnje odstranjevanje odpadkov.
In addition, other precautionary steps shall be taken, such as proper warehousing of goods, compliance with hygiene standards and immediate disposal of waste.
Samo če ti ukrepi niso učinkoviti, je treba sprejeti nadaljnje ukrepe.
Only if those measures show no effect shall further steps be taken.
Biocidni pripravki, ki predstavljajo majhno tveganje za ljudi, živali in okolje, se vedno uporabijo pred drugimi.
Biocidal products that pose low risks for humans, animals and the environment shall always be used in preference to others.
Biocidni pripravki, ki bi ubili ali uničili živali, ki so sposobne čutiti bolečino in stisko, ali jim škodovali, se uporabijo samo v skrajni sili.
Biocidal products that are intended to harm, kill or destroy animals that are capable of experiencing pain and distress shall be applied only as a last resort.
Z okvirno direktivo za ukrepanje Unije se vzpostavijo in izvajajo obvezni ukrepi, s katerimi bi dosegli trajnostno profesionalno uporabo biocidnih pripravkov, vključujejo pa uvedbo nacionalnih akcijskih načrtov, celostno zatiranje škodljivcev, ukrepe za zmanjševanje tveganja ter spodbujanje alternativnih možnosti.
Mandatory measures shall be established through a framework directive for Union action and thereafter implemented in order to achieve the sustainable professional use of biocidal products including the introduction of National Action Plans, integrated pest management, risk-reduction measures and the promotion of alternatives.
Dve leti po začetku veljavnosti te uredbe.
Two years after entry into force of this Regulation.
poda predlog za tako okvirno direktivo Evropskemu parlamentu in Svetu.
, the Commission shall submit a proposal for such a framework directive to the European Parliament and the Council.
Biocidni pripravek se lahko dovoli samo, če so izpolnjeni naslednji pogoji:
A biocidal product shall be authorised only if the following conditions are met:
so aktivne snovi, ki jih vsebuje, vključene v Prilogo I in so izpolnjeni vsi pogoji, ki so za navedene aktivne snovi vključeni v isto prilogo;
the active substances included therein are listed in Annex I and any conditions included in that Annex together with those active substances are complied with;
se v skladu s splošnimi načeli za oceno dokumentacije, določenimi v Prilogi VI, ugotovi, da biocidni pripravek tedaj, ko se uporablja, kot je dovoljeno in ob upoštevanju dejavnikov iz odstavka 2, izpolnjuje naslednja merila:
it is established according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised and having regard to the factors referred to in paragraph 2, complies with the following criteria:
je dovolj učinkovit;
it is sufficiently effective;
nima nesprejemljivih učinkov na ciljne organizme, predvsem nesprejemljive odpornosti ali navzkrižna rezistence ali nepotrebnega trpljenja in bolečine pri vretenčarjih;
it has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates;
sam po sebi ali njegovi ostanki
immediate or delayed harmful effect
na zdravje ▌živali
, or animal health
neposredno ali prek pitne vode (ob upoštevanju snovi, nastalih pri obdelavi vode), hrane, krme ali zraka ali posledic na delovnem mestu ali preko drugih neposrednih učinkov, ob upoštevanju ugotovljenih kumulativnih in sinergijskih učinkov, kadar so na voljo znanstvene metode za ocenjevanje takšnih učinkov, ki jih priznava agencija
, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Agency to assess such effects are available
nima sam po sebi ali njegovi ostanki nesprejemljivih učinkov na okolje, pri čemer je treba predvsem upoštevati naslednje:
it has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations:
njegovo razgradnjo in porazdelitev v okolju,
its fate and distribution in the environment;
onesnaženje površinskih voda (vključno s somornico in morsko vodo), podtalnice in pitne vode, zraka ter tal
contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil
ob upoštevanju lokacij, oddaljenih od kraja uporabe snovi zaradi prenosa v okolju na velike razdalje
, taking into account locations distant from its use following long-range environmental transportation
vpliv na neciljne organizme;
its impact on non-target organisms;
njegov vpliv na biološko raznovrstnost in ekosistem;
its impact on biodiversity and the ecosystem;
kemijsko identiteto
chemical identity
, količino in tehnično enakovrednost aktivnih snovi v biocidnem pripravku, in kadar je to primerno, vse toksikološko ali ekotoksikološko pomembne nečistote in neaktivne snovi ter
, the quantity and the technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant impurities and non-active substances, and its
metabolite in
metabolites and
ostanke toksikološkega in okoljskega pomena, ki so posledica dovoljene uporabe;
residues of toxicological or environmental significance, which result from uses that are to be authorised, can be determined according to the relevant requirements in Annexes II and III;
Pri ocenjevanju, ali biocidni pripravek izpolnjuje merila iz točke (b) odstavka 1, se upoštevajo zlasti naslednji dejavniki:
The evaluation of the compliance of the biocidal product with the criteria set out in point (b) of paragraph 1 shall take into account the following factors:
vsi običajni pogoji, v katerih se biocidni pripravek lahko uporablja;
all normal conditions under which the biocidal product may be used;
kako se lahko uporabljajo snovi ali izdelki, tretirani z biocidnim pripravkom;
how any material or article treated with it or containing it may be used;
ustreznih koncentracij iz člena 3(3) Direktive 1999/45/ES,
the applicable concentrations laid down in Article 3(3) of Directive 1999/45/EC;
najvišje dovoljene koncentracije iz Priloge I Direktive 67/548/EGS,
the concentration limit values laid down in Annex I to Directive 67/548/EEC;
mejnih koncentracij iz dela B Priloge II k Direktivi 1999/45/ES,
the concentration limit values laid down in Part B of Annex II to Directive 1999/45/EC;
mejnih koncentracij iz dela B Priloge III k Direktivi 1999/45/ES,
the concentration limit values laid down in Part B of Annex III to Directive 1999/45/EC;
mejna koncentracije iz sporazumno določenih vrednosti v popisu razvrstitev in oznak, vzpostavljenem v skladu z naslovom V Uredbe (ES) št. 1272/2008,
the concentration limit values laid down in an agreed entry in the classification and labelling inventory established under Title V of Regulation (EC) No 1272/2008;
0,1 % masnega deleža (w/w), če snov izpolnjuje merila iz Priloge XIII Uredbe (ES) št. 1907/2006.
0.1% weight by weight (w/w), if the substance meets the criteria in Annex XIII to Regulation (EC) No 1907/2006.
Dovoljenje za dajanje biocidnega pripravka z manjšim tveganjem v promet
An authorisation to place a low-risk biocidal product on the market
se lahko izda samo, če se oceni, da gre za aktivne snovi z manjšim tveganjem, ki so vključene v Prilogo I v skladu s členoma 4 in 5
may be granted only if the active substances are evaluated as low-risk active substances and included in Annex I in accordance with Articles 4 and 5.
je skladno z zahtevami iz točk
shall be subject to compliance with the requirements of points
do (d) odstavka 1.
to (d) of paragraph 1.
Biocidni pripravek se dovoli samo za načine uporabe, za katere so bile skladno s členom 18 predložene ustrezne informacije.
A biocidal product shall be authorised only for uses for which relevant information has been submitted in accordance with Article 18.
Če izpolnjuje katero izmed naslednjih meril za razvrščanje, se dajanje biocidnega pripravka v promet in njegova uporaba za splošno rabo ne dovolita:
A biocidal product shall not be authorised for placing on the market to, or use by, the general public if it fulfils any of the following criteria for classification:
je strupen, zelo strupen ali rakotvoren kategorije 1 ali 2 ali mutagen kategorije 1 ali 2 ali strupen za razmnoževanje kategorije 1 ali 2 po Direktivi 1999/45/ES;
it is toxic, very toxic or a category 1 or 2 carcinogen, or a category 1 or 2 mutagen or toxic for reproduction category 1 or 2 according to Directive 1999/45/EC;
je strupen, zelo strupen ali rakotvoren kategorije 1A ali 1B ali mutagen kategorije 1A ali 1B ali strupen za razmnoževanje kategorije 1A ali 1B po Uredbi (ES) št. 1272/2008;
it is toxic, very toxic or a category 1A or 1B carcinogen, or a category 1A or 1B mutagen or toxic for reproduction category 1A or 1B according to Regulation (EC) No 1272/2008;
ima lastnosti povzročiteljev endokrinih motenj;
it is considered to have endocrine-disrupting properties;
V primeru okvirne formulacije
In the case of a frame formulation,
izločitev aktivne snovi pri referenčnem biocidnem pripravku z vsaj dvema aktivnima snovema;
elimination of an active substance in a reference biocidal product with at least two active substances;
zmanjšanje odstotka aktivnih snovi;
a reduction in the percentage of the active substances;
opustitev ene ali več neaktivnih snovi;
elimination of one or more non-active substances;
sprememba strukturnega odstotka ene ali več neaktivnih snovi
an alteration in percentage composition of one or more non-active substances
nadomestitev ene ali več neaktivnih snovi z drugimi, ki pomenijo enako ali manjše tveganje.
the replacement of one or more non-active substances by others presenting the same or lower risk.
Komisija v skladu s postopkom iz člena 76(2) zagotovi tehnične in znanstvene smernice za izdajo dovoljenja za pripravek, ob tem pa zlasti upošteva usklajene zahteve za podatke, ocenjevalne postopke in odločitve držav članic.
The Commission should, in accordance with the procedure set out in Article 76(2), provide technical and scientific guidance for product authorisation, with particular regard to harmonised data requirements, evaluation procedures and decisions by the Member States.
Za lažjo uskladitev postopkov za izdajo dovoljenj po vsej Uniji in odpravo administrativnih bremen za podjetja in pristojne organe Komisija v obliki delegiranih aktov v skladu s členom 73 in pogoji iz členov 74 in 75 sprejme ukrepe, ki določajo pogoje, merila in postopke za ureditev izdajanja dovoljenj in trženja enakih pripravkov za enako uporabo, ki jih različna podjetja prodajajo pod različnimi imeni.
In order to facilitate the harmonisation of authorisation practices throughout the Union and to reduce the administrative burden on companies and competent authorities, the Commission shall adopt, by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75, measures specifying the conditions, criteria and procedures for regulating the authorisation and placing on the market of the same product for the same use, under different trade names and by different companies.
dodatna ocena se ne opravi, saj gre za že odobren pripravek,
no additional evaluation will be performed as it concerns an already authorised product;
odločitve o izdaji dovoljenj se sprejmejo v kratkem roku,
authorisation decisions shall be taken within a short timeframe;
pristojbine za dovoljenja so glede na manjši obseg potrebnega administrativnega dela nizke.
authorisation fees shall be low in accordance with the limited administrative work required.
Biocidni pripravek šteje za biocidni pripravek z manjšim tveganjem, če
A biocidal product shall be considered a low-risk biocidal product
so aktivne snovi, ki jih vsebuje, vključene v Prilogo I in so izpolnjena vsa spodnja merila
if the active substances therein are included in Annex I and
za kateri koli dani ekosistem je mogoče izračunati razmerje med napovedano koncentracijo v okolju (PEC) in predvideno koncentracijo brez učinka (PNEC), navedeno razmerje pa ne presega 0,1;
for any given environmental compartment, the ratio of the predicted environmental concentration (PEC) to predicted no-effect concentration (PNEC) may be derived and does not exceed 0.1;
Vendar pa biocidni pripravek ne šteje kot biocidni pripravek z manjšim tveganjem, če je izpolnjen kateri koli izmed naslednjih pogojev:
However, a biocidal product shall not be considered a low-risk biocidal product if at least one of the following conditions is met:
vsebuje eno ali več aktivnih snovi, ki izpolnjujejo merila, da štejejo za snovi, ki so
it contains one or more ▌substances which fulfil the criteria for being
obstojna organska onesnaževala po Uredbi (ES) št. 850/2004, so
a persistent organic pollutant under Regulation (EC) No 850/2004, for being
obstojne, se kopičijo v organizmih in so strupene (PBT) ali so zelo obstojne in se zelo kopičijo v organizmih, kot je določeno v Prilogi XIII k Uredbi (ES) št. 1907/2006;
persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) in accordance with Annex XIII of Regulation (EC) No 1907/2006;
vsebuje eno ali več aktivnih snovi, opredeljenih kot snovi, ki so po svojih lastnostih endokrini motilci;
it contains one or more active substances qualified as endocrine disrupters;
vsebuje eno ali več aktivnih snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot, oziroma izpolnjujejo merila za katero izmed naslednjih razvrstitev:
it contains one or more active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as or which meet the criteria to be classified as one of the following:
strupena za razmnoževanje;
toxic to reproduction;
strupena ali zelo strupena
very toxic or toxic