natgillin/translations-raw huggingface dataset:
Opredelitev razširi področje tretiranih izdelkov ali snovi, tako da vključuje tako izdelke, kot so npr. barve, ki vsebujejo konzervanse, kot tudi izdelke z zunanjim delovanjem, kot so mreže proti komarjem.
The definition expands the scope of treated articles or materials to include articles with an external effect, such as mosquito nets, as well as products such as paint that are conserved in this way.
Ocenjevanje se pri tem izvaja na ravni kemikalije.
The evaluation is made in relation to the chemical.
(ka) „zunanje biocidno delovanje“
( ka ) ' e xternal biocidal effect' means
učinek uporabe, pri kateri se biocidni pripravek izpusti ob običajnih pogojih uporabe ali ob pogojih, ki jih je mogoče razumljivo predvideti.
the effect of applications whereby the incorporated biocidal product is intended to be released under normal or reasonably foreseeable conditions of use.
Pojem zunanjega delovanja ni opredeljen v sami uredbi o biocidnih pripravkih, ampak v priročniku o odločitvah.
The term 'external effect' is not defined in the regulation on biocidal products itself, but in the 'Manual of Decisions'.
Člen 3 – odstavek 1 – točka p
Article 3 – paragraph 1 – point p
(p) „okvirna formulacija“
(p) ‘frame formulation’ means
skupina biocidnih pripravkov, ki imajo podobne uporabe in so omejene različice referenčnega biocidnega pripravka iz te skupine, ki vsebuje iste aktivne snovi istih specifikacij, ki pa ne vplivajo škodljivo na raven tveganja, povezano z njimi, in njihovo učinkovitost zaradi dovoljenih razlik v njihovi sestavi;
a group of biocidal products having similar uses and presenting limited variations in their composition with regard to a reference biocidal product belonging to that group which contains the same active substances of the same specifications where such permitted variations do not adversely affect the level of risk or the efficacy of these products;
skupina biocidnih pripravkov z manjšim tveganjem , ki imajo podobne uporabe in so omejene različice referenčnega biocidnega pripravka iz te skupine, ki vsebuje iste aktivne snovi istih specifikacij, ki pa ne vplivajo škodljivo na raven tveganja, povezano z njimi, in njihovo učinkovitost zaradi dovoljenih razlik v njihovi sestavi, in kjer je razlika manjši odstotek aktivne snovi ali sprememba strukturnega odstotka ene ali več neaktivnih snovi;
a group of low-risk biocidal products having similar uses and presenting limited variations in their composition with regard to a reference biocidal product belonging to that group which contains the same active substances of the same specifications where such permitted variations do not adversely affect the level of risk or the efficacy of these products and where the variation is a reduction in the percentage of the active substance or a change in percentage composition of one or more of the non-active substances ;
S predlogom spremembe se okvirna formulacija uskladi z Direktivo 98/8/ES.
This brings the frame formulation in accordance with Directive 98/8/EC.
Poudarek, da okvirne formulacije veljajo le za pripravke z manjšim tveganjem, bo spodbudil trajnostne inovacije pripravkov in ustrezne ukrepe za obvladovanje tveganja.
Underlining that the frame-formulations only apply for low-risk products will encourage sustainable product innovation and an appropriate risk-management.
Člen 3 – odstavek 1 – točka q
Article 3 - paragraph 1 - point q
(q) „izjava o dostopnosti podatkov “
(q) 'letter of access' means
(q) „izjava o dostopu “
(q) 'letter of access' means
originalni dokument, ki so ga podpisali lastnik ali lastniki informacij, v katerem je navedeno, da lahko pristojni organi , Evropska agencija za kemikalije ali Komisija uporabljajo informacije, in sicer za ocenjevanje aktivne snovi ali podelitev dovoljenja;
an original document, signed by the owner or owners of information, which states that the information may be used by the competent authorities , the European Chemicals Agency, or the Commission for the purpose of evaluating an active substance or granting an authorisation;
originalni dokument, ki so ga podpisali lastnik ali lastniki informacij ali njihov pooblaščeni predstavnik, v katerem je navedeno, da lahko imenovani pristojni organ , Evropska agencija za kemikalije ali Komisija uporabljajo informacije, in sicer za ocenjevanje aktivne snovi ali podelitev dovoljenja v korist tretje strani ;
an original document, signed by the owner or owners of information or their authorised representative , which states that the information may be used by the designated competent authority , the European Chemicals Agency, or the Commission for the purpose of evaluating an active substance or granting an authorisation for the benefit of a third party ;
Opredelitev izjave o dostopu v predlogu Komisije ni dovolj natančna.
The definition of 'letter of access' in the Commission proposal is not sufficiently precise.
Člen 3 – odstavek 1 – točka t a (novo)
Article 3 – paragraph 1 – point t a (new)
(ta) „upravna sprememba“
(ta) 'administrative change' means
sprememba obstoječega dovoljenja, ki je povsem upravne narave in ne zajema ponovne ocene tveganja za javno zdravje ali okolje ali učinkovitosti pripravka;
a variation to an existing authorisation of a purely administrative nature, which does not involve a re-assessment of the risk for public health or the environment or the efficacy of the product;
Opredeliti je treba vrste sprememb, ki so možne pri obstoječem dovoljenem biocidnem pripravku.
It is necessary to define the type of variations that can be made to an existing authorised biocidal product.
Člen 3 – odstavek 1 – točka t b (novo)
Article 3 – paragraph 1 – point t b (new)
(tb) „manjša sprememba“
(tb) 'minor change' means
sprememba obstoječega dovoljenja, ki je ne moremo šteti za upravno spremembo, saj zajema manjšo ponovno oceno tveganja za javno zdravje ali okolje ali učinkovitosti pripravka ter ne vpliva negativno na stopnjo tveganja za javno zdravje ali okolje in na učinkovitost pripravka.
a variation to an existing authorisation which cannot be deemed to be an administrative variation as it involves a limited re-assessment of the risk for public health or the environment or of the efficacy of the product, and does not adversely affect the level of risk for public health or the environment and the efficacy of the product;
Člen 3 – odstavek 1 – točka t c (novo)
Article 3 – paragraph 1 - point t c (new)
(tc) „večja sprememba“
(tc) 'major change' means
sprememba obstoječega dovoljenja, ki je ne moremo šteti kot upravno ali manjšo spremembo;
a variation to an existing authorisation which cannot be deemed to be an administrative change or a minor change;
Člen 3 – odstavek 1 – točka u a (novo)
Article 3 - paragraph 1 - point u a (new)
namensko proizvedena snov, pri kateri je velikost ene ali več dimenzij 100 nm ali manj ali ki je v notranjosti ali na površini sestavljena iz ločenih funkcionalnih delov, od katerih imajo številni eno ali več dimenzij velikosti 100 nm ali manj, vključno s strukturami, aglomerati ali agregati, katerih velikost lahko presega 100 nm, vendar pa ohranijo lastnosti, značilne za nanomerilo.
any intentionally produced material that has one or more dimensions of the order of 100 nm or less or is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale .
Lastnosti, ki so značilne za nanomerilo, vključujejo:
Properties that are characteristic of the nanoscale include :
(i) lastnosti v zvezi z veliko specifično površino zadevnih materialov; in/ali
(i) those related to the large specific surface area of the materials considered; and/or
(ii) posebne fizikalno-kemijske lastnosti, ki se razlikujejo od lastnosti enakega materiala, ki nima nanooblike;
(ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material ;
Člen 3 – odstavek 1 – točka u b (novo)
Article 3 - paragraph 1 - point u b (new)
– pri aktivnih snoveh, proizvedenih v Uniji in danih na trg, proizvajalec te aktivne snovi ali oseba s sedežem v Uniji, ki jo je proizvajalec določil za svojega edinega zastopnika za namene te uredbe;
- in the case of an active substance produced within the Union and placed on the market, the manufacturer of that active substance or a person established within the Union designated by the manufacturer as his sole representative for the purposes of this Regulation,
– pri aktivnih snoveh, proizvedenih zunaj Unije, oseba s sedežem v Uniji, ki jo je proizvajalec te aktivne snovi določil za svojega edinega zastopnika za namene te uredbe, ali, kadar taka oseba ni bila določena, uvoznik te aktivne snovi v Unijo;
- in the case of an active substance produced outside the Union, the person established within the Union and designated by the manufacturer of that active substance as his sole representative for the purposes of this Regulation or, where no such person has been so designated, the importer into the Union of that active substance,
– pri biocidnih pripravkih, proizvedenih zunaj Unije, oseba s sedežem v Uniji, ki jo je proizvajalec tega biocidnega pripravka določil za svojega edinega zastopnika za namene te uredbe, ali, kadar taka oseba ni bila določena, uvoznik tega biocidnega pripravka v Unijo;
- in the case of a biocidal product produced outside the Union, the person established within the Union and designated by the manufacturer of that biocidal product as his sole representative for the purposes of this Regulation or, where no such person has been so designated, the importer into the Union of that biocidal product;
Zaradi novega besedila člena 83 je potrebna opredelitev „proizvajalca“.
The new wording of Article 83 means that a definition of 'manufacturer' is required.
Ta opredelitev je enaka tisti v Uredbi Komisije (ES) št. 1896/2000 z dne 7. septembra 2000 o prvi fazi programa iz člena 16(2) Direktive 98/8/ES Evropskega parlamenta in Sveta o biocidnih pripravkih.
This definition is identical to Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products.
Člen 3 – odstavek 1 – točka u c (novo)
Article 3 - paragraph 1 - point u c (new)
(uc) „poklicni uporabnik“
(uc) ‘professional user' means
vsaka fizična ali pravna oseba, ki v svoji poklicni dejavnosti uporablja biocidne pripravke.
any natural or legal person who use s biocid al product s in the framework of his professional activity.
Člen 3 – odstavek 1 – točka u d (novo)
Article 3 – paragraph 1 – point u d (new)
(ud) „ranljive skupine“
( u d) ‘ v ulnerable g roups’ means
osebe, za katere je pri ocenjevanju akutnih in kroničnih učinkov biocidnih pripravkov na zdravje potrebna posebna obravnava.
persons needing specific consideration when assessing the acute and chronic health effects of biocid al products.
To so med drugim nosečnice in doječe matere, nerojeni otroci, dojenčki in otroci, ostareli ter delavci in prebivalci, ki so dolgoročno izpostavljeni visokim koncentracijam biocidov;
These include pregnant and nursing women, the unborn, infants and children, the elderly and workers and residents subject to high biocide exposure over the long term;
Uredba bi morala vključevati opredelitev ranljivih skupin v skladu z Uredbo 1107/2009 in zakonodajo o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH).
The regulation should include a definition of vulnerable groups, in line with regulation 1107/2009 and the REACH legislation.
Člen 3 – odstavek 1 – točka u e (novo)
Article 3 – paragraph 1 – point u e (new)
mala in srednja podjetja, kakor so opredeljena v priporočilu Komisije 2003/361/ES z dne 6. maja 2003 o opredelitvi mikro, malih in srednje velikih podjetij 1 .
small and medium-sized enterprises as defined in the Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises 1 .
Glede na izkušnje iz uredbe REACH je treba mala in srednja podjetja opredeliti posebej.
Following the example in REACH Regulation, it is better to separately set the definition for SMEs.
Aktivno snov se vključi v Prilogo I za začetno obdobje največ 10 let, če biocidni pripravki, ki to aktivno snov vsebujejo, izpolnjujejo pogoje iz točke (b) člena 16(1).
An active substance shall be included in Annex I for an initial period not exceeding 10 years if the biocidal products containing that active substance fulfil the conditions laid down in point (b) of Article 16(1).
Aktivna snov se vključi v Prilogo I za začetno obdobje največ 10 let, če med biocidnimi pripravki, ki to aktivno snov vsebujejo, vsaj eden izpolnjuje pogoje iz točke (b) člena 16(1).
An active substance shall be included in Annex I for an initial period not exceeding 10 years if at least one of the biocidal products containing that active substance fulfils the conditions laid down in point (b) of Article 16(1).
Aktivna snov iz člena 5 se v Prilogo I lahko vključi le za začetno obdobje 5 let.
An active substance referred to in Article 5 may only be included in Annex I for an initial period of 5 years.
Snovi, za katere veljajo merila za izključitev, bi morale biti v Prilogo I vključene le za obdobje največ 5 let.
Substances that fall under the exclusion criteria should only be included in Annex I for a maximum period of 5 years.
Besedilo je v skladu z uredbo o fitofarmacevtskih sredstvih.
This is in line with the PPP regulation.
Aktivne snovi kot take ali v biocidnih pripravkih se lahko dajo v promet v Uniji za uporabo v biocidnih pripravkih samo, če so bile vključene v Prilogo I v skladu z določbami te uredbe.
Active substances as such or in biocidal products may be placed on the market in the Union for use in biocidal products only if they have been included in Annex I in accordance with the provisions of this Regulation.
Če v tej uredbi ni drugače določeno, vsi proizvajalci aktivne snovi kot take ali v biocidnem pripravku pri agenciji vložijo vlogo za vključitev v Prilogo I.
Unless otherwise provided in this Regulation, all manufacturers of an active substance, as such or in a biocidal product, shall submit to the Agency an application for inclusion in Annex I.
Pravično obravnavanje je možno samo, če so vsi proizvajalci dolžni izpolnjevati iste zahteve o podatkih v Prilogi II.
Only if manufacturers are obliged to comply with the same data requirements in Annex II will fair treatment be possible.
Člen 4 - odstavek 3 - uvodni del
Article 4 - paragraph 3 - introductory part
(3) Aktivna snov se, kjer je to primerno, vključi v Prilogo I skupaj z navedbo katerega koli izmed naslednjih pogojev:
(3) An active substance shall, where appropriate, be included in Annex I together with any of the following conditions:
(3) Aktivna snov in opredelitev referenčnega vira aktivne snovi za določitev tehnične enakovrednosti, kot je opredeljena v členu 3(1)(u) , se, kjer je to primerno, vključi v Prilogo I skupaj z navedbo katerega koli izmed naslednjih pogojev:
(3) An active substance and the definition of the reference source for the active substance for the purposes of determining technical equivalence as defined in Article 3(1)(u) shall, where appropriate, be included in Annex I together with any of the following conditions:
Treba je povezati aktivno snov, opisano v Prilogi I, in podatke, na podlagi katerih je bila ta snov vključena v Prilogo I.
It is important to establish a connection between the active substance described in Annex I and the data on the basis of which it was incorporated into that annex.
Poleg tega je izomerna sestava pomembna pri razlikovanju kemijskih identitet.
Moreover, isomer composition is significant in order to distinguish its chemical identity.
Člen 4 – odstavek 3 – točka e a (novo)
Article 4 - paragraph 3 - point e a (new)
(ea) opredelitve kemijske identitete glede na stereoizomere;
(ea) characterisation of the chemical identity with regard to stereoisomers;
Ne glede na člen 4(1) se aktivne snovi iz odstavka 2 vključijo v Prilogo I samo, če je izpolnjen vsaj eden izmed naslednjih pogojev :
Notwithstanding Article 4(1), active substances referred to in paragraph 2 shall be included in Annex I only if at least one of the following conditions is met :
Naslednje aktivne snovi se ne vključijo v Prilogo I:
The following active substances shall not be included in Annex I:
(a) v običajnih pogojih uporabe je izpostavljenost ljudi aktivni snovi v biocidnem pripravku zanemarljiva, zlasti če se pripravek uporablja v zaprtih sistemih ali pod strogo nadzorovanimi pogoji;
(a) the exposure of humans to that active substance in a biocidal product, under normal conditions of use, is negligible, in particular where the product is used in closed systems or strictly controlled conditions;
(a) aktivne snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot rakotvorne kategorije 1A ali 1B, oziroma izpolnjujejo merila za tako razvrstitev;
(a) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, carcinogen category 1A or 1B;
(b) aktivna snov je dokazano potrebna za nadzor resne nevarnosti za javno zdravje;
(b) it is shown that the active substance is necessary to control a serious danger to public health;
(b) aktivne snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot mutagene kategorije 1A ali 1B, oziroma izpolnjujejo merila za tako razvrstitev;
(b) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, mutagen category 1A or 1B;
(c) nevključitev aktivne snovi v Prilogo I bi imela v primerjavi s tveganjem za zdravje ljudi ali okolje, ki nastane pri uporabi snovi, dokazano nesorazmerne negativne učinke, ob tem pa ne obstajajo primerne alternativne snovi ali tehnologije.
(c) it is shown that not including the active substance in Annex I would cause disproportionate negative impacts when compared with the risk to human health or the environment arising from the use of the substance and that there are no suitable alternative substances or technologies.
(c) aktivne snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot strupene za razmnoževanje kategorije 1A ali 1B, oziroma izpolnjujejo merila za tako razvrstitev;
(c) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, toxic for reproduction category 1A or 1B;
Točka (c) ne velja za aktivne snovi za vrste pripravkov 4 in 14 do 19.
Point (c) shall not apply to active substances for product types 4 and 14 to 19.
(d) aktivne snovi, ki so na podlagi ocene Unije ali mednarodno dogovorjenih smernic za preskuse ali drugih strokovno pregledanih podatkov in informacij, vključno s pregledom znanstvene literature, ki ga pregleda Agencija, opredeljene kot snovi, ki imajo lahko po svojih lastnostih kot endokrini motilci negativne učinke na ljudi, ali ki so opredeljene v členu 57(f) Uredbe (ES) št. 1907/2006 kot snovi, ki so po svojih lastnostih endokrini motilci.
(d) active substances which, on the basis of the assessment of Union or internationally agreed test guidelines or other peer - reviewed scientific data and information, including a review of the scientific literature, reviewed by the Agency, are considered as having endocrine - disrupting properties that may cause adverse effect in humans, or which are identified under Article 57(f) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties.
Komisija z delegiranimi akti v skladu s členom 71a in pod pogoji iz členov 71b in 71c najkasneje do 13. decembra 2013 sprejme ukrepe o posebnih znanstvenih merilih za določanje lastnosti endokrinih motilcev.
Not later than 13 December 2013, the Commission shall adopt , by means of delegated acts in accordance with Articles 71a and subject to the conditions of Articles 71 b and 71 c , measures on specific scientific criteria for determining endocrine-disrupting properties.
Do sprejetja teh meril snovi, ki so ali še morajo biti razvrščene v skladu z določbami iz Uredbe (ES) št. 1272/2008 kot rakotvorne kategorije 2 in strupene za razmnoževanje kategorije 2, štejejo za snovi, ki so po svojih lastnostih endokrini motilci.
Pending the adoption of th o se criteria, substances that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogenic category 2 and toxic for reproduction category 2, shall be considered as having endocrine-disrupting properties.
Poleg tega lahko na primer snovi, ki so ali še morajo biti razvrščene v skladu z določbami iz Uredbe (ES) št. 1272/2008 kot strupene za razmnoževanje kategorije 2 in ki imajo strupen učinek na endokrine organe, štejejo za snovi, ki so po svojih lastnostih endokrini motilci;
In addition, substances such as those that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 2 and which have toxic effects on the endocrine organs, may be considered as having such endocrine - disrupting properties ;
(e) aktivne snovi, ki so obstojne, se kopičijo v organizmih in so strupene;
(e) active substances that are persistent, bio-accumulative and toxic;
(f) aktivne snovi, ki so zelo obstojne in se zelo kopičijo v organizmih;
(f) active substances that are very persistent and very bio-accumulative;
(g) obstojna organska onesnaževala (POP) v okviru Uredbe Evropskega parlamenta in Sveta (ES) št. 850/2004 z dne 29. aprila 2004 o obstojnih organskih onesnaževalih 1 .
(g) persistent organic pollutants (POP) under Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants 1 ;
Naslednje aktivne snovi se vključijo v Prilogo I, če je izpolnjen vsaj eden izmed pogojev iz odstavka 1 :
The following active substances shall be included in Annex I where at least one of the conditions set out in paragraph 1 is met:
Aktivne snovi iz odstavka 1 se vključijo v Prilogo I samo , če je izpolnjen vsaj eden od naslednjih pogojev:
The active substances referred to in paragraph 1 may be included in Annex I only if at least one of the following conditions is met:
(a) aktivne snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot rakotvorne kategorije 1A ali 1B, oziroma izpolnjujejo merila za tako razvrstitev;
(a) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meets the criteria to be classified as, carcinogen category 1A or 1B;
(a) v običajnih pogojih uporabe je izpostavljenost ljudi ali okolja zadevni aktivni snovi v biocidnem pripravku zanemarljiva, kar pomeni, da se pripravek uporablja v zaprtem sistemu ali v drugih pogojih, pri katerih ni stika z ljudmi;
(a) the exposure of humans or to the environment to the active substance in question in a biocidal product, under normal conditions of use, is negligible, meaning that the product is used in closed systems or under other conditions excluding contact with humans;
(b) dokazano je, da je aktivna snov potrebna za preprečitev ali nadziranje resne nevarnosti za javno zdravje ali zdravje živali ali okolje, varnosti hrane in krme ali za javni interes ter da ni na razpolago drugih učinkovitih snovi ali tehnologij.
(b) it is shown by evidence that the active substance is necessary to prevent or control a serious danger to public or animal health or to the environment , to food and feed safety, or to the public interest and that there are no effective alternative substances or technologies available .
Za uporabo vseh biocidnih pripravkov, ki vsebujejo aktivne snovi iz Priloge I, v skladu s tem odstavkom veljajo ustrezni ukrepi za zmanjšanje tveganja, da bi se zagotovila najmanjša izpostavljenost ljudi in okolja.
The use of any biocidal product containing active substance s included in Annex I pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment is minimised.