natgillin/translations-raw huggingface dataset:
Glede na izkušnje iz uredbe REACH je treba mala in srednje velika podjetja posebej opredeliti.
Following the example in REACH Regulation, it is better to separately set the definition for SMEs.
Člen 3 – odstavek l – točka u b (novo)
Article 3 – paragraph 1 – point u b (new)
– pri aktivnih snoveh, proizvedenih v Uniji in danih na trg, proizvajalec aktivne snovi ali oseba s sedežem v Uniji, ki jo je proizvajalec določil za svojega edinega zastopnika za namene te uredbe,
- with reference to an active substance produced within Community territory or placed on the market, the person who manufactures that active substance or a person resident in the Community who is designated by the manufacturer as his sole representative for the purposes of the present Regulation,
– pri aktivnih snoveh, proizvedenih zunaj Unije, oseba s sedežem v Uniji, ki jo je proizvajalec aktivne snovi določil za svojega edinega zastopnika za namene te uredbe, ali, če taka oseba ni bila določena, uvoznik te aktivne snovi v Unijo,
- with reference to an active substance produced outside Community territory, the person resident in the Community who is designated by the manufacturer of the active substance as his sole representative for the purposes of the present Regulation or, if no such person has been designated, the person who imports the biocidal product or the active substance in question into the Community,
Nova opredelitev proizvajalca je potrebna zaradi novega besedila člena 83.
In view of the new wording of Article 83, it is necessary to define 'manufacturer'.
Ta je skladna z določbami Uredbe 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.
In fact the definition is in line with the provisions of 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 a (novo – prvi člen poglavja II)
Article 3 a (new – first Article of Chapter II)
Vsak bodoči predlagatelj vključitve aktivne snovi v Prilogo I se v agenciji pozanima, ali
Any prospective applicant for inclusion of an active substance in Annex I shall inquire of the Agency whether
– je bil zahtevek za vključitev snovi v Prilogo I že predložen, ali
- an application for inclusion of the same substance in Annex I has already been submitted or
– je snov zajeta v Prilogi I, ali
- the same substance is included in Annex I or
– je snov že registrirana v skladu z Uredbo (ES) št. 1907/2006.
- the same substance is registered pursuant to Regulation (EC) No 1907/2006.
Vsak bodoči predlagatelj priloži zahtevku, ki ga pošlje agenciji, naslednje podatke:
Any prospective applicant shall forward the following information to the Agency with the application:
(a) svoje osebne podatke, kot je določeno v odstavku 1 Priloge VI Uredbe (ES) št. 1907/2006, razen točk 1.2 in 1.3;
(a) its identity as specified in section 1 of Annex VI to Regulation (EC) No 1907/2006, with the exception of points 1.2 and 1.3;
(b) podatke o identiteti snovi, kot je določeno v odstavku 2 Priloge VI Uredbe (ES) št. 1907/2006;
(b) the identity of the substance as specified in section 2 of Annex VI to Regulation (EC) No 1907/2006;
(c) kateri zahtevki za informacije bodo zahtevali nove študije na vretenčarjih, ki jih bo moral opraviti;
(c) which requests for information will require new studies involving vertebrate animals which it will have to perform;
(d) kateri zahtevki za informacije bodo zahtevali dodatne nove študije, ki jih bo moral opraviti.
(d) which requests for information will require other new studies which it will have to perform.
Če snov ni vključena v Prilogo I ali ni registrirana skladno z Uredbo (ES) št. 1907/2006, agencija bodočega predlagatelja o tem obvesti.
If the same substance is not included in Annex I or not registered pursuant to Regulation (EC) No 1907/2006, the Agency shall inform the prospective applicant accordingly.
Če je bil že vložen zahtevek za vključitev aktivne snovi v Prilogo I, pa je že vključena ali če je registrirana v skladu z Uredbo (ES) št. 1907/2006, agencija bodočemu predlagatelju takoj posreduje ime in naslov prejšnjih predlagateljev in registracijskih zavezancev ter, odvisno od primera, povzetke in grobe povzetke študij, ki so bili že posredovani.
If an application for inclusion of the same active substance in Annex I has already been submitted , if the same active substance is already included in Annex I or if it has been registered pursuant to Regulation (EC) No 1907/2006, the Agency shall inform the prospective applicant, without delay, of the name and address of the previous applicants and registrants and the study summaries or robust study summaries of the information, as the case may be, already supplied.
Ti postopki so potrebni, da bi preprečili podvajanje preskusov na vretenčarjih in izpolnili zahteve po podatkih iz Priloge II.
These procedures are necessary in order to avoid duplication of tests on vertebrate animals and to comply with requests for Annex II information.
Obveznost posredovanja podatkov iz uredbe REACH postane vzajemna, saj bo imela agencija na voljo infrastrukturo in izkušnje, potrebne za sprejetje tega postopka.
The 'obligation to provide information' under the REACH Regulation is made mutual, as the Agency will have the requisite infrastructure and expertise to adopt this procedure.
Aktivna snov se vključi v Prilogo I za začetno obdobje največ 10 let, če med biocidnimi pripravki, ki to aktivno snov vsebuje, 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).
Ob vključitvi v Prilogo I je treba predložiti dokumentacijo o najmanj enem reprezentativnem biocidnem pripravku, katerega aktivna snov izpolnjuje predpisane pogoje.
At the time of entry in Annex I, the dossier must be submitted for at least one representative biocidal product whose active substance meets the conditions laid down.
Po mnenju predlagateljev predloga spremembe predlagana zamenjava bolje odraža koncept vključitve v Prilogo I.
The proposed change is considered to reflect the concept of entry in Annex I more satisfactorily.
Člen 4 – odstavek 3 – uvodni del
Article 4 – paragraph 3 - introductory part
Aktivna snov in navedba referenčnega vira aktivne snovi za določitev tehnične enakovrednosti se, kjer je to primerno, vključita v Prilogo I skupaj z navedbo katerega koli izmed naslednjih pogojev:
An active substance and a statement of the reference source for the determination of technical equivalence shall, where appropriate, be included in Annex I together with any of the following conditions:
Kemikalijo, opredeljeno v Prilogi I, je treba povezati s podatki, na podlagi katerih je bila vključena v prilogo.
It is important to link the chemical substance described in Annex I to the data which have supported its inclusion in the annex.
Pri razlikovanju kemijske identitete je pomembna tudi izomerna sestava.
In addition, the isomeric composition is important for the purpose of distinguishing chemical identity.
Člen 4 – odstavek 3 – točka f a (novo)
Article 4 – paragraph 3 – point f a (new)
(fa) navedbe kemijske identitete glede na stereoizomere,
(fa) indication of the chemical identity as regards stereoisomers.
Ni znanstvenih razlogov, zaradi katerih bi lahko zapostavljali vrste pripravkov (na primer PT4 in 14–19).
There are no scientific grounds for discriminating against product types (e.g. PT4 and 14-19).
Ti pripravki so rodenticidi, akaricidi, moluskicidi, dezinfekcijska sredstva, piskicidi in insekticidi in koristijo zlasti prebivalcem juga Evrope, kjer so zaradi higienskih razlogov deratizacije in dezinsekcije nujne.
These products are rodenticides, acaricides, molluscicides, disinfectants, piscicides and insecticides and are beneficial, in particular, to people in Southern Europe, where it is vital to combat rat or insect infestations for hygiene reasons.
O izključitvi proizvodov je treba odločiti na podlagi tveganja (kombinacija nevarnosti in izpostavljenosti).
Exclusion should be decided on the basis of a risk analysis (a combination of hazardousness and exposure).
Če se znanstveno dokaže, da so tveganja dobro nadzorovana, je treba aktivne snovi dovoliti.
If it is scientifically proven that the risks are well controlled, the active substances should be authorised.
Znanstvena utemeljitev za izvzem nekaterih vrst pripravkov (4 in 14 do 19) je nejasna in deluje samovoljno ter je zato pri teh vrstah pripravkov neutemeljena.
The scientific rationale for discriminating against particular product types (i.e. PT’s 4 and 14-19) is unclear and appears to be arbitrary and therefore unjustly targets these particular product types.
Uporabijo se izvedbeni ukrepi, sprejeti v skladu z Uredbo (ES) št. … [ o dajanju fitofarmacevtskih sredstev na trg ] , ki podrobno določajo znanstvena merila za določitev lastnosti endokrinega motenja.
Implementing measures adopted in accordance with Regul ation (EC) No ... [ concerning the placing of plant protection products on the market ] , which specify the scientific criteria for determining the endocrine-disrupting properties , shall be applied .
Zaenkrat ni meril za odobritev endokrinih motilcev, zato jih je treba izdelati.
At present no criteria exist for approval of endocrine-disrupters, and it is necessary to draft them.
Sprejeti jih je treba v skladu z Uredbo (ES) št. 1107/2009 o dajanju fitofarmacevtskih sredstev na trg, ki je začela veljati 24. novembra 2009.
These criteria should be adopted in accordance with Regulation (EC) No 1107/2009 on the placing on the market of plant protection products, which entered into force on 24 November 2009.
(a) dokumentacijo o aktivni snovi, ki izpolnjuje zahteve iz Priloge II, ali izjavo o dostopnosti teh podatkov ;
(a) a dossier for the active substance satisfying the requirements set out in Annex II or a letter of access ;
Mogoče je, da predlagatelji niso zakoniti lastniki vseh podatkov v podporo vloge.
Applicants may not be in legitimate possession of all the data in support of the application.
(b) dokumentacijo ali izjavo o dostopnosti podatkov o najmanj enem reprezentativnem biocidnem pripravku, ki vsebuje aktivno snov, ki izpolnjuje zahteve iz Priloge III.
(b) a dossier or a letter of access for at least one representative biocidal product that contains the active substance satisfying the requirements set out in Annex III.
Agencija vsaki vlogi določi referenčno številko, ki se uporablja za vso korespondenco v zvezi z vlogo, dokler aktivna snov ni vključena v Prilogo I, in datum vložitve, ki je datum, ko je agencija prejela vlogo.
The Agency shall assign a reference number to each application, which shall be used for all correspondence concerning the application until the substance is included in Annex I, and a submission date, which shall be the date of receipt by the Agency.
Člen 7 – odstavek 3 – uvodni del
Article 7 – paragraph 3 – introductory part
V dveh mesecih po prejemu vloge agencija validira vlogo , če so izpolnjene naslednje zahteve:
Within two months after the receipt of an application, the Agency shall validate the application if it complies with the following requirements:
Agencija vlogo v treh tednih po prejemu validira, če so izpolnjene naslednje zahteve:
Within three weeks after the receipt of an application, the Agency shall validate the application if it complies with the following requirements:
V dveh mesecih po prejetju vloge agencija vse dele podatkov v dokumentaciji označi z enkratno identifikacijsko kodo.
Within two months after the receipt of an application, the Agency shall register each part of the information in the dossier with a unique identifying code.
Člen 8 – odstavek 2 – pododstavek 1
Article 8 – paragraph 2 - subparagraph 1
Če se pri oceni dokumentacije pokaže, da so potrebne dodatne informacije za izvedbo ocene, ocenjevalni pristojni organ od predlagatelja zahteva, da v določenem roku predloži te informacije in o tem obvesti agencijo.
If, when the dossiers are evaluated, it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit , and shall inform the Agency thereof.
Če se pri oceni dokumentacije pokaže, da so potrebne dodatne informacije za izvedbo ocene, ocenjevalni pristojni organ od predlagatelja zahteva, da jih predloži v roku , ki ne presega šestih mesecev .
If, when the dossiers are evaluated, it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit that shall not exceed six months.
V izjemnih okoliščinah in po ustrezni obrazložitvi, se rok lahko podaljša za dodatno obdobje, ki ne presega šestih mesecev.
In exceptional circumstances and following proper justification, the time limit may be extended by up to a further six months.
Ocenjevalni pristojni organ o tem obvesti agencijo.
The evaluating competent authority shall inform the Agency thereof.
Izkušnje so pokazale, da izvedba ocene lahko traja neupravičeno dolgo.
Experience has shown concluding an evaluation procedure could take an unjustifiably long time.
Zato je treba postaviti ustrezne roke, da bi preprečili vrzeli, ki bi lahko po nepotrebnem podaljšale postopek.
It is therefore essential that proper time limits are put in place to avoid loopholes that could protract the procedure unnecessarily.
Roki predlagatelju omogočijo nekaj gotovosti v zvezi z najdaljšim možnim trajanjem postopka.
These also bring some certainty to the applicant as to the possible maximum duration of this procedure.
Člen 8 – odstavek 5 – pododstavek 1 a (novo)
Article 8 – paragraph 5 – subparagraph 1 a (new)
Številko in datum vključitve takoj sporoči predlagatelju.
The Agency shall without delay inform the applicant of the number and the date of registration.
Številka vključitve se uporablja za vso nadaljnjo komunikacijo v zvezi z aktivno snovjo in za dovoljenje za pripravek v skladu s poglavjem IV te uredbe.
This registration number shall be used in all further correspondence regarding the active substance and for product authorisation as referred to in Chapter IV of this Regulation.
Agencija pri pripravljanju mnenja o vključitvi ali obnovitvi vključitve aktivne snovi v Prilogo I preuči, ali aktivna snov izpolnjuje katero izmed meril, naštetih v odstavku 1, in če izpostavljenost ob upoštevanju nevarnih lastnosti snovi ni ustrezno nadzorovana, zadevo obravnava v svojem mnenju.
When preparing an opinion on the inclusion or renewal of the inclusion of an active substance in Annex I, the Agency shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and , if exposure is not adequately controlled, bearing in mind the intrinsic hazards of the substance, shall address the matter in its opinion.
Merila za identifikacijo možnih aktivnih snovi za zamenjavo so zaradi uskladitve obeh uredb usklajena z merili za snovi, za katere je potrebno dovoljenje v skladu z Uredbo (ES) št. 1907/2006 – glej člen 57 Uredbe (ES) št. 1907/2006.
The criteria for identifying active substances which are candidates for substitution are aligned with the criteria for substances subject to authorisation as referred to in Regulation (EC) No 1907/2006 for reasons of harmonisation between the two regulations - see Article 57 of Regulation (EC) No 1907/2006.
Naloga agencije (ECHA) bo preverjanje, ali aktivna snov izpolnjuje merila, zato se priporoča uskladitev uredb.
As the Agency (ECHA) will have the task of examining whether an active substance meets the criteria, harmonisation between the two regulations is advisable.
Če se Komisija odloči za obnovitev vključitve aktivne snovi v Prilogo I, se navede ime predlagatelja/predlagateljev.
If the Commission decides to renew the inclusion of the active substance in Annex I, mention should be made of the name of the applicant(s).
Vključitev aktivne snovi v Prilogo I v povezavi s podjetjem je ustrezen in učinkovit način omejevanja koristoljubnih teženj, saj omogoča hitro identifikacijo podjetja, ki je podprlo aktivno snov, ter s tem zmanjša upravno obremenitev.
Including the active substance in Annex I, together with the name of the applicant firm, is an appropriate and effective means of preventing free-riding, since it enables the firm which supported the substance to be identified quickly and thereby reducing the administrative burden.
Namen predloga spremembe je zagotovitev skladnosti, saj mora agencija povsod drugje v predlogu na zahtevo Komisije izdati mnenje v šestih mesecih.
Amendment for sake of consistency since everywhere else in the proposal the limit for issuing an opinion by the Agency at the request of the Commission is six months.
Vlogo za izdajo dovoljenja vloži oseba, ki bo odgovorna za dajanje biocidnega pripravka v promet v določeni državi članici oziroma v Skupnosti, ali se vloži v njenem imenu.
Application for authorisation shall be made by, or on behalf of, the person who shall be responsible for the placing on the market of a biocidal product in a particular Member State or in the Community.
Vlogo za izdajo dovoljenja vloži imetnik dovoljenja , ki lahko je, lahko pa tudi ni oseba, odgovorna za dajanje biocidnega pripravka v promet v določeni državi članici oziroma v Skupnosti, ali se vloži v njegovem imenu.
Application for authorisation shall be made by, or on behalf of, the person holding the authorisation, who may or may not be the person responsible for the placing on the market of a biocidal product in a particular Member State or in the Community.
Možnost, da ocenjevalni pristojni organ lahko izbere, je prednost predvsem za mala in srednje velika podjetja, saj tako lahko sodelujejo s svojimi nacionalnimi organi.
The possibility of choosing the evaluating competent authority is an advantage for small and medium-sized enterprises in particular, since they are able to work with their national authorities.
Člen 15 – odstavek 2 – pododstavek 3
Article 15 – paragraph 2 – subparagraph 3
Vlagatelj lahko po predhodnem dogovoru državi članici predloži svojo vlogo v oceno in v skladu s členom 22 v vlogi navede pristojni organ, ki je odgovoren za oceno vloge.
The applicant may, in agreement with a Member State , have his application validated by that Member State and must identify the evaluating competent authority in the application itself, as laid down in Article 22.
Agencija (ECHA) bi morala opraviti prvotno validacijo vseh vlog za dovoljenje Skupnosti, da bi se lahko ocenjevalni pristojni organ osredotočil na dejansko oceno vloge.
The ECHA should carry out the initial validation of all applications throughout the Community, so that the evaluating competent authorities can concentrate on the actual evaluation of applications.
a) 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 ;
a) 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;
a) so aktivne snovi, ki jih vsebuje, vključene v Prilogo I , jim je bila dodeljena številka vključitve v skladu s členom 8(5)(a) in so izpolnjeni vsi pogoji iz te priloge za navedene aktivne snovi;
a) the active substances included therein are listed in Annex I , a registration number is assigned to them in accordance with Article 8 ( 5a ) and any conditions included in Annex I together with those active substances are complied with;
Za uskladitev s postopkom ocenjevanja, opisanim v členu 8(5)(a).
In the interests of consistency with the evaluation procedure described in Article 8(5a).
Člen 16 – odstavek 1 – točka (c)
Article 16 – paragraph 1 – point c
c) je v skladu z zahtevami iz Prilog II in III mogoče določiti vrsto , količino in tehnično enakovrednost aktivnih snovi v biocidnem pripravku, in kadar je to primerno, vse toksikološko ali ekotoksikološko pomembne nečistote in neaktivne snovi ter ostanke toksikološkega in okoljskega pomena, ki so posledica dovoljene uporabe;
c) the nature , 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 residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III;
c) je v skladu z zahtevami iz Prilog II in III mogoče določiti kemijsko identiteto , količino in tehnično enakovrednost aktivnih snovi v biocidnem pripravku, in kadar je to primerno, vse toksikološko ali ekotoksikološko pomembne nečistote in neaktivne snovi ter ostanke toksikološkega in okoljskega pomena, ki so posledica dovoljene uporabe;
c) the chemical identity , 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 residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III;
Izraz „vrsta“ ni dovolj natančno opredeljen.
The term ‘nature’ has not been clearly defined.
Za opis aktivne snovi je primernejši izraz kemijska identiteta.
'Chemical identity' seems a better way of describing the active substance.
Člen 16 – odstavek 2 – pododstavka 2 a in 2 b (novo)
Article 16 – paragraph 2 – subparagraphs 2 a and 2 b (new)
Pri ocenjevanju, ali biocidni pripravek izpolnjuje merila iz točke (b) odstavka 1, se morajo po možnosti iz že obstoječih podatkov pridobiti podatki o pogojno nevarni snovi, ki jih vsebuje biocidni pripravek, da se čim bolj zmanjša število poskusov na živalih.
The evaluation of the compliance of the biocidal products with the criteria set out in point (b) of paragraph 1 should be based as far as possible on existing information on the substances of concern contained in the biocidal product in order to keep tests on animals to a minimum.
Za ugotavljanje nevarnosti biocidnega pripravka in ustrezno oceno tveganja se morajo uporabljati zlasti določbe Direktive 1999/45/ES ali Uredbe (ES) št. 1272/2008.
In particular, use should be made of the provisions of Directive 1999/45/EC or Regulation (EC) No 1272/2008 on identifying the danger posed by biocidal products and consequent risk evaluation.
Za snov, ki je sestavina biocidnega pripravka, ni treba oceniti izpolnjevanja meril iz točke (b) odstavka 1, če je koncentracija snovi v biocidnem pripravku nižja od vrednosti, določene v kateri koli od naslednjih točk:
The evaluation of the compliance of the biocidal product with the criteria set out in point (b) of paragraph 1 and the requirements set out in point (c) of that paragraph shall not take into account a substance contained in the biocidal product if it is present in a preparation at a concentration lower than any of the following:
(a) veljavne koncentracije iz člena 3(3) Direktive 1999/45/ES;
(a) the applicable concentrations laid down in Article 3(3) of Directive 1999/45/EC;
(b) najvišje dovoljene koncentracije iz Priloge I Direktive 67/548/EGS;
(b) the concentration limit values given in Annex I to Directive 67/548/EEC;
(c) najvišje dovoljene koncentracije iz dela B Priloge II k Direktivi št. 1999/45/ES;
(c) the concentration limit values given in Part B of Annex II to Directive 1999/45/EC;
(d) najvišje dovoljene koncentracije iz dela B Priloge III k Direktivi št. 1999/45/ES;
(d) the concentration limit values given in Part B of Annex III to Directive 1999/45/EC;
(e) najvišja dovoljena koncentracija iz sporazumno določenega popisa razvrstitev in oznak, vzpostavljenega v naslovu V Uredbe (ES) št. 1272/2008;
(e) the concentration limit given in an agreed entry in the classification and labelling inventory established under Title V of Regulation (EC) No 1272/2008;