natgillin/translations-raw huggingface dataset:
Komisija sprejme izvedbene ukrepe, ki določajo merila in postopke v zvezi s preklicem dovoljenja ali spremembami pogojev za dovoljenje iz členov od 39 do 41, vključno z mehanizmom za reševanje sporov.
The Commission shall adopt implementing measures specifying the criteria and procedures related to a cancellation of an authorisation or amendments of the terms and conditions of an authorisation under Articles 39 to 41, including a dispute settlement mechanism.
Za zagotovitev nemotenega delovanja postopkov za odpoved in spremembe Komisija sprejme nadaljnje podrobne ukrepe, ki določajo merila in postopke v zvezi s preklicem dovoljenja ali spremembami pogojev za dovoljenje iz členov od 39 do 41, vključno z mehanizmom za reševanje sporov , z delegiranimi akti v skladu s členom 71a in pod pogoji iz členov 71b in 71c.
In order to ensure the smooth functioning of the cancellation and amendment procedures, the Commission shall adopt further detailed measures specifying the criteria and procedures related to a cancellation of an authorisation or amendments of the terms and conditions of an authorisation under Articles 39 to 41, including a dispute settlement mechanism , by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c .
Pristojni organ lahko izda dovoljenje za vzporedno trgovanje za biocidni pripravek, ki je odobren v drugi državi članici (v nadaljnjem besedilu država članica porekla), za dajanje v promet in uporabo v tej državi članici (v nadaljnjem besedilu država članica vnosa), če pristojni organ te države članice ugotovi, da je biocidni pripravek po sestavinah zelo podoben biocidnemu pripravku, ki je že dovoljen na njenem ozemlju (v nadaljnjem besedilu referenčni pripravek).
A competent authority of a Member State (hereinafter referred to as 'Member State of introduction') may grant a parallel trade permit for a biocidal product that is authorised in another Member State (hereinafter referred to as 'Member State of origin') to be placed on the market and used in the Member State of introduction, if it determines that the biocidal product is substantially identical in composition to a biocidal product already authorised in that Member State (hereinafter referred to as 'the reference product').
Pristojni organ države članice (v nadaljnjem besedilu: država članica vnosa) lahko izda dovoljenje za vzporedno trgovanje z biocidnim pripravkom, ki je odobren v drugi državi članici (v nadaljnjem besedilu: država članica porekla), zaradi dajanja v promet in uporabe v državi članici vnosa, če ugotovi, da je biocidni pripravek po svoji sestavi identičen biocidnemu pripravku, ki je že dovoljen v tej državi članici (v nadaljnjem besedilu: referenčni pripravek).
A competent authority of a Member State (hereinafter referred to as 'Member State of introduction') may grant a parallel trade permit for a biocidal product that is authorised in another Member State (hereinafter referred to as 'Member State of origin') to be placed on the market and used in the Member State of introduction, if it determines that the biocidal product is identical in composition to a biocidal product already authorised in that Member State (hereinafter referred to as 'the reference product').
Da bi ugotovili ustrezno ravnovesje med prosto trgovino dobrin in varnim trgom, mora biti ta člen o vzporedni trgovini omejen na enake pripravke na podlagi enakih specifikacij in vsebnosti aktivnih snovi ter sestavin.
In order to find an appropriate balance between free trade of goods and a safe market then this article on parallel trade should be limited to identical products based on the same specification and content of active substances and co-formulants.
Člen 44 – odstavek 3 – uvodni del
Article 44 – paragraph 3 – introductory part
Biocidni pripravek se šteje za zelo podobnega referenčnemu biocidnemu pripravku, če je izpolnjen eden od naslednjih pogojev :
A biocidal product shall be considered as substantially identical to the reference product if one of the following conditions is met:
Biocidni pripravek se šteje za identičnega referenčnemu biocidnemu pripravku, če so izpolnjeni vsi naslednji pogoji :
A biocidal product shall be considered as identical to the reference product if all of the following conditions are met:
Člen 44 – odstavek 3 – točka a
Article 44 – paragraph 3 – point a
(a) vir aktivnih snovi, ki jih vsebuje, je isti, kar zadeva proizvajalca in lokacijo proizvodnega obrata ;
(a) the source of the active substances it contains is the same in terms of manufacturer and location of the production plant;
(a) proizvedla ga je ista družba ali povezano podjetje ali je bil proizveden v okviru dovoljenja v skladu z istim proizvodnim postopkom ;
(a) it has been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process ;
Člen 44 – odstavek 3 – točka b
Article 44 – paragraph 3 – point b
(b) je enak ali podoben, kar zadeva vsebnost neaktivnih snovi in vrsto formulacije;
(b) it is either the same or similar with regard to the non-active substances present and the type of formulation;
(b) je identičen po specifikaciji in vsebini aktivnih snovi in po vrsti formulacije,
(b) it is identical with regard to the specification and content of the active substances and in the type of formulation;
Člen 44 – odstavek 3 – točka c
Article 44 – paragraph 3 – point c
(c) je enak ali enakovreden v smislu možnega neželenega učinka na varnost pripravka, kar zadeva zdravje ljudi ali živali ali okolje.
(c) it is either the same or equivalent in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
(c) je enak ali enakovreden po prisotnih pomožnih snoveh v formulaciji in po velikosti, materialu in obliki embalaže, v smislu možnega neželenega učinka na varnost pripravka, kar zadeva zdravje ljudi ali živali ali okolje.
(c) it is either the same or equivalent with regard to the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
Člen 44 – odstavek 4 – točka (a a) (novo)
Article 44 – paragraph 4 – point a a (new)
(aa) številka vključitve aktivnih snovi, ki jih vsebuje pripravek, in izjava o dostopu v skladu s členom 50, ki jo predloži predlagatelj iz člena 7;
( aa) the registration numbers of the active substances contained in the product and a letter of access in accordance with Article 50 from the applicant referred to in Article 7 ;
Prošnja za dovoljenje za vzporedno trgovanje mora vsebovati tudi številko vključitve aktivnih snovi.
The application for a parallel trade licence must also contain the number of registrations for the active substances.
(c) ime in naslov imetnika dovoljenja za biocidni pripravek v državi članici porekla;
(c) name and address of the authorisation holder in the Member State of origin;
(c) ime in naslov imetnika dovoljenja za biocidni pripravek v državi članici porekla in izjavo o dostopu v skladu s členom 50, ki jo predloži predlagatelj ;
(c) name and address of the authorisation holder in the Member State of origin and a letter of access in accordance with Article 50 from the authorisation holder ;
Prošnja za dovoljenje za vzporedno trgovanje mora vsebovati tudi podatke o izjavi o dostopu, kot določa člen 50.
The application for a parallel trade licence must also contain information relating to the letter of access, as indicated in Article 50.
Ne glede na člena 15 in 16 lahko pristojni organ dovoli za obdobje, ki ne presega devet mesecev , dajanje v promet biocidnega pripravka, ki ni v skladu z določbami te uredbe, in sicer za omejeno in nadzorovano uporabo, če je takšen ukrep potreben zaradi nevarnosti za javno zdravje in okolje, ki je ni mogoče obvladati z drugimi sredstvi.
By way of derogation from Articles 15 and 16, a competent authority may authorise for a period not exceeding nine months , the placing on the market of a biocidal product not complying with the provisions of this Regulation for a limited and controlled use if such a measure is necessary because of a danger to public health or the environment which cannot be contained by other means.
Ne glede na člena 15 in 16 lahko pristojni organ dovoli za obdobje, ki ne presega štirih mesecev , dajanje v promet biocidnega pripravka, ki ni v skladu z določbami te uredbe, in sicer za omejeno in nadzorovano uporabo , če so izpolnjeni vsi naslednji pogoji:
By way of derogation from Articles 15 and 16, a competent authority may authorise for a period not exceeding four months , the placing on the market of a biocidal product not complying with the provisions of this Regulation for a limited and controlled use if all of the following conditions are met:
(a) takšen ukrep je potreben zaradi nevarnosti za javno zdravje in okolje, ki je ni mogoče obvladati z drugimi sredstvi ;
(a) such a measure is necessary because of a danger to public health or the environment which cannot be contained by other means ;
(b) zadevne aktivne snovi je dovoljeno vključiti v Prilogo I ali se jih oceni v skladu s členom 4 te uredbe, zagotovi pa se tudi popolna dokumentacija;
(b) the active substances concerned are approved for inclusion into Annex I or evaluated according to Article 4 of this Regulation and a full dossier is provided ;
(c) če so zadevne aktivne snovi razvrščene kot snovi, ki bodo črtane ali zamenjane, predlagatelj ali pristojni organ pripravi in izvede obvezen načrt nadomestitve, da zadevne snovi zamenja z nenevarnimi kemičnimi snovmi ali drugimi nekemičnimi možnostmi v dveh letih po datumu odobritve; ter
(c) if the relevant active substances are classified as cut-off substances or candidates for substitution, a mandatory substitution plan is established and implemented by the applicant or competent authority in order to replace the relevant substances with non-hazardous chemical or non-chemical alternatives within two years of the date of approval ; and
(d) uporaba pripravka je omejena na pooblaščene poklicne uporabnike v skladu z zahtevami za celostno zatiranje škodljivcev, poleg tega pa se jo ustrezno nadzoruje .
(d) the application of the product is restricted to professional users who are certified pursuant to the requirements for an integrated pest management and the use is appropriately monitored .
(2) Ne glede na točko (a) člena 16(1) in dokler se aktivna snov ne vključi v Prilogo I, lahko pristojni organi in Komisija za obdobje, ki ni daljše od treh let, dovolijo dajanje v promet biocidnega pripravka, ki vsebuje novo aktivno snov, ki ni vključena v Prilogo I.
(2) By way of derogation from point (a) Article 16(1) and until an active substance is listed in Annex I, competent authorities and the Commission may authorise, for a period not exceeding three years, the placing on the market of a biocidal product containing a new active substance not listed in Annex I.
Takšno dovoljenje se lahko izda le, če je bila dokumentacija ocenjena v skladu s členom 8, če je ocenjevalni pristojni organ predložil priporočilo za vključitev nove aktivne snovi v Prilogo I in če pristojni organ, ki je prejel vlogo za začasno dovoljenje, oz. agencija v primeru dovoljenja Skupnosti, meni, da je biocidni pripravek najverjetneje v skladu s točkama (c) in (d) člena 16(1).
Such an authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 8, the evaluating competent authority has submitted a recommendation for inclusion of the new active substance in Annex I and the competent authority which received the application for the provisional authorisation or in case of Community authorisation, the Agency, considers that the biocidal product may be expected to comply with points (c) and (d) of Articles 16(1).
Pristojni organi ali Komisija vnese informacije o dovoljenju iz člena 23(5) v Register biocidnih pripravkov Skupnosti.
The competent authorities or the Commission shall enter the information on the authorisation referred to in Article 23(5) in the Community Register of Biocidal Products.
Če se Komisija odloči, da aktivne snovi ne bo vključila v Prilogo I, pristojni organ, ki je izdal dovoljenje iz prvega pododstavka, ali Komisija prekliče dovoljenje.
If the Commission decides not to include an active substance in Annex I, the competent authority which granted an authorisation referred to in the first subparagraph or the Commission shall cancel that authorisation.
Če Komisija po preteku treh let še ni sprejela odločitve o vključitvi aktivne snovi v Prilogo 1, lahko pristojni organ, ki je izdal začasno dovoljenje, ali
Where a decision on the inclusion of an active substance in Annex I has not yet been adopted by the Commission when the period of three years expires, the competent authority which granted a provisional authorisation, or the
Komisija podaljša začasno dovoljenje za obdobje, ki ni daljše od enega leta, pod pogojem, da obstajajo tehtni razlogi za predpostavko, da bo aktivna snov ustrezala zahtevam iz člena 4.
Commission, may extend the provisional authorisation for a period not exceeding one year, provided there are good reasons to believe that the active substance will satisfy the requirements of Article 4.
Pristojni organi, ki so podaljšali začasno dovoljenje, o tem obvestijo pristojne organe in Komisijo, kjer je primerno.
Competent authorities which extended the provisional authorisation shall inform the other competent authorities and, where appropriate, the Commission of such action.
Nedovoljeni biocidni pripravek ali aktivna snov za izključno uporabo v biocidnem pripravku se ne sme dajati v promet za namen kakršnega koli poskusa ali preskusa, ki lahko vključuje ali ima za posledico sproščanje v okolje, razen če pristojni organ oceni podatke, ki jih je predložila oseba, ki želi dati tak pripravek v promet, in izda nacionalno dovoljenje za ta namen , ki omejuje uporabljene količine ter površine, ki se bodo tretirale, in lahko naloži še druge pogoje.
An unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve, or result in, release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a national authorisation for this purpose which limits the quantities to be used and the areas to be treated and which may impose further conditions.
Pristojni organ nemudoma obvesti Komisijo in druge pristojne organe o izdanem nacionalnem dovoljenju .
The competent authority shall without delay inform the Commission and other competent authorities about the issued national authorisation.
Nedovoljeni biocidni pripravek ali aktivna snov za izključno uporabo v biocidnem pripravku se ne sme dajati v promet za namen kakršnega koli poskusa ali preskusa, ki lahko vključuje ali ima za posledico sproščanje v okolje, razen če pristojni organ oceni podatke, ki jih je predložila oseba, ki želi dati tak pripravek v promet, in za ta namen poda pozitivno mnenje, v katerem lahko naloži še druge pogoje.
An unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve, or result in, release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and delivered a favourable opinion for this purpose which may impose further conditions.
Če pristojni organ ne poda mnenja v tridesetih dneh po prejemu zahtevanih informacij iz odstavka 1, se biocidni pripravek ali aktivna snov lahko da v promet za namen sporočenih poskusov ali preskusov .
If the competent authority fails to deliver an opinion within 30 days after notification of the information required in paragraph 1, the biocidal product or active substance may be placed on the market for the purposes of the notified experiment or test.
V predlogu Komisije bi bilo treba za preskušanje nedovoljenega biocidnega pripravka za namene raziskav in razvoja, ki bi ga bilo treba sprostiti v okolje, prej pridobiti nacionalno dovoljenje.
Under the Commission proposal, a test on an unauthorised biocidal product for research and development purposes which involved the release of the product into the environment would require prior national authorisation.
Čas, potreben za njegovo pridobitev, bi lahko oviral inovacije.
The time required in order to obtain it could hamper innovation.
Namesto tega se zato predlaga, da se določi petnajstdnevni rok, v katerem bi organ ocenil, ali je predlagano preskušanje povezano s kakršnimi koli tveganji, in podal svoje mnenje.
It is proposed instead that a fifteen-day period be set to allow the authority to assess whether the proposed test gives rise to any concern and to deliver its opinion.
Člen 46 – odstavek 3 – pododstavek 2
Article 46 – paragraph 3 – subparagraph 2
Če imajo predlagani poskusi ali preskusi iz odstavkov 1 in 2 neželene učinke na zdravje človeka ali živali, ali nesprejemljiv neželen učinek na okolje, jih pristojni organ zadevne države članice lahko prepove ali pa dovoli ob pogojih, za katere meni, da so potrebni za preprečitev teh posledic.
If the proposed experiments or tests referred to in paragraphs 1 and 2 may have harmful effects on human or animal health or any unacceptable adverse effect on the environment, the competent authority of the Member State concerned may prohibit them or allow them subject to such conditions as it considers necessary to prevent those consequences.
Pristojni organ o teh ukrepih nemudoma obvesti Komisijo in druge pristojne organe.
The competent authority shall without delay inform the Commission and other competent authorities about such measures.
Če imajo predlagani poskusi ali preskusi iz odstavkov 1 in 2 takojšnje ali poznejše neželene učinke na zdravje človeka, zlasti otrok, ali živali, ali nesprejemljiv neželen učinek na okolje, človeka ali živali, jih pristojni organ zadevne države članice lahko prepove ali pa dovoli ob pogojih, za katere meni, da so potrebni za preprečitev teh posledic.
If the proposed experiments or tests referred to in paragraphs 1 and 2 may have harmful effects , whether immediate or delayed on human health, in particular on the health of children, or animal health or any unacceptable adverse effect on the environment , humans, or animals , the competent authority of the Member State concerned may prohibit them or allow them subject to such conditions as it considers necessary to prevent those consequences.
Otroci se pogosto, ne da bi to vedeli, znajdejo na krajih, ki so škropljeni z biocidi in pesticidi in se na njih takoj ali na dolgi rok pokažejo posledice, ki jih je mogoče neposredno ali posredno pripisati škodljivim snovem.
Children are often to be found - unbeknown to themselves - in places which have been sprayed with biocidal products and pesticides, and show reactions – immediately or in the longer term – which are directly or indirectly attributable to the harmful substances.
Člen 46 – odstavek 4 – pododstavek 1
Article 46 – paragraph 4 – subparagraph 1
Komisija sprejme ukrepe za natančno določitev splošno veljavnih največjih količin aktivnih snovi ali biocidnih pripravkov ali biocidnih pripravkov, ki se jih sme sprostiti med preskusi, ter najnujnejše podatke, ki jih je treba predložiti v skladu z odstavkom 2.
The Commission shall adopt measures to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted in accordance with paragraph 2.
Za spodbujanje raziskav in razvoja aktivnih snovi in biocidnih pripravkov Komisija z delegiranimi akti v skladu s členom 71a in pod pogoji iz členov 71b in 71c sprejme ukrepe za natančno določitev splošno veljavnih največjih količin aktivnih snovi ali biocidnih pripravkov ali biocidnih pripravkov, ki se jih sme sprostiti med preskusi, ter najnujnejše podatke, ki jih je treba predložiti v skladu z odstavkom 2.
In order to encourage research and development in active substances and biocidal products, the Commission shall adopt , by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, measures to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted in accordance with paragraph 2.
Člen 46 – odstavek 4 – pododstavek 2
Article 46 – paragraph 4 – subparagraph 2
Tretirane snovi ali izdelki, ki vsebujejo enega ali več biocidnih pripravkov, se ne smejo dajati v promet, razen če so biocidni pripravki , uporabljeni za tretiranje snovi ali izdelkov, dovoljeni za tako uporabo v Skupnosti ali vsaj eni državi članici .
Treated materials or articles that incorporate one or more biocidal products shall not be placed on the market unless the biocidal product(s) used for treating the materials or articles are authorised for this use in the Community or in at least one Member State .
Tretirane snovi ali izdelki, ki vsebujejo enega ali več biocidnih pripravkov, se ne smejo dajati v promet, razen če so aktivne snovi , uporabljene za tretiranje snovi ali izdelkov, navedene v Prilogi I .
Treated materials or articles that incorporate one or more biocidal products shall not be placed on the market unless the active substances used for treating the materials or articles are included in Annex I .
Oseba, odgovorna za dajanje tretiranih izdelkov ali materialov v promet, mora pridobiti izjavo o certifikaciji, ki jo izda imetnik dovoljenja, za vse biocidne pripravke, ki so bili uporabljeni za tretiranje ali so bili dodani izdelkom ali materialom.
The person responsible for placing treated articles or materials on the market shall obtain a letter of certification by the authorisation holder in respect of all biocidal products which have been used in the treatment of those articles o r materials or which have been inserted into the articles or materials.
Tudi oseba, ki daje z biocidnimi pripravki tretirane izdelke ali snovi v promet, mora imeti izjavo o certifikaciji, v kateri so navedeni vsi biocidni pripravki, ki so bili uporabljeni pri izdelku ali snovi.
Any person placing articles or materials treated with biocides on the market should also have a letter of certification listing all the biocides which have been used in the articles and materials.
Člen 47 – odstavek 2 – pododstavek 1 – točka a
Article 47 – paragraph 2 – subparagraph 1 – point a
(a) imena vseh aktivnih snovi, uporabljenih za tretiranje izdelka ali snovi ali iz katerih so izdelki ali snovi sestavljene;
(a) the name of all active substances that were used to treat the article or materials or that were incorporated in the articles or materials;
Določbe o označevanju tretiranih izdelkov in snovi ne bi smele voditi v zahteve po nepotrebnih podatkih ter se ne bi smele prekrivati z obstoječimi zahtevami v sektorski zakonodaji.
The labelling provisions for treated articles and materials should not lead to requirements for unnecessary information and should not overlap with existing requirements under sectoral legislation.
Vedno je treba upoštevati veljavno sektorsko zakonodajo in njene zahteve po podatkih (npr. podatki v zvezi z označevanjem).
Existing sectoral legislation and their information requirements (e.g. labelling,) should always be taken into consideration.
Po uredbi o detergentih mora biti na primer ime sredstva za konzerviranje po INCI označeno na izdelkih za splošno uporabo, za izdelke za institucionalno in industrijsko uporabo pa se zahtevajo podatki o SDS.
E.g, under the Detergent Regulation, the INCI name of the preservative must be labelled on products for the general public and reported in the SDS for Institutional and Industrial products.
Zahteve po dodatnem označevanju so zaradi tega nepotrebne.
Additional labelling requirements are therefore unnecessary.
Člen 47 – odstavek 2 – pododstavek 1 – točka b
Article 47 – paragraph 2 – subparagraph 1 – point b