FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION:
Polish: Zgodnie z zasadą proporcjonalności określoną w tym artykule, niniejsze rozporządzenie nie wykracza poza to, co jest konieczne do osiągnięcia tego celu,
English: CHAPTER I SCOPE AND DEFINITIONS
Polish: PRZYJMUJĄ NINIEJSZE ROZPORZĄDZENIE:
English: The Murine Local Lymph Node Assay (LLNA) including, where appropriate, the reduced variant of the assay, is the first-choice method for in vivo testing. If another skin sensitisation test is used justification shall be provided
Polish: ocena dostępnych danych uzyskanych w wyniku badań na ludziach i zwierzętach oraz danych alternatywnych; badania in vivo Jeżeli zastosowano inny test działania uczulającego na skórę, należy przedstawić uzasadnienie.
English: An assessment shall be made to demonstrate that the biocidal product does not cause unnecessary suffering in its effect on target vertebrates. This shall include an evaluation of the mechanism by which the effect is obtained and the observed effects on the behaviour and health of the target vertebrates; where the intended effect is to kill the target vertebrate, the time necessary to obtain the death of the target vertebrate and the conditions under which death occurs shall be evaluated.
Portuguese: Proceder-se-á a uma avaliação para demonstrar que os efeitos do produto biocida não provocam sofrimento desnecessário nos vertebrados visados, devendo ser também avaliado o mecanismo através do qual se obtém o efeito, bem como os efeitos observados no comportamento e na saúde dos vertebrados visados; nos casos em que o efeito pretendido for a morte do vertebrado, serão avaliados o tempo necessário para provocar a morte e as condições em que esta ocorre.
English: Applicants seeking the authorisation of a biocidal product meeting the conditions of Article 25 shall submit an application to the Agency, informing it of the name of the competent authority of the Member State that it proposes should evaluate the application and providing written confirmation that that competent authority agrees to do so. That competent authority shall be the evaluating competent authority.
Romanian: Solicitanții care urmăresc autorizarea unui produs biocid care îndeplinește condițiile prevăzute la articolul 25 depun o cerere la Agenție și o informează în legătură cu numele autorității competente a statului membru pe care aceștia o propun pentru evaluarea cererii și furnizează o confirmare scrisă că respectiva autoritate competentă este de acord să evalueze cererea.
English: New tests involving vertebrates shall be conducted as the last available option to comply with the data requirements set out in this Annex when all the other data sources have been exhausted. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall also be avoided. TITLE 1 CHEMICAL PRODUCTS Core data set and additional data set for chemical products
Romanian: Se efectuează teste noi pe vertebrate ca ultimă opțiune disponibilă pentru respectarea cerințelor privind datele prevăzute în prezenta anexă, după ce toate celelalte surse de date au fost epuizate.
English: Information required to support the authorisation of a biocidal product is listed in the table below. For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall also apply.
Romanian: Este necesar să se evite, de asemenea, testarea in vivo cu substanțe corozive la niveluri de concentrație/doză care provoacă coroziune.
English: Article 5(1) 19(1)
Romanian: Articolul 19
English: The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS). The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all active substances.
Slovak: Údaje uvedené v tejto prílohe sú zaradené do súboru základných údajov (CDS – Core Data Set) a súboru doplnkových údajov (ADS – Additional Data Set).
English: However, in some cases the physical or chemical properties of the substance may mean that it is impossible or unnecessary to provide specific data elements belonging to the CDS. With regard to the ADS, the data elements to be provided for a specific active substance shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the substance, existing data, information which is part of the CDS and the types of products in which the active substance will be used and the exposure patterns related to these uses.
Slovak: Údaje, ktoré patria do CDS, sa považujú za základné údaje, ktoré by sa mali v zásade poskytovať pri všetkých účinných látkach.
English: The general considerations regarding adaptation of information requirements as set out in Annex IV shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the Annex II table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates.
Slovak: Pokiaľ ide o ADS, údaje, ktoré sa majú poskytnúť pri konkrétnej účinnej látke, sa určia po zvážení jednotlivých údajov ADS uvedených v tejto prílohe s ohľadom okrem iného na fyzikálne a chemické vlastnosti danej látky, existujúce údaje, informácie zahrnuté do CDS a typy výrobkov, v ktorých sa účinná látka použije, ako aj spôsoby expozície súvisiace s týmto použitím.
English: Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account: the vapour pressure of the substance (a volatile substance has vapour pressure > 1 × 10–2 Pa at 20 °C) and/or
Slovak: Testovanie inhalačným vstupom je vhodné, keď je pravdepodobná expozícia ľudí inhaláciou, pričom sa zohľadňuje:
English: New tests involving vertebrates shall be conducted as the last available option to comply with the data requirements set out in this Annex when all the other data sources have been exhausted. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall also be avoided. TITLE 1 CHEMICAL PRODUCTS
Slovak: Nové testy na stavovcoch sa uskutočňujú po vyčerpaní všetkých ostatných zdrojov údajov ako posledná možnosť ako splniť požiadavky na údaje stanovené v tejto prílohe.
English: Core data set and additional data set for chemical products Information required to support the authorisation of a biocidal product is listed in the table below.
Slovak: Zamedzí sa aj testovaniu žieravých látok in vivo v koncentrácii/dávkach spôsobujúcich poleptanie.
English: Article 69 Article 20(1) and 20(2)
Slovak: článok 69
English: The applicant shall also submit the name of the competent authority of the Member State that it proposes should evaluate the application for renewal and provide written confirmation that that competent authority agrees to do so. That competent authority shall be the evaluating competent authority.
Swedish: Sökanden ska även ange namnet på den behöriga myndighet i medlemsstaten som denne föreslår ska utvärdera ansökan om förnyelse och tillhandahålla en skriftlig bekräftelse på att denna behöriga myndighet samtycker till det.
English: Applicants wishing to apply for a national authorisation in accordance with Article 17 shall submit an application to the receiving competent authority. The receiving competent authority shall inform the applicant of the fees payable under Article 80(2), and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.
Swedish: De sökande som vill ansöka om ett nationellt produktgodkännande i enlighet med artikel 17 ska lämna in en ansökan till den mottagande behöriga myndigheten.
English: Applicants wishing to seek the mutual recognition in sequence, in one or more Member States (‘the Member States concerned’), of the national authorisation of a biocidal product already granted in another Member State in accordance with Article 17 (‘the reference Member State’) shall submit an application to each of the competent authorities of the Member States concerned containing, in each case, a translation of the national authorisation granted by the reference Member State into such official languages of the Member State concerned as it may require. The competent authorities of the Member States concerned shall inform the applicant of the fees payable under Article 80 and shall reject the application if the applicant fails to pay the fees within 30 days. They shall inform the applicant and the other competent authorities accordingly.
Swedish: Sökande som vill ansöka om på varandra följande ömsesidiga erkännanden i en eller flera medlemsstater (nedan kallade de berörda medlemsstaterna) av det nationella godkännande av en biocidprodukt som redan beviljats i en annan medlemsstat i enlighet med artikel 17 (nedan kallad referensmedlemsstaten) ska lämna in en ansökan till de behöriga myndigheterna i de berörda medlemsstaterna som i varje enskilt fall ska innehålla en översättning av referensmedlemsstatens nationella produktgodkännande till de officiella språk som den berörda medlemsstaten kan kräva.
English: This Annex sets out the common principles for the evaluation of dossiers for biocidal products referred to in Article 19(1)(b). A decision by a Member State or the Commission to authorise a biocidal product shall be taken on the basis of the conditions set down in Article 19, taking account of the evaluation carried out according to this Annex.
Swedish: I denna bilaga fastställs de gemensamma principerna för den bedömning av dossierer om biocidprodukter som avses i artikel 19.1 b. Ett beslut av en medlemsstat eller av kommissionen om att godkänna en biocidprodukt ska fattas på grundval av de villkor som anges i artikel 19 och med beaktande av den bedömning som gjorts enligt denna bilaga.