FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: If, following the procedures laid down in Articles 27 and 28(2), it is decided that the active substance does not satisfy the requirements specified in Article 10, the Member State shall ensure that the provisional authorisation is cancelled. In cases where evaluation of dossiers for the purposes of inclusion of an active substance in Annex I or IA is not completed when the period of three years expires, the competent authority may further provisionally authorise the product for a period not exceeding one year, providing there are good reasons to believe the active substance will satisfy the requirements of Article 10.
Lithuanian: Valstybė narė, nukrypdama nuo 3 straipsnio 1 dalies, 5 straipsnio 1 dalies, 8 straipsnio 2 ir 4 dalių nuostatų ir nepažeisdama šio straipsnio 2 ir 3 dalių, gali dar dešimt metų nuo 34 straipsnio 1 dalyje nurodytos datos taikyti jos dabartinę biocidinių produktų pateikimo į rinką sistemą arba praktiką.
English: Member States shall inform other Member States and the Commission of such action. Article 16 Transitional measures
Lithuanian: Visų pirma, laikydamasi nacionalinių taisyklių, ji gali leisti pateikti į jos teritorijos rinką biocidinį produktą, turintį veikliosios medžiagos, kuri neįrašyta į I arba IA priedą šiai produktų grupei.
English: By way of further derogating from Articles 3(1), 5(1), 8(2) and 8(4), and without prejudice to paragraphs 2 and 3, a Member State may, for a period of 10 years from the date referred to in Article 34(1), continue to apply its current system or practice of placing biocidal products on the market. It may, in particular, according to its national rules, authorise the placing on the market in its territory of a biocidal product containing active substances not listed in Annex I or IA for that product type.
Polish: W drodze dalszych odstępstw od przepisów art. 3 ust. 1, art. 5 ust. 1 i art. 8 ust. 2 i 4, i bez uszczerbku do ust. 2 i 3, Państwo Członkowskie może, na okres 10 lat licząc od daty, określonej w art. 34 ust. 1, w dalszym ciągu stosować swój system i praktykę obowiązującą przy wprowadzaniu na rynek produktów biobójczych. W szczególnych wypadkach może ono, zgodnie z obowiązującymi przepisami krajowymi, zezwolić na wprowadzenie na rynek na jego terytorium produktu biobójczego zawierającego substancje czynne, które nie są ujęte w załączniku I lub I A dla produktu tego typu.
Lithuanian: 34 straipsnio 1 dalyje nurodytą datą tokios veikliosios medžiagos turi būti rinkoje kaip biocidinio produkto veikliosios medžiagos, nenaudojamos pagal 2 straipsnio 2 dalies c ir d punktuose nurodytą paskirtį.
English: Following the adoption of this Directive, the Commission shall commence a 10-year programme of work for the systematic examination of all active substances already on the market on the date referred to in Article 34(1) as active substances of a biocidal product for purposes other than those defined in Article 2(2)(c) and (d). A Regulation, adopted according to the procedure laid down in Article 28(3), will provide for all provisions necessary for the establishment and implementation of the programme including the setting of priorities for the evaluation of the different active substances and a timetable. No later than two years before completion of the work programme, the Commission shall forward to the European Parliament and the Council a report on the progress achieved with the programme. During that 10-year period and from the date referred to in Article 34(1), it may be decided pursuant to the procedure laid down in Article 28(3) that an active substance shall be included in Annexes I, IA or IB and under which conditions, or, in cases where the requirements of Article 10 are not satisfied or the requisite information and data have not been submitted within the prescribed period, that such active substance shall not be included in Annex I, IA or IB.
Lithuanian: Per tuos dešimtį metų, pradedant 34 straipsnio 1 dalyje nurodyta data, 28 straipsnio 3 dalyje nustatyta tvarka gali būti nuspręsta įrašyti veikliąją medžiagą į I, IA arba IB priedus ir nustatyti įrašymo sąlygas, o tada, kai nesilaikoma 10 straipsnio reikalavimų arba per nustatytą laiką nebuvo pateikta reikalinga informacija arba duomenys, - neįrašyti jos į I, IA arba IB priedus.
English: Labels shall not be misleading or give an exaggerated impression of the product and, in any case, not mention the indications 'low-risk biocidal product`, 'non-toxic`, 'harmless` or similar indications. In addition, the label must show clearly and indelibly the following:
Lithuanian: Etiketės neturi klaidinti arba daryti pernelyg gerą įspūdį apie produktą, ir jose niekada neturi būti nuorodų "mažos rizikos biocidinis produktas", "netoksiškas", "nekenksmingas" ir pan. Be to, etiketėje turi būti aiškiai ir neištrinamai nurodyta:
English: GIL-ROBLES For the Council
Lithuanian: GIL-ROBLES J. CUNNINGHAM
English: The President J. CUNNINGHAM
Lithuanian: I PRIEDAS
English: Opinion of the European Parliament of 18 April 1996 (OJ C 141, 13.5.1996, p. 191), Council common position of 20 December 1996 (OJ C 69, 5.3.1997, p. 13) and Decision of the European Parliament of 13 May 1997 (OJ C 167, 2.6.1997, p. 24). Council Decision of 18 December 1997.
Lithuanian: VEIKLIŲJŲ MEDŽIAGŲ SĄRAŠAS, KURIAME IŠDĖSTYTI BENDRIJOS LYGIU SUDERINTI REIKALAVIMAI DĖL BIOCIDINIŲ PRODUKTŲ ĮRAŠYMO
English: ANNEX I LIST OF ACTIVE SUBSTANCES WITH REQUIREMENTS AGREED AT COMMUNITY LEVEL FOR INCLUSION IN BIOCIDAL PRODUCTS
Lithuanian: VEIKLIŲJŲ MEDŽIAGŲ SĄRAŠAS, KURIAME IŠDĖSTYTI BENDRIJOS LYGIU SUDERINTI REIKALAVIMAI DĖL MAŽOS RIZIKOS BIOCIDINIŲ PRODUKTŲ ĮRAŠYMO
English: LIST OF BASIC SUBSTANCES WITH REQUIREMENTS AGREED AT COMMUNITY LEVEL ANNEX IIA
French: LISTE DES SUBSTANCES DE BASE ET DES EXIGENCES Y RELATIVES APPROUVÉES AU NIVEAU COMMUNAUTAIRE ANNEXE II A
German: LISTE DER GRUNDSTOFFE MIT AUF GEMEINSCHAFTSEBENE VEREINBARTEN ANFORDERUNGEN ANHANG IIA
Spanish: LISTA DE SUSTANCIAS BÁSICAS Y REQUISITOS ACEPTADOS A NIVEL COMUNITARIO ANEXO IIA
Portuguese: LISTA DE SUBSTÂNCIAS DE BASE CUJOS REQUISITOS FORAM DECIDIDOS A NÍVEL COMUNITÁRIO ANEXO II A
Greek: ΚΑΤΑΛΟΓΟΣ ΒΑΣΙΚΩΝ ΟΥΣΙΩΝ ΚΑΙ ΑΠΑΙΤΗΣΕΙΣ ΠΟΥ ΕΧΟΥΝ ΣΥΜΦΩΝΗΘΕΙ ΣΕ ΚΟΙΝΟΤΙΚΟ ΕΠΙΠΕΔΟ ΠΑΡΑΡΤΗΜΑ IIA
Lithuanian: PAGRINDINIŲ MEDŽIAGŲ SĄRAŠAS, KURIAME IŠDĖSTYTI BENDRIJOS LYGIU SUDERINTI REIKALAVIMAI IIA PRIEDAS
English: COMMON CORE DATA SET FOR ACTIVE SUBSTANCES CHEMICAL SUBSTANCES
Lithuanian: CHEMINĖS MEDŽIAGOS
English: (1*) OJ L 154, 5.6.1992, p. 1. (2**) OJ L 229, 30.8.1980, p. 11.
Lithuanian: Šie duomenys turi būti pateikti dėl nurodytos specifikacijos grynosios veikliosios medžiagos.
English: Eye irritation test shall not be necessary where the active substance has been shown to have potential corrosive properties. (6) The long-term toxicity and carcinogenicity of an active substance may not be required where a full justification demonstrates that these tests are not necessary.
Lithuanian: Jei išimtiniais atvejais tvirtinama, kad tokie tyrimai nebūtini, toks tvirtinimas turi būti visapusiškai pagrįstas.
English: COMMON CORE DATA SET FOR BIOCIDAL PRODUCTS CHEMICAL PRODUCTS
Lithuanian: CHEMINIAI PRODUKTAI
English: Summary and evaluation of parts 1, 2, 3 and 4 (1) These data must be submitted for the purified active substance of stated specification.
Lithuanian: 1, 2, 3 ir 4 dalių santrauka ir įvertinimas.
English: ANNEX IIIB ADDITIONAL DATA SET FOR BIOCIDAL PRODUCTS
Lithuanian: CHEMINIAI PRODUKTAI
English: CHEMICAL PRODUCTS 1. Dossiers on biocidal products are required to address at least all the points listed under 'Dossier requirements`.
Lithuanian: Reikalaujama, kad biocidinių produktų dokumentuose būtų išdėstyta bent jau ta informacija, kuri išvardyta "Dokumentų reikalavimuose".
English: Methods and precautions to be taken for storage, handling, transport and use;
Portuguese: Métodos e precauções a adoptar no que respeita ao armazenamento, manuseamento, transporte e utilização,
Czech: Postupy a bezpečnostní opatření, které je třeba přijmout pro skladování, manipulaci, přepravu a používání;
Slovenian: Postopki in previdnostni ukrepi pri shranjevanju, rokovanju, prevozu in uporabi;
Latvian: Ieteicamās metodes un profilakse uzglabāšanai, apstrādei, transportēšanai un izmantojumam;
Lithuanian: Metodai ir atsargumo priemonės, kurių reikia imtis saugant, tvarkant, vežant ir naudojant veikliąsias medžiagas;
Maltese: Il-metodi u l-prekawzjonijiet li jridu jittieħdu għall-ħażna, it-tqandil, it-trasport u l-użu;
English: or in the event of fire or other likely incident
Portuguese: ou em caso de incêndio ou de qualquer outro acidente provável
Czech: nebo v případě požáru či jiné předvídatelné události
Slovenian: ali ob požaru ali drugi morebitni nesreči
Latvian: ugunsgrēka, vai cita iespējama incidenta gadījumā
Lithuanian: arba gaisro atveju bei kitais netikėtais atvejais.
Maltese: jew fl-eventwalità ta' nar jew inċident ieħor li x'aktarx li jiġri
English: Where, for any of the effects set out in paragraph 21 a NOAEL or LOAEL had been identified, the risk characterisation shall entail comparison of the NOAEL or LOAEL with the evaluation of the dose/concentration to which the population will be exposed. Where a NOAEL or LOAEL cannot be established a qualitative comparison shall be made.
Lithuanian: Jei 21 punkte nurodytiems poveikiams nustačius dozę (koncentraciją), kuri nesukelia pastebimo žalingo poveikio, arba mažiausią dozę (koncentraciją), kuri sukelia pastebimą žalingą poveikį, atliekant rizikos apibūdinimą ji turi būti palyginta su doze (koncentracija), kuri veikia ar gali paveikti visuomenę, o kai dozė (koncentracija), kuri nesukelia pastebimo žalingo poveikio, ar mažiausia dozė (koncentracija), kuri sukelia pastebimą žalingą poveikį, nenustatytos, tai atliekamas kokybinis palyginimas.
English: If relevant acceptable field data exist, these can be used. - ISO, CEN or other international standard method
Estonian: ISO (Rahvusvaheline Standardiorganisatsioon), CEN (Euroopa Standardikomitee) või mõni muu rahvusvaheline standard,
Lithuanian: Tarptautinės standartų organizacijos, Europos standartizacijos komiteto ir kiti tarptautiniai standartiniai metodai.
English: specifies in particular the conditions or restrictions under which the biocidal product may or may not be used. Before issuing an authorisation the Member State shall confirm that these requirements must be satisfied.
Lithuanian: pirmiausia nurodo sąlygas ir apribojimus, pagal kuriuos biocidinis produktas gali ar negali būti naudojamas.
English: Acting in accordance with the procedure laid down in Article 189b of the Treaty in the light of the joint text approved on 16 December 1997 by the Conciliation Committee,
Spanish: De conformidad con el procedimiento establecido en el artículo 189 B del Tratado, a la vista del texto conjunto aprobado el 16 de diciembre de 1997 por el Comité de conciliación,
Italian: deliberando secondo la procedura di cui all'articolo 189 B del trattato , visto il progetto comune approvato il 16 dicembre 1997 del comitato di conciliazione,
English: Whereas, in their resolution of 1 February 1993 on a Community programme of policy and action in relation to the environment and sustainable development, the Council and the representatives of the Governments of the Member States, meeting within the Council, approved the general approach and strategy of the programme presented by the Commission, in which the need for risk management of non-agricultural pesticides is emphasised;
Italian: considerando che nella risoluzione del 1° febbraio 1993 relativa a un programma politico e d'azione della Comunità a favore dell'ambiente e di uno sviluppo sostenibile , il Consiglio e i rappresentanti dei governi degli Stati membri riuniti in sede di Consiglio hanno approvato l'approccio e la strategia generali del programma presentato dalla Commissione, in cui è messa in risalto la necessità della gestione dei rischi dei pesticidi non agricoli;
English: Whereas, both when the eighth Amendment to Council Directive 76/769/EEC of 27 July 1976, on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of dangerous substances and preparations was adopted in 1989 and during the discussion in the Council on Directive 91/414/EEC concerning the placing of plant protection products on the market, the Council expressed concern at the lack of harmonised Community provisions for biocides, formerly known as non-agricultural pesticides, and invited the Commission to examine the situation in Member States and the possibility for action at Community level;
Italian: considerando che nel 1989, al momento dell'adozione dell'ottava modifica della direttiva 76/769/CEE del Consiglio, del 27 luglio 1976, concernente il ravvicinamento delle disposizioni legislative, regolamentari e amministrative degli Stati membri relative alle restrizioni in materia di immissione sul mercato e di uso di talune sostanze e preparati pericolosi, e durante la discussione in sede di Consiglio della direttiva 91/414/CEE relativa all'immissione sul mercato dei prodotti fitosanitari, il Consiglio ha espresso preoccupazione per la mancanza di disposizioni comunitarie armonizzate per i biocidi, un tempo chiamati pesticidi non agricoli, e ha invitato la Commissione a esaminare la situazione negli Stati membri e la possibilità di un'azione a livello comunitario;
English: Whereas when an active substance is evaluated for its entry or otherwise in the relevant annexes of the Directive, it is necessary for such an evaluation to cover, where appropriate, the same aspects as those covered by the evaluation made under Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances and Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances as far as the risk assessment is concerned;
Spanish: Considerando que, por lo que atañe a la evaluación de riesgos, al evaluarse una sustancia activa para su inclusión o no en los anexos correspondientes de la Directiva es preciso que tal evaluación, cuando corresponda, se refiera a los mismos aspectos que la evaluación que se lleve a cabo con arreglo a la Directiva 92/32/CEE del Consejo, de 30 de abril de 1992, por la que se modifica por séptima vez la Directiva 67/548/CEE relativa a la aproximación de las disposiciones legales, reglamentarias y administrativas en materia de clasificación, embalaje y etiquetado de las sustancias peligrosas y al Reglamento (CEE) n° 793/93 del Consejo, de 23 de marzo de 1993, sobre evaluación y control del riesgo de las sustancias existentes;
Italian: considerando che quando si valuta un principio attivo al fine di deciderne l'inclusione o meno nei pertinenti allegati della direttiva è necessario che tale valutazione comprenda, se del caso, gli stessi aspetti contemplati dalla valutazione prevista dalla direttiva 92/32/CEE del Consiglio, del 30 aprile 1992, recante settima modifica della direttiva 67/548/CEE concernente il ravvicinamento delle disposizioni legislative, regolamentari e amministrative relative alla classificazione, all'imballaggio e all'etichettatura delle sostanze pericolose, e dal regolamento (CEE) n. 793/93 del Consiglio, del 23 marzo 1993, relativo alla valutazione e al controllo dei rischi presentati dalle sostanze esistenti, in materia di valutazione dei rischi;
English: Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the EC Treaty was reached on 20 December 1994;
Italian: considerando che il 20 dicembre 1994 è stato raggiunto un accordo sul modus vivendi tra il Parlamento europeo, il Consiglio e la Commissione relativo alle misure di esecuzione degli atti adottati secondo la procedura di cui all'articolo 189 B del trattato;
English: Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States on veterinary medicinal products,
Spanish: Directiva 81/851/CEE del Consejo, de 28 de septiembre de 1981, relativa a la aproximación de las legislaciones de los Estados miembros sobre medicamentos veterinarios;
Italian: direttiva 81/851/CEE del Consiglio, del 28 settembre 1981, per il ravvicinamento delle disposizioni legislative, regolamentari ed amministrative degli Stati membri relative ai medicinali veterinari;
English: Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological medicinal products ,
Italian: direttiva 90/677/CEE del Consiglio, del 13 dicembre 1990, che estende il campo di applicazione della direttiva 81/851/CEE per il ravvicinamento delle legislazioni degli Stati membri relative ai medicinali veterinari e che stabilisce disposizioni complementari per i medicinali veterinari ad azione immunologica;
English: Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption, Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production and European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners,
Italian: direttiva 89/107/CEE del Consiglio, del 21 dicembre 1988, per il ravvicinamento delle legislazioni degli Stati membri concernenti gli additivi autorizzati nei prodotti alimentari destinati al consumo umano, direttiva 88/388/CEE del Consiglio, del 22 giugno 1988, sul ravvicinamento delle legislazioni degli Stati membri nel settore degli aromi destinati ad essere impiegati nei prodotti alimentari e nei materiali di base per la loro preparazione, e direttiva 95/2/CE del Parlamento europeo e del Consiglio relativa agli additivi alimentari diversi dai coloranti e dagli edulcoranti;
English: Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs, Council Directive 82/471/EEC of 30 June 1982 on certain products used in animal nutrition and Council Directive 77/101/EEC of 23 November 1976 on the marketing of straight feedingstuffs,
Italian: direttiva 70/524/CEE del Consiglio, del 23 novembre 1970, relativa agli additivi nell'alimentazione degli animali, direttiva 82/471/CEE del Consiglio, del 30 giugno 1982, relativa a taluni prodotti impiegati nell'alimentazione degli animali e direttiva 77/101/CEE del Consiglio, del 23 novembre 1976, relativa alla commercializzazione degli alimenti semplici per gli animali;
English: Council Directive 80/1107/EEC of 27 November 1980, on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work, Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work and individual Directives based on these Directives,
Spanish: la Directiva 80/1107/CEE del Consejo, de 27 de noviembre de 1980, sobre la protección de los trabajadores contra los riesgos relacionados con la exposición a agentes químicos, físicos y biológicos durante el trabajo, la Directiva 89/391/CEE del Consejo, de 12 de junio de 1989, relativa a la aplicación de medidas para promover la mejora de la seguridad y de la salud de los trabajadores en el trabajo, así como otras directivas fundamentadas en éstas;
Italian: direttiva 80/1107/CEE del Consiglio, del 27 novembre 1980, sulla protezione dei lavoratori contro i rischi derivanti da un'esposizione ad agenti chimici, fisici e biologici durante il lavoro, e direttiva 89/391/CEE del Consiglio, del 12 luglio 1989, concernente l'attuazione di misure volte a promuovere il miglioramento della sicurezza e della salute dei lavoratori durante il lavoro e direttive particolari basate sulle direttive precedenti;
English: Such a substance, unless there are other grounds for concern, would be normally a substance classified as dangerous according to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (39), and present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Article 3 of Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations.
Italian: Tale sostanza, salvo che esistano altri motivi di preoccupazione, sarebbe, in linea di principio, una sostanza definita pericolosa ai sensi della direttiva 67/548/CEE del Consiglio, del 27 giugno 1967, concernente il ravvicinamento delle disposizioni legislative, regolamentari ed amministrative relative alla classificazione, all'imballaggio e all'etichettatura delle sostanze pericolose (39), e presente nel biocida in una concentrazione tale che il prodotto possa essere considerato pericoloso ai sensi dell'articolo 3 della direttiva 88/379/CEE del Consiglio, del 7 giugno 1988, per il ravvicinamento delle disposizioni legislative, regolamentari ed amministrative degli Stati membri relative alla classificazione, all'imballaggio e all'etichettatura dei preparati pericolosi.
English: Article 8
Italian: Articolo 8
Czech: Článek 8
Slovak: Článok 8
Polish: Artykuł 8
Hungarian: 8. cikk
Romanian: Articolul 8
Bulgarian: Член 8
Estonian: Artikkel 8
Latvian: pants
Maltese: L-Artikolu 8
English: Requirements for authorisation
Italian: Requisiti in materia di autorizzazione
Czech: Požadavky na udělení povolení
Slovak: Požiadavky na autorizáciu
Polish: Wymagania dotyczące zezwoleń
Hungarian: Az engedélyezés követelményei
Romanian: Condiții pentru autorizare
Bulgarian: Изисквания за издаване на разрешения
Estonian: Loa andmise nõuded
Latvian: Prasības atļaujai
Maltese: Il-Ħtiġiet għall-awtorizzazzjoni
English: Where appropriate, tests must be conducted in accordance with the provisions laid down in Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes and Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (43).
Italian: Se opportuno, i test devono essere eseguiti in base alle disposizioni di cui alla direttiva 86/609/CEE del Consiglio, del 24 novembre 1986, concernente il ravvicinamento delle disposizioni legislative, regolamentari e amministrative degli Stati membri relative alla protezione degli animali utilizzati a fini sperimentali o ad altri fini scientifici e alla direttiva 87/18/CEE del Consiglio, del 18 dicembre 1986, concernente il ravvicinamento delle disposizioni legislative, regolamentari e amministrative relative all'applicazione dei principi di buona prassi di laboratorio e al controllo della loro applicazione per i test sulle sostanze chimiche (43).
English: In such cases a justification, acceptable to the competent authority must be submitted. Such a justification may be the existence of a frame-formulation to which the applicant has the right of access.
Italian: in tal caso, deve essere presentata una giustificazione accettabile per l'autorità competente, quale ad esempio l'esistenza di una formulazione quadro cui il richiedente abbia diritto di accedere.
Bulgarian: В такива случай трябва да се предаде обяснение, приемливо за компетентният орган.. Това обяснение може да е съществуването на рамкова формулация, до която заявителят има право на достъп.