FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: With a view to achieving a high level of protection of human health, animal health and the environment, active substances with the worst hazard profiles should not be approved for use in biocidal products except in specific situations. These should include situations when approval is justified because of the negligible risk from exposure to the substance, human health, animal health or environmental reasons or the disproportionate negative impact for society of non-approval.
Spanish: Con el fin de conseguir un elevado nivel de protección de la salud humana y animal y del medio ambiente, las sustancias activas con los peores perfiles de peligro no deben aprobarse para su uso en biocidas, salvo en situaciones específicas, como aquellas en que la aprobación se justifique por ser desdeñable el riesgo de exposición a la sustancia, por motivos relacionados con la salud humana o animal o el medio ambiente, o por entrañar la no aprobación de efectos negativos desproporcionados para la sociedad.
English: Where, in the opinion of the Agency, additional information is necessary to carry out the assessment of technical equivalence, the Agency shall ask the applicant to submit such information within a time limit specified by the Agency. The Agency shall reject the application if the applicant fails to submit the additional information within the specified time limit.
Spanish: Si fuera necesaria, en opinión de la Agencia, información adicional para efectuar la evaluación de la equivalencia técnica, la Agencia pedirá al solicitante que presente dicha información dentro de un plazo especificado por la misma.
English: To ensure the uniform application of paragraph 1 of this Article, the Commission shall adopt implementing acts to specify the form and content of the information in records. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 82(2).
Spanish: Con el fin de garantizar la aplicación uniforme de lo dispuesto en el apartado 1 del presente artículo, la Comisión adoptará actos de ejecución para especificar la forma y el contenido de la información contenida en los registros, de acuerdo con el procedimiento consultivo contemplado en el artículo 82, apartado 2.
Polish: Aby zapewnić ujednolicone stosowanie ust. 1 niniejszego artykułu, Komisja przyjmuje akty wykonawcze mające na celu określenie formy i treści informacji zawartych w dokumentacji zgodnie z procedurą doradczą, o której mowa w art. 82 ust. 2.
Latvian: Lai nodrošinātu šā panta 1. punkta vienādu piemērošanu, Komisija saskaņā ar 82. panta 2. punktā minēto konsultēšanās procedūru pieņem īstenošanas aktus, precizējot uzskaites dokumentos norādāmās informācijas formu un saturu.
English: If the biocidal product is in the form of bait or granules ADS
Spanish: Si el biocida está en forma de cebo o gránulos: DOCUMENTACIÓN ADICIONAL
English: The estimation of the incidence and severity of the adverse effects likely to occur in a human population, animals or environmental compartments due to actual or predicted exposure to any active substance or substance of concern in a biocidal product. This may include ‘risk estimation’, i.e. the quantification of that likelihood.
Spanish: Estimación de la incidencia y gravedad de los efectos adversos probables en las poblaciones humanas, los animales o los compartimentos del medio ambiente, debidos a la exposición real o prevista a cualquier sustancia activa o de posible riesgo contenida en un biocida; puede incluir la «estimación del riesgo», es decir, la cuantificación de esa probabilidad.
Dutch: De inschatting van de incidentie en ernst van de schadelijke effecten waarvan de kans bestaat dat zij in een bevolkingsgroep, bij dieren of in een milieucompartiment zullen optreden als gevolg van een feitelijke of verwachte blootstelling aan een werkzame stof of een tot bezorgdheid aanleiding gevende stof in een biocide, eventueel met inbegrip van de „schatting van het risico”, dat wil zeggen de kwantificering van die kans.
English: If there is a positive result from an in vivo somatic cell study available, the potential for germ cell mutagenicity should be considered on the basis of all available data, including toxicokinetic evidence to demonstrate that the substance reached the tested organ. If no clear conclusions about germ cell mutagenicity can be made, additional investigations shall be considered
Polish: jeśli dostępne jest badanie na komórkach somatycznych in vivo i jego wynik jest pozytywny, należy rozważyć potencjał substancji w zakresie mutacji komórek płciowych na podstawie wszystkich dostępnych danych, w tym danych toksykokinetycznych, dowodzących, że substancja dostała się do badanego organu; jeśli nie można dojść do jednoznacznych wniosków na temat powodowania mutacji komórek płciowych, należy rozważyć dodatkowe badania.
Estonian: kui in vivo uuring somaatiliste rakkudega on andnud positiivse tulemuse, tuleks sugurakkudele mutageense toime avaldamise võimalust kaaluda kõikide kättesaadavate andmete, sealhulgas toksikokineetiliste tõendite põhjal, et tõendada aine jõudmist uuritud organisse; kui ei ole võimalik teha järeldusi sugurakkudele mutageense toime avaldamise kohta, tuleks kaaluda täiendavaid uuringuid.
Latvian: ja kādā pieejamā in vivo somatisko šūnu pētījumā ir iegūts pozitīvs rezultāts, vajadzētu apsvērt dzimumšūnu mutagenitātes iespējamību, pamatojoties uz visiem pieejamajiem datiem, tostarp toksikokinētiskiem pierādījumiem, lai pierādītu, ka viela ir sasniegusi orgānu, kuram veic testu; ja nevar izdarīt skaidrus secinājumus par dzimumšūnu mutagenitāti, apsver iespēju veikt papildu pētījumus
English: Respiratory sensitisation ADS
Estonian: Hingamiselundite sensibiliseerimine
English: This concentration is known as PNEC. However, in some cases, it may not be possible to establish a PNEC and a qualitative estimation of the dose (concentration) — response (effect) then has to be made.
Estonian: Mõnikord ei ole siiski võimalik PNECi kindlaks määrata ja sellisel juhul tuleb doosi (kontsentratsiooni) ja sellele reageerimise (mõju) vahelise seose kohta anda kvalitatiivne hinnang.
English: If relevant acceptable field data exist, these can be used. ISO, CEN or other international standard method
Estonian: ISO (Rahvusvaheline Standardiorganisatsioon), CENi (Euroopa Standardikomitee) või muu rahvusvaheline standardmeetod;
English: TITLE 2 MICRO-ORGANISMS Core data set and additional data set 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.
Finnish: Kuhunkin tässä liitteessä säädettyyn tietovaatimukseen sovelletaan myös liitteessä II olevan taulukon sarakkeissa 1 ja 3 saman tietovaatimuksen osalta annettuja ohjeita.
Lithuanian: Kiekvieno šiame priede nustatyto informacijos reikalavimo atveju taip pat taikomi II priedo 1 ir 3 skiltyse pateikti, su tuo pačiu informacijos reikalavimu susiję, nurodymai
English: If the only route of exposure is the oral route, then information for only that route need be provided. If either the dermal or inhalation route is the only route of exposure to humans then an oral test may be considered.
French: Si la seule voie d’exposition est la Si voie orale, il y a lieu de fournir des informations pour cette voie uniquement. la voie cutanée ou respiratoire est la seule voie d’exposition pour l’homme, alors un essai oral peut être envisagé.
English: Where testing is done, a detailed description (specification) of the active substance used and its impurities must be provided. Testing should be performed with the active substance as manufactured or, in the case of some of the physical and chemical properties (see indications given in column I of the table), with a purified form of the active substance.
Hungarian: Vizsgálatok végzése esetén részletes leírást (jellemzést) kell adni a felhasznált hatóanyagról és annak szennyeződéseiről.
Latvian: Ja ir veikta testēšana, jāsniedz izmantotās aktīvās vielas un tās piemaisījumu detalizēts apraksts (specifikācija).
English: Product-type 5: Drinking water Products used for the disinfection of drinking water for both humans and animals.
Hungarian: V. MELLÉKLET
Latvian: V PIELIKUMS
English: Products used as preservatives for the storage or use of rodenticide, insecticide or other baits. Product-type 7: Film preservatives
Hungarian: Élelmiszerrel vagy takarmánnyal közvetlenül nem érintkező felületek, anyagok, berendezések és bútorok fertőtlenítésére használt termékek.
English: The Agency shall inform the applicant of the fees payable under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant and the evaluating competent authority accordingly.
Italian: L’Agenzia informa il richiedente delle tariffe da pagare a norma dell’articolo 80, paragrafo 1, e, qualora il richiedente non paghi le tariffe entro trenta giorni, respinge la domanda e ne informa il richiedente e l’autorità di valutazione competente.
Swedish: Denna behöriga myndighet ska vara den utvärderande behöriga myndigheten.
English: The evaluating 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.
Italian: L’autorità di valutazione competente informa il richiedente delle tariffe da pagare a norma dell’articolo 80, paragrafo 2, e, qualora il richiedente non paghi le tariffe entro trenta giorni, essa respinge la domanda e ne informa il richiedente.
English: 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.
Italian: L’autorità competente ricevente informa il richiedente delle tariffe da pagare a norma dell’articolo 80, paragrafo 2, e, qualora il richiedente non paghi le tariffe entro trenta giorni, respinge la domanda e ne informa il richiedente.
English: 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.
Italian: L’autorità competente ricevente informa il richiedente delle tariffe da pagare a norma dell’articolo 80, paragrafo 2, e, qualora il richiedente non paghi le tariffe entro trenta giorni, respinge la domanda e ne informa il richiedente.
English: 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.
Italian: Le autorità competenti degli Stati membri interessati informano il richiedente delle tariffe da pagare a norma dell’articolo 80 e, qualora il richiedente non paghi le tariffe entro trenta giorni, esse respingono la domanda e ne informano il richiedente e le altre autorità competenti.
English: The competent authorities of the reference Member State and of the Member States concerned shall inform the applicant of the fees payable in accordance with 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.
Italian: Le autorità competenti dello Stato membro di riferimento e degli Stati membri interessati informano il richiedente delle tariffe da pagare a norma dell’articolo 80 e, qualora il richiedente non paghi le tariffe entro trenta giorni, esse respingono la domanda e ne informano il richiedente e le altre autorità competenti.
English: The Agency shall inform the applicant of the fees payable under Article 80(1), and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant and the evaluating competent authority accordingly.
Italian: L’Agenzia informa il richiedente delle tariffe da pagare a norma dell’articolo 80, paragrafo 1, e, qualora il richiedente non paghi le tariffe entro trenta giorni, essa respinge la domanda e ne informa il richiedente e l’autorità di valutazione competente.
English: The Agency shall inform the applicant of the fees payable to it under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant and the evaluating competent authority accordingly.
Italian: L’Agenzia informa il richiedente delle tariffe da pagare a norma dell’articolo 80, paragrafo 1, e, qualora il richiedente non paghi le tariffe entro trenta giorni, essa respinge la domanda e ne informa il richiedente e l’autorità di valutazione competente.
English: At the reasoned request of an authorisation holder, the competent authority that granted the national authorisation or, in the case of Union authorisation, the Commission shall cancel the authorisation. Where such a request concerns a Union authorisation, it shall be submitted to the Agency.
Italian: Su richiesta motivata del titolare dell’autorizzazione l’autorità competente che ha rilasciato l’autorizzazione nazionale, o la Commissione in caso di autorizzazione dell’Unione, revoca l’autorizzazione, Qualora la richiesta riguardi un’autorizzazione dell’Unione, essa è inviata all’Agenzia.
English: Persons carrying out an experiment or test shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data, quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. They shall make this information available to the competent authority on request.
Italian: Le persone che effettuano esperimenti o test redigono e conservano la documentazione scritta che descrive in dettaglio l’identità del biocida o del principio attivo, i dati dell’etichetta, le quantità somministrate e il nome e l’indirizzo delle persone che hanno ricevuto il biocida o il principio attivo, e compilano un fascicolo contenente tutti i dati disponibili relativi ai possibili effetti sulla salute dell’uomo o degli animali o all’impatto sull’ambiente, mettendo a disposizione dell’autorità competente, su richiesta, tali informazioni.
English: That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 82(3). It shall apply only with respect to fees paid to the Agency.
Italian: Tale regolamento di esecuzione è adottato secondo la procedura di esame di cui all’articolo 82, paragrafo 3, e si applica solo riguardo alle tariffe pagate all’Agenzia.
Dutch: De uitvoeringsverordening wordt volgens de in artikel 82, lid 3, bedoelde onderzoeksprocedure vastgesteld en is enkel van toepassing op vergoedingen die aan het agentschap zijn betaald.
English: Further repeat dose studies Further repeat dose studies including testing on a second species (non-rodent), studies of longer duration or through a different route of administration shall be undertaken in case of:
Italian: Ulteriori studi a dose ripetuta Ulteriori studi a dose ripetuta, incluso un test su una seconda specie (di non roditori), studi di più lunga durata o attraverso una diversa via di esposizione saranno effettuati nel caso in cui:
Lithuanian: Tolesni kartotinių dozių tyrimai Tolesni kartotinių dozių tyrimai, įskaitant bandymus su antra rūšimi (ne graužikais), ilgesnės trukmės tyrimus arba kitą poveikį prarijus, atliekami, jei:
English: SUMMARY AND EVALUATION The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed
Italian: RIEPILOGO E VALUTAZIONE Si riepilogano e si valutano le informazioni essenziali identificate a partire dai risultati in ciascuna sottosezione (2-12) e si realizza un progetto di valutazione del rischio.
English: Category 3 — Weak acids Category 4 — Traditionally used substances of natural origin Natural oil
Lithuanian: 3 kategorija.
English: Lavender oil CAS 8000-28-0 Natural oil Peppermint oil
Lithuanian: Silpnosios rūgštys
English: CAS 8006-90-4
Dutch: (CAS 8006-90-4)
Latvian: CAS 8006-9-4
Lithuanian: 4 kategorija. Gamtinės kilmės tradiciškai naudojamos medžiagos Gamtinis aliejus Levandų aliejus CAS 8000–28–0 Gamtinis aliejus Pipirmėčių aliejus CAS 8006–90–4
Maltese: CAS 8006-9-4
English: Repeated dose toxicity In general, only one route of administration is necessary and the oral route is the preferred route.
Lithuanian: Kartotinių dozių toksiškumas Apskirtai būtina ištirti tik vieną poveikį prarijus, o tinkamiausias būdas – poveikis prarijus.
English: A decision on the need to perform additional studies on a second species or mechanistic studies should be based on the outcome of the first test (8.10.1) and all other relevant available data (in particular rodent reprotox studies). Preferred species is rat, oral route of administration
Polish: Decyzja dotycząca potrzeby przeprowadzenia dodatkowych badań na drugim gatunku lub badań dotyczących mechanizmów powinna być oparta na wynikach pierwszego badania (8.10.1) oraz na wszelkich innych dostępnych istotnych danych (w szczególności na badaniach Reprotox na gryzoniach); preferowanym gatunkiem jest szczur, preferowanym sposobem podawania jest droga pokarmowa.
Lithuanian: Sprendimas dėl poreikio atlikti papildomus tyrimus su antra gyvūnų rūšimi ar poveikio mechanizmų tyrimus turėtų būti priimamas remiantis pirmo bandymo (8.10.1.) rezultatais ir visais kitais turimais atitinkamais duomenimis (visų pirma graužikų reproduktyvumo ir toksiškumo tyrimais). tinkamiausia gyvūnų rūšis – žiurkės, tinkamiausias veikimo medžiaga būdas – poveikis prarijus
English: If an alternative route is proposed a justification must be provided. For evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route
Lithuanian: Jei siūlomas alternatyvus būdas, turi būti pateiktas pagrindimas Siekiant įvertinti vartotojų saugą veikliųjų medžiagų, kurių gali būti maiste ar pašaruose, atžvilgiu, būtina atlikti toksiškumo prarijus tyrimus.
English: Summary of mammalian toxicology Provide overall evaluation and conclusion with regard to all toxicological data and any other information concerning the active substances including NOAEL
Lithuanian: Žinduolių toksikologijos apibendrinimas Pateikiamas visų toksikologinių duomenų ir kitos informacijos apie veikliąsias medžiagas bendras vertinimas ir išvados, įskaitant nepastebėto NNPL
English: Extent and nature of bound residues The determination and characteristics of bound residues is recommended to be combined with a soil simulation study
Lithuanian: Surištųjų liekanų kiekis ir pobūdis Rekomenduojama surištųjų liekanų nustatymo ir savybių tyrimą sujungti su dirvožemio modeliavimo tyrimu
English: Phototransformation in air (estimation method) Identification of transformation products
Lithuanian: Fototransformacija ore (skaičiavimo metodas) Transformacijos produktų identifikavimas
English: respiratory sensitiser, skin sensitiser,
Latvian: vielas, kas, saskaroties ar ādu, izraisa paaugstinātu jutīgumu,
English: The exposure assessment shall be based on the information in the technical dossier provided in conformity with Articles 6 and 21 and on any other available and relevant information. Particular account shall be taken, as appropriate, of:
Latvian: Kaitīgās ietekmes novērtējuma pamatā ir tehniskajā dokumentācijā norādītā informācija, kas sniegta saskaņā ar 6. un 21. pantu, un cita pieejamā un vajadzīgā informācija.
English: corrosive of category 1A, 1B or 1C, respiratory sensitiser,
Maltese: kategorija 1 A, 1B jew 1C ta’ korrożiv; sensitizzatur respiratorju;
English: The choice for the second route will depend on the nature of the substance and the likely route of human exposure Gases and volatile liquids should be administered by the inhalation route
Maltese: L-għażla tat-tieni rotta tiddependi min-natura tas-sustanza u r-rotta possibbli ta’ espożizzjoni għall-bniedem.
English: 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. Column 1 Information required: Column 2 All data is CDS unless indicated as ADS
Maltese: Kolonna 3
English: Column 3 Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates
Maltese: Regoli speċifiċi għall-adattament minn informazzjoni standard dwar xi rekwiżiti ta’ informazzjoni li jistgħu jeħtieġu l-użu ta’ ttestjar fuq vertebrati
English: It shall be calculated by applying an assessment factor to the reference values resulting from tests on organisms, e.g. LD50 (median lethal dose), LC50 (median lethal concentration), EC50 (median effective concentration), IC50 (concentration causing 50 % inhibition of a given parameter, e.g. growth), NOEL(C) (no-observed-effect level (concentration)), or LOEL(C) (lowest-observed-effect level (concentration)). Where appropriate, other dose-effect descriptors may be used as reference values.
Maltese: Għandha tiġi kkalkolata bl-applikazzjoni ta’ fattur ta’ stima fuq il-valuri ta’ referenza li jirriżultaw mit-testijiet fuq l-organiżmi, eż. LD50 (id-doża letali medjana), LC50 (il-konċentrazzjoni letali medjana), EC50 (il-konċentrazzjoni effettiva medjana), IC50 (il-konċentrazzjoni li tikkawża 50 % ta’ inibizzjoni ta’ parametru mogħti, eż. it-tkabbir), NOEL(C) (il-livell bla effett osservat (il-konċentrazzjoni), jew LOEL(C) (il-livell bl-inqas effett osservat (il-konċentrazzjoni)). Fejn ikun il-każ, jistgħu jintużaw deskritturi oħrajn tal-effett tad-doża bħala valuri ta’ referenza.
English: An applicant may propose to adapt the data as part of the dossiers required under points (a) and (b) of paragraph 1 in accordance with Annex IV. The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with a reference to the specific rules in Annex IV.
Dutch: Een aanvrager kan voorstellen de gegevensvereisten krachtens lid 1, onder a) en b), aan te passen overeenkomstig bijlage IV. De voorgestelde aanpassingen van de gegevensvereisten moeten in de aanvraag duidelijk worden gemotiveerd met een verwijzing naar de specifieke bepalingen van bijlage IV.
English: The applicant may propose to adapt the data requirements of Article 20 in accordance with Annex IV. The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with reference to the specific rules in Annex IV.
Dutch: De aanvrager kan voorstellen de gegevensvereisten van artikel 20 aan te passen overeenkomstig bijlage IV. De voorgestelde aanpassingen van de gegevensvereisten moeten in de aanvraag duidelijk worden gemotiveerd met een verwijzing naar de specifieke bepalingen van bijlage IV.
English: Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 82(2). A Member State wishing to obtain such a derogation shall apply to the Commission, providing due justification.
Dutch: Deze uitvoeringsmaatregelen worden vastgesteld volgens de in artikel 82, lid 2, bedoelde raadplegingsprocedure. lidstaten die een dergelijke afwijking wensen, dienen daartoe bij de Commissie een met redenen omklede aanvraag in.
English: The Commission shall be assisted by the Standing Committee on Biocidal Products (‘the committee’). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
Dutch: De Commissie wordt bijgestaan door het Permanent Comité voor biociden („het comité”) Dat comité is een comité als bedoeld in Verordening (EU) nr. 182/2011.
English: CAS 8000-28-0
Dutch: (CAS 8000-28-0)