FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: PART B Criteria establishing the safety of GMMs for human health and the environment
German: Dieser Anhang beschreibt allgemein die Kriterien, anhand deren festgestellt werden kann, ob Typen von GVM für die menschliche Gesundheit und die Umwelt sicher sind und in Teil C aufgenommen werden können.
Spanish: En el presente anexo se describen en términos generales los criterios que han de cumplirse para establecer si un MMG es inocuo para la salud humana y el medio ambiente, y puede, por tanto, incluirse en la parte C del mismo.
Dutch: In deze bijlage worden in algemene termen de criteria beschreven waaraan moet worden voldaan bij de vaststelling of typen GGM’s veilig zijn voor de gezondheid van de mens en het milieu en geschikt zijn om in deel C te worden opgenomen.
Finnish: Tässä liitteessä kuvataan yleisellä tasolla arviointiperusteet sen toteamiseksi, ovatko GMM:t turvallisia ihmisten terveydelle ja ympäristölle ja voidaanko ne sisällyttää C osaan.
Hungarian: E melléklet általánosságban meghatározza azon kritériumokat, amelyeknek a GMM-típusok emberi egészségre és a környezetre vonatkozó biztonsági előírásainak létrehozásakor kell megfelelni és e kritériumoknak a C. részbe történő felvételre való alkalmasságát.
Estonian: Käesolevas lisas kirjeldatakse üldiselt kriteeriume, mille põhjal määrata kindlaks GMMi liikide ohutus inimeste tervisele ja keskkonnale ning nende sobivus C osasse.
Maltese: Dan l-Anness jiddeskrivi f’termini ġenerali l-kriterji li jridu jintlaħqu meta tiġi stabbilita s-sigurtà ta’ tipi ta’ GMMs għas-saħħa tal-bniedem u għall-ambjent u kemm ikunu adatti biex jiddaħħlu fil-Parti Ċ.
English: information on such emergency plans, including the relevant safety measures to be applied, is supplied in an appropriate manner, and without their having to request it, to bodies and authorities liable to be affected by the accident. The information shall be updated at appropriate intervals. It shall also be made publicly available.
Greek: στους φορείς και τις αρχές που ενδέχεται να εμπλακούν σε ατύχημα παρέχονται δεόντως στοιχεία σχετικά με τα σχέδια έκτακτης ανάγκης καθώς και τα εφαρμοστέα μέτρα ασφαλείας, χωρίς να το ζητήσουν· ενημέρωση των στοιχείων αυτών πραγματοποιείται σε κατάλληλα χρονικά διαστήματα· επίσης, τα στοιχεία αυτά τίθενται στη διάθεση του κοινού.
English: Containment levels 1 2 3 4 Building
Greek: Επίπεδα περιορισμού
English: Measures to control undesired species such as insects, rodents, arthropods Required Required Required
Greek: Κτήριο
English: Procedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of GMMs Minimise dissemination
Greek: Θερμοκήπιο: μόνιμη κατασκευή [7]
English: Containment and other protective measures for activities in animal units All provisions of Table I A shall apply with the following additions/modifications: Specifications Containment levels 1 2
Greek: Εξοπλισμός
English: Animals kept in appropriate containment facilities such as cages, pens or tanks Optional Optional Optional Optional 6 Filters on isolators or isolated room [11] Not required Optional Required Required Table II Containment and other protective measures for other activities Specifications Containment levels
Greek: Εγκαταστάσεις
English: Extract and input air from the controlled area should be HEPA filtered Not required
Greek: Ο απαγόμενος και ο εισαγόμενος αέρας από και προς τον ελεγχόμενο χώρο πρέπει να διέρχεται από φίλτρο HEPA
English: If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification. However, the applicant may himself request from the competent authority a decision on the grant of a formal authorisation.
Spanish: Si las instalaciones han sido objeto de una notificación previa relativa a actividades confinadas de los tipos 2 o siguientes y se cumplen los requisitos de la autorización, la utilización confinada del tipo 2 podrá iniciarse inmediatamente después de la nueva notificación.
English: Extract and input air from the laboratory should be HEPA [4]-filtered Not required Not required Required (HEPA — extract air except for [3])
Spanish: Exigida (HEPA) [4]: aire de salida, con excepción de [3]
English: details of any biological committees or subcommittees, address and general description of the premises,
Finnish: yksityiskohtaiset tiedot kaikista biologisista komiteoista ja alakomiteoista,
English: Having regard to the opinion of the European Economic and Social Committee [1], Having consulted the Committee of the Regions,
Hungarian: tekintettel a Régiók Bizottságának véleményére [1],
English: The information shall be updated at appropriate intervals. It shall also be made publicly available.
Portuguese: As referidas informações devem ser regularmente actualizadas e colocadas à disposição do público.
Hungarian: A tájékoztatást megfelelő időszakonként, naprakész állapotba kell hozni és a nyilvánosság számára hozzáférhetővé kell tenni.
English: The new elements introduced into this Directive concern only the committee procedures. They therefore do not need to be transposed by the Member States.
Dutch: Daar de nieuwe in deze richtlijn op te nemen onderdelen slechts de comitéprocedure betreffen, is omzetting door de lidstaten niet nodig.
English: The Commission, in consultation with the Member States, shall establish a procedure for the exchange of information pursuant to paragraph 1. It shall also set up and keep at the disposal of the Member States a register of accidents within the scope of this Directive, including an analysis of the causes of the accidents, experience gained and measures taken to avoid similar accidents in the future.
Portuguese: Cabe à Comissão, em consulta com os Estados-Membros, estabelecer um procedimento destinado à troca das informações referidas no n.o 1 e elaborar e manter à disposição dos Estados-Membros um registo dos acidentes abrangidos pela presente directiva, incluindo uma análise das respectivas causas, da experiência adquirida e das medidas tomadas para evitar acidentes semelhantes no futuro.
English: This Annex describes in general terms the elements to be considered and the procedure to be followed to perform the assessment referred to in Article 4(2). Technical guidance notes [1] may be developed in accordance with the regulatory procedure referred to in Article 20(3) in order to facilitate the implementation and explanation of this Annex, in particular as regards Section B.A.
Portuguese: O presente anexo descreve em termos gerais os elementos a considerar e o procedimento a seguir para se efectuar a avaliação referida no n.o 2 do artigo 4.o Poderão ser estabelecidas, pelo procedimento de regulamentação a que se refere o n.o 3 do artigo 20.o, notas técnicas de orientação [1] destinadas a facilitar a execução e explicação do presente anexo, em especial no que se refere à secção B.A.
English: These classes of risk can be used as guidance for the purposes of categorisation of the contained use activities in the four classes of risk referred to in Article 4(3). The user may also take into consideration classification schemes referring to plant and animal pathogens (which are usually established on a national basis).
Portuguese: Essas classes de risco podem ser utilizadas como orientação para a classificação das operações de utilização confinada nas quatro classes de risco referidas no n.o 3 do artigo 4.o O utilizador também poderá tomar em consideração os sistemas de classificação dos patogénios vegetais e animais (habitualmente estabelecidos com base nacional).
English: for contained uses involving only types of GMMs meeting the criteria listed in Annex II, Part B which establish their safety for human health and the environment. These types of GMMs shall be listed in Annex II, Part C.
Slovak: používanie len takých druhov GMM v uzavretých priestoroch, ktoré spĺňajú kritériá uvedené v časti B prílohy II, ktoré zaručujú ich bezpečnosť pre ľudské zdravie a životné prostredie, tieto druhy GMM sú uvedené v časti C prílohy II.
English: Microbiological safety post Not required
Swedish: Mikrobiologisk säkerhetsbänk eller inneslutning