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1–23/23
risk assessment body
1 Objavljeno
RS
DRUGO: TRANS
Assessment of spontaneous body movements of newborns from video recordings is a diagnostic method that has not yet been introduced in Slovenia. Spontaneous movements of neurologically damaged newborns have been evaluated in order to determine if such movement distinguishes newborns at high risk for possible neurological impairment from healthy ones.
Snemanje spontanega gibanja novorojenčka na videotrak in kasnejše ocenjevanje posnetega gibanja je diagnostična metoda za ocenjevanje nevrološkega stanja novorojenčka. Pri nas je do sedaj še niso uporabljali.
2 Objavljeno
gospodarstvo
Ur. l. RS, št. MP 2001-61
the scope of responsibilities; rights of access to the Head of the SAPARD Agency and to all records, personnel and premises (including decentralised and delegated bodies); the exclusion of members of the internal audit unit from day to day operational actions; staffing (competence, training and experience); planning (needs assessments, risk based approach, cycle of audit coverage); documentation (will the rationale for tests and conclusions be adequately recorded, are supporting papers held); audit evidence (will arrangements ensure it is sufficient, relevant and reliable); are there adequate arrangements for quality assurance; reports (are they adequate in conception and will the procedures ensure they will be timely) and conclusions as to the audit plan.
obseg odgovornosti; pravice dostopa do vodje agencije SAPARD in do vseh evidenc, zaposlenih in prostorov (vključno z decentraliziranimi enotami in inštitucijami, na katere so bile prenesene naloge); izključenost članov enote za notranjo revizijo iz vsakodnevnih operativnih nalog; kadrovanje (znanje, usposabljanje in izkušnje); načrtovanje (ocena potreb, pristop glede na oceno tveganja, revizijski ciklus); dokumentacijo (ali so utemeljitve za preskuse in sklepne ugotovitve ustrezno zapisane ali se bo hranila spremljajoča dokumentacija); revizijske dokaze (ali ureditev zagotavlja zadostne, ustrezne in zanesljive dokaze); ali je ustrezno urejeno zagotavljanje kakovosti; poročila (ali ustrezajo po svoji zasnovi in ali postopki zagotavljajo, da bodo pravočasna) in sklepne ugotovitve glede načrta revizij.
3 Pravna redakcija
promet
This Annex applies to all medical devices which in Canada or the European Community are subject to conformity assessment procedures, including scientific technical evaluations of high risk medical devices and quality systems assessments, by a conformity assessment body.
Ta področna priloga velja za vse medicinske pripomočke, za katera je v Kanadi ali v Evropski skupnosti potrebno ugotavljanje skladnosti, vključno z znanstveno-tehničnim vrednotenjem medicinskih pripomočkov z visoko stopnjo tveganj in ocenjevanji sistemov kakovosti, s strani organa za ugotavljanje skladnosti.
4 Pravna redakcija
promet
When a conformity assessment body seeks designation to evaluate a particular product, process or service for compliance with essential requirements, the accreditation process shall incorporate elements which will permit assessment of the capability (technological knowledge and understanding of the generally stated risk protection requirements of the product, process or service or their use) of the conformity assessment body to evaluate compliance with those essential requirements.
Kadar organ za ugotavljanje skladnosti želi biti imenovan za presojanje določenega proizvoda, procesa ali storitve glede skladnosti s temeljnimi zahtevami, proces akreditacije obsega elemente, ki omogočajo ocenjevanje sposobnosti (tehnološkega znanja in razumevanja splošno izraženih zahtev za varovanje izdelka, proces ali storitve pred tveganji) organa za ugotavljanje skladnosti za vrednotenje skladnosti s temi temeljnimi zahtevami.
5 Pravna redakcija
DRUGO
Notified bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the TSE certificate of suitability issued by the European Directorate for the Quality of Medicines, hereinafter TSE certificate', for starting materials, where available.
Priglašeni organi med ovrednotenjem analize in obvladovanja tveganja v okviru postopka ocenjevanja skladnosti upoštevajo certifikat o ustreznosti TSE, ki ga izda Evropski direktorat za kakovost zdravil, v nadaljevanju TSE-certifikat, za vhodne materiale, če je le-ta na voljo.
6 Pravna redakcija
DRUGO
However, the overall evaluation of the available risk assessments of these substances and of the entire body of available scientific information and data indicate that, as concerns the excess intake of hormone residues and their metabolites, and in view of the intrinsic properties of progestagen hormones and epidemiological findings, a potential risk to the consumer has been identified.
Vendar celotna ocena obstoječih ocen tveganja teh snovi ter celotna nadgradnja obstoječih znanstvenih informacij in podatkov nakazujeta, da pri preseženem vnosu zaostankov hormonov in njihovih metabolitov, ob upoštevanju notranjih lastnosti hormonov progestagenov in epidemioloških ugotovitev, obstaja potencialno tveganje za potrošnika.
7 Pravna redakcija
DRUGO
The Parties agree that agreements on mutual recognition concluded by either Party with any third country may under no circumstances give rise to any obligation on the other to accept reports, certificates, authorisations or marks issued by the conformity assessment bodies of such third countries, except where the Parties have agreed formally thereto.
Pogodbenici se strinjata, da Sporazumi o obojestranskem priznavanju, ki jih ena ali druga pogodbenica sklene s tretjo državo, pod nobenim pogojem ne nalagajo drugi pogodbenici obveznosti do sprejemanja poročil, certifikatov, odobritev ali oznak, ki jih izdajajo organi za ugotavljanje skladnosti teh tretjih držav, razen kadar se pogodbenici o tem izrecno strinjata.
8 Pravna redakcija
DRUGO
The SCF adopted an opinion on the Risk Assessment of Dioxins and Dioxin-like PCBs in Food on 30 May 2001, an update based on new scientific information which has become available since the adoption of the SCF opinion on this matter on 22 November 2000. The SCF fixed a tolerable weekly intake ("TWI") for dioxins and dioxin-like PCBs of 14 pg WHO-TEQ/kg body weight.
ZOŽ je 30. maja 2001 sprejel mnenje o oceni tveganja zaradi dioksinov in dioksinom podobnih PCB-jev v hrani, posodobitev na osnovi novih znanstvenih podatkov, ki so na voljo od sprejetja mnenja ZOŽ o tej zadevi z dne 22. novembra 2000. ZOŽ je določil sprejemljiv tedenski vnos ('TWI') za dioksine in dioksinom podobne PCB-je v količini 14 pg WHO-TEQ/kg telesne mase.
9 Prevajalska redakcija
izobraževanje
CELEX: 31995L0044
As a result of the assessment of the risk the responsible official body shall consider and lay down as appropriate:
Na podlagi ocene nevarnosti pristojni uradni organ po potrebi prouči in določi:
10 Prevajalska redakcija
RS
EMEA
The use of the product in dogs of less than 10 kg or more than 40 kg bodyweight, therefore, should be subject to a risk/ benefit assessment performed by the veterinarian.
Pri uporabi zdravila pri psih s telesno težo, manjšo od 10 kg ali večjo od 40 kg, je zato potrebna ocena razmerja med tveganjem in koristjo, ki jo opravi veterinar.
11 Prevajalska redakcija
izobraževanje
CELEX: 32004D0210
It shall provide opinions on questions concerning emerging or newly identified risks and on broad, complex or multidisciplinary issues requiring a comprehensive assessment of risks to consumer safety or public health and related issues not covered by other Community risk assessment bodies.
Ta odbor daje mnenja o vprašanjih, ki se nanašajo na nastajajoča ali na novo ugotovljena tveganja in o obširnih, zapletenih ali multidisciplinarnih vprašanjih, ki zahtevajo obsežno oceno tveganj za varstvo potrošnikov ali javno zdravje ter o vprašanjih, ki so s tem povezana in jih ne pokrivajo drugi organi Skupnosti, zadolženi za oceno tveganja.
12 Prevajalska redakcija
izobraževanje
CELEX: 32002D1786
Close cooperation and consultation will be expected with Community bodies responsible for risk assessment, monitoring and research in the fields of food and feed safety, environmental protection and product safety.
Pričakuje se tesno sodelovanje in posvetovanje z organi Skupnosti, ki so pristojni za oceno tveganja, nadzor in raziskave na področjih prehrane in varnosti živil, zaščite okolja in varnosti izdelkov.
13 Prevajalska redakcija
izobraževanje
CELEX: 32000L0060
Following this initial characterisation, Member States shall carry out further characterisation of those groundwater bodies or groups of bodies which have been identified as being at risk in order to establish a more precise assessment of the significance of such risk and identification of any measures to be required under Article 11.
Po začetni opredelitvi države članice dodatno opredelijo tista telesa ali skupine teles podzemne vode, za katera je bila ugotovljena ogroženost, da se natančneje oceni pomembnost ogroženosti in določijo kakršni koli ukrepi, zahtevani po členu 11.
14 Prevajalska redakcija
izobraževanje
CELEX: 32000L0060
Operational monitoring shall be carried out for all those groundwater bodies or groups of bodies which on the basis of both the impact assessment carried out in accordance with Annex II and surveillance monitoring are identified as being at risk of failing to meet objectives under Article 4.
Obratovalno spremljanje stanja se izvaja za vsa telesa ali skupine teles podzemne vode, za katera je bilo na podlagi presoje vplivov, izvedene v skladu s Prilogo II, in nadzornega spremljanja stanja ugotovljeno, da morda ne bodo dosegla ciljev po členu 4.
15 Prevajalska redakcija
izobraževanje
CELEX: 32003L0032
Notified bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the TSE certificate of suitability issued by the European Directorate for the Quality of Medicines, hereinafter "TSE certificate", for starting materials, where available.
Priglašeni organi med ovrednotenjem analize in obvladovanja tveganja v okviru postopka ocenjevanja skladnosti upoštevajo certifikat o ustreznosti TSE, ki ga izda Evropski direktorat za kakovost zdravil, v nadaljevanju "TSE-certifikat", za vhodne materiale, če je le-ta na voljo.
16 Prevajalska redakcija
izobraževanje
CELEX: 32001R2584
The overall evaluation of the available risk assessments of these substances and of the entire body of available scientific information and data indicate that, as concerns the excess intake of hormone residues and their metabolites, and in view of the intrinsic properties of hormones and epidemiological findings, a risk to the consumer has been identified.
Skupna evalvacija razpoložljivih ocen tveganja glede teh snovi in vseh razpoložljivih znanstvenih informacij in podatkov kaže, da glede na bistvene lastnosti hormonov in epidemiološke ugotovitve obstaja tveganje za potrošnika, če pride do prekomernega vnosa hormonskih ostankov in njihovih metabolitov.
17 Prevajalska redakcija
izobraževanje
CELEX: 32004D0210
Such a structure must provide the flexibility to allow it to advise the Commission on matters falling under established areas of competence as well as on emerging and newly identified health risks and matters not within the competence of other Community risk assessment bodies.
Takšna struktura mora zagotoviti prožnost, ki omogoča svetovanje Komisiji v zvezi z zadevami, ki spadajo med ustaljena področja pristojnosti kakor tudi v zvezi z nastajajočimi in na novo ugotovljenimi zdravstvenimi tveganji ter zadevami, ki ne spadajo v pristojnost drugih organov Skupnosti, zadolženih za oceno tveganj.
18 Prevajalska redakcija
izobraževanje
CELEX: 32000L0060
Bodies of water forming these areas shall be included within the operational monitoring programme referred to above where, on the basis of the impact assessment and the surveillance monitoring, they are identified as being at risk of failing to meet their environmental objectives under Article 4.
Vodna telesa na teh območjih se vključijo v omenjeni program obratovalnega spremljanja stanja, kadar se na podlagi presoje vplivov in nadzornega spremljanja stanja ugotovi, da morda ne bodo dosegla svojih okoljskih ciljev po členu 4.
19 Prevajalska redakcija
izobraževanje
CELEX: 32000L0060
Operational monitoring shall be carried out for all those bodies of water which on the basis of either the impact assessment carried out in accordance with Annex II or surveillance monitoring are identified as being at risk of failing to meet their environmental objectives under Article 4 and for those bodies of water into which priority list substances are discharged.
Obratovalno spremljanje stanja se izvaja za vsa vodna telesa, za katera je bilo na podlagi presoje vplivov, izvajane v skladu s Prilogo II, ali nadzornega spremljanja stanja ugotovljeno, da morda ne bodo dosegla svojih okoljskih ciljev po členu 4, in za tista vodna telesa, v katera se odvajajo snovi s prednostnega seznama.
20 Prevajalska redakcija
izobraževanje
CELEX: 32004D0210
The fields of competence of the Scientific Committees shall be as set out in Annex I, without prejudice to the competence conferred by Community legislation to other Community bodies undertaking risk assessment, such as the European Food Safety Authority and the European Agency for the Evaluation of Medicinal Products.
Področja pristojnosti znanstvenih odborov so določena v Prilogi I, brez poseganja v pristojnost, ki je po zakonodaji Skupnosti dodeljena drugim organom Skupnosti, zadolženim za oceno tveganja, kakor sta Evropska agencija za varnost hrane in Evropska agencija za oceno medicinskih proizvodov.
21 Prevajalska redakcija
izobraževanje
CELEX: 32003L0074
As regards, in particular, the use of oestradiol 17ß, with the aim of promoting growth, the SCVPH assessment is that a substantial body of recent evidence suggests that it has to be considered as a complete carcinogen, as it exerts both tumour-initiating and tumour-promoting effects and that the data currently available do not make it possible to give a quantitative estimate of the risk.
Zlasti glede uporabe estradiola 17ß z namenom pospeševanja rasti SCVPH ocenjuje, da obsežni najnovejši dokazi potrjujejo, da ga je treba šteti za popolnega karcinogena, ker ima tako učinke povzročanja tumorjev kot pospeševanja rasti tumorjev, in da na podlagi trenutno razpoložljivih podatkov ni mogoče izdelati kvantitativne ocene tveganja.
22 Prevajalska redakcija
izobraževanje
CELEX: 31993L0005
Member States shall take the necessary measures to enable their competent authorities and bodies to cooperate with the Commission and lend it the assistance it needs in the scientific examination of questions of public interest relating to food, particularly in the field of public health, through disciplines such as those associated with medicine, nutrition, toxicology, biology, hygiene, food technology, biotechnology, novel foods and processes, risk assessment techniques, physics and chemistry.
Države članice sprejmejo ukrepe, potrebne zato, da organom in telesom omogočijo sodelovanje s Komisijo in zagotavljanje pomoči, ki jo potrebuje pri znanstvenem proučevanju vprašanj javnega interesa v zvezi z živili, zlasti na področju javnega zdravja, s pomočjo ved, povezanih z medicino, prehranjevanjem, toksikologijo, biologijo, higieno, živilsko tehnologijo, biotehnologijo, novimi živilskimi izdelki in postopki, tehniko ocenjevanja tveganja, fiziko in kemijo.
23 Prevajalska redakcija
izobraževanje
CELEX: 32003L0074
In the light of the results of a dispute settlement case brought before the World Trade Organisation (WTO) by the United States of America and by Canada (the Hormones case)(5) and recommendations made in that respect by the WTO Dispute Settlement Body on 13 February 1998, the Commission immediately initiated a complementary risk assessment, in accordance with the requirements of the Agreement on the application of sanitary and phytosanitary measures (WTO-GATT)(6) as interpreted by the appellate body in the Hormones case, of the six hormonal substances (oestradiol 17ß, testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate) whose administration for animal growth promotion purposes is prohibited by Directive 96/22/EC.
Z vidika zaključkov zadeve o poravnavi spora, ki so jo Svetovni trgovinski organizaciji (STO) predložile Združene države Amerike in Kanada (Hormonska tožba) [5] in priporočil, ki jih je v tej zvezi dal Senat STO za poravnavo sporov dne 13. februarja 1998, je Komisija takoj uvedla dopolnilno oceno tveganj, v skladu z zahtevami Sporazuma o uporabi zdravstvenih in fitosanitarnih ukrepov (STO-GATT) [6], kakor ga je razložil pritožbeni senat v Hormonski tožbi, šestih hormonskih snovi (estradiola 17ß, testosterona, progesterona, trenbolon acetata, zeranola in melengestrol acetata), katerih dajanje živalim za pospeševanje rasti prepoveduje Direktiva 96/22/ES.
Prevodi: en > sl
1–23/23
risk assessment body