natgillin/translations-raw huggingface dataset:
Če upoštevamo finančne in institucionalne posledice za vlagatelje prošenj in nacionalne organe, je treba predvideti ustrezno obdobje prilagajanja.
In view of the financial and institutional implications for applicants and the national authorities, there should be an adequate transition period.
I- Predlog Komisije
I- The Commission proposal
Ta predlog uredbe se uporablja za vnos tujih vrst in prenos lokalno neprisotnih vrst za uporabo v ribogojstvu Skupnosti.
This proposal for a regulation applies to the introduction of exotic species and the translocation of locally absent species for their use in Community aquaculture.
Te vrste predstavljajo resnično gospodarsko priložnost za evropsko ribogojstvo, tako z vidika raznolikosti kot zaradi svojih značilnosti, zaradi katerih so lahko bolj primerne za vzrejo v gojiščih kot avtohtone vrste.
These species provide European aquaculture with a real economic opportunity, both in terms of diversification and the characteristics they possess that could make them better suited to rearing in captivity than indigenous species.
Vendar je po mnenju Komisije njihov vnos v evropske ekosisteme v določenih primerih povzročil osiromašenje biotske raznovrstnosti.
However, according to the Commission, in some cases their introduction into European ecosystems has led to a reduction in biodiversity.
Obravnava tega vprašanja predstavlja zato pomemben korak v postopku vnašanja okoljskih vidikov v skupno ribiško politiko (SRP).
Dealing with this issue is therefore an important step towards incorporating environmental concerns in the common fisheries policy (CFP).
Ta predlog je usmerjen v izdelavo sistema dovoljenj na nacionalni ravni za vnose ali prenose vodnih organizmov za uporabo v ribogojstvu.
This proposal centres on the setting-up of an authorisation system at national level for the introduction or translocation of aquatic organisms for use in aquaculture.
Predlagani ukrepi predvidevajo, da se prošnje za vnos ali prenos vložijo pri pristojnih organih države članice prejemnice in da jih obravnava nacionalni svetovalni odbor, ki odloči, ali je predlagani vnos rutinske narave ali ne.
Under the proposed measures, applications for the introduction or translocation of species would be submitted to the competent authority of the Member State of destination and would be subject to consideration by a national advisory committee responsible for establishing whether the proposed introduction is of a routine or non-routine nature.
V primeru, ko gre za nerutinski vnos, se mora oceniti tveganje za okolje.
In the case of non-routine introductions, an environmental risk assessment (ERA) should be carried out.
Dovoljenje se lahko izda samo za premike, pri katerih je ocenjeno tveganje nizko.
Permits should only be granted for movements considered to be of low risk.
Če se predvideva, da je tveganje lahko srednje ali visoko, svetovalni odbor skupaj z vlagateljem prošnje preuči, ali obstajajo primerni blažilni postopki ali tehnologije, ki bi lahko znižali tveganje na sprejemljivo raven.
If the level of risk is deemed to be high or medium, the advisory committee will examine the application in consultation with the applicant to see whether there are suitable mitigation procedures or technologies that could reduce the risk to an acceptable level.
Za nerutinske premike predlog predvideva postopke karantene in v nekaterih primerih lahko pristojni nacionalni organi zahtevajo, da se izvede "poskusni izpust" pred trženjem na široki ravni.
As regards non-routine movements, the proposal provides for quarantine arrangements and, in some cases, the national competent authorities may also request a 'pilot release' prior to the large-scale marketing of species.
Pristojni organ lahko dovoljenja za nerutinske premike izda le v primerih, ko ocena tveganja skupaj z blažilnimi ukrepi kaže nizko stopnjo tveganja za okolje.
The competent authority may only issue permits for non-routine movements in cases where the risk assessment, including any mitigation measures, shows a low risk to the environment.
Vsaka zavrnitev dovoljenja mora biti znanstveno utemeljena.
Any refusal of a permit must be justified on scientific grounds.
Predlagana uredba prav tako postavlja določene zahteve, ki se nanašajo na nepredvidene situacije, postopke nadzorovanja in nacionalne registre.
The proposal for a regulation also sets out a number of requirements in terms of contingency plans, monitoring procedures and national registers.
Predlog se ne uporablja za prenos vodnih organizmov znotraj držav članic, razen v nekaterih primerih, ki so določeni v drugem odstavku člena 2.
The proposal does not cover the translocation of aquatic organisms within Member States except in the cases mentioned in Article 2(2).
Vendar lahko države članice, izjemoma glede na ta odstavek, odločijo, da se predlagana uredba izvaja tudi v primerih prenosa znotraj njihovega ozemlja.
Member States may, however, decide, by derogation from this paragraph, to apply the regulation to translocations within their territories in other cases.
Člen 11 predloga določa poseben postopek posvetovanja z zadevnimi stranmi in potrditev dovoljenj, ko utegnejo morebitni ali znani okoljski vplivi premika morskega organizma, ki je predmet prošnje, vplivati na druge države članice.
Article 11 of the proposal sets out a specific procedure for consulting the parties concerned and confirming permits in cases where the potential or known environmental effects of a proposed movement of an organism are liable to affect other Member States.
Sicer pa pristojni organ lahko dovoljenje kadar koli odvzame, če pride do nepredvidenih dogodkov z negativnimi učinki na okolje ali na avtohtone populacije (člen 12).
Furthermore, at any point in time the competent authority can withdraw the permit if unforeseen events with negative effects on the environment or on native populations occur (Article 12).
Ukrepi v tem predlogu se opirajo na kodeks ravnanja, ki ga je izdelal Mednarodni svet za raziskovanje morja za vnose in prenose morskih organizmov, na Kodeks ravnanja in priročnik s postopki za obravnavanje vnosa in prenosa morskih in sladkovodnih organizmov Evropske svetovalne komisije za ribolov v notranjih vodah, na kanadski nacionalni kodeks za vnos in prenos vodnih organizmov in na instrumente Skupnosti, ki so v veljavi za zaščito biotske raznovrstnosti.
The measures contained in this proposal are based on the 'Code of Practice on the Introductions and Transfers of Marine Organisms' drawn up by the International Council for the Exploration of the Sea (ICES), the 'Code of Practice and Manual of Procedures for consideration of introductions and transfers of marine and freshwater organisms' of the European Inland Fisheries Advisory Commission (EIFAC), the Canadian National Code on the Introduction and Transfer of Aquatic Organisms and on existing Community instruments for the protection of biodiversity.
V letu 2001 se je Komisija v svojem akcijskem načrtu za biotsko raznovrstnost na področju ribištva ( KOM(2001)0162 ) zavezala, da bo preučila vpliv vnosa tujih vrst splošno na okolje.
In its 2001 biodiversity action plan in the area of fisheries ( COM(2001)0162 ), the Commission undertook to study the impact of the introduction of non-indigenous species on the environment as a whole.
Strategija Skupnosti za trajnostni razvoj evropskega ribogojstva iz leta 2002 (KOM(2002)511 končno) je vsebovala zavezo predloga pravil za upravljanje kot odgovor na morebitne negativne posledice teh premikov.
The 2002 Community strategy for the sustainable development of European aquaculture (COM(2002)511 final) promised the proposal of management rules to address the potential negative effects of these movements.
Ukrepi, predvideni v tem predlogu, ne posegajo v pogoje, ki jih postavljajo druge uredbe Skupnosti, zlasti na področju zdravstvenega varstva živali in izdelkov iz ribogojstva in na področju ukrepov proti vnosu v Skupnost organizmov, škodljivih za rastline ali rastlinske proizvode, in proti njihovemu širjenju v Skupnosti (člen 13).
The measures set out in the proposal for a regulation should be without prejudice to the requirements of other Community legislation, in particular that concerning animal health requirements for aquaculture animals and products thereof and protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (Article 13).
II- Pripombe poročevalca
II- Rapporteur's observations
Poročevalec meni, da je izdelava okvira Skupnosti za zagotavljanje primerne zaščite vodnega okolja pred tveganji, povezanimi z uporabo tujih vrst v ribogojstvu, pozitivna.
The rapporteur welcomes the creation of a Community framework to ensure that the marine environment is adequately protected from the risks associated with using exotic species in aquaculture.
Ta okvir je pomemben za razvoj ribogojskega sektorja v Evropi, sektorja, ki je v polnem zamahu in mora začeti z gojenjem različnih vrst, da bi prilagodil proizvodnjo pogojem in potrebam trga.
This framework is important for the development of aquaculture in Europe, a fast-growing sector that must begin diversifying the species reared in order to adapt production to market conditions and requirements.
Potrebno je torej predvideti in preprečiti negativne biološke vplive na avtohtone populacije, vključno z genetskimi spremembami, ter omejiti širjenje nepredvidenih vrst in drugih škodljivih vplivov.
It is necessary therefore, to anticipate and prevent harmful biological interaction with indigenous populations, including genetic change, and to restrict the spread of non-target species and other detrimental effects.
Vendar poročevalec meni, da morajo biti nekatere tuje vrste ali podvrste, vnesene v Evropo že pred desetletji, izvzete s področja izvajanja predlagane uredbe, če nimajo znanih škodljivih vplivov.
Nevertheless, the rapporteur believes that some of the exotic species and varieties that were introduced in Europe several decades ago should be excluded from the scope of the proposal for a regulation if they produce no known harmful effects.
Nekatere tuje vrste so sedaj zelo razširjene in spadajo med običajno uporabljene vrste v ribogojstvu Skupnosti (npr.:šarenka, pacifiška ostriga, krap).
Some originally non-indigenous species are now very widespread and are some the species traditionally used in Community aquaculture (e.g. the rainbow trout, the Pacific oyster and carp).
Poročevalec predlaga, da Komisija, v skladu s členom 30(3) Uredbe (ES) št. 2371/2002, sprejme seznam zadevnih vrst, ki bodo izvzete s področja izvajanja te uredbe na podlagi razpoložljivih znanstvenih podatkov.
The rapporteur proposes that, in line with Article 30(3) of Council Regulation (EC) No 2371/2002, the Commission should adopt a list of species to which this proposal for a regulation will not apply, on the basis of the scientific data available.
Namen drugih predlogov sprememb je:
Other amendments propose:
- skrajšati rok za dajanje ali zavračanje dovoljenj, kajti rok enega leta ni razumen in ne ustreza potrebam sektorja;
- shortening the deadline for decisions to grant or refuse permits, as a one-year deadline seems unreasonable and does not address the sector's needs;
- dovoliti na nacionalni ravni obstoj različnih pristojnih organov in svetovalnih odborov, kadar ta rešitev najbolj ustreza notranji institucionalni organiziranosti vsake države članice;
- allowing the existence at national level of several competent authorities and advisory committees where this arrangement best suits the institutional structure of a Member State;
- zagotoviti zadosten čas med začetkom veljavnosti in začetkom izvajanja predlagane uredbe ter tako omogočiti primerno obdobje prilagajanja.
- ensuring adequate time between the entry into force and the implementation of the proposed regulation for transition purposes.
Poročevalec tudi predlaga dodatno uvodno izjavo, ki bo poudarila, da ribogojstvo ni edini in najbrž tudi ne najpomembnejši vir vnašanja tujih vrst v vodna območja, in da mora ta tema postati del celostnega in skupnega pristopa, ki bo upošteval tveganja, povezana z drugimi področji dejavnosti.
The rapporteur also recommends the inclusion of a recital stressing that aquaculture is not the only or probably even the main reason that exotic species are introduced in the marine environment and that a comprehensive approach should be applied to this issue, taking into account the risks associated with other sectors.
Predlog Uredbe Sveta o uporabi tujih in lokalno neprisotnih vrst v ribogojstvu
Proposal for a Council regulation concerning use of alien and locally absent species in aquaculture
o predlogu Direktive Evropskega parlamenta in Sveta o spremembi direktiv Sveta 90/385/EGS in 93/42/EGS ter Direktive Evropskega parlamenta in Sveta 98/8/ES glede ponovnega pregleda direktiv o medicinskih pripomočkih
on the proposal for a directive of the European Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and of the Council as regards the review of the medical device directives
Anneli Jäätteenmäki , Odbor za notranji trg in varstvo potrošnikov
Anneli Jäätteenmäki , Committee on the Internal Market and Consumer Protection
MNENJE Odbora za notranji trg in zaščito potrošnikov ..........................46
OPINION of the Committee on the Internal Market and Consumer Protection 52
MNENJE Odbora za industrijo, raziskave in energetiko .............................61
OPINION of the Committee on Industry, Research and Energy ...............68
– ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( COM(2005)0681 )
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2005)0681 )
UL C ..., 00.00.2006, str. .... ,
OJ C ..., 00.00.2006, p. .... ,
– ob upoštevanju člena 251(2) in člena 95 Pogodbe ES, v skladu s katerima je Komisija predložila predlog Parlamentu ( C6‑0006/2006 ),
– having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6‑0006/2006 ),
– ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane ter mnenj Odbora za notranji trg in varstvo potrošnikov in Odbora za industrijo, raziskave in energetiko ( A6‑0332/2006 ),
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on the Internal Market and Consumer Protection and the Committee on Industry, Research and Energy ( A6‑0332/2006 ),
(2a) Kar zadeva predelavo, mora Komisija nadalje razmisliti in opraviti širše posvetovanje, da bo lahko preučila, kakšne so možnosti razvoja ustrezne zakonodaje, ki bo zagotavljala visoko raven varnosti bolnikov.
(2a) As regards reprocessing, the Commission should engage in further reflection and wider consultation in order to explore the possible development of appropriate legislation ensuring a high level of patient safety.
Predelovalna industrija je v zadnjih letih razvila potrjene in nadzorovane postopke, ki znatno zmanjšujejo stroške v zdravstvenem sektorju in obseg nevarnih bolnišničnih odpadkov.
In recent years the reprocessing industry has developed validated and controlled procedures, which considerably reduce both costs in the health sector and the volume of hazardous hospital waste.
Vseeno pa zaradi trenutnega pomanjkanja predpisov na ravni EU ne pride do zmanjšanja tveganj, ki jih predstavlja pravno neurejena ponovna predelava medicinskih pripomočkov.
However, the current lack of EU-wide regulation fails to mitigate the risks of the unregulated reprocessing of medical devices.
To pomanjkanje prav tako preprečuje vzpostavitev enakih konkurenčnih pogojev za storitve ponovne predelave.
It also prevents the establishment of level playing field for reprocessing services.
Komisija bi morala zato pripraviti predlog, ki bi temeljil na natančni oceni trenutnih praks in njihovih dejanskih stroškov ter na obstoječih nacionalnih predpisih in tržnih raziskavah.
The Commission should therefore produce a proposal, based on careful assessment of the current practices and their real costs as well as existing national regulations and market studies.
S tem bi morala biti zagotovljena varnost bolnikov in homogeni tržni standardi v sektorju zdravstvenega varstva.
This should ensure patient safety and provide homogeneous market standards in the healthcare sector.
(2b) Kontaktne leče, ki nimajo korekcijskega učinka in se uporabljajo za spreminjanje videza oči, ne veljajo za medicinski pripomoček za namene te direktive.
(2b) Non-corrective contact lenses which are used to change the appearance of the eye are not regarded as medical devices for the purposes of this Directive.
Prodaja in distribucija takih leč brez zdravniškega recepta lahko zaradi odsotnosti posvetovanja ali nadzora okulista vodi k povečanju nepravilne uporabe in tako prestavlja potencialno nevarnost za zdravje.
However, the non-prescribed sale and distribution of those lenses may in the absence of consultation or supervision from professional eye care practitioners lead to an increase in their incorrect use and therefore pose a potential health risk.
UVODNA IZJAVA 2 C (novo)
RECITAL 2 C (new)
(2c) Komisija mora preučiti obstoječi prodajni in distribucijski sistem kontaktnih leč v državah članicah, oceniti možno nevarnost za zdravje in varnost potrošnikov ter sprejeti ustrezne zakonodajne in nezakonodajne ukrepe, da bi zagotovila visoko raven varovanja zdravja v Skupnosti.
(2c) The Commission should investigate the current sale and distribution system of contact lenses in Member States, evaluate the potential risks to the health and safety of consumers and take the appropriate measures, legislative or non-legislative, in order to ensure a high level of health protection in the Community.
Poročilo o teh ugotovitvah in morebitnih ukrepih je treba predstaviti pristojnim odborom Evropskega parlamenta v šestih mesecih po sprejetju Direktive.
A report on such findings and any eventual proceedings should be presented to the relevant committees of the European Parliament within six months of the adoption of this Directive.
(6) Treba je pojasniti, da je obravnavanje izdelka, ki ima medicinski namen, bistveno za opredelitev medicinskega pripomočka in da je programska oprema sama po sebi opredeljena kot medicinski pripomoček.
(6) It is necessary to clarify that consideration of a product having a medical purpose is intrinsic to the definition of a medical device and that software in its own right can be defined as a medical device .
(6) Treba je pojasniti, da je programska oprema sama po sebi, kadar jo proizvajalec posebej nameni za uporabo v enega ali več medicinskih namenov, določenih v opredelitvi medicinskega pripomočka, medicinski pripomoček.
(6) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device.
Programska oprema za splošne namene, ki se uporablja v zdravstvenem okolju, ni medicinski pripomoček.
Software for general purposes when used in a healthcare setting is not a medical device.
(6a) Zaradi sedanje pravne negotovosti je treba natančno določiti mejo med Direktivo 93/42/EGS in Direktivo Sveta 76/768/EGS z dne 27. julija 1976 o približevanju zakonodaje držav članic v zvezi s kozmetičnimi izdelki 1 .
(6a) The current legal uncertainty makes it necessary to make clear the distinction between Directive 93/42/EEC and Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products 1 .
Pri tem je treba upoštevati zlasti predvideni osnovni namen izdelkov.
In so doing, particular account should be taken of the basic intended purpose of the product.
Člen 1(5)(d) Direktive 93/42/EGS glede določitve meje med to direktivo in Direktivo 76/768/EGS v zvezi s kozmetičnimi izdelki se v Združenem kraljestvu in Nemčiji razlaga različno.
There are different interpretations of Article 1(5)(d) of Directive 93/42/EEC in the United Kingdom and Germany as regards the distinction between this Directive and Directive 76/768/EEC on cosmetic products.
Zato da se zagotovi enotna uporaba evropske zakonodaje, je treba dodati pojasnilo.
A clarification is needed to ensure the uniform application of European law.
Posebno upoštevanje namena, ki ga načeloma opredeli proizvajalec, je v skladu s sodno prakso Sodišča Evropskih skupnosti v zvezi z mejnimi izdelki.
Particular account should be taken of the product's purpose as intended by the manufacturer, in line with the case law of the European Court of Justice on borderline products.
(6b) Meja med Direktivo 93/42/EGS in drugimi direktivami, kot je na primer Direktiva 2001/83/ES, ni vedno jasna.
(6b) The distinction between Directive 93/42/EEC and other directives, such as Directive 2001/83/EC, is not always clear.
Zato je treba objaviti seznam z navodili, ki bo vsem udeležencem olajšal odločitev, katero direktivo uporabiti za določen izdelek.
It would be useful, therefore, to publish a list with information that makes it easier for all parties to determine which directives apply to which products.
Več izdelkov ne sodi v Direktivo 93/42/EGS ali druge direktive in so zato neopredeljeni.
Several products fall into the grey area between Directive 93/42/EEC and other directives.
Zato da se bodo organi in proizvajalci lažje odločili, ali je izdelek glede na opredelitev medicinski pripomoček, mora Direktiva zajemati različne primere, iz katerih bo razvidno, ali je pripomoček že vnaprej določen, da sodi v Direktivo 93/42/EGS ali ne.
To make it easier for the authorities and manufacturers to decide whether or not a product is a medical device, the directive should contain examples, from which it should be clear whether or not a product is predestined to fall within the scope of Directive 93/42/EEC.
Vendar ti primeri ne smejo nadomestiti posameznih odločitev.
These examples should not, however, take the place of decisions on individual cases.
(13) Za ustrezno in učinkovito delovanje Direktive 93/42/EGS v zvezi z ureditvenimi nasveti glede vprašanj razvrščanja na nacionalni ravni, zlasti vprašanja, ali je izdelek opredeljen kot medicinski pripomoček ali ne, je v interesu nacionalnega tržnega nadzora ter zdravja in varstva ljudi vzpostavitev postopka za odločanje, ali je izdelek opredeljen kot medicinski pripomoček ali ne.
(13) For the appropriate and efficient functioning of Directive 93/42/EEC as regards regulatory advice on classification issues arising at national level, in particular on whether or not a product falls under the definition of a medical device, it is in the interest of national market surveillance and the health and safety of humans to establish a procedure for decisions on whether or not a products falls under the medical device definition.
(13) Za ustrezno in učinkovito delovanje Direktive 93/42/EGS v zvezi z ureditvenimi nasveti glede vprašanj razvrščanja na nacionalni ravni, zlasti vprašanja, ali je izdelek opredeljen kot medicinski pripomoček ali ne, je v interesu nacionalnega tržnega nadzora ter zdravja in varstva ljudi vzpostavitev postopka za odločanje, ali je izdelek opredeljen kot medicinski pripomoček ali ne.
(13) For the appropriate and efficient functioning of Directive 93/42/EEC as regards regulatory advice on classification issues arising at national level, in particular on whether or not a product falls under the definition of a medical device, it is in the interest of national market surveillance and the health and safety of humans to establish a procedure for decisions on whether or not a product falls under the medical device definition.
Zaradi večje pravne varnosti morajo takšne odločitve zadevati le posamezne izdelke, ki pa lahko spadajo med generične izdelke, in veljajo za države članice in proizvajalce .
To ensure greater legal certainty, such decisions should exclusively concern individual products, which may form part of a generic line of products, and should be geared towards the Member States and manufacturers.
Eden ključnih elementov za opredelitev medicinskega pripomočka je predvidena uporaba, ki jo določi proizvajalec.
One of the key elements in defining a medical device is the manufacturer's intended purpose.