natgillin/translations-raw huggingface dataset:
Koristno je primerjati predlog s podobno nedavno sprejeto zakonodajo na tem področju, kot je uredba REACH o kemikalijah, Uredba (ES) št. 1907/2006, ki je bila (tako obrazložitveni memorandum k predlogu) upoštevana pri sestavi predloga.
It is instructive to compare the proposal with similar recent legislation in this area such as the REACH regulation on chemicals, Regulation (EC) No 1907/2006, which according to the Explanatory Memorandum of the proposal, was taken into consideration in the creation of the proposal.
Uredba REACH, katere pravna podlaga je prav tako člen 114 PDEU, v členu 1 jasno določa, da je njen namen zagotoviti visoko raven varstva zdravja ljudi in okolja, pa tudi prost pretok snovi na notranjem trgu.
REACH, also based on Article 114 TFEU, clearly states in Article 1 that its purpose is to ensure a high level of protection of human health and the environment, as well as the free circulation of substances on the internal market.
Za primerjavo: predlog priznava, da lahko biocidni pripravki „pomenijo tveganje“ za ljudi, živali in okolje, kot izrecen namen pa navaja izbljšanje prostega pretoka biocidnih pripravkov na notranjem trgu.
By contrast; the proposal acknowledges that biocidal products "can pose risks" to humans, animals and the environment, while retaining as its explicit stated purpose improving the free movement of biocidal products on the internal market.
Glede specifičnih sklicevanj na raven varstva v predlogu je v uredbi REACH v členu 3 vključeno previdnostno načelo, ki določa, da se lahko, če obstajajo razumni razlogi za skrb, da ima ukrep morebitne nevarne posledice za okolje, zdravje ljudi, živali in rastlin, ki niso skladne z visoko stopnjo varstva, veljavnega v EU, sprejmejo ukrepi za odpravo teh razmer, vse dokler je tveganje previsoko, da bi ga družba lahko sprejela.
Concerning specific references to the level of protection within the proposal, REACH has embedded within Article 3 the precautionary principle which determines that where there are reasonable grounds for concern that a measure poses potentially dangerous effects to the environment, human, animal or plant health inconsistent with the high level of protection adhered to by the EU, certain action may be taken to remedy the situation as long as there is a risk which is too high to impose on society.
V skladu z uvodno izjavo 10 preambule, najnevarnejših snovi sicer ni mogoče odobriti, „da bi dosegli visoko raven varovanja zdravja ljudi in okolja“, vendar sklicevanja na samo previdnostno načelo v preambuli ali izvedbenih določbah predloga ni.
While according to recital (10) in the preamble, the most hazardous substances are not permitted for authorisation "with a view to achieving a high level of environmental and human health protection", there is no reference to the precautionary principle itself in the preamble or the enacting terms of the proposal.
Razširitev področja uporabe direktive, da se vključijo regulativna sredstva, ki proizvajajo biocide, ter snovi, ki vsebujejo biocide in ki lahko pridejo v stik s hrano, ter proizvode, obdelane z biocidi, kot je pohištvo, pa tudi izključitev proizvodov, ki vsebujejo nevarne rakotvorne snovi, nakazuje, da je namen predloga tudi doseganje optimalnega ravnotežja med koristmi in tveganji trgovine z biocidnimi pripravki v Evropski uniji.
The extension of the scope of the Directive to include in the regulation devices which produce biocides and materials containing biocides which may come into contact with food, and articles treated with biocides such as furniture, as well as the phasing out of products which contain hazardous carcinogenic substances, indicates that the proposal is also aimed at reaching an optimum balance between the benefits and risks attached to trade in biocidal products within the European Union.
Uvodna izjava 1 preambule predloga določa:
Recital (1) in the preamble to the proposal states as follows:
„Biocidni pripravki so potrebni za obvladovanje zdravju človeka ali živali škodljivih organizmov in za obvladovanje organizmov, ki povzročajo škodo naravnim ali izdelanim proizvodom.
"Biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured products.
Vendar lahko biocidni pripravki zaradi vsebovanih lastnosti, združenih z vzorci uporabe, pomenijo tveganje za človeka, živali in okolje.“
However, biocidal products can pose risks to humans, animals and the environment due to their intrinsic property and associated use patterns".
To dokazuje zavest o trenju med koristmi spodbujanja trgovine z biocidnimi pripravki in tveganjem, povezanim z večjo dostopnostjo teh pripravkov in s tem z večjo možnostjo stika z ljudmi, živalmi in okoljem.
This demonstrates an awareness of the tension between the benefits of facilitating trade in biocidal products and the risks of making such products more widely available and therefore increasing the chance of contact with humans, animals and the environment.
V izjavah, ki jih vsebuje predlog v preambuli, se zajtrjuje, da je namen predloga spodbujati prosti pretok blaga in notranji trg, kar nakazuje, da se tveganje večje dostopnosti biocidnih pripravkov ocenjuje v okviru ukrepov, ki se uporabijo za doseganje namena predloga.
It is submitted however that the proposal's statements throughout the preamble that its aim is to facilitate the free movement of goods and the internal market suggest that the risks of making biocidal products more widely available are weighed as an integral part of the measures used to achieve the aim of the proposal.
Varstvo je torej ključni cilj predloga, vendar ni mogoče reči, da je njegov prevladujoči ali glavni namen.
Protection is therefore a key aim of the proposal, but cannot be said to be its dominant or main purpose.
Ta ugotovitev je podkrepljena z nadaljnjimi vsebinskimi sestavinami predloga.
Further substantive elements of the proposal support this argument.
Zdi se, da je z uvodno izjavo 10 preambule prepovedana odobritev „aktivnih snovi z najvišjo stopnjo nevarnosti“, kar nakazuje na trdno zavezo k varovanju življenja ljudi, živali in rastlin.
There is an apparent refusal to authorise "active substances with the worst hazard profiles" in recital (10) in the preamble, which suggests a strong commitment to the protection of human, animal and plant life.
Toda to ugotovitev spodkopajo relativno nenatančne izjeme, kot denimo:
However, this is undermined by relatively imprecise exemptions such as:
i. odobritev teh snovi v okoliščinah, „ko je izpostavljenost ljudi snovi zanemarljiva, ali je snov potrebna zaradi javnozdravstvenih razlogov“ (uvodna izjava 11)
i. the approval of such substances in "situations when the exposure of humans to the substance is negligible or the substance is necessary for public health reasons" (recital (11).
Za primerjavo, cilj ključnih elementov predloga je olajšanje prostega pretoka biocidnih pripravkov v Skupnosti.
By contrast, the key elements of the proposal are targeted at facilitating the free movement of biocidal products within the Community.
Predlog se osredotoča na naslednje elemente:
The proposal focuses on the following measures:
- odstranitev poenostavljenih postopkov za oceno aktivnih snovi, zlasti snovi z majhnim tveganjem
- removing the simplified procedures for the evaluation of active substances, in particular low-risk substances;
- poenostavitev postopka odobritve za biocidne pripravke, vključno z vzpostavitvijo osrednjega sistema odobritve, za katerega bi bila odgovorna Evropska agencija za kemikalije in bi opravila tehnične in znanstvene naloge, ter uskladitev postopkov za vzajemno priznavanje odobritev;
- simplifying the authorisation procedures for biocidal products, including setting up a centralised system for authorisation, for which the European Chemicals Agency will be competent in carrying out the technical and scientific tasks, and harmonising procedures for mutual recognition of authorisations;
- vzpostavitev posebnih vzporednih trgovinskih pravil za zmanjšanje upravnega bremena za čezmejno trgovino z biocidnimi pripravki
- providing for specific parallel trade rules to minimise the administrative burden on cross-border trade in biocidal products.
Cilj vseh zgornjih ukrepov je poenostavitev in uskladitev upravnih postopkov v procesu odobritve, kar bo olajšalo čezmejno trgovino z biocidnimi pripravki.
All the above measures are aimed at simplifying and harmonising administrative procedures in the authorisation process, which will facilitate cross-border trade in biocidal products.
Nadalje, v odstavku 3.3. obrazložitvenega memoranduma, ki obravnava subsidiarnost, je kot razlog za ukrepanje EU na tem področju navedena uskladitev morebitnih „ovir[] pri trgovini z biocidnimi pripravki“ zaradi različne ravni varstva v državah članicah.
Further, in paragraph 3.3 of the Explanatory Memorandum, dealing with subsidiarity, the justification given for the EU taking action in this area is the harmonisation of potential "obstacles to trade in biocidal products" resulting from different levels of protection in different Member States.
Označitev ravni varstva kot morebitnih „[ovir] pri trgovini“, tudi ko je raven varstva v drugi državi članici lahko večja od te, ki jo predpisuje Direktiva, jasno nakazuje, da je pospeševanje trgovine prevladujoč cilj tega predloga.
The characterisation of levels of protection as potential "obstacles to trade", even where the level of protection in another Member State could be higher than is currently provided in the Directive, indicates that the facilitation of trade is clearly the dominant aim of this proposal.
Glede na to, da smo ugotovili, da obstaja en prevladujoč namen predloga in torej bi bilo primerno, da ima v tem primeru zakonodajni akt eno pravno podlago in ne več, je nujno, da sedaj ugotovimo, katera od treh predlaganih pravnih podlag je primerna.
Having established that there is one dominant purpose in the proposal and therefore that following the case law it is appropriate to have a single legal basis rather than multiple bases, it is therefore necessary to determine which of the three proposed legal bases is appropriate.
Nadaljnja primerjava z uredbo REACH pokaže, da ukrep temelji na členu 114 PDEU, vendar je jasno, da je varstvo življenja ljudi, živali in rastlin pomembnejše, kot je v predlogu.
A further comparison with the REACH regulation reveals that that measure is based on Article 114 TFEU, but clearly holds the protection of human, animal and plant life in higher regard than the proposal.
Člena 192 in 168, ki oba pretežno zadevata varstvo življenja ljudi, živali in rastlin, nista uporabljena kot pravna podlaga za REACH.
Neither Article 192 nor Article 168, both of which overwhelmingly concern the protection of human, animal and plant life, is used as a legal basis in REACH.
Zato bi bilo logično, da ima predlog, ki veliko manj poudarja varstvo in veliko bolj prosti pretok blaga v Uniji, pravno podlago v členu 114.
It would therefore be logical that a proposal with a much weaker emphasis on protection, but with a greater emphasis on the free movement of goods within the Union should rely on Article 114 as its legal basis.
Pravna podlaga v členu 168 bi bila šibka, saj predlog ne ustreza merilom iz člena 168(4)(b), in sicer, da je njegov „neposreden cilj“ varstvo javnega zdravja.
Any basis in Article 168 would be weak as the proposal does not satisfy the criteria in Article 168(4)(b) of having as its "direct objective" the protection of public health.
Člen 192 je morda bolj primeren: vendar je neskladje med členom 192 in predlogom jasno iz nedoslednosti med glavnim namenom predloga, ki je pospeševanje notranjega trga, in prevladujočim namenom člena 192 v zvezi z varstvom.
Article 192 is perhaps more applicable; however, the incompatibility of Article 192 and the proposal is clear from the inconsistency between the proposal's dominant aim in facilitating the internal market, and the overriding purpose of Article 192 in terms of protection.
Člen 191 PDEU nadalje zahteva, da politika EU na tem področju temelji na previdnostnem načelu; Vendar se to načelo v predlogu ne pojavlja.
Further, Article 191 TFEU requires Union policy in this area to be based on the precautionary principle; but this principle does not appear in the proposal.
Ob upoštevanju dejstva, da je notranji trg prevladujoč cilj predloga in da je v predlogu vidik varstva postranski ali drugoten cilj, torej ta dva cilja nista neločljiva in enakovredna, v nobenem primeru ne bi bilo primerno odobriti uporabo dvojne pravne podlage na tem področju
Taking into account the fact that the internal market is the dominant aim of the proposal and the protection aspect of the proposal an incidental or secondary aim, rather than the two aims being "indissociable" and equal in status, it would not be appropriate to condone the use of a dual legal basis at all in the context of the case law in this area.
Zadeva C-91/05, Komisija proti Svetu (2008).
Case C-91/05 Commission v Council (2008)
Odbor za pravne zadeve je na svoji seji 17. maja 2010 soglasno
At its meeting of 17 May 2010 the Committee on Legal Affairs accordingly decided, unanimously
Pri končnem glasovanju so bili navzoči: Luigi Berlinguer (predsedujoči), Raffaele Baldassarre (podpredsednik), Evelyn Regner (podpredsednica), Sebastian Valentin Bodu (podpredsednik), Kurt Lechner (poročevalec), Françoise Castex, Christian Engström, Marielle Gallo, Eva Lichtenberger, Antonio Masip Hidalgo, Bernhard Rapkay, Francesco Enrico Speroni, Cecilia Wikström, Tadeusz Zwiefka. sklenil, da priporoči, da kot edino pravno podlago obravnavanega predloga uredbe sprejmete člen 114 Pogodbe o delovanju Evropske unije.
The following were present for the final vote: Luigi Berlinguer (acting Chair), Raffaele Baldassarre (Vice-Chair), Evelyn Regner (Vice-Chair), Sebastian Valentin Bodu (Vice-Chair), Kurt Lechner (rapporteur), Françoise Castex, Christian Engström, Marielle Gallo, Eva Lichtenberger, Antonio Masip Hidalgo, Bernhard Rapkay, Francesco Enrico Speroni, Cecilia Wikström, Tadeusz Zwiefka. , to recommend to you that Article 114 of the Treaty on the functioning of the European Union should be the sole legal basis for the proposal for a regulation in question.
(*) Postopek s pridruženimi odbori – člen 50 poslovnika
(*) Procedure with associated committees – Rule 50 of the Rules of Procedure
Cilj predloga uredbe o dajanju v promet in uporabi biocidnih pripravkov je preoblikovanje obstoječega zakonodajnega okvira Evropske unije, ki ga trenutno ureja Direktiva 98/8/ES in ki bi posledično nehala veljati.
The purpose of the proposal for a regulation concerning the placing on the market and use of biocidal products is to revise the existing European Union regulatory framework; this is currently provided by Directive 98/8/EC, which would consequently be repealed.
Biocidni pripravki so proizvodi, ki vsebujejo aktivne snovi, namenjene uničenju in odstranitvi katerega koli organizma, ki škoduje zdravju ljudi ali živali ter okolju, ga naredijo neškodljivega, preprečijo njegovo delovanje ali ga kakorkoli drugače nadzorujejo.
Biocides are products, containing one or more active substances, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any organism which is harmful to human or animal health and to the environment.
Biocidni pripravki, uporabljeni v razsodnih količinah, so del vsakdanjega življenja v naši družbi, saj preprečujejo širitev bolezni in vzdržujejo visoko raven higiene v gosto poseljenem okolju.
Biocides, used with care, are part of everyday life in our society, in that they prevent the spread of diseases and promote a high standard of hygiene in a heavily populated environment.
Nekateri med temi pripravki lahko postanejo zelo nevarni.
Some of these products may be intrinsically hazardous.
Trgovanje z biocidnimi pripravki v EU se ocenjuje na približno 900 milijonov EUR letno, količina proizvodov, ki so dani na trg, pa znaša 90 000 ton letno.
The biocides market in the European Union is estimated to be worth some € 900 million annually, and around 90 000 tonnes of products are placed on the market every year.
Direktiva 98/8/ES je prvo zakonodajno besedilo za urejanje stopenj uvajanja na trg in za uporabo teh proizvodov.
Directive 98/8/EC constitutes the first legislative framework to regulate the placing on the market and use of such products.
Komisija je s tem predlogom uredbe uvedla vrsto izboljšav različnih vidikov zakonodajnega okvira, kot sta dolžina postopkov za dovoljenja in ocenjevanje aktivnih snovi in biocidnih pripravkov ter uvedba centraliziranega postopka, natančnih pravil za vzporedno trgovanje in obveznosti deliti dognanja študij o vretenčarjih.
In this proposal for a regulation the Commission has introduced a series of improvements to several aspects of the regulatory framework, such as the length of the procedures for authorising and evaluating active substances and biocidal products, and the lack of a centralised procedure, of specific rules on parallel trade and of a requirement to share vertebrate animal studies.
Predlog uredbe, o katerem se razpravlja, ustreza potrebam po reviziji in poenostavitvi ter pravilno obravnava obstoječe težave.
The proposal for a regulation under consideration duly responds to the need that was felt for revision and simplification, and addresses the existing problems properly.
Vendar pripravljavka mnenja meni, da je ta predlog treba dodatno izboljšati, da bi dosegli naslednje cilje:
However, the rapporteur considers that the proposal could be further improved so as to achieve:
– kar največja poenostavitev postopkov za dovoljenja in ocenjevanje aktivnih snovi v biocidnih pripravkih, raziskovalnih in razvojnih dejavnosti ter sistema nacionalnih tarif,
- maximum simplification of the procedures for authorising and evaluating active substances and biocidal products, of research and development activities and of the national tariff system;
– večje poenotenje evropskega trga in nacionalnih zakonodajnih pristopov, zlasti z boljšo opredelitvijo postopkov vzajemnega priznavanja, centraliziranega dodeljevanja dovoljenj in varovanja občutljivih podatkov,
- greater harmonisation of the European market and of national regulatory approaches, primarily through a clearer definition of the procedures for mutual recognition, central authorisation and the protection of sensitive data;
– zmanjšanje stroškov in odstranitev upravnih ovir zlasti za mala in srednja podjetja tako, da se jim zagotovi ustrezna tehnična, jezikovna in upravna podpora v sistemu, ki je lahko zelo zapleten, zlasti ob pomanjkanju izkušenj,
- a reduction in the costs, and the abolition, of administrative obstacles, especially for small and medium-sized firms, ensuring that they have appropriate technical, linguistic and administrative support in a system which may be very complex, particularly for those without the requisite experience;
– večje varstvo potrošnikov z ustreznim sistemom označevanja, ki bi ustrezal ravni tveganja in predvidel uporabne in ne ponavljajoče se informacije za varovanje zdravja vseh potrošnikov, zlasti neizkušenih.
- greater consumer protection, providing an appropriate labelling system which is in keeping with the level of risk and conveys useful and pertinent information with the aim of protecting the health of all types of consumers, especially non-experts.
Zato pripravljavka mnenja predlaga vrsto sprememb besedila Komisije, ki so v skladu z zgoraj povedanim in obravnavajo vprašanja, ki jih po postopku skupnih pristojnosti (člen 50 poslovnika) obravnava odbor IMCO.
This is why the rapporteur has proposed a series of amendments to the Commission text which are along the lines described above and which concern matters which are being dealt with under the joint competence of the Committee on the Internal Market and Consumer Protection in accordance with the procedure with associated committees (Rule 50 of the Rules of Procedure).
Poleg sprememb členov 25, 28, 44, 47, 54, 58 in 62 v skupni pristojnosti odborov pripravljavka mnenja želi predložiti dodatne izboljšave tudi v drugih delih besedila, da bi se:
In addition to the changes proposed to Articles 25, 28, 44, 47, 54, 58 and 62, which are matters of joint competence, the rapporteur considered it appropriate to table further improvements to other parts of the text, as well, with the aim of:
(a) izboljšali postopki in pripomočki za dostop do podatkov, da bi se ustvarili pogoji za uzakonitev pojava tako imenovanih „slepih potnikov“ ali „koristoljubcev (free-riders)“, zlasti z izboljšanjem opredelitve iz člena 83,
(a) improving the procedures and requirements for access to data, in order to create the conditions for regulating the phenomenon of 'free riders', in particular by tightening up Article 83;
(b) skrajšalo trajanje in s tem stroški postopkov validacije in ocenjevanja zahtevkov, sprejemanje sklepov Komisije in pristojnih organov ali obnove dovoljenj,
(b) reducing the time, and hence the cost, involved in the procedures for validating and evaluating applications, for decision-taking by the Commission and the competent authorities, or for renewing authorisations;
(c) bolje opredelile upravne ali manjše spremembe okvirnih formulacij ali odobrenih proizvodov znotraj iste okvirne formulacije;
(c) defining more clearly administrative or non-substantive changes to frame formulations or to products authorised under the same frame formulation;
(d) odpravila neupravičena diskriminacija nekaterih dezinfekcijskih proizvodov, ki ne ustrezajo izjemam iz člena 5,
(d) getting rid of the arbitrary discrimination against those disinfectant products which cannot benefit from the exclusion criteria described in Article 5;
(e) upoštevala možnost, da se proizvod zamenja, ko je dal želene rezultate,
(e) examining the appropriateness of replacing a product once the requisite experience with it has been obtained;
(f) izboljšali postopki vzajemnega priznavanja nacionalnih dovoljenj,
(f) improving the procedures for mutual recognition of national authorisations;
(g) uravnovesili pogoji za vzporedno trgovino enakih proizvodov, ki imajo isti vir in sestavine,
(g) balancing the conditions for parallel trade in identical products based on the same source and the same co-formulants;
(i) prilagodile določbe pravilnika obstoječi zakonodaji, zlati uredbi REACH in ureditvi za fitofarmacevtska sredstva ter pri odpravljanju razlikovanja med novimi in že obstoječimi podatki določbam o raziskavah in razvoju in vlogi agencije.
(i) bringing the provisions of the regulation into line with the existing legislation, with particular reference to REACH and to the rules on plant protection products and concerning the abolition of the distinction between new and existing data, the provisions relating to research and development and the role of the Agency.
Pripravljavka mnenja v tem mnenju ne bo upoštevala sprememb, potrebnih za prilagoditev novemu sistemu delegiranih aktov, ki jih je uvedla Lizbonska pogodba, saj jih bo sprejel pristojni odbor.
The rapporteur will not include in this opinion the changes needed to adjust to the new system of delegated acts introduced by the Lisbon Treaty, since these will be made by the committee responsible.
(11a) Komisija za dosego najvišje ravni varovanja zdravja ljudi in živali ter okolja v dveh letih od začetka veljavnosti te uredbe Evropskemu parlamentu in Svetu predloži poročilo o ustreznih ukrepih za spodbujanje trajnostne uporabe različnih vrst biocidnih pripravkov.
(11a) In order to achieve the highest level of protection of human and animal health and of the environment, the Commission should submit, within two years of the entry into force of this Regulation, a report to the European Parliament and the Council regarding adequate measures to promote the sustainable use of biocidal products across the different product types.