natgillin/translations-raw huggingface dataset:
Med revizijo je bilo ugotovljeno, da bi lahko spremembe Direktive, vključno s postopkovno poenostavitvijo odobritve pripravka, poenostavitvijo in prilagoditvijo področja uporabe Direktive, večplastnim pristopom k podatkovnim zahtevam in poenostavljenim določbam o varstvu podatkov, izboljšanjem poenostavljenih postopkov ter ukrepi za spodbujanje inovacij, prispevale k zmanjšanju stroškov in upravnih obremenitev za družbe in javne organe za dajanje biocidnih pripravkov v promet.
The review found that modifications of the Directive including procedural simplification of product authorisation, simplification and adaptation of the scope of the Directive, a tiered approach to data requirements and simplified data protection rules, improvement of the simplified procedures, and measures to encourage innovation could be beneficial in reducing the costs and administrative burden for companies and public authorities for introducing biocidal products onto the market.
Cilj predloga, kakor je opredeljen v obrazložitvenem memorandumu, je „odpraviti pomanjkljivosti regulativnega okvira, ugotovljene v prvih osmih let njenega izvajanja, da se izboljšajo in posodobijo nekateri elementi sistema ter odpravijo predvidene težave v prihodnosti“.
The aims of the proposal, as stated in the Explanatory Memorandum, are to "tackle the identified weaknesses of the regulatory framework during the first eight years of its implementation, to improve and update certain elements of the system and to avoid problems anticipated in the future".
Glede splošnega cilja predlog v odstavku 3 preambule določa, da: „Namen te uredbe je povečati prosti pretok biocidnih pripravkov v Skupnosti... [d]a bi čim bolje odstranili ovire pri trgovini z biocidnimi pripravki, ki so nastale zaradi različnih ravni varstva v državah članicah“.
As far as an overarching aim is concerned, the proposal states in its Preamble, paragraph 3: "The purpose of this Regulation is to increase the free movement of biocidal products within the Community ... to remove as far as possible obstacles to trade in biocidal products stemming from different levels of protection in the Member States".
Predlagana pravna podlaga
The Proposed Legal Bases
Pravne podlage iz predlagane uredbe so:
The legal bases put forward for the proposed regulation are:
Člen 114 PDEU
Article 114 TFEU
Evropski parlament in Svet se po rednem zakonodajnem postopku ter po posvetovanju z Ekonomsko-socialnim odborom in Odborom regij odločita, katere ukrepe naj Unija sprejme za doseganje ciljev iz člena 191
The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall decide what action is to be taken by the Union in order to achieve the objectives referred to in Article 191
Člen 191
Article 191
Okoljska politika Unije prispeva k uresničevanju naslednjih ciljev:
Union policy on the environment shall contribute to pursuit of the following objectives:
– ohranjanja, varovanja in izboljšanja kakovosti okolja,
— preserving, protecting and improving the quality of the environment,
– varovanja zdravja ljudi,
— protecting human health,
– skrbne in preudarne rabe naravnih virov,
— prudent and rational utilisation of natural resources,
– spodbujanje ukrepov na mednarodni ravni za reševanje regionalnih ali globalnih okoljskih problemov, zlasti v boju proti podnebnim spremembam.";
— promoting measures at international level to deal with regional or worldwide environmental problems, and in particular combating climate change.
Cilj okoljske politike Unije je doseči visoko raven varstva, pri čemer se upošteva raznolikost razmer v posameznih regijah Unije.
Union policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Union .
Pri oblikovanju svoje okoljske politike Unija upošteva:
In preparing its policy on the environment, the Union shall take account of:
– razpoložljive znanstvene in tehnične podatke;
— available scientific and technical data,
– okoljske razmere v različnih regijah Unije;
— environmental conditions in the various regions of the Union ,
– možne koristi in stroške ukrepanja ali neukrepanja;
— the potential benefits and costs of action or lack of action,
– gospodarski in socialni razvoj Unije kot celote in uravnotežen razvoj njenih regij.
— the economic and social development of the Union as a whole and the balanced development of its regions.
V okviru svojih pristojnosti Unija in države članice sodelujejo s tretjimi državami in pristojnimi mednarodnimi organizacijami.
Within their respective spheres of competence, the Union and the Member States shall cooperate with third countries and with the competent international organisations.
Podrobnosti sodelovanja Unije so lahko predmet sporazumov med Unijo in zadevnimi tretjimi osebami.
The arrangements for Union cooperation may be the subject of agreements between the Union and the third parties concerned.
Prejšnji pododstavek ne posega v pristojnost držav članic glede pogajanj v mednarodnih organih in glede sklepanja mednarodnih sporazumov. .
The previous subparagraph shall be without prejudice to Member States’ competence to negotiate in international bodies and to conclude international agreements. .
Z odstopanjem od postopka odločanja iz odstavka 1 in brez poseganja v člen 114 Svet po posebnem zakonodajnem postopku ter po posvetovanju z Evropskim parlamentom, Ekonomsko-socialnim odborom in Odborom regij soglasno sprejme:
By way of derogation from the decision-making procedure provided for in paragraph 1 and without prejudice to Article 114, the Council acting unanimously in accordance with a special legislative procedure and after consulting the European Parliament, the Economic and Social Committee and the Committee of the Regions, shall adopt:
– prostorsko načrtovanje;
— town and country planning,
Svet lahko na predlog Komisije in po posvetovanju z Evropskim parlamentom, Ekonomsko-socialnim odborom in Odborom regij soglasno odloči o uporabi rednega zakonodajnega postopka za področja iz prvega pododstavka.
The Council, acting unanimously on a proposal from the Commission and after consulting the European Parliament, the Economic and Social Committee and the Committee of the Regions, may make the ordinary legislative procedure applicable to the matters referred to in the first subparagraph.
Ukrepi, ki so potrebni za izvajanje teh programov, se glede na primer sprejmejo v skladu s pogoji iz odstavka 1 ali odstavka 2.
The measures necessary for the implementation of these programmes shall be adopted under the terms of paragraph 1 or 2, as the case may be.
Države članice financirajo in izvajajo okoljsko politiko, ne da bi pri tem posegale v nekatere ukrepe, ki jih je sprejela Unija.
Without prejudice to certain measures adopted by the Union, the Member States shall finance and implement the environment policy.
Brez poseganja v načelo, da plača povzročitelj obremenitve, in če je ukrep, ki je bil sprejet na podlagi določb iz odstavka 1, povezan z nesorazmerno visokimi stroški za organe oblasti države članice, se s takšnim ukrepom predvidijo ustrezne določbe v obliki:
Without prejudice to the principle that the polluter should pay, if a measure based on the provisions of paragraph 1 involves costs deemed disproportionate for the public authorities of a Member State, such measure shall lay down appropriate provisions in the form of:
– finančne podpore iz Kohezijskega sklada, ustanovljenega v skladu s členom 177.
— financial support from the Cohesion Fund set up pursuant to Article 177 .
Člen 168 PDEU
Article 168 TFEU
Pri opredeljevanju in izvajanju vseh politik in dejavnosti Unije se zagotavlja visoka raven varovanja zdravja ljudi.
A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.
Dejavnost Unije, ki dopolnjuje nacionalne politike, je usmerjena k izboljševanju javnega zdravja, preprečevanju telesnih in duševnih obolenj in bolezni ter odpravljanju vzrokov, ki ogrožajo zdravje ljudi.
Union action, which shall complement national policies, shall be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health.
Ta dejavnost zajema obvladovanje močno razširjenih težkih bolezni s spodbujanjem raziskovanja njihovih vzrokov, prenosa in preprečevanja, pa tudi obveščanja o zdravju in zdravstvene vzgoje, hkrati zajema tudi nadzor nad veliko čezmejno ogroženostjo zdravja, zgodnje obveščanje o taki ogroženosti in boj proti njej.
Such action shall cover the fight against the major health scourges, by promoting research into their causes, their transmission and their prevention, as well as health information and education, and monitoring, early warning of and combating serious cross-border threats to health.
Unija dopolnjuje ukrepe držav članic za zmanjševanje škode za zdravje zaradi uživanja drog, vključno z obveščanjem in preprečevanjem.
The Union shall complement the Member States' action in reducing drugs-related health damage, including information and prevention.
Unija spodbuja sodelovanje med državami članicami na področjih iz tega člena in, če je potrebno, podpira njihove ukrepe.
The Union shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action.
Zlasti spodbuja sodelovanje med državami članicami za izboljšanje komplementarnosti njihovih zdravstvenih storitev na obmejnih območjih.
It shall in particular encourage cooperation between the Member States to improve the complementarity of their health services in cross-border areas.
Komisija lahko v tesni povezavi z državami članicami daje koristne pobude za pospeševanje takšnega usklajevanja, zlasti pobude, namenjene oblikovanju smernic in kazalcev, organizaciji izmenjave najboljših praks ter pripravi elementov, potrebnih za redno spremljanje in presojo.
The Commission may, in close contact with the Member States, take any useful initiative to promote such coordination, in particular initiatives aiming at the establishment of guidelines and indicators, the organisation of exchange of best practice, and the preparation of the necessary elements for periodic monitoring and evaluation.
Evropski parlament je izčrpno obveščen.
The European Parliament shall be kept fully informed.
Unija in države članice pospešujejo sodelovanje s tretjimi državami in pristojnimi mednarodnimi organizacijami na področju javnega zdravja.
The Union and the Member States shall foster cooperation with third countries and the competent international organisations in the sphere of public health.
Z odstopanjem od člena 2(5) in člena 6(a) ter v skladu s členom 4(2)(k) Evropski parlament in Svet po rednem zakonodajnem postopku ter po posvetovanju z Ekonomsko-socialnim odborom in Odborom regij prispevata k doseganju ciljev iz tega člena s sprejetjem, zaradi zagotavljanja skupnih potreb po varnosti:
By way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns:
(b) ukrepov na veterinarskem in fitosanitarnem področju, katerih neposredni cilj je varovanje javnega zdravja;
(b) measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health;
Evropski parlament in Svet lahko po rednem zakonodajnem postopku in po posvetovanju z Odborom regij in Ekonomsko-socialnim odborom sprejmeta tudi spodbujevalne ukrepe za varovanje in izboljšanje zdravja ljudi in zlasti za boj proti močno razširjenim čezmejnim težkim boleznim, ukrepe v zvezi z nadzorom resne čezmejne ogroženosti zdravja, zgodnjim obveščanjem o taki ogroženosti in bojem proti njej, kakor tudi ukrepe, katerih neposredni cilj je varovanje javnega zdravja glede tobaka in zlorabe alkohola, pri čemer je izključeno kakršno koli usklajevanje zakonov in drugih predpisov držav članic.
The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, may also adopt incentive measures designed to protect and improve human health and in particular to combat the major cross-border health scourges, measures concerning monitoring, early warning of and combating serious cross-border threats to health, and measures which have as their direct objective the protection of public health regarding tobacco and the abuse of alcohol, excluding any harmonisation of the laws and regulations of the Member States.
Svet lahko na predlog Komisije sprejme tudi priporočila za namene iz tega člena.
The Council, on a proposal from the Commission, may also adopt recommendations for the purposes set out in this Article.
Pri dejavnosti Unije se upošteva odgovornost držav članic za opredelitev njihove zdravstvene politike ter za organizacijo in zagotavljanje zdravstvenih storitev in zdravstvene oskrbe.
Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care.
Odgovornosti držav članic vključujejo upravljanje sistema zdravstvenih storitev in zdravstvene oskrbe in razporejanje dodeljenih virov.
The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them.
Ukrepi iz odstavka 4(a) ne vplivajo na nacionalne določbe o darovanju organov in krvi ali njihovi uporabi za namene zdravljenja.
The measures referred to in paragraph 4(a) shall not affect national provisions on the donation or medical use of organs and blood.
Vendar pa dvojna pravna podlaga ni možna, če so postopki, določeni za posamezne pravne podlage, medsebojno nezdružljivi
Recourse to a dual legal basis is not possible where the procedures laid down for each legal basis are incompatible with each other
Analiza Direktive 98/8/ES in predloga
Analysis of Directive 98/8/EC and the proposal
Direktiva predpisuje regulativen sistem odobritve, medsebojnega priznavanja in zaključenega seznama dovoljenih aktivnih snovi, katerega cilj je premagovanje morebitnih preprek za notranji trg biocidnih pripravkov, pogoj pa je „visoka raven varstva za ljudi, živali in okolje“
The Directive provides for a regulatory system of authorisation, mutual recognition and a finite list of authorised active substances, which aims to overcome possible barriers to the internal market in biocidal products while taking as a condition "a high level of protection for humans, animals and the environment"
Uvodna izjava 4 Direktive 98/8/ES .
Recital (4), Directive 98/8/EC .
Predlog je dejansko usklajevalni ukrep, katerega namen je poenostavitev sistema Direktive za odobritev biocidnih pripravkov po vse Uniji, da se olajša prosti pretok blaga in se ohrani notranji trg.
The proposal is essentially a harmonisation measure, designed to simplify the Directive's system of authorisation of biocidal products across the Union in order to facilitate the free movement of goods and to maintain the internal market.
Usmerjen je v šibkosti regulativnega okvira Direktive ter v posodobitev postopka odobritve.
It is aimed at the weaknesses of the Directive's regulatory framework and at updating the authorisation procedures.
Prav tako širi področje uporabe direktive, da se vključijo snovi, ki lahko pridejo v stik s hrano, in proizvodi ali blago, ki je bilo obdelano z biocidnimi pripravki.
It also extends the scope of the Directive to include materials that might come into contact with food, and articles or materials that have been treated with biocidal products.
S spremembo Direktive v uredbo namerava predlog doseči bolj usklajeno izvajanje regulativnega okvira, saj obdobje prenosa ne bo več potrebno, prav tako ne bodo potrebni nacionalni ukrepi za prenos v državah članicah.
By turning the Directive into a regulation, the proposal aims to achieve a more harmonised implementation of the regulatory framework as there will be no need for a transposition period or for national transposition measures in Member States.
Člen 114 PDEU omogoča sprejetje ukrepov Skupnosti po rednem zakonodajnem postopku, „katerih predmet je vzpostavitev in delovanje notranjega trga.“ Ta člen je treba razumeti v povezavi s členom 26 PDEU, ki določa prosti pretok blaga kot temeljno načelo vzpostavitve notranjega trga.
Article 114 TFEU mandates via the ordinary legislative procedure Community measures "which have as their object the establishment and functioning of the internal market".This article should be read in the context of Article 26 TFEU, establishing free movement of goods as a fundamental principle in the establishment of the internal market.
Poleg tega je treba ugotoviti, da člen 114(3) vzpostavlja „visoko raven varovanja“ pri ukrepih, ki zadevajo zdravje, varnost, varstvo okolja in potrošnikov.
In addition Article 114(3) should be noted as establishing a "high level of protection" in measures dealing with health, safety, environmental and consumer protection.
Odstavki 4 do 9 državam članicam omogočajo, da sprejmejo nacionalne ukrepe zato, da uvedejo upravičene prepovedi ali omejitve za uvoz, izvoz ali blago v tranzitu, v skladu s členom 36 PDEU, zatem, ko je bil sprejet usklajevalni ukrep.
Paragraphs (4) to (9) permit Member States to take national measures to introduce justified prohibitions or restrictions on imports, exports or goods in transit, pursuant to Article 36 TFEU, after a harmonisation measure has been adopted.
Zato odstavki od 4 do 9 predstavljajo bistveno kvalifikacijo splošnega cilja člena, ki je spodbujanje vzpostavitve in delovanja notranjega trga.
Paragraphs (4) to (9) therefore represent a significant qualification of the overall aim of the article in fostering the establishment and functioning of the internal market.
Člen 168 PDEU je pod naslovom XIV o javnem zdravju.
Article 168 TFEU comes under Title XIV on Public Health.
Osredotoča se na vzdževanje „visoke ravni varovanja zdravja ljudi“ v zvezi z zdravstnimi storitvami in preprečevanjem čezmejnih groženj za zdravje ljudi.
It concentrates on maintaining a "high level of human health protection" in terms of health services and the prevention of cross border threats to human health.
Vendar člen 168(4)(b) z odstopanjem omogoča sprejetje „ukrepov na veterinarskem in fitosanitarnem področju, katerih neposredni cilj je varovanje javnega zdravja“, in sicer z rednim zakonodajnim postopkom.
Article 168(4)(b) however provides by way of derogation a mandate for "measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health", using the ordinary legislative procedure.
Lahko bi trdili, da je namen predloga, s tem ko spodbuja notranji trg z biocidi, ki lahko varujejo in ščitijo življenje živali in rastlin, skladen s to določbo, vendar „neposredni cilj“ predloga ni varovanje javnega zdravja.
Whilst it could be argued that the aim of the proposal, in facilitating the internal market in biocides which can protect and preserve animal and plant life, corresponds with this provision, the proposal does not have as its "direct objective" the protection of public health.
Neposredni cilj predloga, določen v uvodni izjavi 3 preambule, je povečanje prostega pretoka biocidnih pripravkov v Skupnosti.
The direct objective of the proposal, as indicated in recital (3) in the preamble, is to increase the free movement of biocidal products within the Community.
Varovanje javnega zdravja je treba razumeti kot enega od ciljev predloga, vendar ne kot glavnega ali prevladujočega, kakor bo bolj podrobno razloženo v nadaljevanju.
As will be posited in more detail below, the protection of public health should be regarded as one, but not the main or dominant, purpose of the proposal.
Člen 192(1) PDEU omogoča, da se z rednim zakonodajnim postopkom sprejmejo ukrepi za uresničitev politike Unije v skladu s členom 191 o, med drugim, ohranjanju, varovanju in izboljšanju kakovosti okolja ter varovanju zdravja ljudi.
Article 192(1) TFEU permits measures to be taken under the ordinary legislative procedure to enact Union policy under Article 191 on, inter alia , preserving, protecting and improving the quality of the environment, and protecting human health.
Člen 192(2) omogoča, da se po posebnem zakonodajnem postopku sprejmejo ukrepi, ki med drugim zadevajo ukrepe o količinskem upravljanju vodnih virov in uporabi tal.
Article 192(2) permits measures to be taken under a special legislative procedure which concern, inter alia , measures affecting the quantitative management of water resources, and land use.
Trdi se, da je najbolj relevantna določba v razmerju do predloga člen 192(1): predlog sodi zlasti v okvir ohranjanja in varovanja kakovosti okolja in varovanja zdravja ljudi, kar ta določba posebej določa.
It is submitted that the more relevant provision in terms of the proposal is Article 192(1): in particular the proposal falls within the scope of preserving and protecting the quality of the environment and protecting human health specifically set out in that provision.
Videli smo, da sodna praksa jasno določa, da ko obstaja več kot ena možna pravna podlaga za ukrep Skupnosti, je splošno pravilo to, da je treba uporabiti podlago, ki ustrezna glavnemu ali prevladujočemu namenu ukrepa, razen v izjemnih primerih, ko so nameni ukrepa medsebojno neločljivo povezani, ne da bi bil en drugoten v primerjavi z drugim, ustrezne pravne podlage pa so postopkovno združljive.
As we have seen, the case law makes it clear that where there is more than one possible legal basis for a Community measure, the general rule is that the basis which corresponds to the main or dominant purpose of the measure should be used, unless exceptionally the purposes of the measure are indissociably linked without one being secondary to the other, and the corresponding legal bases are procedurally compatible.
Jasno je, da so pravne podlage, ki jih predlaga Odbor za okolje, javno zdravje in varnost hrane, postopkovno združljive: deli predlaganih členov, ki določajo posebne zakonodajne postopke, ne ustrezajo namenu in cilju predloga, medtem ko ključni deli vsake predlagane podlage, ki ustrezajo namenu in cilju predloga, vsi predvidevajo redni zakonodajni postopek.
It is clear that the legal bases put forward in the Committee on the Environment, Public Health and Food Safety are procedurally compatible: those parts of the suggested articles which provide for special legislative procedure do not correspond to the scope and aim of the proposal, while the key parts of each proposed legal basis which do correspond to the scope and aim of the proposal all apply the ordinary legislative procedure.
Zato je treba preučiti, ali lahko cilje predloga razumemo kot neločljivo povezane, pri čemer noben nima drugotnega pomena v primerjavi z drugimi: če je temu tako, je možnih več pravnih podlag.
It must therefore be considered whether the aims of the proposal can be regarded as indissociably linked without one being secondary to the other: if so, a multiple legal basis may be possible.
Predpostavlja se, da je cilj ohranjanja notranjega trga s spodbujanjem trgovine z biocidnimi pripravki med državami članicami prevladujoči ali glavni namen predloga, medtem ko je varovanje okolja ter življenja ljudi in živali drugotni namen.
It is posited above that the aim of maintaining the internal market by facilitating inter-Member State trade in biocidal products is the dominant or main purpose of the proposal, while the protection of the environment and human and animal life is a secondary purpose.