natgillin/translations-raw huggingface dataset:
Zadeva: Mnenje o pravni podlagi predloga Uredbe Evropskega parlamenta in Sveta o živilskih encimih ( KOM(2006)0425 – C6 0257/2006 – 2006/0144(COD) )
Subject: Opinion on the legal basis of the Proposal for a Regulation of the European Parliament and of the Council on food enzymes ( COM(2006)0425 – C6‑0257/2006 – 2006/0144(COD) )
v pismu z dne 28. marca 2007 ste v skladu s členom 35(2) Poslovnika Odbor za pravne zadeve zaprosili za mnenje o točnosti in primernosti pravne podlage zgoraj omenjenega predloga Komisije.
By letter of 28 March 2007 you asked the Committee on Legal Affairs pursuant to Rule 35(2), to consider whether the legal basis of the above Commission proposal was valid and appropriate.
Zgoraj omenjeno vprašanje je odbor obravnaval na seji dne 2. maja 2007.
The committee considered the above question at its meeting of 2 May 2007.
Odbor je ugotovil, da ima predlog dvojno pravno podlago, člen 37 in člen 95 Pogodbe o ES, vendar poročevalka Avril Doyle predlaga črtanje člena 37, saj meni, da člen 95 zagotavlja ustrezno in zadostno pravno podlago.
The committee noted that whereas the proposal has a dual legal basis, Article 37 and Article 95 of the EC Treaty, the rapporteur, Mrs Doyle, proposes to delete Article 37 as she considers that Article 95 provides an appropriate and sufficient legal base.
Poleg tega Carl Schlyter in Bart Staes, ob upoštevanju dejstva, da je namen uredbe zagotoviti visoko raven varstva potrošnikov, ne predlagata le, naj se črta sklicevanje na člen 37, temveč tudi, naj se doda sklicevanje na člen 153, tako da bosta pravna podlaga člena 95 in 153.
Furthermore, Mr Schlyter and Mr Staes, taking into consideration the regulation's aim of providing a high level of consumer protection, propose not only to delete the reference to Article 37 but also to add a reference to Article 153, so that the legal bases would be Articles 95 and 153.
Obravnavane pravne podlage
The legal bases under consideration
Če se skupna ureditev za nekatere surovine vzpostavi pred obstojem skupne ureditve za ustrezne predelane proizvode, se lahko surovine, ki se uporabljajo za predelane proizvode, namenjene izvozu v tretje države, uvozijo iz držav zunaj Skupnosti.
If a common organisation for certain raw materials is established before a common 2organisation exists for the corresponding processed products, such raw materials as are used for processed products intended for export to third countries may be imported from outside the Community.
Če se v skladu z odstavkom 6 državi članici dovoli ohranitev ali uvedba nacionalnih določb, ki odstopajo od usklajevalnega ukrepa, Komisija nemudoma preveri, ali naj predlaga prilagoditev temu ukrepu.
When, pursuant to paragraph 6, a Member State is authorised to maintain or introduce national provisions derogating from a harmonisation measure, the Commission shall immediately examine whether to propose an adaptation to that measure.
Člen 153
Article 153
Zato da bi podprli interese potrošnikov in zagotovili visoko raven varstva potrošnikov, Skupnost prispeva k varovanju zdravja, varnosti in ekonomskih interesov potrošnikov, pa tudi k spodbujanju njihove pravice do obveščenosti, izobraževanja in samoorganiziranja za zaščito njihovih interesov.
In order to promote the interests of consumers and to ensure a high level of consumer protection, the Community shall contribute to protecting the health, safety and economic interests of consumers, as well as to promoting their right to information, education and to organise themselves in order to safeguard their interests.
Pri opredeljevanju in izvajanju drugih politik in dejavnosti Skupnosti se upoštevajo zahteve varstva potrošnikov.
Consumer protection requirements shall be taken into account in defining and implementing other Community policies and activities.
Skupnost prispeva k doseganju ciljev iz odstavka 1 z:
The Community shall contribute to the attainment of the objectives referred to in paragraph 1 through:
(a) ukrepi, sprejetimi v skladu s členom 95 v okviru uresničevanja notranjega trga;
(a) measures adopted pursuant to Article 95 in the context of the completion of the internal market;
(b) ukrepi za podporo, dopolnitev in nadzor politike držav članic.
(b) measures which support, supplement and monitor the policy pursued by the Member States.
Svet v skladu s postopkom iz člena 251 in po posvetovanju z Ekonomsko-socialnim odborom sprejme ukrepe iz odstavka 3(b).
The Council, acting in accordance with the procedure referred to in Article 251 and after consulting the Economic and Social Committee, shall adopt the measures referred to in paragraph 3 (b).
Ukrepi, sprejeti v skladu z odstavkom 4, državam članicam ne preprečujejo ohranjanja ali uvedbe strožjih zaščitnih ukrepov.
Measures adopted pursuant to paragraph 4 shall not prevent any Member State from maintaining or introducing more stringent protective measures.
Takšni ukrepi morajo biti združljivi s to pogodbo.
Such measures must be compatible with this Treaty.
O njih se uradno obvesti Komisija.
The Commission shall be notified of them.
V skladu z obrazložitvenim memorandumom je cilj predloga uredbe naslednji:
According to the explanatory memorandum, the aim and purpose of the proposal for a regulation is as follows:
Zakonodaja, ki nadzira uporabo encimov pri predelavi hrane, v EU ni v celoti usklajena.
The legislation controlling the use of enzymes in food processing is not fully harmonised in the EU.
Nacionalni regulativni okvir za encime, ki se uporabljajo kot pomožna tehnološka sredstva v proizvodnji živil, se med državami članicami zelo razlikuje.
The national regulatory context for enzymes used as processing aids in food production differs significantly among Member States.
Le nekaj držav članic ima obvezni ali prostovoljni postopek odobritve, večina ga sploh nima.
Only a few Member States have a mandatory or voluntary authorisation procedure, the majority have none at all.
Razen tega imajo države članice različna mnenja v zvezi s kategorizacijo encimov kot aditivov za živila ali pomožnih tehnoloških sredstev glede na njihovo funkcijo pri proizvodnji živil ali v končnih živilih.
Moreover, there are divided opinions among Member States in relation to the categorisation of enzymes into food additives or processing aids according to their function in the food process or in the final food.
Zaradi pomanjkanja usklajenih pravil v Skupnosti so nastale omejitve za trgovino z živilskimi encimi in ovire za rast na tem področju.
This lack of harmonised rules in the Community created barriers to the trade of food enzymes and has hindered growth in this field.
V zvezi z varnostjo na evropski ravni ni niti ocene varnosti niti odobritve živilskih encimov, razen za tiste, ki se obravnavajo kot aditivi za živila.
With respect to safety, there is neither safety evaluation nor authorisation of food enzymes at European level, except for those that are considered as food additives.
V preteklosti so živilski encimi veljali za nestrupene.
Historically, food enzymes were considered to be non-toxic.
Vseeno si industrija živilskih encimov še naprej prizadeva za razvoj izboljšane tehnologije, ki bi privedla do razvoja živilskih encimov, ki so z leti bolj zapleteni in razviti.
However, the food enzyme industry is continually striving to develop improved technology resulting in the development of food enzymes which became through the years more complex and sophisticated.
Iz njihove kemične narave in vira bi lahko izhajale nekatere možne nevarnosti, kot so alergenost, strupenost, povezana z delovanjem, preostalo mikrobiološko delovanje in kemična strupenost.
There could be some potential hazards arising from their chemical nature and source such as allergenicity, activity-related toxicity, residual microbiological activity, and chemical toxicity.
Zato je za zagotovitev varnosti potrošnika nujna ocena varnosti vseh živilskih encimov, vključno s tistimi, ki so proizvedeni iz gensko spremenjenih mikroorganizmov (GSO).
Therefore safety evaluation of all food enzymes, including those produced by genetically modified micro-organisms (GMOs), is essential in order to ensure consumer safety.
Vsebino predloga uredbe je mogoče razčleniti, kot sledi:
The content of the regulation may be analysed as follows:
Poglavje I – Vsebina, področje uporabe in opredelitve pojmov.
Chapter I - Subject matter, scope and definitions.
Predlagana uredba naj bi veljala za encime, ki se uporabljajo v tehnološke namene v proizvodnji, predelavi, pripravi, obdelavi, pakiranju, prevozu ali skladiščenju živil, vključno s tistimi, ki se uporabljajo kot pomožna tehnološka sredstva.
The proposed Regulation is to apply to enzymes used for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of food, including those used as processing aids.
S pomočjo seznama Skupnosti naj bi se za živilske encime izvedla ocena varnosti in postopek odobritve.
Food enzymes are to be subject to safety evaluation and approval by means of a Community list.
Poglavje II – Seznam Skupnosti odobrenih živilskih encimov
Chapter II - Community list of approved food enzymes
Za vse živilske encime in njihovo uporabo v živilih bo izvedena ocena varnosti, tehnološke potrebe in koristi za potrošnika ter ocena, ki zagotavlja, da potrošnikov njihova uporaba ne zavaja.
All food enzymes and their use in food will be evaluated for safety, technological need, benefit to the consumer and to ensure that the consumer is not misled by their use.
V skladu z odločitvijo, da se ločita obvladovanje in ocena tveganja, bo Evropska agencija za varnost hrane (EFSA) izvedla ocene varnosti.
In line with the decision to separate risk management and risk assessment, the European Food Safety Authority (EFSA) will carry out the safety evaluations.
Vključitev živilskega encima na seznam Skupnosti bo obravnavala Komisija na podlagi mnenja EFSA, ob upoštevanju drugih splošnih meril (tehnološka potreba, vidiki potrošnika).
The inclusion of a food enzyme in the Community list will be considered by the Commission on the basis of the opinion from EFSA, taking into account the other general criteria (technological need, consumer aspects).
Za vsak živilski encim, vključen na pozitivni seznam, naj bi se določile specifikacije, vključno z merili glede čistosti in izvora živilskega encima.
For every food enzyme included in the positive list specifications, including the criteria relating to the purity and the origin of the food enzyme, are to be laid down.
Poglavje III – Označevanje
Chapter III - Labelling
Predlagana uredba bo uvedla zahteve po označevanju za živilske encime, prodane proizvajalcu ali neposredno potrošniku.
The proposed Regulation will introduce labelling requirements for food enzymes sold to the manufacturer or directly to the consumer.
Za namene označevanja je treba encime v živilih obravnavati kot sestavine, podobno kot aditive, v skladu z Direktivo 2000/13/ES o označevanju, predstavljanju in oglaševanju živil.
For the purpose of labelling, enzymes used in food should be considered as ingredients in a similar way to additives in accordance with Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs.
V večini primerov se živilski encimi uporabijo kot pomožna tehnološka sredstva, tj. prisotna so v živilih v obliki ostanka, če sploh, in nimajo tehnološkega vpliva na končni proizvod.
In most cases food enzymes will be used as processing aids, i.e. they will be present in food in the form of a residue, if at all, and will have no technological effect on the finished product.
Ob upoštevanju, da bo ocena varnosti izvedena za vse živilske encime, se predlaga, da bi bili živilski encimi, ki se uporabljajo kot pomožna tehnološka sredstva, izvzeti iz označevanja.
Taking into account that all food enzymes will be assessed for their safety, it is proposed that food enzymes which are used as processing aids should be exempted from labelling.
Živilski encimi s tehnološko funkcijo v končnem živilu bodo označeni s svojo funkcijo (npr. stabilizator itd.) in značilnim imenom.
Food enzymes used to exert a technological function in the final food will be labelled with their function ( e.g. stabiliser, etc) and specific name.
Poglavje IV – Postopkovne določbe in izvajanje
Chapter IV - Procedural provisions and implementation
Po potrebi bodo proizvajalci in uporabniki živilskih encimov morali obvestiti Komisijo o kakršnih koli novih podatkih, ki lahko vplivajo na oceno varnosti živilskega encima.
Wherever necessary, producers or users of food enzymes will be obliged to inform the Commission of any new information which may affect the safety assessment of the food enzyme.
Za izvajanje ukrepov, predlaganih v Uredbi, bo skrbela Komisija v skladu z regulativnim postopkom, določenim v Sklepu Sveta 1999/468/ES.
Implementation of the measures proposed in the Regulation will be effected by the Commission in accordance with the regulatory procedure laid down in Council Decision 1999/468/EC.
Poglavje V – Prehodne in končne določbe
Chapter V -Transitional and final provisions
Ker so številni živilski encimi že na trgu Skupnosti, bi moral biti prehod na pozitivni seznam Skupnosti nemoten in ne bi smel povzročiti nepoštenih pogojev za proizvajalce encimov.
Since many food enzymes are already on the market in the Community, the transition to a Community positive list should be smooth and should not lead to unfair conditions for enzyme producers.
Zato predlog predvideva začetno obdobje 24 mesecev po datumu začetka uporabe izvedbenih ukrepov, predvidenih v skupnem postopku Uredbe, v katerem se lahko predložijo vloge.
Therefore, the proposal provides for an initial period of 24 months, after the date of application of the implementing measures foreseen in the common procedure Regulation, during which applications can be submitted.
Oblikovanje seznama Skupnosti bo izvedeno s postopkom v enem koraku, potem ko bo EFSA izrazila mnenja o vseh proizvodih, za katere so bili v obdobju 24 mesecev predloženi zadostni podatki.
The establishment of the Community list will take place in a single-step procedure after the EFSA has expressed opinions on all products for which sufficient information has been submitted during the 24-month period.
Dokler seznam Skupnosti ne bo oblikovan, se lahko živilski encimi in živila, proizvedena z živilskimi encimi, dajejo na trg in uporabljajo v skladu z obstoječimi nacionalnimi predpisi.
Until such time as the Community list has been established, food enzymes and food produced with food enzymes may be placed on the market and used in accordance with existing national rules.
Prehodno obdobje je določeno tudi za predlagane zahteve po označevanju.
A transitional period is also laid down for the proposed labelling requirements.
Iz ustaljene prakse Sodišča je razvidno, da izbira pravne podlage ni stvar proste presoje zakonodajalca Skupnosti, pač pa mora temeljiti na objektivnih dejavnikih, ki jih je mogoče sodno preskusiti
It is clear from settled case-law of the Court of Justice that the choice of legal basis is not at the discretion of the Community legislator but must be determined by objective factors which can be subject to judicial review
Še več, odločilni dejavnik mora biti glavni cilj ukrepa
Furthermore, the decisive factor should be the main object of a measure
Glede na sodno prakso Sodišča Evropskih skupnosti splošni člen Pogodbe predstavlja ustrezno pravno podlago, čeprav obravnavani ukrep skuša na podrejen način doseči tudi cilj, ki si ga prizadeva doseči specifični člen Pogodbe
According to the case-law of the Court of Justice, a general Treaty article constitutes a sufficient legal basis even though the measure in question also seeks, in a subordinate manner, to attain an aim sought by a specific Treaty article
Glede na navedeno je treba določiti, ali naj ustrezno pravno podlago za predlagano uredbo predstavljata člena 37 in 95 ali samo člen 95 ali člena 95 in 153 Pogodbe o ES.
In the light of the above, it is to be established whether Article 37 together with Article 95, Article 95 alone or Article 95 together with Article 153 of the EC Treaty should constitute the proper legal basis of the proposed regulation.
V zvezi s členom 37 ugotavljamo, da je ta člen sicer omenjen v prvi navedbi sklicevanja v uvodu k predlogu uredbe, vendar obrazložitveni memorandum kot pravno podlago navaja zgolj člen 95.
As far as Article 37 , is concerned, it is noted that, even though that article is mentioned in the first citation in the preamble to the proposed regulation, the explanatory memorandum mentions only Article 95 as the legal basis.
Če se ob tem šteje, da so edine pozitivne omembe kmetijskih proizvodov zelo obrobne, in sicer v uvodnih izjavah 7
When in addition, it is considered that the only positive mentions of agricultural products are very ancillary indeed, namely in recitals 7
Nekateri živilski encimi so dovoljeni za posebne uporabe, na primer v sadnih sokovih in nekaterih podobnih proizvodih ter nekaterih mlečnih beljakovinah, namenjenih za prehrano ljudi, in za nekatere odobrene enološke postopke in obdelave.
Some food enzymes are permitted for specific uses, such as in fruit juices and certain similar products and certain lactoproteins intended for human consumption and for certain authorised oenological practices and processes.
Te živilske encime je treba uporabljati v skladu s to uredbo in posebnimi določbami iz ustrezne zakonodaje Skupnosti.
Those food enzymes should be used in accordance with this Regulation and with the specific provisions laid down in the relevant Community legislation.
Direktivo Sveta 2001/112/ES z dne 20. decembra 2001 o sadnih sokovih in nekaterih podobnih proizvodih, namenjenih za prehrano ljudi, Direktivo Sveta 83/417/EGS z dne 25. julija 1983 o približevanju zakonov držav članic v zvezi z nekaterimi beljakovinami v mleku (kazeini in kazeinati) za prehrano ljudi in Uredbo Sveta (ES) št. 1493/1999 z dne 17. maja 1999 o skupni ureditvi trga za vino je zato treba ustrezno spremeniti. in 16
Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption, Council Directive 83/417/EEC of 25 July 1983 on the approximation of the laws of the Member states relating to certain lactoproteins (caseins and caseinates) intended for human consumption and Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine should therefore be amended accordingly. and 16
Uredba Sveta (ES) št. 1493/1999 odobri uporabo ureaze, beta glukanaze in lizocima v vinu v skladu s pogoji, določenimi v Uredbi Komisije (ES) št. 1622/2000 z dne 24. julija 2000 o določitvi nekaterih podrobnih pravil za izvajanje Uredbe (ES) št. 1493/1999 o skupni ureditvi trga za vino in vzpostavitvi kodeksa Skupnosti na področju enoloških postopkov in obdelav.
Council Regulation (EC) No 1493/1999 authorises the use of urease, beta-glucanase and lysozyme in wine subject to the conditions laid down in Commission Regulation (EC) No 1622/2000 of 24 July 2000 laying down certain detailed rules for implementing Regulation (EC) No 1493/1999 on the common organisation of the market in wine and establishing a Community code of oenological practices and processes.
Te snovi so živilski encimi in morajo biti vključene na področje uporabe te uredbe.
Those substances are food enzymes and they should fall within the scope of this Regulation.
Zato jih je treba dodati tudi na seznam Skupnosti, ko bo oblikovan, za njihovo uporabo v vinu v skladu z Uredbo (ES) št. 1493/1999 in Uredbo (ES) št. 1622/2000. , ter da uvodna izjava 4 jasno določa, da "mikrobiološke kulture, ki se tradicionalno uporabljajo v proizvodnji živil, na primer sira in vina, in ki lahko vsebujejo encime, vendar se ne uporabljajo izrecno za njihovo proizvodnjo, se ne smejo obravnavati kot živilski encimi", ni jasno, kako naj bi člen 37 predstavljal pravno podlago.
They should therefore be also added to the Community list when it is drawn up for their use in wine in accordance with Regulation (EC) No 1493/1999 and Regulation (EC) No 1622/2000. , and that recital 4 makes it clear that "Microbial cultures traditionally used in the production of food, such as cheese and, wine and which may contain enzymes but are not specifically used to produce them should not be considered food enzymes", it is hard to see how Article 37 could constitute the legal basis.
Zato se šteje, da na osnovi meril, določenih s sodno prakso, člen 37 ne izpolnjuje pogojev za skupno pravno podlago, ker predlagana uredba daje poudarek notranjemu trgu in varovanju zdravja, kot jasno kažejo uvodne izjave 1, 2 in 3
Consequently, given the proposed regulation's emphasis on the internal market and the protection of health as evinced in recitals 1, 2 and 3
(1) Prosti pretok varnih in zdravstveno ustreznih živil je pomemben vidik notranjega trga in znatno prispeva k zdravju in dobremu počutju državljanov ter njihovim socialnim in gospodarskim interesom.
(1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.
Zato je treba sprejeti pravila Skupnosti za usklajevanje nacionalnih določb v zvezi z uporabo encimov v živilih. .
It is therefore necessary to adopt Community rules harmonising national provisions relating to the use of enzymes in foods. , it is considered that Article 37 does not qualify as joint legal basis on the basis of the criteria laid down in the case-law.
Upoštevati je treba tudi, da člena 37 in 95 nista videti združljiva: prvi predvideva zgolj posvetovanje s Parlamentom, drugi pa predvideva postopek soodločanja.
It should also be observed that Article 37 and Article 95 do not seem to be compatible - the former provides for the mere consultation of Parliament whilst the latter provides for the codecision procedure.
Pri vprašanju, ali se člen 153 lahko doda pravni podlagi člena 95, je nesporno, da se predlagana uredba ukvarja z varovanjem zdravja potrošnikov ter z njihovimi socialnimi in ekonomskimi interesi, ki so omenjeni v členu 153.
When it comes to the question whether Article 153 may be added to the legal basis of Article 95, it is undeniable that the proposed regulation is concerned with the protection of the health of consumers and with their social and economic interests, of which mention is made in Article 153.
Torej je mogoče zagovarjati stališče, da sta oba cilja, doseganje notranjega trga in zaščita potrošnikov, v okviru pomena iz člena 153 uravnotežena in da se torej lahko uporabljata obe pravni podlagi.
It is indeed possible to take the view that the two aims of achieving the internal market and consumer protection within the meaning of Article 153 are equally balanced and that therefore both legal bases may be used.