natgillin/translations-raw huggingface dataset:
The Commission presented the review report and this draft regulation on the approval of chitosan hydrochloride to the Standing Committee on the Food Chain and Animal Health on 20 March 2014.
Komisija je 20. marca 2014 Stalnemu odboru za prehranjevalno verigo in zdravje živali predložila poročilo o pregledu in ta osnutek uredbe o odobritvi hitosan hidroklorida.
The documentation provided by the applicant and the results of examinations carried out by the Authority [3] in accordance with Regulation (EC) No 1924/2006 of the European Parliament and of the Council [4] show that Chitosan hydrochloride fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council [5].
Dokumentacija, ki jo je predložil vložnik, in rezultati pregledov, ki jih je v skladu z Uredbo (ES) št. 1924/2006 Evropskega parlamenta in Sveta [3] izvedla Agencija [4], kažejo, da hitosan hidroklorid izpolnjuje merila za živilo iz člena 2 Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta [5].
Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water.
Čeprav se običajno ne uporablja za fitofarmacevtske namene, je lahko v sredstvu, ki vsebuje snov in vodo, koristna v fitofarmaciji.
It has appeared from the examinations made that chitosan hydrochloride may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report.
Opravljeni pregledi so pokazali, da se lahko od hitosan hidroklorida pričakuje, da na splošno izpolnjuje zahteve iz člena 23 Uredbe (ES) št. 1107/2009, zlasti v zvezi z uporabami, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to include certain conditions for the approval which are detailed in Annex I of this Regulation.
V skladu s členom 13(2) Uredbe (ES) št. 1107/2009 v povezavi s členom 6 Uredbe ter ob upoštevanju sedanjih znanstvenih in tehničnih dognanj je treba vključiti nekatere pogoje za odobritev, ki so podrobno opredeljeni v Prilogi I k tej uredbi.
In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 [6] should be amended accordingly.
V skladu s členom 13(4) Uredbe (ES) št. 1107/2009 bi bilo treba ustrezno spremeniti Prilogo k Izvedbeni uredbi Komisije (EU) št. 540/2011 [6].
Approval of a basic substance
Odobritev osnovne snovi
The substance chitosan hydrochloride as specified in Annex I is approved as basic substance subject to the conditions laid down in that Annex.
Osnovna snov hitosan hidroklorid, kot je opredeljena v Prilogi I, se odobri kot osnovna snov v skladu s pogoji iz navedene priloge.
Amendments to Implementing Regulation (EU) No 540/2011
Spremembe Izvedbene uredbe (EU) št. 540/2011
The Part C of Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Del C Priloge k Izvedbeni uredbi (EU) št. 540/2011 se spremeni v skladu s Prilogo II k tej uredbi.
Done at Brussels, 23 May 2014.
V Bruslju, 23. maja 2014
Outcome of the consultation with member States and EFSA on the basic substance application for Chitosan hydrochloride and the conclusions drawn by EFSA on the specific points raised.
Rezultat posvetovanja z državami članicami in Agencijo o uporabi osnovne snovi hitosan hidroklorid in sklepi Agencije o obravnavanih posameznih točkah.
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) EFSA Journal 2009; 7(9): 1289 doi: 10.2903/j.efsa.2009.1289.
Uredba (ES) št. 1924/2006 Evropskega Parlamenta in Sveta z dne 20. decembra 2006 o prehranskih in zdravstvenih trditvah na živilih (UL L 404, 30.12.2006, str. 9).
Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, p. 9).
Svet EFSA za dietetične izdelke, prehrano in alergije (NDA); EFSA Journal 2009 7(9):1289 doi: 10.2903/j.efsa.2009.1289.
Chitosan hydrochloride
hitosan hidroklorid
CAS no: 9012-76-4
št.
Not applicable
CAS: 9012-76-4
European Pharmacopeia
ni relevantno
Max content of heavy metals: 40 ppm
Evropska farmakopeja
1 July 2014
Najvišja vsebnost težkih kovin: 40 ppm
Chitosan hydrochloride shall comply with Regulation (EC) No 1069/2009 of the European Parliament and of the Council [2] and Commission Regulation (EU) No 142/2011 [3].
1. julij 2014
Chitosan hydrochloride may be used in accordance with specific conditions included in the conclusions of the review report on Chitosan hydrochloride (SANCO/12388/2013) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014.
Hitosan hidroklorid izpolnjuje zahteve iz Uredbe (ES) št. 1069/2009 Evropskega parlamenta in Sveta [2] in Uredbe Komisije (EU) št. 142/2011 [3].
Further details on identity, specification and manner of use of basic substance are provided in the review report.
Hitosan hidroklorid se lahko uporablja v skladu s posebnimi pogoji, ki so vključeni v ugotovitve iz poročila o pregledu hitosan hidroklorida (SANCO/12388/2013), zlasti dodatka I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 20. marca 2014.
OJ L 300, 14.11.2009, p. 1.
Več podrobnosti o identiteti, specifikaciji in načinu uporabe osnovne snovi je na voljo v poročilu o pregledu.
OJ L 54, 26.2.2011, p. 1
UL L 300, 14.11.2009, str. 1.
ANNEX II
UL L 54, 26.2.2011, str. 1.
In Part C of Annex to Implementing Regulation (EC) No 540/2011, the following entry is added:
PRILOGA II
Chitosan hydrochloride shall comply with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011.
V delu C Priloge k Izvedbeni uredbi (EU) št. 540/2011 se doda naslednji vnos:
Chitosan hydrochloride may be used in accordance with specific conditions included in the conclusions of the review report on Chitosan hydrochloride (SANCO/12388/2013) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014.’
Hitosan hidroklorid izpolnjuje zahteve iz Uredbe (ES) št. 1069/2009 in Uredbe (EU) št. 142/2011.
2013: EN-426.23 pp.
2013: EN-426.23 str.
Commission Implementing Regulation (EU) No 564/2014
Izvedbena uredba Komisije (EU) št. 564/2014
Council Regulation (EU) No 566/2014
Uredba Sveta (EU) št. 566/2014
amending Regulation (EC) No 617/2007 as regards the application of the transition period between the 10th EDF and the 11th EDF until the entry into force of the 11th EDF Internal Agreement
o spremembi Uredbe (ES) št. 617/2007 v zvezi z uporabo prehodnega obdobja med 10.
THE COUNCIL OF THE EUROPEAN UNION,
ERS in 11.
Having regard to the Treaty on the Functioning of the European Union,
ERS do začetka veljavnosti Notranjega sporazuma za 11.
Having regard to the Partnership Agreement between the members of the African, Caribbean and Pacific (ACP) Group of States of the one part, and the European Community and its Member States, of the other part, as last amended [1] (‘the ACP-EU Partnership Agreement’),
ERS
Having regard to the Internal Agreement between the Representatives of the Governments of the Member States, meeting within the Council, on the financing of Community aid under the multiannual financial framework for the period 2008 to 2013 in accordance with the ACP-EC Partnership Agreement and on the allocation of financial assistance for the Overseas Countries and Territories to which Part Four of the EC Treaty applies [2] (the ‘Internal Agreement’), and in particular Article 10(1) thereof,
SVET EVROPSKE UNIJE JE – ob upoštevanju Pogodbe o delovanju Evropske unije,
Having regard to the proposal from the European Commission,
ob upoštevanju Sporazuma o partnerstvu med članicami skupine afriških, karibskih in pacifiških (AKP) držav na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi, [1], kakor je bil nazadnje spremenjen (v nadaljnjem besedilu: Sporazum o partnerstvu AKP-EU),
Having regard to the opinion of the European Investment Bank,
ob upoštevanju Notranjega sporazuma med predstavniki vlad držav članic, ki so se sestali v okviru Sveta, o financiranju pomoči Skupnosti v okviru večletnega finančnega okvira za obdobje 2008–2013 v skladu s Sporazumom o partnerstvu AKP-ES in o dodelitvi finančne pomoči čezmorskim državam in ozemljem, za katera se uporablja četrti del Pogodbe ES [2] (v nadaljnjem besedilu: Notranji sporazum), in zlasti člena 10(1) Notranjega sporazuma,
Whereas:
ob upoštevanju predloga Evropske komisije,
Council Decision 2013/759/EU [3] established transitional European Development Fund (EDF) management measures (‘Bridging Facility’) to ensure the availability of funds for cooperation with African, Caribbean and Pacific countries and with Overseas Countries and Territories, as well as for support expenditure, from 1 January 2014 until the entry into force of the 11th EDF.
ob upoštevanju mnenja Evropske investicijske banke,
It is necessary to modify Council Regulation (EC) No 617/2007 [4] as regards the operational and financial management by the Commission of the Bridging Facility in the transition period between the 10th EDF and the 11th EDF until the entry into force of the 11th EDF Internal Agreement and the 11th EDF Implementation Regulation.
ob upoštevanju naslednjega:
It is appropriate to modify in the same way the implementing rules for the operational and financial management of the Investment Facility during this transitional period.
Sklep Sveta 2013/759/EU [3] je določil prehodne ukrepe za upravljanje Evropskega razvojnega sklada (ERS) (v nadaljnjem besedilu: premostitveni sklad), da se zagotovijo razpoložljiva sredstva za sodelovanje z afriškimi, karibskimi in pacifiškimi državami ter čezmorskimi državami in ozemlji ter podpora odhodkov od 1. januarja 2014 do začetka veljavnosti 11.
The organisation and functioning of the European External Action Service are established in Council Decision 2010/427/EU [5].
ERS.
Regulation (EC) No 617/2007 should be therefore amended accordingly,
Uredbo Sveta (ES) št. 617/2007 [4] je treba spremeniti v zvezi z operativnim in finančnim upravljanjem premostitvenega sklada s strani Komisije v prehodnem obdobju med 10.
HAS ADOPTED THIS REGULATION:
ERS in 11.
Article 1
ERS do začetka veljavnosti Notranjega sporazuma za 11.
For the transition period between the 10th EDF and the 11th EDF until the entry into force of the 11th EDF Internal Agreement, Articles 1 to 16 of Regulation (EC) No 617/2007 are replaced by those laid down in the Annex to this Regulation.
ERS in izvedbene uredbe za 11.
Article 2
ERS.
This Regulation shall apply in accordance with Decision 2010/427/EU.
Primerno je, da se v tem prehodnem obdobju na enak način spremenijo izvedbena pravila za operativno in finančno upravljanje Sklada za spodbujanje naložb.
Article 3
Organizacija in delovanje Evropske službe za zunanje delovanje sta določena v Sklepu Sveta 2010/427/EU [5].
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
Uredbo (ES) št. 617/2007 bi bilo zato treba ustrezno spremeniti –
It shall apply until the entry into force of the 11th EDF Implementation Regulation.
SPREJEL NASLEDNJO UREDBO:
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Člen 1
Done at Brussels, 26 May 2014.
V prehodnem obdobju med 10.
For the Council
ERS in 11.
The President
ERS do začetka veljavnosti Notranjega sporazuma za 11.
OJ L 317, 15.12.2000, p. 3.
ERS se členi 1 do 16 Uredbe (ES) št. 617/2007 nadomestijo s členi iz Priloge k tej uredbi.
OJ L 247, 9.9.2006, p. 32.
Člen 2
Council Decision 2013/759/EU of 12 December 2013 regarding transitional EDF management measures from 1 January 2014 until the entry into force of the 11th European Development Fund (OJ L 335, 14.12.2013, p. 48).
Ta uredba se uporablja v skladu s Sklepom 2010/427/EU.
OJ L 152, 13.6.2007, p. 1.
Člen 3
Council Decision 2010/427/EU of 26 July 2010 establishing the organisation and functioning of the European External Action Service (OJ L 201, 3.8.2010, p. 30).
Ta uredba začne veljati tretji dan po objavi v Uradnem listu Evropske unije.
ANNEX
Uporablja se do začetka veljavnosti izvedbene uredbe za 11.
‘TITLE I
ERS.
OBJECTIVES AND GENERAL PRINCIPLES
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
Objectives and eligibility criteria
V Bruslju, 26. maja 2014
Geographic cooperation with the ACP countries and regions in the context of the European Development Fund (EDF) shall be founded on the objectives, basic principles and values reflected in the general provisions of the Partnership Agreement between the members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part, as last amended [1] (“the ACP-EU Partnership Agreement”).
Za Svet
In particular, and within the framework of the principles and objectives of the Union's external action, of the European Consensus on Development and of the Agenda for Change and subsequent modifications and additions thereto:
Predsednik
the primary objective of cooperation under this Regulation shall be the reduction and, in the long term, the eradication of poverty;
UL L 317, 15.12.2000, str. 3.
cooperation under this Regulation will also contribute to:
UL L 247, 9.9.2006, str. 32.
fostering sustainable and inclusive economic, social and environmental development,
Sklep Sveta 2013/759/EU z dne 12. decembra 2013 o prehodnih ukrepih za upravljanje ERS od 1. januarja 2014 do začetka veljavnosti 11.
consolidating and supporting democracy, the rule of law, good governance, human rights and the relevant principles of international law, and
Evropskega razvojnega sklada (UL L 335, 14.12.2013, str. 48).
implementing a rights-based approach encompassing all human rights.
UL L 152, 13.6.2007, str. 1.
The achievement of those objectives shall be measured using relevant indicators, including human development indicators, in particular Millennium Development Goal (MDG) 1 for point (a) and MDG 1 to 8 for point (b) and, after 2015, other indicators agreed at international level by the Union and its Member States.
Sklep Sveta 2010/427/EU z dne 26. julija 2010 o organizaciji in delovanju Evropske službe za zunanje delovanje (UL L 201, 3.8.2010, str. 30).
Programming shall be designed so as to fulfil to the greatest extent possible the criteria for official development assistance (ODA) established by the Development Assistance Committee of the Organisation for Economic Cooperation and Development (OECD/DAC), taking into account the Union's aim to ensure that over the period 2014-20 at least 90 % of its overall external assistance be counted as ODA.
PRILOGA
Actions covered by Council Regulation (EC) No 1257/96 [2] and eligible for funding under that Regulation shall not, in principle, be funded under this Regulation, without prejudice to the need to ensure continuity of cooperation from crisis to stable conditions for development.
„NASLOV I
In those cases, special consideration shall be given to ensuring that humanitarian relief, rehabilitation and development assistance are effectively linked and contribute to disaster risk reduction and resilience.
CILJI IN SPLOŠNA NAČELA
General principles
Cilji in merila za upravičenost
In implementing this Regulation, consistency with other areas of Union external action and with other relevant Union policies and policy coherence for development shall be ensured, in accordance with Article 208 of the Treaty on the Functioning of the European Union (TFEU).
Geografsko sodelovanje z državami in regijami AKP v okviru Evropskega razvojnega sklada (ERS) temelji na ciljih, osnovnih načelih in vrednotah iz splošnih določb Sporazuma o partnerstvu med članicami skupine afriških, karibskih in pacifiških (AKP) držav na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi, [1], kakor je bil nazadnje spremenjen (v nadaljnjem besedilu: Sporazum o partnerstvu AKP-EU).
To this end, measures financed under this Regulation, including those managed by the European Investment Bank (EIB), shall be based on the cooperation policies set out in documents such as arrangements, declarations and action plans between the Union and the third countries and regions concerned, and on the Union's decisions, specific interests, policy priorities and strategies.
V okviru načel in ciljev zunanjega delovanja Unije, evropskega soglasja o razvoju in agende za spremembe ter naknadnih sprememb in dopolnitev je zlasti:
The Union and the Member States shall work towards joint multiannual programming, based on partner countries' poverty reduction or equivalent development strategies.
poglavitni cilj sodelovanja na podlagi te uredbe zmanjšanje in dolgoročna odprava revščine;
They may undertake joint action including joint analysis of and joint response to those strategies identifying priority sectors of intervention and in-country division of labour, by joint donor-wide missions and by the use of co-financing and delegated cooperation arrangements.
sodelovanje na podlagi te uredbe, ki bo prispevalo tudi k:
The Union shall promote a multilateral approach to global challenges and shall cooperate with Member States and partner countries in that respect.
spodbujanju trajnostnega in vključujočega gospodarskega, družbenega in okoljskega razvoja;
Where appropriate, it shall foster cooperation with international organisations and bodies and other bilateral donors.
utrjevanju in podpori demokracije, pravne države, dobrega upravljanja, človekovih pravic in ustreznih načel mednarodnega prava ter
Relations between the Union and its Member States and partner countries are based on and will promote shared values of human rights, democracy and the rule of law as well as the principles of ownership and of mutual accountability.
izvajanju pristopa na podlagi pravic z upoštevanjem vseh človekovih pravic.
Support to partners will be adapted to their development situation and commitment and progress with regard to human rights, democracy, the rule of law and good governance.
Doseganje teh ciljev se meri z ustreznimi kazalniki, vključno s kazalniki človekovega razvoja, zlasti z razvojnim ciljem tisočletja 1 za točko (a) in razvojnimi cilji tisočletja 1 do 8 za točko (b) ter, po letu 2015, z drugimi kazalniki, ki so jih Unija in njene države članice sprejele na mednarodni ravni.
Furthermore, relations with partner countries shall take into account their commitment and track record in implementing international agreements and contractual relations with the Union, including within the area of migration as stipulated by the ACP-EU Partnership Agreement.
Načrtovanje programov je zasnovano tako, da se v kar največji meri izpolnijo merila za uradno razvojno pomoč (v nadaljnjem besedilu: URP), ki jih je določil Odbor za razvojno pomoč Organizacije za gospodarsko sodelovanje in razvoj (v nadaljnjem besedilu: OECD/DAC), pri čemer se upošteva cilj Unije, ki poskuša doseči, da se v obdobju 2014–2020 vsaj 90 % njene celotne zunanje pomoči šteje za URP.
The Union shall promote effective cooperation with partner countries and regions in line with international best practice.
Ukrepi, predvideni v Uredbi Sveta (ES) št. 1257/96 [2], ki so upravičeni do financiranja v skladu z navedeno uredbo, se načeloma ne financirajo v okviru te uredbe, razen če je treba zagotoviti kontinuiteto sodelovanja med prehodom iz kriznih razmer v stabilne pogoje za razvoj.
It shall align its support with partners' national or regional development strategies, reform policies and procedures wherever possible, and support democratic ownership, as well as domestic and mutual accountability.
V teh primerih je treba posebno pozornost nameniti temu, da se zagotovi dejanska povezava med humanitarno pomočjo, sanacijo in razvojno pomočjo in da ti prispevajo k zmanjševanju tveganja nesreč in odpornosti nanje.
To that end, it shall promote:
Splošna načela
a development process that is transparent, partner country or region led and owned, including the promotion of local expertise;
Pri izvajanju te uredbe se v skladu s členom 208 Pogodbe o delovanju Evropske unije (PDEU) zagotovita skladnost z drugimi področji zunanjega delovanja Unije in drugimi zadevnimi politikami Unije ter koherenca politik za razvoj.
a rights-based approach encompassing all human rights, whether civil and political, economic, social and cultural, in order to integrate human rights principles into the implementation of this Regulation, to assist partner countries in implementing their international human rights obligations and to support the right holders, with a focus on poor and vulnerable groups, in claiming their rights;
Zato ukrepi, financirani na podlagi te uredbe, vključno z ukrepi, ki jih upravlja Evropska investicijska banka (EIB), temeljijo na politikah sodelovanja, določenih v dokumentih, kot so sporazumi, deklaracije in akcijski načrti med Unijo ter zadevnimi tretjimi državami in regijami, pa tudi na odločitvah, posebnih interesih ter prednostnih nalogah politike in strategijah Unije.
the empowerment of the population of partner countries, inclusive and participatory approaches to development and a broad involvement of all segments of society in the development process and in national and regional dialogue, including political dialogue.
Unija in države članice si prizadevajo za skupno večletno načrtovanje programov, ki temelji na strategijah za zmanjševanje revščine ali enakovrednih razvojnih strategijah partnerskih držav.
Particular attention shall be given to the respective roles of parliaments, local authorities and civil society, inter alia, regarding participation, oversight and accountability;
Izvajajo lahko skupne ukrepe, vključno s skupnimi analizami teh strategij in skupnimi odzivi nanje, v katerih določajo prednostne sektorje za ukrepanje ter delitev dela znotraj držav, in sicer s skupnimi misijami na ravni vseh donatorjev ter z uporabo dogovorov o sofinanciranju in prenesenem sodelovanju.
effective cooperation modalities and instruments in line with OECD/DAC best practices, including the use of innovative instruments such as blending grants and loans and other risk-sharing mechanisms in selected sectors and countries, and private sector engagement, with due regard to the issues of debt sustainability and the number of such mechanisms, and the requirement for systematic assessment of the impact in accordance with the objectives of this Regulation, in particular poverty reduction, as well as specific budget support mechanisms such as state building contracts.
Unija spodbuja večstranski pristop h globalnim izzivom in pri tem sodeluje z državami članicami in partnerskimi državami.
All programmes, interventions and cooperation modalities and instruments shall be adapted to the particular circumstances of each partner country or region, with a focus on programme-based approaches, on the delivery of predictable aid funding, on the mobilisation of private resources, including from the local private sector, on universal and non-discriminatory access to basic services, and on the development and use of country systems;
Po potrebi spodbuja sodelovanje z mednarodnimi organizacijami in organi ter drugimi dvostranskimi donatorji.
mobilisation of domestic revenue and reinforcement of partner countries' fiscal policy with the purpose of reducing poverty and aid dependence;
Odnosi med Unijo in njenimi državami članicami ter partnerskimi državami temeljijo na skupnih vrednotah, kot so človekove pravice, demokracija in pravna država ter načeli lastne in vzajemne odgovornosti, ter jih tudi spodbujajo.