natgillin/translations-raw huggingface dataset:
It is appropriate to set out the information that a third-country firm applying for the provision of investment services or performance of activities throughout the Union should provide to the European Securities and Markets Authority (ESMA) and the format in which the information to clients as referred to in Article 46(5) of Regulation (EU) No 600/2014 should be provided in order to establish uniform requirements relating to third-country firms and to benefit from the possibility to provide services throughout the Union.
Ustrezno je določiti informacije, ki bi jih moralo podjetje tretje države, ki vloži vlogo za zagotavljanje investicijskih storitev ali opravljanje poslov po vsej Uniji, predložiti Evropskemu organu za vrednostne papirje in trge (ESMA), in obliko, v kateri bi bilo treba zagotoviti informacije strankam iz člena 46(5) Uredbe (EU) št. 600/2014, da bi se določile enotne zahteve v zvezi s podjetji iz tretjih držav in izkoristila možnost opravljanja storitev po vsej Uniji.
In order to enable ESMA to correctly identify and register the third-country firms, ESMA should be provided with their contact details, their national and international identification codes and proof of their authorisation to provide investment services in the country where the firm is established.
Da bi ESMA lahko pravilno identificirala in registrirala podjetja tretje države, bi morala imeti na razpolago njihove kontaktne podatke, njihove nacionalne in mednarodne identifikacijske kode ter dokazilo o dovoljenju za opravljanje investicijskih storitev v državi, v kateri ima podjetje sedež.
Attention should be paid to the language and layout used to provide information to clients by third-country firms, in order to ensure that the information is understandable and clear.
Pozornost bi bilo treba nameniti jeziku in obliki, ki ju uporabljajo podjetja iz tretjih držav za predložitev informacij strankam, tako da se zagotovi, da so informacije razumljive in jasne.
The application of this Regulation should be deferred in order to be aligned with the date of application of Regulation (EU) No 600/2014.
Začetek uporabe te uredbe bi bilo treba odložiti, da bi bil usklajen z datumom začetka uporabe Uredbe (EU) št. 600/2014.
This Regulation is based on the draft regulatory technical standards submitted by ESMA to the Commission.
Ta uredba temelji na osnutku regulativnih tehničnih standardov, ki ga je ESMA predložila Komisiji.
ESMA has conducted open public consultations on the draft regulatory technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Securities and Markets Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council [2],
ESMA je opravila odprta javna posvetovanja o osnutku regulativnih tehničnih standardov, na katerem temelji ta uredba, analizirala potencialne povezane stroške in koristi ter prosila za mnenje interesno skupino za vrednostne papirje in trge, ustanovljeno v skladu s členom 37 Uredbe (EU) št. 1095/2010 Evropskega parlamenta in Sveta [2] –
Information necessary for the registration
Informacije, potrebne za registracijo
A third-country firm applying for the provision of investment services or performance of activities throughout the Union in accordance with the second subparagraph of Article 46(4) of Regulation (EU) No 600/2014 shall submit the following information to ESMA:
Podjetje tretje države, ki vloži vlogo za zagotavljanje investicijskih storitev ali opravljanje poslov po vsej Uniji v skladu z drugim pododstavkom člena 46(4) Uredbe (EU) št. 600/2014, predloži ESMA naslednje informacije:
full name of the firm, including its legal name and any other trading name to be used by the firm;
polno ime podjetja, vključno z njegovim uradnim imenom in katerim koli drugim trgovskim imenom, ki ga uporablja podjetje;
contact details of the firm, including the head office address, telephone number and email address;
kontaktne podatke podjetja, vključno z naslovom sedeža, telefonsko številko in elektronskim naslovom;
contact details of the person in charge of the application, including telephone number and email address;
kontaktne podatke osebe, odgovorne za vlogo, vključno s telefonsko številko in elektronskim naslovom;
website, where available;
spletno mesto, če je na voljo:
national identification number of the firm, where available;
nacionalno identifikacijsko številko podjetja, če je na voljo;
legal entity identifier (LEI) of the firm, where available;
identifikator pravne osebe (LEI), če je na voljo;
Business Identifier Code (BIC) of the firm, where available;
identifikacijsko kodo podjetja (BIC), če je na voljo;
name and address of the competent authority of the third country that is responsible for the supervision of the firm; where more than one authority is responsible for supervision, the details of the respective areas of competence shall be provided;
ime in naslov pristojnega organa tretje države, ki je odgovoren za nadzor podjetja; če je za nadzor odgovoren več kot en organ, se navedejo podrobnosti o zadevnih področjih pristojnosti;
the link to the register of each competent authority of the third country, where available;
povezavo na register vsakega pristojnega organa tretje države, če je na voljo;
information on which investment services, activities, and ancillary services it is authorised to provide in the country where the firm is established;
informacije o investicijskih storitvah, poslih in pomožnih storitvah, ki jih lahko podjetje opravlja v državi, v kateri ima sedež;
the investment services to be provided and activities to be performed in the Union, together with any ancillary services.
investicijske storitve, ki se zagotavljajo, in posli, ki se opravljajo, v Uniji, skupaj s pomožnimi storitvami.
Information submission requirements
Zahteve glede predložitve informacij
The third-country firm shall inform ESMA, within 30 days, of any change of the information provided under Article 1(a) to (g), (j) and (k).
Podjetje tretje države obvesti ESMA v 30 dneh o kakršnih koli spremembah informacij, zagotovljenih v skladu s členom 1(a) do (g), (j) in (k).
Information provided to ESMA under Article 1(j) shall be provided through a written declaration issued by a competent authority of the third country.
Informacije, ki se predložijo ESMA v skladu s členom 1(j), se zagotovijo s pisno izjavo, ki jo izda pristojni organ tretje države.
The information provided to ESMA under Article 1 shall be in English, using the Latin alphabet.
Informacije, predložene ESMA v skladu s členom 1, so v angleščini in zapisane z latinico.
Any accompanying documents provided to ESMA under Article 1 and in paragraph 2 of this Article shall be in English or, where they have been written in a different language, a certified English translation shall also be provided.
Vsi spremni dokumenti, ki se predložijo ESMA v skladu s členom 1 in odstavkom 2 tega člena, so v angleščini, če pa so bili napisani v drugem jeziku, se predloži tudi overjen prevod v angleščino.
Information concerning type of clients in the Union
Informacije v zvezi z vrsto strank v Uniji
A third-country firm shall provide the information referred to in Article 46(5) of Regulation (EU) No 600/2014 to the clients in a durable medium.
Podjetje tretje države strankam zagotovi informacije iz člena 46(5) Uredbe (EU) št. 600/2014 na trajnem nosilcu podatkov.
The information referred to in Article 46(5) of Regulation (EU) No 600/2014, shall be:
Informacije iz člena 46(5) Uredbe (EU) št. 600/2014 so:
provided in English or in the official language, or one of the official languages, of the Member State where the services are to be provided;
v angleščini ali v uradnem jeziku oziroma enem od uradnih jezikov države članice, kjer se opravljajo storitve;
presented and laid out in a way that is easy to read, using characters of readable size;
predstavljene in oblikovane v lahko čitljivi obliki z znaki primerne velikosti za branje;
without using colours that may diminish the comprehensibility of the information.
brez barv, ki lahko zmanjšajo razumljivost informacij.
It shall apply from the date referred to in the second paragraph of Article 55 of Regulation (EU) No 600/2014.
Uporablja se od datuma, navedenega v drugem odstavku člena 55 Uredbe (EU) št. 600/2014.
Commission Implementing Regulation (EU) 2016/2023
Izvedbena uredba Komisije (EU) 2016/2023
concerning the authorisation of sodium benzoate, potassium sorbate, formic acid and sodium formate as feed additives for all animal species
o izdaji dovoljenja za natrijev benzoat, kalijev sorbat, mravljično kislino in natrijev format kot krmne dodatke za vse živalske vrste
In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, sodium benzoate was entered in the Register of Feed Additives as existing product belonging to the functional group of silage additives, for all animal species.
V skladu s členom 10(1)(b) Uredbe (ES) št. 1831/2003 je bil natrijev benzoat vpisan v register krmnih dodatkov kot obstoječi proizvod iz funkcionalne skupine silirnih dodatkov za vse živalske vrste.
In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, application was submitted for the authorisation of sodium benzoate and in accordance with Article 7 of Regulation (EC) No 1831/2003 applications were submitted for the authorisations of potassium sorbate, formic acid and sodium formate.
V skladu s členom 10(2) Uredbe (ES) št. 1831/2003 in v povezavi s členom 7 navedene uredbe je bil vložen zahtevek za dovoljenje za natrijev benzoat, v skladu s členom 7 Uredbe (ES) št. 1831/2003 pa so bili predloženi zahtevki za dovoljenja za kalijev sorbat, mravljično kislino in natrijev format.
Those applications concern the authorisations of sodium benzoate, potassium sorbate, formic acid and sodium formate as feed additives for all animal species to be classified in the category ‘technological additives’.
Navedeni zahtevki zadevajo dovoljenja za natrijev benzoat, kalijev sorbat, mravljično kislino in natrijev format kot krmne dodatke za vse živalske vrste in njihovo uvrstitev v kategorijo dodatkov „tehnološki dodatki“.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 June 2012 [2] that, under the proposed conditions of use, sodium benzoate does not have an adverse effect on animal health, human health or the environment; however it was considered as a potential sensitizer and a risk for inhalation cannot be excluded.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v mnenju z dne 13. junija 2012 [2] navedla, da natrijev benzoat pod predlaganimi pogoji uporabe nima škodljivega vpliva na zdravje živali in ljudi ali okolje.
The Authority also concluded that the additive has a potential to improve the production of silage by reducing the pH and increasing the preservation of dry matter in easy, moderate difficult and difficult to ensile material.
Vendar ga je obravnavala kot morebitnega povzročitelja preobčutljivosti in tudi tveganja za vdihavanje ni bilo mogoče izključiti.
The Authority concluded in its opinion of 18 June 2013 [3] that, under the proposed conditions of use, potassium sorbate does not have an adverse effect on animal health, human health or the environment; however it was considered irritant for skin and eyes and potential irritant to respiratory tract.
Agencija je tudi navedla, da dodatek lahko izboljša proizvodnjo silaže z znižanjem vrednosti pH in ohranjanjem več suhe snovi pri krmi, ki se preprosto, srednje težko ali težko silira.
The Authority also concluded that the additive has a potential to improve the aerobic stability of silage in easy and moderate difficult to ensile material.
Agencija je v mnenju z dne 18. junija 2013 [3] navedla, da kalijev sorbat pod predlaganimi pogoji uporabe nima škodljivega vpliva na zdravje živali in ljudi ali okolje.
The Authority concluded in its opinion of 11 September 2014 [4] that, under the proposed conditions of use, formic acid does not have an adverse effect on animal health, human health or the environment; however it was considered corrosive for skin and eyes and respiratory tract.
Vendar ga je obravnavala kot dražilca za kožo in oči ter morebitnega dražilca za dihalne poti.
The Authority also concluded that the additive has a potential to improve the ensiling process and the quality of the silage in aerobic stability of silage in easy, in moderate difficult and difficult to ensile material.
Agencija je tudi navedla, da lahko dodatek izboljša aerobno stabilnost silaže v krmi, ki se preprosto do srednje težko silira.
The Authority concluded in its opinion of 11 March 2015 [5] that, under the proposed conditions of use, sodium formate does not have an adverse effect on animal health, human health or the environment; however the liquid form was considered corrosive for skin and eyes and to respiratory tract.
Agencija je v mnenju z dne 11. septembra 2014 [4] navedla, da mravljična kislina pod predlaganimi pogoji uporabe nima škodljivega vpliva na zdravje živali in ljudi ali okolje.
The Authority also concluded that the additive has a potential to improve the preservation of nutrients by reducing the dry matter loss in easy, moderate and difficult to ensile material.
Vendar jo je obravnavala kot jedko za kožo in oči ter dihalne poti.
For sodium benzoate, potassium sorbate, formic acid and sodium formate, the Authority does not consider that there is a need for specific requirements of post-market monitoring.
Agencija je tudi navedla, da lahko dodatek izboljša postopek silaže in kakovost silaže z aerobno stabilnostjo silaže v krmi, ki se srednje težko do težko silira.
It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
Agencija je v mnenju z dne 11. marca 2015 [5] navedla, da natrijev format pod predlaganimi pogoji uporabe nima škodljivega vpliva na zdravje živali in ljudi ali okolje.
The assessments of sodium benzoate, potassium sorbate, formic acid and sodium formate show that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Vendar je njegovo tekočo obliko obravnavala kot jedko za kožo in oči ter dihalne poti.
Accordingly, the use of those additives should be authorised as specified in the Annex to this Regulation.
Agencija je tudi navedla, da dodatek lahko izboljša ohranjanje hranil z znižanjem izgube suhe snovi v krmi, ki se preprosto, srednje težko ali težko silira.
Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of sodium benzoate, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
Agencija meni, da za natrijev benzoat, kalijev sorbat, mravljično kislino in natrijev format ni potrebe po posebnih zahtevah v zvezi s poprodajnim nadzorom.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Potrdila je tudi poročilo o analitski metodi krmnih dodatkov, ki ga je predložil referenčni laboratorij, ustanovljen z Uredbo (ES) št. 1831/2003.
HAS ADOPTED THIS REGULATION:
Ocena natrijevega benzoata, kalijevega sorbata, mravljične kisline in natrijevega formata je pokazala, da so pogoji za izdajo dovoljenja iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni.
Article 1
Zato bi bilo treba dovoliti uporabo navedenih dodatkov, kakor je opredeljeno v Prilogi k tej uredbi.
Authorisation
Ker ni varnostnih razlogov, zaradi katerih bi morali takoj začeti veljati spremenjeni pogoji za izdajo dovoljenja za natrijev benzoat, je primerno zagotoviti prehodno obdobje, da se lahko zainteresirane strani pripravijo na izpolnjevanje novih zahtev zaradi izdaje dovoljenja.
The additives specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za rastline, živali, hrano in krmo –
Transitional measures
Člen 1
The sodium benzoate specified in the Annex and feed containing it, which are produced and labelled before 9 June 2017 in accordance with the rules applicable before 9 December 2016 may continue to be placed on the market and used until the existing stocks are exhausted.
Izdaja dovoljenja
Article 3
Dodatki iz Priloge, ki spadajo v kategorijo dodatkov „tehnološki dodatki“ in funkcionalno skupino „silirni dodatki“, se dovolijo kot dodatki v prehrani živali v skladu s pogoji iz navedene priloge.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Prehodni ukrepi
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Natrijev benzoat iz Priloge in krma, ki ga vsebuje, ki sta proizvedena in označena pred 9. junijem 2017 v skladu s pravili, ki se uporabljajo pred 9. decembrom 2016, se lahko še naprej dajeta na trg in uporabljata do porabe obstoječih zalog.
Done at Brussels, 18 November 2016.
Člen 3
OJ L 268, 18.10.2003, p. 29.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
Sodium benzoate ≥ 99,5 %
natrijev benzoat: ≥ 99,5 %
CAS no 532-32-1
št.
Produced by chemical synthesis
CAS: 532-32-1
Analytical method [1]For the determination of sodium benzoate: titrimetric method (01/2008:0123 of European Pharmacopoeia).
pridobljena s kemijsko sintezo
All animal species
Analitska metoda [1]Za določanje natrijevega benzoata: titrimetrična metoda (Evropska farmakopeja 01/2008:0123).
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use.
vse živalske vrste
Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
Nosilci dejavnosti poslovanja s krmo zaradi morebitnih tveganj za uporabnike dodatka in premiksov pri ravnanju z njimi določijo postopke varnega ravnanja in organizacijske ukrepe.
The mixture of different sources of sodium benzoate shall not exceed the permitted maximum contents.
Kadar navedenih tveganj s takimi postopki in ukrepi ni mogoče odpraviti ali čim bolj zmanjšati, se dodatek in premiksi uporabljajo z osebno zaščitno opremo, vključno z zaščito za dihala, zaščitnimi očali in rokavicami.
9 December 2026
Mešanica različnih virov natrijevega benzoata ne sme presegati najvišje dovoljene vsebnosti.
Potassium sorbate
9. december 2026
Potassium sorbate ≥ 99 %
kalijev sorbat
CAS no 24634-61-5
kalijev sorbat ≥ 99 %
Analytical method [1]For the determination of potassium sorbate in feed additive: titration with perchloric acid (European Pharmacopoeia, monographs 6.0 method 01/2008:0618).
št.
For the determination of potassium sorbate in premixture and feedingstuffs: ion exclusion High Performance Liquid Chromatography with UV detection (HPLC-UV).
CAS: 24634-61-5
Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.
Analitska metoda [1]Za določanje kalijevega sorbata v krmnem dodatku: titracija s perklorovo kislino (Evropska farmakopeja, monografija 6.0, metoda 01/2008:0618).
The additive shall be used in easy and moderate difficult to ensile materials.
Za določanje kalijevega sorbata v premiksih in krmi: ionska izključitvena tekočinska kromatografija visoke ločljivosti z UV-detekcijo (HPLC-UV).
[2]
Kadar navedenih tveganj s takimi postopki in ukrepi ni mogoče odpraviti ali čim bolj zmanjšati, se dodatek in premiksi uporabljajo z osebno zaščitno opremo, vključno z zaščito za dihala, zaščitnimi očali in rokavicami.
Formic acid
Dodatek se uporablja v krmi, ki se preprosto do srednje težko silira [2].
Formic acid (≥ 84,5 %)
mravljinčna kislina
Liquid form
mravljinčna kislina (≥ 84,5 %)
Formic acid ≥ 84,5 %
v tekoči obliki
CAS no 64-18-6
mravljinčna kislina ≥ 84,5 %
Analytical method [1]For the determination of formic acid: ion chromatography method equipped with electrical conductivity detection (IC-ECD).
št.
Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves
CAS: 64-18-6
The mixture of different sources of formic acid shall not exceed the permitted maximum content in complete feedingstuffs.
Analitska metoda [1]Za določanje mravljinčne kisline: ionska kromatografija z detekcijo na osnovi električne prevodnosti (IC–ECD)
Sodium formate
Kadar navedenih tveganj s takimi postopki in ukrepi ni mogoče odpraviti ali čim bolj zmanjšati, se dodatek in premiksi uporabljajo z osebno zaščitno opremo, vključno z zaščito za dihala, zaščitnimi očali in rokavicami.
Sodium formate ≥ 98 %
Mešanica različnih virov mravljične kisline ne sme presegati najvišje dovoljene vsebnosti v popolnih krmnih mešanicah.
Sodium formate ≥ 15 %
natrijev format
Formic acid ≤ 75 %
natrijev format: ≥ 98 %
Water ≤ 25 %
natrijev format: ≥ 15 %
Sodium formate ≥ 98 % (solid form)
mravljinčna kislina: ≤ 75 %
CAS no 141-53-7
voda: ≤ 25 %
formaldehyde ≤ 6,2 mg/kg
natrijev format: ≥ 98 % (v trdni obliki)
acetaldehyde ≤ 5 mg/kg
št.
butylaldehyde ≤ 25 mg/kg
CAS: 141-53-7
Sodium formate ≥ 15 % (liquid form)
formaldehid: ≤ 6,2 mg/kg
Analytical method [1]Determination of sodium in feed additives: EN ISO 6869: atomic absorption spectrometry (AAS) or EN 15510: inductively coupled plasma atomic emission spectrometry, (ICP-AES).
acetaldehid: ≤ 5 mg/kg
Determination of total formate in feed additives: EN 15909 reverse phase HPLC with UV detection (RP-HPLC-UV).
butilaldehid: ≤ 25 mg/kg
Determination of total formate in premixtures and feedingstuffs: Ion-exclusion high performance liquid chromatography with UV or with refractive index detection (HPLC-UV/RI) or Ion chromatography method equipped with electrical conductivity detection (IC-ECD).
natrijev format: ≥ 15 % (v tekoči obliki)
(formic acid equivalent)
Analitska metoda [1]Določanje natrija v krmnih dodatkih: EN ISO 6869: atomska absorpcijska spektrometrija (AAS) ali EN 15510: atomska emisijska spektrometrija z induktivno sklopljeno plazmo (ICP-AES).
The mixture of different sources of formic acid shall not exceed the permitted maximum contents in complete feedingstuffs.
Določanje celotnega formata v krmnih dodatkih: EN 15909 tekočinska kromatografija visoke ločljivosti z reverzno fazo z UV-detekcijo (RP-HPLC-UV).
Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
Določanje celotnega formata v premiksih in krmi: ionska izključitvena tekočinska kromatografija visoke ločljivosti z UV-detekcijo ali detekcijo na osnovi lomnega količnika (HPLC-UV/RI) ali ionska kromatografija z detekcijo na osnovi električne prevodnosti (IC-ECD).
Easy to ensile forage: > 3 % soluble carbohydrates in fresh materials.
(ekvivalent mravljične kisline)
Moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in fresh materials.
Mešanica različnih virov mravljične kisline ne sme presegati najvišje dovoljene vsebnosti v popolnih krmnih mešanicah.
Commission Implementing Regulation (EU) 2016/2024
Izvedbena uredba Komisije (EU) 2016/2024
amending Council Regulation (EC) No 338/97 on the protection of species of wild fauna and flora by regulating trade therein
o spremembi Uredbe Sveta (ES) št. 338/97 o varstvu prosto živečih živalskih in rastlinskih vrst z zakonsko ureditvijo trgovine z njimi