natgillin/translations-raw huggingface dataset:
The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 25(1) of Regulation (EC) No 1005/2009,
Ukrepi iz tega sklepa so v skladu z mnenjem odbora, ustanovljenega s členom 25(1) Uredbe (ES) št. 1005/2009 –
The quantities of controlled substances subject to Regulation (EC) No 1005/2009 which may be released for free circulation in the Union in 2015 from sources outside the Union shall be the following:
Količine nadzorovanih snovi v skladu z Uredbo (ES) št. 1005/2009, ki se smejo leta 2015 sprostiti v prosti promet v Uniji iz virov zunaj Unije, so naslednje:
Group I (chlorofluorocarbons 11, 12, 113, 114 and 115) and group II (other fully halogenated chlorofluorocarbons)
Skupina I (klorofluoroogljikovodiki 11, 12, 113, 114 in 115) in skupina II (drugi popolnoma halogenirani klorofluoroogljikovodiki)
The allocation of quotas for chlorofluorocarbons 11, 12, 113, 114 and 115 and other fully halogenated chlorofluorocarbons during the period 1 January to 31 December 2015 shall be for the purposes and to the undertakings indicated in Annex I.
Dodelitev kvot za klorofluoroogljikovodike 11, 12, 113, 114 in 115 ter druge popolnoma halogenirane klorofluoroogljikovodike se v obdobju od 1. januarja do 31. decembra 2015 dodelijo za namene in podjetja iz Priloge I.
The allocation of quotas for halons during the period 1 January to 31 December 2015 shall be for the purposes and to the undertakings indicated in Annex II.
Kvote za halone se v obdobju od 1. januarja do 31. decembra 2015 dodelijo za namene in podjetja iz Priloge II.
The allocation of quotas for carbon tetrachloride during the period 1 January to 31 December 2015 shall be for the purposes and to the undertakings indicated in Annex III.
Kvote za ogljikov tetraklorid se v obdobju od 1. januarja do 31. decembra 2015 dodelijo za namene in podjetja iz Priloge III.
The allocation of quotas for 1,1,1-trichloroethane during the period 1 January to 31 December 2015 shall be for the purposes and to the undertakings indicated in Annex IV.
Kvote za 1,1,1-trikloroetan se v obdobju od 1. januarja do 31. decembra 2015 dodelijo za namene in podjetja iz Priloge IV.
The allocation of quotas for methyl bromide during the period 1 January to 31 December 2015 shall be for the purposes and to the undertakings indicated in Annex V.
Kvote za metil bromid se v obdobju od 1. januarja do 31. decembra 2015 dodelijo za namene in podjetja iz Priloge V.
The allocation of quotas for hydrobromofluorocarbons during the period 1 January to 31 December 2015 shall be for the purposes and to the undertakings indicated in Annex VI.
Kvote za delno halogenirane bromofluoroogljikovodike se v obdobju od 1. januarja do 31. decembra 2015 dodelijo za namene in podjetja iz Priloge VI.
The allocation of quotas for hydrochlorofluorocarbons during the period 1 January to 31 December 2015 shall be for the purposes and to the undertakings indicated in Annex VII.
Kvote za delno halogenirane klorofluoroogljikovodike se v obdobju od 1. januarja do 31. decembra 2015 dodelijo za namene in podjetja iz Priloge VII.
The allocation of quotas for bromochloromethane during the period 1 January to 31 December 2015 shall be for the purposes and to the undertakings indicated in Annex VIII.
Kvote za bromoklorometan se v obdobju od 1. januarja do 31. decembra 2015 dodelijo za namene in podjetja iz Priloge VIII.
The quotas for importing and producing controlled substances for laboratory and analytical uses in the year 2015 shall be allocated to the undertakings listed in Annex X.
Kvote za uvoz in proizvodnjo nadzorovanih snovi za laboratorijske in analitske uporabe za leto 2015 se dodelijo podjetjem iz Priloge X.
The maximum quantities that may be produced or imported in 2015 for laboratory and analytical uses allocated to those undertakings are set out in Annex XI.
Največje količine, ki so dodeljene tem podjetjem in se lahko v letu 2015 proizvedejo ali uvozijo za laboratorijske in analitske uporabe, so navedene v Prilogi XI.
This Decision shall apply from 1 January and shall expire on 31 December 2015.
Ta sklep se uporablja od 1. januarja 2015 in preneha veljati 31. decembra 2015.
1348 Louvain-la-Neuve
Belgija
Arkema Quimica SA
Španija
DuPont de Nemours (Nederland) BV
Češka
Palackého 2087/8
Madžarska
ICL-IP Europe BV
38070 St-Quentin-Fallavier
Frankfurter Straße 250
Ltd.
Runcorn, Cheshire WA7 4QX
Consett,County Durham DH8 7ND
Ministry of Defence — Chemical Laboratory — Den Helder
V Bruslju, 11. decembra 2014
Poz-Pliszka Sp. z o.o. ul.
Za Komisijo
Szczecińska 45
Član Komisije
Riedstraße 2
Uredba Komisije (EU) št. 537/2011 z dne 1. junija 2011 o mehanizmu za dodeljevanje količin nadzorovanih snovi, ki so dovoljene za laboratorijske in analitične uporabe v Uniji v skladu z Uredbo (ES) št. 1005/2009 Evropskega parlamenta in Sveta o snoveh, ki tanjšajo ozonski plašč (UL L 147, 2.6.2011, str. 4).
Malta
Uvozne kvote za klorofluoroogljikovodike 11, 12, 113, 114 in 115 ter druge popolnoma halogenirane klorofluoroogljikovodike, dodeljene uvoznikom v skladu z Uredbo (ES) št. 1005/2009 za uporabo kot surovina in predelovalno sredstvo v obdobju od 1. januarja do 31. decembra 2015.
Werner-von-Siemens-Straße 18
ABCR Dr. Braunagel GmbH & Co.
Thomas Swan & Co.
KG (DE)
Ltd
PRILOGA II
Consett, County Durham DH8 7ND
SKUPINA III
Done at Brussels, 11 December 2014.
Uvozne kvote za halone, dodeljene uvoznikom v skladu z Uredbo (ES) št. 1005/2009 za uporabo kot surovina in nujno uporabo v obdobju od 1. januarja do 31. decembra 2015.
For the Commission
PRILOGA III
Member of the Commission
SKUPINA IV
OJ L 286, 31.10.2009, p. 1.
Uvozne kvote za ogljikov tetraklorid, dodeljene uvoznikom v skladu z Uredbo (ES) št. 1005/2009 za uporabo kot surovina in predelovalno sredstvo v obdobju od 1. januarja do 31. decembra 2015.
Commission Regulation (EU) No 537/2011 of 1 June 2011 on the mechanism for the allocation of quantities of controlled substances allowed for laboratory and analytical uses in the Union under Regulation (EC) No 1005/2009 of the European Parliament and of the Council on substances that deplete the ozone layer (OJ L 147, 2.6.2011, p. 4).
PRILOGA IV
OJ C 98, 3.4.2014, p. 10.
SKUPINA V
ANNEX I
Uvozne kvote za 1,1,1–trikloretan, dodeljene uvoznikom v skladu z Uredbo (ES) št. 1005/2009 za uporabo kot surovina v obdobju od 1. januarja do 31. decembra 2015.
GROUPS I and II
PRILOGA V
Import quotas for chlorofluorocarbons 11, 12, 113, 114 and 115 and other fully halogenated chlorofluorocarbons allocated to importers in accordance with Regulation (EC) No 1005/2009 for feedstock uses and process agent uses during the period 1 January to 31 December 2015.
SKUPINA VI
Company
Uvozne kvote za metil bromid, dodeljene uvoznikom v skladu z Uredbo (ES) št. 1005/2009 za uporabo kot surovina v obdobju od 1. januarja do 31. decembra 2015.
ABCR Dr Braunagel GmbH & Co.
ICL-IP Europe B.V.
KG (DE)
(NL)
ANNEX II
PRILOGA VI
GROUP III
SKUPINA VII
Import quotas for halons allocated to importers in accordance with Regulation (EC) No 1005/2009 for feedstock uses and critical uses during the period 1 January to 31 December 2015.
Uvozne kvote za delno halogenirane bromofluoroogljikovodike, dodeljene uvoznikom v skladu z Uredbo (ES) št. 1005/2009 za uporabo kot surovina v obdobju od 1. januarja do 31. decembra 2015.
ANNEX III
PRILOGA VII
GROUP IV
SKUPINA VIII
Import quotas for carbon tetrachloride allocated to importers in accordance with Regulation (EC) No 1005/2009 for feedstock uses and process agent uses for the period 1 January to 31 December 2015.
Uvozne kvote za delno halogenirane klorofluoroogljikovodike, dodeljene uvoznikom v skladu z Uredbo (ES) št. 1005/2009 za uporabo kot surovina v obdobju od 1. januarja do 31. decembra 2015.
ANNEX IV
Aesica Queenborough Ltd.
GROUP V
(UK)
Import quotas for 1,1,1–trichloroethane allocated to importers in accordance with Regulation (EC) No 1005/2009 for feedstock uses for the period 1 January to 31 December 2015.
AGC Chemicals Europe, Ltd.
GROUP VI
Arkema Quimica S.A.
Import quotas for methyl bromide allocated to importers in accordance with Regulation (EC) No 1005/2009 for feedstock uses for the period 1 January to 31 December 2015.
(ES)
ICL-IP Europe BV (NL)
PRILOGA VIII
ANNEX VI
SKUPINA IX
GROUP VII
Uvozne kvote za bromoklorometan, dodeljene uvoznikom v skladu z Uredbo (ES) št. 1005/2009 za uporabo za surovine v obdobju od 1. januarja do 31. decembra 2015.
Import quotas for hydrobromofluorocarbons allocated to importers in accordance with Regulation (EC) No 1005/2009 for feedstock uses for the period 1 January to 31 December 2015.
Laboratorios Miret S.A.
ANNEX VII
(ES)
GROUP VIII
PRILOGA IX
Import quotas for hydrochlorofluorocarbons allocated to importers in accordance with Regulation (EC) No 1005/2009 for feedstock uses for the period 1 January to 31 December 2015.
(Zaupni poslovni podatki – ni za objavo)
Aesica Queenborough Ltd (UK)
PRILOGA X
AGC Chemicals Europe, Ltd (UK)
PODJETJA, KI SO UPRAVIČENA DO PROIZVODNJE ALI UVOZA ZA LABORATORIJSKE IN ANALITSKE UPORABE V LETU 2015
Arkema Quimica SA (ES)
Kvote nadzorovanih snovi, ki se smejo uporabljati za laboratorijske in analitske uporabe, se dodelijo:
ANNEX VIII
Gedeon Richter Plc.
GROUP IX
(HU)
Import quotas for bromochloromethane allocated to importers in accordance with Regulation (EC) No 1005/2009 for feedstock uses for the period 1 January to 31 December 2015.
Ministry of Defense – Chemical Laboratory – Den Helder (NL)
Laboratorios Miret SA (ES)
PRILOGA XI
(Commercially sensitive — in confidence — not to be published)
TEGA – Technische Gase und Gastechnik GmbH
ANNEX X
DuPont de Nemours (Nederland) B.V.
UNDERTAKINGS ENTITLED TO PRODUCE OR IMPORT FOR LABORATORY AND ANALYTICAL USES IN 2015
(NL)
The quota of controlled substances which may be used for laboratory and analytical uses, are allocated to:
HR-42000 Varaždin
authorising the placing on the market of methyl vinyl ether-maleic anhydride copolymer as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
o odobritvi dajanja na trg kopolimera metil vinil etra in anhidrida maleinske kisline kot nove živilske sestavine v skladu z Uredbo (ES) št. 258/97 Evropskega parlamenta in Sveta
(notified under document C(2014) 9333)
(notificirano pod dokumentarno številko C(2014) 9333)
On 30 June 2008 the company Reading Scientific Services Ltd made a request to the competent authorities of the Netherlands to place methyl vinyl ether-maleic anhydride copolymer on the market as a novel food ingredient for the use in chewing gum base.
Družba Reading Scientific Services Ltd. je 30. junija 2008 pri pristojnih organih Nizozemske vložila zahtevek za dajanje kopolimera metil vinil etra in anhidrida maleinske kisline na trg kot nove živilske sestavine za uporabo v osnovi za žvečilni gumi.
On 14 July 2011, the competent food assessment body of the Netherlands issued its initial assessment report.
Pristojni organ Nizozemske za presojo živil je 14. julija 2011 izdal poročilo o začetni presoji.
In that report it came to the conclusion that methyl vinyl ether-maleic anhydride copolymer meets the criteria set out in Article 3(1) of Regulation (EC) No 258/97.
V navedenem poročilu je navedel ugotovitev, da kopolimer metil vinil etra in anhidrida maleinske kisline izpolnjuje merila iz člena 3(1) Uredbe (ES) št. 258/97.
On 18 August 2011, the Commission forwarded the initial assessment report to the other Member States.
Komisija je 18. avgusta 2011 poročilo o začetni presoji poslala drugim državam članicam.
On 12 June 2012, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for methyl vinyl ether-maleic anhydride copolymer as food ingredient in accordance with Regulation (EC) No 258/97.
Komisija se je 12. junija 2012 posvetovala z Evropsko agencijo za varnost hrane (v nadaljnjem besedilu: EFSA) in jo prosila za dodatno oceno kopolimera metil vinil etra in anhidrida maleinske kisline kot nove živilske sestavine v skladu z Uredbo (ES) št. 258/97.
On 10 October 2013 EFSA adopted a Scientific Opinion on the safety of methyl vinyl ether-maleic anhydride copolymer (chewing gum base ingredient) as a novel food ingredient [2], concluding that it is safe under the proposed uses and use levels.
EFSA je 10. oktobra 2013 sprejela znanstveno mnenje o varnosti kopolimera metil vinil etra in anhidrida maleinske kisline (sestavine osnove za žvečilni gumi) kot nove živilske sestavine [2] in ugotovila, da je varen v okviru predlaganih načinov in ravni uporabe.
The opinion gives sufficient grounds to establish that methyl vinyl ether-maleic anhydride copolymer in the proposed use and use levels in chewing gum base complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
Mnenje je zadosten razlog, da se kopolimer metil vinil etra in anhidrida maleinske kisline v okviru predlaganih načinov in ravni uporabe v osnovi za žvečilni gumi šteje za skladnega z merili iz člena 3(1) Uredbe (ES) št. 258/97.
Methyl vinyl ether-maleic anhydride copolymer as specified in the Annex may be placed on the market in the Union as a novel food ingredient to be used in chewing gum base up to a maximum of 2 % in the finished chewing gum product.
Kopolimer metil vinil etra in anhidrida maleinske kisline, kot je določen v Prilogi, se lahko daje na trg v Uniji kot nova živilska sestavina za uporabo v osnovi za žvečilni gumi do največ 2 % v končnem žvečilnem gumiju.
The designation of the novel chewing gum base authorised by this Decision on the labelling of the foodstuff containing it shall be ‘gum base (including methyl vinyl ether-maleic anhydride copolymer)’ or ‘gum base (including CAS No 9011-16-9)’.
Poimenovanje nove osnove za žvečilni gumi, odobrene s tem sklepom, na oznaki živil, ki jo vsebujejo, je „gumijeva osnova (vsebuje kopolimer metil vinil etra in anhidrida maleinske kisline)“ ali „gumijeva osnova (št.
Article 3
CAS 9011-16-9)“.
This Decision is addressed to Reading Scientific Services Ltd, The Lord Zuckerman Research Centre, Whiteknights Campus, Pepper lane, Reading, RG6 6LA, United Kingdom.
Člen 3
Done at Brussels, 11 December 2014.
Ta sklep je naslovljen na družbo Reading Scientific Services Ltd., The Lord Zuckerman Research Centre, Whiteknights Campus, Pepper lane, Reading, RG6 6LA, Združeno kraljestvo .
For the Commission
V Bruslju, 11. decembra 2014
EFSA Journal 2013;11(10):3423.
UL L 43, 14.2.1997, str. 1.
ANNEX
EFSA Journal 2013; 11(10): 3423.
SPECIFICATION OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER
PRILOGA
Definition:
SPECIFIKACIJA KOPOLIMERA METIL VINIL ETRA IN ANHIDRIDA MALEINSKE KISLINE
Methyl vinyl ether-maleic anhydride copolymer is an anhydrous copolymer of methyl vinyl ether and maleic anhydride.
Opredelitev:
Structural formula:
Kopolimer metil vinil etra in anhidrida maleinske kisline je brezvodni kopolimer metil vinil etra in anhidrida maleinske kisline.
Description:
Strukturna formula:
Free-flowing, white to white-off powder.
Opis:
Identification:
Sipek, bel do umazano bel prah.
CAS No
Identifikacija:
Purity:
Št.
At least 99,5 % in dry matter
Čistost:
Specific viscosity (1 % MEK)
Analizirana vrednost
Residual methyl vinyl ether
vsaj 99,5 % v suhi snovi
Not more than 150 ppm
Posebna viskoznost (1 % MEK)
Residual maleic anhydride
Ostanki metil vinil etra
Not more than 250 ppm
ne več kot 150 ppm
Acetaldehyde
Ostanki anhidrida maleinske kisline
Not more than 500 ppm
ne več kot 250 ppm
Methanol
Acetaldehid
Dilauroyl peroxide
ne več kot 500 ppm
Total heavy metals
Dilauroil peroksid
Not more than 10 ppm
ne več kot 15 ppm
Microbiological criteria:
Težke kovine skupaj
Total aerobic plate count
ne več kot 10 ppm
Not more than 500 CFU/g
Mikrobiološka merila:
Mould/yeast
Skupno število aerobnih mikroorganizmov
Negative to test
ne več kot 500 CFU/g
2-10
negativen test
Council Decision 2014/906/CFSP
Sklep Sveta 2014/906/SZVP
amending Decision 2013/726/CFSP in support of the UNSCR 2118 (2013) and OPCW Executive Council EC-M-33/Dec 1, in the framework of the implementation of the EU Strategy against Proliferation of Weapons of Mass Destruction
o spremembi Sklepa 2013/726/SZVP o podpori Resoluciji VS ZN 2118 (2013) in sklepu Izvršnega sveta OPCW EC-M-33/Dec 1 v okviru izvajanja Strategije EU proti širjenju orožja za množično uničevanje
Having regard to the Treaty on European Union, and in particular Articles 28(1) and 31(1) thereof,
ob upoštevanju Pogodbe o Evropski uniji ter zlasti členov 28(1) in 31(1) Pogodbe,
On 9 December 2013, the Council adopted Decision 2013/726/CFSP [1].
Svet je 9. decembra 2013 sprejel Sklep 2013/726/SZVP [1].
Decision 2013/726/CFSP provides for a 12-month implementation period of the project referred to in Article 1(2) thereof after the date of the conclusion of the financial agreement referred to in Article 3(3) thereof.
V Sklepu 2013/726/SZVP je določeno, da obdobje izvajanja projekta iz člena 1(2) Sklepa traja 12 mesecev po datumu sklenitve sporazuma o financiranju iz člena 3(3) Sklepa.
On 6 November 2014, the Technical Secretariat of the Organisation for the Prohibition of Chemical Weapons (OPCW) requested the authorisation of the Union for extending the implementation period of Decision 2013/726/CFSP until 30 September 2015 to allow for the continuation of the implementation of the project beyond the expiry date referred to in Article 5(2) thereof.
Tehnični sekretariat Organizacije za prepoved kemičnega orožja (OPCW) je 6. novembra 2014 zaprosil, naj mu Unija dovoli podaljšati obdobje izvajanja Sklepa 2013/726/SZVP do 30. septembra 2015, da bi lahko projekt izvajali še naprej, po datumu prenehanja veljavnosti iz člena 5(2) Sklepa.
The requested amendment of Decision 2013/726/CFSP concerns Article 5(2) thereof and the first paragraph of the Section ‘Activities’ of the Annex where the duration of the implementation of the project has to be modified.
Zaprošena sprememba Sklepa 2013/726/CFSP zadeva člen 5(2) Sklepa in prvi odstavek odseka „Dejavnosti“ v Prilogi, v katerih je treba spremeniti obdobje izvajanja projekta.
The continuation of the project referred to in Article 1(2) of Decision 2013/726/CFSP, as specifically quoted in the request made by the OPCW on 6 November 2014, could be performed without any resource implication.
Nadaljevanje projekta iz člena 1(2) Sklepa 2013/726/SZVP, na katerega se je OPCW izrecno sklicevala v prošnji z dne 6. novembra 2014, bi lahko potekalo brez posledic za sredstva.
Decision 2013/726/CFSP should, therefore, be amended to enable the full implementation of the project contained therein, by extending its duration accordingly,
Sklep 2013/726/SZVP bi bilo zato treba spremeniti, da bi se omogočila popolna izvedba projekta iz Sklepa, ter v ta namen ustrezno podaljšati njegovo trajanje –
Decision 2013/726/CFSP is hereby amended as follows:
Sklep 2013/726/SZVP se spremeni:
In the Annex, in the Section ‘Activities’, the first paragraph is replaced by the following:
„Podpora OPCW bo zagotovljena z dostavljanjem do petih satelitskih posnetkov Satelitskega centra EU (EU SATCEN) na teden, in sicer ves čas od podpisa pogodbe do 30. septembra 2015.“
‘Support to OPCW will be provided through delivery of up to 5 satellite imagery products of the EU Satellite Centre (EU SatCen) per week for a total duration starting from the signing of the contract until 30 September 2015.’ .
Člen 2
This Decision shall enter into force on the date of its adoption.
V Bruslju, 15. decembra 2014
Done at Brussels, 15 December 2014.
Za Svet
The President
Sklep Sveta 2013/726/SZVP z dne 9. decembra 2013 o podpori Resoluciji VS ZN 2118 (2013) in sklepu Izvršnega sveta OPCW EC-M-33/Dec 1 v okviru izvajanja Strategije EU proti širjenju orožja za množično uničevanje (UL L 329, 10.12.2013, str. 41).
Council Decision 2013/726/CFSP of 9 December 2013 in support of the UNSCR 2118 (2013) and OPCW Executive Council EC-M-33/Dec 1, in the framework of the implementation of the EU Strategy against Proliferation of Weapons of Mass Destruction (OJ L 329, 10.12.2013, p. 41).
Veljati preneha 30. septembra 2015.“
authorising the placing on the market of Clostridium butyricum (CBM 588) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
o odobritvi dajanja na trg Clostridium butyricum (CBM 588) kot nove živilske sestavine v skladu z Uredbo (ES) št. 258/97 Evropskega parlamenta in Sveta
(notified under document C(2014) 9345)
(notificirano pod dokumentarno številko C(2014) 9345)
On 2 February 2012, the company Miyarisan Pharmaceutical Co.
Družba Miyarisan Pharmaceutical Co.
Ltd made a request to the competent authorities of the United Kingdom to place Clostridium butyricum (CBM 588) on the market as a novel food ingredient to be used in food supplements.
Ltd. je 2. februarja 2012 pri pristojnih organih Združenega kraljestva vložila zahtevek za dajanje Clostridium butyricum (CBM 588) na trg kot nove živilske sestavine za uporabo v prehranskih dopolnilih.
On 14 May 2013, the competent food assessment body of the United Kingdom issued its initial assessment report.
Pristojni organ Združenega kraljestva za presojo živil je 14. maja 2013 izdal poročilo o začetni presoji.
In that report it came to the conclusion that Clostridium butyricum (CBM 588) meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.
V navedenem poročilu ugotavlja, da Clostridium butyricum (CBM 588) izpolnjuje merila za novo živilo iz člena 3(1) Uredbe (ES) št. 258/97.
On 4 September 2013, the Commission forwarded the initial assessment report to the other Member States.
Komisija je 4. septembra 2013 poročilo o začetni presoji poslala drugim državam članicam.
In accordance with Article 7(1) of Regulation (EC) No 258/97 a Commission Implementing Decision should be made that takes into account the objections raised.
V skladu s členom 7(1) Uredbe (ES) št. 258/97 bi bilo treba sprejeti izvedbeni sklep Komisije, ki upošteva vložene ugovore.
The additional explanations provided by the applicant alleviated the concerns to the satisfaction of the Member States and the Commission.
Dodatna pojasnila vložnika so zadovoljivo odpravila zaskrbljenost držav članic in Komisije.
Directive 2002/46/EC of the European Parliament and of the Council [2] lays down requirements on food supplements.
Direktiva 2002/46/ES Evropskega parlamenta in Sveta [2] določa zahteve glede prehranskih dopolnil.
The use of Clostridium butyricum (CBM 588) should be authorised without prejudice to the requirements of that legislation.
Uporabo Clostridium butyricum (CBM 588) bi bilo treba odobriti brez poseganja v zahteve navedenih predpisov.
Clostridium butyricum (CBM 588) as specified in the Annex may be placed on the market in the Union as a novel food ingredient to be used in food supplements with a maximum dose of 1,35 × 108 CFU per day without prejudice to the specific provisions of Directive 2002/46/EC.
Clostridium butyricum (CBM 588), kakor je določen v Prilogi, se lahko daje na trg Unije kot nova živilska sestavina, ki se uporablja v prehranskih dopolnilih v največji dovoljeni količini 1,35 × 108 CFU na dan, brez poseganja v posebne določbe Direktive 2002/46/ES.
The designation of Clostridium butyricum (CBM 588) authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘Clostridium butyricum MIYAIRI 588 (CBM 588)’ or ‘Clostridium butyricum (CBM 588)’.
Poimenovanje Clostridium butyricum (CBM 588), odobrenega s tem sklepom, na oznakah živil, ki jo vsebujejo, je „Clostridium butyricum MIYAIRI 588 (CBM 588)“ ali „Clostridium butyricum (CBM 588)“.
This Decision is addressed to Miyarisan Pharmaceutical Co.
Ta sklep je naslovljen na družbo Miyarisan Pharmaceutical Co.
Ltd, 1-10-3, Kaminakazato, Kita-Ku, Tokyo 114-0016, Japan
Ltd., 1-10-3, Kaminakazato, Kita-Ku, Tokio 114-0016, Japonska
Done at Brussels, 11 December 2014.
V Bruslju, 11. decembra 2014
Clostridium butyricum (CBM 588) is a Gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium.
Clostridium butyricum (CBM 588) je Gram pozitivna, spore formirajoča, obvezno anaerobna, nepatogena, gensko nespremenjena bakterija.
White or pale grey tablets with characteristic odour and sweet taste.
bele ali bledo sive tablete z značilnim vonjem in sladkim okusom.
Not more than 103 CFU/g
ne več kot 103 CFU/g
Not detected in 1 g
neodkrit v 1 g