natgillin/translations-raw huggingface dataset:
In addition, in accordance with Article 12(3) of Regulation (EC) No 854/2004, the competent authorities of the third country concerned should keep those lists of establishments updated and communicate them accordingly to the Commission.
V skladu s členom 12(3) Uredbe (ES) št. 854/2004 bi pristojni organi zadevne tretje države poleg tega morali navedene sezname obratov posodabljati in jih ustrezno sporočati Komisiji.
Article 15(2)(a) of Regulation (EC) No 854/2004 provides that fishery products imported from a factory or freezer vessel flying the flag of a third country are to come from vessels that appear on a list drawn up and updated in accordance with the procedure set out in Article 12(4) of that Regulation.
Člen 15(2)(a) Uredbe (ES) št. 854/2004 določa, da morajo ribiški proizvodi, uvoženi iz tovarne ali zamrzovalnega plovila, ki pluje pod zastavo tretje države, prihajati s plovil, ki so na seznamu, sestavljenem in posodobljenem v skladu s postopkom, določenim v členu 12(4) navedene uredbe.
In September 2017, a Commission inspection revealed that primary production establishments supplying Brazilian establishments from which imports of fishery products are permitted are neither identified, nor subject to official controls.
Inšpekcijski pregled, ki ga je Komisija opravila septembra 2017, je pokazal, da obrati primarne proizvodnje, ki dobavljajo brazilskim obratom, iz katerih je dovoljen uvoz ribiških proizvodov, niso niti opredeljeni niti predmet uradnega nadzora.
Consequently, that audit concluded that the competent authority in Brazil is neither in the position to provide the guarantees set out in Article 12(2)(a) and (b) of Regulation (EC) No 854/2004, nor to provide all the guarantees referred to in the health certificate for fishery products laid down in Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005.
Pri navedenem nadzornem pregledu je bilo tako ugotovljeno, da pristojni organ v Braziliji ne more zagotoviti jamstev iz člena 12(2)(a) in (b) Uredbe (ES) št. 854/2004 niti vseh jamstev iz veterinarskega spričevala za ribiške proizvode iz Dodatka IV k Prilogi VI k Uredbi Komisije (ES) št. 2074/2005.
Moreover, that inspection revealed serious deficiencies with regard to infrastructure and hygiene requirements in a number of inspected Brazilian establishments from which imports of fishery products are permitted.
Poleg tega so bile pri navedenem inšpekcijskem pregledu odkrite resne pomanjkljivosti glede infrastrukture in higienskih zahtev v številnih pregledanih brazilskih obratih, iz katerih je dovoljen uvoz ribiških proizvodov.
The aforesaid deficiencies have shown a systemic lack of effective controls by the Brazilian competent authorities with regard to fishery products.
Navedene pomanjkljivosti so pokazale sistematično pomanjkanje učinkovitega nadzora s strani pristojnih brazilskih organov v zvezi z ribiškimi proizvodi.
However, Member States notified the Commission that consignments of fishery products originating from Brazil were presented at the Union borders with certificates issued after the date of suspension.
Zato je primerno črtati vse obrate s seznama brazilskih obratov, iz katerih se lahko v Unijo uvažajo ribiški proizvodi, namenjeni za prehrano ljudi.
In light of these considerations, and in the absence of new information from the Brazilian authorities, there are no sufficient guarantees that any of the establishments authorised to export fishery products from Brazil to the Union fulfil the conditions of Article 12(2) of Regulation (EC) No 854/2004 and their products therefore constitute a risk for public health.
Zaradi tveganja za javno zdravje, povezanega z njihovimi proizvodi, bi bilo treba navedenim obratom nemudoma preklicati dovoljenje za izvoz v Unijo.
It is therefore appropriate to remove all establishments from the list of Brazilian establishments from which fishery products intended for human consumption can be imported into the Union.
Zato je primerno, da ta uredba začne veljati dan po njeni objavi.
In light of the risk to public health associated with their products, those establishments should cease to be authorised to export to the Union without delay.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za rastline, živali, hrano in krmo –
It is therefore appropriate that the date of entry into force of this Regulation is the date following that of its publication.
SPREJELA NASLEDNJO UREDBO:
HAS ADOPTED THIS REGULATION:
Seznam obratov iz člena 12 Uredbe (ES) št. 854/2004 se spremeni, da se črtajo vsi vnosi brazilskih obratov, iz katerih je dovoljen uvoz ribiških proizvodov za prehrano ljudi v Unijo.
The list of establishments referred to in Article 12 of Regulation (EC) No 854/2004 shall be amended in order to remove all entries of Brazilian establishments from which imports into the Union of fishery products for human consumption are permitted.
Ta uredba začne veljati dan po objavi v Uradnem listu Evropske unije.
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
V Bruslju, 11. julija 2018
Done at Brussels, 11 July 2018.
Predsednik
The President
Uredba Komisije (ES) št. 2074/2005 z dne 5. decembra 2005 o določitvi izvedbenih ukrepov za nekatere proizvode iz Uredbe (ES) št. 853/2004 in za organizacijo uradnega nadzora po uredbah (ES) št. 854/2004 in (ES) št. 882/2004, o odstopanju od Uredbe (ES) št. 852/2004 ter spremembi uredb (ES) št. 853/2004 in (ES) št. 854/2004 (UL L 338, 22.12.2005, str. 27).
OJ L 139, 30.4.2004, p. 206.
V odgovor na priporočila iz predhodnega inšpekcijskega poročila so brazilski organi z uradnim dopisom z dne 22. decembra 2017 Komisijo obvestili, da z dnem 3. januarja 2018 začasno prekinjajo izdajanje veterinarskih spričeval za vse ribiške proizvode, namenjene za izvoz v Unijo.
Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (OJ L 338, 22.12.2005, p. 27).
Vendar so države članice Komisijo obvestile o pošiljkah ribiških proizvodov s poreklom iz Brazilije, ki so bile na mejah Unije predložene s spričevali, izdanimi po navedenem datumu.
Commission Implementing Regulation (EU) 2018/982
Izvedbena uredba Komisije (EU) 2018/982
concerning the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as feed additive for chickens for fattening and chickens reared for laying (holder of the authorisation Novus Europe N.A./S.V.)
o izdaji dovoljenja za pripravek iz benzojske kisline, kalcijevega formata in fumarne kisline kot krmni dodatek za pitovne piščance in piščance za nesnice (imetnik registracije Novus Europe N.A./S.V.)
That application concerns the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as a feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying, to be classified in the additive category ‘zootechnical additives’.
Agencija je prav tako ugotovila, da bi lahko izboljšal proizvodnost pitovnih piščancev in da bi se ta sklep lahko razširil na piščance za nesnice.
The European Food Safety Authority (‘the Authority’) concluded in its opinions of 2 December 2014 and 28 September 2017 that, under the proposed conditions of use, the preparation of benzoic acid, calcium formate and fumaric acid does not have an adverse effect on animal health, human health or the environment.
Ker pa se ne da sklepati o varnostnem razponu dodatka za pomembne ciljne vrste, se sklepov o varnosti ne more ekstrapolirati na manj pomembne avirarne vrste za pitanje in manj pomembne aviarne vrste za nesnice.
The Authority also concluded that it has the potential to improve the performance of chickens for fattening and this conclusion can be extended to chickens reared for laying.
Agencija meni, da ni potrebe po posebnih zahtevah glede spremljanja po dajanju na trg.
However, since no conclusions can be drawn on the margin of safety of the additive for major target species, the conclusions on safety cannot be extrapolated to minor avian species for fattening and to minor avian species reared for laying.
Potrdila je tudi poročilo o analizni metodi krmnega dodatka v krmi, ki ga je predložil referenčni laboratorij, ustanovljen z Uredbo (ES) št. 1831/2003.
The Authority does not consider that there is a need for specific requirements of post-market monitoring.
Ocena pripravka iz benzojske kisline, kalcijevega formata in fumarne kisline je pokazala, da so pogoji za dovoljenje iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni.
It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
Zato bi bilo treba dovoliti uporabo navedenega pripravka, kakor je opredeljena v Prilogi k tej uredbi.
The assessment of the preparation of benzoic acid, calcium formate and fumaric acid shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za rastline, živali, hrano in krmo –
HAS ADOPTED THIS REGULATION:
Pripravek iz Priloge, ki spada v kategorijo dodatkov „zootehnični dodatki“ in funkcionalno skupino „drugi zootehnični dodatki“, se dovoli kot dodatek v prehrani živali v skladu s pogoji iz navedene priloge.
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
V Bruslju, 11. julija 2018
OJ L 268, 18.10.2003, p. 29.
Identifikacijska številka dodatka
ANNEX
Sestava, kemijska formula, opis, analizna metoda
Minimum content
mg dodatka/kg popolne krmne mešanice z vsebnostjo vlage 12 %
Maximum content
Kategorija zootehničnih dodatkov.
Other provisions
Funkcionalna skupina: drugi zootehnični dodatki (izboljšanje zootehničnega delovanja)
End of period of authorisation
pripravek iz benzojske kisline, kalcijevega formata in fumarne kisline
mg of additive/kg of complete feedingstuff with a moisture content of 12 %
Sestava dodatka
Category of zootechnical additives.
pripravek iz benzojske kisline, kalcijevega formata in fumarne kisline z najnižjo vsebnostjo:
Functional group: other zootechnical additives (improving zootechnical performance)
benzojska kislina: 42,5 %–50 %
Preparation of benzoic acid, calcium formate and fumaric acid
kalcijev format: 2,5 %–3,5 %
Additive composition
fumarna kislina: 0,8 %–1,2 %
Preparation of benzoic acid, calcium formate and fumaric acid having a minimum content of:
v granulah
Benzoic acid: 42,5-50 %
Lastnosti aktivne snovi
Calcium formate: 2,5-3,5 %
benzojska kislina: številka CAS: 65-85-0 (≥ 99,0 % čistost); C7H6O2
Fumaric acid: 0,8-1,2 %
kalcijev format: številka CAS: 544-17-2; C2H2O4Ca;
Granulated form
fumarna kislina (≥ 99,5 % čistost): številka CAS: 110-17-8;C4H4O4.
benzoic acid CAS number: 65-85-0 (≥ 99,0 % purity); C7H6O2
Za določanje benzojske kisline, kalcijevega formata in fumarne kisline v krmnem dodatku:
calcium formate: CAS number 544-17-2; C2H2O4Ca;
tekočinska kromatografija visoke ločljivosti z UV-detekcijo (HPLC-UV).
fumaric acid (≥ 99,5 % purity): CAS number 110-17-8; C4H4O4.
Za določanje količine skupnega kalcija v krmnem dodatku:
Analytical method
atomska absorpcijska spektrometrija (AAS) – EN ISO 6869; ali
For the determination of benzoic acid, calcium formate and fumaric acid in the feed additive:
atomska emisijska spektrometrija z induktivno sklopljeno plazmo (ICP-AES) – EN 15510.
high performance liquid chromatography with UV detection (HPLC-UV)
Za določanje benzojske kisline v premiksih in krmi:
For the determination of total calcium in the feed additive:
Za določanje kalcijevega formata in fumarne kisline v premiksih:
atomic absorption spectrometry (AAS) – EN ISO 6869; or
ionska izključitvena tekočinska kromatografija visoke ločljivosti z UV-detekcijo ali detekcijo na osnovi lomnega količnika (HPLC-UV/RI).
inductively coupled plasma atomic emission spectrometry (ICP-AES) – EN 15510
pitovni piščanci
For the determination of benzoic acid in premixtures and feedingstuffs:
piščanci za nesenje jajc
For the determination of calcium formate and fumaric acid in premixtures:
V navodilih za uporabo dodatka in premiksov se navedejo pogoji skladiščenja in obstojnost pri toplotni obdelavi.
ion-exclusion high performance liquid chromatography with UV or refractive index detection (HPLC-UV/RI)
Dodatek se ne sme uporabljati z drugimi viri benzojske kisline ali benzoatov, kalcijevega formata ali formata in fumarne kisline.
Chickens for fattening
Nosilci dejavnosti poslovanja s krmo zaradi morebitnih tveganj, ki izhajajo iz uporabe dodatka in premiksov, za uporabnike določijo postopke varnega ravnanja in organizacijske ukrepe.
Chickens reared for laying
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.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
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The additive shall not be used with other sources of benzoic acid or benzoates, calcium formate or formate and fumaric acid.
Podrobnosti o analiznih metodah so na voljo na naslovu referenčnega laboratorija: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their use.
Novus Europe N.A./S.V.V.
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.
V skladu s členom 7 Uredbe (ES) št. 1831/2003 je bil vložen zahtevek za izdajo dovoljenja za pripravek iz benzojske kisline, kalcijevega formata in fumarne kisline kot krmni dodatek za pitovne piščance, piščance za nesnice, manj pomembne aviarne vrste za pitanje in manj pomembne aviarne vrste za nesnice. aviarne vrste Zahtevku so bili priloženi zahtevani podatki in dokumenti iz člena 7(3) Uredbe (ES) št. 1831/2003.
Commission Implementing Regulation (EU) 2018/983
Izvedbena uredba Komisije (EU) 2018/983
concerning the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction (holder of authorisation DSM Nutritional Products Sp. z o. o.)
o izdaji dovoljenja za benzojsko kislino kot krmni dodatek za manj pomembne vrste prašičev za pitanje in za reprodukcijo (imetnik dovoljenja DSM Nutritional Products Sp. z o. o.)
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction.
V skladu s členom 7 Uredbe (ES) št. 1831/2003 je bil vložen zahtevek za izdajo dovoljenja za benzojsko kislino kot krmni dodatek za manj pomembne vrste prašičev za pitanje in za reprodukcijo.
That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
Zahtevku so bili priloženi zahtevani podatki in dokumenti iz člena 7(3) Uredbe (ES) št. 1831/2003.
That application concerns the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction, to be classified in the additive category ‘zootechnical additives’.
Navedeni zahtevek zadeva dovoljenje za benzojsko kislino kot krmni dodatek za manj pomembne vrste prašičev za pitanje in za reprodukcijo ter njegovo uvrstitev v kategorijo dodatkov „zootehnični dodatki“.
That additive was already authorised as a feed additive for use in weaned piglets by Commission Regulation (EC) No 1730/2006, in pigs for fattening by Commission Regulation (EC) No 1138/2007 and in sows by Commission Implementing Regulation (EU) 2016/900.
Z Uredbo Komisije (ES) št. 1730/2006 je bila odobrena uporaba navedenega dodatka kot krmnega dodatka za odstavljene pujske, z Uredbo Komisije (ES) št. 1138/2007 njegova uporaba kot krmnega dodatka za prašiče za pitanje, z Izvedbeno uredbo Komisije (EU) 2016/900 pa za svinje.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 September 2017 that, under the proposed conditions of use, the benzoic acid does not have an adverse effect on human health or the environment, and that it has a potential to decrease urinary pH in minor porcine species.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v mnenju z dne 28. septembra 2017 navedla, da benzojska kislina pod predlaganimi pogoji uporabe nima škodljivega vpliva na zdravje ljudi ali na okolje ter da njegova uporaba lahko nekoliko zniža pH urina pri manj pomembnih vrstah prašičev.
However, due to the lack of margin of safety in weaned major piglets, the Authority could not extrapolate the conclusion on the safety to weaned minor porcine species.
Ker pa se ne da sklepati o varnostnem razponu dodatka za pomembne vrste odstavljenih pujskov, Agencija ni mogla sklepa o varnosti ekstrapolirati na manj pomembne vrste odstavljenih pujskov.
Therefore it was established the additive is safe for minor porcine species for fattening and for reproduction.
Zato je bilo ugotovljeno, da je dodatek varen za manj pomembne vrste prašičev za pitanje in za reprodukcijo.
Commission Regulation (EC) No 1730/2006 of 23 November 2006 concerning the authorisation of benzoic acid (VevoVitall) as a feed additive (OJ L 325, 24.11.2006, p. 9).
Uredba Komisije (ES) št. 1730/2006 z dne 23. novembra 2006 o izdaji dovoljenja za benzojsko kislino (VevoVitall) kot dodatka v krmi (UL L 325, 24.11.2006, str. 9).
Commission Regulation (EC) No 1138/2007 of 1 October 2007 concerning the authorisation of a new use of benzoic acid (VevoVitall) as a feed additive (OJ L 256, 2.10.2007, p. 8).
Uredba Komisije (ES) št. 1138/2007 z dne 1. oktobra 2007 o izdaji dovoljenja za novo uporabo benzojske kisline (VevoVitall) kot krmnega dodatka (UL L 256, 2.10.2007, str. 8).
Commission Implementing Regulation (EU) 2016/900 of 8 June 2016 concerning the authorisation of benzoic acid as a feed additive for sows (holder of authorisation DSM Nutritional Products Ltd) (OJ L 152, 9.6.2016, p. 18).
Izvedbena uredba Komisije (EU) 2016/900 z dne 8. junija 2016 o izdaji dovoljenja za benzojsko kislino kot krmni dodatek za svinje (imetnik dovoljenja DSM Nutritional Products Ltd) (UL L 152, 9.6.2016, str. 18).
Species or category of animal
Najvišja starost
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
Kategorija zootehničnih dodatkov.
Category of zootechnical additives.
Funkcionalna skupina: drugi zootehnični dodatki (znižanje pH urina)
Functional group: other zootechnical additives (urinary pH decrease).
benzojska kislina
Benzoic acid
Sestava dodatka
Additive composition:
benzojska kislina (≥ 99,9 %)
Benzoic acid (≥ 99,9 %)
Lastnosti aktivne snovi
Characterisation of the active substance:
benzenkarboksilna kislina, fenilkarboksilna kislina,
Benzenecarboxylic acid, phenylcarboxylic acid,
Št.
CAS number 65-85-0
CAS 65-85-0
Maximum level of the impurities:
Zgornja meja nečistoč:
Phthalic acid: ≤ 100 mg/kg
ftalna kislina: ≤ 100 mg/kg
For the quantification of benzoic acid in the feed additive:
Za določanje količine benzojske kisline v krmnem dodatku:
titration with sodium hydroxide (European Pharmacopoeia monograph 0066)
titracija z natrijevim hidroksidom (monografija Evropske farmakopeje 0066).
For the quantification of the benzoic acid in the premixtures and feedingstuffs:
Za določanje količine benzojske kisline v premiksih in krmnih mešanicah:
reversed phase liquid chromatography with UV detection (RP-HPLC/UV) — method based on ISO9231:2008
tekočinska kromatografija z reverzno fazo z UV-detekcijo (RP-HPLC/UV) – metoda, ki temelji na standardu ISO9231:2008.
Minor porcine species for fattening and for reproduction
manj pomembne vrste prašičev za pitanje in za reprodukcijo
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated..
V navodilih za uporabo dodatka in premiksov se navedejo pogoji skladiščenja in obstojnost pri toplotni obdelavi.
The additive shall not be used with other sources of benzoic acid or benzoates.
Dodatek se ne sme uporabljati z drugimi viri benzojske kisline ali benzoatov.
The directions of use shall be indicated the following in complementary feed: ‘Complementary feedingstuffs containing benzoic acid shall not be fed to minor porcine species for fattening and for reproduction as such'.
V navodilih za uporabo dopolnilnih krmnih mešanic je treba navesti: „Manj pomembne vrste prašičev za pitanje in za reprodukcijo se ne smejo krmiti z dopolnilnimi krmnimi mešanicami, ki vsebujejo benzojsko kislino.
Complementary feedingstuffs for sows shall be thoroughly mixed with other feed materials of the daily ration’.
Dopolnilne krmne mešanice za svinje je treba temeljito zmešati z drugimi posamičnimi krmili v dnevnem obroku.“
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their use.
Nosilci dejavnosti poslovanja s krmo zaradi morebitnih tveganj, ki izhajajo iz uporabe dodatka in premiksov, za uporabnike določijo postopke varnega ravnanja in organizacijske ukrepe.
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 eyes and skin protection.
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 oči in zaščito za kožo.
1 August 2028
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of 12 February 2018
z dne 12. februarja 2018
supplementing Regulation (EU) No 167/2013 of the European Parliament and of the Council as regards environmental and propulsion unit performance requirements for agricultural and forestry vehicles and their engines and repealing Commission Delegated Regulation (EU) 2015/96
o dopolnitvi Uredbe (EU) št. 167/2013 Evropskega parlamenta in Sveta glede zahtev za okoljske značilnosti in zmogljivost pogonskega sistema za kmetijska in gozdarska vozila ter njihove motorje in o razveljavitvi Delegirane uredbe Komisije (EU) 2015/96
Having regard to Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles, and in particular Articles 19(6) and 20(8), 28(6) and 53(12), thereof,
ob upoštevanju Uredbe (EU) št. 167/2013 Evropskega parlamenta in Sveta z dne 5. februarja 2013 o odobritvi in tržnem nadzoru kmetijskih in gozdarskih vozil ter zlasti člena 19(6), člena 20(8), člena 28(6) in člena 53(12) Uredbe,