natgillin/translations-raw huggingface dataset:
The provisions adopted pursuant to this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product-type 14 containing the active substance powdered corn cob and also to facilitate the proper operation of the biocidal products market in general.
Določbe, sprejete na podlagi te direktive, bi se morale uporabljati hkrati v vseh državah članicah, da se tako na trgu Unije zagotovi enaka obravnava biocidnih pripravkov v 14. vrsti izdelkov, ki vsebujejo aktivno snov koruzni storž v prahu, in omogoči ustrezno delovanje trga biocidnih pripravkov na splošno.
A reasonable period should be allowed to elapse before an active substance is included in Annex I and Annex IA to Directive 98/8/EC in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.
Pred vključitvijo aktivne snovi v prilogi I in IA k Direktivi 98/8/ES bi bilo treba zagotoviti ustrezno dolgo obdobje, ki bo državam članicam in zainteresiranim stranem omogočilo, da se pripravijo na izpolnjevanje novih zahtev, prijaviteljem, ki so pripravili dokumentacijo, pa zagotovilo, da lahko povsem izkoristijo desetletno obdobje za varstvo podatkov, ki se v skladu s členom 12(1)(c)(ii) Direktive 98/8/ES začne z dnem vključitve.
In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents [3], Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.
Države članice so se v skladu s skupnimi političnimi izjavami z dne 28. septembra 2011 držav članic in Komisije o obrazložitvenih dokumentih [3] zavzele, da bodo v utemeljenih primerih uradnemu obvestilu o svojih ukrepih za prenos priložile enega ali več dokumentov, ki bodo pojasnjevali razmerje med sestavnimi deli direktive in ustreznimi deli nacionalnih instrumentov za prenos.
The Committee established by Article 28(1) of Directive 98/8/EC has not delivered an opinion on the measures provided for in this Directive, and the Commission therefore submitted to the Council a proposal relating to the measures and forwarded it to the European Parliament.
Odbor, ustanovljen v skladu s členom 28(1) Direktive 98/8/ES, ni podal mnenja o ukrepih, določenih v tej direktivi, zato je Komisija Svetu predložila predlog glede ukrepov in ga poslala Evropskemu parlamentu.
The Council did not act within the two-month period provided for by Article 5a of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [4], and the Commission therefore submitted the proposal to the European Parliament without delay.
Svet ni ukrepal v obdobju dveh mesecev, kot določa člen 5a Sklepa Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [4], zato je Komisija predlog nemudoma predložila Evropskemu parlamentu.
They shall forthwith communicate to the Commission the text of those provisions.
Države članice Komisiji takoj sporočijo besedilo navedenih predpisov.
Powdered corn cob
Koruzni storž v prahu
Not allocated
Ni dodeljeno
When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.’
Kadar je za določen pripravek to potrebno, države članice pri ocenjevanju vloge za izdajo dovoljenja za pripravek v skladu s členom 5 in Prilogo VI ocenijo možne uporabe oziroma primere izpostavljenosti ter tveganja za populacije ljudi in dele okolja, ki v oceni tveganja na ravni Unije niso bili reprezentativno obravnavani.“
Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)
Rok za uskladitev s členom 16(3) (razen za pripravke, ki vsebujejo več kot eno aktivno snov, za katere je rok za uskladitev s členom 16(3) enak roku, določenem v zadnji odločitvi o vključitvi njihovih aktivnih snovi)
Specific provisions [4]
Posebne določbe [4]
Member States shall ensure that registrations are subject to the following condition:
Države članice zagotovijo, da je za izdajo dovoljenj izpolnjen naslednji pogoj:
Only for use in the form of pellets in dry locations.’
Samo za uporabo v obliki peletov v suhem okolju.“
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 11.
Čistost, navedena v tem stolpcu, je minimalna stopnja čistosti aktivne snovi, uporabljene za presojo v skladu s členom 11.
For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm
Za izvajanje splošnih načel Priloge VI so vsebina in sklepne ugotovitve poročil o oceni na voljo na spletišču Komisije: http://ec.europa.eu/comm/environment/biocides/index.htm.
Commission Implementing Directive 2013/45/EU
Izvedbena direktiva Komisije 2013/45/EU
amending Council Directives 2002/55/EC and 2008/72/EC and Commission Directive 2009/145/EC as regards the botanical name of tomato
o spremembi direktiv Sveta 2002/55/ES in 2008/72/ES ter Direktive Komisije 2009/145/ES glede botaničnega imena paradižnika
Having regard to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed [1], and in particular Articles 2(2), 44(2), Article 45 and Article 48(1)(b) thereof,
ob upoštevanju Direktive Sveta 2002/55/ES z dne 13. junija 2002 o trženju semena zelenjadnic [1] ter zlasti člena 2(2), člena 44(2), člena 45 in člena 48(1)(b) Direktive,
Having regard to Council Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable propagating and planting material, other than seed [2], and in particular Article 1(3) thereof,
ob upoštevanju Direktive Sveta 2008/72/ES z dne 15. julija 2008 o trženju razmnoževalnega in sadilnega materiala zelenjadnic, razen semena [2], in zlasti člena 1(3) Direktive,
In the light of the development of scientific knowledge, the International Code of Botanical Nomenclature (ICBN) has been revised, in particular with respect to the botanical name of the species tomato.
Zaradi novih znanstvenih dognanj je bil Mednarodni kodeks botanične nomenklature (ICBN) popravljen, zlasti glede botaničnega imena vrste paradižnik.
In order to reflect that development, Directives 2002/55/EC, 2008/72/EC and Commission Directive 2009/145/EC of 26 November 2009 providing for certain derogations, for acceptance of vegetable landraces and varieties which have been traditionally grown in particular localities and regions and are threatened by genetic erosion and of vegetable varieties with no intrinsic value for commercial crop production but developed for growing under particular conditions and for marketing of seed of those landraces and varieties [3] should therefore be amended accordingly.
Da bi upoštevali navedene spremembe, bi bilo treba direktivi 2002/55/ES in 2008/72/ES ter Direktivo Komisije 2009/145/ES z dne 26. novembra 2009 o določitvi nekaterih odstopanj za sprejetje domačih sort in sort zelenjadnic, ki se tradicionalno gojijo v posebnih krajih in regijah in so ogrožene zaradi genske erozije, in sort zelenjadnic, ki nimajo resnične vrednosti za komercialno pridelavo, ampak so se razvile za pridelavo v posebnih pogojih ter za trženje semena navedenih domačih sort in sort zelenjadnic [3], ustrezno spremeniti.
in Article 2(1)(b) the words ‘Lycopersicon esculentum Mill.’ are replaced by the words ‘Solanum lycopersicum L.’;
v členu 2(1)(b) se besede „Lycopersicon esculentum Mill.“ nadomestijo z besedami „Solanum lycopersicum L.“;
in the table in point 3(a) of Annex II, the words ‘Lycopersicon esculentum’ are replaced by the words ‘Solanum lycopersicum L.’;
v razpredelnici v točki 3(a) Priloge II se besedi „Lycopersicon esculentum“ nadomestita z besedami „Solanum lycopersicum L.“;
in the table in point 2 of Annex III, the words ‘Lycopersicon esculentum’ are replaced by the words ‘Solanum lycopersicum L.’.
v razpredelnici v točki 2 Priloge III se besedi „Lycopersicon esculentum“ nadomestita z besedami „Solanum lycopersicum L.“.
Amendments to Directive 2008/72/EC
Spremembe Direktive 2008/72/ES
In the table in Annex II to Directive 2008/72/EC, the words ‘Lycopersicon esculentum Mill.’ are replaced by the words ‘Solanum lycopersicum L.’.
V razpredelnici v Prilogi II k Direktivi 2008/72/ES se besede „Lycopersicon esculentum Mill.“ nadomestijo z besedami „Solanum lycopersicum L.“.
Amendments to Directive 2009/145/EC
Spremembe Direktive 2009/145/ES
Directive 2009/145/EC is amended as follows:
Direktiva 2009/145/ES se spremeni:
in the table in Annex I, the words ‘Lycopersicon esculentum Mill.’ are replaced by ‘Solanum lycopersicum L.’;
v razpredelnici v Prilogi I se besede „Lycopersicon esculentum Mill.“ nadomestijo z besedami „Solanum lycopersicum L.“;
in the table in Annex II, the words ‘Lycopersicon esculentum Mill.’ are replaced by ‘Solanum lycopersicum L.’.
v razpredelnici v Prilogi II se besede „Lycopersicon esculentum Mill.“ nadomestijo z besedami „Solanum lycopersicum L.“.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2014 at the latest.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 31. marca 2014.
amending Directive 2006/141/EC with regard to protein requirements for infant formulae and follow-on formulae
o spremembi Direktive 2006/141/ES v zvezi z zahtevami glede beljakovin za začetne formule za dojenčke ter nadaljevalne formule za dojenčke in majhne otroke
Having regard to Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses [1], and in particular Article 4(1) thereof,
ob upoštevanju Direktive 2009/39/ES Evropskega parlamenta in Sveta z dne 6. maja 2009 o živilih za posebne prehranske namene [1] in zlasti člena 4(1) Direktive,
Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC [2] lays down, inter alia, compositional and labelling rules for infant formulae and follow-on formulae.
Direktiva Komisije 2006/141/ES z dne 22. decembra 2006 o začetnih formulah za dojenčke in nadaljevalnih formulah za dojenčke in majhne otroke in o spremembi Direktive 1999/21/ES [2] določa pravila glede sestave in označevanja za začetne formule za dojenčke ter nadaljevalne formule za dojenčke in majhne otrok.
Directive 2006/141/EC specifically provides for infant formulae and follow-on formulae to only be manufactured from protein sources defined in that Directive.
Direktiva 2006/141/ES izrecno določa, da morajo biti začetne formule za dojenčke ter nadaljevalne formule za dojenčke in majhne otrok izdelane iz virov beljakovin, določenih v navedeni direktivi.
Those protein sources are cows’ milk proteins and soya protein isolates, alone or in a mixture, as well as protein hydrolysates.
Ti viri beljakovin so beljakovine kravjega mleka in izolati beljakovin iz soje, sami ali v mešanici, ter beljakovinski hidrolizati.
On request from the Commission, the European Food Safety Authority delivered, on 28 February 2012, a scientific opinion on the suitability of goat milk protein as a source of protein in infant formulae and in follow-on formulae.
Evropska agencija za varnost hrane je na zahtevo Komisije 28. februarja 2012 predložila znanstveno mnenje o primernosti beljakovin kozjega mleka kot vira beljakovin v začetnih formulah za dojenčke ter nadaljevalnih formulah za dojenčke in majhne otroke.
That opinion concluded that protein from goats’ milk can be suitable as a protein source for infant formulae and follow-on formulae provided that the final product complies with the compositional criteria laid down in Directive 2006/141/EC.
V mnenju je ugotovljeno, da so beljakovine kozjega mleka lahko primeren vir beljakovin za začetne formule za dojenčke ter nadaljevalne formule za dojenčke in majhne otroke, če končni proizvod izpolnjuje merila glede sestave iz Direktive 2006/141/ES.
On the basis of that opinion, infant formulae and follow-on formulae manufactured from goats’ milk proteins should be allowed on the market provided that the final product complies with the compositional criteria laid down in Directive 2006/141/EC.
Na podlagi navedenega mnenja bi bilo treba začetne formule za dojenčke ter nadaljevalne formule za dojenčke in majhne otroke, izdelane iz beljakovin kozjega mleka, dovoliti na trgu, če končni proizvod izpolnjuje merila glede sestave iz Direktive 2006/141/ES.
Directive 2006/141/EC should therefore be amended accordingly.
Direktivo 2006/141/ES bi bilo zato treba ustrezno spremeniti.
On request from the Commission, the European Food Safety Authority delivered, on 5 October 2005, a scientific opinion on the safety and suitability for particular nutritional use by infants of formula based on whey protein partial hydrolysates with a protein content of at least 1,9 g/100 kcal, which was below the minimum level provided for in the Union legislation at that time.
Evropska agencija za varnost hrane je na zahtevo Komisije 5. oktobra 2005 predložila znanstveno mnenje o varnosti formul, ki temeljijo na delnih hidrolizatih beljakovin sirotke, z vsebnostjo beljakovin najmanj 1,9 g/100 kcal, kar je bilo manj od najmanjše vrednosti, določene v takratni zakonodaji Unije, in o njihovi primernosti za posebne prehranske namene dojenčkov.
That opinion concluded that infant formula, based on hydrolysates of whey protein derived from cows’ milk with a protein content of 1,9 g/100 kcal (0,47 g/100 kJ) and corresponding to the protein formulation assessed, is safe and suitable for use as the sole source of nutrition of infants.
V mnenju je ugotovljeno, da so začetne formule za dojenčke, ki temeljijo na hidrolizatih beljakovin sirotke kravjega mleka, z vsebnostjo beljakovin 1,9 g/100 kcal (0,47 g/100 kJ), in ustrezajo ocenjeni sestavi beljakovin, varne in primerne za uporabo kot edini prehranski vir dojenčkov.
On the basis of that opinion, Directive 2006/141/EC, as amended by Commission Regulation (EC) No 1243/2008 of 12 December 2008 amending Annexes III and VI to Directive 2006/141/EC as regards compositional requirements for certain infant formulae [3], authorises the marketing of infant formulae manufactured from protein hydrolysates with such a protein content provided that the product complies with certain specific criteria set out therein.
Na podlagi navedenega mnenja Direktiva 2006/141/ES, kakor je bila spremenjena z Uredbo Komisije (ES) št. 1243/2008 z dne 12. decembra 2008 o spremembi prilog III in VI k Direktivi 2006/141/ES v zvezi z zahtevami glede sestave nekaterih formul za dojenčke [3], dovoljuje trženje začetnih formul za dojenčke, izdelanih iz hidrolizatov beljakovin, s tako vsebnostjo beljakovin, če proizvod izpolnjuje posebna merila iz navedene direktive.
That opinion also concluded that, while no data on follow-on formulae based on hydrolysed whey protein with a protein content of 1,9 g/100 kcal (0,47 g/100 kJ) had been submitted, a formula with that protein formulation would be suitable for older infants in conjunction with complementary foods.
Čeprav ni bilo predloženih podatkov o nadaljevalnih formulah za dojenčke in majhne otroke, ki temeljijo na hidroliziranih beljakovinah sirotke, z vsebnostjo beljakovin 1,9 g/100 kcal (0,47 g/100 kJ), je bilo v mnenju nadalje ugotovljeno, da bi bile formule s tako sestavo beljakovin primerne za starejše dojenčke v povezavi z dopolnilnimi živili.
On the basis of that opinion, and in order to allow the development of innovative products, such follow-on formulae should be allowed on the market.
Na podlagi navedenega mnenja in da bi omogočili razvoj inovativnih proizvodov, bi bilo treba take nadaljevalne formule za dojenčke in majhne otroke dovoliti na trgu.
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, and neither the European Parliament nor the Council have opposed them,
Ukrepi iz te direktive so v skladu z mnenjem Stalnega odbora za prehranjevalno verigo in zdravje živali, Evropski parlament in Svet pa jim nista nasprotovala –
Directive 2006/141/EC is amended as follows:
Direktiva 2006/141/ES se spremeni:
‘In the case of infant formulae manufactured from cows’ milk or goats’ milk proteins defined in point 2.1 of Annex I with a protein content between the minimum and 0,5 g/100 kJ (2 g/100 kcal), the suitability of the infant formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies.’;
„V primeru začetnih formul za dojenčke, izdelanih iz beljakovin kravjega ali kozjega mleka, opredeljenih v točki 2.1 Priloge I, z vsebnostjo beljakovin med najmanjšo vrednostjo in 0,5 g/100 kJ (2 g/100 kcal), se primernost začetne formule za dojenčke za posebne prehranske namene dojenčkov dokaže z ustreznimi študijami, izvedenimi v skladu s splošno sprejetimi navodili znanstvenikov o zasnovi in izvedbi takih študij.“;
‘In the case of follow-on formulae manufactured from protein hydrolysates defined in point 2.2 of Annex II with a protein content between the minimum and 0,56 g/100 kJ (2,25 g/100 kcal), the suitability of the follow-on formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies and shall be in accordance with the appropriate specifications set out in Annex VI.’;
„V primeru nadaljevalnih formul za dojenčke in majhne otroke, izdelanih iz hidrolizatov beljakovin, opredeljenih v točki 2.2 Priloge II, z vsebnostjo beljakovin med najmanjšo vrednostjo in 0,56 g/100 kJ (2,25 g/100 kcal), se primernost nadaljevalne formule za dojenčke in majhne otroke za posebne prehranske namene dojenčkov dokaže z ustreznimi študijami, izvedenimi v skladu s splošno sprejetimi navodili znanstvenikov o zasnovi in izvedbi takih študij; upoštevane so specifikacije iz Priloge VI.“;
in Article 12, the introductory phrase is replaced by the following:
v členu 12 se uvodni stavek nadomesti z naslednjim:
‘The name under which infant formulae and follow-on formulae manufactured entirely from cows’ milk or goats’ milk proteins are sold shall be respectively:’;
„Imeni, pod katerima se prodajajo začetne formule za dojenčke ter nadaljevalne formule za dojenčke in majhne otroke, ki so v celoti izdelane samo iz beljakovin kravjega ali kozjega mleka, sta:“;
Annexes I, II, III and VI are amended in accordance with the Annex to this Directive.
priloge I, II, III in VI se spremenijo v skladu s Prilogo k tej direktivi.
Annexes I, II, III and VI to Directive 2006/141/EC are amended as follows:
Priloge I, II, III in VI k Direktivi 2006/141/ES se spremenijo:
point 2.1 is amended as follows:
točka 2.1 se spremeni:
Infant formulae manufactured from cows’ milk or goats’ milk proteins’;
Začetne formule za dojenčke, izdelane iz beljakovin kravjega ali kozjega mleka“;
footnote 1 is replaced by the following:
opomba 1 se nadomesti z naslednjim:
Infant formulae manufactured from cows’ milk or goats’ milk protein with a protein content between the minimum and 0,5 g/100 kJ (2 g/100 kcal) shall be in accordance with the second subparagraph of Article 7(1).’;
Začetne formule za dojenčke, izdelane iz beljakovin kravjega ali kozjega mleka, z vsebnostjo beljakovin med najmanjšo vrednostjo in 0,5 g/100 kJ (2 g/100 kcal), so v skladu z drugim pododstavkom člena 7(1).“;
in point 2.3, the title is replaced by the following:
v točki 2.3 se naslov nadomesti z naslednjim:
Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins’;
Začetne formule za dojenčke, izdelane iz izolatov beljakovin iz soje, samih ali v mešanici z beljakovinami kravjega ali kozjega mleka“;
in point 10.1, the title is replaced by the following:
v točki 10.1 se naslov nadomesti z naslednjim:
Infant formulae manufactured from cows’ milk or goats’ milk proteins or protein hydrolysates’;
Začetne formule za dojenčke, izdelane iz beljakovin kravjega ali kozjega mleka ali hidrolizatov beljakovin“;
in point 10.2, the title is replaced by the following:
v točki 10.2 se naslov nadomesti z naslednjim:
in point 2.1, the title is replaced by the following:
v točki 2.1 se naslov nadomesti z naslednjim:
Follow-on formulae manufactured from cows’ milk or goats’ milk proteins’;
Nadaljevalne formule za dojenčke in majhne otroke, izdelane iz beljakovin kravjega ali kozjega mleka“;
in point 2.2, the table is replaced by the following:
v točki 2.2 se preglednica nadomesti z naslednjim:
‘Minimum [1]
„Najmanj [1]
Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins’;
Nadaljevalne formule za dojenčke in majhne otroke, izdelane iz izolatov beljakovin iz soje, samih ali v mešanici z beljakovinami kravjega ali kozjega mleka“;
in point 8.1, the title is replaced by the following:
v točki 8.1 se naslov nadomesti z naslednjim:
Follow-on formulae manufactured from cows’ milk or goats’ milk proteins or protein hydrolysates’;
Nadaljevalne formule za dojenčke in majhne otroke, izdelane iz beljakovin kravjega ali kozjega mleka ali hidrolizatov beljakovin“;
in point 8.2, the title is replaced by the following:
v točki 8.2 se naslov nadomesti z naslednjim:
in point 3 of Annex III, footnote 1 is replaced by the following:
v točki 3 Priloge III se opomba 1 nadomesti z naslednjim:
L-arginine and its hydrochloride shall only be used in the manufacture of infant formulae referred to in the third subparagraph of Article 7(1) and follow-on formulae referred to in the second subparagraph of Article 7(2).’;
L-arginin in njegov hidroklorid se uporabljata le pri izdelavi začetne formule za dojenčke iz tretjega pododstavka člena 7(1) in nadaljevalne formule za dojenčke in majhne otroke iz drugega pododstavka člena 7(2).“;
the title of Annex VI is replaced by the following:
naslov Priloge VI se nadomesti z naslednjim:
‘Specification for the protein content and source and the processing of protein used in the manufacture of infant formulae and follow-on formulae with a protein content less than 0,56 g/100 kJ (2,25 g/100 kcal) manufactured from hydrolysates of whey proteins derived from cows’ milk protein’.
„Specifikacija za vsebnost beljakovin, vir beljakovin in predelavo beljakovin, uporabljenih za izdelavo začetnih formul za dojenčke ter nadaljevalnih formul za dojenčke in majhne otroke z vsebnostjo beljakovin manj kot 0,56 g/100 kJ (2,25 g/100 kcal), izdelanih iz hidrolizatov beljakovin sirotke, pridobljenih iz beljakovin kravjega mleka“.
Follow-on formulae manufactured from protein hydrolysates with a protein content between the minimum and 0,56 g/100 kJ (2,25 g/100 kcal) shall be in accordance with the second subparagraph of Article 7(2).’
Nadaljevalne formule za dojenčke in majhne otroke, izdelane iz hidrolizatov beljakovin, z vsebnostjo beljakovin med najmanjšo vrednostjo in 0,56 g/100 kJ (2,25 g/100 kcal), so v skladu z drugim pododstavkom člena 7(2).“