natgillin/translations-raw huggingface dataset:
The particulars and documents on the starting materials, i.e. all of the materials used including raw materials and intermediates up to the final dilution to be incorporated into the finished homeopathic veterinary medicinal product, accompanying the application shall be supplemented by additional data on the homeopathic stock.
Podrobni podatki in dokumenti o vhodnih snoveh, tj. o vseh uporabljenih snoveh, vključno s surovinami in intermediati do končnih razredčin, ki bodo vključene v končno homeopatsko zdravilo, ki so priloženi vlogi, se dopolnijo z dodatnimi podatki o homeopatski surovini.
The general quality requirements shall apply to all of the starting and raw materials as well as intermediate steps of the manufacturing process up to the final dilution to be incorporated into the finished homeopathic product.
Splošne zahteve za kakovost se uporabljajo za vse vhodne snovi in surovine ter za vmesne stopnje postopka izdelave do končne razredčine, ki se vključi v končno homeopatsko zdravilo.
Where a toxic component is present, this should be controlled if possible in the final dilution.
Kadar je prisotna toksična sestavina, jo je treba kontrolirati v končni razredčini, če je mogoče.
However, if this is not possible because of the high dilution, the toxic component shall normally be controlled at an earlier stage.
Vendar če to ni mogoče zaradi visoke razredčitve, se toksična sestavina praviloma kontrolira na začetnih stopnjah.
Every step of the manufacturing process from the starting materials up to the final dilution to be incorporated into the finished product must be fully described.
V celoti se mora opisati vsaka stopnja postopka izdelave od vhodnih snovi do končne razredčine, ki se vključi v končno zdravilo.
In case dilutions are involved, these dilution steps shall be done in accordance with the homeopathic manufacturing methods laid down in the relevant monograph of the European Pharmacopoeia or, in absence thereof, in an official pharmacopoeia of a Member State.
Če so vključene razredčine, se te stopnje razredčitve pripravijo v skladu s homeopatskimi metodami izdelave, določenimi v ustrezni monografiji Evropske farmakopeje ali, kadar ta ne obstaja, uradni farmakopeji države članice.
Control tests on the finished medicinal product
Kontrolni preskusi končnega zdravila
The general quality requirements shall apply to the homeopathic finished veterinary medicinal products.
Splošne zahteve za kakovost se uporabljajo za končna homeopatska zdravila za uporabo v veterinarski medicini.
Any exception shall be duly justified by the applicant.
Predlagatelj vsako izjemo natančno utemelji.
Identification and assay of all the toxicologically relevant constituents shall be carried out.
Izvede se identifikacija in določitev vseh toksikološko pomembnih sestavin.
If it can be justified that identification and/or an assay on all the toxicologically relevant constituents is not possible e.g. due to their dilution in the finished medicinal product the quality shall be demonstrated by complete validation of the manufacturing and dilution process.
Če je mogoče utemeljiti, da identifikacija in/ali določitev vseh toksikološko pomembnih sestavin ni mogoča, npr. zaradi njihove razredčitve v končnem zdravilu, se kakovost dokaže s popolno potrditvijo postopka izdelave in razredčitve.
Stability tests
Preskusi stabilnosti
The stability of the finished product shall be demonstrated.
Dokaže se stabilnost končnega zdravila.
Stability data from the homeopathic stocks are generally transferable to dilutions/potentisations obtained thereof.
Podatke o stabilnosti homeopatskih surovin se ponavadi lahko prenese na razredčine/potence, pridobljene iz surovin.
If no identification or assay of the active substance is possible due to the degree of dilution, stability data of the pharmaceutical form may be considered.
Če identifikacija ali določitev zdravilne učinkovine ni mogoča zaradi stopnje razredčitve, se lahko upoštevajo podatki o stabilnosti farmacevtske oblike.
The provisions of Part 3 shall apply to the simplified registration of homeopathic veterinary medicinal products referred to in Article 17(1) of this Directive with the following specification, without prejudice to the provisions of Regulation (EEC) No 2377/90 for substances included in the homeopathic stocks intended for administration to food-producing animal species.
Določbe iz dela 3 se brez poseganja v določbe Uredbe (EGS) št. 2377/90 uporabljajo za poenostavljeno registracijo homeopatskih zdravil za uporabo v veterinarski medicini iz člena 17(1) te direktive s posebno specifikacijo za snovi, vključene v homeopatske surovine za dajanje živalim za proizvodnjo živil.
Any missing information must be justified, e.g. justification must be given why demonstration of an acceptable level of safety can be supported although some studies are lacking.’
Če katere koli informacije manjkajo, je treba utemeljiti, npr. predložiti se mora utemeljitev, zakaj je mogoče dokazati sprejemljivo stopnjo varnosti, čeprav nekatere študije manjkajo.“
OJ L 228, 17.8.1991, p. 70.
UL L 228, 17.8.1991, str. 70.
OJ C 24, 28.1.2004, p. 6.
UL C 24, 28.1.2004, str. 6.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 6 September 2009 at the latest.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje 6. septembra 2009.
Pharmacological, toxicological, residue and safety tests shall be carried out in conformity with the provisions related to Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC of the European Parliament and of the Council [2] and Directive 2004/9/EC of the European Parliament and of the Council [3].7. Member States shall ensure that all experiments on animals are conducted in accordance with Council Directive 86/609/EEC [4].8. In order to monitor the risk/benefit assessment, any new information not in the original application and all pharmacovigilance information shall be submitted to the competent authority.
Farmakološki in toksikološki preskusi ter preskusi ostankov in varnosti se izvedejo v skladu z določbami dobre laboratorijske prakse (DLP) iz Direktive 2004/10/ES Evropskega parlamenta in Sveta [2] in Direktive 2004/9/ES [3] Evropskega Parlamenta in Sveta.(7) Države članice zagotovijo, da se vsi poskusi na živalih izvajajo v skladu z Direktivo Sveta 86/609/EGS [4].(8) Za spremljanje ocene razmerja med koristjo in tveganjem se pristojnemu organu predložijo vse nove informacije, ki niso v prvotni vlogi, ter vse informacije o farmakovigilanci.
After marketing authorisation has been granted, any change to the content of the dossier shall be submitted to the competent authorities in accordance with Commission Regulations (EC) No 1084/2003 [5] or (EC) No 1085/2003 [6] for veterinary medicinal products authorised as defined in Article 1 of those Regulations, respectively.9. The environmental risk assessment connected with the release of veterinary medicinal products containing or consisting of Genetically Modified Organisms (GMOs) within the meaning of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council [7] shall be provided in the dossier.
Po izdaji dovoljenja za promet z zdravilom se zahteva za kakršno koli spremembo dokumentacije odobrenih zdravil za uporabo v veterinarski medicini, kakor so opredeljena v členu 1 Uredbe Komisije (ES) št. 1084/2003 [5] in členu 1 Uredbe Komisije (ES) št. 1085/2003 [6], predloži pristojnim organom v skladu z navedenima uredbama.(9) Vloga vključuje oceno tveganja za okolje v zvezi s sproščanjem zdravil za uporabo v veterinarski medicini, ki vsebujejo gensko spremenjene organizme (GSO) ali so iz njih sestavljena v smislu člena 2 Direktive 2001/18/ES [7] Evropskega parlamenta in Sveta.
The information shall be presented in accordance with the provisions of Directive 2001/18/EC and Regulation (EC) No 726/2004 of the European Parliament and of the Council [8], taking into account guidance documents published by the Commission.10. In cases of applications for marketing authorisations for veterinary medicinal products indicated for animal species and indications representing smaller market sectors, a more flexible approach may be applicable.
Informacije se predložijo v skladu z določbami Direktive 2001/18/ES in Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta [8] in ob upoštevanju dokumentov o smernicah, ki jih je objavila Komisija.(10) Pri vlogah za pridobitev dovoljenja za promet z zdravili za uporabo v veterinarski medicini, namenjenimi živalskim vrstam in indikacijam, ki predstavljajo manjše tržne sektorje, se lahko uporabi prožnejši pristop.
PART 3: SAFETY AND RESIDUES TESTS The particulars and documents which shall accompany the application for marketing authorisation pursuant to the second and fourth indents of Article 12(3)(j) shall be submitted in accordance with the requirements below.
Podrobni podatki in dokumenti, ki so priloženi vlogi za pridobitev dovoljenja za promet v skladu z drugo in četrto alineo člena 12(3)(j), se predložijo v skladu s spodaj naštetimi zahtevami.
Reversion to virulence shall be investigated with the master seed. If the master seed is not available in sufficient quantity the lowest passage seed used for the production shall be examined.
Če matična kultura ni na voljo v zadostni količini, se pregleda matična snov iz najnižje ravni prenosa, ki se uporablja pri izdelavi.
Commission Directive 2009/10/EC
Direktiva Komisije 2009/10/ES
amending Directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners
o spremembi Direktive 2008/84/ES o posebnih merilih čistosti aditivov za živila razen barvil in sladil
Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption [1], and in particular Article 3(3)(a) thereof,
ob upoštevanju Direktive Sveta 89/107/EGS z dne 21. decembra 1988 o približevanju zakonodaj držav članic o aditivih za živila, ki se smejo uporabljati v živilih, namenjenih za prehrano ljudi [1], ter zlasti člena 3(3)(a) Direktive,
After consulting the Scientific Committee on Food (SCF) and the European Food Safety Authority (EFSA),
po posvetovanju z Znanstvenim odborom za hrano (SCF) in Evropsko agencijo za varnost hrane (EFSA),
Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners [2] sets out the purity criteria for the additives mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners [3].
V Direktivi Komisije 2008/84/ES [2] z dne 27. avgusta 2008 o posebnih merilih čistosti aditivov za živila razen barvil in sladil so določena merila čistosti za aditive iz Direktive Evropskega parlamenta in Sveta št. 95/2/ES z dne 20. februarja 1995 o aditivih za živila razen barvil in sladil [3].
The European Food Safety Authority (hereinafter EFSA) concluded in its opinion of 20 October 2006 [4] that nisin produced through a modified production process using a sugar-based medium is equivalent with respect to health protection to the one produced by the original milk-based medium process.
Sklep mnenja Evropske agencije za varnost hrane (v nadaljnjem besedilu: EFSA) z dne 20. oktobra 2006 [4] je bil, da je nizin, proizveden s spremenjenim postopkom proizvodnje z uporabo gojišča na podlagi sladkorja, enako varen za zdravje kot nizin, proizveden z originalnim postopkom z uporabo gojišča na podlagi mleka.
On the basis of that opinion, the existing specifications for E234 nisin should be amended in order to adapt the definition and the purity criteria set out for that additive.
Obstoječe specifikacije za E 234 nizin je treba na podlagi navedenega mnenja spremeniti, da se posodobita definicija in merila čistosti za navedeni aditiv.
Formaldehyde is used as a preservative during the manufacture of alginic acid, alginate salts and esters of alginic acid.
Formaldehid se uporablja kot konzervans pri izdelavi alginske kisline, alginatnih soli in estrov alginske kisline.
It has been reported that residual formaldehyde, up to 50 mg/kg, may be present in the final gelling additives.
V poročilih je bilo navedeno, da lahko v končnih želirnih aditivih ostane tudi do 50 mg/kg formaldehida.
At the request of the Commission, EFSA assessed the safety in use of formaldehyde as a preservative during the manufacture and preparation of food additives [5].
EFSA je na zahtevo Komisije ocenila varnost in uporabo formaldehida kot konzervansa pri izdelavi in pripravi aditivov za živila [5].
EFSA in its opinion of 30 November 2006 concluded that the estimated exposure to gelling additives containing residual formaldehyde at the level of 50 mg/kg of additive would be of no safety concern.
Sklep mnenja EFSA z dne 30. novembra 2006 je bil, da ocenjena izpostavljenost želirnim aditivom, v katerih je vrednost ostanka formaldehida 50 mg/kg aditiva, ni tvegana za zdravje.
Therefore the existing purity criteria for E400 alginic acid, E401 sodium alginate, E402 potassium alginate, E403 ammonium alginate, E404 calcium alginate, and E405 propane-1,2-diol alginate should be amended in such a way that the maximum level of formaldehyde is set at 50 mg/kg.
Zato je treba obstoječa merila čistosti za E 400 alginsko kislino, E 401 natrijev alginat, E 402 kalijev alginat, E 403 amonijev alginat, E 404 kalcijev alginat in E 405 propan-1,2-diol alginat spremeniti tako, da se določi mejna vrednost formaldehida 50 mg/kg.
Formaldehyde is not currently used in the processing of seaweeds for the production of E407 carrageenan and E407a processed eucheuma seaweed.
Formaldehid se trenutno ne uporablja pri obdelavi morskih alg za proizvodnjo E 407 karagenana in E 407a obdelanih rdečih morskih alg eucheuma.
However, it may be naturally occurring in marine algae and be consequently present as an impurity in the finished product.
Vendar se lahko naravno pojavlja v morskih algah in je zato lahko prisoten kot nečistoča v končnem proizvodu.
It is therefore appropriate to fix a maximum level of adventitious presence of the above substance in those food additives.
Zato je treba določiti mejno vrednost naključne prisotnosti zgoraj navedene snovi v navedenih aditivih za živila.
Guar gum is authorised as a food additive for use in foodstuffs by Directive 95/2/EC.
Guma guar je z Direktivo 95/2/ES odobrena kot aditiv za živila za uporabo v živilih.
In particular, it is used as thickener, emulsifier, and stabiliser.
Zlasti se uporablja kot sredstvo za zgoščevanje, emulgator in stabilizator.
A request to use a partially depolymerised guar gum as a food additive, produced from native guar gum by one of the three manufacturing processes consisting of heat treatment, acid hydrolysis or alkaline oxidation, was submitted to the Commission.
Komisiji je bila predložena zahteva za uporabo delno polimerizirane gume guar kot aditiva za živila, proizvedene iz naravne gume guar z enim od treh postopkov izdelave: toplotno obdelavo, kislo hidrolizo ali bazično oksidacijo.
EFSA assessed the safety in use of that additive and, in its opinion of 4 July 2007 [6], estimated that partially depolymerised guar gum has been shown to be very similar to native guar gum with respect to the composition of the final product.
EFSA je ocenila varnost in uporabo navedenega aditiva in v mnenju z dne 4. julija 2007 [6] ocenila, da je v sestavi končnega proizvoda delno depolimerizirana guma guar zelo podobna naravni gumi guar.
It also concluded that partially depolymerised guar gum is of no safety concern for its use as thickener, emulsifier or stabiliser.
Prav tako je ocenila, da se delno depolimerizirana guma guar lahko varno uporablja kot sredstvo za zgoščevanja, emulgator ali stabilizator.
However, in the same opinion, EFSA recommended that the specifications for E412 guar gum should be adjusted to take into account the increased level of salts and the possible presence of undesirable by-products that may result from the manufacturing process.
Vendar je EFSA v istem mnenju priporočila, da je treba spremeniti specifikacije za E 412 gumo guar, da se upošteva višjo vrednost soli in morebitno prisotnost neželenih stranskih proizvodov zaradi postopka izdelave.
On the basis of the recommendations issued by EFSA, the specifications of guar gum should be amended.
Specifikacije za gumo guar je zato treba na podlagi priporočila EFSA spremeniti.
It is necessary to adopt specifications for E504(i) magnesium carbonate authorised as a food additive for use in foodstuffs through Directive 95/2/EC.
Spremeniti je treba specifikacije za E 504(i) magnezijev karbonat, z Direktivo 95/2/ES odobren kot aditiv za živila za uporabo v živilih.
On the basis of data provided by the European Lime Association, it appears that the manufacturing of lime products from available raw materials does not permit them to comply with the existing purity criteria set for E526 calcium hydroxide and E529 calcium oxide, as regards the level of magnesium and alkali salts.
Podatki, ki jih je predložila Evropska zveza za apno (European Lime Association), kažejo, da pri izdelavi apnenih proizvodov iz razpoložljivih surovin ni možno izpolnjevati obstoječih meril čistosti za E 526 kalcijev hidroksid in E 529 kalcijev oksid glede vrednosti magnezija in bazičnih soli.
Taking into account that magnesium salts are of no safety concern and the specifications as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (hereafter JECFA), it is appropriate to adjust the levels of magnesium and alkali salts for E526 calcium hydroxide and E529 calcium oxide to the lowest achievable values, which remain lower or equal to the levels set by JECFA.
Ob upoštevanju varnosti magnezijevih soli in specifikacij iz Codexa Alimentariusa, ki ga je oblikoval skupni znanstveni odbor Organizacije ZN za prehrano in kmetijstvo in Svetovne zdravstvene organizacije o aditivih za živila (v nadaljnjem besedilu: JECFA), je primerno spremeniti vrednosti magnezija in bazičnih soli za E 526 kalcijev hidroksid in E 529 kalcijev oksid na najnižjo dosegljivo vrednost, ki je nižja ali enaka tisti, ki jo je določil JECFA.
In addition, it is necessary to take into account the specifications as set out in the Codex Alimentarius drafted by JECFA with regard to the level of lead for E526 calcium hydroxide and E529 calcium oxide.
Poleg tega je treba upoštevati specifikacije iz Codexa Alimentariusa, ki ga je oblikoval JECFA, glede vrednosti svinca za E 526 kalcijev hidroksid in E 529 kalcijev oksid.
However, due to the natural high background of lead contained in the raw material (calcium carbonate) extracted in some Member States, and from which those additives are derived, it appears difficult to align the level of lead contained in those food additives with the upper limit of lead set by JECFA.
Vendar je zaradi naravne vsebnosti svinca v surovinah (kalcijev karbonat), pridobljenih v nekaterih državah članicah in iz katerih se pridobivajo navedeni aditivi, težko uskladiti vrednost svinca v navedenih aditivih za živila z mejno vrednostjo, ki jo je določil JECFA.
Therefore the current level of lead should be reduced to the lowest achievable threshold.
Zato je treba trenutno raven svinca znižati na najnižjo dosegljivo vrednost.
E 901 beeswax is authorised as a food additive in Directive 95/2/EC.
V Direktivi 95/2/ES je E 901 čebelji vosek odobren kot aditiv za živila.
EFSA in its opinion of 27 November 2007 [7] confirmed the safety in use of this food additive.
EFSA je v mnenju z dne 27. novembra 2007 [7] potrdila varnost uporabe tega aditiva za živila.
However, it also indicated that the presence of lead should be restricted to the lowest possible level.
Vendar je prav tako navedla, da je treba omejiti prisotnost svinca na najnižjo možno vrednost.
Taking into account the revised specifications for beeswax as set out in the Codex Alimentarius as drafted by JECFA, it is appropriate to amend the existing purity criteria for E901 beeswax in order to lower the maximum permitted level of lead.
Ob upoštevanju revidiranih specifikacij za čebelji vosek iz Codexa Alimentariusa, ki ga je oblikoval JECFA, je primerno spremeniti obstoječa merila čistosti za E 901 čebelji vosek, da se zmanjša najvišja dovoljena vrednost svinca.
Highly refined waxes deriving from synthetic hydrocarbon feedstock (synthetic waxes) and from petroleum based feedstock were jointly evaluated by the Scientific Committee on Food (hereinafter SCF) [8] and an opinion on mineral and synthetic hydrocarbons was issued on 22 September 1995.
Znanstveni odbor za hrano (v nadaljnjem besedilu: SCF) [8] je ocenil visokorafinirane voske iz sintetičnih ogljikovodikovih surovin (sintetični voski) in naftnih surovin in 22. septembra 1995 izdal mnenje o mineralnih in sintetičnih ogljikovodikih.
The SCF considered that sufficient data had been provided to allocate a full group ADI (acceptable daily intake), covering both types of waxes, i.e. waxes deriving from petroleum based or synthetic hydrocarbon feed stocks.
SCF je menil, da so bili predloženi zadostni podatki za dodelitev celotne skupine ADI (sprejemljivega dnevnega vnosa) za obe skupini voskov, tj. voskov iz naftnih ali sintetičnih ogljikovodikovih surovin.
When purity criteria for E905 microcrystalline wax were established, the synthetic hydrocarbon waxes were omitted and not included in the specifications.
Pri določitvi meril čistosti za E 905 mikrokristalinični vosek niso bili določeni sintetični ogljikovodikovi voski in niso bili vključeni med specifikacije.
The Commission considers it therefore necessary to amend the purity criteria for E905 microcrystalline wax in order to also cover waxes derived from synthetic hydrocarbon feedstocks.
Zato Komisija meni, da je treba spremeniti merila čistosti za E 905 mikrokristalinični vosek, da se vključi voske iz sintetičnih ogljikovodikovih surovin.
(biphenyl) and E233 (thiabendazole) are no longer permitted as food additives in the EU legislation.
E 230 (bifenil) in E 233 (tiabendazol) nista več dovoljena kot aditiva za živila v zakonodaji EU.
These substances have been removed respectively by Directive 2003/114/EC and Directive 98/72/EC.
Bifenil je bil umaknjen z Direktivo 2003/114/ES, tiabendazol pa z Direktivo 98/72/ES.
Consequently, the Annex I to Directive 2008/84/EC should be updated accordingly and the specifications to E230 and E233 should be withdrawn.
Zato je treba Prilogo I k Direktivi 2008/84/ES ustrezno posodobiti in specifikacije za E 230 in E 233 črtati.
It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius drafted by the JECFA.
Upoštevati je treba specifikacije in analitske tehnike za aditive iz Codexa Alimentariusa, ki ga je oblikoval JECFA.
In particular where appropriate, the specific purity criteria need to be adapted to reflect the limits for individual heavy metals of interest.
Zlasti je treba, kadar je to primerno, spremeniti posebna merila čistosti, da izražajo meje za posamezne zadevne težke kovine.
Directive 2008/84/EC should therefore be amended accordingly.
Direktivo 2008/84/ES je zato treba ustrezno spremeniti.
The Annex I to Directive 2008/84/EC is amended in accordance with the Annex to this Directive.
Priloga I k Direktivi 2008/84/ES se spremeni v skladu s Prilogo k tej direktivi.
Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on a request from the Commission related to use of formaldehyde as a preservative during the manufacture and preparation of food additives; Question No EFSA Q-2005-032.http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620766610.htm
Mnenje Znanstvenega odbora o aditivih za živila, aromah, pomožnih tehnoloških sredstvih in materialih za stik z živili (AFC) na zahtevo Komisije glede uporabe formaldehida kot konzervansa pri izdelavi in pripravi aditivov za živila; vprašanje št. EFSA-Q-2005-032.http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620766610.htm