natgillin/translations-raw huggingface dataset:
no ADI allocated (applicable to substances for which the available information is not sufficient to establish their safety).
ADI ni dodeljen (uporablja se za snovi, pri katerih razpoložljive informacije ne zadoščajo za določitev njihove varnosti).
If the use level as for the feed additive is similar to that used in food, the safety for target species can be assessed based on the in vivo toxicological data available, a consideration of chemical structure and the metabolic capacity of the target species.
Če je raven uporabe za krmni dodatek podobna ravni uporabe dodatka v živilih, se lahko varnost za ciljno vrsto oceni na podlagi razpoložljivih toksikoloških podatkov in vivo ob upoštevanju kemične strukture in presnovne zmogljivosti ciljne vrste.
If the use level in feed is considerably higher than the corresponding use in food, a tolerance study in the target animal may be required, depending on the nature of the substance.
Če je raven uporabe v krmi znatno večja od ustrezne uporabe v živilih, je morda glede na naravo snovi potrebna študija o toleranci na ciljni živali.
If the use as a feed additive results in a higher consumer exposure, or to a different pattern of metabolites than that resulting from use in food, then further toxicological and residue data will be required.
Če uporaba dodatka kot krmnega dodatka povzroči večjo izpostavljenost potrošnikov ali vzorec metabolitov, drugačen od vzorca, ki nastane zaradi uporabe v živilih, bodo potrebni dodatni podatki o toksičnosti in ostankih.
Food additives for which an ADI is not specified
Živilski dodatki, za katere ADI ni opredeljen
Assessment of the safety for consumers is not required, except when the use of the additive in feed leads to a different pattern of metabolites than when used in food.
Ocena varnosti za potrošnike ni potrebna, razen kadar uporaba dodatka v krmi povzroči vzorec metabolitov, ki se razlikuje od vzorca metabolitov pri uporabi dodatka v živilih.
Food additives with an established ADI or UL
Živilski dodatki z določenim ADI ali UL
Consumer safety must be assessed taking into consideration the additional exposure from feed use, or specific exposure related to metabolites arising from the target species.
Pri oceni varnosti za potrošnika je treba upoštevati dodatno izpostavljenost zaradi uporabe v krmi ali posebno izpostavljenost, povezano z metaboliti, ki izhaja iz ciljne vrste.
This can be done by extrapolating residue data from literature.
To se lahko stori z ekstrapolacijo podatkov o ostankih iz literature.
Where residue studies are necessary, the requirement is limited to a comparison of the tissue or product levels in an untreated group to the group supplemented with the highest dose that is claimed.
Kadar so potrebne študije o ostankih, je zahteva omejena na primerjavo ravni v tkivih ali proizvodih pri skupini brez dodatka in skupini, ki je prejela največji zahtevani odmerek.
Food additives for which no ADI is allocated
Živilski dodatki, za katere ADI ni dodeljen
The reasons why an ADI was not allocated shall be clearly specified.
Jasno se navedejo razlogi, zakaj ni bil dodeljen ADI.
If concerns arise from this, and the use of the additive in feed would contribute to a significant increase in consumer exposure, a full toxicological evaluation is required.
Če to povzroča zaskrbljenost in bi uporaba dodatka v krmi prispevala k znatnemu povečanju izpostavljenosti potrošnikov, je potrebna celotna ocena toksičnosti.
Additional exposure from feed use can be extrapolated from residue data from the literature.
Dodatna izpostavljenost zaradi uporabe v krmi se lahko ekstrapolira s podatkov o ostankih iz literature.
Where residue studies are necessary, the requirement is limited to a comparison of the levels in tissues or products in an untreated group with the group supplemented with the highest dose that is claimed.
Kadar so potrebne študije o ostankih, je zahteva omejena na primerjavo ravni v tkivih ali proizvodih pri skupini brez dodatka in skupini, ki je prejela največji zahtevani odmerek.
The whole of the subsection 3.3 of Annex II applies.
Uporablja se celoten pododdelek 3.3 Priloge II.
Precautionary measures set for handling these substances used in food shall be taken into account when considering user safety for the feed additive.
Pri proučitvi varnosti krmnega dodatka za uporabnika se upoštevajo previdnostni ukrepi za ravnanje s temi snovmi, ki se uporabljajo v živilih.
Subsection 3.4 of Annex II is required.
Potreben je pododdelek 3.4 Priloge II.
Where the function requested for feed is the same as that used in food, no further demonstration of efficacy might be necessary.
Kadar je zahtevana funkcija za krmo enaka funkciji za živila, dodatno dokazovanje učinkovitosti morda ni potrebno.
Otherwise the requirements for efficacy are as those shown in Section IV of Annex II.
V drugih primerih so zahteve za učinkovitost enake zahtevam iz oddelka IV Priloge II.
MODIFICATION OF THE AUTHORISATIONS
SPREMEMBA DOVOLJENJ
Since reliance can be placed on the evaluation of the data supplied for previous authorisations, a dossier prepared for an application under Article 13(3) of Regulation (EC) No 1831/2003 needs to comply only with the requirements listed below.
Ker se lahko ocena podatkov, predložena za prejšnja dovoljenja, šteje za zanesljivo, mora dokumentacija, ki se pripravi za vlogo v skladu s členom 13(3) Uredbe (ES) št. 1831/2003, izpolnjevati le spodaj navedene zahteve.
An application for modification of the terms included in an existing authorisation Regulation, such as the identification, the characterisation or the conditions of use of the additive, shall demonstrate that the modification does not have any harmful effect on the target species, the consumer, the user or the environment.
Vloga za spremembo pogojev iz obstoječe uredbe o dovoljenjih, kot je identifikacija, opis lastnosti ali pogoji uporabe dodatka, dokazuje, da sprememba ne vpliva škodljivo na ciljno vrsto, potrošnika, uporabnika ali okolje.
An additive can be considered as identical for this purpose if the active substance(s) or agent(s) and the conditions of use are the same, its purity is essentially similar and no new components of concern have been introduced.
Dodatek se za ta namen šteje za enakega, če so aktivne snovi ali sredstva in pogoji uporabe enaki, če je njegova čistost bistveno podobna in niso uvedene nove sestavine, ki povzročajo zaskrbljenost.
For such products an abridged application may be submitted as it will normally not be necessary to repeat studies to demonstrate the safety for the target species, the consumer and the environment and efficacy.
Za takšne proizvode se lahko predloži skrajšana vloga, ker običajno ne bo treba ponavljati študij za dokazovanje varnosti za ciljno vrsto, potrošnika in okolje ter za dokazovanje učinkovitosti.
The application shall address the following requirements:
Vloga obravnava naslednje zahteve:
the whole of Annex I applies — this includes details of the modification requested;
uporablja se celotna Priloga I – to vključuje podrobnosti o zahtevani spremembi;
the whole of Section II of Annex II applies;
uporablja se celoten oddelek II Priloge II;
data must be provided indicating that the, chemical or biological characteristics of the additive are essentially the same to those of the established product;
predložiti je treba podatke, ki kažejo, da so kemijske ali biološke lastnosti dodatka bistveno enake lastnostim uveljavljenega proizvoda;
where appropriate, evidence for bioequivalence shall be provided either by specification, or by published literature or from specific studies.
kadar je primerno, se bioekvivalenca dokaže s specifikacijo, navedbo objavljene literature ali na podlagi posebnih študij.
Where bioequivalence is not fully demonstrated, conformity of the withdrawal period with the MRL has to be demonstrated;
Kadar bioekvivalenca ni popolnoma dokazana, je treba dokazati, da je karenca v skladu z MRL;
evidence shall be presented that in the light of current scientific knowledge that the additive remains safe under the approved conditions for target species, consumers, workers and the environment;
predložijo se dokazi, da je dodatek glede na sedanje znanstveno spoznanje pod odobrenimi pogoji še vedno varen za ciljno vrsto, potrošnike, delavce in okolje;
a report on the results of the post-market monitoring, if such monitoring requirements are included in the authorisation, shall be provided; and
predloži se poročilo o rezultatih poprodajnega nadzora, če so takšne zahteve za nadzor vključene v dovoljenje; in
the specific data supporting the request for change must be submitted in compliance with the relevant parts of Sections III, IV and V of Annex II.
v skladu z ustreznimi deli oddelkov III, IV in V Priloge II je treba predložiti posebne podatke, ki podpirajo zahtevo za spremembo.
RENEWAL OF AUTHORISATIONS
PODALJŠANJE DOVOLJENJ
Applications for renewal of authorisation under Article 14 of Regulation (EC) No.1831/2003 shall comply with the following requirements:
Vloge za podaljšanje dovoljenja v skladu s členom 14 Uredbe (ES) št. 1831/2003 izpolnjujejo naslednje zahteve:
A copy of the original Community authorisation for placing the feed additive on the market, or the last renewal of authorisation, shall be provided.
Predloži se izvod izvirnega dovoljenja Skupnosti za dajanje krmnega dodatka na trg ali zadnjega podaljšanja dovoljenja.
An updated dossier shall be prepared according to the most up-to-date requirements and a list providing all variations since the original authorisation, or the last renewal of authorisation shall be submitted.
Posodobljena dokumentacija se pripravi v skladu z najnovejšimi zahtevami in predloži se seznam vseh odstopanj od izvirnega dovoljenja ali zadnjega podaljšanja dovoljenja.
The applicant has to provide a summary of the dossier, detailing the scope of the application, and any new information that has become available since the previous authorisation/renewal in terms of identity and safety.
Vložnik mora predložiti povzetek dokumentacije, v katerem navede podrobnosti o obsegu vloge, in kakršne koli nove informacije glede identitete in varnosti, ki so na voljo od prejšnjega dovoljenja/podaljšanja.
for additives subject to a specific holder of the authorisation, the whole of the Section II applies,
za dodatke, povezane s posebnim imetnikom dovoljenja, se uporablja celoten oddelek II,
Evidence shall be presented to show that the additive has not been significantly changed or altered in composition, purity or activity in respect of the additive that was authorised.
Predložijo se dokazi, ki potrjujejo, da dodatek po svoji sestavi, čistosti ali učinkovanju ni bistveno drugačen ali spremenjen glede na dodatek, za katerega je bilo izdano dovoljenje.
Any change in the manufacturing process shall be reported.
Poroča se o kakršni koli spremembi postopka izdelave.
Evidence shall be presented that in the light of the current knowledge the additive remains safe under the approved conditions for target species, consumers, workers and the environment.
Predložijo se dokazi, ki potrjujejo, da je dodatek glede na sedanje znanje pod odobrenimi pogoji še vedno varen za ciljno vrsto, potrošnike, delavce in okolje.
A safety update for the period since the original authorisation, or the last renewal of authorisation with information on the following items shall be presented:
Za obdobje od izvirnega dovoljenja ali zadnjega podaljšanja dovoljenja se predložijo novi podatki o varnosti z informacijami o naslednjih elementih:
reports on adverse effects including accidents (previously unknown effects, severe effects of any type, increased incidence of known effects) for target animals, consumers, users and the environment.
poročila o škodljivih učinkih, vključno z nezgodami (predhodno neznani učinki, resni učinki kakršnega koli tipa, naraščajoč pojav znanih učinkov), za ciljne živali, potrošnike, uporabnike in okolje.
The report on adverse effects shall include the nature of the effect, number of affected individuals/organisms, outcome, conditions of use, and causality assessment,
Poročilo o škodljivih učinkih vključuje naravo učinka, število prizadetih posameznikov/organizmov, izid, pogoje uporabe in oceno vzrokov,
reports on previously unknown interactions and cross-contaminations,
poročila o predhodno neznanih medsebojnih vplivih in navzkrižnih onesnaženjih,
data from residue monitoring, where appropriate,
po potrebi podatki iz spremljanja ostankov,
data from epidemiologic and/or toxicological studies,
podatki iz epidemioloških in/ali toksikoloških študij,
any other information concerning the safety of the additive and risks of the additive to animals, humans, and environment.
kakršne koli druge informacije o varnosti dodatka in tveganjih zaradi dodatka za živali, ljudi in okolje.
If no further information is provided on any of these issues, the reasons for this shall be clearly identified.
Če za katerega koli od teh elementov niso navedene dodatne informacije, se za to jasno navedejo razlogi.
A report on the results of the post-market monitoring program shall be provided, if such a monitoring requirement is included in the previous authorisation.
Predloži se poročilo o rezultatih programa poprodajnega nadzora, če je takšna zahteva za nadzor vključena v prejšnje dovoljenje.
Where, as provided for in Article 14(2)(d) of Regulation (EC) No 1831/2003, the application for renewal of the authorisation includes a proposal for amending or supplementing the conditions of the original authorisation, inter alia, the conditions concerning future monitoring, the specific data supporting the proposal for amendment must be submitted in compliance with the relevant parts of Sections III, IV and V of Annex II.
Kadar vloga za podaljšanje dovoljenja v skladu s členom 14(2)(d) Uredbe (ES) št. 1831/2003 vključuje predlog za spremembo ali dopolnilo pogojev izvirnega dovoljenja, med drugim pogojev v zvezi s prihodnjim nadzorom, je treba v skladu z ustreznimi deli oddelkov III, IV in V Priloge II predložiti posebne podatke, ki podpirajo predlog spremembe.
RE-EVALUATION OF CERTAIN ADDITIVES ALREADY AUTHORISED UNDER DIRECTIVE 70/524/EEC
PONOVNA OCENA NEKATERIH DODATKOV, KI SE ŽE SMEJO UPORABLJATI V SKLADU Z DIREKTIVO 70/524/EGS
The additives concerned by this point 11 are additives which were authorised under Directive 70/524/EEC and are to be re-evaluated in accordance with Article 10(2) of Regulation (EC) No 1831/2003 and which belong to the following groups:
Dodatki, ki jih zajema točka 11, so dodatki, ki so dovoljeni v skladu z Direktivo 70/524/EGS in jih je treba ponovno oceniti v skladu s členom 10(2) Uredbe (ES) št. 1831/2003 in ki spadajo v naslednje skupine:
antioxidant substances,
antioksidanti,
flavouring and appetising substances,
aromatične snovi in snovi za spodbujanje teka,
emulsifying and stabilising substances, thickeners and gelling agents,
emulgatorji in stabilizatorji, sredstva za zgoščevanje in sredstva za želiranje,
colourants, including pigments,
barvila, vključno s pigmenti,
preservatives,
konzervansi,
vitamins, provitamins and chemically well-defined substances having similar effect,
vitamini, provitamini in kemijsko natančno opredeljene snovi s podobnim učinkom,
trace elements,
elementi v sledeh,
binder, anti-caking agents and coagulants,
vezalci, sredstva proti strjevanju in koagulanti,
acidity regulators, and
regulatorji kislosti, in
radionuclide binders.
vezalci radionuklidov.
The level and quality of risk evaluation for these additives shall be similar to other additives.
Stopnja in kakovost ocene tveganja za te dodatke je podobna kot pri drugih dodatkih.
However, due to their long history of safe use, data from studies already published may be used, under provisions provided by this Regulation, to show that the additive remains safe under the approved conditions for the target species, consumers, users and the environment.
Vendar se lahko zaradi njihove dolgotrajne pretekle varne uporabe v skladu z določbami iz te uredbe uporabijo podatki iz že objavljenih študij, da se potrdi, da je dodatek pod odobrenimi pogoji še vedno varen za ciljno vrsto, potrošnike, uporabnike in okolje.
Where an additive has been assessed for safety for target species, consumers, users/workers and the environment, a summary of the safety studies submitted for the previous authorisation, plus any new information arising since the previous authorisation shall be provided.
Kadar je dodatek ocenjen glede varnosti za ciljno vrsto, potrošnike, uporabnike/delavce in okolje, se zagotovi povzetek študij o varnosti, ki so bile predložene za prejšnje dovoljenje, skupaj s kakršnimi koli novimi informacijami, ugotovljenimi od prejšnjega dovoljenja.
Where a formal safety assessment has not been undertaken for the use of the substance as a feed additive, studies and data from the scientific literature can be used provided it is equivalent to that which would be required in a new application.
Kadar ni izvedena uradna ocena varnosti za uporabo snovi kot krmnega dodatka, se lahko uporabijo študije in podatki iz znanstvene literature, če je enaka uporabi, ki bi bila potrebna v novi vlogi.
Otherwise, a complete set of safety studies shall be provided.
V nasprotnem primeru se zagotovi celoten sklop študij o varnosti.
Where appropriate, the compliance with the requirement of efficacy provided for in Article 5(3) of Regulation (EC) No 1831/2003 may be demonstrated by submission of material other than studies, in particular relating to the long history of use.
Kadar je primerno, se lahko skladnost z zahtevo glede učinkovitosti iz člena 5(3) Uredbe (ES) št. 1831/2003 dokaže s predložitvijo materiala, ki ne vključuje študij in je povezan zlasti z dolgotrajno preteklo uporabo.
A xenobiotic is a chemical substance which is not a natural component of the organism exposed to it.
Ksenobiotična snov je kemična snov, ki ni naravna sestavina organizma, ki ji je izpostavljen.
It can also cover substances which are present in much higher concentrations than are usual.
Zajema lahko tudi snovi, ki so prisotne v veliko večji koncentraciji od običajne.
For purpose of this Regulation, ‘ensiling process’ means process by which natural deterioration of organic matter is controlled by acidification in anaerobic condition resulting from natural fermentation or/and addition of silage additives.
V tej uredbi pomeni „postopek siliranja“ postopek, s katerim se nadzoruje naravno poslabšanje organske snovi z zakisljevanjem v anaerobnih pogojih zaradi naravne fermentacije in/ali dodajanja silirnih dodatkov.
Identification number for chemically defined flavouring substances used in FLAVIS, the EU Flavour Information System, the database used within the Commission Regulation (EC) No 1565/2000 of 18 July 2000 (OJ L 180, 19.7.2000 p. 8) laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council (OJ L 299, 23.11.1996, p. 1).
Identifikacijska številka za kemijsko opredeljene aromatične snovi, ki se uporablja v informacijskem sistemu EU za aromatične snovi FLAVIS, tj. zbirki podatkov, ki se uporablja v okviru Uredbe Komisije (ES) št. 1565/2000 z dne 18. julija 2000 (UL L 180, 19.7.2000, str. 8) o določitvi ukrepov, potrebnih za sprejetje programa ocenjevanja, skladno z Uredbo Evropskega parlamenta in Sveta (ES) št. 2232/96 (UL L 299, 23.11.1996, str. 1).
CoE no.: Council of Europe number used for botanically defined flavouring products in the Council of Europe's Report no. 1 on ‘Natural sources of flavourings’, Volume I, Strasbourg, 2000 and its subsequent volumes.
Številka CoE: številka Sveta Evrope, ki se uporablja za botanično opredeljene aromatične proizvode v poročilu Sveta Evrope št. 1 z naslovom „Naravni viri aromatičnih snovi“, zvezek I, Strasbourg, 2000, in naslednji zvezki.
CAS Number (CAS No) Chemical Abstracts Service Registry Number, unique identifier for chemical substances widely used in chemical inventory listings.
Številka CAS (št. CAS): številka Službe za izmenjavo kemijskih izvlečkov, posebni identifikator za kemične snovi, ki se pogosto uporablja pri izdelavi seznamov kemičnih snovi.
For the purpose of this section of this Regulation, ‘substance of toxicological concern’ means a substance with a tolerable daily or weekly intake (TDI or TWI), an ADI, or with a restriction in its use, or an active principle as defined in Council Directive 88/388/EEC relating to flavourings for use in foodstuffs and to source materials for their production, or an undesirable substance.
V tem oddelku te uredbe „snov, ki povzroča zaskrbljenost zaradi toksikoloških lastnosti“, pomeni snov z dovoljenim dnevnim ali tedenskim vnosom (TDI ali TWI), ADI ali z omejitvijo uporabe ali učinkovino, kakor je opredeljena v Direktivi Sveta 88/388/EGS o aromah za uporabo v živilih in izhodnih surovinah za njihovo proizvodnjo, ali neželeno snov.
Defined in Appendix 4 of the Council of Europe's Report no. 1 on ‘Natural sources of flavourings’, Volume I, Strasbourg, 2000.
Opredeljeni v Dodatku 4 poročila Sveta Evrope št. 1 z naslovom „Naravni viri aromatičnih snovi“, zvezek I, Strasbourg, 2000.
JECFA (FAO/WHO, 1996, Food additive series 35, IPCS, WHO Geneva) corresponding threshold for target animal should be adjusted to take into account of animal weight and feed intake.
Ustrezni prag JECFA (FAO/SZO, 1996, Serija o živilskih dodatkih 35, Mednarodni program za kemijsko varnost – IPCS, SZO v Ženevi) za ciljno žival je treba prilagoditi, da se upoštevata teža živali in vnos krme.
OJ L 180, 19.7.2000, p. 8.
UL L 180, 19.7.2000, str. 8.
Note for guidance of the establishment of maximum residue limits for Salmonidae and other fin fish.
Navodilo za smernico o določitvi mejnih vrednosti ostankov za salmonide in druge ribe kostnice.
The European Agency for the Evaluation of Medicinal Products.
Evropska agencija za zdravila.
Categories and definitions of target animals and indication of the minimum duration of efficacy studies
Kategorije in opredelitve ciljnih živali ter navedba najkrajšega trajanja študij o učinkovitosti
Table.
Tabela.
Animal categories: Pigs
Kategorije živali: prašiči
Definition of the animal category
Opredelitev kategorije živali
Approximate duration period (weight/age)
Približno obdobje trajanja (teža/leto)
Minimum duration of long term efficacy studies
Najkrajše trajanje dolgoročnih študij o učinkovitosti
Period/age
Obdobje/starost
Piglets (suckling)
Pujski (sesni)
Young porcine animals getting milk from sows
Mladi prašiči, ki dobivajo mleko pri svinjah
From birth
Od rojstva
Up to 21-42 days
Do 21–42 dni
Up to 6-11 kg
Do 6–11 kg
Young porcine animals having completed the suckling period and being reared for reproduction or meat production
Mladi prašiči po obdobju sesanja, ki se redijo za razmnoževanje ali proizvodnjo mesa
From 21-42 days
Od 21–42 dni
Up to 120 days
Do 120 dni
Up to 35 kg
Do 35 kg
Piglets (suckling and weaned piglets)
Pujski (sesni in odstavljeni pujski)
Young porcine animal from birth being reared for reproduction or meat production purposes
Mladi prašič od rojstva, ki se redi za razmnoževanje ali proizvodnjo mesa
58 days
58 dni
Porcine animals having completed the weaning period and intended for meat production until day of transport to slaughterhouse
Prašiči po obdobju odstavljanja, ki so namenjeni za proizvodnjo mesa, do dneva prevoza v klavnico
From 60-120 days
Od 60–120 dni
Up to 120-250 days (or according to local custom)
Do 120–250 dni (ali v skladu z lokalnimi navadami)
80-150 kg (or according to local custom)
80–150 kg (ali v skladu z lokalnimi navadami)
Until slaughter weight, but not less than 70 days
Do teže za zakol, vendar najmanj 70 dni
Female porcine animals having been inseminated/mated at least once
Samice, ki so najmanj enkrat osemenjene/pripuščene
From first insemination
Od prve osemenitve
From insemination to the end of the second weaning period (two cycles)
Od osemenitve do konca drugega obdobja odstavljanja (dva cikla)
Sows, in order to have benefit in piglets
Svinje, v korist pujskov
At least two weeks before the parturition until the end of weaning period
Najmanj dva tedna pred kotitvijo do konca obdobja odstavljanja
Animal categories: Poultry
Kategorije živali: perutnina
Minimum duration of long term studies for efficacy
Najkrajše trajanje dolgoročnih študij o učinkovitosti
Birds raised for fattening
Perutnina, ki se goji za pitanje