natgillin/translations-raw huggingface dataset:
When there is an indication of sequence homology or structure similarities, an important procedure for assessing the potential that exposure to the newly expressed proteins might elicit an allergic reaction in individuals already sensitised to cross-reactive proteins, is based on in vitro tests that measure the capacity of specific IgE from serum of allergic patients to bind the test protein(s).
Kadar obstaja znak za homologijo zaporedja ali podobnost strukture, temelji pomemben postopek za ocenjevanje možnosti, da bi izpostavljenost novoizraženim beljakovinam lahko sprožila alergični odziv pri posameznikih, ki so že senzibilizirani na navzkrižno reaktivne beljakovine, na testih in vitro, ki merijo zmogljivost specifičnega IgE iz seruma alergičnih pacientov, da se veže na testne beljakovine.
There is inter-individual variability in the specificity and affinity of the human IgE response.
Med posameznimi ljudmi obstajajo razlike v specifičnosti in afiniteti odziva IgE.
In particular, the specificity of the IgE antibodies to the different allergens present in a given food/source and/or to the different epitopes present on a given protein may vary amongst allergic individuals.
Zlasti specifičnost protiteles IgE za različne alergene, navzoče v zadevnem živilu/viru in/ali različnih epitopih, navzočih v zadevni beljakovini, se lahko med alergičnimi posamezniki zelo razlikuje.
In order to optimise the sensitivity of the test, individual sera from well-characterised allergic individuals shall be used.
Da bi optimizirali občutljivost testa, se uporabijo posamezni serumi iz zelo značilnih alergičnih posameznikov.
The applicant shall perform specific serum screening in the following cases:
Vlagatelj opravi presejanje specifičnih serumov ko:
the source of the introduced gene is considered allergenic, even if no sequence homology of the newly expressed protein to a known allergen is demonstrated; or
se vir uvedenega gena šteje za alergen, čeprav ni dokazane homologije zaporedja novoizražene beljakovine za znan alergen, ali
the source is not known to be allergenic, but there are indications of a relationship between the newly expressed protein and a known allergen, based on sequence homology or structure similarity.
za vir ni znano, da bi bil alergen, vendar obstajajo znaki zveze med novoizraženo beljakovino in znanim alergenom na podlagi homologije zaporedja ali podobnosti strukture.
Specific serum screening shall be undertaken with individual sera from individuals with a proven and well-characterised allergy to the source or to the potentially cross-reacting allergen using relevant immunochemical tests.
Presejanje za specifični serum se opravi za posamezne serume iz posameznikov z dokazano ali zelo značilno alergijo na vir ali za morebitni navzkrižno reaktivni alergen z ustreznimi imunokemijskimi testi.
IgE-binding assays (such as Radio or Enzyme Allergosorbent Assay (RAST or EAST), Enzyme Linked Immunosorbent Assay (ELISA) and electrophoresis followed by immunoblotting with specific IgE-containing sera) are adequate methods.
Primerne metode so analize vezanega IgE (kot so radijski ali encimski alergosorbentni test (RAST ali EAST), encimski imunski test (ELISA) in elektroforeza, ki ji sledi metoda imunoblot s specifičnim serumom, ki vsebuje IgE).
Pepsin resistance and in vitro digestibility tests
Test odpornosti na pepsin in testi prebavljivosti in vitro
Stability to digestion by proteolytic enzymes has long been considered a characteristic of allergenic proteins.
Odpornost na razgradnjo s proteolitičnimi encimi je dolgo veljala za značilnost alergenih beljakovin.
Although it has been established that no absolute correlation exists, resistance of proteins to pepsin digestion is an additional criterion to be considered in the weight-of-evidence approach for the assessment of allergenicity.
Čeprav je bilo ugotovljeno, da ne obstaja nobena absolutna povezava, je odpornost beljakovin na razgradnjo s pepsinom dodatno merilo, ki se upošteva pri oceni alergenosti v pristopu na podlagi teže dokazov.
The pepsin resistance test is generally performed under quite standardised conditions, at low pH values and high pepsin:protein ratios.
Test odpornosti na pepsin se ponavadi izvede v povsem standardiziranih razmerah, pri nizkih vrednostih pH in visokih razmerjih med pepsinom in beljakovino.
It is recognised that the pepsin resistance test does not reflect the physiological conditions of the digestion.
Potrjeno je, da test odpornosti na pepsin ne izraža fizioloških pogojev prebave.
The digestibility of the newly expressed proteins in specific segments of the population, such as infants and individuals with impaired digestive functions, may be assessed using in vitro digestibility tests using different conditions.
Prebavljivost novoizraženih beljakovin v posebnih segmentih prebivalstva, kot so dojenčki in posamezniki z oslabljenimi prebavnimi funkcijami, se lahko oceni s testi prebavljivosti in vitro v različnih pogojih.
Also, since the protein encoded by the newly introduced genes will be present in the product as a complex matrix, the impact of the possible interaction between the protein and other components of the matrix, as well as the effects of the processing, shall be taken into account in additional in vitro digestibility tests.
Ker je beljakovina, kodirana z novouvedenimi geni, navzoča v produktu kot sestavljena matrica, se vpliv morebitnega medsebojnega učinkovanja med beljakovino in drugimi sestavinami v matrici, pa tudi učinki obdelave, upoštevajo tudi v dodatnih testih prebavljivosti in vitro.
Depending on the outcome of the in vitro digestibility test, a comparison of the intact, the heat-denatured and the pepsin-digested proteins for IgE binding shall be assessed since an altered digestibility may impact on the allergenicity of the newly expressed protein.
Odvisno od rezultata testa prebavljivosti in vitro se oceni primerjava intaktnih, toplotno denaturiranih in s pepsinom razgrajenih beljakovin glede vezave na IgE, ker lahko spremenjena prebavljivost vpliva na alergenost novoizražene beljakovine.
Additional tests
Dodatni testi
Although additional tests including in vitro cell based assays or in vivo tests on animal models have not been validated to date for regulatory purposes, they may provide useful additional information, for example, on the potential of the newly expressed protein for de novo sensitisation.
Čeprav dodatni testi, ki vključujejo analizo in vitro, ali testi na živalih do zdaj niso bili validirani v regulativne namene, lahko priskrbijo uporabne dodatne informacije, na primer o možnosti novoizražene beljakovine za senzibilizacijo de novo.
Assessment of allergenicity of the genetically modified food or feed
1.5.2 Ocena alergenosti gensko spremenjenega živila ali krme
When the recipient plant is known to be allergenic, the applicant shall assess any potential change in the allergenicity of the genetically modified food or feed by comparison of the allergen repertoire with that of its conventional counterpart.
Kadar je znano, da je prejemna rastlina alergena, vlagatelj oceni morebitno spremembo alergenosti gensko spremenjenega živila ali krme s primerjavo zbirke alergenov z alergeni v podobni konvencionalni vrsti.
The potential over-expression of natural endogenous allergen(s) in the genetically modified plant shall, in particular, be investigated.
Zlasti je treba raziskati morebitno preveliko izraženost naravnega endogenega alergena v gensko spremenjeni rastlini.
The applicant shall follow a case-by-case approach depending on the available information on the allergenic potential of the recipient plant.
Vlagatelj uporabi za vsak primer drugačen pristop, odvisno od razpoložljivih informacij o alergenem potencialu prejemne rastline.
It is generally performed by analytical methodologies such as proteomics in association with the use of allergic human sera as probes.
Ponavadi se izvedejo analitične metodologije, kot je proteomika, v povezavi z alergijskimi človeškimi serumi, ki se uporabijo kot sonde.
Sera from clinically well-characterised allergic individuals that are the reference material for IgE binding studies may be available in limited number and quantity.
Serumi iz klinično zelo značilnih alergičnih posameznikov, ki so referenčni material za študije o vezavi na IgE, so morda na voljo v omejenem številu in količini.
In order to minimise the use of human sera, preliminary important information on the likelihood of an unintended alteration of the overall allergenicity of the genetically modified plant can be obtained by using sera of animals experimentally sensitised in well-defined conditions and by including relevant identified endogenous allergens in the comparative compositional analysis.
Da bi čim bolj zmanjšali uporabo človeških serumov, se lahko pomembne predhodne informacije o verjetnosti nenamerne spremembe celotne alergenosti gensko spremenjene rastline pridobijo z uporabo serumov živali s poskusno povečano občutljivostjo v dobro opredeljenih pogojih in z vključitvijo ustreznih ugotovljenih endogenih alergenov v primerjalno analizo sestave.
In addition, the applicant shall provide, where available, information on the prevalence of allergy in persons working with, coming into contact with or in the vicinity of genetically modified plant cultivation.
Poleg tega vlagatelj, kadar je mogoče, zagotovi informacije o razširjenosti alergije pri osebah, ki delajo z gensko spremenjeno rastlino ali prihajajo v stik z njo ali pa se rastlina prideluje v njihovi bližini.
Adjuvanticity
1.5.3 Sposobnost povečanja imunskega odziva
Adjuvants are substances that, when co-administered with an antigen, increase the immune response to the antigen and therefore might increase as well the allergic response.
Adjuvansi so snovi, ki takrat, ko so dane skupaj z antigenom, povečajo imunski odziv na antigen, zato lahko povečajo tudi alergični odziv.
In cases when known functional aspects of the newly expressed protein or structural similarity to known strong adjuvants may indicate possible adjuvant activity, the applicant shall assess the possible role of these proteins as adjuvants.
Ko lahko znani funkcionalni vidiki novoizražene beljakovine ali strukturna podobnost z znanimi močnimi adjuvansi kaže na morebitno adjuvantno dejavnost, vlagatelj oceni možnost, da imajo te beljakovine vlogo adjuvansov.
As for allergens, interactions with other constituents of the food matrix and/or processing may alter the structure and bioavailability of an adjuvant and thus modify its biological activity.
Kar zadeva alergene, lahko medsebojno učinkovanje z drugimi sestavinami v prehranski matrici in/ali obdelava spremenita strukturo in biološko razpoložljivost adjuvansa in s tem spremenita njegovo biološko dejavnost.
The conclusion of the allergenicity assessment shall indicate:
V sklepni ugotovitvi ocene alergenosti se navede:
whether the novel protein(s) is likely to be allergenic;
ali je verjetno, da je nova beljakovina alergena;
whether the genetically modified food or feed is likely to be more allergenic than its conventional counterpart.
ali je verjetno, da je gensko spremenjeno živilo ali krma bolj alergeno kot njegova podobna konvencionalna vrsta.
When there is a likelihood of increased allergenicity due to the genetic modification, the genetically modified food or feed shall be further characterised in the light of its anticipated intake (see Section 2).
Kadar obstaja verjetnost povečane alergenosti zaradi genske spremembe, se gensko spremenjena živila ali krma nadalje opredelijo glede pričakovanega vnosa (glej oddelek 2).
The applicant shall propose appropriate conditions for placing on the market (such as post-market monitoring and labelling).
Vlagatelj predlaga ustrezne razmere za dajanje na trg (na primer spremljanje in označevanje po dajanju na trg).
Objectives of the nutritional assessment
1.6.1 Cilji ocene hranilne vrednosti
The applicant shall provide a nutritional evaluation to demonstrate that:
Vlagatelj predloži oceno hranilne vrednosti, ki dokaže, da:
the introduction of the genetically modified food and feed into the market is not nutritionally disadvantageous to humans and animals, respectively.
uvedba gensko spremenjenih živil in krme na trg ni prehransko neugodna za ljudi in živali.
This evaluation shall include the relevance for the nutrition of newly expressed proteins, other new constituents, and changes in the levels of food and feed constituents, as well as potential alterations in the total diet of the consumer or the animal;
Ta ocena vključuje sklicevanje na hranilno vrednost novoizraženih beljakovin, drugih novih sestavin ter sprememb ravni sestavin živil in krme, pa tudi morebitne spremembe v skupni prehrani potrošnika ali živali;
unintended effects of the genetic modification that were identified or that may be assumed to have occurred based on the preceding molecular, compositional or phenotypic analyses, in accordance with Sections 1.2 and 1.3, have not adversely affected the nutritional value of the genetically modified food and feed.
nenamerni učinki genske spremembe, ki so ugotovljeni na podlagi predhodnih primerjalnih analiz molekul, sestave ali fenotipa v skladu z oddelkoma 1.2 in 1.3 ali se lahko predvideva, da so se pojavili, niso škodljivo vplivali na hranilno vrednost gensko spremenjenih živil in krme.
For stacked transformation events combined by conventional crossing, an assessment of the potential changes in nutritional value that might arise from synergistic or antagonistic effects of the gene products including compositional changes shall be provided by the applicant.
Za transformacijske dogodke z nalaganjem v kombinaciji s konvencionalnim križanjem vlagatelj predloži oceno morebitnih sprememb hranilne vrednosti, ki lahko izhajajo iz sinergijskih ali nasprotnih učinkov genskih proizvodov, vključno s spremembami sestave.
This may be particularly relevant where the combined expression of the newly introduced genes has unexpected effects on biochemical pathways.
To je morda posebno primerno, kadar ima kombinirano izražanje novouvedenih genov nepričakovane učinke na biokemijske poti.
Points to consider for the nutritional assessment of genetically modified food and feed
1.6.2 Točke za upoštevanje pri oceni hranilne vrednosti gensko spremenjenih živil in krme
The nutritional assessment of genetically modified food and feed shall consider:
Ocena hranilne vrednosti gensko spremenjenih živil in krme upošteva:
the composition of the genetically modified food and feed with regard to the levels of nutrients and anti-nutrients (see compositional studies as described in Section 1.3);
sestavo gensko spremenjenih živil in krme glede na stopnje hranilnih in protihranilnih snovi (glej študije sestave, opisane v oddelku 1.3);
the bioavailability and biological efficacy of nutrients in the food and feed taking into account the potential influences of transport, storage and expected treatment of the food and feed;
biološko razpoložljivost in biološko učinkovitost hranilnih snovi v živilih in krmi ob upoštevanju morebitnih vplivov prevoza, shranjevanja in pričakovanega ravnanja z živili in krmo;
the anticipated dietary intake of the food and feed (see Section 2) and resulting nutritional impact.
pričakovani vnos živil in krme z zaužitjem (glej oddelek 2) in posledični vpliv na hranilno vrednost.
When the comparative analysis has identified compositional characteristics of the genetically modified food and feed that are different from its conventional counterpart and/or not equivalent to the characteristics of the reference varieties, their nutritional relevance shall be assessed on the basis of current scientific knowledge.
Kadar so s primerjalno analizo ugotovljene značilnosti sestave gensko spremenjenih živil in krme, ki so drugačne od podobne konvencionalne vrste in/ali niso enakovredne značilnostim referenčnih sort, se njihova prehranska ustreznost oceni na podlagi sedanjih znanstvenih spoznanj.
If that assessment does conclude to the nutritional equivalence between the genetically modified food and feed and its conventional counterpart, no further studies shall be carried out.
Če je sklepna ugotovitev te ocene, da obstaja med gensko spremenjenimi živili in krmo ter podobno konvencionalno vrsto prehranska enakovrednost, se nadaljnje študije ne izvajajo.
By contrast if, on the basis of the assessment of the information obtained from the comparative analysis, it is not possible to conclude on the nutritional equivalence, further nutritional studies shall be carried out.
Nasprotno pa se nadaljnje prehranske študije izvedejo, če prehranske enakovrednosti ni mogoče ugotoviti na podlagi ocene informacij, pridobljenih iz primerjalne ocene.
Comparative growth studies shall be conducted with young rapidly growing animal species (such as broiler chicks as animal model for non-ruminants; lambs for ruminants; or other rapidly growing species).
Primerjalne študije rasti se izvedejo na mladih, hitro rastočih živalskih vrstah (na primer na brojlerskem piščancu kot modelu živali za neprežvekovalce in jagnjetih za prežvekovalce ali na drugih hitro rastočih vrstah).
Nutritional studies of genetically modified food
1.6.3 Prehranske študije gensko spremenjenih živil
The applicant shall determine the necessity and design of nutritional studies on the basis of the introduced trait(s), the outcome of the comparative analysis, and of the 90-day feeding study, where available.
Vlagatelj odloči o nujnosti in načrtu prehranskih študij na podlagi vnesenih lastnosti, rezultata primerjalne analize in 90-dnevne študije o krmljenju, če je na voljo.
Supplementary information regarding the nutritional value may be obtained from comparative growth performance studies conducted with other animal species, such as broiler chickens, addressing the nutritional assessment of genetically modified feed.
Dodatne informacije o hranilni vrednosti se lahko pridobijo iz primerjalnih študij rasti, ki so bile opravljene na drugih živalskih vrstah, na primer brojlerskih piščancih, in ki obravnavajo oceno hranilne vrednosti gensko spremenjene krme.
When nutritional studies are conducted, the control diet(s) shall include the conventional counterpart and where appropriate additional comparator(s).
Pri izvajanju prehranskih študij vključuje kontrolna prehrana podobne konvencionalne vrste in, kjer je primerno, dodatne primerjalne vrste.
Genetically modified foods modified to provide additional health benefits to the consumer as compared to conventional foods, may benefit specific populations or subpopulations while others may be at risk from the same food.
Gensko spremenjena živila, spremenjena tako, da bi zagotavljala dodatne koristi za zdravje potrošnika v primerjavi s podobnimi konvencionalnimi živili, so lahko za posebne skupine ali podskupine prebivalstva koristne, za druge pa lahko isto živilo pomeni tveganje.
In cases where an altered bioavailability needs to be established and may raise concern for subpopulation(s), the level of the nutrient in the food shall be determined, taking into account all the different forms of the compound.
Ko je treba vzpostaviti spremenjeno biološko razpoložljivost in lahko to zbuja pomisleke za podskupine prebivalstva, je treba določiti raven hranilne snovi v živilu ob upoštevanju vseh različnih oblik snovi.
The methods to test for bioavailability shall be selected on a case-by-case basis depending on the nutrient or other constituent, the food containing these constituents, as well as the health, nutritional status and dietary practices of the specific population(s) anticipated to consume the food.
Metode za testiranje biološke razpoložljivosti se izberejo za vsak primer posebej, odvisno od hranilne snovi ali drugih sestavin, živil, ki vsebujejo to hranilno snov, pa tudi zdravja, stanja prehranjenosti in vrste prehrane posebnih skupin prebivalstva, za katere se pričakuje, da bodo uživali živilo.
Nutritional studies of genetically modified feed
1.6.4 Prehranske študije gensko spremenjene krme
The applicant shall determine the necessity and design of further nutritional studies on the basis of the introduced trait(s), the outcome of the comparative analysis, and the 90-day feeding study, where available.
Vlagatelj odloči o nujnosti in načrtu dodatnih prehranskih študij na podlagi vnesenih lastnosti, rezultata primerjalne analize in 90-dnevne študije o krmljenju, kadar je ta na voljo.
In the case of genetically modified feed with improved nutritional characteristics, feeding studies with target animal of food producing species shall be conducted to assess the impact on the feed.
Pri gensko spremenjeni krmi z izboljšanimi hranilnimi značilnostmi se opravijo študije o krmljenju s ciljnimi živalskimi vrstami za proizvodnjo živil, da se oceni vpliv krme.
In the case of genetically modified plants modified for improved content and bioavailability of nutrients, studies with target food producing animal species shall be conducted to determine the bioavailability of individual nutrients in the genetically modified plant compared to its conventional counterpart.
Pri gensko spremenjenih rastlinah, spremenjenih zaradi izboljšanja vsebnosti in biološke razpoložljivosti hranilnih snovi, se izvedejo študije s ciljnimi živalskimi vrstami za proizvodnjo živil, da se določi biološka razpoložljivost posameznih hranilnih snovi v gensko spremenjeni rastlini v primerjavi s podobno konvencionalno vrsto.
In the case of genetically modified plants specifically modified with traits to enhance animal performance through increased nutrient density (such as increased oil content) or an enhanced level of a specific nutrient (such as an essential amino acid or a vitamin), an appropriate control diet using its conventional counterpart shall be formulated by supplementing it with the specific nutrient to the extent of the change effected in the genetically modified plant.
Pri gensko spremenjenih rastlinah, ki so posebej spremenjene z lastnostmi za povečanje proizvodnosti živali s povečanjem hranilne gostote (na primer povečana vsebnost olja) ali s povečanjem določene hranilne snovi (na primer esencialne aminokisline ali vitamina), se ustrezna kontrolna prehrana s podobno konvencionalno vrsto oblikuje tako, da se dopolni s posebno hranilno snovjo v obsegu spremembe, dosežene v gensko spremenjeni rastlini.
Regarding co-products (such as oilseeds meals), from which the ingredient targeted by the genetic modification has been extracted, these may be compared with co-products produced from the conventional counterpart.
Stranski proizvodi (kot so obroki iz oljnih semen), iz katerih je pridobljena ciljna sestavina genske spremembe, se lahko primerjajo s stranskimi proizvodi, proizvedenimi iz podobne konvencionalne vrste.
Target animal feeding studies shall span either the growing and/or finishing period to slaughter for chickens, pigs, and cattle for fattening or a major part of a lactation cycle for dairy cows, or laying cycle for laying hens or quails.
Študije o krmljenju ciljnih živali zajemajo bodisi obdobje rasti in/ali končne faze do zakola za piščance, svinje in govedo za pitanje bodisi glavni del laktacijskega cikla za krave molznice ali nesni cikel za kokoši ali prepelice nesnice.
For feedstuffs intended only for aquaculture, growth studies with aquatic species such as carp, catfish, salmonidae or typical herbivores shall be chosen.
Za krmo, namenjeno le za akvakulturo, se izberejo študije rasti na vodnih vrstah, kot so krap, ostrigar, salmonidi ali tipične rastlinojede živali.
When appropriate, tests with various experimental designs shall be provided to demonstrate that the nutritionally improved genetically modified plant fulfils the expected nutritional value.
Kadar je primerno, se zagotovijo testi z različnimi načrti poskusa, da bi dokazali, da hranilno izboljšana gensko spremenjena rastlina izpolnjuje pričakovano hranilno vrednost.