natgillin/translations-raw huggingface dataset:
When a mixture of both chemically well-defined substances and complex ingredients is present, the above guidance also applies.
Zgoraj navedena navodila se uporabljajo tudi, kadar je prisotna zmes kemijsko natančno opredeljenih snovi in kompleksnih sestavin.
Where any fragrance (or flavour) compound comprising a mixture of fragrance (or flavour) ingredients and functional components with olfactory, odour-enhancing, odour-protecting or blending properties is formulated and intentionally added to a cosmetic product to impart a scent (or flavour) or to cover a malodour, its identification is to include the name and code number as well as the identity of the supplier.
Kadar se formulira in kozmetičnemu izdelku namerno doda kakršna koli dišavna (ali aromatična) spojina, ki je zmes dišavnih (ali aromatičnih) sestavin in funkcionalnih elementov za ustvarjanje, krepitev, ohranjanje ali mešanje vonja, da bi se izdelku zagotovila vonjava (ali aroma) ali prikril njegov neprijeten vonj, mora identifikacija te spojine vključevati ime in številko šifre ter identiteto dobavitelja.
Qualitative and quantitative information about regulated substances in the fragrance (or flavour) compound and information relevant for a safety assessment should be disclosed to the responsible person and the safety assessor, and should be included in the safety report.
Kvalitativne in kvantitativne informacije o nadzorovanih snoveh v dišavni (ali aromatični) spojini ter informacije, pomembne za oceno varnosti, je treba razkriti odgovorni osebi in ocenjevalcu varnosti ter jih vključiti v poročilo o varnosti.
The aim of that section of the cosmetic product safety report is to describe the relevant physical and chemical specifications of the substances or mixtures used and the cosmetic product itself.
Namen tega oddelka poročila o varnosti kozmetičnega izdelka je opisati ustrezne fizikalne in kemijske specifikacije uporabljenih snovi ali zmesi in samega kozmetičnega izdelka.
These specifications are crucial for an appropriate safety assessment, as they may influence the safety of a cosmetic product.
Te specifikacije so bistvene za ustrezno oceno varnosti, saj lahko vplivajo na varnost kozmetičnega izdelka.
For example, physico-chemical properties, in combination with other information, can help the safety assessor determine the need to investigate relevant toxicological parameters.
Fizikalno-kemijske lastnosti v povezavi z drugimi informacijami lahko ocenjevalcu varnosti na primer pomagajo ugotoviti, ali je treba preiskati relevantne toksikološke parametre.
In addition, the physico-chemical characteristics of the substances or mixtures and finished products set the benchmark against which the products and the raw materials can be considered acceptable from a quality point of view [6].
Poleg tega fizikalno-kemijske značilnosti snovi ali zmesi in končnih izdelkov določajo merilo, glede na katero se lahko izdelki in surovine štejejo za sprejemljive z vidika kakovosti [6].
That section of the cosmetic product safety report also requires an assessment of the stability of the cosmetic product, under reasonably foreseeable storage conditions.
V tem oddelku poročila o varnosti kozmetičnega izdelka se zahteva tudi ocena stabilnosti kozmetičnega izdelka v razumno predvidljivih pogojih shranjevanja.
The aim is to evaluate if the stability of the cosmetic product affects the safety and quality of the product, and to use the information to determine its minimum durability and period-after-opening (PAO).
Namen je oceniti, ali stabilnost kozmetičnega izdelka vpliva na njegovo varnost in kakovost, ter te informacije uporabiti za določitev njegovega minimalnega roka trajanja in obdobja po odprtju (PAO).
Physical/chemical characteristics of substances or mixtures
Fizikalne/kemijske značilnosti snovi ali zmesi
This description is to include the most relevant physico-chemical properties of each substance and mixture contained in the product, for example: chemical identification, physical form, molecular weight, solubility, partition coefficient, substance purity, other parameters relevant for the characterisation of specific substances and mixtures, and, for polymers, the average molecular weight and range.
Ta opis mora vključevati najpomembnejše fizikalno-kemijske lastnosti vsake snovi in zmesi, ki jo vsebuje izdelek, kot so: kemijska identiteta, agregatno stanje, molekulska masa, topnost, porazdelitveni koeficient, čistost snovi, drugi parametri, potrebni za opredelitev posebnih snovi in zmesi, ter v primeru polimerov, povprečna molekulska masa in razpon.
Where relevant, the particle-size distribution curve of substances should be included in the physico-chemical characteristics, especially for nanomaterials.
Kjer je to ustrezno, je treba med fizikalno-kemijske značilnosti vključiti porazdelitveno krivuljo velikosti delcev snovi, kar velja zlasti za nanomateriale.
Cosmetics manufacturers should ensure that the specifications of raw materials are properly documented by their suppliers.
Proizvajalci kozmetičnih izdelkov morajo zagotoviti, da njihovi dobavitelji ustrezno dokumentirajo specifikacije surovin.
Specifications should be available for each raw material actually used in the product.
Te morajo biti na voljo za vsako surovino, ki se dejansko uporabi v izdelku.
Based on function, additional specifications may be needed.
Glede na funkcijo so lahko potrebne dodatne specifikacije.
For UV absorbers, for instance, the absorption spectra should be provided.
Za UV-absorberje je treba na primer navesti absorpcijske spektre.
For each description of physico-chemical properties and specifications (for each substance and mixture contained in the product), the reference methods should be stated in the safety report.
Za vsak opis fizikalno-kemijskih lastnosti in specifikacij (za vsako snov in zmes, ki jo vsebuje izdelek), je treba v poročilu o varnosti navesti referenčne metode.
Physical/chemical characteristics of the finished cosmetic product
Fizikalne/kemijske značilnosti končnega kozmetičnega izdelka
This description is to contain the specifications of the finished product.
Opis mora vsebovati specifikacije končnega izdelka.
Each specification should be given with relevant limits, e.g. pH between 5.5 and 6.5.
Vsaka specifikacija mora biti podana z ustreznimi mejami, npr. pH med 5,5 in 6,5.
For each description of physico-chemical properties and specifications of the finished product, the reference methods should be stated in the cosmetic product safety report.
Za vsak opis fizikalno-kemijskih lastnosti in specifikacij končnega izdelka je treba v poročilu o varnosti kozmetičnega izdelka navesti referenčne metode.
Stability of the cosmetic product
Stabilnost kozmetičnega izdelka
As the requirement is to assess the stability of the cosmetic product under reasonably foreseeable storage conditions, if stability is dependent on storage conditions, information about these conditions should be passed on throughout the supply chain, and, if relevant for the end user, it should be indicated on the labelling of the product.
Ker se zahteva ocena stabilnosti kozmetičnega izdelka v razumno predvidljivih pogojih shranjevanja, je treba, če je stabilnost odvisna od takih pogojev, informacije o teh pogojih posredovati skozi celotno dobavno verigo in jih, če so pomembne za končnega uporabnika, navesti na označbi izdelka.
The methodology used to determine the product’s minimum durability should be described.
Opisati je treba metodologijo, ki se uporabi za določanje minimalnega roka trajanja izdelka.
Any specific preservation precautions should be mentioned.
Navesti je treba vsakršen specifičen varnostni ukrep v zvezi s konzerviranjem.
All available data used to justify the indicated minimum durability should be listed in the safety report.
V poročilu o varnosti je treba našteti vse razpoložljive podatke za utemeljitev navedenega minimalnega roka trajanja.
In order to determine the coherence of the stability study conducted, and to check the relevance of the date of minimum durability chosen for the product, the description of the tests specific to the stability study and the results of those tests should be included in the cosmetic product safety report.
Za presojanje usklajenosti izvedene študije stabilnosti in preverjanje ustreznosti minimalnega roka trajanja, izbranega za izdelek, je treba v poročilo o varnosti kozmetičnega izdelka vključiti opis posebnih preskusov za študijo stabilnosti in njihove rezultate.
In addition, the following should also be provided:
Poleg tega je treba zagotoviti:
evidence that the composition of the product used for stability testing corresponds to the product actually placed on the market;
dokaze, da sestava izdelka, uporabljenega za preskušanje stabilnosti, ustreza izdelku, ki se dejansko da na trg;
the results of the preservative efficacy study, e.g. challenge test, if applicable [7];
rezultate študije učinkovitosti konzervansov, npr. izzivnega preskusa, kadar je to potrebno [7];
when applicable, the period-after-opening (PAO) [8] and its justification.
kjer je to ustrezno, obdobje po odprtju (PAO) [8] in njegovo utemeljitev.
The SCCS has recommended that ‘relevant stability tests, adapted to the type of cosmetic product and its intended use, should be carried out. To make sure that no stability problems are induced by the type of container and packaging used, physical stability tests are currently carried out with inert containers and those intended to be used on the market.’ [9]
Kot priporoča ZOVP, bi bilo treba opraviti „ustrezne preskuse stabilnosti, ki so prilagojeni vrsti kozmetičnega izdelka in njegovi predvideni uporabi. Za zagotovitev, da uporabljena vrsta primarne in sekundarne embalaže ne povzroča težav v zvezi s stabilnostjo, se preskusi stabilnosti danes izvajajo z inertno embalažo in embalažo, ki se namerava uporabiti na trgu.“ [9]
The aim of that section of the cosmetic product safety report is to determine the acceptable microbiological specifications of the raw materials (substances or mixtures) and finished product from a microbiological point of view.
Namen tega oddelka poročila o varnosti kozmetičnega izdelka je določiti sprejemljive mikrobiološke specifikacije surovin (snovi ali zmesi) in končnega izdelka z mikrobiološkega vidika.
In accordance with Annex I to Regulation (EC) No 1223/2009, particular attention is to be paid to the microbiological specifications of cosmetic products intended to be used on sensitive body parts and on specific populations.
V skladu s Prilogo I k Uredbi (ES) št. 1223/2009 je treba posebno pozornost nameniti mikrobiološkim specifikacijam kozmetičnih izdelkov, namenjenih uporabi na občutljivih delih telesa in posebnim populacijam.
In addition, information regarding microbiological quality is essential in order to justify the effectiveness of the preservation system and justify the indicated minimum durability of the cosmetic product stored under appropriate conditions and period-after-opening (PAO) [10]of the finished product in terms of safety.
Poleg tega so informacije o mikrobiološki kakovosti bistvene za utemeljitev učinkovitosti sistema konzerviranja ter navedenega minimalnega roka trajanja kozmetičnega izdelka, shranjenega pod ustreznimi pogoji, in obdobja po odprtju (PAO) [10]končnega izdelka v smislu varnosti.
The microbiological specifications of the raw materials (substances or mixtures) and cosmetic product are to form part of the safety assessment.
Mikrobiološke specifikacije surovin (snovi in zmesi) in kozmetičnega izdelka morajo biti del ocene varnosti.
Particular attention is to be paid to the microbiological specifications of cosmetic products intended to be used around the eyes, on mucous membranes in general, on damaged skin (e.g. skin care products suitable for atopic or irritated skin), on children under three years of age, on elderly people or on persons with compromised immune responses.
Posebno pozornost je treba nameniti mikrobiološkim specifikacijam kozmetičnih izdelkov, namenjenih uporabi okoli oči, na sluznicah na splošno, na poškodovani koži (npr. izdelki za nego kože, primerni za atopično ali vneto kožo), na otrocih, mlajših od treh let, na starejših ljudeh ali osebah z zmanjšano odpornostjo.
Microbiological quality of substances and mixtures
Mikrobiološka kakovost snovi in zmesi
The main parameters for microbiological quality are the original level of contamination and the possibility of microbial growth.
Glavna parametra za mikrobiološko kakovost sta prvotna raven kontaminacije in možnost rasti mikroorganizmov.
Particular attention should be paid to the raw materials (substances and mixtures) most susceptible to microbial growth (e.g. water-based mixtures, protein-rich materials, plant or animal raw materials).
Posebno pozornost je treba nameniti surovinam (snovem in zmesem), ki so najdovzetnejše za rast mikroorganizmov (npr. zmesem na vodni osnovi, snovem, bogatim z beljakovinami, surovinam rastlinskega ali živalskega izvora).
On the other hand, there are raw materials which do not support microbial growth, e.g. organic solvents.
Nasprotno pa nekatere surovine ne podpirajo rasti mikroorganizmov, npr. organska topila.
Microbiological quality of the finished cosmetic product
Mikrobiološka kakovost končnega kozmetičnega izdelka
Concerning microbiological susceptibility, there is a difference between three product categories:
Kar zadeva mikrobiološko dovzetnost, je mogoče razlikovati med tremi kategorijami izdelkov:
low microbiological risk products (e.g. products with an alcohol content > 20 %, products based on organic solvents, high/low-pH products), for which neither a preservation challenge test nor microbiological quality tests on the finished product are necessary.
izdelki z majhnim mikrobiološkim tveganjem (npr. izdelki z vsebnostjo alkohola > 20 %, izdelki na osnovi organskih topil, izdelki z visoko/nizko vrednostjo pH), za katere niso potrebni ne izzivni preskus učinkovitosti konzerviranja ne preskusi mikrobiološke kakovosti na končnem izdelku.
A scientific justification is to be provided, however;
Vendar je treba zagotoviti znanstveno utemeljitev;
single-use products, and products which cannot be opened (e.g. for which the packaging allows dosing the product without it coming in contact with the air), for which only microbiological quality tests on the finished product are necessary.
izdelki za enkratno uporabo in izdelki, ki se ne odpirajo (npr. tisti, katerih embalaža omogoča odmerjanje izdelka, ne da bi ta prišel v stik z zrakom), za katere so potrebni samo preskusi mikrobiološke kakovosti na končnem izdelku.
all other products, for which both a preservation challenge test and microbiological quality tests on the finished product are necessary.
vsemi drugimi izdelki, za katere so potrebni izzivni preskus učinkovitosti konzerviranja in preskusi mikrobiološke kakovosti na končnem izdelku.
Specific ‘Guidelines on Microbiological Quality of the Finished Product’ are provided in the SCCS Notes of Guidance [11].
Posebne „Smernice o mikrobiološki kakovosti končnega izdelka“ so v navodilih ZOVP [11].
The aim of that section of the cosmetic product safety report is to assess whether the cosmetic product contains substances that have not been intentionally added to the formulation, and which may have an impact on its safety.
Namen tega oddelka poročila o varnosti kozmetičnega izdelka je oceniti, ali kozmetični izdelek vsebuje snovi, ki niso bile namerno dodane formulaciji in lahko vplivajo na njegovo varnost.
Impurities are unintended substances in raw materials.
Nečistote so nenamerne snovi v surovinah.
A trace is a small quantity of an unintended substance in the finished product.
Sled je majhna količina nenamerne snovi v končnem izdelku.
Traces are to be evaluated with regard to safety of the finished product.
Sledi je treba ocenjevati z vidika varnosti končnega izdelka.
When traces of prohibited substances are present, evidence of their technical unavoidability are also to be provided.
Kadar so prisotne sledi prepovedanih snovi, je treba zagotoviti tudi dokaze o njihovi tehnični neizogibnosti.
Traces can originate from the following sources: impurities in the raw materials/substances; the manufacturing process; potential chemical evolution/interaction and/or migration of substances in the product that could occur under normal storage conditions and/or through contact with the packaging material.
Sledi lahko izvirajo iz naslednjih virov: nečistot v surovinah/snoveh, proizvodnega postopka ali morebitne kemijske evolucije/medsebojnega delovanja in/ali migracije snovi v izdelek, ki se lahko zgodijo v normalnih pogojih shranjevanja in/ali v stiku z embalažnim materialom.
Because substances may migrate from the packaging to the formulation, the relevant characteristics of the packaging material are to be considered.
Ker lahko snovi migrirajo iz embalaže v formulacijo, je treba preučiti ustrezne značilnosti embalažnega materiala.
In accordance with point 4 of Annex I to Regulation (EC) No 1223/2009, the section on ‘Impurities, traces, information about the packaging material’ is to address three specific issues:
V skladu z oddelkom 4 Priloge I k Uredbi (ES) št. 1223/2009 je treba v tem oddelku o nečistotah, sledeh in podatkih o embalažnem materialu obravnavati tri specifične vidike:
the purity of substances and mixtures;
čistost snovi in zmesi;
in case of traces of prohibited substances, evidence of their technical unavoidability;
v primeru sledi prepovedanih snovi, dokaz o njihovi tehnični neizogibnosti;
the relevant characteristics of the packaging material, in particular purity and stability.
ustrezne značilnosti embalažnega materiala, zlasti čistost in stabilnost.
In practical terms, those elements may be interpreted as follows:
V praktičnem smislu je mogoče navedene elemente razlagati kot:
precise definition of impurities and traces (see 3.4.1);
natančno opredelitev nečistot in sledi (glej točko 3.4.1);
evidence of technical unavoidability of prohibited substances (see 3.4.2);
dokaze o tehnični neizogibnosti prepovedanih snovi (glej točko 3.4.2);
potential release of substances from the packaging or possible deterioration of the product in contact with the packaging (see 3.4.3).
morebitno sproščanje snovi iz embalaže ali morebitno kvarjenje izdelka v stiku z embalažo (glej točko 3.4.3).
For the analysis of impurities and packaging material, data from suppliers are of crucial importance and should be preferred.
Za analizo nečistot in embalažnega materiala je treba dajati prednost podatkom dobaviteljev, ki so bistvenega pomena.
Purity of substances and mixtures
Čistost snovi in zmesi
The presence of unintended substances, such as impurities and traces, can have an impact on the safety of the finished product.
Prisotnost nenamernih snovi, kot so nečistote in sledi, lahko vpliva na varnost končnega izdelka.
The cosmetic product safety report is to include data on the purity of raw materials (substances and mixtures) and the identification of the toxicologically relevant unintended substances.
Poročilo o varnosti kozmetičnega izdelka mora vključevati podatke o čistosti surovin (snovi in zmesi) in identifikaciji toksikološko relevantnih nenamernih snovi.
These substances should be taken into account in the safety assessment of the product.
Te snovi je treba upoštevati v oceni varnosti izdelka.
The presence of traces in the finished product can be evaluated in two ways:
Prisotnost sledi v končnem izdelku se lahko oceni na dva načina:
through the specifications/technical data for each raw material, based on knowledge of the process for manufacturing the raw material (origin of substance, production process, synthesis route, extraction process, solvent used, etc.);
s specifikacijami/tehničnimi podatki za vsako surovino na podlagi poznavanja postopka za proizvodnjo surovine (izvor snovi, proizvodni postopek, sintezna pot, postopek ekstrakcije, uporabljeno topilo itd.);
through a physico-chemical analysis of possible impurities in raw materials and, if necessary, in the final product (e.g. nitrosamines which are potentially generated during or after the manufacturing process).
s fizikalno-kemijsko analizo mogočih nečistot v surovinah in po potrebi v končnem izdelku (npr. nitrozaminov, ki bi nastali med proizvodnim postopkom ali po njem).
Traces of prohibited substances are dealt with in paragraph 3.4.2 of these Guidelines.
Sledi prepovedanih snovi so obravnavane v točki 3.4.2 teh smernic.
Some traces have regulatory concentration limits.
Za nekatere sledi so mejne koncentracije zakonsko določene.
For the presence of traces of substances that are not prohibited, and for which there are no regulatory concentration limits, but which could be expected to impact consumer safety, the safety assessment needs to be carried out by the safety assessor.
Za prisotnost sledi snovi, ki niso prepovedane in za katere ni zakonsko določenih mejnih koncentracij, vendar za katere se lahko pričakuje, da bodo vplivale na varnost potrošnikov, mora ocenjevalec varnosti izvesti oceno varnosti.
Evidence of the technical unavoidability of traces of prohibited substances
Dokazi o tehnični neizogibnosti sledi prepovedanih snovi
While the procedure outlined in paragraph 3.4.1 should be followed for all known impurities and traces to evaluate their toxicological impact, further investigation is required for prohibited substances present as traces in the finished product [12].
Medtem ko je treba za oceno toksikološkega učinka vseh znanih nečistot in sledi upoštevati postopek, opisan v točki 3.4.1, so za prepovedane snovi, ki so prisotne kot sledi v končnem izdelku, potrebne nadaljnje preiskave [12].
When such presence is technically unavoidable, the cosmetics manufacturers are required to provide evidence of the technical unavoidability.
Kadar je taka prisotnost tehnično neizogibna, morajo proizvajalci kozmetičnih izdelkov zagotoviti dokaze o tehnični neizogibnosti.
That means they have to justify the presence of those traces by all necessary means.
To pomeni, da morajo prisotnost navedenih sledi utemeljiti z vsemi potrebnimi sredstvi.
The presence of traces of prohibited substances should be kept as low as is reasonably achievable under good manufacturing practices.
Prisotnost sledi prepovedanih snovi je treba ohranjati tako nizko, kolikor se razumno še lahko doseže ob dobrih proizvodnih praksah.
In addition, the safety assessor has to decide whether their levels are toxicologically acceptable and whether the product is still safe.
Poleg tega mora ocenjevalec varnosti odločiti, ali so ravni sledi toksikološko sprejemljive in ali je izdelek še vedno varen.
Especially in the case of non-threshold genotoxic and carcinogenic substances [13], the cosmetic industry should keep improving its best practices in order to eliminate these substances (ALARA principle [14]) in the finished cosmetic product.
Zlasti v primeru genotoksičnih in rakotvornih snovi brez praga [13] mora kozmetična industrija še naprej izboljševati svoje najboljše prakse, da te snovi v končnem kozmetičnem izdelku odpravi (načelo ALARA [14]).
The main concern is to ensure the protection of human health, as required by Article 3 of Regulation (EC) No 1223/2009.Traces generated by the degradation of substances within the final product (stability issues), by preservation or transport problems, or by the interaction of raw materials should be avoided through good manufacturing practices, or possibly through re-formulation of the product.
Predvsem je treba zagotoviti varovanje zdravja ljudi, kot se zahteva s členom 3 Uredbe (ES) št. 1223/2009.Sledem, ki nastanejo zaradi razgradnje snovi v končnem izdelku (težav s stabilnostjo), težav s konzerviranjem ali prevozom ali zaradi medsebojnega delovanja surovin, se je treba izogibati z dobrimi proizvodnimi praksami, lahko pa tudi s ponovno formulacijo izdelka.
The relevant characteristics of packaging material
Ustrezne značilnosti embalažnega materiala
Packaging material means the container (or primary packaging) that is in direct contact with the formulation.
Embalažni material je primarna (ali notranja) embalaža, ki je v neposrednem stiku s formulacijo.