natgillin/translations-raw huggingface dataset:
For these missing parameters, or where the risk characterisation is based on an approach using toxicological data acquired for other substances (for example similar structures) or for uses other than cosmetics (food, biocides, pharmaceutical products, etc.), justifications should be included in the report.
Za te manjkajoče parametre ali kadar opredelitev tveganja temelji na pristopu, pri katerem se uporabijo toksikološki podatki, pridobljeni za druge snovi (npr. strukturno sorodne snovi) ali nekozmetične uporabe (živila, biocide, farmacevtske izdelke itd.), je treba v poročilo vključiti utemeljitve.
The aim of that section of the cosmetic product safety report is to monitor the safety of the product after it has been placed on the market and to take corrective action, where necessary.
Namen tega oddelka poročila o varnosti kozmetičnega izdelka je spremljati varnost izdelka po tem, ko je bil dan na trg, in po potrebi sprejeti korektivne ukrepe.
To this end, the responsible person (in collaboration with the distributors) is required to set up a system to collect, document, establish the causality of and manage the undesirable effects caused by the product after its use in the Union [43].
V ta namen mora odgovorna oseba (v sodelovanju z distributerji) vzpostaviti sistem za zbiranje, dokumentiranje, ugotavljanje vzročnosti in obvladovanje neželenih učinkov, ki jih povzroči izdelek po uporabi, v Uniji [43].
When the undesirable effects are serious, the responsible person (and the distributors) are to notify the competent authority of the Member State where the effects occurred [44].
Kadar so neželeni učinki resni, jih mora odgovorna oseba (kot tudi distributerji) sporočiti pristojnemu organu države članice, v kateri so se ti učinki pojavili [44].
Information on undesirable effects and serious undesirable effects is to be included in the cosmetic product safety report, kept up-to-date and made available to the safety assessor, who may revise their assessment or take the information into account when assessing similar products.
Informacije o neželenih učinkih in resnih neželenih učinkih je treba vključiti v poročilo o varnosti kozmetičnega izdelka, jih posodabljati in dati na razpolago ocenjevalcu varnosti, ki lahko spremeni svojo oceno ali te informacije upošteva pri ocenjevanju podobnih izdelkov.
The cosmetic product safety report is to include all the available data, including statistical data, on the undesirable effects and serious undesirable effects of the cosmetic product or, where relevant, other cosmetic products.
Poročilo o varnosti kozmetičnega izdelka mora vključevati vse razpoložljive podatke, vključno s statističnimi, o neželenih učinkih in resnih neželenih učinkih zadevnega kozmetičnega izdelka ali, če je to ustrezno, drugih kozmetičnih izdelkov.
In particular, information on undesirable effects which, according to the causality assessment, are found to be very likely, likely, not clearly attributable or unlikely to be attributable [45] to the cosmetic product in question are to be included in the safety report.
Zlasti je treba v poročilo o varnosti vključiti informacije o neželenih učinkih, za katere se v skladu z oceno vzročnosti ugotovi, da je zelo verjetno, verjetno, ni gotovo ali je malo verjetno, da jih je mogoče pripisati [45] zadevnemu kozmetičnemu izdelku.
Data on undesirable effects may be included in this part of the safety report in the form of statistical data such as the number and type of undesirable effects per year.
Podatki o neželenih učinkih se lahko v ta del poročila o varnosti vključijo v obliki statističnih podatkov, kot sta število in vrsta neželenih učinkov na leto.
Information on serious undesirable effects which, according to the causality assessment, are found to be very likely, likely, not clearly attributable or unlikely to be attributable to the cosmetic product in question are to be included in the safety report in accordance with section 9 of Part A of Annex I to Regulation (EC) No 1223/2009, and notified to the national competent authorities, in accordance with Article 23 of the same Regulation [46].
Informacije o resnih neželenih učinkih, za katere se v skladu z oceno vzročnosti ugotovi, da je zelo verjetno, verjetno, ni gotovo ali je malo verjetno, da jih je mogoče pripisati zadevnemu kozmetičnemu izdelku, je treba v skladu z oddelkom 9 dela A Priloge I k Uredbi (ES) št. 1223/2009 vključiti v poročilo o varnosti in jih v skladu s členom 23 iste uredbe sporočiti nacionalnim pristojnim organom [46].
The notification forms sent to the competent authorities are therefore to be attached to the cosmetic product safety report.
Zato je treba obrazce za sporočanje, ki se pošljejo pristojnim organom, priložiti k poročilu o varnosti kozmetičnega izdelka.
The responsible person’s reaction to and handling of the reported serious undesirable effects is to be stated.
Navesti je treba, kako se je odgovorna oseba odzvala na sporočene resne neželene učinke in kako je ta sporočila obravnavala.
The corrective and preventive measures taken, if any, should be described.
Opisati je treba korektivne in preventivne ukrepe, če so bili sprejeti.
The information on undesirable effects is to be kept up-to-date and regularly made available to the safety assessor [47], who may consider it necessary to revise the safety assessment, suggest improvements to the formulation or use the information to establish the safety assessment for similar products.
Informacije o neželenih učnikih je treba posodabljati in redno dajati na razpolago ocenjevalcu varnosti [47], ki lahko presodi, da je treba spremeniti oceno varnosti, predlaga izboljšave za formulacijo ali te informacije uporabi za pripravo ocene varnosti za podobne izdelke.
Additional cosmetovigilance data, such as serious undesirable effects of a non-intended use may also provide helpful information that the safety assessor should consider.
Koristne informacije, ki jih mora ocenjevalec varnosti upoštevati, se lahko zagotovijo tudi z dodatnimi podatki iz kozmetovigilance, kot so resni neželeni učinki nepredvidene uporabe.
That section of the cosmetic product safety report allows the inclusion of any additional information which is not covered under the other headings of Part A of Annex I to Regulation (EC) No 1223/2009, but is considered relevant in order to carry out the safety assessment of the product.
Ta oddelek poročila o varnosti kozmetičnega izdelka omogoča vključitev morebitnih dodatnih informacij, ki niso zajete v drugih oddelkih dela A Priloge I k Uredbi (ES) št. 1223/2009, vendar se štejejo za pomembne za izvedbo ocene varnosti izdelka.
This section of the cosmetic product safety report should contain other relevant information, either relating to the product or similar formulations, such as existing studies on human volunteers, or relating to specific substances, such as the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas.
Ta oddelek poročila o varnosti kozmetičnega izdelka mora vsebovati druge pomembne informacije, povezane bodisi z izdelkom ali podobnimi formulacijami, npr. obstoječe študije na prostovoljcih, bodisi s posebnimi snovmi, npr. jasno potrjene in utemeljene ugotovitve ocen tveganja, ki so bile izvedene na drugih ustreznih področjih.
This section could be used to refer to information on substances or mixtures also used in other kinds of products, such as food and pharmaceuticals.
Ta oddelek je mogoče uporabiti za sklicevanje na informacije o snoveh ali zmeseh, ki se uporabljajo tudi v drugih vrstah izdelkov, kot so živila in farmacevtski izdelki.
PART B OF ANNEX I TO REGULATION (EC) No 1223/2009 — COSMETIC PRODUCT SAFETY ASSESSMENT
DEL B PRILOGE I K UREDBI (ES) št. 1223/2009 – OCENA VARNOSTI KOZMETIČNEGA IZDELKA
Part B of the report is the actual assessment of the safety of the product.
Del B poročila je dejanska ocena varnosti izdelka.
In their reasoning, the safety assessor is required to take into account all the hazards identified for the product and the exposure to it.
Ocenjevalec varnosti mora v svoji obrazložitvi upoštevati vse opredeljene nevarnosti izdelka in izpostavljenost izdelku.
Part B of the cosmetic product safety report comprises:
Del B poročila o varnosti kozmetičnega izdelka zajema:
The assessment conclusion;
zaključek ocene;
The labelled warnings and instructions of use;
označena opozorila in navodila za uporabo;
The reasoning;
obrazložitev;
The credentials of the safety assessor and their final approval.
dokazila o verodostojnosti ocenjevalca varnosti in njegovo dokončno odobritev.
The assessment conclusion is a statement on the safety of the cosmetic product in relation to the safety requirement of Article 3 of Regulation (EC) No 1223/2009.
Zaključek ocene je izjava o varnosti kozmetičnega izdelka glede na zahtevo o varnosti iz člena 3 Uredbe (ES) št. 1223/2009.
The conclusion should state whether the product is safe, safe with restrictions or not safe for human health when used under normal or reasonably foreseeable conditions of use.
V zaključku je treba navesti, da je izdelek varen ali varen z omejitvami oziroma da ni varen za zdravje ljudi, če je uporabljen pod normalnimi ali razumno predvidljivimi pogoji uporabe.
The legal framework for the assessment should be explicitly mentioned, in particular Regulation (EC) No 1223/2009 on cosmetic products.
Izrecno je treba navesti pravni okvir za oceno, zlasti Uredbo (ES) št. 1223/2009 o kozmetičnih izdelkih.
If the product has been assessed as not safe, it cannot be considered to comply with Regulation (EC) No 1223/2009 and therefore is not to be placed on the market.
Če izdelek ni bil ocenjen kot varen, se ne more šteti za skladnega z Uredbo (ES) št. 1223/2009 in se torej ne sme dati na trg.
The aim of that section of the cosmetic product safety report is to explicitly list the particular precautions to be observed in use, including at least those listed in Annexes III to VI to Regulation (EC) No 1223/2009 and any special precautionary information on cosmetic products for professional use, which should appear on the labelling.
Namen tega oddelka poročila o varnosti kozmetičnega izdelka je, da se izrecno navedejo podrobni varnostni ukrepi, ki jih je treba upoštevati pri uporabi, vključno z vsaj tistimi, ki so našteti v prilogah III do VI k Uredbi (ES) št. 1223/2009, in vsa posebna varnostna opozorila na kozmetičnih izdelkih za poklicno uporabo, ki morajo biti na označbi.
In accordance with Annex I to Regulation (EC) No 1223/2009, this section is to be a statement regarding the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d) of Regulation (EC) No 1223/2009.
V skladu s Prilogo I k Uredbi (ES) št. 1223/2009 mora ta oddelek vsebovati izjavo o nujnosti označevanja katerih koli posebnih opozoril in navodil za uporabo v skladu s členom 19(1)(d) Uredbe (ES) št. 1223/2009.
It is the task of the safety assessor to determine which warnings or instructions of use, in addition to those listed in Annexes III to VI, need to be labelled to ensure the safe use of the product.
Naloga ocenjevalca varnosti je, da določi, katera opozorila ali navodila za uporabo – poleg tistih iz prilog III do VI – je treba navesti na označbi za zagotovitev varne uporabe izdelka.
The safety assessor should decide what is to appear on the labelling on a case-by-case basis, taking into account the legal obligations deriving from Article 19 and the Annexes to Regulation (EC) No 1223/2009 and, where relevant, instruments such as Commission Recommendation 2006/647/EC [48] and other guidelines published by the Commission such as those on the ‘period of time after opening’ labelling [49] and the labelling of ingredients under Directive 76/768/EEC [50].
Ocenjevalec varnosti mora o tem, kaj je treba navesti na označbi, odločiti v vsakem primeru posebej, pri tem pa upoštevati pravne obveznosti, ki izhajajo iz člena 19 Uredbe (ES) št. 1223/2009 in prilog k tej uredbi, ter, kjer je to ustrezno, akte, kot so Priporočilo Komisije 2006/647/ES [48] in druge smernice, ki jih je objavila Komisija, npr. o označevanju „časovnega obdobja po odprtju izdelka“ [49] in o označevanju sestavin na podlagi Direktive 76/768/EGS [50].
The reasoning is the core of the safety assessment, as its aim is to clearly and accurately explain how the safety assessor reaches his or her conclusions on the safety of the cosmetic product from the data gathered under Part A of Annex I to Regulation (EC) No 1223/2009.
Obrazložitev je osrednji del ocene varnosti, saj je njen namen jasno in natančno pojasniti, kako je ocenjevalec varnosti oblikoval svoje ugotovitve o varnosti kozmetičnega izdelka na podlagi podatkov, zbranih v skladu z delom A Priloge I k Uredbi (ES) št. 1223/2009.
The safety assessment is to be performed on a case-by-case basis for each individual cosmetic product and be the result of an expert evaluation of the available data.
Ocena varnosti mora biti opravljena za vsak primer posebej za vsak posamezni kozmetični izdelek in mora biti rezultat strokovne presoje razpoložljivih podatkov.
The safety assessor should ensure that all the information (s)he needs to carry out a safety assessment is available; (s)he should check the relevance of the data provided on the product to be assessed; and (s)he should justify the absence of data required under Part A, when (s)he considers they are not relevant or necessary.
Ocenjevalec varnosti mora zagotoviti, da so na voljo vse informacije, ki jih potrebuje za izvedbo ocene varnosti, preveriti ustreznost podatkov, zagotovljenih za izdelek, ki ga je treba oceniti, in utemeljiti neobstoj podatkov, zahtevanih v delu A, kadar meni, da niso ustrezni ali potrebni.
In order to draw conclusions on the safety of a cosmetic product, the safety assessor is required to evaluate the safety of the individual substances or mixtures present in the formulation and the safety of the finished product.
Za oblikovanje ugotovitev o varnosti kozmetičnega izdelka mora ocenjevalec varnosti oceniti varnost posameznih snovi ali zmesi, prisotnih v formulaciji, in varnost končnega izdelka.
His/her conclusions are to be based on a body of evidence showing that, for all the hazards identified, the product can be considered safe in terms of human health.
Njegove ugotovitve morajo temeljiti na sklopu dokazov, ki za vse opredeljene nevarnosti kažejo, da se lahko izdelek šteje za varen v smislu zdravja ljudi.
The safety assessor may accept, reject, or accept under specific conditions the formulation under consideration.
Ocenjevalec varnosti lahko formulacijo, ki jo preučuje, odobri, zavrne ali odobri pod posebnimi pogoji.
A product that does not comply with Regulation (EC) No 1223/2009 is to be rejected and not marketed.
Izdelek, ki ni v skladu z Uredbo (ES) št. 1223/2009, se mora zavrniti in se ne sme tržiti.
The reasoning for the safety assessment sets out the considerations that lead the safety assessor, based on all available safety-related information, to an overall conclusion on the safety of a product.
V obrazložitvi ocene varnosti se navedejo premisleki, ki ocenjevalca varnosti na podlagi vseh razpoložljivih informacij v zvezi z varnostjo pripeljejo do splošnega zaključka o varnosti izdelka.
In their reasoning, the safety assessor is required to take into account all the hazards identified, the intended and reasonably foreseeable exposure conditions of the individual substances or mixtures present in the formulation and of the finished cosmetic product.
Ocenjevalec varnosti mora v svoji obrazložitvi upoštevati vse opredeljene nevarnosti ter predvidene in razumno predvidljive pogoje izpostavljenosti posameznih snovi ali zmesi v formulaciji in končnega kozmetičnega izdelka.
Analysis and evaluation of the validity/reliability of all existing information is the task of the safety assessor.
Analiza in ocenjevanje veljavnosti/zanesljivosti vseh obstoječih informacij sta naloga ocenjevalca varnosti.
By conducting this analysis, the safety assessor is able to decide whether the available data are sufficient to perform a safety assessment or whether additional data need to be obtained on an individual substance or the finished cosmetic product.
S to analizo lahko odloči, ali razpoložljivi podatki zadoščajo za izvedbo ocene varnosti ali pa je treba pridobiti dodatne podatke o posamezni snovi ali končnem kozmetičnem izdelku.
The reasoning is based on the data compiled in Part A of the cosmetic product safety report and takes into account the safety evaluation of substances and mixtures, carried out by the Scientific Committee for Consumer Safety when the substances appear in the Annexes to Regulation (EC) No 1223/2009, by other competent scientific committees or panels, or by the safety assessor him/herself, and the safety evaluation of the cosmetic product.
Obrazložitev temelji na podatkih, zbranih v delu A poročila o varnosti kozmetičnega izdelka, poleg tega pa se v obrazložitvi upoštevata ocena varnosti snovi in zmesi, ki jo izvedejo Znanstveni odbor za varstvo potrošnikov, ko so snovi navedene v prilogah k Uredbi (ES) št. 1223/2009, drugi pristojni znanstveni odbori ali ocenjevalec varnosti sam, ter ocena varnosti kozmetičnega izdelka.
Safety Evaluation of Substances and/or Mixtures
Ocena varnosti snovi in/ali zmesi
The safety evaluation of substances and/or mixtures consists of three main steps:
Ocena varnosti snovi in/ali zmesi je sestavljena iz treh glavnih faz:
hazard characterisation of substances and mixtures;
opredelitve nevarnosti snovi in zmesi;
assessment of the local and systemic exposure (considering absorption data);
ocene lokalne in sistemske izpostavljenosti (ob upoštevanju podatkov o absorpciji);
risk assessment of systemic effects (calculation of margin of safety) and risk assessment of local effects (such as skin allergy, skin irritation).
ocene tveganja sistemskih učinkov (izračun meje varne uporabe) in ocene tveganja lokalnih učinkov (npr. kožne alergije, draženja kože).
For fragrance and flavour compounds, where information on their composition is confidential, a safety assessment may be provided to the responsible person for the finished cosmetic product by the manufacturer of that mixture.
Za dišavne in aromatične spojine, pri katerih so informacije o sestavi zaupne, lahko oceno varnosti odgovorni osebi za končni kozmetični izdelek zagotovi proizvajalec zadevne zmesi.
Taking into account the concentration in the final cosmetic product and its exposure pattern, the safety assessment of the fragrance and flavour compound should be prepared following the principles described in Annex I to Regulation (EC) No 1223/2009 and these guidelines.
Ob upoštevanju koncentracije v končnem kozmetičnem izdelku in njegovega vzorca izpostavljenosti je treba oceno varnosti dišavne in aromatične spojine pripraviti na podlagi načel, opisanih v Prilogi I k Uredbi (ES) št. 1223/2009 in teh smernicah.
An appropriate document demonstrating the safety of the fragrance or flavour compound should be provided by the supplier to the responsible person for the finished cosmetic product.
Dobavitelj mora odgovorni osebi za končni kozmetični proizvod zagotoviti ustrezen dokument, ki dokazuje varnost dišavne ali aromatične spojine.
Safety Evaluation of the Cosmetic Product
Ocena varnosti kozmetičnega izdelka
The safety evaluation of the cosmetic product covers three main aspects:
Ocena varnosti kozmetičnega izdelka zajema tri glavne vidike:
summary of the risk assessment based on the local and systemic effects of all individual substances/mixtures [51];
povzetek ocene tveganja na podlagi lokalnih in sistemskih učinkov vseh posameznih snovi/zmesi [51];
additional assessment of the safety of the formulated product, which cannot be assessed by assessing the substances/mixtures separately.
dodatno oceno varnosti formuliranega izdelka, ki je ni mogoče izvesti z ločenim ocenjevanjem snovi/zmesi.
This could for instance be the formulation’s skin compatibility, assessment of possible combination effects, such as one ingredient that can increase the absorption rate of another ingredient, possible effects that could arise from interaction with packaging material, or possible effects due to chemical reactions between the individual substances/mixtures in the formulated product [52];
To so lahko na primer združljivost formulacije s kožo, ocena možnih kombiniranih učinkov, kot v primeru ene sestavine, ki lahko poveča stopnjo absorpcije druge sestavine, možni učinki, ki se lahko pojavijo ob medsebojnem delovanju z embalažnim materialom, ali možni učinki zaradi kemijskih reakcij med posameznimi snovmi/zmesmi v formuliranem izdelku [52];
other factors that influence the safety assessment, such as stability, microbiological quality, packaging, and labelling, including use instructions and precautions for use.
druge dejavnike, ki vplivajo na oceno varnosti, kot so stabilnost, mikrobiološka kakovost, embalaža in označevanje, vključno z navodili in varnostnimi ukrepi za uporabo.
The specific assessment for cosmetic products intended for use on children under the age of three which is required in accordance with Regulation (EC) No 1223/2009 should take into account the specific recommendations in the SCCS Notes of Guidance [53].
Pri posebni oceni kozmetičnih izdelkov, namenjenih za uporabo pri otrocih, mlajših od treh let, ki se zahteva z Uredbo (ES) št. 1223/2009, je treba upoštevati posebna priporočila v Navodilih ZOVP [53].
In the specific assessment required in accordance with Regulation (EC) No 1223/2009 for cosmetic products intended exclusively for use in external intimate hygiene, the particular characteristics of the application site also are to be taken into account.
V posebni oceni, ki se v Uredbi (ES) št. 1223/2009 zahteva za kozmetične izdelke, namenjene izključno za zunanjo intimno higieno, je treba upoštevati tudi posebne značilnosti mesta uporabe.
A product that does not comply with Regulation (EC) No 1223/2009 is to be rejected and is not be marketed.
Izdelek, ki ni v skladu z Uredbo (ES) št. 1223/2009, se mora zavrniti in se ne sme tržiti.
Recommendations by the safety assessor regarding the safe use of the product should be followed.
Priporočila ocenjevalca varnosti v zvezi z varno uporabo izdelka je treba upoštevati.
In order to ensure that the cosmetic product safety report is kept up to date as required by Article 10(1)(c) of Regulation (EC) No 1223/2009, the safety of the finished product should be reassessed regularly.
Za zagotovitev, da se poročilo o varnosti kozmetičnega izdelka posodablja, kot določa člen 10(1)(c) Uredbe (ES) št. 1223/2009, je treba redno izvajati ponovne ocene varnosti končnega izdelka.
When changes in the legal requirements occur (e.g. restrictions of one of the substances included in the formulation), it should be checked, amongst others (e.g. labelling), whether the formulation still complies with the law, and the safety assessment should be reviewed and, if necessary, updated.
Kadar se pravne zahteve (npr. omejitve za eno od snovi, vključenih v formulacijo) spremenijo, je treba med drugim (npr. poleg označevanja) preveriti, ali je formulacija še vedno zakonsko skladna, ter pregledati oceno varnosti in jo po potrebi posodobiti.
The safety assessment should also be reviewed and, if necessary, updated, where one or more of the following circumstances apply:
Oceno varnosti je treba pregledati in po potrebi posodobiti tudi, kadar velja ena od ali več naslednjih okoliščin:
new scientific findings and toxicological data on the substances are available which could modify the result of the existing safety assessment;
na voljo so nove znanstvene ugotovitve in toksikološki podatki o snovi, ki bi lahko spremenili rezultat obstoječe ocene varnosti;
changes occurring in the formulation or specifications of raw materials;
spremenjene so bile formulacija ali specifikacije surovin;
changes occurring in the conditions of use;
spremenjeni so bili pogoji uporabe;
a rising trend in terms of the nature, severity and frequency of undesirable effects, both under reasonably foreseeable conditions of use and in the case of misuse [54].
povečuje se opažanje neželenih učinkov v smislu njihove narave, resnosti in pogostnosti, in sicer pod razumno predvidljivimi pogoji uporabe in v primeru napačne uporabe [54].