natgillin/translations-raw huggingface dataset:
Det kan f.eks. dreje sig om formuleringens hudkompatibilitet, vurdering af mulige kombinationseffekter, f.eks. hvis én bestanddel øger en anden bestanddels absorption, mulige virkninger som følge af interaktion med emballeringsmateriale eller mulige virkninger som følge af kemiske reaktioner mellem de enkelte stoffer/blandinger i produktet [52]
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];
andre faktorer med betydning for sikkerhedsvurderingen, f.eks. stabilitet, mikrobiologisk kvalitet, emballage og mærkning, herunder brugsanvisning og forsigtighedsregler.
other factors that influence the safety assessment, such as stability, microbiological quality, packaging, and labelling, including use instructions and precautions for use.
Den specifikke vurdering af kosmetiske produkter, der er beregnet til børn under tre år, som er påkrævet i henhold til forordning (EF) nr. 1223/2009, bør tage højde for de specifikke anbefalinger i SCCS's retningslinjer [53].
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].
I den specifikke vurdering, der er påkrævet i henhold til forordning (EF) nr. 1223/2009, for kosmetiske produkter, som udelukkende er beregnet til intimhygiejneprodukter til udvortes brug, skal de specifikke karakteristika for påføringsstedet også tages i betragtning.
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.
Et produkt, der ikke overholder bestemmelserne i forordning (EF) nr. 1223/2009, skal afvises og må ikke markedsføres.
A product that does not comply with Regulation (EC) No 1223/2009 is to be rejected and is not be marketed.
Sikkerhedsekspertens henstillinger vedrørende sikker brug af produktet skal overholdes.
Recommendations by the safety assessor regarding the safe use of the product should be followed.
For at sikre, at rapporten om det kosmetiske produkts sikkerhed opdateres, jf. artikel 10, stk. 1, litra c), i forordning (EF) nr. 1223/2009, bør det færdige produkts sikkerhed vurderes løbende.
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.
Når lovgivningen ændres (og der f.eks. indføres begrænsninger for et af de stoffer, der indgår i formuleringen), bør det bl.a. (f.eks. med hensyn til mærkning) undersøges, om formuleringen stadig er i overensstemmelse med lovgivningen, og sikkerhedsvurderingen bør revideres og om nødvendigt opdateres.
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.
Sikkerhedsvurderingen bør også revideres og om nødvendigt opdateres, hvis en eller flere af følgende omstændigheder forekommer:
The safety assessment should also be reviewed and, if necessary, updated, where one or more of the following circumstances apply:
nye videnskabelige resultater og toksikologiske oplysninger om stofferne kan risikere at ændre resultatet af den eksisterende sikkerhedsvurdering
new scientific findings and toxicological data on the substances are available which could modify the result of the existing safety assessment;
ændringer i formuleringen eller specifikationerne for råvarer
changes occurring in the formulation or specifications of raw materials;
ændringer i anvendelsen
changes occurring in the conditions of use;
en stigende tendens, hvad angår de uønskede virkningers art, sværhedsgrad og hyppighed, både når produktet anvendes under normale betingelser og ved misbrug [54].
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].
Der bør indføres strukturer og procedurer, som skal sikre, at de oplysninger, der er relevante for opdateringen af rapporten om det kosmetiske produkts sikkerhed, reelt udveksles mellem den ansvarlige person og sikkerhedseksperten, og at sikkerhedseksperten er i stand til at gribe ind, når der er behov for en opdatering.
Structures and processes should be established to ensure that the information relevant for the update of the cosmetic product safety report is efficiently exchanged between the responsible person and the safety assessor, and that the safety assessor is in a position to intervene where an update is necessary.
Oplysninger om eksperten og godkendelse af del B
Assessor’s credentials and approval of Part B
Sikkerhedseksperten skal være en fagperson med den viden og ekspertise, der er nødvendig for at udarbejde en præcis sikkerhedsvurdering, jf. kvalifikationskravene i artikel 10, stk. 2, i forordning (EF) nr. 1223/2009.
The safety assessor is to be a professional with the necessary knowledge and expertise to draw up an accurate safety assessment, as indicated by the qualification requirements in Article 10(2) of Regulation (EC) No 1223/2009.
Formålet med dette afsnit i rapporten om det kosmetiske produkts sikkerhed er at sikre, at dette krav er opfyldt, og at der er adgang til den nødvendige dokumentation.
That section of the cosmetic product safety report aims at ensuring that this requirement is met and that the necessary evidence is provided.
Dette afsnit af sikkerhedsrapporten skal angive sikkerhedsekspertens navn og adresse og skal dateres og underskrives.
That section of the safety report is required to list the name and address of the safety assessor and to be dated and signed.
Resultatet af sikkerhedsvurderingen underskrives med angivelse af udarbejdelsesdatoen eller udstedes i form af en elektronisk udgivelse, der fastlægger et klart forhold mellem sikkerhedseksperten, udformningen og vurderingsdatoen.
The result of the safety assessment is to be signed stating the date of preparation or be issued based on an electronic release establishing a clear relationship between the assessor, the formulation and the date of assessment.
Den elektroniske version skal være beskyttet mod uautoriserede personers adgang.
The electronic version should be protected from abuse by unauthorised persons.
I henhold til artikel 10, stk. 2, i forordning (EF) nr. 1223/2009 skal sikkerhedseksperten være en person, »som er i besiddelse af et eksamensbevis eller lignende, der godtgør, at [vedkommende] har gennemført en akademisk uddannelse inden for farmakologi, toksikologi, medicin eller en lignende disciplin eller en uddannelse, der sidestilles hermed i den pågældende medlemsstat«.
In accordance with Article 10(2) of Regulation (EC) No 1223/2009, the safety assessor is required to be ‘a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline or a course recognised as equivalent by a Member State’.
En person, som har opnået kvalifikationer i et tredjeland, kan fungere som sikkerhedsekspert, hvis vedkommende har afsluttet en »uddannelse, der sidestilles [med en akademisk uddannelse inden for farmakologi, toksikologi, medicin eller en lignende disciplin eller uddannelse] i den pågældende medlemsstat«.
A person who has obtained qualifications in a third country may act as a safety assessor if they have completed ‘a course recognised as equivalent [to a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline] by a Member State’.
Sikkerhedseksperten skal dokumentere sine kvalifikationer (dvs. kopi af eksamensbeviset og om nødvendigt dokumentation for ækvivalens), jf. artikel 10 i forordning (EF) nr. 1223/2009.
Proof is to be provided of the safety assessor’s qualification (i.e. copy of the diploma and, where needed, proof of equivalence) laid down in Article 10 of Regulation (EC) No 1223/2009.
(Règlement (CE) No 1223/2009), Collection: Les guides pratiques des entreprises — Editions 2011-2012
(Règlement (CE) No 1223/2009), Collection: Les guides pratiques des entreprises — Editions 2011-2012.,
Det Europæiske Kemikalieagentur (ECHA), Guidance on information requirements and chemical safety assessment, kapitel R.7a: Endpoint specific guidance, maj 2008
European Chemicals Agency (ECHA), Guidance on information requirements and chemical safety assessment — Chapter R.7a: Endpoint specific guidance, May 2008.
Det Europæiske Kemikalieagentur (ECHA), Guidance on information requirements and chemical safety assessment, kapitel R.7c: Endpoint specific guidance, maj 2008
European Chemicals Agency (ECHA), Guidance on information requirements and chemical safety assessment — Chapter R.7c: Endpoint specific guidance, May 2008.
Europa-Kommissionen, Composition and undesirable effects of cosmetic products to be made easily accessible to the public — practical implementation of Article 7a(1)(h), second subparagraph, of Directive 76/768/EEC (http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/guide_access_info_en.pdf)
European Commission, Composition and undesirable effects of cosmetic products to be made easily accessible to the public — practical implementation of Article 7a(1)(h), second subparagraph, of Directive 76/768/EEC (http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/guide_access_info_en.pdf).
John Wiley & Sons Ltd., 2008
John Wiley & Sons Ltd, 2008.
Klimisch H.J., Andreae E. and Tillmann U., A systematic approach for evaluating the quality of experimental and ecotoxicological data, Regulatory Toxicology and Pharmacology 25 (1997), s. 1-5
Regulatory Toxicology and Pharmacology 25 (1997), p. 1-5.
Miljøstyrelsen, Vejledning til sikkerhedsvurdering af kosmetiske produkter, Vejledning fra Miljøstyrelsen nr. 10, 2000
Miljøstyrelsen, Guideline on Safety Assessment of Cosmetic Products, Environmental Guidelines No 10 2000.
SCENIHR (Den Videnskabelige Komité for Nye og Nyligt Identificerede Sundhedsrisici), udtalelse om »Scientific Basis for the Definition of the Term »nanomaterial« « af 8. december 2010.
SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), Opinion on the scientific basis for the definition of the term ‘nanomaterial’, 8 December 2010.
Workshop Report, Assessment of undesirable events in cosmetic market surveillance: Background, description and use of a causality assessment method in cosmetovigilance, Regulatory Toxicology and Pharmacology 58 (2010), s. 349-353
Workshop Report ‘Assessment of undesirable events in cosmetic market surveillance: Background, description and use of a causality assessment method in cosmetovigilance’, Regulatory Toxicology and Pharmacology 58 (2010) 349–353.
Artikel 11, stk. 2, i forordning (EF) nr. 1223/2009.
Article 11(2) of Regulation (EC) No 1223/2009.
Artikel 10, stk. 1, i forordning (EF) nr. 1223/2009.
Article 10(1) of Regulation (EC) No 1223/2009.
Artikel 10, stk. 1, litra c), i forordning (EF) nr. 1223/2009.
Article 10(1)(c) of Regulation (EC) No 1223/2009.
SCCS's retningslinjer for tests af kosmetiske stoffer og deres sikkerhedsevalueringer, 8. udgave, SCCS/1501/12, og efterfølgende opdateringer.
The SCCS’s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8th Revision, SCCS/1501/12, and its subsequent updates.
SCCS's retningslinjer, punkt 3-6.2, s. 35-36.
SCCS Notes of Guidance, para. 3-6.2, pp. 35-36.
Dette spørgsmål er relevant i forbindelse med god fremstillingspraksis og behandles eksplicit i standard EN ISO 22716:2007.
This point is relevant in the context of Good Manufacturing Practices, and is explicitly addressed by the relevant standard EN ISO 22716:2007.
Nærmere bestemt hænger det sammen med kravene til markedsføring af råvarer og det færdige produkt.
More specifically, it matches the requirements for the release of raw materials and the finished product.
Se afsnit 3.3 om mikrobiologisk kvalitet.
See section 3.3 on Microbiological quality.
Se »Practical implementation of Article 6(1)(c) of the Cosmetics Directive (76/768/EEC): LABELLING OF PRODUCT DURABILITY: »PERIOD OF TIME AFTER OPENING« (Rådets direktiv 76/768/EØF, EFT L 262 af 27.9.1976, s. 169), http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/wd-04-entr-cos_28_rev_version_adoptee20040419_en.pdf
See ‘Practical implementation of Article 6(1)(c) of the Cosmetics Directive (76/768/EEC): Labelling of product durability: “period of time after opening” ’ (Council Directive 76/768/EEC, OJ L 262, 27.9.1976, p. 169) http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/wd-04-entr-cos_28_rev_version_adoptee20040419_en.pdf
SCCS's retningslinjer, punkt 4-3.3, s. 74.
SCCS Notes of Guidance, para. 4-3.3, p. 74.
SCCS's retningslinjer, punkt 4-4, s. 75-76.
SCCS Notes of Guidance, para 4-4, pp. 75–76.
I henhold til artikel 17 i forordning (EF) nr. 1223/2009 tillades spor af forbudte stoffer kun, hvis det er teknisk uundgåeligt, og de ikke har indflydelse på de kosmetiske produkters sikkerhed.
Article 17 of Regulation (EC) No 1223/2009 establishes that traces of prohibited substances are only permitted if they are technically unavoidable and if they have no impact on the safety of the cosmetic products.
Genotoksiske og kræftfremkaldende stoffer uden tærskelværdi er stoffer uden tærskelværdi, hvad angår de kræftfremkaldende/genotoksiske virkninger.
The ‘non-threshold genotoxic and carcinogenic substances’ are the genotoxic and carcinogenic substances without a threshold for the carcinogenic-genotoxic effects.
Udtalelse fra Den Videnskabelige Komité på foranledning af EFSA, A Harmonised Approach for Risk Assessment of Substances Which are both Genotoxic and Carcinogenic, The EFSA Journal (2005) 282, s. 1-31.
Opinion of the Scientific Committee on a request from EFSA related to A Harmonised Approach for Risk Assessment of Substances Which are both Genotoxic and Carcinogenic, the EFSA Journal (2005) 282, pp. 1-31.
For at evaluere risikoen skal man vurdere faren sammenholdt med eksponeringen, og det er sikkerhedsekspertens opgave.
To evaluate the risk, one needs to consider the hazard together with the exposure, and this is the duty of the safety assessor.
SCCS's retningslinjer, punkt 4, s. 66 ff.
SCCS Notes of Guidance, para 4, p. 66 et seq.
M. Pauwels, V. Rogiers, Human Health Safety Evaluation of Cosmetics in the EU: A Legally Imposed Challenge to Science, Toxicology and Applied Pharmacology, 243 (2010), s. 261.
M. Pauwels, V. Rogiers, Human Health Safety Evaluation of Cosmetics in the EU: A Legally Imposed Challenge to Science, Toxicology and Applied Pharmacology, 243 (2010), p. 261.
Meddelelse fra Kommissionen til Europa-Parlamentet og Rådet om forbuddene mod dyreforsøg og markedsføring og status for alternative metoder i kosmetiksektoren, COM(2013) 135 final.
Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics, COM(2013) 135 final.
Se især punkt 3.1 i meddelelsen.
See in particular point 3.1 of the Communication.
SCCS's retningslinjer, punkt 3.4.11.
SCCS Notes of Guidance, para. 3.4.11.
Se også udtalelse SCCNFP/0068/98, som er en tidligere version af retningslinjerne, og udtalelse SCCNFP/0245/99 om Basic Criteria of the Protocols for the Skin Compatibility Testing of Potentially Cutaneous Irritant Cosmetic Ingredients or Mixtures of Ingredients on Human Volunteers.
Also cf. opinions SCCNFP/0068/98, an earlier version of the Notes of Guidance, and SCCNFP/0245/99 on Basic Criteria of the Protocols for the Skin Compatibility Testing of Potentially Cutaneous Irritant Cosmetic Ingredients or Mixtures of Ingredients on Human Volunteers.
Analogisering er en teknik til udfyldelse af huller i data, hvor oplysninger for en eller flere kildekemikalier anvendes til at foretage en forudsigelse for et målkemikalie, der på en eller anden måde betragtes som tilsvarende.
Read-across is a technique for data gap filling in which information for one or more source chemicals is used to make a prediction for a target chemical, which is considered to be similar in some way.
Fra Det Europæiske Kemikalieagentur (ECHA), Guidance on information requirements and chemical safety assessment, kapitel R.4: Evaluation of available information, december 2011, s. 12. http://echa.europa.eu/documents/10162/17235/information_requirements_r4_en.pdf
From ECHA, ‘Guidance on information requirements and chemical safety assessment Chapter R.4: Evaluation of available information’, December 2011, p. 12. http://echa.europa.eu/documents/10162/17235/information_requirements_r4_en.pdf
En definition af »weight of evidence« er: »den proces, hvorved forskellige oplysningers styrker og svagheder overvejes med henblik på at drage og understøtte en konklusion vedrørende en egenskab ved stoffet«. Fra ECHA, Praktisk vejledning 2: Rapportering af »weight of evidence«, 2010, http://echa.europa.eu/documents/10162/13655/pg_report_weight_of_evidence_da.pdf
One definition for weight of evidence is: ‘the process of considering the strengths and weaknesses of various pieces of information in reaching and supporting a conclusion concerning a property of the substance.’ From ECHA, ‘Practical guide 2: How to report weight of evidence’, 2010, p. 2, http://echa.europa.eu/documents/10162/13655/pg_report_weight_of_evidence_en.pdf
Se SCCS's retningslinjer, afsnit 3-6, Basic Requirements for Cosmetic Substances Present in Finished Cosmetic Products (which are to be evaluated by individual safety assessors).
Cfr. SCCS Notes of Guidance, Section 3-6 Basic Requirements for Cosmetic Substances Present in Finished Cosmetic Products (which are to be evaluated by individual safety assessors).
Retningslinjerne behandler klart dette spørgsmål i punkt 3-6.1, General toxicological requirements.
The SCCS Notes of Guidance clearly address this issue in para. 3-6.1 General toxicological requirements.
Ifølge SCCS's retningslinjer (punkt 3-4.5) bør NOAEL vælges fra et subkronisk toksicitetsstudie (90 dage).
According to the SCCS’s Notes of Guidance (para. 3-4.5), priority should be given to the NOAEL as regards sub-chronic toxicity (90 day study).
Kun hvis sådanne værdier ikke foreligger, bør der anvendes resultater vedrørende subakut toksicitet (28 dage).
Only if such values are not available should results relating to sub-acute toxicity (28-day study) be used.
ECHA, Guidance on information requirements and chemical safety assessment — kapitel R.7a: Endpoint specific guidance, maj 2008.
ECHA, Guidance on information requirements and chemical safety assessment — Chapter R.7a: Endpoint specific guidance, May 2008.
Se ECHA, Vejledning om identifikation og navngivning af stoffer i henhold til REACH og CLP, november 2011, s. 29, http://echa.europa.eu/documents/10162/17235/substance_id_da.pdf
Cfr. ECHA, Guidance for identification and naming of substances under REACH and CLP, November 2011, p. 29. http://echa.europa.eu/documents/10162/17235/substance_id_en.pdf
Dvs. den systemisk tilgængelige dosis, der passerer de relevante fysiske barrierer (gastrointestinalt, dermalt eller pulmonalt) og når ind i blodstrømmen med efterfølgende fordeling til væv og organer, se M. Pauwels, V. Rogiers, s. 262.
I.e.‘the systemically available dose that passes the relevant physical barriers (gastro-intestinal, skin or lung structures) and becomes available in the blood stream for subsequent distribution to tissues and organs’, ref. M. Pauwels, V. Rogiers, p. 262.
Basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients (SCCS/1358/10)
Basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients (SCCS/1358/10).
SCCS's retningslinjer, punkt 3-7.2, s. 49.
SCCS Notes of Guidance, para 3-7.2, p. 49.
SCCS, SCHER og SCENIHR, Opinion on Use of the Threshold of Toxicological Concern (TTC) Approach for Human Safety Assessment of Chemical Substances with focus on Cosmetics and Consumer Products, SCCP/1171/08.
SCCS, SCHER and SCENIHR, Opinion on Use of the Threshold of Toxicological Concern (TTC) Approach for Human Safety Assessment of Chemical Substances with focus on Cosmetics and Consumer Products, SCCP/1171/08.
SCCS's retningslinjer, punkt 3-7, s. 46.
SCCS Note of Guidance, para 3-7, p. 46.
Se eksempelvis: SCCS (Den Videnskabelige Komité for Forbrugersikkerhed), Guidance on the safety assessment of nanomaterials in cosmetics, SCCS/1484/12; SCENIHR (Den Videnskabelige Komité for Nye og Nyligt Identificerede Sundhedsrisici), udtalelse om »Scientific Basis for the Definition of the Term »nanomaterial«« af 8. december 2010.
See for example: SCCS (Scientific Committee on Consumer Safety), Guidance on safety assessment of nanomaterials in cosmetics, SCCS/1484/12; SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), Opinion on the scientific basis for the definition of the term ‘nanomaterial’, 8 December 2010.
R. Kroes, A. G. Renwick, V. Feron, C. L. Galli, M. Gibney, H. Greim, R. H. Guy, J. C. Lhuguenot, J. J. M. van de Sandt, Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients, Food and Chemical Toxicology 45 (2007), s. 2533-2562.
R. Kroes, A. G. Renwick, V. Feron, C. L. Galli, M. Gibney, H. Greim, R. H. Guy, J. C. Lhuguenot, J. J. M. van de Sandt, Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients, Food and Chemical Toxicology 45 (2007), pp. 2533–2562.
Der findes flere offentligt tilgængelige databaser med toksikologiske oplysninger om stoffer anvendt i kosmetiske produkter, se bilag I til disse retningslinjer.
Several publicly available databases containing toxicological data on substances used in cosmetics exist, and are listed in the Appendix to this Guideline.
EUT L 353 af 31.12.2008, s. 1, og ECHA's registreringswebsted: http://apps.echa.europa.eu/registered/registered-sub.aspx
OJ L 353, 31.12.2008, p. 1, and ECHA’s registration website: http://apps.echa.europa.eu/registered/registered-sub.aspx
Det følger af artikel 23 i forordning (EF) nr. 1223/2009, som fastlægger den ansvarlige persons pligt til at indberette alvorlige uønskede virkninger til de kompetente myndigheder i EU-medlemsstaterne.
This is a consequence of the requirement of Article 23 of Regulation (EC) No 1223/2009, which establishes the obligation for responsible persons to notify serious undesirable effects to competent authorities in the EU Member States.
Artikel 23 i forordning (EF) nr. 1223/2009.
Article 23 of Regulation (EC) No 1223/2009.
Hvad angår virkninger, der højst sandsynligt eller sandsynligvis er fremkaldt af det kosmetiske produkt, finder artikel 21 i forordning (EF) nr. 1223/2009, »Offentlighedens adgang til informationer«, anvendelse.
For undesirable effects that are very likely or likely to be attributable to the cosmetic product, Article 21 of Regulation (EC) No 1223/2009, ‘Access to information for the public’, applies.
Europa-Kommissionen, Serious Undesirable Effects (SUE) Reporting Guidelines, http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/sue_reporting_guidelines_en.pdf
European Commission, Serious Undesirable Effects (SUE) Reporting Guidelines, http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/sue_reporting_guidelines_en.pdf
Det er en af den ansvarlige persons pligter i henhold til artikel 10, stk. 1, litra c), i forordning (EF) nr. 1223/2009.
This is an obligation of the responsible person according to article 10(1)(c) of Regulation (EC) No 1223/2009.