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Ebook Safety assessment of cosmetics in Europe: Part 2

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Ebook Safety assessment of cosmetics in Europe: Part 2

https: //khoth u Vi e n .comSafety Assessment of Cosmetic Ingredients Present in Technical Information Files of Finished ProductsSafety Assessment of

Ebook Safety assessment of cosmetics in Europe: Part 2 Cosmetic Ingredients Present in Technical Information Files of Finished ProductsRogiers V. Pauwels M (eds): Safety Assessment of Cosmetics in Europe.

Curr Probl Dermatol Basci. Karger, 2008. vol 36, pp 94 1144.1 IntroductionAs explained in detail in section 1.2.7, two distinct channels are operative Ebook Safety assessment of cosmetics in Europe: Part 2

for the safety evaluation of cosmetic ingredients, namely the safety evaluation of cosmetic ingredients of direct relevance to Council Directive 76/7

Ebook Safety assessment of cosmetics in Europe: Part 2

68/EEC |EU, 1976a], currently taken care of by the SCCP, and the safety evaluation of all ingredients present in finished cosmetic products, carried o

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Ebook Safety assessment of cosmetics in Europe: Part 2 irritation and corrosivity, (3) skin sensitisation, (4) dermal/percutaneous absorption, (5) repeated dose toxicity, (6) mutagenic-ity/genoloxicily, (

7) carcinogenicity, (8) reproductive toxicity, (9) toxicokinetics, (10) photo-induced toxicity, (11) human data.Points 1 6 are generally considered th Ebook Safety assessment of cosmetics in Europe: Part 2

e minimal base set requirements, whereas points 7 9 may become necessary when considerable oral intake is expected or when the data on dermal/percutan

Ebook Safety assessment of cosmetics in Europe: Part 2

eous absorption indicate a considerable DA. Photoinduced toxicity data (point 10) are specifically required when the cosmetic product is expected or i

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Ebook Safety assessment of cosmetics in Europe: Part 2ontained points 1-6, but equally point 8 (see 3.2.5.a).As opposed to cosmetic ingredients taken up in the Annexes of the Cosmetic Products Directive,

there is no official framework providing clear guidelines for the safety assessment of ingredients used Ù1 finished cosmetic products. The cosmetic le Ebook Safety assessment of cosmetics in Europe: Part 2

gislation only states that the safety of a cosmetic product needs to be assessed ‘by taking into consideration the general toxicological profile of th

Ebook Safety assessment of cosmetics in Europe: Part 2

e ingredients, their chemical structure and then level of exposure’ I Eư, 19931. Experience has learnt that the retrieval ol sound and sufficient toxi

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Ebook Safety assessment of cosmetics in Europe: Part 2o the respective raw material suppliers to obtain physicochemical specifications and minimal toxicological data packages on their ingredients.Although

the SCCP is not responsible for the safety assessment of ingredients not taken up in the Annexes to Dir. 76/768/EEC [EƯ, 1976a], some general conside Ebook Safety assessment of cosmetics in Europe: Part 2

rations are provided in the SCCP Notes of Guidance. Inter alia, the Committee alleges that acute toxicity, skin and eye irritation, skin sensitisation

Ebook Safety assessment of cosmetics in Europe: Part 2

and a basic set of mutagenicity data, form the minimal data package to enable a scientifically sound safetyevaluation of a cosmetic ingredient.The SC

https: //khoth u Vi e n .comSafety Assessment of Cosmetic Ingredients Present in Technical Information Files of Finished ProductsSafety Assessment of

Ebook Safety assessment of cosmetics in Europe: Part 2ubstances are so-called ‘actives’ and are not necessarily safe at all concentrations used [SCCP, 2006b].In a real-life situation, the aforementioned m

inimal toxicological data package can not always be obtained, e.g. when a cosmetic company wants to develop a ‘new’ cosmetic product and needs certain Ebook Safety assessment of cosmetics in Europe: Part 2

ingredients from a raw material supplier. The latter may be reluctant to disclose all information on these substances, in particular since in this ea

Ebook Safety assessment of cosmetics in Europe: Part 2

rly phase no commercial links yet exist. Another example is the typical situation of SMEs, which may be pul at a disadvantage because of reduced spend

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Ebook Safety assessment of cosmetics in Europe: Part 2ifficult to obtain or are incomplete, it maybe necessary to consult external sources of physicochemical and toxicological data that can be accessed in

dependently’ from raw material suppliers.Before such an extensive search is initiated, it is useful to know which data can be found on specific types Ebook Safety assessment of cosmetics in Europe: Part 2

of compounds. Since Dir. 76/768/EEC [EU, 1976a] does not impose specific data requirements for the majority’ of cosmetic ingredients that are no candi

Ebook Safety assessment of cosmetics in Europe: Part 2

dates for inclusion in one of the Annexes of the Cosmetic Products Directive, we have to refer to the complex web of EU regulations mentioned in chapt

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Ebook Safety assessment of cosmetics in Europe: Part 2 the requirements and data accessibility’ measures laid down in the other legislation(s) governing these substances. A useful evaluation of expected d

ata availability is given in section 1.3.Finally’, it must be emphasised that the accessible parts of available toxicological data not necessarily con Ebook Safety assessment of cosmetics in Europe: Part 2

sist of full study reports. In general, summaries and Studyresults are described, while the details and raw data of the studies remain property’ of th

Ebook Safety assessment of cosmetics in Europe: Part 2

e company involved.The list of available sources is long and includes websites of official organisations, freely’ accessible databases and their comme

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Ebook Safety assessment of cosmetics in Europe: Part 2his comprehensive task.4.2 Database Search for Safety Information on Cosmetic Ingredients4.2.1.General ConsiderationsFrom a practical point of view, p

otentially relevant safety data for cosmetic ingredients usually are a combination of:96Rogiers • Pauwels-the standard toxicological data package avai Ebook Safety assessment of cosmetics in Europe: Part 2

lable for chemical substances, typically consisting of LDjo values, irritation and sensitisation data, NOAEL values out of repeated dose toxicity stud

Ebook Safety assessment of cosmetics in Europe: Part 2

ies, results of mutagenicity, carcinogenicity and/or reproductive toxicity studies, etc.,-additional relevant data including official classifications

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Ebook Safety assessment of cosmetics in Europe: Part 2tes at the EU and non EU level, free andcommercial databases and websites all over the world have proven to be storehouses of information. As the numb

er of data sources containing safety data is very diverse, they need to be compiled in a structured overview in order to obtain, within a limited time Ebook Safety assessment of cosmetics in Europe: Part 2

frame, the key information that exists on a particular cosmetic ingredient. In addition, a general and realistic overview of the usefulness of the av

Ebook Safety assessment of cosmetics in Europe: Part 2

ailable data sources and points of strength and weaknesses forms the basis of a good search, followed by a scientific evaluation of the quality of the

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Ebook Safety assessment of cosmetics in Europe: Part 2gment of their quality and relevance.Although the focus of this section clearly resides on the search for human toxicity data, the same channels as th

ose mentioned hereunder may equally be explored to search for physicochemical and/or ecoloxicological data.4.2.2.Useful Data Sourcesa) Types of Data S Ebook Safety assessment of cosmetics in Europe: Part 2

ourcesRelevant information can be extracted from worldwide official instances’ websites, industry-governed websites and freely available and commercia

Ebook Safety assessment of cosmetics in Europe: Part 2

l databases. As far as the latter arc concerned, it is important to distinguish between bibliographical databases containing citations from extended l

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Ebook Safety assessment of cosmetics in Europe: Part 2re factual databases comprising fields with physicochemical, toxicological and/or ecoloxicological data, by preference accompanied by plain references

.Companies such as the Scientific and Technical Network (STN*)1 and Thomson Dialog Datastar2 commercialise sets of bibliographical and factual databas Ebook Safety assessment of cosmetics in Europe: Part 2

es by selling CD-ROMs and/or allowing registered users to consult the databases through the Internet.1http://www.stn -internationnl.de/ (consulted Jul

Ebook Safety assessment of cosmetics in Europe: Part 2

y 2007).2httpư/www.diaJog.com/pfoducts/datastar/ (consulted July 2007).Safety Assessment of Cosmetic Ingredients Present in TlFs of Finished Products9

https: //khoth u Vi e n .comSafety Assessment of Cosmetic Ingredients Present in Technical Information Files of Finished ProductsSafety Assessment of

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