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Risk assessment of nanomaterials in cosmetics: a European union perspective.

Henkler F, Tralau T, Tentschert J, Kneuer C, Haase A, Platzek T, Luch A, Götz ME - Arch. Toxicol. (2012)

Bottom Line: According to the cosmetics directive [76/768/EEC], compounds that are classified as mutagenic, carcinogenic or toxic to reproduction are banned for the use in cosmetic products.Special notification procedures are mandatory for preservatives, colourants and UV-filters where a safety approval from the European 'Scientific Committee on Consumer Safety' (SCCS) is needed prior to marketing.The risk assessment of nanomaterials in consumer products still poses a significant challenge as highlighted by the example of UV-filters in sunscreens since nanomaterials cannot be classified as a homogenous group of chemicals but still need to be addressed in risk characterisation on a case by case basis.

View Article: PubMed Central - PubMed

ABSTRACT
In Europe, the data requirements for the hazard and exposure characterisation of chemicals are defined according to the REACH regulation and its guidance on information requirements and chemical safety assessment (Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and its guidance documents; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF ; and at: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm ). This is the basis for any related risk assessment. The standard reference for the testing of cosmetic ingredients is the SCCP's 'Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation' (The SCCP's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (2006); available at: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_03j.pdf ), which refers to the OECD guidelines for the testing of chemicals (The OECD Guidelines for the Testing of Chemicals as a collection of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to assess the safety of chemical products; available at: http://www.oecd.org/topic/0,2686,en_2649_34377_1_1_1_1_37407,00.html ). According to the cosmetics directive [76/768/EEC], compounds that are classified as mutagenic, carcinogenic or toxic to reproduction are banned for the use in cosmetic products. Since December 2010, the respective labelling is based on the rules of regulation (EC) No. 1272/2008 (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, Official Journal L 353, 31/12/2008, pages 1-1355; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF ) on classification, labelling and packaging of substances and mixtures (CLP). There is no further impact from the CLP regulation on cosmetic products, because regulation (EC) No. 1223/2009 on cosmetic products defines its own labelling rules (Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF ). Special notification procedures are mandatory for preservatives, colourants and UV-filters where a safety approval from the European 'Scientific Committee on Consumer Safety' (SCCS) is needed prior to marketing. The risk assessment of nanomaterials in consumer products still poses a significant challenge as highlighted by the example of UV-filters in sunscreens since nanomaterials cannot be classified as a homogenous group of chemicals but still need to be addressed in risk characterisation on a case by case basis.

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Notification process for cosmetics that contain NM according to the new EU Cosmetic Regulation 1223/2009
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Fig1: Notification process for cosmetics that contain NM according to the new EU Cosmetic Regulation 1223/2009

Mentions: The ‘Cosmetics Regulation’ is the first act in Europe that explicitly considers the putative risks from NM on consumers. Its article 16 is solely dedicated to NM. Each cosmetic product requires a designated ‘responsible person’ for a placement on the European market. This representative is requested to notify the European Commission 6 months in advance before any cosmetics containing NM are marketed. Required specifications for NM include particle sizes, used raw materials and information on product impurities. In addition, a toxicological profile needs to be provided that covers all relevant endpoints, especially skin and eye irritation, as well as skin sensitisation (Annex I, 6). The European Commission (COM) may request an opinion from the ‘Scientific Committee on Consumer Safety’ (SCCS) in case of safety concerns about the respective product notification or the particular NM used in the cosmetic product. This opinion has to be provided within 6 months and may ask for additional data, recommend a restricted application, or even propose the ban of the corresponding substance. Opinions by the SCCS will be published by COM. Safety concerns initiating a further or new evaluation process can also be raised after a substance has been placed on the market. Reasons for such action include new scientific knowledge as well as novel data on substance exposure or toxicology as provided by third parties (i.e. institutions of the member states). This can also lead to further requirements for NM in general. The notification process for NM, as outlined in article 16, does not apply for materials that are intended to be used as preservatives, colourants and UV-filters, as these preparations still need to be approved by inclusion into annexes IV–VI. Moreover, COM is responsible for market and safety surveillance measures and will provide an up-to-date catalogue of NM used in cosmetics (Fig. 1).Fig. 1


Risk assessment of nanomaterials in cosmetics: a European union perspective.

Henkler F, Tralau T, Tentschert J, Kneuer C, Haase A, Platzek T, Luch A, Götz ME - Arch. Toxicol. (2012)

Notification process for cosmetics that contain NM according to the new EU Cosmetic Regulation 1223/2009
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3472063&req=5

Fig1: Notification process for cosmetics that contain NM according to the new EU Cosmetic Regulation 1223/2009
Mentions: The ‘Cosmetics Regulation’ is the first act in Europe that explicitly considers the putative risks from NM on consumers. Its article 16 is solely dedicated to NM. Each cosmetic product requires a designated ‘responsible person’ for a placement on the European market. This representative is requested to notify the European Commission 6 months in advance before any cosmetics containing NM are marketed. Required specifications for NM include particle sizes, used raw materials and information on product impurities. In addition, a toxicological profile needs to be provided that covers all relevant endpoints, especially skin and eye irritation, as well as skin sensitisation (Annex I, 6). The European Commission (COM) may request an opinion from the ‘Scientific Committee on Consumer Safety’ (SCCS) in case of safety concerns about the respective product notification or the particular NM used in the cosmetic product. This opinion has to be provided within 6 months and may ask for additional data, recommend a restricted application, or even propose the ban of the corresponding substance. Opinions by the SCCS will be published by COM. Safety concerns initiating a further or new evaluation process can also be raised after a substance has been placed on the market. Reasons for such action include new scientific knowledge as well as novel data on substance exposure or toxicology as provided by third parties (i.e. institutions of the member states). This can also lead to further requirements for NM in general. The notification process for NM, as outlined in article 16, does not apply for materials that are intended to be used as preservatives, colourants and UV-filters, as these preparations still need to be approved by inclusion into annexes IV–VI. Moreover, COM is responsible for market and safety surveillance measures and will provide an up-to-date catalogue of NM used in cosmetics (Fig. 1).Fig. 1

Bottom Line: According to the cosmetics directive [76/768/EEC], compounds that are classified as mutagenic, carcinogenic or toxic to reproduction are banned for the use in cosmetic products.Special notification procedures are mandatory for preservatives, colourants and UV-filters where a safety approval from the European 'Scientific Committee on Consumer Safety' (SCCS) is needed prior to marketing.The risk assessment of nanomaterials in consumer products still poses a significant challenge as highlighted by the example of UV-filters in sunscreens since nanomaterials cannot be classified as a homogenous group of chemicals but still need to be addressed in risk characterisation on a case by case basis.

View Article: PubMed Central - PubMed

ABSTRACT
In Europe, the data requirements for the hazard and exposure characterisation of chemicals are defined according to the REACH regulation and its guidance on information requirements and chemical safety assessment (Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and its guidance documents; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF ; and at: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm ). This is the basis for any related risk assessment. The standard reference for the testing of cosmetic ingredients is the SCCP's 'Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation' (The SCCP's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (2006); available at: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_03j.pdf ), which refers to the OECD guidelines for the testing of chemicals (The OECD Guidelines for the Testing of Chemicals as a collection of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to assess the safety of chemical products; available at: http://www.oecd.org/topic/0,2686,en_2649_34377_1_1_1_1_37407,00.html ). According to the cosmetics directive [76/768/EEC], compounds that are classified as mutagenic, carcinogenic or toxic to reproduction are banned for the use in cosmetic products. Since December 2010, the respective labelling is based on the rules of regulation (EC) No. 1272/2008 (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, Official Journal L 353, 31/12/2008, pages 1-1355; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF ) on classification, labelling and packaging of substances and mixtures (CLP). There is no further impact from the CLP regulation on cosmetic products, because regulation (EC) No. 1223/2009 on cosmetic products defines its own labelling rules (Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF ). Special notification procedures are mandatory for preservatives, colourants and UV-filters where a safety approval from the European 'Scientific Committee on Consumer Safety' (SCCS) is needed prior to marketing. The risk assessment of nanomaterials in consumer products still poses a significant challenge as highlighted by the example of UV-filters in sunscreens since nanomaterials cannot be classified as a homogenous group of chemicals but still need to be addressed in risk characterisation on a case by case basis.

Show MeSH
Related in: MedlinePlus