A survey and health assessment of cosmetic products for children

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10 fragrances in the product. For the five other products, a declaration of a few of the 26 fragrances was missing as these fragrances according to the analyses are found in a concentration in the products so they have to be declared separately as described in the Cosmetics Statutory Order. According to the Cosmetics Statutory Order the new legislation applies for products being produced after March 2005. It is possible that the analyzed products are produced before March 2005 and therefore still keep the Cosmetics Statutory Order. The analyses of the 11 products for Kathon showed that none of the products exceeded the permissible content of 15 mg/kg. However, in three of the products a content of Kathon was identified even if the products according to the declaration of content had no content of Kathon. Analysis of the packaging material of the products A number of products (14) were examined for a content of chlorine in the packaging material as an indication that the material was made of PVC. Based on the plastic type code on the packaging the survey showed that eight other products had packaging of PVC. In total 10 packaging materials were examined for the content of phthalates. The phthalate types being identified were primarily DEHP and DINP. The total phthalate content in the examined packaging materials was 31% as a maximum. All the examined products with a content of phthalates were designed as a cartoon figure, an animal or similar. DEHP and DINP were banned as per 16 April 2007 in toys for children up to 14 years in a concentration above 0.1% - for DINP only in toys which children might put into the mouth. The Danish Safety Technology Authority has indicatively stated that two of the analyzed products are toys while the other analyzed products are child care articles. Some of these products will thus be in discrepancy with the new phthalate legislation. All the analyzed products were legal at the time of analysis (November 2006). Ten products were analyzed for their content of heavy metals in the packaging material. All the measured total values of heavy metals in the packaging materials are significantly below the set threshold values indicating the amount of metals which may migrate out of the toys when in use. The measured total values are not cause for concern in relation to the existing threshold limits for migration of substances from toy materials. For the same reason no migration analyses of selected products were conducted. Health assesment/risk assesment On the basis of the results of the quantitative analyses of cosmetic products for children a risk assessment of the analyzed products for their content of Kathon and benzyl alcohol is conducted based on the acute toxicity of the substances. The risk assessment showed that the margin of safety (MoS) is far from being exceeded in most cases. In general, there is no health risk by using the analyzed products in relation to the content of Kathon and benzyl alcohol respectively.
1 Introduction A number of cosmetic products, especially shampoo, soap, eau de toilette and hair dyes, are marketed as products for children. The Danish Environmental Protection Agency had the assumption that the market for this product group is increasing. The packaging of the products is often very colourful and can be designed as for instance cartoon figures. This causes that the products can also be used as toys in some cases. The products are regulated by the Cosmetics Statutory Order (Danish: Kosmetikbekendtgørelsen) and in some cases also the regulations for toys. It is the Danish Safety Technology Authority who as a competent authority assesses which products coming under the regulations for toys. In this project there is a distinction between products being assessed to be designed as for instance figures and therefore can be used as toys, and products which according to the indicative statement of the Danish Safety Technology Authority are assessed to be covered by the regulations for toys. The purpose of the project was to • Map whether cosmetic products for children contain substances which can be problematic for children’s health. Focus is especially on perfume substances, preservatives and colouring agents. • Map whether the product packaging causes that the products can be used as toys. • Investigate whether cosmetic products for children meet the labelling requirements for cosmetics (i.e. whether the declaration of contents and producer is stated) and possibly also for toys (CE marking). • Assess possible health consequences of the found constituents in cosmetic products for children. • Assess possible health consequences of the found constituents in the packaging of products which can be used as toys. 11
Page 1 and 2: A survey and health assessment of c
Page 3 and 4: Contents PREFACE 5 SUMMARY AND CONC
Page 5: Preface This project ”A survey an
Page 8 and 9: 8 that cosmetic products for childr
Page 12 and 13: 12 2 Definition of cosmetic product
Page 14 and 15: 14 3 Legislation In the following t
Page 16 and 17: 16 According to §13 of the Cosmeti
Page 18 and 19: 18 4 Survey One of the purposes of
Page 20 and 21: 20 Shops where we have looked for p
Page 22 and 23: 22 Table 4.2: information about the
Page 24 and 25: 24 • There are spelling mistakes
Page 26 and 27: 26 in the survey period from mid-Ap
Page 28 and 29: 28 whereas a high number (low ranki
Page 30 and 31: INCI Name CAS No. CI 16255 2611-82-
Page 32 and 33: 32 an offer to importers/producers
Page 34 and 35: 34 4.3.9 Constituents with restrict
Page 36 and 37: 36 Table 4.9: Overview of products
Page 38 and 39: 38 The 26 fragrances mandatory to d
Page 40 and 41: 40 INCI Name 5-BROMO-5-NITRO-1,3- D
Page 42 and 43: 42 INCI Name Function (as stated in
Page 44 and 45: 44 things. According to the Toys St
Page 46 and 47: 46 5 Analysis results The purpose o
Page 48 and 49: 48 Kathon - one series of five prod
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60 5.3 Analyses of selected packagi
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62 5.3.2.2 Content of heavy metals
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64 Table 5.15: Content of phthalate
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66 6 Health assessment 6.1 Selectio
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68 Identification Chemical name Ben
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70 Tabel 6-1: Acute toxicy (LD50) o
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72 fragrance/preservative benzyl al
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74 regards sodium benzoate as being
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76 Table 6.3: Identification of Kat
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78 Table 6.5: Acute toxicity (LD50)
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80 this test a NOAEL of 250 ppm act
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82 Identification Chemical name 2-p
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84 Phenoxyethanol has shown damagin
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86 Table 6.8: Acute toxicity (LD50)
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88 7.1 Kathon Product type Number o
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90 100% of the Kathon to which the
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92 the content corresponds to a sma
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94 8 Discussion 8.1 Risk assessment
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96 Recommendations to consumers •
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98 http://www.videncenterforallergi
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100 Graham & Kuizenga, 1945. Graham
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102 NPIRI, 1974. ”Raw Materials D
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104 SCCNFP 0670, 2003. The Scientif
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106 Wibbertmann et al, Fraunhofer I
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108
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110 the product whereas a high numb
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112 2 All chemical substances found
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Chemical name as described in Is in
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118 INCI Name CAS No. Chemical name
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124 INCI Name CAS No. BRASSICA CAMP
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148 INCI Name CAS No. CITRUS AURANT
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164 Chemical name as described in I
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170 3 Chemical substances in the ma
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172 Is in number of Average INCI Na
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176 3.2 Balsam Is in number of Aver
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180 3.3 Body lotion/cream Is in num
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190 3.4 Body shampoo/bath gel Is in
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196 3.5 Shampoo Is in number of Ave
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198 2-BROMO-2- NITROPROPANE- 1,3-DI
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200 CI 42051 CI 16185 ECHINACEA ANG
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202 SODIUM LAUROAMPHOACE TATE PRUNU
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204 MAGNESIUM LAURETH-8 SULFATE sur
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Is in number of Average INCI Name C
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216 4 Constituents with restriction
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218 INCI Name CAS N. Function Is in
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A survey and health assessment of cosmetic products for children

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