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Survey of chemical substances in kohl and henna products

5 Conclusion

5.1 Kohl products

According to the Danish Statutory Order on Cosmetics (Bkg. 489, 2003) lead must not be added intentionally in cosmetics.

Lead was found in the main part of the analysed products above the detection limit of 0.05 µg/g, in 10 products between 0.30 and 1 µg/g, and in 4 products between 1 and 4 µg/g. Lead was only found in a high concentration (280 µg/g) in product no. 60 that was manufactured in India. The measured 280 µg/g corresponds to approx. 0.028 % of the product and is thus far below the concentrations measured in the foreign referenced studies.

According to the Danish Statutory Order on Cosmetics no. 489 (2003) besides lead the cosmetic products are not allowed to contain:

  • Antimony (Sb) and its compounds. Antimony was found in the screening at trace levels below 3 times the detection limit of 0.05 mg/kg in 3 products (ranging 0.09 to 0.15 mg/kg).
  • Arsenic (As) and its compounds. Arsenic was found in the screening in kohl product sample no. 60 at a concentration of 6 times the detection limit of 1 mg/kg (6.1 mg/kg).
  • Barium salts with the exception of barium sulphate, barium sulphide under the conditions laid down in Annex 3 in the Statutory Order, and lakes, salts and pigments prepared from the coloring agents listed with the note (3) in Annex 4 (i.e. must pass the test for insolubility which will be determined by the procedure laid down in the EU regulation). Barium was found unspecified as barium in 3 samples by the quantitative analysis between 14.5 and 6700 mg/kg.
  • Cadmium (Cd) and its compounds. Cadmium was found in the screening in kohl product sample no. 60 at 1.8 mg/kg. Further 2 products were found to contain cadmium around the detection limit of 0.05 mg/kg at 0.06 and 0.08 mg/kg.
  • Chromium; chromic acid and its salts. Chromium was found unspecified as chromium in the screening in all kohl products at the concentration interval from 0.6 to 18 mg/kg. The detection limit was 0.5 mg/kg.
  • Thallium (Tl) and its compounds. Thallium was found in the screening of kohl product samples no. 35, 51, 52 and 60 but only at trace levels below 5 times the detection limit of 0.05 mg/kg.

The amendment to the Directive on cosmetics (Directive 2003/15/EC, EC 2003) prohibits the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1, 2 and 3, under Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, but allows the use of substances classified in category 3 pursuant to Directive 67/548/EEC subject to evaluation and approval by the SCCNFP (Directive 2004/93/EC, EC2004).

The Directive mentions besides “lead and its compounds” also:

  • Nickel and certain of its compounds. Nickel was found in the screening of all kohl products at the interval between 1.4 and 56 mg/kg and in 10 out of 17 henna products at the interval between 1.7 and 8.7 mg/kg.
  • Cobalt dichloride and cobalt sulphate. Cobalt was found in the screening of 16 out of 18 kohl products at the interval between 0.11 and 51 mg/kg and in 10 out of 17 henna products at the interval between 0.59 and 1.1 mg/kg.
  • Potassium bromate. Bromine was not included in the analysis.

Based on the inorganic analyses a difference between ”Western” i.e. European and American manufactured and ”Eastern” i.e. from the Middle East and Asia manufactured kohl products was indicated.

5.2 Henna products

Lead was found in 10 out of the 17 analysed products. The contents of lead in the 10 products were measured at the interval from 0.5 mg/kg to 2.0 mg/kg.

According to the Statutory Order on Cosmetics no. 489, 2003, cosmetic products are not allowed to contain:

  • Antimony (Sb) and its compounds. Antimony was found in the screening of henna product sample no. 2 close to the detection limit of 0.05 mg/kg.
  • Arsenic (As) and its compounds. Arsenic was found in the screening of henna products sample no. 2, 3, 5 and 23 at concentrations below 3 times the detection limit at the range 1.3 to 2.5 mg/kg.
  • Barium salts with the exception of barium , barium sulphide under the conditions laid down in Annex 3 in the Statutory Order, and lakes, salts and pigments prepared from the coloring agents listed with the note (3) in Annex 4 (i.e. must pass the test for insolubility which will be determined by the procedure laid down in the EU regulation). Barium was found unspecific as barium in 10 samples by the quantitative analysis: In 8 samples at the interval between 24 and 65 mg/kg and in 2 samples, sample no. 57 and 58, at concentrations of 178000 mg/kg (17.8% m/m) and 17000 (17.0% m/m), respectively.
  • Cadmium (Cd) and its compounds. Cadmium was found in the screening of henna product samples no. 2, 12, 23 and 63 at trace levels close to the detection limit of 0.05 mg/kg at the range 0.05 to 0.07 mg/kg.
  • Chromium; chromic acid and its salts. Chromium was found unspecified as chromium in 10 of the products in the screening at the concentration range from 2 to 10 mg/kg. The detection limit was 0.5 mg/kg.

p-Phenylenediamine was found in 3 of the 17 products. The content in sample no. 11 and 58 was 0.5% (m/m) and 0.003% (m/m), respectively, while the content in sample no. 57 was 17% (m/m). The highest found concentration of 17% corresponding to 170 g/kg was above the limit of 6% given in the Statutory Order on cosmetics (Bkg. 489, 2003).

According to the Statutory Order (Bkg. 74, 14th of January 2005) p-phenylenediamine is placed in Annex 3 (i.e. allowed to be used in cosmetic preparations) with the following notes (cf. table below):

Table 8. Notations to p-phenylenediamine in the Statutory Order on Cosmetics, Annex 3

Reference no. (Annex, part and reference no. in Directive 76/768/EEC and later amendments 46 III, 8
Substance p-Phenylenediamine CAS-no. 106-50-3. Benzenediamines (1,4-benzenediamine, nitrogen substituted compounds of 1,2-, 1,3- and 1,4-benzenediamine and salts of 1,3- and 1,4-benzenediamine) (4), except those compounds mentioned elsewhere in this annex

(4 = These substances may be used individually or mixed depending that the sum of the concentration of each substance expressed as a fraction of the highest allowed concentration of the substance does not exceed 1)
Field of application and/or use Oxidising colouring agents for hair dyeing
a) general use
b) professional use
Maximum authorised concentration in the finished cosmetic product 6% calculated as free base
Other limitations and requirements -
Conditions of use and warnings which must be printed on the label a) Can cause allergic reaction (sensitivity test recommended). Do not use to dye eyelashes or eyebrows. Contain phenylenediamines
b) For professional use only. Can cause allergic reaction (sensitivity test recommended). Contains phenylenediamines.
Wear suitable gloves.

It is noted that p-phenylenediamine was found on the ingredients list to the products sample no. 57 and 58 but not in product no. 11.

Lawsone was found in 14 out of 25 analysed products above the detection limit. The 23 of the 25 samples had declared to contain lawsone (Lawsonia inermis, henna extract or herbal henna). One product (sample no. 3) did not declare to contain Lawsonia inermis but a different plant species. One product (no. 63) did not have an ingredients list.

How large a fraction of the products the ingredients Lawsonia inermis, henna extract or herbal henna actually covers is not given in the ingredients lists. The highest concentrations is therefore expected in products of powdered plant parts of Lawsonia inermis. This also appears to be the case for products no. 5, 6, 7, 8, 12, 23 and 63. The products all consisted of powdered plant parts and contained more than 1000 mg lawsone/kg product. The remaining 6 out of 12 powdered henna products contained between 40 and 730 mg lawsone/kg.

The highest concentration of lawsone was found in product no. 63 that was a foreign import from India and without an ingredients list. The highest measured concentration was 3400 mg/kg corresponding to 0.34% (m/m). The next highest concentration of lawsone was found in product no. 5 imported from United Kingdom and containing 3300 mg/kg corresponding to 0.33% (m/m). Product no. 6 from the same manufacturer in UK contained 2100 mg/kg corresponding to 0.21% of the product.

The concentrations in the remaining products were between 0.004 and 0.15% (m/m) of the product.

5.3 Summary conclusion

Comparing the results from this analysis to results found in the literature indicate a difference between ”Western” and ”Eastern” manufactured kohl products. Thus lead was not found at concentrations above 0.028% in the kohl products but the highest concentration was measured in a product from India. The highest concentration of the remaining analysed inorganic substances were mainly found in products made by ”Eastern” manufacturers (e.g. boron, barium, copper, strontium and zinc).

The same apparently applies to henna where the highest concentration of barium, p-phenylenediamine and lawsone was measured in products of ”Eastern” origin. The high concentrations of lawsone in products manufactured in the United Kingdom may be explained by import of raw materials (“natural henna”) from Asia.

 

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Version 1.0 September 2005, © Danish Environmental Protection Agency