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Kant. Laboratorium BS Page 2 of 4 Sample description The samples were collected at customs (6 sets), and further samples were taken from stores in the Cantons of Aargau and Basel-City. Country of origin Number of sets (samples) Germany 7 (39) China 3 (14) Netherlands 2 (9) Malaysia 1 (8) France 1 (2) Total 14 (72) Test method Because of the broad scope of this investigation, a wide range of methods were used to test the finger paints: Parameter group Number of of which parameters permitted Methods UV-active preservatives 46 24 HPLC-DAD Isothiazolinones 3 2 HPLC-DAD Redox-active preservatives 3 3 HPLC-ECD Free formaldehyde 1 1 HPLC-DAD Quaternary ammonium compounds 15 8 HPTLC Iodopropynyl butylcarbamate (Screening) 1 1 HPLC-MS Bittering agents (Screening) 3 3 HPLC-MS Aromatic amines 33 - HPLC-MS Aromatic amines following reductive cleavage 29 - HPLC-MS Colouring agents (KLVD customs samples) approx. 100 - HPTLC and UV Results Preservatives • Three sets (19 paints) contained more than the permitted 15 mg/kg of methyl isothiazolinone/methylchloro isothiazolinone (MI/MCI). On the basis of the values found and the fact that particularly MCI is not stable, it can be concluded that the finger paints were originally preserved with between 30 and 60 mg/kg depending on the set. MI/MCI is known to be a potent allergen. Allergies to MI/MCI are particularly problematic as several cosmetics, every-day chemic<strong>als</strong> (for example starch sprays for ironing), as well as colourants and varnish are preserved with MI/MCI. • Furthermore, the following preservatives were found (number of sets affected shown in brackets). All concentrations were within the legal requirements. Phenoxyethanol (2), methyl- (8), ethyl- (1), propyl- (6), and butyl- (2) paraben, 4-hydroxybenzoic acid [as degradation product of the parabens (2)], sorbic acid (3), o- phenylphenol (5), bronopol (3), free formaldehyde (6). Formaldehyde is not usually used directly but is released by several different preservatives, such as bronopol, diazolidinyl urea and imidazolidinyl urea. • No non-permitted preservatives were detected. Bittering agents According to EN 71/7, finger paints need to contain denatonium benzoate, saccharose octaacetate, or naringin as a bittering agent. A bittering agent (denatonium benzoate) was only detected in 7 of the sets. However, the LC-MS method, with a limit of detection of approximately 25 µg/g, does not cover the whole activity range specified by the standard for denatonium benzoate (up to 4 µg/g). The concentration of denatonium benzoate in samples was generally between 100 and 300 µg/g. In those cases where no bittering agent was detected, the manufacturers were asked. The answers indicated that none of the samples contained the required bittering agent. Report0602.doc compiled: 25.01.06 07:31:00
Kant. Laboratorium BS Page 3 of 4 Colourants No non-permitted colourants or pigments were detected. Phthalocyanin pigments (C.I. 74160 and 74260) were the most common colourants used to produce blue and green tones. Azo and quinoline colourants were most commonly used for yellow, orange and red colours – this colour group <strong>als</strong>o contained the majority of the 31 non-identified colourants and pigments. One sample contained Pigment Red 2, which is not on the positive list for finger paints. It is however covered by EN 71/7, 4.2.2, according to which all colourants which are not classified as being carcinogenic, mutagenic, teratogenic, very toxic, toxic, harmful to health, corrosive, irritant or sensitizing may, nevertheless, be used as colouring agents in finger paints. C.I. Number C.I. Level Number of samples C.I. 74160 Pigment Blue 15 13 C.I. 74260 Pigment Green 7 10 C.I. 47005 Acid Yellow 3 6 C.I. 16255 Acid Red 18 4 C.I. 42051 Acid Blue 3 4 C.I. 11680 Pigment Yellow 1 3 C.I. 21100 Pigment Yellow 13 3 C.I. 11710 Pigment Yellow 3 1 C.I. 12310 Pigment Red 2 1 C.I. 77007 Pigment Blue 29 1 C.I. 77268 Food Black 3 1 Iron oxide 1 Titanium dioxide 1 not identified 31 Total 80 Aromatic amines as impurities or following reductive cleavage • The finger paints investigated did not contain detectable levels of carcinogenic primary aromatic amines according to 4.5. The tertiary aromatic amines Michler’s ketone, methane base and auramine O were likewise not detected. • In one sample, approx. 7 mg/kg o-toluidine following reductive cleavage with sodium hydrosulfite (according to EN 71/7). This was just under the limit value of 10 mg/kg, but indicates that o-toluidine is present as a pigment component. The red pigment itself could not be identified. Declaration Not for the first time, warning notices were not present in all three official languages (5 of 14), as required due to Switzerland being a trilingual country. It is however astonishing that so many products bearing the CE label do not conform to the requirements of European Standard 71/7 regarding declaration and warning notices. The declaration of preservatives and bittering agents, required by the standard was absent in no less than 8 of 14 cases. In one case, only the trade name for the preservative, which will mean little to the consumer, was used. The warning notice “Caution! Children under 3 years must be supervised by an adult” was completely absent from two packs. Measures taken The Canton in which the importer is based is responsible for measures taken. Sale of samples containing MI/MCI in excess of the limit value was forbidden. Conclusions • The requirements for finger paints are clearly defined in a European standard. All samples carried the CE sign, thereby indicating their conformity with EN 71/7. Despite this, 12 of 14 finger-paint sets failed to fulfil important aspects of this standard, casting the manufacturers and their accrediting agencies in a poor light. Indeed, analytical investigations had to be carried out in our laboratory to demonstrate the limit value exceedance and absence of bittering agents, whereas simple inspection of the formulations and packaging would have Report0602.doc compiled: 25.01.06 07:31:00
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