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Kant. Laboratorium BS Page 1 of 4<br />

Finger paints / preservatives, primary aromatic amines, bittering agents,<br />

colourants and declaration<br />

Customs campaign by the Federal Office of Public Health (BAG) (6 sets and 30 individual<br />

samples) – measurements by Basel-City (specialist laboratory) and Vaud (colourants)<br />

Further samples from the Cantons of Aargau (3 / 16) and Basel-City (5 / 26)<br />

Number of sets investigated: 14<br />

(72 individual samples):<br />

Grounds for objection:<br />

Sets objected to: 13 (93%)<br />

Excessive amounts of preservative (3); no bittering<br />

agent (7); no declaration of bittering agent and/or<br />

preservative (8); no warning notices (2); warning notice<br />

not present in all official languages (5)<br />

Background<br />

Finger paints are mainly used by pre-school children.<br />

During use, considerable skin surface area comes into<br />

contact with the paint. There is <strong>als</strong>o the possibility that<br />

children will lick their fingers and therefore swallow fairly<br />

large quantities of the paints.<br />

For these reasons, finger paints were the first toys for<br />

which the use of organic chemical compounds was<br />

regulated. The European Standard on Toy Safety – part<br />

7, finger paints – requirements and test methods (EN<br />

71/7, for short) came into force in 2002. It includes three<br />

positive lists, regulating preservatives, colourants and<br />

bittering agents permitted for use in finger paints. Furthermore, it specifies that finger paints<br />

must contain bittering agents to prevent children from licking their fingers. As many colourants<br />

and pigments may contain toxic aromatic amines, limit values are established for the most<br />

critical of these substances. Concrete warning notices are <strong>als</strong>o prescribed. In general, all<br />

information should be present in the relevant national language.<br />

Following a transitional period in which manufacturers were allowed time to adapt their products<br />

to the standard, an inspection of this product category was considered necessary in 2005.<br />

Aims of the investigation<br />

The aim of the investigation was a broad inspection of the Swiss market for compliance of the<br />

most important parameters with EN 71/7. This was achieved through a customs inspection<br />

programme led by the BAG. Further samples were collected in the Cantons of Basel-City and<br />

Aargau.<br />

Preservatives, bittering agents and aromatic amines, present either as impurities or due to<br />

reductive cleavage of the colourants were investigated by the state laboratory of Basel-City.<br />

Colourants were investigated by the state laboratory of the Canton of Vaud (KLVD).<br />

Furthermore, the required warning notices were checked, although in the case of customs<br />

samples these can theoretically be added by the Swiss importer at a later stage.<br />

Statutory basis<br />

Parameter<br />

Assessment<br />

Warning notice EN 71/7, 6.2.2<br />

Warning notice in three official languages EN 71/7, 6.1<br />

Declaration of preservative and bittering agent EN 71/7, 6.2.2<br />

Preservatives<br />

EN 71/7, 4.3 and appendix B<br />

Bittering agents EN 71/7, 4.6<br />

Colouring agents<br />

EN 71/7, 4.2.2. and appendix A<br />

Aromatic amines – impurities EN 71/7, 4.5<br />

Aromatic amines from reductive cleavage of azo-dyes EN 71/7, 4.2.3<br />

Report0602.doc compiled: 25.01.06 07:31:00


Kant. Laboratorium BS Page 2 of 4<br />

Sample description<br />

The samples were collected at customs (6 sets), and further samples were taken from stores in<br />

the Cantons of Aargau and Basel-City.<br />

Country of origin<br />

Number of sets<br />

(samples)<br />

Germany 7 (39)<br />

China 3 (14)<br />

Netherlands 2 (9)<br />

Malaysia 1 (8)<br />

France 1 (2)<br />

Total 14 (72)<br />

Test method<br />

Because of the broad scope of this investigation, a wide range of methods were used to test the<br />

finger paints:<br />

Parameter group<br />

Number of of which<br />

parameters permitted<br />

Methods<br />

UV-active preservatives 46 24 HPLC-DAD<br />

Isothiazolinones 3 2 HPLC-DAD<br />

Redox-active preservatives 3 3 HPLC-ECD<br />

Free formaldehyde 1 1 HPLC-DAD<br />

Quaternary ammonium compounds 15 8 HPTLC<br />

Iodopropynyl butylcarbamate (Screening) 1 1 HPLC-MS<br />

Bittering agents (Screening) 3 3 HPLC-MS<br />

Aromatic amines 33 - HPLC-MS<br />

Aromatic amines following reductive cleavage 29 - HPLC-MS<br />

Colouring agents (KLVD customs samples) approx. 100 - HPTLC and UV<br />

Results<br />

Preservatives<br />

• Three sets (19 paints) contained more than the permitted 15 mg/kg of methyl<br />

isothiazolinone/methylchloro isothiazolinone (MI/MCI). On the basis of the values found and<br />

the fact that particularly MCI is not stable, it can be concluded that the finger paints were<br />

originally preserved with between 30 and 60 mg/kg depending on the set. MI/MCI is known to<br />

be a potent allergen. Allergies to MI/MCI are particularly problematic as several cosmetics,<br />

every-day chemic<strong>als</strong> (for example starch sprays for ironing), as well as colourants and<br />

varnish are preserved with MI/MCI.<br />

• Furthermore, the following preservatives were found (number of sets affected shown in<br />

brackets). All concentrations were within the legal requirements.<br />

Phenoxyethanol (2), methyl- (8), ethyl- (1), propyl- (6), and butyl- (2) paraben,<br />

4-hydroxybenzoic acid [as degradation product of the parabens (2)], sorbic acid (3), o-<br />

phenylphenol (5), bronopol (3), free formaldehyde (6). Formaldehyde is not usually used<br />

directly but is released by several different preservatives, such as bronopol, diazolidinyl urea<br />

and imidazolidinyl urea.<br />

• No non-permitted preservatives were detected.<br />

Bittering agents<br />

According to EN 71/7, finger paints need to contain denatonium benzoate, saccharose<br />

octaacetate, or naringin as a bittering agent. A bittering agent (denatonium benzoate) was only<br />

detected in 7 of the sets. However, the LC-MS method, with a limit of detection of approximately<br />

25 µg/g, does not cover the whole activity range specified by the standard for denatonium<br />

benzoate (up to 4 µg/g). The concentration of denatonium benzoate in samples was generally<br />

between 100 and 300 µg/g. In those cases where no bittering agent was detected, the<br />

manufacturers were asked. The answers indicated that none of the samples contained the<br />

required bittering agent.<br />

Report0602.doc compiled: 25.01.06 07:31:00


Kant. Laboratorium BS Page 3 of 4<br />

Colourants<br />

No non-permitted colourants or pigments were detected. Phthalocyanin pigments (C.I. 74160<br />

and 74260) were the most common colourants used to produce blue and green tones. Azo and<br />

quinoline colourants were most commonly used for yellow, orange and red colours – this colour<br />

group <strong>als</strong>o contained the majority of the 31 non-identified colourants and pigments.<br />

One sample contained Pigment Red 2, which is not on the positive list for finger paints. It is<br />

however covered by EN 71/7, 4.2.2, according to which all colourants which are not classified<br />

as being carcinogenic, mutagenic, teratogenic, very toxic, toxic, harmful to health, corrosive,<br />

irritant or sensitizing may, nevertheless, be used as colouring agents in finger paints.<br />

C.I. Number<br />

C.I. Level<br />

Number of<br />

samples<br />

C.I. 74160 Pigment Blue 15 13<br />

C.I. 74260 Pigment Green 7 10<br />

C.I. 47005 Acid Yellow 3 6<br />

C.I. 16255 Acid Red 18 4<br />

C.I. 42051 Acid Blue 3 4<br />

C.I. 11680 Pigment Yellow 1 3<br />

C.I. 21100 Pigment Yellow 13 3<br />

C.I. 11710 Pigment Yellow 3 1<br />

C.I. 12310 Pigment Red 2 1<br />

C.I. 77007 Pigment Blue 29 1<br />

C.I. 77268 Food Black 3 1<br />

Iron oxide 1<br />

Titanium dioxide 1<br />

not identified 31<br />

Total 80<br />

Aromatic amines as impurities or following reductive cleavage<br />

• The finger paints investigated did not contain detectable levels of carcinogenic primary<br />

aromatic amines according to 4.5. The tertiary aromatic amines Michler’s ketone, methane<br />

base and auramine O were likewise not detected.<br />

• In one sample, approx. 7 mg/kg o-toluidine following reductive cleavage with sodium<br />

hydrosulfite (according to EN 71/7). This was just under the limit value of 10 mg/kg, but<br />

indicates that o-toluidine is present as a pigment component. The red pigment itself could<br />

not be identified.<br />

Declaration<br />

Not for the first time, warning notices were not present in all three official languages (5 of 14),<br />

as required due to Switzerland being a trilingual country. It is however astonishing that so many<br />

products bearing the CE label do not conform to the requirements of European Standard 71/7<br />

regarding declaration and warning notices. The declaration of preservatives and bittering<br />

agents, required by the standard was absent in no less than 8 of 14 cases. In one case, only the<br />

trade name for the preservative, which will mean little to the consumer, was used. The warning<br />

notice “Caution! Children under 3 years must be supervised by an adult” was completely absent<br />

from two packs.<br />

Measures taken<br />

The Canton in which the importer is based is responsible for measures taken. Sale of samples<br />

containing MI/MCI in excess of the limit value was forbidden.<br />

Conclusions<br />

• The requirements for finger paints are clearly defined in a European standard. All samples<br />

carried the CE sign, thereby indicating their conformity with EN 71/7. Despite this, 12 of 14<br />

finger-paint sets failed to fulfil important aspects of this standard, casting the manufacturers<br />

and their accrediting agencies in a poor light. Indeed, analytical investigations had to be<br />

carried out in our laboratory to demonstrate the limit value exceedance and absence of<br />

bittering agents, whereas simple inspection of the formulations and packaging would have<br />

Report0602.doc compiled: 25.01.06 07:31:00


Kant. Laboratorium BS Page 4 of 4<br />

been adequate for the accrediting agencies to determine that the products did not conform to<br />

the standard.<br />

• The high objection rate, in a product category for which there are uniform requirements<br />

throughout Europe demonstrates yet again that official inspection of these products is<br />

essential. It is less surprising that finger paints have apparently not yet been investigated by<br />

any other European laboratory, since the analysis of non-food products is a secondary<br />

consideration.<br />

• Because of the poor results from this year, a repeat of the campaign in 2006 is planned.<br />

Report0602.doc compiled: 25.01.06 07:31:00

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