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New EU Toys Directive doesn’t sufficiently protect children’s health

29/2008, 29.12.2008

BfR recommends improvements to safety and non-toxicity of toys

The provisions concerning the chemical safety of toys approved in the new EU Toys Directive in December 2008 are not sufficient. Some of them even lead to a worsening of consumer protection. This is the conclusion of the Federal Institute for Risk Assessment (BfR). "As children are far more sensitive to chemical substances than adults, we need particularly stiff provisions on the non-toxicity of toys", says BfR President Professor Dr. Dr. Andreas Hensel. BfR is particularly critical of the new limit values for heavy metals in children’s toys. According to the new Directive toys may, in future, actually release more lead than in the provisions in force up to now. The Directive does not afford children sufficient protection against fragrances and nickel that can cause allergies either.

Young children in particular hold toys for several hours in their hands and also put them in their mouths. Chemical substances may be released from the toys and reach their bodies. The manufacturers of toys must, therefore, ensure that these substances will not harm the children’s health. They must act in accordance with the European Toys Directive, the amended version of which was adopted on 18 December 2008. According to BfR the provisions in the Directive are not sufficient to protect children from the health risks posed by chemical substances.

The Directive does stipulate that CMR substances - these are substances that can trigger cancer (carcinogenic), damage the genotype (mutagenic) or impair reproduction (reprotoxic) - may not be used in toys. On the other hand, the limit values of chemical legislation are to apply in future to toys. According to that, toys may contain up to 0.1 percent (1 g/kg toy material) of these CMR substances. This is not sufficient to protect children’s health. Hence, BfR is of the opinion that any toys that can fit into a child’s mouth must be assessed just as strictly as materials that come into contact with food. According to that, the release of CMR must not be detectable analytically. The new Directive only envisages this for toys intended for children under the age of 36 months.

Many substances can also be taken up through the skin. They include CMR substances, biocides or allergens. This should be borne in mind especially in the case of toys that come into prolonged and intensive contact with the skin like fingerpaints or play-dough. There are no provisions on this in the Directive. BfR is of the opinion that cosmetics legislation points the way on how to close this gap.

The development of allergies can only be prevented by keeping contact with allergenic substances as far as possible to a minimum. The new Toys Directive does contain a list of 55 banned allergenic substances. However, in reality this ban on use is partially revoked through the introduction of a limit value of 0.01 percent (100 ppm = 100 mg/kg) for admissible trace levels.

Nickel is the most frequent trigger of contact allergies of the skin. For products with prolonged skin contact like jewellery or buttons, there is therefore a nickel limit value which, in the opinion of BfR, should be applied to toys. However, the new Toys Directive does not envisage a limit value for nickel.

BfR deems the new provisions for heavy metals in toys to be unacceptable from the angle of the health protection of children. The Directive allows children in future to take in far higher amounts of lead, mercury, arsenic, antimony and barium from toys than in the past. This is particularly well illustrated by the example of materials that children can nibble on and swallow from toys. Up to now, 90 milligrams of lead per kilogram toy was the permitted amount that could be released from these materials. In future, the limit value is 160 mg/kg. The previously valid value of 1000 milligram barium per kilogram toy was even raised to 56000 mg/kg. This is particularly critical in the case of lead as this heavy metal can damage the nervous system and even the smallest amounts have been proven to have a negative effect on the development of intelligence in children.

BfR is pleased with the new maximum levels for the release of nitrosamines and nitrosatable substances from toys that are placed in the mouth like balloons. Older children will be afforded far greater health protection against these carcinogenic and mutagenic substances. However, children under the age of 36 months put toys in their mouths daily for periods of up to several hours. BfR, therefore, believes it is necessary to apply lower limit values for nitrosamines to toys for this age group. These values could be oriented towards the limit values for dummies and teats.

Toys on sale in the retail trade must be safe. Up to now, manufacturers themselves confirm the compliance of their products with the safety requirements by using the CE mark. Despite this, unsafe toys were often found on the market in the past. Unfortunately, the demand by the German government for this process to be rendered more objective by means of products tests carried out by independent laboratories was not taken over into the Directive.