18 July 2011
Formamide is classified as a reprotoxic substance (1B) under the terms of European regulations (1). At the end of 2010, when it was shown to be present in foam puzzle mats intended for young children, France's Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) suspended all marketing of these items. At the same time, it asked ANSES to carry out an expert assessment of the hazards associated with this substance, to identify its uses in common consumer goods and to assess the risks related to its presence in puzzle mats. The Agency issued a preliminary report in March 2011 and has today published an Opinion and a Collective Expert Assessment Report on the uses of formamide in common consumer goods and, more specifically, on the risks related to the presence of this substance in foam puzzle mats.
An analytical survey shows that the sectors that use formamide are principally the chemical, pharmaceutical,plastics and polymers industries, for which it is mainly used as a solvent, plasticiser or adjuvant for a blowing agent in the production of foam. It was not possible to characterise either theorigin or the precise reason for its presence in puzzle mats. However, ANSES emphasises that other consumer goods, including toys, are likely to contain formamide, particularly those produced from Ethylene-Vinyl Acetate (EVA) foam, which is similar to the foam used in puzzle mats.
An infrequent risk, but one that cannot be excluded
As regards the toxic effects of formamide, the results of studies on animals indicate that formamide initially acts on the hematopoietic (2) and reproductive systems, irrespective of the duration and route of exposure. Some data from rats exposed throughout their lifetimes suggest a potential carcinogenic effect, but these need to be confirmed by acquiring more extensive data. No studies were found that had investigated the direct effects on humans.
An assessment of the risk concerning formamide in puzzle mats shows that exposure of both children and adults occurs principally through inhalation. Tests carried out on three puzzle mats each produced emission profiles behaving similarly over time:
- strong emission of formamide, decreasing rapidly during the first few days;
- more moderate emission (from 50 to 200 µg/m3) for the first week of use;
- emission in the region of 20 to 30 µg/m3 after the first month of use.
ANSES used these figures as a basis for calculating short- and long-term exposure to formamide. Although it is not possible to exclude health risks (hematopoietic disorders) related to exposure to formamide in puzzle mats recently placed on the market in France (at the end of 2010), especially with regard to infants, the probability of these risks occurring is low (less than 5%). Furthermore, there appears to be no likelihood of health risk for adults, including pregnant women.
Recommendations for five types of action
In the light of these findings, ANSES first stresses that toys should not contain dangerous substances or preparations, especially carcinogenic, mutagenic or reprotoxic substances such as formamide, which has been classified as a reprotoxic substance in category 1B under the terms of the European Regulation.
Second, concerning the specific case of puzzle mats, ANSES recommends:
minimising as best as possible exposure of young children (under three years old) to the formamide contained in puzzle mats. This can be achieved by the following measures:
- Risk managers should limit the sale of puzzle mats by subjecting them to tests to ensure that formamide emissions from puzzle mats do not exceed a concentration of 20 µg/m3 measured after 28 days of confinement in an outgassing chamber after unpacking a new puzzle mat.
- Consumers should unpack new puzzle mats and keep them for several days in a room not frequented by the child, before using them; this is to avoid the exposure of young children (up to three years) to formamide emission levels that are potentially higher during the first few days after the puzzle mat has been unpacked.
ensuring that toys, and especially puzzle mats, are not produced using formamide:
- by finding out why this substance is present in these products, especially by investigating the hypotheses that it is used either as a plasticiser or as a substance associated with a blowing agent (azodicarbonamide) used in the production of objects formed from foam;
- by identifying or developing, if necessary, substitutes for formamide in these products, which should be possible as this substance is not found systematically in these articles.
screening other foam-based consumer goods for the possible presence of formamide, especially in products intended for very young children.
acquiring further knowledge concerning:
- the effects of formamide on fertility, for example by mechanistic and targeted exposure studies on animals for periods of exposure likely to exacerbate sensitivity to effects on fertility (juvenile and pubertal phases);
- the carcinogenic potential of formamide and its mechanism of action.
(1) Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging
(2) Organs contributing to the formation of blood components