Plasticizers in Toys

The Consumer Council has commissioned research work on the subject of release of chemicals from plastics used in toys. In practical sucking experiments involving students — world-wide the first ones of that kind — it was be demonstrated that the released amounts could be much higher than those measured using static migration tests of food contact materials. The Consumer Council also had a leading role in the development of analytical methods for the determination plasticizers in the standardisation of chemicals in toys. In addition, it represents European consumer organisations in a working group of the Commission on chemicals in toys.

Additional Information

The Consumer Council has been dealing with the subject: “Release of chemicals from plastics” for many years. In a diploma thesis prepared at the Institute of Food Chemistry at the Vienna University of Technology the migration of a plasticizer (diethylhexylphthalate) from a PVC film was investigated between 1996 and 1997. There was evidence that, under practical conditions, a much higher release of the substance occurs than that in usual food packaging tests. The value determined in sucking experiments was a factor of 25 above the result of static migration tests during which the materials to be tested were simply dipped into a solution (simulant). This is of relevance with respect to toys and baby articles which are put into the mouth by small children.

Disquieting high release

A further diploma thesis focussed on the release of phthalates from PVC teethers. As was the case in the prior work practical sucking experiments were carried out. As to these products it could also be confirmed that sucking or biting leads to a considerably higher migration than static laboratory tests have proved so far. Thus critical amounts of these substances can be ingested by small children and the respective limitting values might be exceeded. The work has been published (“Migration of DEHP and DINP from PVC articles” - PDF-file 48KB)

Research activities carried out so far have met with high interest as witnessed by enquiries from abroad. Following the example of the Consumer Council practical sucking experiments have also been carried out within the framework of an extensive Dutch study later on. Among others the results of the studies have been drawn upon by the EU Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE), a European committee of toxicologists advising the Commission concerning the evaluation of such chemicals.

In 1999 the Commission has imposed preliminary bans on phthalates used in toys and baby articles, intended to be mouthed by children up to 3 years of age. However, consumer and environmental organisations have strongly pushed for a permanent ban of phthalates in all products intended to be used by children of this age group. Instead of a ban the Commission under the pressure of industry initially intended to establish a migration limit instead of a ban. However, the Member States refused this.

In December 2005 the Directive “relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles)” was eventually approved (2005/84/EC). It provides that the phthalates DEHP (diethylhexylphthalate), DBP (dibutylphthalate) and BBP (butylbenzylphthalate) must not be used generally in child care articles and toys (limit 0.1%). In addition, DINP (diisononylphthalate), DIDP (diisodecylphthalate) and DNOP (di-n-octylphthalate) are banned in toys which can be mouthed. These restrictions were subsequently taken over in Annex XVII of REACH (1907/2006).

In this context it is worth mentioning that phthalates are just a small group out of the complete chemical repertoire used in toys. Therefore, the Commission entrusted CEN with the preparation of respective standards in 1996. These standards were intended to cover the most important substance groups - solvents, preservatives, colorants, plasticizers, monomers and flame retardants.

Consumer Council “Lead Laboratory”

Jointly with the Institute of Food Chemistry at the Vienna University of Technology (now: Institute of Chemical Engineering) the Consumer Council has applied as “Lead Laboratory” in the field of plasticizers (with the exemption of phthalates) and has been charged with this task. The Lead Laboratory develops the method, which is subsequently checked by two “peer review laboratories”.

First, however, individual plasticizers to be included in the standard had to be defined. The selection was based on recommendations by a group of toxicologists. Initially 33 substances were on the list of plasticizers to be tested. However, it turned out that in most cases the available toxicological data were insufficient for a risk assessment.

In addition, the Commission insisted that only chemicals classified as dangerous according to European chemical legislation are incorporated into the standard (the Commission was concerned about delays in the preparation of the standard and wanted to prevent further hold-ups of the work). Thus only 4 plasticizers were included in the standards (EN 71-9 bzw. -11) which were published in 2005.

Nevertheless the analytical work of the Consumer Council covered more than 20 different plasticizers. After successful verification of the results by two laboratories (LGA, Nuremberg and AIJU, Alicante) the project report was finalised in February 2003. It was approved by the CEN working group soon afterwards. The final report is available here as PDF-file (“Determination of plasticizers”, 567KB):

Later on the Consumer Council has commissioned a follow-up study in order to test the new method on practice. The validation results of the first study could be cofirmed using real toy samples this time. 20 toy samples purchased in the Vienna area were tested for plasticizers. Critical phthalates were found in two samples in higher amounts. Also this work is available here as PDF-file (“Plasticizers in toys: Method validation using toy samples and analysis of toys”, 3267KB).

Further, the Consumer Council supported a doctoral thesis which extended the investigations carried out on the subject of phthalates in the past to cover other plasticizers (adipates, citrates). It could be shown that the migration behaviour of these substances is similar to that of phthalates which is relevant when a risk assessment is carried out.

Chemical apparatus

Revision of the Toy Safety Directive

The European standards for chemicals in toys cover only a small fraction of the used substances. Hence, they cannot sufficiently protect children. There were also big gaps in the EU Toy Safety Directive adopted in 1988 (88/378/EEC) in this field. That’s why the European consumer associations ANEC and BEUC have called for a significant strengthening of the directive. The Consumer Council had a leading role in the preparation of several position papers prepared in this context.

The papers focused on a complete ban of:

In addition, an evaluation of substances with adverse effects on the hormone system (endocrine disrupters) was called for. Another demand was to permit in toys for children up to 3 years only substances which are approved as food contact materials. Finally, it was suggested to enable the Commission the setting of limit values for problematic chemicals in a so-called comitology procedure. From a consumer perspective it did not seem to be useful to charge the standardisation bodies with this task in view of the strong dominance of business interests.

Unfortunately these demands were taken up only in a very limited way in the revised Directive (2009/48/EC). There was, for instance, a (patchy) ban of CMR substances but linked to very high concentration thresholds. The consumer organisations were not satisfied at all. But also some Member States and test institutions expressed criticism.

The flaws became more and more apparent. At least the Directive foresees that limits can be established for toys intended for children below 36 months and other toys intended to be placed in the mouth using a Comitology procedure. In October 2010 a working group was established to assist decision making in this respect. However, progress was rather limited. A comprehensive critique of the chemical provisions of the Toy Safety Directive and the activities of this group is included in an ANEC/BEUC position paper prepared under the lead of the Consumer Council at the end of 2012. It is here available as PDF-file (202KB).