Toddler with a plastic toy in the mouth

Chemicals in Articles for Children

The Consumer Council has commissioned several research projects concerning chemicals in toys and other articles for children. The first ones concerned the release of chemicals from plastics used in toys in the years 1996-2000. 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 a standardisation project addressing organic chemicals in toys within the European standardisation organisation CEN and has been involved in standardisation related to toy safety for more than 25 years.

In addition, the Head of the Office of the Consumer Council (Franz Fiala) represented European consumer organisations in a working group of the Commission on chemicals in toys. In this function he could initiate two legal restrictions concerning formaldehyde and aniline in certain toys.

The Consumer Council had also a leading role in the development of a guideline dealing with chemicals in child care articles (CEN/TR 13387-2). In September 2017 work was initiated to transform the guideline into a standard. Despite some opposition and some delays among other as a result of corona measures the development of the draft standard progressed well. The public enquiry is expected to be initiated in autumn 2021.

Release of chemicals from plastic toys

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.

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 limit values might be exceeded. The work was published in 2000: "Migration of di-(2-ethylhexyl)phthalate (DEHP) and diisononyl phthalate (DINP) from PVC articles" (see "Downloads Project").

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" for plasticizers

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, respectively, -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 as PDF-file: "Determination of plasticizers" (see "Downloads Project").

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 confirmed 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 as PDF-file: "Plasticizers in toys: Method validation using toy samples and analysis of toys" (see "Downloads Project").

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.

Revision of the Toy Safety Directive

There were big gaps in the EU Toy Safety Directive first 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.

Unfortunately these demands were taken up only in a very limited way in the revised Directive adopted in 2009 (2009/48/EC). For instance, a ban of CMR substances was introduced which was linked to very high concentration thresholds which are based on the rules for classification of mixtures according to Regulation 1272/2008/EC on classification, labelling and packaging of substances and mixtures (CLP) allowing e.g. up to 0,1% of a category 1A or 1B carcinogen or mutagen and even up to 1% of a category 2 carcinogen or mutagen. For substances toxic for reproduction up to 0,3% are allowed for category 1A or 1B and up to 3% for category 2. These provisions were found inadequate in an opinion on organic CMR substances in toys expressed by the Scientific Committee on Health and Environmental Risks (SCHER) in 2010. Hence, the limits must be significantly lowered.

One of the fundamental flaws of the Directive is that the Commission can only set specific limits for chemicals in toys intended for children below 36 months and other toys intended to be placed in the mouth using a Comitology procedure. Such limits have been adopted for several chemicals - the Consumer Council could initiate two legal restrictions concerning formaldehyde and aniline - but do not apply to toys for older children. This is absurd. The Directive should include a Committee procedure (Member States voting) which allows the adoption or modification of limits for chemicals in all kinds of toys for all age groups and all kinds of substances including generic limits for groups of substances in a fast and flexible way.

Further deficits which should be addressed include, for instance:

- Substances of Very High Concern (SVHCs) included in REACH Annex XIV should be prohibited in toys.

- Sensitizers other than allergenic fragrances (currently covered) should be banned.

- Persistent, bio-accumulative and toxic chemicals (PBT), as well as very toxic and very bio-accumulative (vPvB) chemicals, should be prohibited.

- Endocrine disrupting chemicals (EDCs) shall be addressed in toys following a priority list.

- Migration limits for nitrosamines and nitrosatable substances in toys intended for use by children under 36 months, or in other toys intended to be placed in the mouth are inadequate and shall be reduced.

- Either an approval system for biocides shall be introduced in the TSD, or the current exemption for toys in the biocidal products regulation shall be removed.

- Nanomaterials shall not be used in toys unless endorsed by a scientific committee.

- In the long run an approval system (positive list system) shall be established for certain substances such as colourants or preservatives in certain toys in line with current provisions in the Cosmetics Regulation.

The European Commission published a Staff Working Document concerning the evaluation of the Toy Safety Directive (TSD) and an associated Executive Summary in November 2020. It is stated that "the Directive’s effectiveness is deficient in several points, in particular on chemicals" which "require urgent attention" and highlights some of the points mentioned above. This gives some hope that at least some of the deficits will be remedied in the next revision - but this may take years.

Children's products other than toys

Directed by the Consumer Council (Franz Fiala) the Guide CEN/TR 13387-2 "Child use and care articles - General safety guidelines - Part 2: Chemical hazards" of the CEN/TC 252 was elaborated and published in Juli 2015. Three years later the publication of a revised version followed. The other parts of the series address the safety philosophy and safety assessment (Part 1), mechanical hazards (Part 3), thermal hazards (Part 4) und product information (Part 5). These Guides are primarily intended to inform the activities of the working groups of the Techical Committee (TC), but are in principle also addresssed to external parties concerned with the safety of products.

Unfortunately the recommendations concerning chemical hazards were taken into consideration in the preparation of specific product standards only in a limited way. Hence, the upgrading of the Guide to a standard was debated subsequently. Finally the Technical Committee gave green light for the preliminary activation of a related work item im September 2017. This allowed to initiate the development of a standard but does not constitute a final decision to filalise the work.

After several years of discussion a draft entitled "Child care articles - Chemical hazards - Requirements and test methods" was completed. In the following ballot the necessary majority was failed by a small margin. Hence, the publication of the draft standard (public enquiry) was delayed. Also the corona measures have contributed to the postponement. The draft was once again revised and subjected to another vote in summer 2021. This time the necessary majority could be achieved. Hence, the document will be submitted to the public enquiry. It is pleasing that the level of the draft is somewhat higher than the applicable rules in the toy sector which constituted an important point of reference.

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