25 Nov 2016
Expert Assessment on Phthalate Substitutes in Plastic Toys and Children’s Equipment Shows No Health Risk for Children Less Than Three Years of Age
The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) recently published the results of its expert assessment on the health risks of oral exposure to chemicals found in plastic toys and children’s equipment intended for children less than three years of age.
While Hong Kong traders may be relieved to know that the study did not find any risk to children’s health for four of the phthalate substitutes studied, ANSES did nonetheless make a number of important recommendations in its conclusion. If implemented by French authorities, some of these recommendations could potentially impact manufacturers and importers offering toys and children’s products on both the French and EU markets.
The expert assessment, carried out by the French Expert Committee (CES) on risks related to chemical substances, was requested by ANSES in light of the existing hypothesis that exposure to chemicals found in consumer products, during the critical years in children’s development, is linked to the increased occurrence of certain diseases. These include neurodevelopmental disorders, reproductive problems and obesity. Considering the ratio between exposure and body weight, children are thought to be relatively more exposed than adults to many chemicals.
In this context, ANSES issued a formal internal request in order to examine health risks of mouthing plastic toys – in particular, infant toys, dolls and construction toys – and children’s equipment intended for children up to three years of age. Children’s equipment refers to products intended to ensure or facilitate the seating, bathing, sleeping, transportation, and the movement and physical protection of children as well as teething rings, pacifiers, etc.
Justifying its decision to pursue this particular assessment, ANSES referred to the existence of several behavioural studies on children under the age of three which showed that plastic is the material most commonly put in the mouth, as well as the fact that plastic toys account for the majority of toys purchased in France.
Following the request, the CES made a health risk assessment choosing to focus on phthalate substitutes because such substances are widely included in plastic toys, especially since 2005 when the EU introduced a ban on certain toxic phthalates in toys. The assessment therefore concentrated on the following five substances used as substitutes for phthalates: (i) 1,2-cyclohexane dicarboxylic acid diisonyl ester (DINCH), (ii) diethylhexyl-terephthalate (DEHTP), (ii) bis(2-ethylhexyl) isophthalate (DOIP), (iv) acetyl-tributyl-citrate (ATBC), and (v) 2,2,4-trimethyl-1,3-pentanediol diisobutyrate (TXIB). The assessment specified that DEHP and DINP were not selected as their uses are already subject to restriction measures in toys and childcare articles under the REACH Regulation.
In the assessment, the CES performed composition tests on a sample of toys and articles for children (bibs, teething rings, pacifiers), followed by migration testing in saliva simulant. Measurements of the endocrine activity of the migration fluid were then taken and a risk assessment was made.
The assessment was limited to exposure through diffusion and dissolution by saliva, so exposure through direct ingestion of part of the toy was not taken into consideration. In choosing to narrow the assessment, the CES referred to the fact that EU legislation already prohibits the use of detachable small parts in toys aimed at children less than three years, in order to prevent the risk of choking.
Following a detailed examination of existing scientific information, the methodology used, and the results of the health risk assessment, the CES concluded that there was no health risk for children under three years old who mouthed the tested toys containing ATBC, DEHTP, DINCH and TXIB. In their findings, the CES noted that these results were consistent with those of investigations that had been carried out by other organisations.
With respect to DOIP, the assessment found that the health risk could not be determined due to the absence of existing information on the substance’s hazards. The study did, however, confirm it had been found in toys in France, and moreover, some safety data sheets indicated that DOIP caused reprotoxic effects.
While describing the results of the assessment as “mainly optimistic”, the CES made a number of recommendations which were endorsed by ANSES.
Firstly, the CES identified from several product safety “RAPEX” alerts (which can be found on the European Commission’s website) that many restricted or prohibited phthalates are still found in toys marketed in Europe. It therefore sought to underline the need for continued controls in the toy sector to ensure that all toys available on the market comply with safety regulations.
Secondly, the CES recommended integrating into the Toy Safety Directive 2009/48/EC an additional obligation to perform migration tests in saliva simulant before toys for children less than three years of age could be placed on the market.
Thirdly, the CES recommended systematic risk assessment for all new substances used in the manufacturing of plastics which are to be made into toys and equipment for children.
Fourthly, given the lack of published data currently available for DOIP, the CES recommended avoiding its use before knowledge on its toxicity has first been acquired.
Fifthly, as regards the methodology used in the assessment, the CES recommended conducting in vivo measurements in children under three who intentionally put plastic toys in their mouths (e.g. saliva samples from young children, etc.). It also recommended performing tests on worn, used, old or artificially aged toys in order to obtain information on the evolution of migration by salvia.
Sixthly, noting that only migration by saliva was investigated in this study, the CES recommended conducting additional studies in order to assess the contribution of each route to the exposure of children during contact with a plastic toy. In particular, the CES emphasised the value of determining the exposure levels of children via the skin and through other mediums (e.g., air, dust, food, etc.).
Following on from this last recommendation, ANSES has announced its plans to undertake an assessment in the near future on the cumulative health risks associated with certain phthalates classified as toxic for reproduction, taking into account exposure through several mediums.