August 18, 2020
Why it’s dangerous?
The risk of infection is posed if the toy containing aqueous media is swallowed or comes into contact with skin when microbiological contamination is present. Examples of toys containing aqueous media are toys with an aqueous liquid, modeling clay, finger paints and gels.
Specific risk
Microbiological contents contain the following:
- Mesophilic aerobic microorganism
- Pseudomonas aeruginosa
- Pseudomonas species
- Aerobic colony
- Enterobacteriaceae
- Pathogenic micro
- Staphylococcus haemolyticus
- Staphylococcus warneri
Requirements
Microbiological safety of toys (Rev 1 v2) under the Notified Bodies Recommendations and Protocols specifies microbiological requirements for:
- Toys containing aqueous liquid (bubble soap)
- Modeling clays based on aqueous formulations
- Finger paints
- Gels and semi-liquids based on aqueous formulations
Limitations on different microbiological contents:
NOTE:
1 Great care is required in using this measure because it is not a good indicator of the risk posed. For example many categories of food such as fresh fruit and vegetables, cooked meats, sandwiches (especially with salad fillings), cream cakes, pastries, cheesecake etc all are considered acceptable to eat if they have a TAMC of 105 to 107 (10 E5 to 10 E7) c.f.u per gram, especially as testing is performed on finished products and not on raw materials. A TAMC value over 1000 cfu/g or ml shall not necessarily be regarded as a non-compliance and should be reviewed on a case by case basis taking into account the nature of the material and the way it is used in a toy. It is advised to retest values over 1000 cfu/g or ml after storage for 7 days at room temperature. If the second test is decreasing (at least 1 log) with reference to the first test result, the TAMC value can be considered as immaterial. Samples with TAMC over 100 000 cfu/g or ml should be regarded as non-compliant in general.
2 Guidelines should not be taken alone to prove that the product is unsafe or non-compliant. Further work may be necessary to establish whether sufficient preservation was used and its effectiveness.
3 E. Coli is used as an indicator of potential contamination by pathogens of the family of Enterobacteriaceae.
4 As pathogens other than Escherichia Coli and Salmonella spp are not specified, the Enterobacteriaceae limit is introduced to cover for other pathogens.
Suggested testing package
The microbiological risk in toys containing aqueous media should be tested accordingly to the EC-type approval protocol No. 2, Microbiological safety of toys containing aqueous media.
Overview reports of SAFETY GATE notifications, published free of charge in English on ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/index_en.htm, © European Union, 2005–2020. The official contact points of the Member and EFTA-EEA States provide the information published in these weekly overviews. Under the terms of Annex II.10 to the General Product Safety Directive (2001/95/EC) responsibility for the information provided lies with the notifying party. The Commission does not take any responsibility for the accuracy of the information provided.