October 12, 2023
In August 2023, the ISO organization published Part 12 of the ISO 8124 standard series for toy safety.
This document specifies acceptable criteria for microbiological cleanliness and adequacy of preservation for specified toy materials. The requirements in this document apply to all toys that contain or are supplied with aqueous materials (e.g., paste, putty, liquid or gel). In addition, this document applies to toys that are or include a cosmetic. Powders and similar substances intended to be mixed with water are also within the scope of this document.
This document has been developed under working group WG 10 Microbiological Properties of ISO TC 181 that is related to the safety of toys.
Part 12 is the first ISO 8124 addressing microbiological requirements of toys, even if there are already other documents published with reference to microbiological safety.
This standard is largely based on existing requirements in ASTM F963, with some modifications to narrow the scope and facilitate the use of the document in multiple jurisdictions.
There are some differences in this standard in comparison with the European microbiological reference for toys called Protocol No 2: Microbiological safety of toys containing aqueous media (Rev 4).
The main differences are summarized in the table below:
| EU NB Protocol No. 2: Microbiological safety of toys containing aqueous media (Rev 4) | ISO 8124-12:2023 | |
|
Scope |
The following toy categories: Aqueous liquid, modelling clays based on aqueous formulations, finger paints, gels and semi-liquids based on aqueous formulations reported in the scope are subject to microbial requirements |
The requirements in this document apply to all toys that are, contain or are supplied with aqueous materials (e.g., paste, putty, liquid or gel). In addition, this document applies to toys that are or include a cosmetic. Powders and similar substances intended to be mixed with water are also within the scope of this document. |
|
Risk assessment |
Risk evaluation not mentioned |
There is a specific risk evaluation section to determine if products are susceptible to microbial growth or have a low likelihood of supporting microbial growth. |
|
Aqueous liquid definition |
Aqueous liquids are defined as a water-containing liquid/paste in a toy, on a toy or accompanying a toy to which the child is likely to become exposed during normal or foreseeable use of the toy (e.g., liquid paints, bubble liquids, ink in pens, liquid provided with toys for squirting, liquid in teethers and pacifiers). |
Aqueous toy material is defined as toy material with a water activity of ≥0,5. |
|
Limits |
Limits for total aerobic mesophilic count (TAMC) and total yeast and mold count (TYMC) aren’t differentiated for toys categories. -Total aerobic microbial count (TAMC) for all toys covered ≤ 1000 cfu/g or ml -Yeast and mold for all toys covered (TYMC) ≤ 100 cfu/g or ml. Note: if values are over limits for TAMC, test after seven days is needed. |
Limits for total aerobic mesophilic count (TAMC) and total yeast and mold count (TYMC), assessed separately, are differentiated for toys categories. In particular, limits for TAMC are lower for specific kinds of toys, such as face paints for use by a child or on a doll, materials specifically intended to be used in or around the eye area or mucous membrane, for example, lipstick or eye shadow, toys for children under 3 years. |
|
Challenge |
Microbiological Challenge (preservation effectiveness) not mentioned in the requirements |
Microbiological Challenge (preservation effectiveness) with different limits for different category of products |
UL Solutions laboratories can help you test your articles for compliance with this new standard.
Our global team of experts and worldwide network of testing laboratories offer you a variety of services to help increase consumer confidence in your products, including in the microbiological safety of toys.
Reference
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