In January,2022, the European Commission published the fourth Revision of Protocol No2 on Microbiological safety of toys containing aqueous media. This protocol provides a specification of the microbiological requirements on toys covered by its scope and since there are no particular microbiological requirements for toys, the Notified Body toys group elaborated a protocol on the basis of the requirements for cosmetic products.
Previous revisions and changes
The document includes an overview of the previous and the latest revisions of protocols on the microbiological safety of toys containing aqueous media since microorganisms increase in the presence of water. The newest version of the Protocol contains only one change in paragraph 2 as regards the limitations of microbiological safety, where “Enterobacteriaceae” will be replaced by their general category of “bile-salts tolerant gram-negative bacteria”. This is to ensure that all the parts of that category will be included in the Protocol.
Provisions of the Protocol
The protocol starts with its scope, which constitutes toys including aqueous liquid, modelling clays based on aqueous formulations, finger paints, gels and semi-liquids based on aqueous formulations, and their respective definitions.
Limitations indicating microbiological safety – following European test methods – are presented as follows:
· Total aerobic microbial count (TAMC) 1 ≤ 1000 cfu/g or ml
· Yeast and mould: ≤ 100 cfu/g or ml
· Staphylococcus aureus: Absent in 1 ml or g
· Pseudomonas aeruginosa: Absent in 1 ml or g
· Candida albicans: Absent in 1 ml or g
· Escherichia Coli: Absent in 1 ml or g
· Salmonella spp.: Absent in 1 ml or g
· bile-salts tolerant gram-negative bacteria: ≤ 100 cfu/g or ml
Thereafter, the Protocol illustrates the test procedures and divides methods of use in four categories:
1. Test for microbial contamination European Pharmacopeia EP
2. United States Pharmacopeia USP
3. The European methods for the microbiological testing of cosmetics
4. The European methods for the microbiological testing of water and foods
Eventually, the final paragraph presents some conclusive remarks. In particular, it indicates that these specifications should not apply to raw materials, as this does not necessarily impact the hazards of the final product (toys). ’So it is inappropriate to expect that the technical dossier should contain microbiological test data for raw materials’’ (NB-Toys, 2022). Moreover, the Protocol does not apply to products being returned as a result of a consumer complaint due to lack of knowledge on possible adverse treatments.
Manufacturers who wish to place toys in the EU market need to comply with the Toys Safety Directive (TSD 2009/48/EC). Obelis will gladly act as your professional Authorized Representative!
Contact us now to learn more on how to place your toys in the EU market!
Regulatory Affairs Department
· European Commission. 2022. Protocol No 2: Microbiological Safety of toys containing aqueous media. Retrieved on 24/02/2022 from https://ec.europa.eu/docsroom/documents/48375?locale=en.
· European Commission. 2009. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys. Retrieved on 24/02/2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009L0048.