Chemical safety of toys has long been a concern of the toy manufacturers. The reason is that toy manufacturing involve different raw materials and chemicals which may potential having the hazardous chemical like heavy metals, phthalates, PAH, formaldehyde, nitrosamine, etc….Worldwide countries to ensure that toys are safe and non-toxic having regulation to govern the hazardous chemicals.
In this article, the recent regulation update of chemical requirement for toys in EU and US markets will be interpreted for details.
1. EU Chemical Updates for Toys
A. Toy Safety Directive Appendix C – Formaldehyde
(EU) 2019/1929 was published on 20 Nov 2019 to restrict formaldehyde in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth. (Effective on May 21, 2021)
|Substance||Limit Value||Toy Material||Test Method|
|Formaldehyde migration||1.5 mg/L||Polymeric||EN 71-10:2005 & EN 71-11:2005|
|Formaldehyde emission||0.1 ml/m³||Resin-bonded wood||EN 717-1:2004|
|Formaldehyde||30 mg/kg||Textile||EN ISO 14184-1:2011|
|30 mg/kg||Leather||EN ISO 17226-1:2008|
|30 mg/kg||Paper||EN 645:1993 & EN 1541:2001|
|10 mg/kg||Water-based||EDQM method|
- Polymeric toy material, actual testing only on melamine-formaldehyde, urea-formaldehyde, polyacetal resin, phenolic resin polymer and rubber.
- Water-based material such as finger paint, bubble solution, playdough, and modelling clay will be tested
- Resin-bonded wood material, perform first screening by EN 717-3 first. PASS will be issued if no detectable formaldehyde is found. If any detectable formaldehyde is found, EN 717-1 (the chamber method) will be performed for confirmation.
B. EU Commission Amends 2009/48/EC for Aluminium Limits
EU Commission Amends 2009/48/EC with respect to Aluminium limits. The limit values for AI have been amended and effective on 20 May 2021. You may also refer to below summary of changes
|Mg/kg in dry, brittle, powder-like or pliable toy material||Mg/kg in liquid or sticky toy material||Mg/kg in scraped-off toy material|
|Aluminium (current limits)||5,625||1,406||70,000|
|Aluminium (revised limits)||2,250||560||28,130|
CEN Published EN 71-3:2019+A1:2021 for Migration of Certain Elements in Toys
The amendment is expected to be harmonized under the Toy Safety Directive 2009/48/EC when it is accepted by the European Commission and announced in the Official Journal of the European Union (OJEU).
Major Changes in Amendment
Modifications to clause 4.2 “Specific requirements” will include the new migration limits for Aluminium which have been amended by Commission Directive (EU) 2019/1922 and will be applied from May 20, 2021, under EU Toy Safety Directive.
|Migration limit (mg/kg)|
|Element||Category I||Category II||Category III|
NOTE : Harmonised standard of EN 71-3 is still 2019 version.
C. New update of EU food contact 10/2011 amendment
The European Commission published Regulation (EU) 2020/1245 to amend Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food is effective on 23 March 2021.
Added more metal elements in SM test
|Specific migration limit (SML) (mg/kg food or food simulant)|
(Detection Limit = 0.01)
(Detection Limit = 0.002)
(Detection Limit = 0.01, if pre-existing documentary evidence can proof Cr VI in the material is excluded during the entire production process, detection limit of 3.6 mg/kg can be applied)
|Lead||Not Detectable (Detection Limit = 0.01)|
|Mercury||Not Detectable (Detection Limit = 0.01)|
Specific migration of Primary Aromatic Amines (Annex II)
Detection limits for Primary Aromatic Amine (PAA) are revised:
- ≤ 0.002 mg/kg for each PAA listed under REACH Annex XVII Entry 43 (Appendix 8) and for which no migration limit is specified in Table 1 of Annex I
- ≤ 0.01 mg/kg for the sum of PAAs not listed under REACH Annex XVII Entry 43 (Appendix 8) and for which no migration limit is specified in Annex I
Overall Migration Testing Condition
- New testing condition OM 0 (30 mins at 40˚C) is introduced for any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes)
Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, and which were first placed on the market before March 23, 2021 may continue to be placed on the market until September 23, 2022 and remain on the market until the exhaustion of stocks.
D. New update of Fragrance under EU TSD
The European Commission has published Directives (EU) 2020/2088 and 2020/2089 to amend Annex II to Toy Safety Directive 2009/48/EC regarding the prohibition and labelling of allergenic fragrances in toys.
Member states shall apply the amendments from July 5, 2022.
Summary of the Amendment:
List of prohibited allergenic fragrance extended (from 55 to 58 allergenic fragrances)
- Add 3 allergenic fragrances
|Name of allergenic fragrances||CAS Number|
|Methyl heptane carbonate||111-12-6|
Presence of traces of these fragrances shall be allowed provided that such presence is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg.
List of allergenic fragrances which require labelling extended (from 11 to 71 allergenic fragrances)
- Add 61 allergenic fragrances
- Add 2 CAS no. to Citronellol (111-12-6) as it becomes a prohibited allergenic fragrance
If the fragrance is added to a toy or its component at a concentration exceeding 100 mg/kg, the name of the allergenic fragrances shall be labelled on the toy & on an affixed label & on the packaging, or in an accompanying leaflet.
E. EU Restricts Aniline Under Toy Safety Directive Appendix C
European Commission published (EU) 2021/903 to restrict aniline in certain toy materials in Jun 2021. The Directive introduce new limit values for aniline in textile, leather toy materials and finger paints under Appendix C to Annex II of the Toy Safety Directive 2009/48/EC with effective date 5 Dec, 2022. Limit values for aniline (CAS no. 62-53-3) used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth.
|Anline||30 mg/kg after reductive cleavage in textile toy materials|
|30 mg/kg after reductive cleavage in finger paints|
|10 mg/kg as free aniline in finger paints|
Note: Textile and leather material of aniline can be covered by azo dye testing reference to EN ISO 14362-1 and EN ISO 17234-1. Finger painting can be well covered by EN 71- 7
F. EU harmonized standard for toys testing
European Commission published (EU) 2021/867 to announce an updated complete list of harmonised standards in support of Toy Safety Directive 2009/48/EC in May 2021
The new version of standards EN 71-7:2014+A3:2020, EN 71-12:2016 are now listed as the harmonised standards under Toy Safety Directive (Note: BV can offer the most updated harmonized testing of EN 71 part 7 and part 12)
|No||Reference of the standard|
|1||EN 71-1:2014+A1:2018 Safety of Toys – Part I: Mechanical and physical properties|
|2||EN 71-2:2011+A1:2014 Safety of Toys – Part 2: Flammability|
|3||EN 71-3:2019 Safety of Toys – Part 3: Migration of certain elements|
|4||EN 71-4:2013 Safety of Toys – Part 4: Experimental sets for chemistry and related activities|
|5||EN 71-5:2015 Safety of Toys – Part 5: Chemical Toys (sets) other than experimental sets|
|6||EN 71-7:2014+A3:2020 Safety of Toys – Part 7: Finger paints – Requirements and test methods|
|7||EN 71-8:2018 Safety of Toys – Part 8: Activity toys for domestic use|
|8||EN 71-12:2016 Safety of Toys – Part 12: N-Nitrosamines and N-nitrosatable substances
Informative note: The limit values in point a) of Table 2 of clause 4.2 of standard “EN 71-12:2016 Safety of Toys – Part 12: N-Nitrosamines and N-nitrosatable substances” are lower than the limit values to be complied with set in point 8 of part III of Annex II to Directive 2009/48/EC in particular those values are as follows:
|9||EN 71-13:2014 Safety of Toys – Part 13: Olfactory board games, cosmetic kits and gustative games|
|10||EN 71-14:2018 Safety of Toys – Part 14: Trampolines for domestic use|
Note: Our position of EN 71-12 adopt to 2016 version, for type (a) product below when failure EN 71-12 : 2016 requirement but data is still below 2009/48/ EC level of nitrosamine.
According to EN 71-12:2016, requirement for Elastomers
|Product Type||N-Nitrosamines||N-Nitrosatable Substances|
|Toys intended for use by children under 36 months and intended or likely to be ok placed into the month||0.01mg/kg in total||0.1 mg/kg in total as N-Nitrosamines after Nitrosation|
EN 71-12:2016 Safety of Toys – Part 12: N-Nitrosamines and N-nitrosatable substances
Informative notes: The limit values in standard “EN 71-12:2016 Safety of Toys – Part 12: N-Nitrosamines and N-nitrosatable substances’ are lower than the limit values to be complied with set in point 8 of part III of Annex II to Directive 2009/48/EC. In particular those values are as follows:
|Substance||Standard EN 71-12:2016||Directive 2009/48/EC|
|N-nitrosamines||0.01 mg/kg||0.05 mg/kg|
|N-nitrosatable||0.1 mg/kg||1 mg/kg|
2. US & Canada Chemical Updates for Toys
A. US state - Massachusetts Restricts Flame Retardants in Bedding, Furniture, Window Treatments, Carpeting and Children’s Products
- Scope of products included under the state law
- Covered products: bedding (mattress pad, sheeting, pillow, comforter, blanket, sleeping bag or any other stuffed article for reclining or sleeping),
- Window treatments (curtain, shades, blinds),
- Carpeting (fabric floor covering including padding),
- Residential upholstered furniture, seating or other upholstered products
- Children’s product, a consumer product intended made or marketed for use by children 12 years of age or under.
- The following chemical flame retardants are restricted under the law
- Tris(1,3-dichloro-2-propyl) phosphate (TDCPP)
- Tris(2-chloroethyl) phosphate (TCEP)
- Antimony trioxide
- Hexabromocyclododecane (HBCD)
- Bis(2-Ethylhexyl)-3,4,5,6-tetrabromophthalate (TBPH)
- 2-EthylhexY1-2,3,4,5-tetrabromobenzoate (TBB)
- Chlorinated paraffins
- Tris (1-chloro-2-propyl)phosphate (TCPP)
- PentaBDE, • OctaBDE, • Tetrabromobisphenol A (TBBPA)
The law restricts the chemicals used as follows: “A manufacturer or retailer shall not sell, offer or manufacture for sale, distribute a covered product, except for inventory manufactured prior to December 31, 2021, that contains any of the chemical flame retardants or a chemical analogue the total weight of which exceeds 1,000 ppm.
B. Canada Seeking Comments on Proposed Regulation Amending Surface Coating Materials Regulations
Health Canada is proposing the Regulations Amending to modify the Surface Coating Materials Regulation under CCPSA
Canada expects that most products on the Canadian market already comply with the proposed amendments. The proposal would benefit industry by improving aligning with the US regulations, thereby, reducing regulatory testing.
Key proposed changes include:
- Expands the meaning of a surface coating to include surface coating materials that do not “dry” on application, such as powder coatings that are applied electrostatically, and other decorative surface coating materials that may be applied to products during manufacture, such as stickers, decals or films that can be removed from the surface.
- Expands the 90 mg/kg total lead limit in surface coating materials applied, to ALL furniture, not just children’s furniture as currently required. This will align with the US requirement of 16 CFR 1303.
- Removes the heavy metal restriction on inaccessible materials and the soluble heavy metal test method and allows the use of ASTM F963 or EN71-3 test method.
- Provides clarity that the Surface Coating Materials Regulations apply to Expansion Gates and Expandable Enclosures Regulations. And consistency regarding the Surface Coating Materials Regulations across the Toys Regulations, the Expansion Gates and Expandable Enclosures Regulations, the Cribs, Cradles and Bassinets Regulations and the Playpens Regulations.
NOTE : Health Canada is proposing that the regulations come into force on the 180th day after the regulations are published in the Canada Gazette, Part II. Comments regarding the proposed regulations will be accepted until July 3, 2021.
Click the below link for proposed regulation and background information: https://www.gazette.gc.ca/rp-pr/p1/2021/2021-04-24/html/reg1-eng.html
Recommendations from Bureau Veritas:
The safety of classical & juvenile products is the most prior concern for consumers, especially parents. To protect children from hazardous chemicals and minimize the risk of being recalled, it is suggested to gain an authorized certificate of related tests.
Bureau Veritas is an authorized lab to deliver the above certification, all the mentioned testing method and other international testing, inspection/audit and certification. To design optimized solutions for your global market access needs, you are welcomed to contact us. If you have any comments and/or questions about this article, please visit: https://www.cps.bureauveritas.com and click HERE for more technical news update or webinars like this.