Toys & Hardlines regulatory updates August 2023
Revision of the Toy Safety Directive
On 28 July 2023, the European Parliament and Council published a proposal for a regulation of the safety of toys and a repeal of Directive 2009/48/EC. On the same date, the European Commission also opened the feedback period for this adopted act.
Until 31 October 2023, all feedback received will be summarised by the European Commission and presented to the European Parliament and Council with the aim of feeding into the legislative debate.
On the European Commission website, several documents are available regarding this proposal, including an impact assessment report, a staff working document, and the proposal itself and its annexes.
For more information, please visit the European Commission website here.
Scientific opinion on the safety of titanium dioxide in toys
On 27 June 2023, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published a scientific opinion on the safety of titanium dioxide (TiO2) in toys. Inhalation and oral exposure were evaluated, and it can be concluded that toys containing pigmentary TiO2 can be used with no or negligible risk in the worst-case exposure scenarios considered, as long as the absence of an ultrafine fraction in the TiO2 pigments can be demonstrated.
For more information, please read the final opinion here on the European Commission website.
New amendment for plastic materials in FCM Regulation
On 1 August 2023, the Regulation EU 2023/1442 came into force. This amends the list of authorised substances in Annex I of the EU 10/2011.
The main amendments to the list of authorised substances in Annex I of Regulation (EU) No 10/2011 are as follows:
- Modification of the Specific Migration Limit (SML) for:
- Entry 159: Benzyl butyl phthalate, (BBP, CAS 85-68-7) to 6 mg/kg
- Entry 157: Dibutyl phthalate (DBP, CAS 84-74-2) to 0.12 mg/kg
- Entry 283: Di (2-ethylhexyl)phthalate (DEHP, CAS 117-81-7) to 0.6 mg/kg
- The sum of Diisodecyl phthalate (DIDP, CAS 68515-49-1) and diisononyl phthalate (DINP, CAS 28553-12- 1) to 1.8 mg/kg.
- Removed entry 96 on wood flour and fibres, untreated, and entry 121 on salicylic acid.
- Added five new entries:
|
Entry |
CAS No |
Substance name |
SML |
|
1078 |
3319-31-1 |
tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate |
1 mg/kg |
|
1080 |
156157-97-0 |
(triethanolamine-perchlorate, sodium salt) dimer |
0.05 mg/kg (sum of the triethanolamine and the hydrochloride compound expressed as triethanolamine) |
|
1081 |
- |
N, N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids |
1.2 mg/kg expressed as tertiary amine |
|
1082 |
52628-03-2 |
Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate |
0.05 mg/kg |
|
1083 |
2421-28-5 |
Benzophenone-3,3',4,4'-tetracarboxylic dianhydride (‘BTDA’) |
0.05 mg/kg |
To read the full amendments and requirements, visit the official publication on the European Commission website here.
Interesting technical publication related to food contact materials
The table below summarises the recent technical publications regarding food contact materials:
|
Date |
Entity |
Title |
|
31 July 2023 |
EFSA (European Food Safety Authority) |
|
|
27 July 2023 |
BfR (German Federal Institute for Risk Assessment) |
New EFSA risk assessment: Some mineral oil residues in food remain a health concern |
|
26 July 2023 |
EFSA (European Food Safety Authority) |
Oregon amends Toxic-Free Kids Act
On 27 July 2023, the State of Oregon passed HB 3043 to amend the Toxic-Free Kids Act that requires manufacturers of children’s products to report products containing High Priority Chemicals of Concern for Children’s Health (HPCCCH) if intentionally added or present as a contaminant that is equal to or greater than 100 ppm.
Please see below for some of the notable changes to the Toxic-Free Kids Act under the amendments:
- Authorises the inclusion of a class of chemicals on the list and exclusion from the list specific members of the class of chemicals, or a subclass of chemicals, that do not share the same hazards as the other members of the class of chemicals;
- Requires reports to also include brand name and model beginning;
- Allows a hazard assessment approved or deemed approved to be valid for a period of 3 years after the date of submittal of the hazard assessment; and
- Allows for a waiver if the HPCCCH is inaccessible to the consumer.
The amendment requiring brand name and model in reports will apply to reports submitted on or after 31 January 2026. All other amendments will become effective on 1 January 2024.
CPSC publishes final rule to codify the ban on crib bumpers
On 14 August 2023, the Consumer Product Safety Commission issued final rule 16 CFR 1309 to codify the ban of crib bumpers pursuant to the Safe Sleep for Babies Act of 2021, which requires that crib bumpers shall be considered a banned hazardous product under the Consumer Product Safety Act.
Crib bumpers are defined as any material that is intended to cover the sides of a crib to prevent injury to any crib occupant from impacts against the side of a crib or to prevent partial or complete access to any openings in the sides of a crib to prevent a crib occupant from getting any part of the body entrapped in any opening. It includes a padded crib bumper, a supported and unsupported vinyl bumper guard, and vertical crib slat covers; and does not include a non-padded mesh crib liner.
The statutory ban went into effect on 12 November 2022, and the effective date of the final rule will be 13 September 2023.
CPSC publishes final rule to codify the ban on inclined sleepers for infants
On 16 August 2023, the Consumer Product Safety Commission issued final rule 16 CFR 1310 to codify the ban of inclined sleepers for infants pursuant to the Safe Sleep for Babies Act of 2021, which requires that inclined sleepers for infants shall be considered a banned hazardous product under the Consumer Product Safety Act.
An Inclined sleeper for infants is defined as a product with an inclined sleep surface greater than ten degrees that is intended, marketed, or designed to provide sleeping accommodations for an infant up to 1 year old.
The statutory ban went into effect on 12 November 2022, and the effective date of the final rule will be 15 September 2023.
Extension of the adaptation date for pacifier conformity identification
On 9 August 2023, the Ministry of Development, Industry, Commerce and Services/National Institute of Metrology, Quality and Technology published a rectification of Inmetro Ordinance no. 301, of 12 July 2021, published in the Official Gazette of 16 July 2021. This consolidates the conformity assessment requirements for pacifiers/dummies.
It indicates the extension of the adaptation date of the design of the Conformity Identification Seal provided for in Annex II of Ordinance No. 301 to 30 June 2024.
The below table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):
|
The International Organization for Standardization (ISO) |
|||
|
Reference |
Title |
Publication date |
Previously |
|
Safety of toys — Part 2: Flammability |
May 2023 |
||
|
Safety of toys — Part 10: Experimental sets for chemistry and related activities |
May 2023 |
||
|
Safety of toys — Part 6: Certain phthalate esters |
August 2023 |
||
|
Safety of toys — Part 12: Microbiological safety |
August 2023 |
|
|
Below, you will find a monthly table summarising product recalls and alerts in Europe (Source” Safety Gate (RAPEX)” and “RASFF”) and the U.S. (Source “CPSC”)
Safety Gate (RAPEX) (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities)
The following 41 alerts regarding toy products were reported between week 29 and 34 of 2023.
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Toy police set |
|
|
Inflatable ball |
|
|
|
Plastic doll |
|
|
|
Finger paints |
|
|
|
|
Soft toy |
|
|
|
Toy masks |
|
|
Children's fancy dress outfit |
|
|
|
Ponytail artificial hair |
|
|
|
|
Heatable soft toy |
|
|
|
Soft toy |
|
|
Plastic toy set |
|
|
|
Pencil case |
|
|
|
Playdough |
|
|
|
Toy car keys |
|
|
|
Push-along toy |
|
|
|
Car toys |
|
|
|
Fishing toy |
|
|
|
|
Key ring |
|
|
|
Whistle toy |
|
|
|
Toy gun set |
|
|
|
Toy scooters |
|
|
Balance bicycles |
The following 11 alerts regarding childcare articles and children's equipment were reported between week 29 and 34 of 2023.
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Baby carrier/walker |
|
|
|
Baby self-feeding pillow |
|
|
|
Baby sleeping bag |
|
|
|
Children’s fancy dress outfit |
|
|
|
Children’s swimming jacket |
|
|
|
Soother holder |
|
|
|
Baby sleeping bag |
The following 1 alert regarding decorative articles was reported between week 29 and 34 of 2023.
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Mirror |
The following 1 alert regarding furniture was reported between week 29 and 34 of 2023.
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Furniture set bench |
The following 3 alerts regarding hobby/sports equipment were reported between week 29 and 34 of 2023.
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Bicycle |
|
|
|
Badminton set |
|
|
|
Swim seat |
The following 5 alerts regarding jewellery were reported between week 29 and 34 of 2023.
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Leather neckband |
|
|
Ring and ring set |
|
|
|
Earrings |
The following 1 alert regarding kitchen/cooking accessories was reported between week 29 and 34 of 2023.
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Disposable barbecues grill |
RASFF (European Commission Rapid Alert System for Food and Feed - Alerts reported by EU national authorities)
The following 4 alerts regarding food contact materials related to children's tableware were related to children's tableware were reported from 21 July 2023 to 20 August 2023.
|
Product |
Notes |
|
|
Bamboo cup |
Unauthorised use of bamboo fibres mixed with plastics in food contact material. |
|
|
Paper straws |
High content of isothiazolinone in paper straws. |
|
|
Food contact materials |
Levels above the MRL for formaldehyde in Food Contact Materials. |
|
|
Childrens Dish set made of bamboo |
Unauthorised use of bamboo fibres mixed with plastics in food contact material. The use of bamboo fibres with plastics is unauthorised for use in FCM. |
|
|
Children's sushi helpers |
Insufficient stability due to melamine migration in children's sushi helpers. |
|
OPSS issues Product Safety Alerts on the UK market.
The following 4 alerts regarding toy products were reported between week 29 and 34 of 2023.
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Activity gym |
|
|
|
Reusable water balloons |
|
|
|
Knitted toy |
|
|
|
Activity gym |
The following 3 alerts regarding childcare articles was reported between week 29 and 34 of 2023.
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Silicone dummy clip |
|
|
|
Pushchair (Pram) |
|
|
Baby playpen |
The following 2 alerts regarding sports equipment articles were reported between week 29 and 34 of 2023.
|
Hazard |
Number of alerts |
Notes |
|
|
|
Bicycle |
|
|
|
Stainless-steel beehive smoker |
The following 1 alert regarding decorative articles was reported between week 29 and 34 of 2023.
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Giraffe lantern and bear lantern |
The following 3 alerts regarding jewellery articles were reported between week 29 and 34 of 2023.
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Necklace and ring jewellery set |
|
|
Fashion jewellery - earrings |
From 27 July 2023 to 24 August 2023, the CPSC (Consumer Product Safety Commission) published the following recalls:
2 recalls regarding toy and childcare products.
|
Hazard |
Number of alerts |
Notes |
|
|
|
Sky wheels |
|
Toddler towers |
5 recalls of consumer products
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Table lamps |
|
|
|
Candles |
|
|
|
Carboys |
|
|
|
Fireworks |
|
|
|
Bike helmets |
2 recalls of furniture
|
Type of Risk |
Number of alerts |
Notes |
|
|
|
Mattresses |
|
|
|
Bed frames and floor beds |
