Toys & Hardlines regulatory updates September 2023

EUROPE

Technical publications related to toys

Below is a table with two recent publications related to toys:

Date	Entity	Publication
24 July 2023	German Federal Institute for Risk Assessment (BfR)	Aniline in finger paints: Health impairments for children shouldn’t be expected according to current understanding
16 August 2023	The UK Office for Product Safety and Standards (OPSS)	The Office for Product Safety and Standards warns of magnetic reusable water balloons danger OPSS is warning consumers about certain magnetic reusable water balloons that can present a risk of death or serious injury if two or more magnets are ingested.

Standard updates

The below table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):

(*) Date of withdrawal: The latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

(**) Date of announcement: the latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at the national level.

Reference	Title	*Date of withdrawal ()**	Supersedes
EN 14350:2020+ A1:2023	Childcare articles - Drinking equipment - Safety requirements and test methods	31 August 2024	EN 14350:2020 /prA1:2023 EN 14350:2020
EN 16232:2013+ A2:2023	Child use and care articles - Infant swings	30 September 2024	EN 16232:2013 /prA2 EN 16232:2013+ A1:2018
EN ISO 11243:2023	Cycles - Luggage carriers for bicycles - Requirements and test methods (ISO 11243:2023)	31 March 2024	EN ISO 11243:2016
EN 15194:2017+A1:2023	Cycles - Electrically power assisted cycles - EPAC Bicycles	23 August 2025	EN 15194:2017/FprA1:2022 EN 15194:2017
EN 17885:2023	Candle Accessories - Specification for fire safety and product safety labels	29 February 2024

New amendment for plastic materials in FCM Regulation

On 11 August 2023, the Regulation (EU) 2023/1627 was published. This amends Annex I to Regulation (EU) No 10/2011 regarding the authorisation of the substance bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (FCM No 1079).

The following entry is inserted in numerical order in Annex I to the Regulation (EU) No 10/2011:

Entry	CAS No	Substance	SML (mg/kg)	Restrictions and specifications
1079	84731-70-4	bis(2-ethylhexyl) cyclohexane-1,4- dicarboxylate (DEHCH)	0.05	Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25% w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III.

Technical publication related to food contact materials

The table below summarises the recent technical publications regarding food contact materials:

Date	Entity	Title
2 August 2023	EFSA (European Food Safety Authority)	Safety assessment of the process Silver Plastics, based on the Reifenhäuser technology, used to recycle post‐consumer PET into food contact material
2 August 2023	EFSA (European Food Safety Authority)	Safety assessment of the process Plastrec, based on the Polymetrix technology, used to recycle post‐consumer PET into food contact material
4 August 2023	EFSA (European Food Safety Authority)	Safety assessment of the process Langgeng, based on the Starlinger deCON technology, used to recycle post‐consumer PET into food contact materials
7 August 2023	EFSA (European Food Safety Authority)	Safety assessment of the process Dialog Diyou PCR, based on the Starlinger iV+ technology, used to recycle post‐consumer PET into food contact materials
7 August 2023	EFSA (European Food Safety Authority)	Safety assessment of the process ISKO, based on Gneuss 4 technology, used to recycle post‐consumer PET into food contact materials
7 August 2023	EFSA (European Food Safety Authority)	Safety assessment of the process Tanrikulu Plastik, based on the Starlinger iV+ technology, used to recycle post‐consumer PET into food contact materials
7 August 2023	EFSA (European food safety authority)	Safety assessment of the process Lerg‐Pet, based on the Starlinger iV+ technology, used to recycle post‐consumer PET into food contact materials
7 August 2023	EFSA (European Food Safety Authority)	Safety assessment of the process PCR Ambalaj, based on the Starlinger iV+ technology, used to recycle post‐consumer PET into food contact materials
7 August 2023	EFSA (European Food Safety Authority)	Safety assessment of the process RE–PETKunststoffrecycling, based on Gneuss 4 technology, used to recycle post‐consumer PET into food contact materials
9 August 2023	EFSA (European Food Safety Authority)	Safety assessment of the process Veolia Huafei Polymer Technology (Zhejiang), based on the Vacunite (EREMA Basic and Polymetrix SSP V‐LeaN) technology, used to recycle post‐consumer PET into food contact materials
9 August 2023	EFSA (European Food Safety Authority)	Safety assessment of the process Loreco Plast Recyclage, based on the VACUNITE (EREMA basic and Polymetrix SSP V‐leaN) technology, used to recycle post‐consumer PET into food contact materials
10 August 2023	EFSA (European Food Safety Authority)	Safety assessment of the process CPE based on the VACUNITE (EREMA basic and Polymetrix SSP V‐leaN) technology, used to recycle post‐consumer PET into food contact materials
13 September 2023	EFSA (European Food Safety Authority)	Update of the risk assessment of mineral oil hydrocarbons in food
15 September 2023	European Commission	Commission Implementing Regulation (EU) 2023/1776 of 14 September 2023 imposing a definitive anti-dumping duty on imports of melamine originating in the People’s Republic of China following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council

Publications related to national requirements for ERP

The table below summarises the recent publications regarding national requirements of extended producer responsibility (ERP).

Date	Country	Title
25 July 2023	UK	One year more to discuss the ERP's scheme design New rules to ensure packaging producers pay for the cost of recycling their packaging will be deferred a year from October 2024 to 2025.
1 August 2023	Netherlands	Ban on plastic straws, plates, and other single-use plastics New rules will be introduced for disposable plastic cups and food packaging. EPR from 1 January 2023 applies to: Tobacco products with filters Single-serve food packaging Disposable cups Bags and wrappers Light plastic carrier bags Beverage packaging Balloons Wet wipes EPR as of 31 December 2024: Fishing gear
1 August 2023	Netherlands	Contribute to cleaning up plastic litter EPR applies to the party that first brings the product to market in the Netherlands, producers as well as importers. In addition, other parties in the sales or waste chain may have responsibilities, such as distributors (including retail)
30 August 2023	France	Opinion relating to the values of the packages used in the formula for calculating the internal costs of an eco-organization is to be taken into account in the calculation of the balancing between holders of approval for household packaging. (Text nº 70)
16 September 2023	France	Order of 7 September 2023 amending the Order of 12 December 2022 relating to data from extended producer responsibility (EPR) sectors. (Text nº 13). Law No. 2020-105 of 10 February 2020 provides that producers subject to the principle of extended producer responsibility (EPR) and eco-organizations transmit each year to the authority responsible for monitoring and observation of the sectors REP, (ADEME), information relating to the quantity of waste generated.
21 September 2023	UK	Update to the following guidance related to ERP: Extended producer responsibility for packaging: who is affected and what to do. Packaging data: what to collect for extended producer responsibility.

Czech Republic

Repealed national requirements for toys and childcare products

On 16 June 2023, the following law was published in the Czech Republic:

Act No. 167/2023 which amends Law No. 258/2000 Coll., on the protection of public health and amending certain related laws, as amended, and other related laws.

This Act repealed Decree No. 84/2001 and Decree No. 521/2005 related to hygienic requirements for toys and products for children under three years of age. At this moment, there are no national deviations for this type of product.

It came into effect on 1 July 2023.

Recognition of the CE marking after 2024 in the UK market

On 31 August 2023, guidance about using the UKCA marking was updated by the Department for Business and Trade and the Department for Business, Energy & Industrial Strategy.

The update indicates the extension of the recognition period of the CE marking for placing goods on the market in Great Britain, beyond December 2024 and indefinitely. This update affects the following products and their regulations:

Toys
Pyrotechnics
Recreational craft and personal watercraft
Simple pressure vessels
Electromagnetic compatibility
Non-automatic weighing instruments
Measuring instruments
Measuring container bottles
Lifts
Equipment for potentially explosive atmospheres (ATEX)
Radio equipment
Pressure equipment
Personal protective equipment (PPE)
Gas appliances
Machinery
Equipment for use outdoors
Aerosols
Low voltage electrical equipment

There are different rules for medical devices, construction products, cableways, transportable pressure equipment, unmanned aircraft systems, rail products, marine equipment and ecodesign. The relevant departments covering these sectors either have communicated or will communicate, plans in due course.

Public consultation related to flammable upholstered furniture

On 2 August 2023, the Office for Product Safety and Standards and the Department for Business and Trade opened a public consultation related to the fire safety of domestic upholstered furniture.

They are seeking views on a proposed new approach to the Furniture and Furnishings (Fire) (Safety) Regulations 1988 to maintain and improve fire safety for consumers in their homes while facilitating manufacturing innovation and a reduction in the use of chemical flame retardants.

It is open until 24 October 2023.

For more information, visit the UK Government website here.

CPSC publishes direct final rule for products containing button cell or coin batteries

On 21 September 2023, the U.S. Consumer Product Safety Commission (CPSC) published in the Federal Register the direct final rule (DFR) 16 CFR 1263 that establishes the safety requirements for button cell or coin batteries and consumer products containing such batteries, as mandated by Reese’s Law. The new rule incorporates by reference the voluntary standard, ANSI/UL 4200A-2023, as the mandatory standard for consumer products containing button cell or coin batteries.

The DFR will become effective on 23 October 2023, unless the CPSC receives a significant adverse comment by 5 October 2023. Third-party testing and certification of children’s products subject to the rule will not be required until 20 December 2023. However, in recognition of limited testing availability and for the avoidance of hardship, the CPSC has granted a 180-day transitional period of enforcement discretion from 21 September 2023, through to 19 March 2024.

Also, in the same issue of the Federal Register, the CPSC published a final rule (FR) to establish the requirements for warning labels on the packaging of button cell or coin batteries, which will become effective on 21 September 2024.

Scope: With the adoption of 16 CFR 1263, the scope of the requirements will be consumer products containing or designed to use one or more button cell or coin batteries, regardless of whether such batteries are intended to be replaced by the consumer or are included with the product or sold separately.

A button cell or coin battery is defined as “a single cell battery with a diameter greater than the height of the battery; or any other battery, regardless of the technology used to produce an electrical charge, that is determined by the Commission to pose an ingestion hazard.”

The scope exempts:

Toy products that are in compliance with the battery accessibility and labelling requirements of 16 CFR 1250; and
Button cell or coin batteries that the CPSC has determined do not present an ingestion hazard, such as zinc-air buttons cell or coin batteries.

Requirements: Under 16 CFR 1263, ANSI/UL 4200A-2023, Standard for Safety for Products Incorporating Button Batteries or Coin Cell Batteries, will become mandatory.

ANSI/UL 4200A-2023 includes the following:

Performance Requirements for Battery Compartment Securement;
Preconditioning requirements;
Use and abuse tests;
Packaging requirements; and
Labelling requirements.

Additionally, 16 CFR 1263 includes warning label requirements for packaging of button cell or coin batteries, including button cell or coin batteries packaged separately with a consumer product.

Sources:

Direct Final Rule: Safety requirements for products containing a button cell or coin batteries.

Final Rule: Warning label requirements for packaging of button cell or coin batteries.

Japan

Japan prohibits magnet sets and balls that expand with water

Japan’s Ministry of Economy, Trade and Industry (METI) recently announced a Cabinet Decision on the Cabinet Order for the Partial Revision of the Order for Enforcement of the Consumer Product Safety Act. The Cabinet Order lists the following products in the specified products under the Consumer Product Safety Act and will prohibit the sale of these products that do not comply with the technical requirements under the Act:

Magnet amusement products (limited to those used as toys or other amusement products with the mutual attraction between magnets, in which the individual magnets or parts using magnets that make one product are not larger than the size specified by the Order of the METI) (for both children and adults).
Water-absorbing synthetic resin toys (limited to those which contain the part using the synthetic resin that expands by absorbing water with the size before absorbing water being not larger than the size specified by the Order of the METI).

These types of products will not meet the safety requirements under the Act and will be prohibited, effective on 19 June 2023.

PRODUCT RECALLS / ALERTS

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”)

Europe

Safety Gate (RAPEX) (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities)

The following 33 alerts regarding toys, childcare articles and children's equipment products were reported between weeks 35 and 38 of 2023.

Type of Risk	Number of alerts	Notes
Burns	1	Fancy-dress costume The feather in the costume is easily flammable and the flame propagation is too high. The product does not comply with the requirements of the Toy Safety Directive or EN 71-2.
Chemical	1	Plastic doll The plastic material of the head of the doll has an excessive concentration of bis(2-ethylhexyl) phthalate (DEHP). The product does not comply with the REACH Regulation.
	1	Fancy-dress costume The product has an excessive concentration of bis(2-ethylhexyl) phthalate (DEHP) and diisooctyl phthalate (DIOP). The product does not comply with the REACH Regulation.
	1	SpongeBob figures The plastic material of the product has an excessive concentration of bis(2-ethylhexyl) phthalate (DEHP) and di-‘isononyl’ phthalate (DINP). The product does not comply with the REACH Regulation.
	3	Toy slime The migration of boron from the toy slime is too high. The products do not comply with the requirements of the Toy Safety Directive or EN 71-3.
Chemical, Entrapment, Injuries	1	Fancy-dress costume The product has an excessive concentration of bis(2-ethylhexyl) phthalate (DEHP) and diisooctyl phthalate (DIOP). Moreover, the zip fastener can cause the child to be entrapped or injured. The product does not comply with the requirements of the Toy Safety Directive, EN 71-1 or EN 14682.
Choking	4	Soft toy The toy has small parts and fibrous stuffing material which is easily accessible and may easily detach. These products do not comply with the requirements of the Toy Safety Directive or EN 71-1.
	1	Plush toy Small part (eye) can be detached. The product does not comply with the requirements of the Toy Safety Directive or EN 71-1.
	1	Wooden car track The product can easily break, resulting in small parts. The product does not comply with the requirements of the Toy Safety Directive or EN 71-1.
	1	Activity cube The beads can easily break, resulting in small parts. The product does not comply with the requirements of the Toy Safety Directive or EN 71-1.
	5	Baby self-feeding pillow During self-feeding, the baby is not able to control the flow of fluid. The product does not comply with the requirements of the General Product Safety Directive.
	1	Backpack The suction cup of the soft toy detaches easily and its seams are too weak, making the fibrous stuffing material accessible. The product does not comply with the requirements of the Toy Safety Directive or EN71-1.
	1	Toy truck The toy has small parts (two plastic splinters) that can easily detach. The product does not comply with the requirements of the Toy Safety Directive or EN 71-1.
Choking, Injuries	1	Dart set Small magnets with high magnetic flux can easily detach from the toy. In addition, if a child swallows them, they could attract one another and cause intestinal blockage or perforation. The product does not comply with the requirements of the Toy Safety Directive or EN 71-1.
Choking, Injuries	1	Magnetic toy figure The toy contains small parts (magnets) with high magnetic flux that can easily detach. The product does not comply with the requirements of the Toy Safety Directive or the European standard EN 71-1.
Damage to sight	1	Toy gun set The kinetic energy of the projectiles fired is too high, which can lead to eye injuries. The product does not comply with the requirements of the Toy Safety Directive or EN 71-1.
Environment	1	Electric toy The solders have an excessive concentration of lead. The product does not comply with the requirements of the Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Directive).
Entrapment, Injuries	1	Baby-changing table with pull-out bath The gap between the bath and the changing table can cause limbs and head entrapment. The product does not comply with the requirements of the General Product Safety Directive nor with EN 12221.
Injuries	3	Toy scooters The steering tube is not sufficiently stable. The product does not comply with the requirements of the Toy Safety Directive or EN 71-8.
	1	Baby walker The baby walker does not protect against falls and could fall a flight of stairs. The product does not comply with the requirements of the General Product Safety Directive or EN 1273.
	1	Toy gun with projectiles The material of the projectiles fired from the toy gun is too hard and can cause eye injuries. The product does not comply with the requirements of the Toy Safety Directive or EN 71-1.
Suffocation	1	Baby sleep bags The neck opening is too large concerning the child’s height/age. The product does not comply with the requirements of the General Product Safety Directive or EN 16781.

The following 2 alerts regarding miscellaneous products were reported between weeks 35 and 38 of 2023.

Type of Risk	Number of alerts	Notes
Chemicals	1	Key chain The plastic material of the product has an excessive concentration of bis(2-ethylhexyl) phthalate (DEHP). The product does not comply with the REACH Regulation.
Chemical, Environment	1	Cosmetic bag The plastic material of the product has an excessive concentration of bis(2-ethylhexyl) phthalate (DEHP), diisobutyl phthalate (DIBP) and dibutyl phthalate (DBP) and short-chain chlorinated paraffins (SCCPs). The product does not comply with the REACH Regulation or the Persistent Organic Pollutants (POP) Regulation.

The following 5 alerts regarding hobby/sports equipment were reported between weeks 35 and 38 of 2023.

Type of Risk	Number of alerts	Notes
Chemicals	2	Gym ball The plastic material of the product has an excessive concentration of diisobutyl phthalate (DIBP). The products do not comply with the REACH Regulation.
Drowning	1	Inflatable swimming float A defect in the product design could pose a risk of drowning. The product does not comply with the requirements of the General Product Safety Directive.
Environment	1	Yoga mat The product has an excessive concentration of short-chain chlorinated paraffins (SCCPs). The product does not comply with the Persistent Organic Pollutants (POP) Regulation.
Drowning	1	Swim seat The product is sold as a toy a can be confused as a learning device that should be used under direct adult supervision. The product does not comply with the requirements of the General Product Safety Directive or EN 13138.

The following 18 alerts regarding jewellery were reported between weeks 35 and 38 of 2023.

Type of Risk	Number of alerts	Notes
Chemical	1	Brooch The product contains or releases an excessive amount of metals such as cadmium or lead. The product does not comply with the REACH Regulation.
	2	Necklace The product contains or releases an excessive amount of lead. The product does not comply with the REACH Regulation.
	3	Bracelet The product contains or releases an excessive amount of metals such as cadmium or lead. The product does not comply with the REACH Regulation.
	4	Jewellery set The product contains or releases an excessive amount of metals such as cadmium or lead. The product does not comply with the REACH Regulation.
	8	Earrings The product contains or releases an excessive amount of metals such as cadmium, nickel or lead. The product does not comply with the REACH Regulation.

RASFF (European Commission Rapid Alert System for Food and Feed - Alerts reported by EU national authorities)

The following 9 alerts regarding food contact materials related to children's tableware were reported from 21 August 2023 to 20 September 2023.

Product	Notes
Bamboo Tableware Set	Unauthorised use of bamboo fibres mixed with plastics in food contact material	RASFF Window - Notification detail (europa.eu)
Food contact items	Presence of formaldehyde above the legal limit in materials in contact with food from China	RASFF Window - Notification detail (europa.eu)
Plate	Unstable migration of formaldehyde and melamine from plates at homestore and more	RASFF Window - Notification detail (europa.eu)
Silicone plates	High content of volatile constituents in silicone plates	RASFF Window - Notification detail (europa.eu)
Baby bottle teats	Free volatile organic matter content exceeded on baby bottle teats	RASFF Window - Notification detail (europa.eu)
Small bowl	Unstable migration of formaldehyde from melamine bowl stopped	RASFF Window - Notification detail (europa.eu)
Wheat corn cutlery	Border rejection of plastic cutlery due to containing the unauthorised substance wheat straw	RASFF Window - Notification detail (europa.eu)
Food contact materials	Unacceptable global limits of migration in lunch boxes	RASFF Window - Notification detail (europa.eu)
Paper straws	Migration of Isothiazolinone in paper straws	RASFF Window - Notification detail (europa.eu)

OPSS issues Product Safety Alerts on the UK market.

The following 4 alerts regarding toys and childcare products were reported between weeks 35 and 38 of 2023.

Type of Risk	Number of alerts	Notes
Chemical	1	Skeleton zombie plush toy The product presents a serious chemical risk as it contains excess concentrations of phthalates (DEHP). The product does not meet the requirements of the REACH Regulations 2008 or the Toys (Safety) Regulations 2011.
Chemical	1	Cricket set The product presents a serious chemical risk as it contains excess concentrations of phthalates (DBP, DEHP and DIBP). The product does not meet the requirements of the REACH Regulations 2008 or the Toys (Safety) Regulations 2011.
Chemical Choking	1	Boy puppet with accessories The product contains an excess concentration of DEHP. Moreover, Small parts are detached from the product, and it also does not possess the required markings and labelling. The product does not meet the requirements of the REACH Regulations 2008 or the Toys (Safety) Regulations 2011.
Choking	1	Baby teether The product presents a serious risk of choking as small parts have been reported as falling off the string clip part of the baby teether. The product does not meet the requirements of the Toys (Safety) Regulations 2011.

U.S.

From 31 August 2023 to 21 September 2023, the CPSC (Consumer Product Safety Commission) published the following recalls:

4 recalls regarding toy and childcare products

Hazard	Number of alerts	Notes
Fall	1	Highchairs The bolts used to secure the seat of the recalled highchair to the pedestal base can become loose and allow the seat to detach, posing a fall hazard.
Ingestion, choking and intestinal obstruction	1	Water bead activity kit If a water bead is ingested, it expands and can pose ingestion, choking and intestinal obstruction hazards inside a child’s body, resulting in severe discomfort, vomiting, dehydration and a risk of death to a child.
Violation of Safety Standard for Infant Swings	1	Infant swings The swing violates the Safe Sleep for Babies Act because the product was marketed for infant sleep and has an incline angle greater than 10 degrees. Infant fatalities have occurred in inclined sleepers after the infants rolled from their back to their stomach or side while unrestrained, or under other circumstances. The swing also violates the Safety Standard for Infant Swings.
Choking	1	Board Books The plastic binding rings can detach from the books, posing a choking hazard to young children.

7 recalls of consumer products

Type of Risk	Number of alerts	Notes
Laceration	1	Glass doorknobs The recalled glass doorknobs can crack and separate from the doorknob assembly, posing a laceration hazard to consumers.
Fall	1	Bicycle tires The tire bead can unseat from the rim and lead to rapid air loss in the tires, resulting in loss of control and posing a fall hazard.
Burn and impact injury	1	Fire tables The lava rocks can split and eject from the fire table, posing burn and impact injury hazards.
Lead	1	Clasp beaded bracelets The clasp on the beaded bracelet contains levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects.
Suffocation	1	Mattresses The recalled crib mattresses fail to comply with multiple provisions of the Federal Safety Standard for Crib Mattresses, including the firmness test and missing warnings and labels. The product poses a suffocation hazard to infants.
Mould	1	Mattresses The mattresses could have been exposed to water during the manufacturing process allowing mould to develop and posing a health risk to individuals with compromised immune systems, damaged lungs or an allergy to mold.
Crash	1	Bicycle cranksets The recalled bonded crank parts can separate and break, posing a crash hazard to consumers.

1 recall of furniture

Type of Risk	Number of alerts	Notes
Fall	1	Chairs The wooden frame of the chair can break or collapse when a consumer is seated in the chair, posing a fall hazard.