Eurofins Toys & Hardlines Monthly Bulletin (June 2021)

EUROPE

Updated Harmonised Standards for Toys

On 31 May 2021, the European Commission published: The Commission Implementing Decision (EU) 2021/867 of 28 May 2021 on harmonised standards for toys drafted in support of Directive 2009/48/EC of the European Parliament and of the Council and consequently, implementation of Decision (EU) 2019/1728 is repealed. The main changes are:

EN 71-7:2014+A3:2020 Safety of toys - Part 7: Finger paints – Requirements and test methods

Maximum concentration for climbazole preservative is changed from 0.5% to 0.2%
“Benzo[α]pyrene” is replaced by “Benzo[a]pyrene”
References of “Directive 2008/128/EC” is updated to “Regulation 231/2012” in Tables A.1 and A.2
The limit of quantitation (LOQ) for benzo[a]pyrene is changed from 0.02 mg/kg to 0.05 mg/kg

Standard	Major Changes
EN 71-12:2016 Safety of toys — Part 12: N-Nitrosamines and N-nitrosatable substances	Improved test methods concerning the ability to detect (the often carcinogenic) N-nitrosamines even at low levels, Alternative ways to measure and identify any N-nitrosamines potentially present in certain toys Scope of the standard extended with regard to the materials to be tested and the duration of the migration step for elastomers
EN IEC 62115:2020 Electric toys — Safety EN IEC 62115:2020/A11:2020	Further warnings associated with swallowing coin batteries Accessibility requirements for coin and button batteries New requirements for toys connected to domestic appliances, including computers, in order to protect users from electric shock Simplified requirements for electric toys with low levels of power Further requirements for the safety of LEDs in toys in order to minimise the risk of ocular injury New requirements to address hazards associated with the use of remote-controlled electric ride-on toys Specifies the type of batteries to be used for testing electric toys that are provided without batteries

The references of the harmonised standards for toys listed in Annex I to this Decision are:

No	Reference of the Standard
1.	EN 71-1:2014+A1:2018 Safety of toys — Part 1: 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:
	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
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
11.	EN IEC 62115:2020 Electric toys — Safety EN IEC 62115:2020/A11:2020

However, the following references of the harmonised standards for toys drafted in Article 1 of Implementing Decision (EU) 2019/1728 shall continue to apply until the dates set out:

No	Reference of the Standard	Date of Withdrawal
1.	EN 71-7:2014+A2:2018 Safety of toys - Part 7: Finger paints – Requirements and test methods Note: For the allowed preservative climbazole (entry 22 in Table B.1 of Annex B to this standard) the presumption of conformity applies up to a maximum allowed concentration of 0,2 % (not: 0,5 %). This is based on the ‘ADDENDUM to the Opinion on Climbazole (P64) ref. SCCS/1506/13’ of the Scientific Committee on Consumer Safety (SCCS) that was adopted after the publication of the standard by CEN. https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_212.pdf	28 November 2021
2.	EN 71-12:2013 Safety of toys — Part 12: N-Nitrosamines and N-nitrosatable substances	28 November 2021
3.	EN 62115 :2005 Electric toys – Safety IEC 62115:2003 (Modified) + A1:2004 EN 62115:2005/A11:2012/AC:2013 EN 62115:2005/A11:2012 EN 62115:2005/A12:2015 EN 62115:2005/A2:2011/AC:2011 EN 62115:2005/A2:2011 IEC 62115:2003/A2:2010 (Modified)	21 February 2022

New Requirements for Finger Paints and Textile Toys

On 4 June 2021, the European Commission published: Commission Directive (EU) 2021/903 of 3 June 2021 amending Directive 2009/48/EC of the European Parliament and of the Council as regards specific limit values for aniline in certain toys

The following entry is added in Appendix C to Annex II to Directive 2009/48/EC:

Substance	CAS No	Limit value
‘Aniline	62-53-3	30 mg/kg	after reductive cleavage in textile toy material and leather toy material
		10 mg/kg	as free aniline in finger paints
		30 mg/kg	after reductive cleavage in finger paints’

It shall apply that provision from 5 December 2022.

New Guidance Document for Decorative Products

On 17 May 2021, the European Commission published guidance document nº 20: Guidance document on decorative products and products for collectors.

The aim of this guidance is to help to make the distinction between toys and other consumer products.

This document contains several annexes which refer to different product categories relating to decoration, festivities or collector products. The annexes are:

Annex 1: Dolls, animals, figures.

Annex 2: Decorations for interior design.

Annex 3: Souvenirs.

Annex 4: Party novelties for celebrations / parties.

Annex 5: Other, various and dual-use.

Annex 6: Products for adult collectors. Part A: Detailed and faithful scale models; Part B: Folk dolls and decorative dolls and other similar articles.

Standards Updates

Please see the below table summarising the most recent standards 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.

CENELEC / CEN
Reference	Title	*Date of Withdrawal()**	Supersedes
EN IEC 60086-1:2021	Primary batteries - Part 1: General	2024-06-01	EN 60086-1:2015
EN IEC 60086-2:2021	Primary batteries - Part 2: Physical and electrical specifications	2024-06-01	EN 60086-2:2016
EN IEC 60086-3:2021	Primary batteries - Part 3: Watch batteries	2024-06-01	EN 60086-3:2016

Technical Publications

Please find below a table summarising recent technical publications (non-exhaustive):

Date	Entity	Comments
03/06/2021	SCHEER (European Scientific Committee on Health, Environmental and Emerging Risks)	Toxicological reference values for certain organic chemicals emitted from squishy toys with regard to adopting limit values under the Toy Safety Directive 2009/48/EC ‘Chemicals in squishy toys’

GERMANY

New Legislation on the Rights of People and the Environment

On 3 March 2021, the Germany Federal Cabinet passed a draft of a law on the responsibility of German companies in respect to human rights in global supply chains, which is to be regulated in a binding manner: Supply Chain Act (Lieferkettengesetz)(in German only).

The parliamentary procedure was opened on 22 April, 2021 with the first reading in the Bundestag. The Bundestag passed the law on 11 June, 2021. It must now be confirmed by the Federal Council and signed by the Federal President.

The main points of the Supply Chain Act are:

Ensuring better human rights protection
Companies must ensure compliance with human rights regulations along their entire supply chain
They must set up grievance mechanisms and report on their activities
This will apply as of 2023 to companies with a workforce of at least 3,000 and later to companies with a workforce of at least 1,000
Environmental protection. Environment-related obligations are established, based on two international conventions to prevent health and environmental hazards: The Minimata Convention on Mercury and the Stockholm Convention on Persistent Organic Pollutants

For more information, visit the Germany Federal Government website here.

U.S.

Completed Rule Review on Product Certification of Children's Products

On 7 June 2021, the Consumer Product Safety Commission (CPSC) announced that the rule review on Regulatory Flexibility Act Section 610 - Review of the Safety Standards for the Testing and Labeling Regulations Pertaining to Product Certification of Children's Products, Including Reliance on Component Part Testing is available.

They concluded is that the testing and component part testing regulations should be maintained without change.

The completed review is available on the CPSC website here.

CPSC Revised Safety Standard for Children’s Folding Chairs and Stools

On 17 May 2021, the Consumer Product Safety Commission (CPSC) issued a direct final rule in the Federal Register to revise the mandatory standards for children’s folding chairs and stools incorporating by reference the most recent version of ASTM F2613-21. The related federal regulation is 16 CFR 1232 Safety Standard for Children’s Folding Chairs and Stools.

Compared to the ASTM F2613-19, the main changes are as follow:

Update the definition of stools in the standard to ensure the scope include ottomans.
Clarify that infant/toddler rockers do not fall into this scope, they shall comply with the voluntary standard, ASTM F3084-20, Standard Consumer Safety Specification for Infant and Infant/Toddler Rockers.
Remove previous version of the locking test method, as it is no longer used.

The final revised rule will come into force on 21 August, 2021, unless the CPSC receives significant contrary evidence by 16 June, 2021.

For more information please click here.

Vermont Passes Senate Bill S.20 into Law - Chemicals in Consumer Goods

On 18 May 2021, the governor of Vermont signed Senate Bill S.20 into law, which regulates several chemicals in certain consumer goods and amends the list of chemicals of high concern to children (CHCCs). The Act will be implemented in phases, starting 1 July, 2021.

The definitions of "Perfluoroalkyl and polyfluoroalkyl substances", "Ortho-phthalates” and " Bisphenols " in the Act are as follow:

"Perfluoroalkyl and polyfluoroalkyl substances mean a family of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.
"Ortho-phthalates” means any member of the class of organic chemicals that are esters of phthalic acid containing two carbon chains located in the ortho position.
“Bisphenols” means any member of a class of industrial chemicals that contain two hydroxyphenyl groups.

Summary table 1:

Substance	Scope with some exemptions	Requirement
PFAS	Personal protective equipment	Notice statement
PFAS	Ski wax Class B firefighting foam Class B firefighting foams for use at a terminal Residential rugs and carpets Aftermarket stain and water-resistant treatments for rugs or carpets Food Packaging	Prohibited
Effective date: Personal protective equipment, 1 July, 2021 Class B firefighting foam, 1 July, 2022 Class B firefighting foam used at a terminal, 1 January, 2024 Others, 1 July, 2023
Ortho-phthalates	Food Packaging	Prohibited
Effective date: 1 July, 2023
Bisphenols	Food Packaging	Dept. of Health (DOH) may adopt rules for prohibition
Effective date: 2 years after the DOH adopts the rule

A Certificate of Compliance (CoC) should be produced by the manufacturer within 30 days upon request by the Attorney General.

Summary table 2:

Substance	Scope with some exemptions	Requirement
PFHxS, PFHpA, PFNA	Children’s products	Add them as chemicals of high concern to children
Effective date: 1 July, 2022

For more information please click here.

Nevada Passes Assembly Bill 97 into Law - PFAS and Flame Retardants in Certain Consumer Goods

On 27 May, 2021, the governor of Nevada signed Assembly Bill 97 into law, which regulates perfluroalkyl and polyfluoroalkyl substances (PFAS) and organohalogenated chemical in certain consumer goods. The Act amends the state’s Revised Statutes on Chapters 459 ‘Hazardous Materials’ and Chapters 597 ‘Miscellaneous Trade Regulations and Prohibited Acts’.

The definitions of "Perfluoroalkyl and polyfluoroalkyl substances" and "Organohalogenated chemical" in the Act are as follows:

"Perfluoroalkyl and polyfluoroalkyl substances" (PFAS) means a class of fluorinated organic chemicals that contain at least one fully fluorinated carbon atom.
"Organohalogenated chemical" means any chemical that contains one or more carbon elements and one or more halogen elements, including but not limited to: fluorine, chlorine, bromine or iodine.

Summary table:

Substance	Scope	Requirement
PFAS	Class B firefighting foam for the purpose of testing and firefighting training	Prohibited
Organohalogenated chemical	Children’s products Business textiles Residential textiles Mattresses Upholstered residential furniture	≤ 1,000 ppm
Organohalogenated chemical	“Children’s product” means a product primarily designed or intended to be used for or by a child under 12 years of age, it does not include: Tents or sleeping bags Consumer electronic products and components or products Devices as defined in the Federal Food, Drug and Cosmetic Act Food, beverage, dietary supplement, pharmaceutical or biological products Outdoor sports equipment Toys
	Exemption: Pr-eemption by federal law Second-hand products Any chemical that is a polymeric or a reactive flame retardant Children’s products, mattresses, upholstered residential furniture or residential textile where there is a federal flammability standard Electronic components of a children’s product, mattress, residential textile or upholstered residential furniture or associated casing Components of an adult mattress other than foam Thread or fiber for stitching mattress components together

The legal requirements for PFAS will come into force on 1 January, 2022, and the legal requirements for organohalogenated chemicals will come into force on 1 July, 2022.

For more information please click here.

CPSC Approves New Rule 16 CFR 1236 Safety Standard for Infant Sleep Products

On 2 June 2021, the Consumer Product Safety Commission (CPSC) approved a new 16 CFR 1236 Safety Standard for Infant Sleep Products.

The definitions of “Infant sleep products” in the ruling are “products marketed or intended to provide a sleeping accommodation for an infant up to 5 months of age”, and that is not already subject to CPSC sleep standards:

16 CFR part 1218 Safety Standard for Bassinets and Cradles
16 CFR part 1219 Safety Standard for Full-Size Baby Cribs
16 CFR part 1220 Safety Standard for Non-Full-Size Baby Cribs
16 CFR part 1221 Safety Standard for Play Yards
16 CFR part 1222 Safety Standard for Bedside Sleepers

This rule specifies the following requirements:

The scope of the infant sleep products standard includes various sleep products and any related item that is not already subject to federal rule.
Must meet the requirements of 16 CFR 1218 Safety Standard for Bassinets and Cradles.
Must have a seat back/sleep surface angle no greater than 10°
Incorporate by reference ASTM F3118-17a, with some exclusions and modifications

The rule will come into force 12 months after the final ruling published in the Federal Register.

For more information please click here.

CHINA

Total Ban on the Production and Use of Hexabromocyclododecane (HBCDD)

On 8 June 2021, the Ministry of Ecology and Environment of the PRC, the Ministry of Industry and Information Technology of the PRC, the Ministry of Housing and Urban-Rural Development of the PRC and the State Administration for Market Regulation jointly published announcement No. (2021) 237. It made a clear statement that starting from 26 December, 2021, the production, use, import and export of HBCDD will be prohibited. All provinces (including autonomous regions and municipalities) shall formulate provincial implementation plans to actively promote this important compliance task and ensure the Stockholm Convention on Persistent Organic Pollutants is implemented in China.

In order to meet the schedule, the following strategies shall be deployed:

Investigating and dynamically tracking the production and the use of HBCDD, establishing a ledger, and strengthening dynamic management
Guiding and urging enterprises to fulfil their own obligations
Enforcing the supervision and management of the rules, imposing penalties on illegally production and marketing activities
Strengthening the environmental supervision and management of the disposal of waste stocks.

The complete notification can be found here (in Chinese).

INTERNATIONAL

Regulatory Proposals Notified to WTO

The table below summarises the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):

Notification number	Countries	Title
G/TBT/N/ISR/1201	Israel	SI 1811 - Reference test method for release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with skin. This draft standard revision adopts the European Standard EN 1811: 2011 and A1: July 2015, with a few changes that appear in the standard's Hebrew section. The major difference between the old standard edition and this new draft is the removal of the American route of compliance.
G/TBT/N/ISR/1202	Israel	SI 16232: Child use and care articles - Infant swings The standard specifies the safety requirements and the corresponding test methods for infant swings intended for children up to a weight of 9 kg or unable to sit up unaided. It adopts the European Standard EN 16232: 2013 and A1: August 2018 with a few national changes and deviations that appear in the standard's Hebrew section.
G/TBT/N/ISR/1205	Israel	SI 562 part 1 - Safety of toys: Mechanical and physical properties This draft standard revision adopts the European Standard EN 71-1: 2014 + A1: June 2018. All significant technical changes introduced in this draft are due to the adoption of the new edition of the International Standard. Both the old standard and this new revised standard will apply from the entry into force of this revision for 90 days. During this time product may be tested according to the old standard or the new revised standard.
G/TBT/N/BRA/1151	Brazil	Inmetro Ordinance 123, 16 February 2021 This Technical Regulation establishes the mandatory requirements for costume jewellery, to be met by the entire supply chain of the product in the national market. Costume Jewellery is any adornment, male or female, metal or not, whose intended use provides contact of this or part of it with the human body, such as: metallic beads and other metallic components for the manufacture of jewellery pieces; metallic jewellery and jewellery items including hair accessories, bracelets, necklaces and rings, piercings, wrist ornaments (including watches), cufflinks and earrings.

PRODUCT RECALLS/ALERTS

Below you will find a monthly summary table of product recalls and alerts in Europe (Source “RAPEX” and “RASFF”) and the U.S. (Source “CPSC”).

Europe

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

The following 61 alerts regarding Childcare articles, equipment and toys were reported, between week 21 and week 24 of 2021.

Type of Risk	Number of alerts	Notes
Chemical	30	Plastic toys The toy contains an excessive amount of bis(2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DNOP), benzyl butyl phthalate (BBP), diisodecyl phthalate (DIDP), dibutyl phthalate (DBP), di-isonylephthalate (DINP), diisobutyl phthalate (DIBP) and the flame retardant tris(2-chlor-1-methylethyl phosphate (TCPP). It does not comply with Toy Safety Directive nor with REACH
		Finger paint set There is an excessive migration of lead in the white paint and The red and green finger paints release an excessive amount nitrosamines , among which n-nitrosodiethanolamine (NDELA). It does not comply with the Toy Safety Directive and with EN 71-3 and EN 71-12.
		Slime toy The migration of boron from the toy slime is too high. It does not comply with the Toy Safety Directive and with the EN 71-3.
		Children necklace with pendant The crown of the watch (pendant) contains an excessive amount of lead. It does not comply with the REACH Regulation.
		Squeezable toys The rubber of the toys releases an excessive amount of nitrosamines, among which n-nitrosodimethylamine (NDMA). They do not comply with the Toy Safety Directive nor with EN 71-12.
		Balloons They contain an excessive amount of n-nitrosodiethylamine (NDEA), n-nitrosomorpholine (NMOR) and n-nitrosodiethanolamine (NDELA). They do not comply with the Toy Safety Directive nor with EN 71-12.
		Baby’s soother It contains Bisphenol A (BPA). It does not comply with the requirements of the General Product Safety Directive and EN 1400.
		Baby’s sleep suit The product releases an excessive amount of nickel. The product does not comply with the REACH Regulation.
Burn, fire	4	Inflatable play equipment does not resist fire, does not stop burning when the ignition source is removed and burns rapidly. They do not comply with the requirements of the General Product Safety Directive and European standard EN 14960-1.
Choking	13	Small parts. Does not comply with EN 71-1
Choking	13	Expandable toy: The expanding material increases in size when placed in water by more than 50%. It does not comply with Toy Safety Directive nor with EN 71-1.
Injuries	2	Plastic toy The toy contains protruding parts. It does not comply with the Toy Safety Directive and with the EN 71-1.
	2	Doll stroller The pushchair is not sufficiently resistant to load. It does not comply with the requirements of the Toy Safety Directive and EN 71-1.
	1	Pushchair The pushchair is not stable and can tip unexpectedly. It does not comply with the requirements of the General Product Safety Directive and EN 1888-1
	1	Children's car seat In the event of a car crash, the car seat may not properly restrain the child to minimize the displacement of the body. It does not comply with Regulation UN/ECE No 44-04.
Entrapment, Injuries	1	Play frame with slide and swings The toy has partially closed openings and accessible holes (between the seat and the backrest of the face-to-face swing) in which children can become trapped or suffer injuries. It does not comply with the requirements of the Toy Safety Directive and EN 71-8.
Entrapment, Injuries	1	Foldable sunbed Due to the sunbed folding mechanism, the user´s fingers can get trapped between the seat and the folding mechanism. This can also lead to injuries and even amputation of one or more fingers. It does not comply with the requirements of the General Product Safety Directive and EN 581-1
Microbiological	1	Face paint set The product contains an excessive level of aerobic mesophilic bacteria. It does not comply with the Cosmetic Products Regulation.
Strangulation	2	Flashing Yoyo Ball The toy is elastic and can be considerably stretched during use. It does not comply with the Toy Safety Directive and with the EN 71-1.
Strangulation	3	Baby nest The drawstrings at the bottom of the product are too long when tightened. It does not comply with the requirements of the General Product Safety Directive and the EN 16890, EN 16780, EN 16781 and EN 1466.

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 May 2021 to June 2021.

Product	Substance / Hazard
Tableware	Melamine products with bamboo fibers Mislabelling of the products: the product is falsely declared as made of 100% bamboo	Details
Tableware / kitchenware	Melamine products with plant fibers (wheat) The labelling as 'biodegradable' & 'healthy' is misleading as it focuses the customer’s attention on the ‘natural’ aspect rather than the real composition of the product. (Art. 3 EU 1935/2004).	Details
Tableware for kids	Melamine products with bamboo fibers the identified claim "made from natural bamboo fibres and so are plastic-free and also fully biodegradable” is misleading as it focuses the customer’s attention on the ‘natural’ aspect rather than on the real composition of the product, and the product is falsely declared as made of 100% bamboo (Art. 3 EU 1935/2004). It does not look like the product is made of 100% bamboo, because it has not the typical bamboo look.	Details
Melamine spoon	Migration of melamine and formaldehyde from melamine spoons	Details
Tableware	Melamine products with bamboo and maize fibers the claim "Duurzaam" (=Dutch / EN translation: "sustainable") is misleading as it focuses the customer’s attention on the ‘natural’ aspect rather than on the real composition of the product (Art. 3 EU 1935/2004).	Details
Tableware	Melamine products with plant fibers (bamboo) The labelling as 'natural elements', 'sustainable' or ‘ecofriendly’, ' is misleading as it focuses the customer’s attention on the ‘natural’ aspect rather than the real composition of the product. (Art. 3 EU 1935/2004).	Details
Plastic plates	Migration of melamine from plastic plates	Details
Tableware	Unauthorised use of bamboo in Tableware made from a mix of bamboo fibres and melamine	Details
Children's tableware	Risk of burns due to breakage (physical damage)	Details

U.S.

From 21 May 2021 to 20 June 2021, CPSC (Consumer Product Safety Commission) published the following recalls: 3 recalls regarding Childcare and children’s products.

Hazard	Number of alerts	Notes
Choking	1	Strollers The button on some buckles that release the harness can break and detach when pressed by the user while the child is in the stroller, making it difficult to release.
Suffocation	1	Glide Soothers and Play Gliders Infants who are placed unrestrained in the product and later found on their stomach.
Adverse health issues	1	Children’s Fishing Games The metal rollers on the bottom of the flying dinosaur figures contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children.