Toys & Hardlines regulatory updates January 2023
New update to Candidate List of Substances of Very High Concern (SVHCs)
On 17 January 2023, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs. With the addition of nine new substances, the current list of SVHCs now contains 233 substances.
See below a table indicating the latest substances addition:
Nº |
Substance name |
EC number |
CAS number |
Reason for inclusion |
Examples of use(s) |
1 |
1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] |
253-692-3 |
37853-59-1 |
Very persistent and very bioaccumulative |
While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future non-advisable substitution. |
2 |
2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol |
201-236-9 |
79-94-7 |
Carcinogenic |
As a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxycoated circuit boards, printed circuit boards, paper and textiles. |
3 |
4,4'-sulphonyldiphenol (Bisphenol S) |
201-250-5 |
80-09-1 |
Toxic for reproduction (Article 57 c); Endocrine disrupting properties (Article 57 f – environment); Endocrine disrupting properties (Article 57 f – human health) |
In the manufacture of pulp, paper and paper products, textile, leather or fur and chemicals. |
4 |
Barium diboron tetraoxide |
237-222-4 |
13701-59-2 |
Toxic for reproduction |
In paints and coatings. |
5 |
Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof |
- |
- |
Very persistent and very bioaccumulative (Article 57 e) |
As a flame retardant and a plasticiser for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings and adhesives. |
6 |
Isobutyl 4-hydroxybenzoate |
224-208-8 |
4247-02-3 |
Endocrine disrupting properties |
In the manufacture of substances and in the following products: coating products, fillers, putties, plasters, modelling clay and inks and toners. |
7 |
Melamine |
203-615-4 |
108-78-1 |
Equivalent level of concern with probable serious effects on human health (Article 57 f – human health); |
In polymers and resins, coating products, adhesives and sealants, leather treatment products, laboratory chemicals. |
8 |
Perfluoroheptanoic acid and its salts |
- |
- |
Toxic for reproduction |
While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future regrettable substitution. |
9 |
reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine |
473-390-7 |
- |
Very persistent and very bioaccumulative (Article 57 e) |
Used in items used by professional workers (widespread use), in formulation or re-packing, at industrial sites and in manufacturing. |
Legal obligations for companies using SVHC substances include:
- Suppliers provide customers and consumers with enough information to allow for safe use of products that contain a substance of very high concern (SVHC) above a concentration of 0.1 % (weight by weight).
- Importers and producers of these products must notify the ECHA if their article contains SVHC substances above a concentration of 0.1% weight by weight (w/w) and the substance is present in those products in quantities totalling over one tonne per producer or per importer per year. The notifications have to be submitted within six months from the date that the substance is included in the list.
- Suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to provide their customers with a safety data sheet.
- Under the Waste Framework Directive (Directive 2008/98/EC on waste- WFD), any supplier of an article containing a substance of very high concern (SVHC) in a concentration above 0.1% weight by weight (w/w) on the EU market is required to submit a SCIP Notification on that article to ECHA, as of 5 January 2021. SCIP is the database holding information on Substances of Concern in articles, as such or in complex objects (products), established under the WFD. The SCIP database complements the existing notification obligations for Candidate List substances in articles subject to REACH regulation and its related communication through the supply chain, according to Articles 7 (2) and 33 respectively.
Click here to access the official List on ECHA’s website.
Closer to new European General Product Safety Regulation
On 21 December 2022, the ‘final’ text of the new European General Product Safety Regulation (GPSR) was sent to the Chair of the European Parliament IMCO Committee.
Following an informal meeting on 28 and 29 November 2022 between the representatives of the three institutions (European Commission, Parliament and Council), a draft overall package was agreed by the Permanent Representatives’ Committee.
This 'final' text represents a substantial update from the current rules. Some of the key changes include under the GPSR include:
- Direct application to all Member States.
- New accident reporting obligation in the EU.
- Additional factors to consider in an assessment of whether a product is safe.
- Lays down new requirements for non CE marked products (e.g. some accessories) to align with requirements for CE marked products.
- New requirements for online offers.
- E-labelling (a digital form such as a QR code).
- New requirements for advertising recalls and recall notices.
- Lays down rules for recall remedies.
- New obligations for online marketplaces.
- Expanded role of Safety Gate (product recall notification and accident reporting).
- Increased enforcement (particular products / product categories inspections by authorities).
- Between others changes related to penalties, class actions and transition period of 18 months.
The legislation could be published in the Official Journal of the European Union around the second quarter 2023 with an enforcement date of the fourth quarter of 2024.
Designing products that last longer and can be repaired
On 15 November 2022, the European commission published the Resolution of 7 April 2022 on the right to repair (2022/2515(RSP)).
This regulation emphasises in that the effective right to repair should address aspects of the product lifecycle, for example: product design, key ethical principles of production, standardisation, consumer information, consumer rights and guarantees, and public procurement.
Another point that the Regulations emphasises is that it balances the principles of sustainability, consumer protection and a highly competitive social market economy for green transition.
This year, there have already been changes in the French Market related to consumer products. Below is, a summary with some relevant points on selling products in France in 2023.
- Replace disposable fast-food dishes with reusable dishes
Fast food restaurants must, as of 1 January 2023, use reusable tableware for meals and drinks served on site (cups, lids, plates, containers, cutlery). - Producers and/or those responsible for certain products are responsible for the waste they produce. They have the choice of setting up collective structures (eco-organisations) or an individual system for the management of waste from their products to comply the Extended Producer Responsibility (EPR).
- Info-Tri signage (Logo Triman and sorting information) on products with the aim to make sorting more effective.
- Prohibit the disposal of unsold non-food items and promote donations and recycling.
- The in-store collection obligation
Since 1 January 2023, the "AGEC" law has extended the in-store take-back obligations for toys, sports and leisure items, as well as DIY and garden items. The products can be brought back to the store in the collection bins provided. - The systematic printing of cash receipts, credit card receipts, and tickets distributed by automatic machines and purchase vouchers and promotional tickets will be prohibited.
- Apply a reparability index and tend towards a durability index.
- Facilitate repair and promote the use of spare parts from the circular economy.
For more information, consult the French Ministry of Ecological Transition and Territorial Cohesion website here.
Relevant publication related to ERP and Environmental Code
The latest publications in relation to Extended Producer Responsibility (ERP) and Environmental Code are summarised in the table below:
Date |
Publication |
13 December 2022 |
Order of 26 July 2022 amending the amended order of 29 November 2016 relating to the approval procedure and the specifications of eco-organisations in the household packaging sector. |
14 December 2022 |
Order of 12 December 2022 relating to data from extended producer responsibility (REP) sectors. |
15 December 2022 |
Decree No. 2022-1565 of 14 December 2022 relating to the terms and conditions of application of IV of Article L. 541-15-10 of the Environment Code. |
18 December 2022 |
Order of 8 December 2022 setting the tariff provided for in Article R. 541-171 of the Environment Code for the fee relating to inter-sector communication actions of extended producer responsibility. |
24 December 2022 |
Order of 21 December 2022 amending the order of 26 December 2017 approving an eco-organisation in the furniture component waste sector pursuant to Article R. 543-252 of the Environment Code (the company Eco-mobilier). |
24 December 2022 |
Order of 21 December 2022 amending the order of 5 May 2017 approving an eco-organisation whose purpose is to take charge of packaging waste, the final holders of which are households under the conditions provided for in Articles R. 543 -53 to R. 543-65 of the environment code (ADELPHE). |
24 December 2022 |
Order of 21 December 2022 amending the order of 5 May 2017 approving an eco-organisation whose purpose is to take charge of packaging waste, the final holders of which are households under the conditions provided for in Articles R. 543 -53 to R. 543-65 of the environment code (CITEO). |
24 December 2022 |
Order of 23 December 2022 approving an eco-organisation in the extended responsibility sector of the producer of graphic papers (CITEO). |
Ministerial Guidelines on environmental labelling published
On 21 November 2022, the Ministry of the Environment and Energy Security (MASE) published the Ministerial Decree n. 360 of 28 September 2022, which adopts the Guidelines on environmental labelling pursuant to art. 219, paragraph 5, of the legislative decree 3 April 2006, n. 152, for the correct fulfillment of the packaging labelling obligations defined by Legislative Decree 116/2020.
Digital channels (App, QR code, EAN code, websites, etc.) can be an alternative to the physical affixing of information. Below are some options:
- Completely replace physical labelling with a digital one.
- Choose to communicate only some of the mandatory information via digital cables. For example, to print the identification coding of the material directly on the packaging, and refer to the consultation of digital channels for information on separate collection.
- Report the mandatory information directly on the packaging, and refer to the consultation of digital channels for further additional and voluntary information about the environmental characteristics of the packaging.
The information reported on the digital channels must be in line with the regulatory provisions and be clear, direct, punctual and easy to interpret.
Updated national non-harmonised standards list
On 19 December 2022, The German Federal Institute for Safety and Health at Work (BAUA) published the ProdSG Non-Harmonised Area - Part 1 National Standards. This document compiles Standards according to the Product Safety Act – ProdSG. After their determination by the Committee for Product Safety (AfPS) and the publication of the references by the Federal Institute for Occupational Safety and Health in the Joint Ministerial Gazette, these standards develop the presumption of conformity according to § 5 Para. 2 ProdSG.
For more information, consult the BAUA website here.
New composition requirements for containers and packaging
On 27 December 2022, the Spanish Ministry for the Ecological Transition and the Demographic Challenge published the Royal Decree 1055/2022, of 27 December, on packaging and packaging waste. This decree repeals Law 11/1997 that previously regulated these issues.
This royal decree establishes the legal requirements applicable to packaging and packaging waste, with the aim of preventing and reducing their impact on the environment throughout their entire life cycle.
The Decree entered into force on 29 December 2022, one day after its publication in the Official State Gazette. However, the new marking obligations outlined in article 13 will only apply from 1 January 2025.
Please find below a summary of the main points with which manufactures, importers or those otherwise responsible of packaging must comply:
- Product producers or authorised representatives must register in the packaging section of the Register of Product Producers. Registration must be made within a period of three months from the date of entry into force of the aforementioned royal decree.
- An annual declaration, corresponding to the containers that have been placed on the market in each calendar year, must be made. The period for reporting information for a given year will run from 1 January to 31 March of the following year.
- Marking obligations detailing the packaging’s reuse or the container in which packaging waste must be deposited. The nature of the marking is not defined in the Royal Decree, so this is left to the discretion of the producer.
- It is forbidden to indicate that the packaging is “respetuoso con el medio ambiente” (environmentally friendly) or any other equivalent text.
- The decree regulates specifications of packaging "recyclability", the content of recycled material, and its compostable nature:
- Compostable plastic packaging must be designed in such a way that no non-compostable elements interfere with the recycling and composting process. It must bear a label indicating its quality based on the EN 13432:2001 standard.
- Marking packaging with the percentage of packaging material available for quality recycling is regulated. This information has been obtained through an auditable and certifiable evaluation, which must be reviewed at least every five years.
- Packaging may also be marked to indicate the percentage of recycled material it contains. This information must be certified by an accredited entity that issues certification from the National Accreditation Entity or the national accreditation body of any other Member State of the European Union, or in the case of products manufactured outside the European Union, any other accreditor with whom the National Accreditation Entity (hereafter ENAC) has an international recognition agreement.
- It will be presumed that the packaging meets the abovementioned criteria of it complies with the following standards:
- UNE-EN 13427:2005 “Packaging and packaging. Requirements for the use of European standards in the field of containers and packaging and their waste”
- UNE-EN 13428:2005 “Packaging and packaging. Specific requirements for manufacturing and composition. Prevention by reduction at source”
- UNE-EN 13429:2005 “Packaging and packaging. Reuse”
- UNE-EN 13430:2005 “Packaging and packaging. Requirements for containers and packaging that can be recovered through the recycling of materials”
- UNE-EN 13431:2005 “Packaging and packaging. Requirements for containers and packaging that can be recovered through energy recovery, including the specification of the minimum lower calorific value"
- UNE-EN 13432:2001 "Containers and packaging. Requirements for containers and packaging that can be recovered through composting and biodegradation. Test programme and evaluation criteria for the final acceptance of the container or packaging"
- Packaging made with non-compostable plastic must incorporate a sufficient amount of recycled plastic to meet the objectives established in this Royal Decree. The amount of recycled plastic contained in the products must be certified by an accredited entity that issues certification under the UNE-EN 15343:2008 "Plastics. Recycled plastics. Traceability and conformity assessment of the recycling of plastics and recycled content”.
- On 1 January 2023, the information on the environmental impacts and waste management obligations of the packaging must be available in shop, provided they have a useful area for exhibition and sale to the public equal to or greater than 300 meters squared in shop. These obligations will also apply to e-commerce platforms and retail businesses that make distance sales, which must clearly report the means used for the sale.
- For single-use plastic bottles, the percentage of recycled plastic content in containers has been established for the period 2025-2030.
- The obligation requires that businesses offer fruit and vegetables in bulk, prohibiting the sale of packaged in batches of less than 1.5 kilograms.
- The conditions of the reuse of containers must be laid out, i.e. detailing the deposit, return and return systems or similar mechanisms, within the framework of the regulation established by the royal decree.
As of 30 November 2022, a proposal for a Commission Regulation on packaging and packaging waste has been in process, which will increase the requirements surrounding eco-design and reuse.
New statement on control of imports for toys and consumer products
On 31 December 2022, Turkiye’s Ministry of Commerce published two communications which establish the nation’s import control requirements for toys and some consumer products. They became effective on 1 January 2023. Below a summary containing information on these new communications:
- Communication on import control of toys (Product safety and audit: 2023/10)
This stablishes the nation’s import control of toys the Risk-Based Control System on Foreign Trade (TAREKS). - Communication on control of imports of consumer products (Product safety and audit: 2023/12)
This establishes a list of consumer goods with health and safety codes for control, and also requires certain products or materials to comply with specified restricted chemicals under Turkey REACH (Kimyasalların Kaydı, Değerlendirilmesi, İzni Ve Kısıtlanması Hakkında Yönetmelik (KKDIK)).
Some affected products include:- Toilet seats for children
- Imitation jewelry
- Watches and straps
- Cases for cell phones and tablets
- TS EN 1273 Baby walking frames and TS EN 1466 Carry cots and stands
- TS EN 1400 Soothers for babies and young children
- TS EN 14350 Drinking equipment intended for young children
- TS EN 14988:2017+A1 Children’s highchairs
- TS EN 13138-3 Buoyant aids for swimming instruction
California designates nail products containing toluene as a priority product
California’s Department of Toxic Substances Control (DTSC) listed a new Priority Product under the Safer Consumer Products Regulations: nail products containing toluene. The covered products include nail products containing toluene, including nail coatings and nail polish thinners that contain toluene as an added ingredient, contaminant, or residual. Nail coating includes any clear or colored paint, polish, lacquer, enamel, or gel product marketed or sold for application to fingernails or toenails.
By 2 March 2023, domestic and foreign manufacturers of the covered products must submit to the DTSC a Priority Product Notification (PPN), naming all of the manufacturer’s products that contain toluene, either as an intentionally added ingredient or as a contaminant. After submitting the PPN, manufacturers will have the option to submit one of the following by 30 June 2023:
- an Alternatives Analysis Threshold Notification;
- a Chemical Removal Intent/Confirmation Notification;
- a Product Removal Intent/Confirmation Notification;
- a Product-Chemical Replacement Intent/Confirmation Notification; or
- a Preliminary Alternatives Analysis Report or other alternate reporting options.
The Alternatives Analysis Threshold (AAT) for toluene in nail products is set at 100 parts per million (ppm). Manufacturers that demonstrate and certify that the concentration of toluene in their priority product does not exceed the ATT of 100 ppm will not be required to submit an Alternative Analysis Report.
For more information on the PPN, please visit the DTSC’s website here. To see the full text of the new Regulation, please click here.
New York regulates mercury in cosmetics and personal care products
The State of New York recently approved Bill S8291A to amend Section 37-0117 of the Environmental Conservation Law to prohibit mercury in cosmetics and personal care products, effective 1 June 2023.
Mercury is defined as elemental mercury Hg, mercuric iodide, mercury oxide, mercurous chloride, ethyl mercury, phenyl mercuric salts, ammoniated mercury, amide chloride of mercury, mercury sulfide or cinnabaris, or mercury iodide.
A cosmetic product is defined as any article (a) intended to be rubbed, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for beautifying, promoting attractiveness, or altering the appearance, and (b) intended for use as a component of any such article.
A personal care product is defined as any product intended for cleaning or cleansing any part of the body, such as the skin and hair, and including but not limited to, hair shampoo, hair conditioner, soap, bath gels and other bath products.
STURDY Act passes as part of 2023 spending bill
The Stop Tip-overs of Unstable, Risky Dressers on Youth Act (“STURDY Act”) has recently passed through the Congress as part of the 2023 omnibus spending bill. The STURDY Act will now supersede the U.S. Consumer Products Safety Commission (CPSC) final rule on the Safety Standard for Clothing Storage Units (CSUs) that was set to go into effect on 24 May 2023. The STURDY Act will require the CPSC to adopt a new rule to protect children from tip-over-related death or injury with:
- tests that simulate the weight of children up to 60 pounds;
- objective, repeatable, reproducible, and measurable tests or series of tests that simulate real-world use and account for impacts on clothing storage unit stability that may result from placement on carpeted surfaces, drawers with items in them, multiple open drawers, and dynamic force;
- testing of all CSUs, including those 27 inches and above in height; and
- warning requirements based on ASTM F2057-19, or its successor at the time of enactment, provided that the CPSC may strengthen the warning requirements of ASTM F2057-19, or its successor, if reasonably necessary to protect children from tip-over-related death or injury.
ASTM International will have 60 days to publish revisions to the ASTM F2057 standard to meet the requirements of the STURDY Act outlined above. The CPSC will then have 90 days to determine whether to adopt the updated ASTM F2057 standard in whole or in parts and promulgate a final consumer product safety rule that meets the requirements of the STURDY Act. The new CSU product safety rule will go into effect 120 days after the date of the promulgation or such a later date as the CPSC determines appropriate.
CPSC’s custom window covering safety rule not effective while court case pending
On 30 November 2022, the Window Covering Manufacturers Association (WCMA) filed a lawsuit to challenge the Consumer Product Safety Commission’s (CPSC) rule, Safety Standard for Operating Cords on Custom Window Coverings (16 CFR 1260), claiming that the rule does not substantively advance child safety. On 10 January 2023, the U.S. Court of Appeals for the D.C. Circuit granted the motion by WCMA to stay the CPSC rule. As a result, the CPSC rule that was set to come into force on 30 May 2023 will not take effect while WCMA’s lawsuit against CPSC is pending.
Thailand issues new standard for food utensils coated with fluropolymer
The Thai Industrial Standards Institute (TISI) has recently released a new and updated industry product standard. Please see Table 1 below:
Table 1:
Category |
Standard |
Effective Date |
Food Contact Materials |
TIS 2622-2556 Fluropolymer-Coated Utensils for Food |
2 April 2024 |
Miscellaneous technical publications relating to food contact materials
The latest publications in relation to food contact materials are summarised in the table below:
Date |
Entity |
Publication |
17 November 2022 |
MERCOSUR |
Publication of MERCOSUR/GMC/ Res. No 26/22 which modifies the Resolution no. 40/15 “MERCOSUR technical regulation on cellulosic materials, packaging and equipment intended to be in contact with food” |
05 January 2023 |
Brazilian Health Regulatory Agency (ANVISA) |
Draft resolution number 1134, 23 December 2022 |
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 67 alerts regarding childcare articles, equipment and toys were reported in week 52 of 2022 and between week 1 and 3 of 2023.
Type of Risk |
Number of alerts |
Notes |
|
|
Head band with LED lights |
|
Balloons |
|
|
Multifunctional toy |
|
|
Modelling clay |
|
|
Plastic toy set |
|
|
Slime toy |
|
|
Inflatable plastic ball |
|
|
Jumping ball |
|
|
Plastic dolls and accessories |
|
|
|
Multifunctional toy |
|
|
Plastic toy |
|
|
Plastic toys |
|
Mattress |
|
|
Puzzle play mat |
|
|
Rattle |
|
|
Squeezable toy |
|
|
Soft toy |
|
|
|
Plastic toy gun |
|
|
Toy gun set |
|
Rattle toy |
|
|
|
Magnetic puzzle |
|
|
Soother holder |
|
|
Children's cot |
|
|
Battery operated toy |
|
|
Baby carrier |
|
Children´s highchair |
|
|
Children’s scooter |
|
|
Magnetic balls |
|
|
Toy bow set |
|
|
Toy rake |
|
|
|
Squeeze toy |
The following 12 alerts regarding hard goods/ miscellaneous goods were reported in week 52 of 2022 and between week 1 and 3 of 2023.
Type of Risk |
Number of alerts |
Notes |
|
|
Bioethanol fireplace |
|
|
Pencil case |
|
Jewellery |
|
|
|
Jump rope |
|
|
Decorative food |
|
Tablecloth weights |
RASFF (European Commission Rapid Alert System for Food and Feed - Alerts reported by EU national authorities)
The following 3 alerts regarding Food Contact Materials related to children's tableware were reported from 21 December 2022 to 20 January 2023.
Product |
Substance / Hazard |
|
Bamboo fibre children's tableware |
Bamboo melamine tableware for children |
|
Kids Melamine Dinner Set |
Migration of Melamine from a Kids Melamine Dinner Set from Bangladesh |
|
Gold coloured metal bowl 20cm |
Colour migration from the gold coloured metal bowl from China |
OPSS issues Product Safety Alerts on the UK market. The following alerts regarding toys and childcare products were reported in week 52 of 2022 and between week 1 and 3 of 2023.
12 recalls regarding toys and childcare products
Type of Risk |
Number of alerts |
Notes |
|
|
Toy head wear |
|
|
Flashing sword |
|
|
Educational Toy |
|
|
Dress-up America costumes |
|
|
Light-up paint toy |
|
Musical toy |
|
|
Magnetic fishing toy |
|
|
Plush toy |
|
|
Children’s jumpsuit |
|
|
LED flashing rings |
3 recalls regarding furniture
Type of Risk |
Number of alerts |
Notes |
|
|
Swivel chair |
|
|
Upholstered sofas and chairs |
|
Corner sofa |
5 recalls regarding hard goods/ miscellaneous goods
Type of Risk |
Number of alerts |
Notes |
|
|
Earring and necklace set |
|
Pendants |
|
|
|
Mountain bike |
|
|
Bicycle stems |
|
|
Mirror |
From 22 December 2022 to 19 January of 2023, the CPSC (Consumer Product Safety Commission) published the following recalls:
3 recalls regarding Toys and childcare products
Hazard |
Number of alerts |
Notes |
|
|
Weighted blankets |
|
|
Rocking sleepers |
6 recalls of consumer products
Type of Risk |
Number of alerts |
Notes |
|
|
Kid’s bicycles |
|
|
Home bed rails |
|
|
Inflatable stand-up paddleboards |
|
|
Bicycle handlebars |
|
|
Bicycle helmets |
|
|
Scented candles |
1 recall of food contact materials
Type of Risk |
Number of alerts |
Notes |
|
|
Pots |