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Robust regulations and requirements for toys and toy safety in the European Union and USA are impacting product recall notifications and leading to an increase in market surveillance.
 
In the USA, a tough testing regime has seen notifications drop, as non-compliant products do not reach the marketplace.  In the EU though, toys must comply with the requirements of the EU Toy Safety Directive (2009/48/EC). This comprehensive set of requirements includes the safety assessment, which highlights any issues, thereby helping to reduce recalls in the EU by preventing non-compliant products from reaching the market.
 
Toys are essential tools for children and fundamental to their development.  Manufactured using modern processes, new materials and techniques are constantly being introduced. To meet the production challenges and minimise the risk of recalls, it is vital that manufacturers, importers, notified bodies and competent national authorities ensure that only compliant toys are placed on the market.
 
Requirements in the US and EU are different, but their objective is the same, to deliver safe toys to the market.

EU TOY RECALLS UP 58%

Over the years, toys have been one of the most frequent products being notified under the EU RAPEX system. Since 2012, toy notifications have increased from 366 to 580, an increase of 58%.
 
According to RAPEX, toys were recalled for failure to meet the Toy Safety Directive 2009/48/EC and chemical requirements, including:

  • Choking hazards (EN 71-1)
  • Strangulations (EN 71-1)
  • Sharp edges (EN 71-1) 
  • Suffocation (EN 71-1)
  • Accessible filling fibrous materials (EN 71-1)
  • Insufficient warnings (EN 71-1)
  • High flammability (EN 71-2)
  • Chemicals such as soluble elements (EN 71-3) and phthalates 
  • Overheating rechargeable batteries (EN 62115)
  • Electromagnetic disturbance (Electromagnetic Compatibility Directive 2004/108/EC) 
  • Food imitation
  • Loosen knots in swings (EN 71-8)
  • Microbiological risks

From the documented list of noncompliance parameters, the most common violations were: 

  • The presence of small parts for violation of the Toy Safety Directive 2009/48/EC
  • Excessive levels of phthalates for violation of ANNEX XVII of REACH

Recalls as a result of excessive levels of short chain chlorinated paraffins (SCCPs), have increased steadily since the restriction/prohibition of SCCPs in articles, including toys, under Regulation 519/2012 on Persistent Organic Pollutants (POPs Regulation).
 
Toys entering the EU must undergo a safety assessment, as required by Article 18 of the Toy Safety Directive.  The objective is to identify any potential hazards (physical, chemical, electrical, flammability, etc.) that a toy may present, to improve design and minimise risk.
 
In addition to meeting harmonised toy safety standards1, toys destined for the EU market must meet all applicable standards and legislation at EU and national levels (summarised in Table 1).

US TOY RECALLS

In the 2013 fiscal year, the US Consumer Product Safety Commission (CPSC) issued only 31 toy recalls (against 172 in fiscal year 2008), none of which involved a lead violation. The majority of toy recalls announced last year involved ingestion hazards, including chemical and magnetic dangers.
 
In the last few years, the range of hazards identified by CPSC includes:

  • Aspiration and choking (small parts) 
  • Entrapment (storage and toy chests)
  • Fall 
  • Fire and burn   
  • High powered magnets   
  • Impact
  • Ingestion 
  • Lead (paint and substrate)
  • Laceration (sharp edges) 
  • Projectile
  • Strangulation

Toys and children’s products entering the US must undergo mandatory third party testing and certification to all applicable consumer product safety rules, any other rule, regulation, standard or ban under the Consumer Product Safety Act (CPSA), or any other statutes enforced by the CPSC. Toys destined for specific states are also required to conform to toy safety legislation/standards at the state level. These are summarised in Table 2.
 
During the last five years, CPSC and the US Customs and Border Protection (CBP) have stopped more than 9.8 million units of about 3,000 different toys that violated applicable standards.

EUROPE’S RAPID ALERT SYSTEM

RAPEX is the European rapid alert system for dangerous products with the exception of food, pharmaceutical and medical devices, as these are regulated by other mechanisms. It facilitates the rapid exchange of information between Member States and the Commission on measures taken, prevention or restriction on the sale of consumer products posing a serious risk to consumer health and safety. Since 2013, the Commission has also published notifications on products posing less serious risks, including on products posing a risk to the public interests protected by relevant EU legislation, e.g. persistent organic pollutants (POPs).
 
The RAPEX2 system currently includes 31 countries, 28 Member States from the EU, including three countries from the European Free Trade Agreement/European Economic Area (EFTA/EEA): Iceland, Liechtenstein and Norway.

US CPSC TOY SAFETY SYSTEM

In recent years, the CPSC3 has created a robust toy safety system, by requiring testing by independent, third party testing laboratories around the world; enforcing stringent lead and phthalates limits for toys; imposing some of the most stringent toy standards in the world; and stopping non-compliant and dangerous toys at ports and in the marketplace before they reach children’s hands. These combined efforts continue to foster the confidence of American families.

STRATEGIES TO AVOID TOY RECALLS

Testing, at every stage of development and manufacture, can identify problems before toys reach the marketplace, minimising the risk of product recall. Key testing categories include:

  • Mechanical/physical
  • Flammability
  • Chemical
  • Electrical safety

Inspection before, during and at the end of the production:

  • Reduce the risk that production is jeopardised by insufficient or sub-standard supply of material and Components
  • Ensure consistency of production, samples are randomly picked up from production lines to check the general quality of components, materials and finished products
  • Pre-Shipment Testing enables to check that no deviation in production happened        
  • Loading Supervision (LS) to ensure that the consignment previously inspected is actually shipped

Table 1. Applicable Legislation or Standard for EU Toy Compliance

item    toy productsLEGISLATION / STANDARD
1 Toy Toy Safety Directive 2009/48/EC
2 Toy

Member State legislation e.g.

  • Danish Order 855 of 5 September 2009: Phthalates in products for children aged 0-3 years old 
  • French Decree of 1 August 2013: Formamide content in puzzle mats
3 Toy POPs Regulation (EC) 850/2004
4 Toy REACH Regulation (EC) 1907/2006
5 Toy Toxicological Risk Assessment (TRA)
6 Cosmetic Toys Cosmetics Regulation (EC) 1223/2009
7 Electrical Toys
  •  Batteries Directive 2006/66/EC
  • Electromagnetic Compatibility Directive 2004/108/EC (EMC)
  • Low Voltage Directive 2006/95/EC (LVD)
  • RoHS Recast Directive 2011/65/EU 
  • Radio-Controlled Toys, Directive 1999/5/EC (R&TTE)
  • WEEE and WEEE Recast Directives 2002/92/EC and 2012/19/EU
8 Food Contact e.g. kitchen set
  • Overall Framework Regulation (EC) 1935/2004
  • Plastics Regulation (EU) 10/2011
9 Packaging (not integral part of toy
nor has play value)
Directive 94/62/EC
10 Substances and Mixtures
  • CLP Regulation (EC) 1272/2008 ‘Classification, Labelling and Packaging of Substances and Mixtures’
  • Microbiological Examination of Non-Sterile Products (European Pharmacopeia)
 Table 2. Legislation or Standard for Toy Safety for US
itemtoy productslegislation/standard
1 Toy CPSIA including: ASTM F 963, Lead (paint and substrate), Phthalates, Tracking label
2 Toy 16 CFR 1500.3 (toxicity / irritancy)
3 Toy California AB 1108 (Chapter 762, Statutes of 2007, phthalates)
4 Toy
  • 19 CFR 134.11 (country of origin label)
  • 15 CFR 1159 (toy gun label)
  • Label or tag (stuffing toys, state laws) 
  • USP 51 and 61 (mixtures)
5 Toy
  • Chemicals of High Concern to Children (CHCCs, Vermont and Washington
  • Priority Chemicals (PCs, Maine)
6 Toy Flame retardants (state laws)
Penta-BDE, Octa-BDE, Deca-BDE, TCEP (TRIS) and TDCPP
7 Toy Toxicological Risk Assessment (TRA)
8 Art Materials 16 CFR 1500.14 / ASTM D 4236 (LHAMA)
9 Dive Stick 16 CFR 1500
10 Substances and Mixtures
  • Battery Management Act (mercury in button cells, Federal)
  • Mercury in button cells (state laws)
11 Electrical and radio controlled Federal Communications Commission (FCC)
12 Food Contact 21 CFR 175-189
13 Rattle 16 CFR 1510

For further details, please see SGS Product Recalls and contact your local sales representative or the global team.
 
Hingwo Tsang, Ph.D.
Information and Innovation Manager
SGS Hong Kong Limited
t +852 2774 7420

References

1 SGS Technical Bulletin - European Toy Legislation (PDF 76 KB)
2 European Commission - RAPEX - Latest Notifications
3 US Consumer Product Safety Commission - Recent Recalls