Navigating the new European Toys Safety Directive

May 2010

The 2009 Toy Safety Directive (TSD) was published in the Official Journal of the European Union and entered into force on 20 July 2009. The 2009 TSD is written to be aligned with the current practices of toy manufacturers and strengthens the rules as laid down in the 1988 TSD. As a result, 2009 TSD requires adaptations in the manufacturing chain, as well as new procedures along the supply chain.

The general provisions of the 2009 TSD are applicable to toys placed on the market as of 20 July 2011, while the chemical provisions will be applicable to toys placed on the market as of 20 July 2013 (additional 2-year transition period for chemical properties). In practice, this means that the toys compliant with the 1988 TSD will be allowed to be placed on the market until 19 July 2011 or 19 July 2013 in the case of certain chemical provisions.

The 2009 TSD provides a definition for toys and therefore determines whether a product falls under the scope of the Directive: “Any product or material designed or intended, whether or not exclusively, for use in play by children under 14 years of age”.
 
Compared to the 1988 TSD, the new element is the wording ‘whether or not exclusively’, that has been added to indicate that the product does not have to be exclusively intended for playing purposes in order to be considered as a toy. Accordingly, products with double functions are considered as toys (e.g. the regularly quoted key-ring with a teddy bear attached to it).  Due to this change the 2009 TSD embraces more products than previously. It also imposes a more rigid regulation, including restrictions on 19 chemical elements as opposed to the previous 8, 55 allergenic fragrances and carcinogenic, mutagenic, or toxic for reproduction (CMR) substances

The new Directive is detailed and lengthy but inevitably there are “grey areas” that are recognised by the TSD that impacts on businesses working not strictly in the toy industry. It includes examples that are not considered as toys but that could be subject to confusion and it includes a list of a limited number of products that comply with the definition of toys but are nonetheless excluded from the scope of the 2009 TSD.

It is important to note that the 2009 TSD does not affect the requirement that all items must comply with the existing General Product Safety Directive (2001/95/EC), which defines a safe product as one that "presents minimal or no risk when used in a foreseeable way."

So what should you do as a Toy Manufacturer/ Importer/ Retailer?

  • Ensure that you put in place Technical Documentation for each product you market. Review the content of these files; specifically the new requirements
    • Safety (or risk assessment) 
    • Conformity assessment procedures
    • Declarations of conformity 
  • Review your products and retail packaging to see whether your products will need changing. Toys will have to bear a type, batch, serial or model number
  • Review with the factories and/or the manufacturers what conformity assessment procedures are currently in place for your products
  • The essential safety requirements of the revised directive will now be incorporated into new toy standards (EN71 and EN61125), therefore keep abreast of the new standards as they are published and ensure that toys are manufactured to these new standards.
  • New requirements will be incorporated into a new standard (probably EN71 part 3) ready for implementation within four years. In the meantime, you should ensure that any accessible materials containing the restricted elements given in the TSD are below the required limits.
  • Ensure that your products conform to REACH and encourage the use of food grade plastics for products for under threes and mouth contact products.
  • Ensure your products meet the current cosmetic requirements and phase out any preparations that use the additional fragrances banned by the revised directive. Request declarations of conformity for these additional fragrances from your supplier. 
  • Ensure that your products do not contain nitrosamines or nitrosable substances for products for under threes and mouth contact products. (rubber and rubber based products are particularly likely to contain these substances) 
  • Keep abreast of the new standards for Warnings and Packaging as they are published and ensure that toys are manufactured to these new standards.
  • Review your retail packaging to ensure that it does not include any parts that can cause strangulation or asphyxiation according to the current standard for toys. 
  • Review if your products are coupled with food, review these products (with the food distribution company, if appropriate) to see if they have any products that will have to conform to the new standards.

Written by Samantha Duffy and Dr Derek S Hepburn


NOTES

US$ 900 million annual sales and 8,000 employees across 150 sites in 29 countries, Eurofins is a leading international group of laboratories providing an unparalleled range of testing and support services to the pharmaceutical, food, environmental and consumer products industries and to governments.

Eurofins has a network of 9 sites in the UK and Ireland through which our customers access a portfolio of over 25,000 analytical methods addressing the authenticity, origin, safety, identity, composition and purity of products.

The Laboratory in Manchester is accredited to ISO17025 and is an Approved body under Regulation 8 of the Toys (Safety) Regulations to carry out examinations and tests and issue EC type-examination certificates in respect of models of toys.