Revised Toy Safety Directive 2009/49/EC - Summary – 21/09/09

 

On June 30th the revised Toy Safety Directive 2009/49/EC was published in the EU Official Journal.  This article will provide an overview of this directive and its implications.

 

For more than twenty years the safety of toys has been controlled under directive 88/378/EEC. However technologies, knowledge of hazardous substances and the trading environment has changed over this time and a full revision of the directive has been considered necessary.

 

When does it come into force?

 

  • Member states must transpose the directive into law by December 2010.
  • The majority of the requirements within the directive become applicable in July 2011
  • The chemical provisions within the directive become applicable in July 2013

 

What products are affected? - Products designed or intended, whether or not exclusively for, use in play by children under 14 years of age. There is a subtle rewording in this statement from the previous directive but it is probably intended to reflect many of the decisions companies currently make about "grey area" products. There is an updated list of excluded products.

 

What are the top ten changes?

 

  • 1. Traceability - There is more emphasis on the ability to trace the origin and supply route for the toy by adding manufacturer addresses and a unique identification on the toy or packaging or accompanying documents.

 

  • 2. Obligations of Economic Operators - Company roles are defined in the directive as; Manufacturers, Importers and Distributors. Each role has a related list of obligations they must meet. In general obligations are more onerous for manufacturers who must ensure toys comply with safety requirements. Importers are obligated to place only compliant toys on the market and distributors have to take due care. However it should be noted that a company's usual trading role may not be the role they adopt under the directive. For instance there are times when an importer takes on the obligations of a manufacturer i.e. if they design a toy or modify the design of an existing toy in any way. Companies will need to define their role for each buying method, type of toy and the stage in the product cycle they become involved.

 

  • 3. Toys in Food - Toys contained within food or co-mingled in food must have their own packaging which must not be a "small part" likely to cause a choking hazard. Toys included in food in a way that means the food is consumed to access the toy are prohibited.

 

  • 4. Warnings - Warnings must be preceded by the word "Warning" and where they relate to age grading of the toy they must be visible at the point of purchase - this includes on-line or catalogue purchase. Extra requirements for "age limitations" have been added for certain toys which need to be defined by the manufacturer.

 

  • 5. Safety Assessments - Safety assessments, which must consider the behaviour of children (not just the "normal" behaviour), must be conducted for every toy to ensure a full analysis of the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy may present have been assessed. In additional an assessment of a child's potential exposure to these hazards must be included. The safety assessment will form part of the Product File.

 

  • 6. Hygiene Requirements - Toys for children under 36 months must be designed so that they are able to be cleaned effectively and soft toys (without mechanisms) must be washable.

 

  • 7. Chemicals - As well as referring to existing EU chemical restriction legislation (such as REACH and the EU Cosmetics Directive) the chemical requirements of the directive have changed significantly. Toys (with some derogations) must not contain substances that are CMR 1 and 2 (CMR = carcinogenic, mutagenic or toxic to reproduction). The list of 8 elements in EN71 Part 3 (toxicity) has been increased 19 elements with three different migration limits depending on the material "state" (i.e. dry or liquid). Nitrosamines and nitrosable substances have also been restricted in toys likely to be mouthed and intended for children under 36 months. "Product File" documentation (previously called the "Technical file") still needs to be kept and the expected contents have been updated in-line with the latest requirements.

 

  • 8. Conformity Assessments - Production controls must be in place to ensure toys are manufactured to the relevant standards. Procedures to ensure ongoing production remains in conformance must also be in place.

 

  • 9. Documentation - An EC Declaration of Conformity must be signed and be available for inspection by enforcement authorities for all toys. It must be in a set format, indicate the harmonised standards that have been used to confirm conformity and must be kept updated. Documentation must be kept for 10 years "after the toy has been placed on the market".

 

  • 10. Fragrances - There are 55 banned allergenic fragrance ingredients and 11 further listed ingredients that (if used above a certain concentration) require warning labelling. Some exemptions exist for specific toy types.

 

Next Steps - The EN71 series of standards will need to be updated to give companies a method of demonstrating conformance. Mandates have already been issued by the commission to the standards development bodies. Guidance documents are also due for publication, produced by the EU Commission.

 

Further information is available at;

 

http://ec.europa.eu/enterprise/toys/index_en.htm