EU toy safety new directive 2009/48/EC released formally
2009-09-02
The EU Toy Safety Directive 88/378/EEC is the first New Approach Directive. Since the issue in 1988, it has made great achievements in ensuring the safety of toys in EU market and eliminating the trade barriers among EU member states. Up to now, the EU has amended it once through CE Marking Directive 93/68/EEC. However, after 20 years of operation, certain deficiencies have been discovered inevitably; for example, the security requirement needs further improvement, the implementation of the directive is inefficient, the range and certain concepts are not clear, etc.
Since 2003, the EU has got around to amending the 88/378/EEC directive and collecting suggestions from the public. By the end of 2007, the EU had successively released three research reports about the influence of amending the 88/378/EEC directive. Refer to the “Reference” at the bottom of this page for details. On January 25, 2008, the EU released the directive amendment proposal COM(2008)9; on December 18, 2008, the European Parliament passed the proposal; the official copy was passed on June 18, 2009 and published in OJ on June 30, 2009. The number of the new directive is 2009/48/EC.
The objective for EU to modify the 88/378/EEC directive is to improve the toy safety and the implementation efficiency of directive. The specific modifications include:
1. Changes of scope and definition
(1) Definition of toy
The new directive modifies the definition of toy to “products designed or predetermined for children under 14 years old, no matter special or not”. This definition extends the scope of the toy directive. For example, the candles in fruit shape are not designed for children to play with, but the children may play these candles. According to the definition of the new directive, these products must satisfy the chemical safety performance and related requirements specified in the directive.
In addition, the new directive also specifies that 19 products including the decorative articles and artificial models for festival or ceremony are not toys. Comparing with the toy safety directive of 88/378/EEC, the definition of toy is clearer in the new directive and the scope is extended. For example, the ice skate (for children under 20kg) and household children sports equipment are listed in the category of toys.
(2) Define the manufacturer and importer, and clarify the responsibilities
The new directive defines the manufacturer, importer and distributor clearly, and adds the obligation requirements on importers and distributors, aiming to ensure that the toys in EU market are safe through the cooperation of the entire supply chain.
2. Provide strict requirements on chemical properties
(1) The category of migratory elements is increased and allowance is reduced dramatically
The migratory elements are increased from 8 to 19 including aluminum, boron, cobalt, copper, manganese, nickel, stannum, strontium and zinc;
For the limitation on chromium, only total chromium is limited in the old Directive without considering of valence; the new directive sets limitation on trivalent chromium and sexivalent chromium; for the limitation on stannum, besides the inorganic stannum, organic stannum is also limited.
The old directive sets same limitation on all materials, while the new directive sets different limitations according to dry, frangible, powder or lithe toy materials, liquid or glutinous toy materials, and scraper painting toy materials.
(2) In the new directive 66 anaphylactic aromatizers are prohibited in toys for the first time
55 prohibited anaphylactic aromatizers are added in the new direction and 11 anaphylactic aromatizers that should be marked if the contents exceed 0.01%. Organic compounds are not in prohibit specifically in the Direction 88/378/EEC.
3. Changes in mechanical, physical and sanitation properties
(1) Risks of asphyxia: the 88/378/EEC directive focuses on children under 3 years old to avoid the risk of swallowing and asphyxia by small parts. The new directive requires that all mouth toys for children shouldn’t have small parts. In addition, 88/378/EEC only regulates the risk of external airway asphyxia, e.g. asphyxia caused when the mouth and nose are covered; the new directive extends to the internal air way asphyxia, e.g. asphyxia caused by toys with sucker.
(2) Toy foods: Requirements on foods in toys in the new directive: i) foods and toy accessories should be packaged separately when these toys are sold; ii) packaging shouldn’t be small parts; iii) toys integrated together with foods are prohibited. i) the foods and toy accessories should be packaged separately when these toys are sold; ii) the packaging shouldn’t be small parts; iii) toys integrated together with foods are prohibited.
(3) General safety requirement: at present, EU general safety requirements on toys indicate the risks caused in normal operation and foreseeable condition. Along with the technology advance and increase of toys category, there are new risks that are not covered by existing standard. The latest example is the risk caused by strong magnet toys. Therefore, in the directive manufacturers are required to consider the risks caused in unforeseeable conditions when designing toys, so as to further improve the toy safety.
(4) Sanitation requirement: the new directive emphasizes the requirements on cleanness and sanitation of toys. The plush toys designed for children under 3 years should still satisfy the safety requirements after being washed.
4. Warning sign and manufacturer’s responsibility
(1) Warning sign
At present, the toy directive requires that the toys must have warning signs to reduce risks. The proposal supplements the existing sign clauses and requires marking the limitations of users on the products, e.g. the age limitation, ability requirement on users, body weight limitation, as well as adult supervision requiring or not. In addition, it is necessary to specify the age limitation on users when the products are sold. For the specific Implementation rules, EU will cooperate with member states’ supervision organizations and relating parties to make a guide document.
(2) Manufacturer’s responsibility
The new directive requires that the technical documents of the products must include harm analysis. That is to say, the manufacturers must analyze the toys’ risks in chemical, physical, mechanical, electrical, inflammability, health and radiation before launching the market, and evaluate possibilities of exposing users to the dangers; assess according to the procedure specified in the directive; label the model and batch on the toy, packaging or accessory data; the importers or distributors must take the manufacturers’ responsibility if they use their own trademarks or have refitted toys.
(3) Requirements on importers and distributors
The new directive requires the importers and distributors inspecting by levels, including the importers checking whether the manufacturers meet related requirements, e.g. whether there is technical document, whether qualification evaluation has been carried out, and random sampling inspection if necessary; conformity mark, e.g. print the importer name on toys or packaging; make sure that the instructions or other data on the toys are written in the language that the customers can understand; make sure that the toys still accord with the requirements in transportation or storage, etc.
5. Certification procedure of toys and market supervision in member states
The new directive requires enforcing the CE symbol certification and strengthening the market supervision of CE symbol according to the EU (EC) No765/2008 act. The new directive reinforces market supervision responsibility by giving specific power to the market supervision departments of member states. The new directive is same to 88/378/EEC directive in the qualification evaluation procedure for toy products, and no compulsory third party certification is added. It only requires manufacturers establishing and implementing appropriate qualification evaluation procedure to ensure that the basic requirements are obeyed.