July 2010 (10B-142)
The new EU Toy Safety Directive (2009/48/EC) was published on 30 June 2009. It substantially amends the old Directive (88/378/EEC) across virtually all safety aspects. Member States must bring into force the laws, regulations and administrative provisions necessary to comply with the Directive by 20 January 2011. However, the chemical migration of harmful elements of 88/378/EEC is only repealed from 20 July 2013 and as such, chemical requirements do not apply until that date.
Background and Timeline
The new Directive (2009/48/EC) came into force on 20 July 2009, and will become a legal document in all Member States once it has been implemented into national legislation by January 20, 2011. Following is the timeline of the new Directive and recommended actions for clients.
Major Requirements of New Toy Safety Directive
Safety Assessment – Manufacturers shall, before placing a toy on the market, carry out a safety assessment which is an analysis of the chemical, physical, mechanical, electrical, flammability, hygienic and radioactivity hazards that the toy may present, and an assessment of the potential exposure to them.
EC Declaration of Conformity – The document, which needs to be continuously updated, shall state the fulfillment of the essential safety requirements and shall indicate which harmonized standards have been used.
Internal Production Control – Manufacturers shall take all measures necessary so that the manufacturing process, and its monitoring, ensure compliance of the manufactured product with the requirements.
Technical Documentation – The technical documentation shall contain all relevant data and details of the means (e.g. safety assessment, EC declaration of conformity, test report…) used by the manufacturer to ensure that toys comply with the requirement.
Chemical Compliance –
a. Toys must comply with EU chemicals legislation, including REACH.
b. Toys and components of toys shall not contain carcinogenic, mutagenic, or toxic for reproduction CMR 1 and 2, substances.
c. Cosmetic toys, such as play cosmetics for dolls, shall comply with the compositional and labeling requirements of EU Cosmetic Directive 76/768/EEC.
d. Toys shall not contain allergenic fragrances (55 substances listed, with 100ppm limit). For some other allergenic fragrances (11 substances), they shall be listed if added to a toy at concentrations exceeding 0.01% by weight.
New Proposed Limits with New Requirements for Certain Substances
|Element ||New Requirement ||Current Requirement in EN 71-3 |
|mg/kg in dry, brittle, powder-like or pliable toy material ||mg/kg in liquid or sticky toy material ||mg/kg in scraped off toy material ||Any toy materials excluding modeling clay ||Modeling clay |
|Aluminum ||5625 ||1406 ||70000 ||- ||- |
|Antimony ||45 ||11.3 ||560 ||60 ||60 |
|Arsenic ||3.8 ||0.9 ||47 ||25 ||25 |
|Barium ||4500 ||1125 ||56000 ||1000 ||250 |
|Boron ||1200 ||300 ||15000 ||- ||- |
|Cadmium ||1.9 ||0.5 ||23 ||75 ||50 |
|Chromium (III) ||37.5 || 9.4 || 460 ||60 ||25 |
|Chromium (VI) || 0.02 || 0.005 || 0.2 |
|Cobalt || 10.5 || 2.6 || 130 || - || - |
|Copper || 622.5 || 156 || 7700 || - ||- |
|Lead || 13.5 || 3.4 || 160 ||90 ||90 |
|Manganese || 1200 || 300 || 15000 || - || - |
|Mercury || 7.5 || 1.9 || 94 || 60 ||25 |
|Nickel || 75 || 18.8 || 930 || - ||- |
|Selenium || 37.5 || 9.4 || 460 || 500 ||500 |
|Strontium || 4500 || 1125 || 56000 || - || - |
|Tin || 15000 || 3750 || 180000 || - || - |
|Organic Tin || 0.9 || 0.2 || 12 || - || - |
|Zinc || 3750 || 938 || 46000 || - ||- |
Monitoring the Directive Developments
Since the Directive is new and not yet implemented, national Regulations and guidance have yet to be published. It will be important for manufacturers, importers and distributors to keep abreast of the situation as it develops.
Also, due to the added complexity of the new Directive requirements relating to prohibited toxic chemicals,
it should be noted that those requirements will come into force on 20 July 2013. The sections of the old Directive relating to migration of certain elements will remain in force until then.
The Directive contains a section on “amendments and implementing measures”, outlining changes that may be made to specific parts of the Directive for the purposes of adapting them to technical and scientific developments. Apart from amendments to the list of exclusions in Annex I, these deal with amendments to the lists of allergenic fragrances, chemicals and heavy metals, and also relevant warnings. It will be important for manufacturers to be aware of these changes when/if they are made.
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