Toy CE
EU toy safety directive 88/378/EEC (the latest toy directive is 2009/48/EC) is the first new method directive. Since its promulgation in 1988, great achievements have been made in ensuring toy safety in the EU market and eliminating trade barriers between member countries. So far, the EU has only revised it once through CE Marking Directive 93/68/EEC. However, after 20 years of operation, it is inevitable to find some shortcomings, such as security requirements should be further improved, the efficiency of instruction implementation is not high, the scope and some concepts are not clear enough, etc.
Since 2003, the EU has been considering revising the 88/378/EEC Directive and soliciting public opinions widely. By the end of 2007, the European Union had published three studies on the impact of the revision of the 88/378/EEC Directive. On January 25, 2008, the European Union issued COM (2008) 9, which was approved by the European Parliament on December 18, 2008, and adopted by the formal text on June 18, 2009. It was finally published in OJ on June 30, 2009. The new directive is numbered 2009/48/EC.
After the issuance of the new directive, Member States will convert it into their own laws within 18 months, that is, before January 20, 2011. In addition, the Directive also sets a two-year transition period, that is, products meeting the requirements of the old Directive can continue to be put on the market before July 20, 2011; and the transition period of the chemical requirements clause is four years, that is, products meeting the chemical requirements of the old Directive but not the chemical requirements of the new Directive can be put on the market before July 20, 2013. Continue to market.
The EU's revision of the 88/378/EEC Directive aims to improve the safety of toys and the efficiency of the implementation of the Directive. Specific amendments include:
1. Change in scope of application and definition
(1) Definition of toys
The new directive revises the definition of toys to "products designed or intended for use by children under 14 years of age, whether or not they are exclusive products." This definition invisibly expands the scope of application of toy instructions, such as fruit-shaped candles, which are certainly not designed for children under 14 years of age to play with, but are likely to be used by children to play with. According to the definition of the new instructions, these products must meet the requirements of chemical safety performance stipulated in the instructions.
In addition, the new directive also lists 19 products that are not toys, such as decorative items and simulation models for festivals or celebrations. Compared with the toy safety instructions of 88/378/EEC version, the definition of toys in the new instructions is clearer and the scope is increased. For example, skates (used by children below 20 kg) and household sports equipment for children are included in the category of toys.
(2) Definition of manufacturers and importers and further clarification of responsibilities
The new directive clearly defines the toy "manufacturer", "importer" and "distributor", and adds new obligations to importers and distributors, aiming to ensure the safety of toys put into the EU market through the cooperation of the whole supply chain.
2. Strict safety requirements for chemical properties are put forward.
The enhancement of chemical safety requirements for toys is the most important change in the new instructions. The restrictions on migrable elements in the new instructions have increased from 8 to 19. For the first time, special provisions for CMR (carcinogenic, genetic mutation or reproductive toxicity) substances in toys have been introduced to increase the ban on the use of certain allergenic aromatics. It is clearly put forward that the chemical composition of toy materials must be in accordance with EU regulations on classification, packaging and labelling of hazardous substances (67/548/EEC, 1999/45/EC, and Regulation No. 1272/2008). The specific contents are as follows:
(1) The types and limits of migration elements increased and decreased significantly.
The limitation of migration elements increased from 8 to 19, and nine new limitations of migration elements such as Al, B, Co, Cu, Mn, Ni, Sn, Sr and Zn were added.
For the limitation of migrating element chromium, the old directive only requires total chromium, and does not divide the valence state; the new Directive requires that trivalent chromium and hexavalent chromium be restricted separately; and for tin, besides inorganic tin, organic tin is also restricted.
The old directive is basically a unified limit for all materials. The new directive will set different limits for toy materials according to "dry, fragile, powdered or bendable toy materials", "liquid or sticky toy materials" and "scratch paint toy materials".
(2) The new directive is the first to ban 66 allergic fragrances in toys.
The new directive adds 55 banned allergenic fragrances and 11 allergenic fragrances that need to be labeled when the content exceeds 0.01%. There is no clear prohibition of organic compounds in the 88/378/EEC directive.
3. Changes in mechanical, physical and hygienic properties
(1) Hazard of asphyxia: The 88/378/EEC directive is mainly directed at children under 3 years of age to prohibit the occurrence of widgets to avoid the risk of suffocation. On this basis, the new Directive requires that oral toys used by all children should not contain widgets. In addition, 88/378/EEC only regulates the risk of external airway asphyxia, such as asphyxia caused by covering the mouth and nose; the new directive extends it to internal airway asphyxia, such as asphyxia caused by toys with suction cups.
(2) Toy food: The new directive adds requirements for food in toys: i) When selling such toys, food should be packaged separately from toy accessories; ii) packaging itself should not be small parts; iii) toys closely linked to food should be strictly prohibited.
(3) General Safety Requirements: The new current EU's general safety requirements for toys refer to taking into account the risks arising from "normal use" and "predictable use". With the progress of science and technology and the increase of toy types, there are some risks that are not covered by the existing standards. A recent example is strong. Risks caused by magnet toys. Therefore, the instructions require manufacturers to take into account the risks arising from the "use in an unpredictable manner" when designing toys in order to further improve the safety of toys.
(4) Hygienic requirements: The new directive emphasizes the requirements of toys'cleanliness and hygiene. The plush toys designed for children under three years of age should still meet the safety requirements after washing.
4. Warning Marks and Manufacturer Responsibility
(1) Warning signs
At present, toy instructions require toys to be warned correctly to reduce the risk in use. The proposal supplements the existing labeling provisions, requiring the correct labeling of users on products, such as minimum and maximum age requirements, user capacity requirements, maximum or minimum weight requirements, and whether adult supervision is required. In addition, the minimum and maximum age of the user must be declared when the product is sold. As for the specific implementation rules of warning labels, the EU will work with the regulators and stakeholders of Member States to produce a guidance document.
(2) Manufacturer's Responsibility
The new Directive requires that hazard analysis of products be included in the technical files of the products provided. Before putting toys on the market, manufacturers must analyze the hazards of toys in the fields of chemistry, physics, machinery, electricity, flammability, hygiene and radiation, and assess the possibility of users'exposure to these hazards. The conformity assessment procedures prescribed by the order shall be evaluated; the models and batches shall be marked on the toys or packages or attached materials for tracing purposes; and the importer or distributor shall bear the responsibility of the manufacturer after using his own trademark or modifying the toys.
(3) Requirements for importers and distributors
The new Directive requires importers and distributors to inspect step by step, including: importers should inspect whether the manufacturer meets the relevant requirements, such as whether there are technical files, whether the conformity assessment procedures have been carried out, if necessary, random sampling inspection; qualified signs, such as placing the name of the importer on the toys or packaging, for liaison purposes; and guarantees to play; Instructions or other materials are written in a language that consumers can understand; ensuring that toys are still in conformity with requirements during transportation or storage.
5. Toy Product Certification Procedure and Market Supervision of Member States
The new directive calls for strict CE logo certification requirements and enhanced market supervision in accordance with EU (EC) No765/2008 regulation. The new directive strengthens market supervision responsibilities by increasing the specific powers conferred on market supervision authorities of member countries.
The new EU Directive is the same as the 88/378/EEC Directive in terms of conformity assessment procedures for toy products, without adding compulsory third-party certification. Only manufacturers are required to develop appropriate conformity assessment procedures and implement them to ensure that their basic requirements are complied with.
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