The new European Toy Safety Directive entered into force on 20 July 2011 with the exception of the new chemical requirements, which come into force on 20 July 2013. These new chemical requirements mean extensive changes so it is high time to check that any toys you export to Europe to be placed on the market after 20 July this year will meet the new requirements.
As more than 80% of toys sold in Europe are made in China, it is important that Chinese operators have a comprehensive dialogue with their European clients in order to make sure that the supplier manuals they are following are up-to-date. Your client could be faced with penalties such as a hefty fine, one year’s imprisonment or closure of a company for five years, not to mention substantial reputation damage, if they were found to place non-compliant toys on the market.
The new requirements apply for all toys placed on the market after 20 July whether or not similar toys were manufactured or exported before the July deadline.
无论玩具是否是在7月的最后期限之前制造或出口的,只要是 720日后投放市场的,新规定都适用。
Below follows a summary of the major changes introduced by the new chemical rules.
Safety requirements
The Toy Safety Directive specifies that even if a toy meets the particular requirements (below), market surveillance authorities may request action if they suspect that the toy involves a chemical risk. The Directive also stipulates that toys must be designed and manufactured in such a way that there are no risks of adverse effects on human health due to exposure to the chemical substances or mixtures of which the toys are composed or which they contain.
Migration limits
The Directive sets maximum migration limitsfor 19 chemical elements. The limits are different depending on which of the three categories of material are used:
1.            dry, brittle, powder-like or pliable
2.            liquid or sticky
3.            scraped-off
This means that the number of chemical elements regulated by migration limits has been extended from the current 8 to 19 in total, and that different limits apply depending on the toy material category. The limit values presently in place ​​for the eight substances already regulated will generally become stricter. The reason for the different limits for different categories of material is that a child can, for example, ingest larger amounts of a liquid material such as a soap bubble solution, than of, for example, a thin layer of paint that has to be scraped off the surface of a toy. The elements covered by the migration requirements are aluminium, antimony, arsenic, barium, boron, cadmium, chromium (III), chromium (VI), cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, organic tin and zinc.
Prohibition of CMR substances
Substances that are carcinogenic, mutagenic or toxic for reproduction (CMRs) are banned in accessible parts of a toy in concentrations above those laid down in the Regulation on classification, labelling and packaging of substances (CLP Regulation 1272/2008). The limits depend on the substance classification (categories 1A, 1B or 2) and range from 0,1% to 3%. This requirement applies in addition to the migration limits and to each part of the toy. The requirement does not apply to CMRs that are inaccessible to children using the toy.
Prohibition of certain fragrances
55 allergenic fragrances are banned in the Directive and must not be used in toys (at levels greater than 100 mg/kg per fragrance). 11 additional fragrances must be labelled on the packaging if they are present in a concentration above 100 mg/kg. The requirements for fragrances in toys are stricter than those for cosmetic products.
欧盟新指令中55种过敏性芳香剂被禁止,而且不得用于玩具(每种芳香剂含量不超过100毫克/公斤)。 11种过敏性芳香剂当含量超100mg/kg时需要在玩具包装上进行标识。玩具中对芳香剂的要求比化妆品更加严格。
Migration limits for nitrosamines
The Directive stipulates that nitrosamines, which can be found in rubber for example, and nitrosatable substances must not migrate from toy materials at levels greater than 0,05 ppm and 1 ppm respectively. These requirements apply to toys intended for children under 36 months and to other toys intended to be placed in the mouth.
该指令规定,包含亚硝胺的材料(如橡胶)和亚硝基胺物质在玩具材料中的迁移水平分别不能大于0.05 ppm1PPM。这些要求适用于供36个月以下儿童使用的玩具和其他拟放入口中的玩具。
The requirements may still change
Some requirements of the Directive may be amended by a special Committee. The list of substances covered by migration limits, the migration limits themselves, as well as the list of banned fragrances can be altered. Even before the new requirements come into force, the migration limits for cadmium have changed and discussions about further changes for other substances are ongoing.
Other legislation
Toys must also comply with other relevant EU legislation relating to certain product categories and restrictions for certain substances and mixtures. This means that while these other chemical regulations were not always specifically written for toys, they also apply to certain toys and must be considered in terms of a toy’s chemical safety. Examples of such legislation are:
-              REACH Regulation 1907/2006 (Registration, Evaluation and Authorisation of Chemicals): regulates the presence of substances such as phthalates, benzene, AZO dyes and cadmium in particular toys.
-    The issue of phthalates in toys deserves particular attention. In 2012, 43% of all toys notified on a European system for products presenting serious risks were due to chemical-related issues. Almost 40% of all notifications were due to excessive amounts of phthalates. The majority of these products originated in China. As a result of these notifications, toys are one of the most frequently notified unsafe products in Europe, which damages the sector’s safety record.
-              RoHS Directive 2011/65 (Restriction on the use of certain Hazardous Substances in electric and electronic products): applies to electrical and electronic toys and regulates lead, mercury, hexavalent chromium, cadmium and flame retardants PBDE and PBB
-              Cosmetics Regulation 1223/2009: cosmetic toys must comply with these rules (new rules applicable from 11 July 2013)
-              Directive 94/62/EC on packaging and packaging waste: covers the presence of heavy metals in packaging including toy packaging
-              Regulation 1935/2004 on materials and articles intended to come into contact with food: applies to toys that are intended to come into contact with food
-          REACH法规(1907/2006/EC,“化学品注册、评估、许可和限制”):规定了某些物质,诸如苯、邻苯二甲酸盐、偶氮染料、镉的含量特别是玩具中的含量;
-          玩具中邻苯二甲酸盐的问题,值得特别关注。2012年,由于化学品相关问题而可能存在严重风险被欧盟系统通报的玩具产品有43%,而其中又有40%的通报是由于邻苯二甲酸盐过量。这些产品大部分来自中国。正基于此,玩具在欧洲是最频繁被通报的不安全产品,因此降低了行业的安全记录。
-          RoHS 2.0指令(2011/65/EU,关于在电子电气设备中限制使用某些有害物质指令):适用于电器及电子玩具,规定了铅、汞、六价铬、镉和阻燃剂多溴二苯醚和多溴联苯的要求;
-          欧盟化妆品新规(1223/2009/EC):化妆玩具必须遵守这些规则(新规则于2013711日开始适用);
-          包装和包装废弃物指令(94/62/EC):规定了包括玩具包装在内的包装中重金属的含量要求;
-          食品接触材料的框架性指令(1935/2004/EC):适用于拟与食品接触的玩具。
Further information about the new Toy Safety Directive is available here: http://www.tietoy.org/toy-safety/
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