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在美国销售合规玩具
美国消费品安全委员会
高德
亚太地区消费品安全参赞
美国驻华使馆, 北京
本介绍材料由CPSC工作人员编写,未获得委员会的审阅或批准,不一定反映委员会的观点。
美国消费品安全委员会使命
 通过教育、安全标准活动、制定法规和强制执法来保护公

众,避免消费品造成的不合理的伤害风险。

2
进口来源
来自5个最大来源国的消费品进口
(10亿美元)
$350

$320

$340

$301
$300

$269

$245

$244

$250

Billions of Dollars

$273

$214
$200

$150

$177
$141

$100
$48

$54

$56

$64

$71

$69

$76

$77

$63

$50

$81

$38
$31
$20

$0
2003

2004

2005

China

2006

Mexico

2007

Canada

来源:美国国际贸易委员会统计数字和经济分析局计算数字。

2008

2009

Japan

2010

2011

2012

Taiwan
3
以产品来源统计的产品召回
400

382

350
300

261

262

249

250

260
205

200
150

110

129

126
108

100

119
95

112
81

82

94

85
50

50
0
FY08

FY09

United States

FY10

FY11

China

最后更新:2013年9月36日

FY12

FY13 as
of 9/26

Rest of the World
4
2008年《消费品安全改进法》 (CPSIA)
美国国会2008年通过《消费品安全改进法》(CPSIA),改善
本机构,使之现代化。2007和2008年的许多引人注意的产
品召回,尤其是涉及下列产品的召回:
• 儿童玩具上的含铅油漆
• 危险婴儿床

5
CPSIA主要条款
•

•

•
•
•
•

对于以12岁及12岁以下儿童为对象的产品,禁止超过微量的含铅。
• 儿童产品和玩具含铅量100 ppm。
• 儿童产品和玩具表面油漆90 ppm。
永久性禁止玩具和儿童保育物品中的三种邻苯二甲酸酯;暂时禁止另外三种邻苯
二甲酸酯:
• 不超过1%的DEHP,DBP,或者BBP—永久性禁止
• 不超过1%的DINP,DIDP,或者DnOP—在慢性危害顾问委员会提出建议之前
暂时禁止
规定在儿童产品上放置追踪标签
视美国材料和试验协会 (ASTM) 的玩具标准为CPSA强制性标准
强令CPSC对耐用婴幼儿产品颁布强制性联邦安全标准
强令由得到认证的实验室对儿童产品的含铅量以及是否符合广泛的安全标准进行
上市前检测。

6
CPSIA条款
• 建立一个公众可以搜索的受伤或者受伤风险网络数据库
(www.saferproducts.gov)
• 授予更大权力,以便CPSC下令实施强制性产品召回,保
护公众
• 禁止销售或者重新销售被召回的产品
• 提高对于违反CPSC法律者的最高民事处罚,加强刑事处
罚条款

7
CPSA儿童产品强制性第三方检测
规定要求进行检测,以提供产品合规的“高度保证”。

•
•
•
•
•

初步认证检测
零部件检测 (自愿)
材料更换检测
持续生产定期检测
建立严格的记录制度, 将涉及设计和制造的方方面面都记录
在案, 以保证所有的变动都可以很容易地被追踪
8
初步认证检测
• 找到一个 (或者多个) CPSC接受的实验室进行相应法规规
定的检测
• 根据通过检测结果用儿童产品证书 (CPC) 认证
• 向零售商和分销商提供儿童产品证书 (CPC),并且在
CPSC或者美国海关和边境保卫局提出要求的情况下向其
提供。

美国法典15 USC §2063; 16 CRF §1107.20; 16 CFR 1110.

9
零部件检测
• 如果成品制造商从自愿检测自己产品的供货商(例如一个
油漆供应商)那里购买一个零部件,这个制造商在起草儿
童产品证书时,如果依赖该零部件证书或者零部件检测结
果,必须“行使适当关注”。
• “适当关注”的概念依情况不同和产业性质不同而有所不
同。
联邦法规 16

CFR Part 1109

10
零部件检测
• 例如,根据产业和情况不同,适当关注可以包括:
• 熟悉检测和抽样程序,
• 请求提供书面检测程序
• 确保供货商的第三方实验室是CPSC接受的实验室
• 抽查供货商的检测结果
• 访问供货商工厂或者第三方实验室,或者
• 以协议方式就检测和记录保存事宜达成一致
把“适当关注”记录在案,保存记录。
联邦法规 16 CFR Part 1109

11
材料更换检测
• 材料更换指的是行使适当关注的制造商知道或者应该知道
的、可能影响产品符合相应联邦消费者产品安全法律和法
规的产品设计、生产流程、或者零部件来源的任何变化。
联邦法规 16 CFR Part 1107

12
材料更换检测
• 如果制造商或者进口商在初步认证之后对儿童产品进行了
材料更换,就必须:
• 重新检测受到影响的零部件或者产品可能由于材料更
换而受到影响的合规情况;而且
• 颁发新的儿童产品证书
联邦法规 16 CFR Part 1107

13
定期检测
• 定期检测有助于向制造商提供“高度保证”,确认儿童产品
在产品持续生产的过程中保持符合相应的儿童产品安全规
则,而不仅仅在初步检测和认证时符合。
• www.cpsc.gov/periodic-testing
联邦法规16 CFR Part 1107

14
定期检测
• 如果你—制造商或者进口商—持续生产你的儿童产品,你
必须使用CPSC接受的实验室定期重新检测你的产品。
• 定期检测只在持续生产的情况下适用。
强制性, 联邦法规 16 CFR Part 1107

15
制造商记录保存
• 在5年之内,制造商必须保存如下记录:
• 所有儿童产品证书,
• 所有第三方初步认证和材料更换检测的认证检测结
果,以及
• 在持续生产一个产品的产品设计、生产流程和零部件
来源中有关材料更换的所有描述。

16
检测方和认证方的零部件记录保存
• 每个检测方和认证方都必须在5年期间内向以下列记录为
依据出具证书的认证方以文本或电子形式提供下述记录:
• 检测报告,包括相应的检测值;
• 进行每次检测的有关机构的具体身份信息;
• 确定下述具体信息:
• 零部件或者成品
• 检测的批量或者批次
• 检测使用的相应规则
• 使用的检测方法和抽样规程
• 零部件或者成品检测的日期或者日期范围
17
根据 Section 15规定报告
• 如果一个公司得到下述信息,必须向CPSC报告
• 产品违反了安全法规或禁令,或者
• 合理地支持该产品存在可能造成重大产品危害的缺陷
的结论。
• 公司必须“立即”报告
• 24小时之内
• https://www.cpsc.gov/cgibin/sec15.aspx

18
发现缺陷/危险
• 缺陷模式
• 缺陷、缺点、失误、或者与产品设计、工程、质量控
制、标签、使用、装配等等有关的其它问题
• 分销到商业领域的有缺陷单位的数量
• 危险严重程度
• 受伤严重程度
• 发生伤害的可能性
• 受到影响的人口

19
报告时提供什么
初步报告 – 联邦法规16 CFR 1115.13(c)
• 公司得到报告理由充分的信息后必须立即报告。
• 包括产品、制造商或者进口商、潜在缺陷和危险、样品、
以及其它现有信息的详细情况。
完整报告 – 联邦法规16 CFR 1115.13(d)
• 所有CFR要求的信息,包括产品、制造商、零售商、缺
陷、
受伤情况、以及补救措施的详细情况。
20
快速追踪报告
• 公司根据Section 15(b)报告,并且在20个工作日内实施
纠正措施。
• CPSC工作人员不做出风险“初步确认”(PD)。
• 对于利益攸关者的益处在于:
• 公司不收到产品初步确认 (PD)
• 公司可以迅速实施产品召回
• 需要CPSC的工作人员较少
• 消费者较早得到通知

21
快速追踪报告
• 在CPSC同意的情况 , 公司仍然可以提供修理、更
换、或者退款,作为纠正措施。
• 工作人员必须在实施之前仍然审查修理和更换。
• 公司必须仍然提供一份完整
报告,以及用于快速追踪产
品召回的所有规定信息。

22
以财政年度统计的自愿产品召回

23
民事处罚
•
•

任何人在知情的情况下违法违规,都可以受到民事处
罚。
从2012年1月开始,每次违法违规罚款10万美元,一系列
相关“知情”违法违规的最高处罚不超过1515万美元。

24
我们的进口安全战略







与亚洲监管机构和制造商合作,以便符合美国安全标准
在设计和生产中使用最佳方式
独立检测
追踪运输中的货物 (CTAC)
在美国重点港口与美国海关和边境保卫局 (CBP) 大力合作
发现、扣押、销毁/重新出口违法违规货物

25
与产业合作
• 2009年,在中国北京,在美国大使官邸旁边建立第一个
CPSC海外办事处。
• 2010年,CPSC建立教育、全球联络及小企业申诉专员办
公室,协调利益攸关者并为其提供对外联络服务,包括制
造商、零售商、转销商、小企业、以及外国政府。将小企
业申诉专员确定为全职职位。
• 2011-12年期间,CPSC在世界各地培训了17000多个企业
高管、质量控制和制造业的专业人员。

26
其它信息
• 关注CPSC活动:
• 在社交媒体上关注 (Twitter, YouTube, Flickr)
• 访问 www.cpsc.gov
• 《产品召回通知》订阅
• 《公共日历》订阅
• www.SaferProducts.gov (公司应登记)
• www.recalls.gov
• 《产品召回手册》(2012年3月修订)
http://www.cpsc.gov/businfo/8002.pdf
27
谢谢!
高德
亚太地区消费品安全参赞
美国驻华使馆, 北京
电话: 86-10-8531-3318
传真: 86-10-8531-3652 (fax)
JGolden@cpsc.gov
GoldenJx@state.gov

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Selling Compliant & Safe Children's Toys in The United States (Chinese)

Editor's Notes

  1. Lead content for children’s products: 100 ppm; 90 ppm surface coating for paint used for children’s products.
  2. Civil penalties: $100,000 per violation; $15,150,000 maximum fine.