BPA Testing 双酚A检测-PTS精锐检测服务机构

BPA Testing 双酚A检测

全球有关双酚A的管控汇总 Global Requirements of Bisphenol A (BPA)

自2009年美国开始关注双酚A以来，引发全球热议，各国纷纷对双酚A进行风险评估，并频频对双酚A进行法规限制。欧盟、美国、我国等均对食品接触儿童用品中双酚A进行禁用，可见各国限制使用双酚A的决心。很多企业已经开始对双酚A实施严格的管控，来适应各个地区的双酚A相关法案。作为相关产品制造商，需要清楚地了解不同国家、不同产品对双酚A （BPA）的限制。

Since 2009 the United States began to focus on BPA, this topic caused a global debate. Many countries have to conduct the risk assessment and frequently establish legal limits of BPA. The European Union, the United States, China and other countries are prohibited the use of BPA in children's products which are belong to food contact materials, showed the determination that many countries restrict the use of BPA. In order to adapt to the various regions of BPA related bills, many enterprises have begun the implementation of strict control of BPA. We need to clearly understand the limitations of BPA in different products at different countries.

加拿大 Canada

加拿大环境保护法1999 (CEPA 1999)将BPA列入有毒物质清单

BPA included in the List of Toxic Substances of the Canadian Environmental Protection Act，1999

2008年10月18日，加拿大宣布双酚A为有毒化学物质，由此成为世界上第一个将双酚A列为有毒化学物质的国家，并禁止在婴儿奶瓶的制作过程中使用双酚A。依据CEPA 1999第64部分，将双酚A对人类和环境的危害进行了科学评估认定，双酚A对人体健康和环境构成或可能构成危害。因此，加拿大主管机构对CEPA 1999目录1进行了修改，将双酚A列入有毒物质清单。这项修改从2010年9月23日开始生效。加拿大消费品安全法（CCPSA）将含BPA的聚碳酸酯婴儿奶瓶列入禁止物品清单。

October 18, 2008, Canada declared BPA as a toxic chemical, thus Canada became the world's first country of BPA as toxic chemical and to prohibit the use of BPA in baby bottles. According to the CEPA 1999 Part 64, after scientific assessment and identified results showed that BPA may hazard to human health and the environment. Therefore, BPA is included in the List of Toxic Substances of Canadian authorities CEPA 1999 Contents 1. This change came into effect from September 23, 2010. The Canada consumer product safety (CCPSA) taken polycarbonate baby bottles which is contained BPA into the prohibited items list.

欧盟 European Union

(EU)No. 10/2011、(EU)No.321/2011对双酚A的限制

(EU) No 10/2011, (EU) No.321/2011 of BPA limit

欧盟在2002/72/EC指令（委员会关于与食品接触的塑料材料和制品的指令）中规定双酚A特定迁移量（SML）应小于等于0.6mg/L。2011年欧盟(EU) No. 10/2011号法规替代了2002/72/EC指令，其中双酚A的限量并未修改。在2008年的一份欧盟食品安全局（European Food Safety Authority，EFSA）对双酚A的风险评估报告中认为，双酚A相关产品，如聚碳酸酯塑料和环氧树脂的使用对消费者和环境是安全的。欧盟食品安全局（EFSA）在2014年1月17日发布的声明中说：“EFSA审核了有关双酚A潜在健康危害的450多项研究，发现它可能对肝脏和肾脏有不良影响，且对乳腺的不良作用也可能与双酚A暴露有关。因此推荐降低现行的每日可容忍摄入量。”双酚A的每日可容忍摄入量目前为50μg/kg体重/天（即0.05mg/kg/bw/天），而EFSA现在提议降至5μg/kg体重/天（0.005mg/kg/bw/天）。EFSA设定的这一每日可容忍摄入量属于临时性质。这是因为还存在不确定性，还要等待美国国家毒理学计划的研究结果。相信各方对于双酚A使用风险的争议还将继续，而相继的法规和限量也将随之不断更新，目前欧盟有关双酚A的管控如下表1所示。

The Directive 2002/72/EC on plastic materials and articles provided the specific migration of BPA (SML) should be no more than 0.6 mg /L. In 2011, the Regulation (EU) No. 10/2011 replaced the Directive 2002/72/EC, but the limit on specific migration of BPA (SML) was not modified. In 2008, according to a report about the risk assessment of BPA, the European Food Safety Authority (EFSA) considered that the use of BPA related products, such as polycarbonate plastic and epoxy resins were safe for consumers and the environment. In January 17, 2014 European Food Safety Authority (EFSA) issued a statement saying that “After reviewed more than 450 studies about potential hazards related to BPA, we found that BPA may have an adverse effect on the liver and kidneys, and the adverse effects on the breast may also be related to exposure to BPA. It is recommended to reduce the current tolerable daily intake.” BPA tolerable daily intake is currently 50μg/kg bw/day (ie 0.05mg/kg/bw/day), while EFSA proposal now dropped to 5μg/kg bw/day (0.005mg/kg/bw/day). The EFSA set this tolerable daily intake belongs temporary, because there are still uncertainties and need to wait for the results of the U.S. National Toxicology Program. The risk arising from the use of BPA controversy will continue, and the related regulations and limits will subsequently be constantly updated. EU BPA control is showed in the following table1.

法律引文 laws	范围 Scope	BPA限值 BPA limit	生效日期 Effective Date
(EU)No.10/2011	食品接触塑料 Food contact plastics	迁移量≤0.6mg/kg migrate≤0.6mg/kg	2011.5.1
(EU)No.321/2011	1岁以下儿童用聚碳酸酯婴儿奶瓶 polycarbonate (PC) infant bottles for children under the age 1	禁止含有 Prohibit	2011.5.1（制造商） 2011.6.1（市场） 2011.5.1（manufacturer） 2011.6.1（market）
EN 14372:2004	用于36个月及以下婴幼儿餐具及喂养器具 Infants and young children cutlery and feeding utensils for children under 36 months	迁移量≤0.03μg/ml migrate≤0.03μg/ml	2004.8.18
EN 14350-2:2004	饮水设备（奶瓶、奶头、奶嘴和水杯） Drinking water equipment (bottles, teats, pacifiers and cups)	迁移量≤0.03μg/ml migrate≤0.03μg/ml	2004.8.18
EN 1400:2013	儿童使用和护理用品-婴幼儿安抚奶嘴-安全要求和测试 Child use and articles - soothers for babies and young children – safety requirements and tests	迁移量≤0.125mg/L migrate≤0.125mg/L	2013.3.27
2009/48/EC	玩具安全指令 The Safety of Toys	按照EN 71-10:2005和EN 71-11:2005中的方法，不得超过0.1 mg/L（迁移量限值） 0,1 mg/L (migration limit) in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005	2015.12.21

美国 United States
州一级颁布双酚A禁令，主要集中在可重复使用的儿童食品和饮料容器
U.S. state enacted the ban on BPA, mainly in children reusable food and beverage containers

20世纪60年代，美国联邦法规（FDA 21CFR 177.1580 Polycarbonate resins）接受双酚A作为食品接触材料的原料使用。2009年6月通过的《美国食品安全加强法案》规定，美国卫生及公共服务部应对食品和饮料容器中的双酚A对人体危害进行风险评估，由此引发全球对双酚A的新一轮讨论和关注。在美国国会对双酚A的最终限制作出规定之前，美国各州纷纷颁布双酚A使用禁令，限制双酚A的使用，尤其是在婴幼儿用品中的使用。表2汇总了美国各州对双酚A实施禁令的法规进展信息。
In the 1960s, the United States Code of Federal Regulations (FDA 21CFR 177.1580 Polycarbonate resins) accepted BPA used as raw materials in food contact materials. June 2009 by the U.S. Food Safety Enhancement Act provided that about the health hazards of BPA in food and beverage containers, the U.S. Department of Health and Human Services should conduct a risk assessment, which triggered the global BPA new round of discussion and concern. Before the the U.S. Congress make provision for the ultimate limit of BPA, U.S. states have issued the ban on BPA, aimed to limit the use of BPA, especially in baby products. Table 2 summarizes the ban of the U.S. states about BPA progress information.

州 States	法案 bills&laws	生效日期 Effective Date	范围 Scope	BPA限值 BPA Limit
阿拉斯加州 Alaska	HB172	2012. 1.1	婴儿食品和配方奶粉的塑料容器，产品包括玩具和 7岁以下儿童用可循环食品或饮料容器 Plastic container for baby food or infant formula product including toy Reusable food or beverage for children under the age of 7	禁止含有 Prohibit
亚利桑那州 Arizona	SB 1376	2016. 1.1	婴儿配方奶粉或婴儿食品用塑料容器、罐；儿童容器（设计用于5岁及以下儿童使用的杯子或防溢瓶） Infant formula or baby food that is stored in a plastic container or can container for children under the age of 5	禁止含有 Prohibit
阿肯色州 Arkansas	S 350	2012.1.1	3岁或以下儿童用可循环食品或饮料容器任何辅助3岁或以下儿童饮食的工具 any assisted diet tools for children under the age of 3	禁止含有 Prohibit
加利福尼亚州 California	AB 1319	2013.1.1	3岁以下儿童用液体、食品或饮料罐头、瓶子或塑料瓶 Any baby bottles, toddlers’ cups, food and drinking containers for aged 3 and younger	禁止含有 Prohibit
加利福尼亚州 California	Prop 65	2016.5	消费品 Consumer products	警告标识 Warning Labeling
科罗拉多州 Colorado	HB 1174	2012.7.1	3岁以下儿童用奶嘴或空的容器，包括盛放食品或液体的婴儿奶瓶、婴儿奶瓶衬里、杯子衬里、吸管或水杯 pacifier or empty containers for children under the age of 3 including baby bottles, Baby bottle liners, Cup liners, Straws or cups	禁止含有 Prohibit
康涅狄格州 Connecticut	HB 6572	2011.10.1	可重复使用食品或饮料容器用于储存食品或饮料的婴儿奶瓶、防溢水杯、运动杯，但不包括初次使用后就丢弃的容器 Reusable food or beverage container Infant formula or baby food that is stored in a plastic container, jar or can，but not included the discarded container after initial use	禁止含有 Prohibit
特拉华州 Delaware	SB 70	2011.12.31	4岁以下儿童用盛放食品或饮料的空杯子或水杯 Baby bottles and sippy cups for aged 4 or younger	禁止含有 Prohibit
夏威夷州 Hawaii	HB 1934	2013.1.1	3岁以下儿童用玩具或儿童护理产品。 Toy and childcare article for children under 3 years old	禁止含有 Prohibit
伊利诺伊州 Illinois	SB 2950	2013.1.1	儿童食品或饮料容器 Food or beverage container for children	禁止含有 Prohibit
爱荷华州 Iowa	HF147/SF60	2012.1.1	婴儿用可循环食品和饮料容器、塑料容器、罐或瓶子 Infant formula or baby food that is stored in a reusable plastic container, jar or can	禁止含有 Prohibit
肯塔基州 Kentucky	HB 236	2013.1.1	可重复使用的食品或饮料容器婴儿食品或婴儿配方奶粉塑料容器、罐或瓶子 Reusable food or beverage container Infant formula or baby food that is stored in a plastic container, jar or can	禁止含有 Prohibit
马里兰州 Maryland	HB 33&SB 213	2012.1.1	4岁以下儿童用盛放食品或饮料的儿童护理用品 Food or beverage container, toy or childcare article under 4 years old	禁止含有 Prohibit
马萨诸塞州 Massachusetts	S 382	2014.1.1	玩具或儿童护理产品，儿童食品或婴儿配方奶粉塑料容器、罐和瓶子 Toy and childcare article for children Infant formula or baby food that is stored in a plastic container, jar or can	禁止含有 Prohibit
密歇根州 Michigan	S 4522	2012.10.1	可循环食品或饮料容器婴儿配方或儿童食品容器 Reusable food or beverage container Infant formula or baby food container	禁止含有 Prohibit
明尼苏达州 Minnesota	SF 247	2011.1.1	任何3岁以下儿童用瓶子或水杯 Bottle, cup or container for aged 3 or younger	禁止含有 Prohibit
明尼苏达州 Minnesota	HF 459	2015.1.1	12岁及以下儿童的食品容器 Food Containers for aged 12 or younger	禁止含有 Prohibit
新罕布什尔州 New Hampshire	HB 1182	2013.1.1	可重复使用婴儿食品或饮料容器婴儿食品或婴儿配方奶粉塑料容器、罐或瓶子 Reusable baby food or beverage container Infant formula or baby food that is stored in a plastic container, jar or can	禁止含有 Prohibit
新泽西州 New Jersey	S 1804 / A 2112	2010.1.1	食品或饮料储存容器 Food and beverage containers	禁止含有 Prohibit
纽约州 New York	A06919 / S 3296	2010.12.1	安抚奶嘴、婴儿水杯、鸭嘴杯和其他3岁以下儿童用饮料容器 Toy or childcare article for children under 3 years old	禁止含有 Prohibit
俄勒冈州 Oregon	HB 2367	2012.1.1	12岁以下儿童用产品 Products for children under 12 years old	禁止含有 Prohibit
宾夕法尼亚州 Pennsylvania	HB 192	2011.3.24	婴儿或3岁及以下儿童用于盛放任何液体、食品或饮料的容器 Food or beverage container for children under age of 3	禁止含有 Prohibit
南达科塔州 South Dakota	HB 1246	2013.7.1	可循环食品或饮料容器儿童食品或婴儿配方奶粉塑料容器、罐或瓶子 Reusable baby food or beverage container Food product that is contained in a jar, can or other container	禁止含有 Prohibit
田纳西州 Tennessee	SB 246	2012.1.1	可循环食品或饮料容器任何婴儿配方奶粉或儿童食品塑料容器、罐或瓶子 Reusable baby food or beverage container Infant formula or baby food stored in a plastic container, can or jar	禁止含有 Prohibit
德克萨斯州 Texas	H129	2011.9.1	三岁以下儿童用玩具、化妆品珠宝等儿童用品 Toy or cosmetics, jewelry and other children's products for children under 3 years old	禁止含有 Prohibit
佛蒙特州 Vermont	S．247	2012.7.1	可重复使用食品或饮料容器、儿童食品或婴儿配方奶粉塑料容器或罐头，儿童食品或婴儿配方奶粉瓶子 Reusable food or beverage container Infant formula or baby food that is stored in a plastic container, jar or can	禁止含有 Prohibit
华盛顿州 Washington	2010法律第140章 2010 law, Chapter 140	2011.7.1	三岁以下儿童用于盛放食品或饮料的塑料容器，金属罐除外 RBottles or cups in contact with food for infants up to 3 years old	禁止含有 Prohibit
华盛顿州 Washington	2010法律第140章 2010 law, Chapter 140	2012.7.1	运动水壶 Sport bottle	禁止含有 Prohibit
西弗吉尼亚州 West Virginia	HB 3261	2012.7.1 2012.7.1 2014.7.1	可循环食品或饮料容器婴儿食品或配方奶粉塑料容器或罐头儿童食品或婴儿配方奶粉瓶子 Reusable food or beverage container Infant formula or baby food that is stored in a plastic container, jar or can Baby food or infant formula bottle	禁止含有 Prohibit
威斯康辛州 Wisconsin	法案145 Wisconsin act chapter 145 Children Act to forbid BPA	2010.6.1	三岁以下儿童使用的容器 Any child's container intended for aged 3 or younger	禁止含有 Prohibit

中国 China
卫生部2011年第15号公告在婴幼儿奶瓶中禁用双酚A
China promulgated Announcement No. 15, 2011 of the Ministry of Public Health prohibited the use of bisphenol A in baby bottles

2011年5月23日，中国在继加拿大、欧洲以及美国一些州之后也开始对婴儿奶瓶中的双酚A实施限制措施。中国卫生部连同其他五大国内权威机构发布关于禁止使用聚碳酸酯（PC）婴幼儿奶瓶和含双酚A（BPA）婴幼儿奶瓶的公告（卫生部公告2011年第15号）。这一举措旨在保护婴幼儿的健康免受不良影响。禁令的详情和执行时间如下表3所示。此外，该公告规定双酚A允许用于生产除婴幼儿奶瓶以外的其他食品包装材料、容器和涂料，其迁移量应当符合相关食品安全国家标准规定的限量。

生效日期 Effective Date	禁令 Ban
2011年6月1日 2011.6.1	禁止生产聚碳酸酯婴幼儿奶瓶和其他任何含双酚A的婴幼儿奶瓶 Banning the production of polycarbonate (PC) infant bottles and any other infant baby bottles containing BPA
2011年9月1日 2011.9.1	禁止进口和销售聚碳酸酯婴幼儿奶瓶和其他任何含双酚A的婴幼儿奶瓶 Prohibit the import and sale of polycarbonate (PC) infant bottles and any other infant baby bottles containing BPA

相关国家标准包括：
GB 9685-2008标准《食品容器、包装材料用添加剂使用卫生标准》中规定，双酚A用于食品接触塑料、涂料、粘合剂时，其特定迁移量应不超过0.6 mg/kg；
GB 13116-1994《食品容器及包装材料用聚碳酸酯树脂卫生标准》;
GB 14942-1994《食品容器、包装材料用聚碳酸酯成型品卫生标准》中规定游离酚溶出量不得超过0.05mg/L。
May 23, 2011, following Canada, Europe and some American states，China also began to impose restrictive measures on BPA in baby bottles. Chinese Ministry of Health, together with the other five domestic authority published a notice prohibiting the use of polycarbonate (PC) infant baby bottles and infant baby bottles containing BPA (Announcement No. 15, 2011 of the Ministry of Public Health). The aim was to protect the health of infants and young children from adverse effects. Details and execution time of the ban showed in the table 3. In addition, the notice also regulated that BPA can be used to produce food packaging materials, containers and paints, and paints, except for infant bottles. Relevant national standards, including: Revised and updated in 2008, GB 9685-2008 standard, BPA was used for food contact plastics, coatings, adhesives, its specific migration limit should be no more than 0.6 mg/kg; GB 13116-1994 "food containers and packaging materials standard for polycarbonate resin, standards" in accordance with the amount of free phenol dissolution shall not exceed 0.05 mg /L.

国家 Country	法律引文 bills&laws	范围 Scope	BPA限值 BPA limit	生效日期 Effective Date
奥地利 Austria	食品安全和消费者保护法案 Food Safety and Consumer Protection Act	奶嘴和牙胶 Collars or shields of teats and soothers, teethers	禁止 Prohibit	2012.1.1
丹麦 Denmark	丹麦兽医和食品管理局 The Danish Veterinary and Food Administration	3岁以下儿童用食品接触材料和物品 food-contact materials used for children under 3 years old	禁止 Prohibit	2010.1.1
澳大利亚 Australia	联邦法律公报 Federal Law Gazette	婴儿奶嘴和固齿牙胶产品 Collars or shields of teats and soothers, teethers	禁止 Prohibit	2012.1.1
比利时 Belgium	2012年9月法案 Law 09/2012	3岁以下儿童用食品接触材料和物品 food-contact materials used for children under 3 years old	禁止 Prohibit	2013.1.1
法国 France	2010-729法案 Law No. 2010-729	婴儿奶瓶 Baby bottles	禁止 Prohibit	2010.1.1
法国 France	2012-1442法案 Law No.2012-1442	奶嘴，安抚奶嘴和咬牙胶 Collars or shields of teats and soothers, teethers	禁止 Prohibit	2013.1.1
法国 France	2012-1442法案 Law No.2012-1442	三岁以下儿童使用的直接与食品接触的食品包装材料 Food Packaging that would come into direct contact with food for children under 3 years of age	禁止 Prohibit	2013.1.1
法国 France	2012-1442法案 Law No.2012-1442	除上述两项以外的食品接触材料 Other food-contact materials	禁止 Prohibit	2015.1.1
瑞典 Sweden	SFS 2012:991	3岁以下儿童用食品包装涂料和涂层 Food packaging, paints and coatings for children under 3 years old	禁止 Prohibit	2013.7.1
阿根廷 Argentina	2269/2012法规 Law No.2269/2012	聚碳酸酯婴儿奶瓶 Polycarbonate baby bottles	禁止 Prohibit	2013.1.10
韩国 Korea	食品器具、容器和包装的标准和规范 Standards and Specifications for Food Utensils, Containers and Packages	食品接触材料:聚碳酸酯、环氧树脂、聚芳砜、聚芳脂、金属（具有有机涂层）类制品 Food contact materials: polycarbonate, epoxy resin, poly aryl sulfone, poly aromatic resin, metal type products (organic coating)	双酚A迁移（苯酚，双酚A和对 - 叔丁基苯酚）：总和≤2.5mg/L（BPA≤0.6 mg/L） BPA Migrant (as sum of phenol, BPA and p-tert-butylphenol) : ≤ 2.5 mg/L (However, migrant specification of BPA≤ 0.6 mg/L)	已实施 Has been implemented
日本 Japan	食品卫生法 Food Sanitation Law	食品接触材料：聚碳酸酯塑料制品 Food contact materials: polycarbonate plastic products	双酚A迁移量≤2.5μg/ml BPA Migrant≤2.5μg/ml	2008.1.1
日本 Japan	食品卫生法 Food Sanitation Law	食品接触材料：聚碳酸酯塑料制品 Food contact materials: polycarbonate plastic products	双酚A含量 ≤500μg/g Content of BPA≤500μg/g	2008.1.1
台湾 Taiwan	食品器具容器包装卫生标准 Food utensils container packaging hygiene standards	任何婴幼儿奶瓶 Any baby bottles	禁止 Prohibit	2013.1.1
台湾 Taiwan	食品器具容器包装卫生标准 Food utensils container packaging hygiene standards	任何聚碳酯食品容器 Any polycarbonate food containers	禁止 Prohibit	2014.1.1
南非 South Africa	南非卫生部 The Ministry of Health in South Africa	聚碳酸酯婴儿奶瓶 polycarbonate plastic baby bottles	禁止 Prohibit	2011.10.21

PTS Testing Service精锐检测建议:
根据各国家或地区法规，含有双酚A的材料不能用来做婴幼儿奶瓶，另外食品接触材料及玩具中也限制使用双酚A, 因此玩具及婴幼儿用品、食品接触材料的相关性企业应注意双酚A在产品的使用。做到在原料端管控，尽可能不使用聚碳酸酯（PC）和环氧树脂。精锐检测提醒相关企业留意最新消息，掌握法规动态，以便及时应对。
PTS Testing Service Lab advice:
According to various national laws and regulations, a materials if contains bisphenol can not be used to make baby bottles,.Food contact materials and toys are also limited to use bisphenol A,. So companies should pay attention to the use of bisphenol A in the product of toys and infant supplies, food contact materials. Control the raw material, as far as possible without using polycarbonate (PC) and epoxy resin. In order to timely response, PTS testing Serviceremind the relevant companies to pay attention to the latest news, to grasp the rules and regulations.