Global Requirements of Bisphenol A (BPA)
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.
Canada
BPA included in the List of Toxic Substances of the Canadian Environmental Protection Act,1999
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.
European Union
(EU) No 10/2011, (EU) No.321/2011 of BPA limit
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.
laws |
Scope |
BPA limit |
Effective Date |
(EU)No.10/2011 |
Food contact plastics |
migrate≤0.6mg/kg |
2011.5.1 |
(EU)No.321/2011 |
polycarbonate (PC) infant bottles for children under the age 1 |
Prohibit |
2011.5.1(manufacturer)2011.6.1(market) |
EN 14372:2004 |
Infants and young children cutlery and feeding utensils for children under 36 months |
migrate≤0.03μg/ml |
2004.8.18 |
EN 14350-2:2004 |
Drinking water equipment (bottles, teats, pacifiers and cups) |
migrate≤0.03μg/ml |
2004.8.18 |
EN 1400:2013 |
Child use and articles - soothers for babies and young children – safety requirements and tests |
migrate≤0.125mg/L |
2013.3.27 |
2009/48/EC |
The Safety of Toys |
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 |
United States
U.S.state enacted the ban on BPA, mainly in children reusable food and beverage containers
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.
States |
bills&laws |
Effective Date |
Scope |
BPA Limit |
Alaska |
HB172 |
2012. 1.1 |
Plastic container for baby food or infant formula product including toy Reusable food or beverage for children under the age of 7 |
Prohibit |
Arizona |
SB 1376 |
2016. 1.1 |
Infant formula or baby food that is stored in a plastic container or can container for children under the age of 5 |
Prohibit |
Arkansas |
S 350 |
2012.1.1 |
any assisted diet tools for children under the age of 3 |
Prohibit |
California |
AB 1319 |
2013.1.1 |
Any baby bottles, toddlers’ cups, food and drinking containers for aged 3 and younger |
Prohibit |
California |
Prop 65 |
2016.5 |
Consumer products |
Warning Labeling |
Colorado |
HB 1174 |
2012.7.1 |
pacifier or empty containers for children under the age of 3 including baby bottles, Baby bottle liners, Cup liners, Straws or cups |
Prohibit |
Connecticut |
HB 6572 |
2011.10.1 |
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 |
Prohibit |
Delaware |
SB 70 |
2011.12.31 |
Baby bottles and sippy cups for aged 4 or younger |
Prohibit |
Hawaii |
HB 1934 |
2013.1.1 |
Toy and childcare article for children under 3 years old |
Prohibit |
Illinois |
SB 2950 |
2013.1.1 |
Food or beverage container for children |
Prohibit |
Iowa |
HF147/SF60 |
2012.1.1 |
Infant formula or baby food that is stored in a reusable plastic container, jar or can |
Prohibit |
Kentucky |
HB 236 |
2013.1.1 |
Reusable food or beverage container Infant formula or baby food that is stored in a plastic container, jar or can |
Prohibit |
Maryland |
HB 33&SB 213 |
2012.1.1 |
Food or beverage container, toy or childcare article under 4 years old |
Prohibit |
Massachusetts |
S 382 |
2014.1.1 |
Toy and childcare article for children Infant formula or baby food that is stored in a plastic container, jar or can |
Prohibit |
Michigan |
S 4522 |
2012.10.1 |
Reusable food or beverage container Infant formula or baby food container |
Prohibit |
Minnesota |
SF 247 |
2011.1.1 |
Bottle, cup or container for aged 3 or younger |
Prohibit |
Minnesota |
HF 459 |
2015.1.1 |
Food Containers for aged 12 or younger |
Prohibit |
New Hampshire |
HB 1182 |
2013.1.1 |
Reusable baby food or beverage container Infant formula or baby food that is stored in a plastic container, jar or can |
Prohibit |
New Jersey |
S 1804 / A 2112 |
2010.1.1 |
Food and beverage containers |
Prohibit |
New York |
A06919 / S 3296 |
2010.12.1 |
Toy or childcare article for children under 3 years old |
Prohibit |
Oregon |
HB 2367 |
2012.1.1 |
Products for children under 12 years old |
Prohibit |
Pennsylvania |
HB 192 |
2011.3.24 |
Food or beverage container for children under age of 3 |
Prohibit |
South Dakota |
HB 1246 |
2013.7.1 |
Reusable baby food or beverage container Food product that is contained in a jar, can or other container |
Prohibit |
Tennessee |
SB 246 |
2012.1.1 |
Reusable baby food or beverage container Infant formula or baby food stored in a plastic container, can or jar |
Prohibit |
Texas |
H129 |
2011.9.1 |
Toy or cosmetics, jewelry and other children's products for children under 3 years old |
Prohibit |
Vermont |
S.247 |
2012.7.1 |
Reusable food or beverage container Infant formula or baby food that is stored in a plastic container, jar or can |
Prohibit |
Washington |
2010 law, Chapter 140 |
2011.7.1 |
RBottles or cups in contact with food for infants up to 3 years old |
Prohibit |
Washington |
2010 law, Chapter 140 |
2012.7.1 |
Sport bottle |
Prohibit |
West Virginia |
HB 3261 |
2012.7.1 2012.7.1 2014.7.1 |
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 |
Prohibit |
Wisconsin |
Wisconsinact chapter 145 Children Act to forbid BPA |
2010.6.1 |
Any child's container intended for aged 3 or younger |
Prohibit |
China
Chinapromulgated Announcement No. 15, 2011 of the Ministry of Public Health prohibited the use of bisphenol A in baby bottles
Effective Date |
Ban |
2011.6.1 |
Banning the production of polycarbonate (PC) infant bottles and any other infant baby bottles containing BPA |
2011.9.1 |
Prohibit the import and sale of polycarbonate (PC) infant bottles and any other infant baby bottles containing BPA |
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.
Country |
bills&laws |
Scope |
BPA limit |
Effective Date |
Austria |
Food Safety and Consumer Protection Act |
Collars or shields of teats and soothers, teethers |
Prohibit |
2012.1.1 |
Denmark |
The Danish Veterinary and Food Administration |
food-contact materials used for children under 3 years old |
Prohibit |
2010.1.1 |
Australia |
Federal Law Gazette |
Collars or shields of teats and soothers, teethers |
Prohibit |
2012.1.1 |
Belgium |
Law 09/2012 |
food-contact materials used for children under 3 years old |
Prohibit |
2013.1.1 |
France |
Law No. 2010-729 |
Baby bottles |
Prohibit |
2010.1.1 |
France |
No.2012-1442 |
Collars or shields of teats and soothers, teethers |
Prohibit |
2013.1.1 |
France |
No.2012-1442 |
Food Packaging that would come into direct contact with food for children under 3 years of age |
Prohibit |
2013.1.1 |
France |
Law No.2012-1442 |
Other food-contact materials |
Prohibit |
2015.1.1 |
Sweden |
SFS 2012:991 |
Food packaging, paints and coatings for children under 3 years old |
Prohibit |
2013.7.1 |
Argentina |
Law No.2269/2012 |
Polycarbonate baby bottles |
Prohibit |
2013.1.10 |
Korea |
Standards and Specifications for Food Utensils, Containers and Packages |
Food contact materials: polycarbonate, epoxy resin, poly aryl sulfone, poly aromatic resin, metal type products (organic coating) |
BPA Migrant (as sum of phenol, BPA and p-tert-butylphenol) : ≤ 2.5 mg/L (However, migrant specification of BPA≤ 0.6 mg/L) |
Has been implemented |
Japan |
Food Sanitation Law |
Food contact materials: polycarbonate plastic products |
BPA Migrant≤2.5μg/ml |
2008.1.1 |
Japan |
Food Sanitation Law |
Food contact materials: polycarbonate plastic products |
Content of BPA≤500μg/g |
2008.1.1 |
Taiwan |
Food utensils container packaging hygiene standards |
Any baby bottles |
Prohibit |
2013.1.1 |
Taiwan |
Food utensils container packaging hygiene standards |
Any polycarbonate food containers |
Prohibit |
2014.1.1 |
South Africa |
The Ministry of Health in South Africa |
polycarbonate plastic baby bottles |
Prohibit |
2011.10.21 |
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 Service Lab remind the relevant companies to pay attention to the latest news, to grasp the rules and regulations.