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Restricted Substances Testing

BPA Testing

What is Bisphenol A ?
Bisphenol A scientific name 2,2- bis (4- hydroxy phenyl) propane, also known as two phenolic propane, referred to as bisphenol bisphenol (BPA), the English name A. White crystal, flammable, microstrip phenol odor. Boiling point 250-252℃(1.73kPa). Pure product melting point 155-156 ℃, industrial product melting point 150-152℃. Relative density 1.195 (25℃), flash point 79.4℃. Soluble in ethanol, acetone, ether, benzene and dilute alkali solution, slightly soluble in carbon tetrachloride, almost insoluble in water.
Bisphenol A is synthesized from phenol and acetone in acidic medium. It is used as the main raw material in epoxy resin, polycarbonate, polysulfone, polyurethane, phenolic resin, unsaturated polyester resin, flame retardant and so on. Bisphenol A is basically divided into 2 grades: carbon and epoxy.

Bisphenol A Testing PTS Testing Service offers quick, reliable Bisphenol A testing at our CNAS accredited laboratory; we are one of the fastest testing laboratories in Asia and can provide results within 2-3 working days. 
Expert advice and solutions on legislation and supply chain compliance
Access to chemical supply chain specifications   What is bisphenol A? Bisphenol A (BPA) is a chemical that is mainly used with a combination of other chemicals in the manufacture of plastics and resins. For example, BPA is used in polycarbonate to make food containers, such as returnable beverage bottles, infant feeding (baby) bottles, tableware (plates and mugs) and storage containers. Residues of BPA are also present in epoxy resins used to make protective coatings and linings for food and beverage cans and vats, and can also be used in the production of cash register receipt paper.  The risks…The dangers associated with BPA are in large part due to the fact that BPA can migrate in small amounts into food and beverages stored in materials containing the substance. This can cause adverse health effects as BPA is a known endocrine disruptor; these are toxins that interfere with the normal activities of the endocrine system, which regulates hormone levels in the body. Endocrine disruptors are also problematic in terms of environmental pollution.  Why you need to test for bisphenol AThe restrictions regarding BPA are largely directed at food contact materials; BPA based polycarbonate resins are banned in the EU in infant feeding bottles and sippy cups, whereas in the US, BPA is banned in all recycling and food containers.
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 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 remind the relevant companies to pay attention to the latest news, to grasp the rules and regulations.
Regulations
EU Toy Safety Directive 2009/48/EC
EU Safety of toys EN 71-9
EU Regulation(EU) No 10/2011 for Food Contact Plastic Materials
EU Regulation No 321/2011 Restriction of Use of Bisphenol A in Plastic Infant Feeding Bottle
EN 14372 Cutlery and Feeding Utensils
EN 14350 Child Use and Care Articles—Drinking equipment (feeding bottles, teats and drinking cups)
US FDA 21 CFR 177.1580
CA Prop 65
Canada Consumer Product Safety Act (CCPSA)
Health Ministry of P.R. China, Notification 15 of 2011
GB 9685 Hygienic Standards For Uses of Additives in Food Containers and Packaging Materials
Other related regulations, directives or standards
What is bisphenol A?
Bisphenol A is a chemical that is mainly used with a combination of other chemicals in the manufacture of plastics and resins. For example, BPA is used in polycarbonate to make food containers, such as returnable beverage bottles, infant feeding (baby) bottles, tableware (plates and mugs) and storage containers. Residues of BPA are also present in epoxy resins used to make protective coatings and linings for food and beverage cans and vats, and can also be used in the production of cash register receipt paper.
The risks
The dangers associated with bisphenol A are in large part due to the fact that BPA can migrate in small amounts into food and beverages stored in materials containing the substance. This can cause adverse health effects as BPA is a known endocrine disruptor; these are toxins that interfere with the normal activities of the endocrine system, which regulates hormone levels in the body. Endocrine disruptors are also problematic in terms of environmental pollution.
Why you need to carry out bisphenol A testing
The restrictions regarding bisphenol A are largely directed at food contact materials; BPA based polycarbonate resins are banned in the EU in infant feeding bottles and sippy cups, whereas in the US, BPA is banned in all recycling and food containers.

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