what is bisphenol a bpa and are there any regula

SGSFM_JL_2009/002_4 Sept 09 Revision Date: 4 October 2013

SGS Hong Kong Ltd. 1/F, On Wui Centre, 25 Lok Yip Road, Fanling, NT, Hong Kong 5/F, Manhattan Centre, 8 Kwai Cheong Road, Kwai Chung, NT, Hong Kong

Website: http://www.sgsgroup.com.hk/ Member of the SGS Group (Société Générale de Surveillance)

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What is Bisphenol A (BPA) and are there any Regulatory Requirements

1. What is BPA and what are their applications?

Bisphenol A (BPA) is a monomer used in the production of polycarbonate plastics. These are used in many consumer

products such as reusable water bottles, baby bottles, sports equipment, CDs, DVDs, medical and dental devices.

BPA is also found in epoxy resins which acts as a protective lining on the inside of metal-based food and beverage

cans and containers.

2. How do I know whether my plastic bottle is made from polycarbonate

A polycarbonate plastic bottle is labelled recycling symbol number 7. Recycling number 7 is a broad category and you

can only be sure it is polycarbonate if the number 7 also has a PC beside it.

3. What are the health concerns?

Studies have revealed that exposure to BPA may occur through the consumption of foods and beverages that have

been in contact with PC plastic containers or epoxy resins in food packaging. Exposure for newborns and infants is

through the use of PC baby bottles when they are exposed to high temperatures.

4. Is BPA banned in consumer products?

Bisphenol A is regulated in a number of jurisdictions such as the US, EU, Brazil, Costa Rica, Japan and South Korea.

These are summarised below

EU

Jurisdiction Citation Scope on BPA Ban Requirement Effective Date

EU Directive 2004/19/EC Plastic materials and articles

in contact with food

≤ 0.6 mg/kg ( migration) 2004

Regulation (EU) No 10/2011

(repealing Directive

2002/72/EC, including Directive 2004/19/EC)

Specific

migration limit

applies from

31 December,

2012

EU Regulation (EU) No 321/2011

Polycarbonate infant*

feeding bottle

*children under the age of

12 months as defined in

Commission Directive

2006/141/EC

Prohibited May 1, 2011

(manufacture)

June 1, 2011

(import and

sale)

Austria Food Safety and Consumer Protection Act, LMSVG (Gazette

II, No. 327/2011, 327

th Regulation of

the Ministry of

Pacifiers and Teethers Prohibited January 1,

2012




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Health) Belgium

Act of 4 Sept 2012 amending Law of 24 January 1977 on the protection of health of the users in terms of food and other products

Food containers for children up to the age of 3

Prohibited

1 Jan 2013

Denmark Danish Veterinary and Food Administration

http://www.fvm.dk/Default.aspx?ID=18488&PID=169747&NewsID=6014

Food contact materials for

children up to the age of 3

Prohibited July 1, 2010

France Act 2010-729 Baby bottles Prohibited June 30, 2010

Act 2012-1442 of 24

Dec 2012

Food contact materials

and articles for children

up to 3 years old

including soothers and

teether ( Article 2,

Directive 2006/141/EC)

and follow-on formulas

(Directive 1999/21/EC)

Prohibited 1 Jan 2013

Food contact materials

and articles other than

above


Sweden SFS 2012:991 Paints and coatings in food

packaging intended for

children up to age of three


US


Federal Federal Register Vol 78, No. 134, 12 July

2013

21 CFR 175.300 Resinous and polymeric coatings

Epoxy resins derived from BPA and epichlorohydrin as

coatings in packaging for powdered and liquid infant

formula


California Chapter 467 (AB 1319, 2011

session)

Bottle or cup to be filled with food, liquid or beverage

intended primarily for consumption from that bottle or cup by

children three years of age or younger

≤ 0.1 ppb

July 1, 2013




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City of Chicago

(Illinois)

BPA-Free Kids

Ordinance

Section 7-28-637

Chapter 7-28,

Municipal Code of

Chicago

Containers - Empty bottle or

cup to be filled with food or

liquid for children under 3

years old

Prohibited January 31, 2010

Connecticut Public Act 09-103 Reusable food or beverage

container

Prohibited October 1,2011

Plastic container, jar or can

that contains infant formula

or baby food

Prohibited October 1, 2011

Sell or distribute existing

inventory of infant formula or

baby food containers, jars or

cans as of October1,2011,

provided such items were

purchased or acquired prior

to October 1,2011

Prohibited October 1, 2012

Delaware Volume 78 Chapter 68

(SB 70, 146 th

General

Assembly)

Empty bottle or cup to be

filled with food or beverage

for children under 4 years of

age

Prohibited June 30, 2011

(manufacture)

January 1, 2012

(import and sale)

US Illinois

Public Act 91-1101 - Toxin-Free Toddler Act

(SB 2950, 97

th General

Assembly)

Empty bottle or cup to be filled with food or liquid

intended for children under 3


(Manufacturer or wholesaler)

1 Jan 2014

(Retailer)

Maine

Chapter 882

Manufacturer of infant

formula or baby food sold in

plastic container, jar or can

Submit information to

DEP

By July 8, 2011

(Not later than 180

days after January

9, 2011) Manufacturer of toy,

childcare article and

tableware




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Reusable food or beverage

container


Maryland Chapter 190 (HB 4, 2011 session)

Childcare Article

(Empty bottle or cup to be

filled with food or liquid for a

child under the age of 4

years)


Infant formula in containers ≤ 0.5 ppb

July 1, 2014

Container of infant formula

Massachusetts Public Health Council Reuseable food and

beverage containers for

children up to the age of 3


(manufacturer)

July 1, 2011

(retailer)

Minnesota Chapter 40

(Session 2009-2010)

Empty bottle or cup to be

filled with food or liquid for

children under 3 years old

Prohibited

(manufacturer or

wholesaler)

January 1, 2010

Chapter 325F. 174-

325.F175

(HF 459, 88th

Legislature Session,

2013-2014)

Container containing infant

formula, baby food, or

toddler food for children

under the age of 3

Prohibited

Aug 1, 2014

(manufacturer of

wholesaler)

Aug 1, 2015

(retailer)

Shall not replace BPA with

chemical that has a high

degree of probability to

harming the normal

development of a feotus or

child, or that endangers

human health

------ May 17, 2013

Multnomah County

(Oregon State)

The Multnomah County

Board of Health Order

No. 2011-129

Reusable beverage

containers for children and

adult

Prohibited

October 27, 2010




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http://web.multco.us/site

s/default/files/health/doc

uments/bpa_policy_ord

er.pdf

Nevada Chapter 203

(AB 354, 2013)

Food contact bottles or cups

for children under the age of

4

Prohibited 1 January 2014

Containers containing baby

food for children under the

age of 4

1 July 2014

Containers containing infant

formula

New York State Bisphenol A-Free

Children and babies Act

(Bill A 6919, Session

2009-2010)

Childcare Products:-

Pacifiers and unfilled

beverage containers for

children under 3 years old

for the consumption of

liquids including pacifiers,

baby bottles, baby bottles

liners and cups, cup lids,

straws and sippy cups

Prohibited December 1, 2010

Albany County

(New York State)

Local Law ‘C’ for 2009 Beverage containers for

children under the age of 3


Rockland County

(New York State)

Local Law No. 5 of 2010

The BPA-Free Children

and Babies Law

Children’s beverage

containers

Sucking / teething products

Prohibited September 5, 2010

Schenectady County

(New York State)

Local law No. 02-2009

Beverage containers for


Prohibited November 17, 2009

Suffolk County

(New York State)

Toxin Free Toddler and

Babies Act

Beverage containers for


Prohibited Approved by

County Executive

on

2 April 2009

Vermont Act 112

(S. 247, 2009 - 2010

Legislative Session)

Reusable food or beverage

container

Prohibited

July 1, 2012

Infant formula or baby food




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stored in a plastic container

or jar

Infant formula or baby food

stored in a can


Washington District of

Columbia

(Washington DC)

Act A18-0680 Empty bottle, cup, or other

container designed or

intended to be filled with

food or liquid for

consumption for children

under the age of 4


Medically essential products

in facilities licensed to

provide medical care

May be used if

approved by Food

and Drug

Administration (FDA)

Washington Chapter 140, Laws of

2010

(SB 6248

Relating to the use of

bisphenol A, 61st

Legislature, 2010

Regular Session)

(to Codify)

Food and beverage

containers for children up to

the age of 3

Prohibited

Exemption

Metal can

(≤ 0.0149 inch for

metal substrate and

can ends)

July 1,

2011

Sports water bottles

(≤ 64 ounces)

Prohibited July 1,

2012

Wisconsin Wisconsin Act 145

BPA-Free Kids Act

Children’s containers (baby

bottles or spill-proof cups)

for children up to the age of

3

Prohibited

(Such cups and

bottles must be

clearly stated that

they are BPA-free)

Exemption

Sale of a used child’s

container

June

2010




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Miscellaneous


Argentina Disposición 2269/2012

Polycarbonate baby bottles Prohibited

NB

i) Companies marketing

PC baby bottles before 19

Sept 2012 require labeling

19 Sept 2012

(180 days upon

publication of

Disposición

2269, published

on 23 Apr 2012)

Australia Announcement by

Parliamentary Secretary

for Health, Media

Release, 30 June 2010

http://www.health.gov.a

u/internet/ministers/publ

ishing.nsf/Content/0D1B

D3415FBE24B4CA257

75200179277/$File/mb0

40.pdf

Baby Bottles

Voluntary phase out by

Westfarmers Group

(Coles, K Mart and

Target), Woolworths, Big

W and Aldi

July 1, 2010

Brazil Resolution No. 41 of 16 Sept 2011

Baby and infant feeding bottles

Prohibited

NB Products containing BPA manufactured or imported by 14 Dec 2011 may be marketed until 31 Dec 2011

1 Jan 2012

Canada Order Amending

Schedule I to the

Hazardous Products Act

(bisphenol A),

Hazardous Products Act

Polycarbonate baby bottles Prohibited March 31,

2010

China Ministry of Health Bulletin No. 15 of 2011 23 May, 2011

Polycarbonate baby feeding bottles and other infant

feeding bottles containing BPA

Prohibited

1 June 2011 (Manufacture)

1 Sept 2011 (import and

sale)

Costa Rica Decree 35904-S, Gazette 76, April 2010

Food contact materials and Prohibited April 2010




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articles manufactured from

polycarbonates for children

Ecuador Resolution 29 of 31October 2011

Bottles Prohibited October

2011

Japan Specifications and Standards for Foods, Food Additives, etc. Under the Food Sanitation Act (Abstracts) 2008

Polycarbonate (PC) plastic


≤ 2.5 µg/mL including

phenol and p-tert-

butylphenol

(migration)

2008

≤ 500 µg/g (content)

Malaysia Press release of Ministry of Health, Malaysia, on 14 March, 2011

Polycarbonate (PC) baby

bottles

Prohibited March 1, 2012

South Africa Act No. 54 of 1972 PC infant feeding bottles Prohibited Oct 21, 2011

South Korea Korea Food Code Section 7



≤ 2.5 mg/L including

phenol and p-tert-

butylphenol

(migration)

2004

Taiwan Taiwan Food Sanitation Standards section 8. Sanitation Standard for Food Utensils, Containers and Packages


in Milk bottle

≤ 30 ppb (migration) 2009

The following are standards and are not regulatory

Jurisdiction Scope Standard Method Requirement

Australia Plastic materials for food contact use AS 2070 ≤ 0.6 mg/kg

( migration)

EU Cutlery and feeding utensils for Children under the age of 3 -

Thermoplastics containing polycarbonate (PC) or polysulfone (PSU)

EN 14372 ≤ 0.03 µg/mL

EU Drinking Equipment for Children under the age of 3 - Thermoplastics

containing polycarbonate (PC) or polysulfone (PSU)

EN 14350 ≤ 0.03 µg/mL

what is bisphenol a bpa and are there any regula

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