Over the years, concerns have been raised about its effects on human health, especially when it is used in food contact materials and articles (FCM). Many jurisdictions around the world now regulate the use of BPA, making it important for manufacturers, importers, distributors and retailers to understand and comply with the relevant laws and standards for their target markets.
BPA has been identified as a substance that, due to its estrogenic hormone-like properties and effects on brain development, can be particularly damaging to fetuses, babies and young children. The effects can be particularly dangerous in relation to FCM, with studies showing that BPA can be released into food and beverages. In particular, there is concern that babies may be exposed to BPA when boiling water is added to baby bottle to make formula milk.
BPA is used in polycarbonate plastics and epoxy resins. The latter can be found in FCM where the epoxy resins that act as a protective lining on the inside of aluminum-based food cans and containers.
Polycarbonate plastic is used in number of consumer products and FCM because it is a strong, clear, hard plastic with heat- and shatter-resistant properties. These include:
- Accessories such as mobile phone and tablet cases
- Electronic equipment
- Food contact materials and articles such as baby bottles, storage containers and reusable water bottles
- Medical and dental devices
- Optical discs such as compact discs (CDs) and digital versatile disks (DVDs)
- Sports safety equipment such as helmets and protective sports visors
- Thermal receipt paper
For consumers, it can be hard to identify which products are made from polycarbonate plastics. While their recycling number is 7, this is a broad category of plastics and so the only way to be certain is if the number seven is accompanied by ‘PC’.
To protect their citizens from the harmful effects of BPA, several jurisdictions have introduced regulations to restrict the use of BPA in a range of products, including FCM.
European Union (EU) – new BPA migration limit
The toxicity profile of BPA has been studied in the EU for many years. In 2016, following new scientific data, BPA was reclassified as reprotoxic category 1B, from reprotoxic category 2, by ATP-9 to Regulation (EC) 1272/2008 on ‘Classification, Labelling and Packaging of Substances and Mixtures (CLP Regulation) and its use in thermal paper was restricted by completely new entry 66 under Annex XVII of REACH. In 2017, the BPA migration limit in toys for young children, or other toys that are intended to be placed in the mouth, was strengthened 2.5-fold – from 0.1 mg/L to 0.04 mg/L – and, in February 2018, a new piece of legislation was published to expand the existing law on FCM that strengthened the BPA migration limit by 12-fold, from 0.6 mg/kg to 0.05 mg/kg.
|Citation||Scope||Unless stated, requirement is BPA migration||Effective Date|
|Regulation (EU) 2016/2235 amending Annex XVII of REACH||Thermal paper||≤ 0.02% (BPA content)
|January 2, 2020|
|Directive (EU) 2017/898 amending 2009/48/EC||Toys for children under 36 months or other toys intended to be placed in the mouth||≤ 0.04 mg/L||November 26, 2018|
|Regulation (EU) 2018/213 amending Regulation (EC) 10/2011||Food contact plastics||≤ 0.05 mg/kg||September 6, 2018|
|Food contact varnished or coated products||≤ 0.05 mg/kg|
|Food contact varnished or coated materials and articles for young children for food categories under Regulation (EU) 609/2013||Prohibited|
|PC drinking cups or bottles for infants and young children||Prohibited (BPA content)|
EU Member States – national prohibitions on the use of BPA
In addition to EU-wide regulations, stakeholders should also be aware that several EU Member States have implemented national prohibitions on the use of BPA in products. These go beyond EU regulations and include:
- Ban on BPA in FCM intended for young children in Belgium and Denmark
- Ban on BPA in baby bottles, teethers, collar shields in soothers and FCM in France
- BPA prohibited in pacifiers and teethers in Austria
- Ban on paints and coatings in food packaging for children 0-3 years old in Sweden
|Austria||Food Safety and Consumer Protection Act, LMSVG (Gazette II, No. 327/2011)||Pacifiers and teethers||Prohibited|
|Belgium||Act of 4 Sept 2012||Food containers for children up to the age of 3||Prohibited|
|Denmark||Statutory Order no. 822 of 26 June, 2013||Food contact materials for children 0-3 years old||Prohibited|
|France||Act 2012-1442 of 24 December 2012||Baby bottles||Prohibited|
|Food contact materials and articles for children up to 3 years old, soother shields and teethers||Prohibited|
|Food contact materials and articles other than above||Prohibited|
|Sweden||SFS 2012:991||Paints and coatings in food packaging intended for children up to age of three||Prohibited|
United States of America
BPA is regulated by a host of jurisdictions across the US, including federal, state and county governments. Although the scope of regulated products varies between jurisdictions, many relate to FCM and especially those designed and intended for use by young children.
At the Federal level, epoxy resins are prohibited, when they are derived from BPA and epichlorohydrin, as coatings in packaging for powdered and liquid infant formula. In addition, local jurisdictional regulations for BPA in food contact containers or bottles for young children include California, Connecticut, Delaware, Illinois, Maine, Maryland, Massachusetts, Minnesota, Multnomah County (Oregon), Nevada, New York State, Vermont, Washington, Washington DC and Wisconsin.
Stakeholders should be aware that New York State’s ban is unique because it also covers pacifiers and Wisconsin requires compliant products to display a label indicating that it does not contain BPA.
BPA in children’s products are also subject to reporting rules in the following states:
- Maine: Toxic Chemicals in Children’s Products (Title 38, Chapter 16-D, Priority Chemicals (PCs))
- Oregon: ORS § 431A.253 to § 431A.280 (High Priority Chemicals of Concern for Children’s Health, (HPCCCHs)
- Vermont: 18 V.S.A. Chapter 38A (Chemicals of High Concern to Children, CHCCs)
- Washington: RCW Chapter 70.240 (Children’s Safe Products Act (CSPA), Chemicals of High Concern to Children (CHCCs))
California Proposition 65 (Prop 65)
California’s Prop 65, the ‘Safe Drinking Water and Toxic Enforcement Act of 1986’, is a ballot initiative passed overwhelmingly by residents in November 1986. It requires the state to publish a list of chemicals that are known to cause cancer, birth defects or reproductive harm. Since first being published in 1987 the list has grown to include more than 860 chemicals.
The listing of BPA on the Prop 65 list of chemicals was controversial. It was first listed in April 2013 as a chemical known to cause developmental toxicity but was removed within two weeks. Since then, it was listed as a chemical known to cause female reproductive toxicity in May 2015 and, since May 2016, enforcement actions have been taken against several businesses that fail to warn consumers about exposure to BPA. These have resulted in several settlements for cell phone cases, certain food contact polycarbonate products and thermal paper (see below).
|Entry||Scope||Reformulation/Warning for BPA|
|1||Cell phone cases||≤ 3.0 ppm otherwise warning|
|2||Polycarbonate dishware||BPA-free otherwise warning|
|3||Thermal paper||< 10 ppm|
Several other countries also have legislation designed to either restrict or prohibit the use of BPA in food contact products, especially those designed and intended for use by young children. These include Argentina, Australia (voluntary phase out), Brazil, Canada, China, Costa Rica, Ecuador, Japan, Malaysia, South Africa, South Korea, Taiwan and Turkey.
Since BPA’s identification as a substance that can cause developmental damage to fetuses, babies and young children, several jurisdictions around the world have introduced restrictions on its use in FCM and other consumer products. Manufacturers, importers, suppliers and retailers should therefore check their products comply with the correct regulations for their target markets.
Utilizing its global network of state-of-the-art testing laboratories, SGS provides a comprehensive range of services for the testing of materials and articles in contact with food. Their experts understand international legislation related to BPA and FCM and can help ensure your products are compliant with target market regulations around the world.
For more information, please contact: