Baby feeding bottles sold in the United States are subject to various safety standards, food contact materials regulations, labeling, documentation, and testing requirements.
In this guide, we explain what importers and manufacturers must know about 16 CFR Part 1303, CPSIA, FDA 21 CFR, and other relevant regulations.
We also explain why baby bottle importers must exercise caution when buying from overseas manufacturers.
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16 CFR Part 1303 – Ban of lead-containing paint and similar surface coatings
16 CFR Part 1303 sets the maximum lead content concentration in surface-coating materials for some categories of consumer products, including baby bottles. This value is currently 90 parts per million (ppm), which equals 0.009% of the total weight.
16 CFR Part 1303 might be relevant to manufacturers or importers of baby feeding bottles, for instance in the case they include decorative painted patterns or coatings on the product’s surface. These paints might contain lead, which often is used to accelerate drying, increase durability, and delay corrosion.
Lead is regulated in children’s products, as it might be dangerous to children. The symptoms of babies and children exposed to lead include loss of appetite, vomiting, weight loss, kidney failure, learning disabilities, and other issues.
16 CFR Part 1500.87 – Children’s products containing lead
According to the requirements of 16 CFR Part 1500.87, children’s products are banned in the United States if they contain more than 100 parts per million of lead, which is 0.01% of the total weight. The ban also covers baby bottles.
This ban does not include parts of children’s products considered “inaccessible” by children through normal and reasonably foreseeable use, such as swallowing, breaking the products, or other children’s activities.
The CPSC designates bite tests, usage tests, and abuse tests to determine the accessibilities of specific components.
16 CFR Part 1307 – Prohibition of children’s toys and child care articles containing specified phthalates
Phthalates are often added to plastics, rubber, and coating materials to increase the products’ flexibility, transparency, and longevity. Baby bottles made of plastic materials, including the main body, the nipple, and the cap, could contain a certain amount of phthalates.
16 CFR Part 1307 restricts several phthalates in childcare products to 0.1% by weight. In particular, it restricts the following eight phthalates:
Currently, the CPSC has approved the test method CPSC-CH-C1001-09.4 Standard Operating Procedure for Determination of Phthalates for evaluating the concentration level of phthalates in childcare products.
The following parts and components are exempt from phthalates restrictions:
a. Parts inaccessible to children during reasonably foreseeable use
b. Parts made in materials that are deemed to not contain phthalates, such as metal and natural latex
16 CFR Part 1501 – Small Parts
The CPSIA’s small part requirements are outlined in 16 CFR Part 1501. This method applies to children’s products designed for children between 0-36 months that might contain small parts, including baby feeding bottles.
A small part is an object that can fit entirely into a test cylinder with a length of 2.25 inches and a width of 1.25 inches. This cylinder represents a fully-expanded throat of a child aged three and under. Objects that fit into the test cylinder are prohibited from inclusion in its intended product as they present a choking hazard.
Small parts may be:
a. An entire toy or an article
b. An independent part of an article, game, or toy
c. Part of an article or toy that detaches during testing, simulating abuse or usage by the child
Consumer Product Safety Improvement Act (CPSIA)
The CPSIA regulates children’s products, including “child care articles” intended to be used by children aged 12 years or younger.
According to section 108 of CPSIA, “child care articles” refers to a consumer product designed to facilitate the activities of sleeping, feeding, sucking, or teething performed by children aged three and younger. These products include baby bottles.
Applicable rules and methods
Here we list some rules and methods under CPSIA that are relevant to baby feeding bottles:
a. 16 CFR Part 1303 – Ban of lead-containing paint and similar surface coatings
b. 16 CFR Part 1500.87 – Children’s products containing lead
c. 16 CFR Part 1307 – Prohibition of children’s toys and child care articles containing specified phthalates
d. 16 CFR Part 1501 – Method for identifying toys and other articles intended for use by children under three years of age that present choking, aspiration, or ingestion hazards because of small parts
To our knowledge, the CPSIA hasn’t yet incorporated by reference any specific ASTM standards for baby bottles. However, companies might still use ASTM standards to test the performance and safety of the materials of baby bottles.
For example, ASTM F2853 is a standard using energy-dispersive X-ray fluorescence (EDXRF) to test the lead in paint layers and similar coatings consumer products, including children’s products. This standard can be used to assess the lead in paint content according to 16 CFR Part 1303 requirements and applies to materials that might be used to make baby bottles, such as:
- ABS plastic
- Zinc alloy
Children’s Product Certificate (CPC)
Importers and manufacturers of feeding bottles must issue a Children’s Product Certificate (CPC). The certificate should include the following information:
a. Product identity (i.e., name, description, model number)
b. Relevant CPSC rules or ASTM standards (i.e., 16 CFR Part 1307)
c. Importer or manufacturer information (i.e., business name, postal address, e-mail, contact number)
d. Manufacturing information (i.e., city, province, country of production; date of manufacture)
e. Date and location of the test (i.e., month, year, city, province, country)
f. Lab testing company information, which must be accepted by the CPSC
CPSIA Tracking Label
The CPSIA requires that products designed to be used by children aged 12 or younger must contain tracking information on the label. By definition, this includes products such as baby feeding bottles, sippy cups, or similar drinking equipment.
The tracking label should include the following information:
- Name of the manufacturer or private labeler
- Location and date of production
- Batch or run number
- Additional information for the identification of the product
FDA 21 CFR
Baby bottles are considered food contact materials (FCM). As such, these products are subject to FDA 21 CFR requirements, which include substance restrictions, good manufacturing practices, and test methods.
We cover the following parts in this guide:
- 21 CFR Part 174: General Provisions for Indirect Food Additives
- 21 CFR Part 175: Adhesives and Components of Coatings
- 21 CFR Part 177: Polymers
Note that we do not cover Generally Recognized as Safe (GRAS) because, according to our research, they are mainly relevant for:
- Paper food contact materials
- Cotton and cotton fabric food contact materials
21 CFR Part 174: General Provisions for Indirect Food Additives
This part explains that regulated food additive substances can be deemed safe to use in food if they respect the conditions specified in other parts of this chapter (e.g., Parts 175, 176, and 177).
These conditions might include adhering to good manufacturing practices and ensuring that any added additive substance does not:
a. Exceed reasonable amounts necessary in the food contact materials
b. Exceed prescribed limitations
c. Intentionally affect the food in any physical or technical way
Substances used under good manufacturing practices as FCMs may include the following:
a. Substances permitted by 21 CFR Parts 174-179
b. Substances used per prior sanctions or approval (that is substances explicitly approved by the FDA before September 6, 1958)
c. Food contact substances used per a valid submitted food contact substance premarket notification
21 CFR Part 175: Adhesives and Components of Coatings
21 CFR Part 175 permits manufacturers to use listed substances as adhesives and coating components under certain circumstances, such as the ones listed below.
21 CFR Part 175.105 specifies permitted adhesive substances and their limitations. For example, some substances can only be utilized as preservatives. We list a few of those substances below:
- Ammonium benzoate
- Copper 8-quinolinolate
Components of coatings
21 CFR Parts 175.210 to 175.390 cover substances that may be used as components of coatings, as well as their limitations. Here we list some examples of covered substances:
- Partial phosphoric acid esters of polyester resins
- Poly(vinyl fluoride) resins
- Vinyl acetate/crotonic acid copolymer
21 CFR Part 177: Polymers
21 CFR Part 177 covers substance limitations and test methods for polymers as indirect food additives that can either be used as components of:
a. Food-contact surfaces intended for single and repeated use, or
b. Food-contact articles meant for repeated use
Polycarbonate resins and BPA
21 CFR Part 177.1580 covers polycarbonate resins and allows for safe usage in manufacturing or packaging food under certain conditions.
However, 21 CFR Part 177.1580(d) specifically prohibits the usage of polycarbonate resins, which often contain Bisphenol A, from use in the following items:
- Infant feeding bottles and spill-proof sippy cups
- Their closures and lids
Several states in the US have specific regulations concerning the chemical safety of children’s drinking bottles, especially concerning the use of Bisphenol A in these products. This section introduces several Bisphenol A restrictions enforced in different states of the US.
California: Product Safety: Bisphenol A
The state of California sets the Bisphenol A limit in infant drinking bottles and sippy cups used by children younger than three years to 0.1 parts per billion.
District of Columbia: Restrictions on Bisphenol A
The District of Columbia prohibits manufacturing, selling, or distributing of Bisphenol A-contained food contact containers used by children aged four and under.
Maryland: Childcare Articles Containing Bisphenol A
The state of Maryland forbids manufacturing or distributing childcare articles that contain Bisphenol A. This law affects children’s, infants’, or toddlers’ drinking bottles or cups and other food contact products intended for children younger than four years of age.
Importers and manufacturers of baby feeding bottles often need to have their products lab tested so they can provide evidence that said products comply with relevant substance restrictions, small parts, and other technical requirements.
Several test methods may be relevant to baby bottles. Here we list some examples:
a. CPSC-CH-C1001-09.4 – Standard Operating Procedure for Determination of Phthalates
b. CPSC-CH-E1003-09.1 – Standard Operating Procedure for Determining Lead (Pb) in Paint and Other Similar Surface Coatings
c. CPSC-CH-E1002-08.1 – Standard Operating Procedure for Determining Total Lead (Pb) in Non-Metal Children’s Products
When the products pass lab testing, importers and manufacturers receive a test report that proves their products’ compliance with the requirements.
Lab testing companies
Here we list a few CPSIA-accepted testing companies that offer testing for baby feeding bottles.
- Bureau Veritas
- TUV Rheinland
You can find more CPSIA-accepted testing companies on this page.
Baby bottles manufactured overseas may not always comply with US safety standards and substance restrictions in mind. On the contrary, many baby bottles are manufactured by suppliers who lack expertise in relevant baby bottle compliance requirements in the United States.
Keep in mind that not every baby bottle is made for the US market (despite being available for purchase for US importers). Likewise, not every manufacturer in Asia is experienced in making products for the US market. As an importer, you should never assume that baby bottles are ‘US compliant by default’.
When it comes to baby bottles, there are two primary compliance risks.
Baby bottles may be ‘incorrectly’ designed because they contain small parts or other design elements that don’t comply with US safety standards. Baby bottles must be ‘designed for compliance’ to be sold in the US.
Chemicals and heavy metals
Some materials used to manufacture baby bottles may contain amounts of lead, phthalates, bisphenol A, and other restricted substances that exceed the limits in the United States.
Ensuring compliance often requires that the manufacturer orders high-grade ‘US-compliant’ materials.