Planning to import or manufacture baby feeding bottles in the United States? In this guide, we explain what you must know about safety standards, substance restrictions, labeling requirements, lab testing, and certification.
We also explain why baby bottle importers must be particularly careful when buying from overseas manufacturers.
16 CFR Part 1303 – Ban of lead-containing paint and similar surface coatings
16 CFR Part 1303 lays down the maximum lead content concentration in the surface-coating materials of some categories of consumer products, including baby bottles. Currently, this value is 90 parts per million (ppm), which equals 0.009% of the total weight.
16 CFR Part 1303 is highly relevant to manufacturers or importers of baby feeding bottles, which often include decorative painted patterns on the surface. These paints might contain lead, which is often used in order to accelerate drying, increase durability, and delay corrosion.
Lead is strictly regulated in children’s products, as it might be especially dangerous for 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 1500.87, children’s products are banned in the United States if they contain more than 100 parts per million of lead, which corresponds to 0.01% of the total weight. The ban also covers baby bottles.
This ban does not include component parts of children’s products that are considered as “inaccessible” by children through normal and reasonably foreseeable use, such as swallowing, chewing, breaking the products, or other children’s activities.
The CPSIA designates bite tests, use tests, and abuse tests to determine whether the lead ban applies to certain components that could be used in baby bottles.
16 CFR 1307.3 – 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 flexibility, transparency, and longevity of these products. Baby bottles that are made of plastic materials, including the main body, the nipple, and the cap part could contain a certain amount of phthalates. Children’s exposure to phthalates could lead to infertility, obesity, and cancer.
Currently, the test method CPSC-CH-C1001-09.4 Standard Operating Procedure for Determination of Phthalates is approved by the CPSC to evaluate the concentration level of phthalates in child care products.
The following parts and components are exempted from the phthalates regulations:
a. Parts inaccessible to children during reasonably foreseeable use such as swallowing, mouthing, breaking, or other children’s activities.
b. Materials that do not contain or are treated with substances that may contain phthalates, such as metal and natural latex (i.e. zinc alloy, stainless steel baby bottles, latex nipples)
16 CFR 1501 – Small Parts
The CPSIA’s small part requirements are set forth in 16 CFR 1501.2. These rules apply to children’s products designed for children between 0-36 months, including baby feeding bottles that might contain small parts.
For example, a baby bottle that includes a small detachable teether might cause choking hazards to the infants, and as such would be banned.
CPSIA regulates any children’s products intended to be used by children that have 12 years or less, including “child care articles”.
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 age 3 and younger, such as:
- PVC baby’s feeding bottles
- Stainless steel sipper water bottles
- Infant’s straw cups
- Sucking cups made of glasses
As already explained, these are requirements that are relevant to baby feeding bottles, and that have been incorporated by CPSIA during the years:
a. 16 CFR 1303 – Ban of lead-containing paint and similar surface coatings
b. 16 CFR 1500.87 – Children’s products containing lead
c. 16 CFR 1307.3 – Prohibition of children’s toys and child care articles containing specified phthalates
d. 16 CFR 1501 – Method for identifying toys and other articles intended for use by children under 3 years of age which present choking, aspiration, or ingestion hazards because of small parts
At the moment, CPSIA doesn’t recommend 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 F2853-10 is a standard using energy dispersive X-ray fluorescence (EDXRF) to test the lead in paint layers and similar coatings in children’s products, and other consumer products. This standard applies to materials that could be used to make baby bottles, such as:
- Zinc alloy
The CPSIA requires mandatory third-party testing for children’s products. Test program varies depending on the individual product characteristics and the applicable standards.
For example, for a baby bottle, most testing requirements concern dangerous substances such as lead or phthalates, and the parts that are required to be tested could include the following:
- the body of the bottle
- the spout
- the straw
- the handle
- the cap
- other parts of the bottle
Note that, according to CPSIA, lab testing must be performed by a CPSC-accepted lab.
Children’s Product Certificate (CPC)
Manufacturers or importers of feeding bottles must issue a Children’s Product Certificate (CPC) before importing products to the United States. This certificate shall include the following information:
a. Product identity (i.e. name, description, model number)
b. Relevant CPSC or ASTM standards (i.e.16 CFR 1307.3)
c. Importer, contact person, and lab testing company’s 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)
CPSIA Tracking Label
The CPSIA requires that all products that are designed to be used by children age 12 or younger must contain basic tracking information on the label, which by definition include baby’s feeding bottles, sippy cups, trainer 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
21 CFR mainly concerns the safety of food contact materials, food, and drugs. Several sections of this chapter are related to the materials and restricted substances that might be used in baby bottles.
21 CFR 174: General Provisions for Indirect Food Additives
Section 174 of 21 CFR lays down general requirements to use food additive substances, which should be approved by the FDA when used in food contact products and used in accordance with the prescribed limitations. In general, these food additive substances must not cause harmful effects to humans.
21 CFR 175: Adhesives and Components of Coatings
Section 175 of 21 CFR introduces a list of chemical substances that are allowed to be used as adhesives and coating in food contact materials, including containers that will be used to carry or preserve food. By this definition, feeding bottles that contain coating or adhesive materials fall under its scope.
Chemical substances in adhesives and coatings that are allowed to be used in FCM products include:
- Abietic acid
- Acetone-urea-formaldehyde resin
- Ethylene glycol
Ban on Bisphenol A
By amending 21 CFR 175.300, the FDA has deauthorized the use of Bisphenol A in polycarbonate baby bottles, sippy cups, spill-proof cups, trainers’ cups intended to be used by children, responding to the petitions made by the ACC (American Chemistry Council) and food packaging industries.
21 CFR 177: Polymers
Section 177 of 21 CFR provides technical requirements, specific migration limits (SML), and testing standards for more than 20 kinds of polymers used for food contact materials, such as baby bottles.
Among all the polymers listed in this section, some of them are used as the main materials to produce children’s drinking equipment, such as:
- Polycarbonate resins
Baby Bottles State Regulations
Several states in the US have specific regulations concerning the chemical safety of children’s drinking bottles, particularly the use of Bisphenol A in these products. This section introduces a few Bisphenol A restrictions enforced in different states of the US.
California: Product Safety: Bisphenol A
The state of California sets the Bisphenol A limit contained by the infant drinking bottles and sippy cups used by children younger than 3 years old to be no more than 0.1 parts per billion.
District of Columbia: Restrictions on Bisphenol A
The District of Columbia prohibits the manufacture, sale, or distribution of Bisphenol A-contained food contact containers used by children under the age of 4 years old.
Maryland: Childcare Articles Containing Bisphenol A
Maryland forbids the manufacture or distribution of child care articles that contain Bisphenol A. This law affects child infants or toddlers’ drinking bottles or cups and other food contact products that are intended to be used by children younger than the age of 4.
Third-party lab testing is necessary to verify both material and mechanical compliance of baby bottles. As mentioned, third-party lab testing is mandatory for all baby and children’s products in the United States.
Here are some companies offering baby bottles testing:
Baby bottles manufactured overseas are not always designed to comply with US safety standards and substance restrictions in mind. On the contrary, there are plenty of baby bottles manufactured by suppliers that have little or no expertise when it comes to relevant baby bottle compliance requirements in the United States.
Keep in mind that not every single baby bottle is made for the US market (despite being available for purchase for US importers). Likewise, not every single manufacturer in Asia has experience 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 can be ‘incorrectly’ designed in the sense that it contains small parts or other design elements that are non-compliant with US safety standards. Baby bottles must be ‘designed for compliance’ in order to be sold in the USA.
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.