Food Safety Program

Assembly Bill (AB) 899: Food Safety – Ba​by Food​​
Frequently Asked Questions

AB 899 is a California legislative bill signed into law and enacted on October 10, 2023. AB 899 requires manufacturers of baby food to test and disclose the levels of four toxic elements that may be present in baby food, and to meet particular labeling requirements. These changes were made to the California Health and Safety Code (H&SC) sections 110962 and 110963 which went into effect January 1, 2024. The full text of AB 899 is available.

What is the goal of AB 899?

​The goal of AB 899 is to enhance the safety of baby food products by publicly disclosing information to consumers about levels of the four toxic elements in the products, promoting transparency in the industry, and enabling consumers to make educated decisions associated with their health.

What is California’s definition of a “manufacturer” of baby food?

Per California’s Health and Safety Code, Section 109970:

“Manufacture” means the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic. The term “manufacture” includes repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of the distribution of the food, drug, device, or cosmetic. The term “manufacture” does not include repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer.

​​What are the four toxic elements required by AB 899 that baby food manufacturers must test for?

Arsenic, cadmium, lead, and mercury are the four toxic elements under AB 899.

Does AB 899 apply only to California baby food manufacturers or imported baby foods as well?

AB 899 applies to final baby food products that are sold, manufactured, delivered, held, or offered for sale in California. Imported baby food products to be sold, delivered, held, or offered for sale in California must comply with AB 899.

Does AB 899 have compliance dates for baby food manufacturers?

​Yes. AB 899 has two compliance dates for requirements as follows:

Beginning January 1, 2024, baby food manufacturers must test a representative sample of their final baby food products for levels of arsenic, cadmium, lead, and mercury at least once a month. Manufacturers must keep records and provide them to the California Department of Public Health (CDPH) upon request.

Beginning January 1, 2025, manufacturers must disclose on their internet website the following for baby food products sold, manufactured, delivered, held, or offered for sale in the state:

• The name and level of the toxic elements (arsenic, cadmium, lead, and mercury) present in each production aggregate of their final baby food product.
• Descriptive information (e.g., product name, universal product code, size, lot numbers, or batch numbers) to enable accurate identification of the final baby food product by consumers.

Additionally, if the toxic element is subject to an action level, regulatory limit, or tolerance established by the U.S. Food and Drug Administration (FDA) pursuant to Title 21 Code of Federal Regulations, Part 109, the manufacturer must include the following two items on their label:

1. A statement that reads: “For information about toxic element testing on this product, scan the QR code.”
   
2. A QR code or other machine-readable code, which will allow consumers to access the manufacturer’s website and view the following information:

Does the January 1, 2024, compliance date for the product testing requirements apply to products manufactured on or after that date, and does not apply retroactively to products manufactured before that date that may still be on store shelves/in the supply chain?

​This applies to products manufactured on or after January 1, 2024, and does not retroactively apply. Therefore, there may be products on store shelves and in the supply chain manufactured before January 1, 2024, that would not be subjected to these requirements.

​Does the January 1, 2025, compliance date for the public disclosure and QR code/product labeling requirements apply to products manufactured and labeled on or after that date, and does not apply retroactively to products manufactured and labeled before that date that may still be on store shelves/in the supply chain?

This applies to products manufactured and labeled on or after January 1, 2025, and does not retroactively apply. Therefore, there may be products on store shelves and in the supply chain manufactured and labeled before January 1, 2025, that would not be subjected to these requirements.

​What products are covered given the definition of baby food?

AB 899 defines baby food to mean food packaged in jars, pouches, tubs, and boxes represented or purported to be specifically for babies and young children less than two years of age. “Baby food” does not include infant formula, as defined in Section 321(z) of Title 21 of the United States Code.

Does AB 899 require final baby food products to be tested for all four toxic elements (i.e., arsenic, cadmium, lead, and mercury) regardless of the risk profile or can the industry take an appropriate science- and risk-based approach to which toxic elements are tested?

AB 899 requires testing of all four toxic elements regardless of the risk profile.

For final baby food products, AB 899 requires testing of the four toxic elements “at least once per month.” Can this testing frequency be adjusted?

AB 899 does not allow for less frequent testing. Manufacturers may choose to test their products more frequently.

​Do manufacturers have the flexibility to disclose the required product information on third- party websites that agree to host the information instead of their own company websites?

No. AB 899 states that the information must be made publicly available on the manufacturer’s internet website.

​Does the QR code and labeling requirement apply to both final and draft FDA action levels, regulatory limits, or tolerances?

If a product is tested for a certain toxic element that has a final FDA action level, regulatory limit, or tolerance, AB 899 requires manufacturers to include a QR code or other machine- readable code on the product label that links to a page to the manufacturer’s internet website containing test results for the toxic element and a link to FDA guidance and information about the health effects of the toxic element on children.

​What baby food products currently have an action level, regulatory limit, or tolerance established that triggers the requirement to include a QR code and statement on the label pursuant to AB 899?

Currently, rice cereal and apple juice represented or purported to be specifically for babies and young children less than two years of age must have a QR code and statement on their label pursuant to AB 899 starting January 1, 2025. We recommend you stay informed regarding action levels, regulatory limits and tolerances established by the FDA.

​Will CDPH permit the statement and QR code to be placed at the point-of-sale versus on actual product labels?

CDPH does not have the discretion to change this statutory requirement and it must remain on the actual product labels.

​Is it acceptable to post an internal Certificate of Analysis rather than third party lab analysis report to a consumer-facing website?

Yes, it is acceptable as long as the laboratory is in compliance with AB 899 requirements per H&SC Section 110962 (c).

Is it acceptable to use Smart Label QR code?

​AB 899 requires manufacturers to use a QR code or other machine-readable code. It does not explicitly require or prohibit proprietary software.

Is it acceptable the Smart Label will take consumers to a smart label site, which would contain a link to the toxic elements testing results and guidance?

​No. AB 899 specifies the QR code must link to a page on the manufacturer’s internet website.

Can CDPH advise on the wording of the required QR code statement “For information about toxic element testing on this product, scan the QR code”?

This exact language is in statute and cannot be modified.

​Does CDPH plan to initiate rulemaking prior to the implementation and enforcement of AB 899?

CDPH does not plan to initiate rulemaking to implement or enforce the provisions of AB 899.

What is the U.S. Food and Drug Administration’s “Closer to Zero” Initiative?

​In 2021, the FDA released its Closer to Zero initiative, which aims to decrease the exposure of babies and young children to harmful substances such as lead, arsenic, cadmium, and mercury in food. The initiative includes conducting and evaluating research, proposing draft action levels, consulting with stakeholders, and finalizing regulatory action levels.

What penalties or enforcement actions will be administered against manufacturers that do not comply with the provisions of AB 899?

CDPH has authority to enforce against food manufacturers who are non-compliant with the requirements in AB 899. For example, CDPH has authority to embargo misbranded baby food products, issue penalties, and suspend or revoke registrations and licenses.

How will baby food manufacturers be able to prevent non-compliant products from being sold in California?

​If someone is aware of a person or entity who is not compliant with AB 899, please report the matter to the complaint form on our website.

What is a good contact for questions related to AB 899?

If you have questions related to AB 899, please contact FDB directly by emailing FDBFood@cdph.ca.gov, and include in the subject line AB 899 and inquiry topic.

​Have there been any max limits set for the heavy metals in baby food according to this bill?

​Assembly Bill 899 does not establish limits on the allowable amount of toxic elements (lead, mercury, cadmium, and arsenic) in baby food. Rather, the law requires manufacturers to test their products, disclose the results, and provide access to those results through a website.

With the upcoming timeline of January 1, 2025, will there be a grace period for brands to be able to implement / update their packaging?

The law does not provide an implementation grace period.

Does the law provide any relief for small manufacturers or manufacturers with low sales volume?

​The provisions of AB 899 apply to all manufacturers, irrespective of sales volume.

What frequency of testing is needed for manufacturers who intermittently manufacture applicable products and do not run continuously throughout the year?

Per AB 899 Section 110962 (b)(1)(C), a manufacturer of baby food for sale or distribution in California shall test each final baby food product for toxic elements pursuant to subparagraph

(A) at least once per month.

​Does the law make any special provision for small labels?

​The law does not make any special provision for small labels. Manufacturers must ensure their labels comply with all applicable laws and regulations including those provided in AB 899.

For small manufacturers that have a large inventory of labels, are there any considerations to extend the January 2025 deadline for new labels?

​There are no provisions under the law allowing considerations to extend the January 2025 deadline for new labels. Manufacturers subject to this California law are required to comply with the specified requirements by the set effective dates of January 1, 2024, and January 1, 2025.

​Are QR codes required definitively, or only where heavy metals are detected in product above the regulatory threshold levels?

A QR code or other machine-readable code is required if a product is tested for a certain toxic element subject to an FDA action level, regulatory limit, or tolerance. AB 899 does not state this requirement applies only when heavy metals are detected in the product above the regulatory threshold levels.

What are the requirements that the labs must adhere to?

Per AB 899, the proficient laboratory that analyzes the final baby food product for toxic elements shall meet all of the following criteria:

1. Be accredited under the standards of the International Organization for Standardization (ISO) / International Electrotechnical Commission (IEC) 17025:2017 regarding the general requirements for the competence of testing and calibration laboratories.
2. Use an analytical method that is at least as sensitive as that described in the FDA Elemental Analysis Manual 4.7.
3. Demonstrate proficiency in quantifying each toxic element to at least six micrograms of the toxic element to kilogram of food (μg/kg) through an independent proficiency test. Proficiency means that laboratories achieve a z-score that is less than, or equal to, plus or minus two (≤ ±2).​​