Why Proposition 65 creates unique challenges for food and beverage products

What does Prop 65 require?

Under Prop 65, businesses must provide ‘clear and reasonable’ warning when a product may expose Californians to chemicals known to cause cancer or reproductive or developmental harm.

The Act is exposure-based rather than hazard-based, meaning the presence of a listed chemical in a product does not automatically mean a warning is required. Businesses must consider typical exposure levels in the context of real-world product use and compare them with established Safe Harbor Levels – concentrations below which warnings are generally not required – where the levels are known.

Any product sold in California, including through online platforms, is in scope of Prop 65. This decision-making guidance document from Sagentia Regulatory explores wider technical and regulatory matters in more detail.

Why naturally occurring contaminants create complexity

Prop 65-listed substances can be present in food and beverage products due to several factors including those associated with agricultural production and supply chains. For example, because heavy metals such as lead, cadmium, and arsenic may be present in soil and water, trace levels may appear naturally in products.

This complicates Prop 65 assessment and decision-making as the burden of demonstrating that listed chemicals are present due to natural occurrence falls on food growers and processors. Additionally, obtaining sufficiently detailed information from ingredient suppliers can be difficult, especially across complex international supply chains.

Levels of naturally occurring contaminants can also vary significantly depending on where agricultural products are grown and sourced. Differences in soil composition, water quality, and environmental conditions can affect the chemical profile, meaning the same product manufactured in different geographical regions may present different Prop 65 considerations.

Such variability creates challenges for global manufacturers, especially where ingredient sourcing changes over time due to availability, seasonality, or cost pressures. Understanding sourcing practices, supplier controls, and potential differences in ingredient composition is an important aspect of Prop 65 assessment for many food and beverage companies.

The complexity of naturally occurring contaminants has been evident in litigation surrounding lead in food products, for example. A widely referenced court case involving Beech-Nut baby food products ruled that Prop 65 warnings were not required where estimated average consumer exposures were below Safe Harbor Levels. This case underlines the importance of conducting detailed, scientifically defensible exposure assessment in Prop 65 decision-making, especially for food and beverage products.

What does exposure assessment involve?

A Prop 65 exposure assessment allows companies to make informed decisions about whether a warning is warranted. It can underpin a balanced and proportionate approach, especially where naturally occurring contaminants are involved.

For food and beverage companies, an exposure assessment may include the review of supplier information, ingredient specifications, and analytical testing data to understand the likely concentration of any Prop 65-listed substances in finished products. Screening evaluations are typically based on worst-case assumptions, but more refined approaches consider realistic scenarios. For food and beverage products, this involves evaluating reasonably anticipated consumption patterns for average users to estimate potential exposure.

Prop 65 decisions are rarely driven by technical considerations alone. The commercial and reputational implications of applying a warning to a food or beverage product can be significant.

Simply applying a warning whenever a listed chemical is known to be present, regardless of the estimated exposure level, might minimise enforcement risk but could create commercial and reputational challenges. On the other hand, a more sophisticated evaluation based on realistic levels of consumption may indicate that a warning is not required. This will not eliminate litigation risk, but it can support defensible decision-making.

For many food and beverage companies, Prop 65 is a wider risk management issue, not a simple labelling exercise.

Practical considerations for food and beverage companies

Food and beverage companies that sell into California, directly or indirectly, need to make Prop 65 considerations a central part of product development, sourcing, and market planning. This should extend beyond ingredients, to include packaging materials, other food-contact materials, and manufacturing processes.

Important questions to ask include:

• Could ingredients, processing methods, or packaging introduce Prop 65-listed substances?
• How might ingredient sourcing and agricultural variability affect chemical profiles?
• Does supplier information provide sufficient detail on potential contaminants?
• Is existing product testing adequate to address compliance with Prop 65?
• Have similar food product categories previously been the subject of Prop 65 enforcement activity?

Prop 65 continues to evolve, so ongoing monitoring of listed chemicals, Safe Harbor Levels, and warning requirements is also important.

Combining food industry and Prop 65 expertise

For food and beverage companies, Prop 65 decision-making often requires detailed technical evaluation alongside a clear understanding of evolving US regulatory expectations.

As part of Sagentia Regulatory, Leatherhead Food Research supports food and beverage companies around the world with scientific and regulatory challenges associated with US market access. In addition, Sagentia Regulatory’s US team provides dedicated Prop 65 support, including strategic guidance, exposure assessment, and warning and labelling advice.