Assessment Prop 65

Technical Support for California Compliance
 

Access to the US market is an important business opportunity for many food, cosmetics and manufacturing companies. However, exporting to some states - particularly California - requires specific regulatory requirements that are often complex and difficult to manage without qualified technical support. 
Among these, one of the most important is Proposition 65 (Prop 65), a Californian regulation that regulates the presence of substances potentially carcinogenic or toxic for reproduction in products placed on the market.

We at Lifeanalytics support companies in assessing, verifying and managing compliance with Prop 65 through a comprehensive, scientifically-based assessment designed to reduce legal risks, prevent disputes and ensure safe and compliant access to the California market. We work alongside manufacturers with a multidisciplinary approach that integrates regulatory expertise, analytical experience and in-depth knowledge of regulated substance lists.

What is Proposition 65 and why it’s critical for those exporting to California

The Proposition 65, officially "Safe Drinking Water and Toxic Enforcement Act", is a unique piece of legislation. California requires manufacturers to warn consumers if a product contains one or more of the more than 900 chemicals included in the official list, which is regularly updated by the state.

Failure to comply with Prop 65 may result in:

• extremely high economic penalties, up to $2,500 per day for violation;
• legal actions by individuals, associations and law firms, which are very common in the US;
• product recalls, withdrawals and distribution blocks;
• damage to reputation and loss of business opportunities.

For this reason, a specialist assessment is essential for all companies that produce, distribute or export products destined to the Californian market.

Our professional support in drawing up the nutritional tables USA and Canada

Our Prop 65 Assessment service: a structured and scientific approach

Our support has been developed to guide companies through every step of the Prop 65 compliance journey, combining regulatory assessment, scientific analysis and strategic advice. Our assessment includes several key activities, carried out by a multidisciplinary team with specific expertise in the regulatory and analytical field.
 

1. Preliminary product analysis and risk assessment

We start with a complete technical evaluation of the product, analysing:

• product category;
• production processes;
• raw materials and suppliers;
• any analytical data available;
• packaging and contact materials.

This step allows us to identify the potential contaminants regulated by Prop 65 and determine whether it is necessary to proceed with thorough checks.
 

2. Screening of substances Prop 65

We look at the list of substances subject to mandatory labelling, including:

• heavy metals (lead, cadmium, arsenic, mercury);
• IPA (Polycyclic Aromatic Hydrocarbons);
• phthalates;
• organic solvents;
• pesticides;
• acrylamide;
• residues of working or processing.

Our team constantly updates the official lists to ensure that evaluation always complies with the latest versions of the regulations.
 

3. Planning and execution of laboratory analyses

When necessary, we activate targeted analyses through our accredited laboratories. We carry out highly sensitive tests to verify the presence of regulated substances, using analytical methods that comply with international standards.

Our analyses include:

• research into heavy metals;
• determination of PAHs;
• quantification of phthalates, plasticizers and solvents;
• screening of pesticides;
• testing on packaging and MOCA.

Thanks to our nationwide laboratory network, we ensure accuracy, traceability and speed of response.
 

4. Quantitative assessment and comparison with Prop 65 limits

Prop 65 does not set maximum legal limits for all substances, but defines:

• MADL (Maximum Allowable Dose Level)
• NSRL (No Significant Risk Level)

Our experts perform interpretative assessments based on:

• levels detected analytically;
• quantity of product consumed or used;
• how the consumer is exposed;
• risk categories.

This makes it possible to determine whether the product requires a warning label, thus avoiding 
unwarranted misrepresentation or over-labelling.
 

5. Support in defining labels and warning statements

If the product requires mandatory reporting, we provide support in the drafting of compliant wording, including:

• “⚠️ WARNING: This product can expose you to chemicals including…”;
• indications for oral, dermal or inhalation exposure;
• Indications for specific chemicals such as lead, BPA or acrylamide.

We ensure full compliance with the graphics, positioning and visibility requirements required by California.

6. Management of suppliers and contact materials

Many Prop 65 nonconformities stem from:

• contaminated packaging;
• plastic materials containing phthalates;
• non-conforming printing inks;
• residues from processing processes.

We support companies in evaluating suppliers and defining technical specifications to prevent future critical exposures.
 

7. Support in case of legal disputes and requests

Prop 65 sanctions often start from private lawsuits (private enforcers), very common in the US.

Our experts provide documentation and technical support for:

• responding to requests for evidence;
• demonstrate the absence of significant risk;
• preparation of defensive technical dossiers;
• assess the correctness of the reports requested.

Our goal is to help companies manage with confidence even the most delicate situations.
 

Why choose us for an Assessment Prop 65

Choosing Lifeanalytics means relying on a partner with a complete and multidisciplinary approach, able to combine laboratory analysis, scientific evaluations and regulatory advice.

Our strengths:

• in-depth knowledge of Californian legislation;
• integration of consultancy and laboratory analysis;
• continuing updating of Prop 65 lists and application guidelines;
• practical experience in export and technical support to companies;
• ability to prevent risks and legal disputes;
• customised approach to product-specific features.

We work every day to turn regulatory complexity into a process that is clear, understandable and fully compliant with California requirements.
 

Our mission: secure and compliant access to the Californian market

Compliance with Proposition 65 is not just a regulatory requirement: it is an essential requirement to sell safely in one of the world’s most important and regulated markets.

Our objective is simple: 
to accompany companies in a complete compliance process, scientifically based and oriented towards product and market protection.

We support companies that want to export to California with safety, reliability and full regulatory compliance.

Do you want to go deeper into the subject? Fill out the form below to request your Personalized Consultancy!

REQUEST A PERSONALIZED CONSULTANCY

Looking to protect your business with comprehensive support? Discover the full range of tailored services