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Evaluate safety with a science-based approach.
A safety assessment is a structured evaluation of the available scientific and product-specific information to determine potential safety considerations associated with an ingredient, substance, or product.
Our experts assess the relevant evidence to identify potential hazards, consider exposure and intended use, and develop a scientifically supported conclusion regarding safety.
When should I consider a Safety Assessment?
A safety assessment is beneficial in circumstances such when ingredients fall into the category of an "old dietary ingredient". An ingredient within this category may not require a GRAS or NDIN, but the company still needs to have adequate documentation on file to support safety under the intended conditions of use.
What does a Safety Assessment involve?
The scope of a safety assessment is tailored to the characteristics of the product or ingredient and its intended use. Depending on the project, our assessment may consider:
- Ingredient identity and specifications
- Intended use and conditions of use
- Exposure considerations
- Available safety and scientific information
- Published scientific literature
- Existing toxicological information
- Historical use and regulatory considerations
- Potential safety concerns and areas of uncertainty
- The overall weight of evidence
Our experts evaluate the available information collectively to develop a clear and scientifically supported safety rationale.
Why does it matter?
A comprehensive safety assessment can help establish whether the available evidence adequately supports the intended use of an ingredient or product and identify areas that may require further consideration.
Identify potential safety concerns
Evaluate relevant hazards and areas of uncertainty associated with the ingredient or product.
Build a science-based safety rationale
Bring together available evidence to support a clear and defensible safety conclusion.
Support regulatory requirements
Generate scientific safety documentation that can contribute to compliance activities.
Identify evidence gaps
Highlight areas where additional information or data may be needed to strengthen the overall assessment.
Inform product and regulatory strategy
Use the safety assessment to help guide decisions around product development, intended use, and regulatory pathways.
What is the outcome?
The assessment provides a comprehensive evaluation of the relevant safety information, including the scientific rationale supporting the overall safety conclusion and any limitations or areas requiring further consideration.
The resulting safety assessment can serve as an important component of a broader regulatory submission, safety dossier, or product development strategy.
Science you can build your regulatory strategy on.
From individual ingredients to complex products, our safety assessments help transform scientific evidence into a clear, structured evaluation of safety - supporting informed decisions throughout the product lifecycle.
Evaluate the evidence. Understand the risks. Support safety with science.