Get Assistance for Self-Affirmed GRAS Compliance and Grow Your Business

We guide you in deciding if Self-Affirmed GRAS status is needed for your ingredients. We also help create a Self-Affirmed GRAS dossier and ensure your ingredients meet safety standards for US market sale. Trust our team to navigate this process seamlessly for your food products’ success.

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What is Self-Affirmed GRAS?

Self-affirmed GRAS (Generally Recognized As Safe) is a process where a company, independent of the FDA, determines the safety of their food ingredient or additive using scientific evidence and then notifies the FDA. This allows for faster market entry compared to the traditional GRAS petition process.

Why do You Need It?

In the USA, a company needs self-affirmed GRAS for a new food ingredient or additive to avoid the long and expensive traditional GRAS petition process with the FDA. It allows faster market entry while still ensuring safety through independent scientific evaluation by the company.

Difference between GRAS and Self-Affirmed GRAS

Feature
GRAS
Self-Affirmed GRAS
Submission Process
Formal petition to FDA with GRAS notification dossier
Independent determination by company
Regulatory Oversight
High
Low
Transparency & Public Awareness
High (FDA publishes GRAS list)
Low (no public disclosure required)
Level of Certainty
High (FDA endorsement)
Lower (company responsibility)
Suitable for
Complex substances, seeking high regulatory certainty
Simple substances, lower costs, faster process

What Makes Self-Affirmed GRAS a Better Option?

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Edward Ro Amazing Grass

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Michael T MT Consulting

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and they always come up with great solutions for your needs a great price!

Don Gauvreau Phrama Freak

Connect with FDA Compliance Experts

A company can obtain Self-Affirmed GRAS (Generally Recognized as Safe) for any direct or indirect food ingredient by demonstrating to the FDA that it is safe for its intended use.

This process typically involves preparing a comprehensive GRAS dossier that outlines the scientific evidence supporting the substance's safety.

Quality Smart Services readily helps clients in preparing GRAS notice with its decades of experience and expertise.

Please fill up the Inquiry form to book your free consultation session.

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