Ingredient compliance ensures that substances used in food, beverages, cosmetics, and pharmaceuticals meet stringent safety and regulatory standards set by authorities such as EFSA, Health Canada, and the FDA. Proper compliance not only confirms the safety and efficacy of ingredients but also enables legal market access, prevents delays, and builds consumer trust by demonstrating a commitment to quality and safety.  

While GRAS (Generally Recognized as Safe) certification is a key part of ingredient safety in the U.S., compliance often requires going beyond GRAS to meet the unique standards of different markets.  

At GRAS Experts, we simplify ingredient compliance by identifying risks, preparing detailed submissions, and ensuring your products align with global regulatory requirements, helping you achieve market success efficiently and confidently. Reach out to see how we can support you.  

The timeline depends on the agency and the complexity of the ingredient. Submissions to the FDA, EFSA, or Health Canada typically take 6–18 months. Factors such as toxicology data, testing methods, and the completeness of documentation can also affect timelines. At GRAS Experts, we ensure your submission is comprehensive and accurate, helping to minimize unnecessary delays. Let’s discuss how we can help you.

A rejected submission from FDA, Health Canada, or EFSA typically means the provided data did not meet their specific safety, efficacy, or compliance standards.

• FDA: Rejections often arise from gaps in toxicology studies, inconsistent safety data, or unclear usage conditions. You’ll need to revise and resubmit a stronger GRAS notification with additional scientific evidence. 

• Health Canada: Submissions may be delayed or rejected if clinical trial data, manufacturing processes, or safety assessments don’t align with Canadian regulations. Addressing these gaps with detailed studies or enhanced documentation can help resolve issues. 

• EFSA: Rejections usually result from incomplete dossiers or insufficient risk assessments for novel foods or food additives. A thorough review and addition of missing safety or exposure data can improve the application.

Overcoming rejection requires understanding each agency’s unique requirements. Working with GRAS Experts ensures your resubmission addresses all concerns and complies with regulatory standards. Contact us to learn how we can help you. 

Food additives are substances added to improve the flavor, appearance, or shelf life of food. These additives include preservatives, emulsifiers, and flavoring agents. Regulations such as the Food Additives Amendment of 1958 mandate safety evaluations to protect consumers and ensure proper use.

At GRAS Experts, we support compliance efforts with food testing and guidance for meeting FDA, EFSA, and Health Canada standards. Let us help you achieve your goals. Contact us today.

Animal testing isn’t always necessary. Many regulatory agencies, including the FDA, EFSA, and Health Canada, accept alternative testing methods, such as in vitro studies or human clinical trials, to demonstrate safety. With GRAS Experts, we can help you design compliant safety studies, avoiding animal testing whenever possible and ensuring all testing aligns with global regulatory standards. Get in touch with us to explore your options.

A food safety audit reviews ingredient handling, production processes, and safety practices to ensure they meet regulatory requirements. Audits are critical for identifying risks and ensuring the quality and safety of food additives. GRAS Experts provides expert guidance to prepare for and successfully navigate audits, giving you confidence in meeting FDA, EFSA, and Health Canada standards. Let’s work together. Contact our team to learn more.

Ingredients without a history of safe use require comprehensive safety evaluations, including toxicology studies, exposure assessments, and manufacturing details. Agencies like EFSA and Health Canada assess these data to ensure safety and compliance. GRAS Experts supports ingredient evaluations through GRAS clinical testing, ensuring your documentation meets global regulatory requirements. Find out more about how we can help.

GRAS stands for “Generally Recognized as Safe.” This FDA-specific designation confirms that an ingredient is safe for its intended use based on scientific evidence and expert evaluations. GRAS certification simplifies compliance with FDA regulations and supports smoother market entry. We can help you navigate the GRAS certification process, from safety studies to submission, ensuring all FDA requirements are met. Get in touch with us to explore your options.

Toxicology studies are critical for assessing ingredient safety, identifying potential health risks, and determining acceptable exposure levels. These studies are a key component of regulatory submissions to the FDA, EFSA, and Health Canada. At GRAS Experts, we provide comprehensive toxicology study services, ensuring your ingredient meets all safety requirements and is ready for approval. Start your journey with us today.

Ensuring a successful regulatory submission involves providing complete and accurate safety data, proper documentation, and meeting specific agency requirements. Missing elements often lead to rejections or delays in the approval process. At GRAS Experts, we specialize in the preparation and review of GRAS notices, Health Canada food additive submissions, and compliance for food additives and ingredients. We tailor our approach to your needs, minimizing risks and ensuring your submission aligns with global standards. Talk to us today or book a free consultation to find the right solutions for you.