Why Choose CIRS for Novel Food and Feed Ingredients Registration?

As innovation accelerates across the global food and feed industries, businesses face an increasing demand for regulatory registration and authorization services. These include New Food Ingredients, New Food Additives, New Feed Ingredients, and New Feed Additives—spanning key regulatory frameworks such as China’s Three New Foods, U.S. GRAS Notice, EU Novel Food Authorizations, and China New Feed/Feed Additive Registration.

However, regulatory mandates, technical dossier specifications, toxicological assessments, submission pathways, and review priorities vary significantly across global jurisdictions. To achieve efficient global market access, partnering with a regulatory compliance agency that possesses true international reach, deep technical expertise, robust toxicological capabilities, multiple successful cases, and multi-industry cross-collaboration is critical.

As a leading global product safety and regulatory compliance consulting agency, CIRS Group has long specialized in food, feed, pet food, and synthetic biology ingredients. CIRS Group has established a robust global service network covering China, the United States, the European Union, Canada, Australia, New Zealand, Japan, South Korea, and other major international markets.

Why are an increasing number of global enterprises entrusting CIRS Group with their novel food and feed ingredient registrations? Here are 10 key advantages that set CIRS Group apart.

1. Global Service Network Supporting Multi-Market Submissions (including China, U.S., and EU)

Founded in 2007, CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. For global ingredient registration projects, this footprint delivers capabilities beyond simple regulatory knowledge:

• Local Representation for foreign applicants;
• Real-time tracking and rapid response to evolving regulations;
• Cross-regional submissions across multiple targeted markets; and
• Integrated, multi-market compliance solutions.

For enterprises planning simultaneous market expansion across China, North America, Europe, and Asia-Pacific, CIRS Group is able to provide forward-thinking, internationally coordinated regulatory support.

2. Proven Enterprise Capacity & Large-Scale Project Execution

CIRS Group has over 450 employees across 11 global subsidiaries. To date, CIRS Group has delivered technical compliance services to over 20,000 companies worldwide, including more than 60 top 500 enterprises.

For corporate clients, scale translates directly to reliability. We have:

• High capacity for managing simultaneous, complex multi-market projects;
• Cross-functional collaboration on highly intricate dossiers;
• Sustained execution capability for long-cycle regulatory projects; and
• Extensive experience meeting the rigorous standards of multinational enterprises.

3. Professional Food Compliance Team with Advanced Technical Backgrounds

The CIRS Group Food Division focuses on global novel food and feed ingredient compliance. Most of the team members have over ten years of compliance experience, and more than 80% hold Master's or Ph.D. degrees in food science, biochemistry, or related technical disciplines.

This background enables CIRS Group to go far more than interpreting regulatory texts – the team evaluates the underlying scientific logic, R&D background, production processes, and target applications to build highly actionable compliance strategies. Whether handling traditional food ingredients, synthetic biology products, functional ingredients, or special dietary components, CIRS delivers scientific and regulatory support to clients.

4. World-Class Toxicological Expertise & Safety Evaluation Capabilities

At the heart of every novel food and feed submission lies a singular imperative: demonstrating product safety. Safety and risk assessment represent one of the most challenging hurdles for companies to handle independently.

The CIRS Group toxicological team covers:

• 24 Chinese certified toxicologists (DCST);
• 2 U.S. certified toxicologists (DABT); and
• 2 European registered toxicologists (ERT).

Crucially, CIRS Group’s DABT toxicologists are fully qualified to participate in and sign off on U.S. FDA GRAS Expert Panel evaluations.

This expertise provides a distinct advantage in:

• Toxicological data gap analysis;
• Designing cost-effective safety testing pathways;
• Conducting comprehensive risk and exposure assessments;
• Constructing scientifically sound dossier logic; and
• Integrating complex technical data for GRAS, EU novel food, and China three new food dossiers.

5. Compliance Solutions Across Major Global Markets

CIRS Group offers complete regulatory compliance services across major global markets, including:

• China: Three New Foods Approval (New Food Ingredients, New Food Additives, New Food-Related Products)
• United States: FDA GRAS (Generally Recognized as Safe), New Dietary Ingredient Notifications (NDIN), Color Additive Petition (CAP)
• European Union: Novel Food Application (EFSA), Food Additive Application (EFSA)
• Australia & New Zealand (FSANZ) / Canada: Novel Food Application, TGA
• South Korea / Japan: Temporary Recognition of Novel Food & Food Additive (South Korea), Food Additive Authorizations (Japan)
• Global Feed Compliance: China New Feed / Feed Additive Registration, US Animal Food GRAS, FDA AFIC, AAFCO SRIS, and EFSA Feed Additive Application.

Rather than treating each country in isolation, CIRS Group helps clients design an optimized Global Market Access Roadmap aligned with their commercial goals and product characteristics.

6. Extensive Successful Cases

CIRS Group has successfully assisted over 1,000 enterprises with end-to-end food regulatory compliance. We hold a market-leading portfolio of successful cases across key innovation sectors:

D-Allulose (D-psicose)

● CIRS Assists Zhongda Hengyuan’s D-psicose in Achieving GRAS Notice

● CIRS Assists Shandong Fuyang in Quickly Obtaining Substantial Equivalence for D-Allulose as a New Food Ingredient in China!

● CIRS Successfully Supports China’s First Official Approval of D-psicose

Mycoprotein from Fusarium venenatum

● CIRS Helps Fushine Biotech Successfully Obtain Approval for China’s First Mycoprotein from Fusarium Venenatum

2’-FL

● CIRS Helps Tianjin Hesheng Successfully Obtain US GRAS Notice and China New Food Additive Registration for Its 2’-FL

● CIRS Assists Client in Gaining GRAS Notice for 2’-Fucosyllactose (2’-FL)!

3’-SL

● CIRS Assisted Meihua Group in Securing First NHC Approved 3’-SL

N-Acetylglucosamine (GlcNAc)

● CIRS Assists Runhan in Obtaining GRAS Status for Its GlcNac

SAMe-DT

● CIRS Helps Shandong Freda’s SAMe-DT Successfully Complete FDA NDI Notification

Astaxanthin

● CIRS Assists Shandong Weiyan in Obtaining GRAS Status for Its Astaxanthin

Zeaxanthin

● CIRS Supports Enhe Aiju’s ZeaVida® Zeaxanthin Obtain FDA GRAS Notice

β-carotene

● CIRS Assists VDK in Securing GRAS Status for β-carotene

PQQ

● CIRS Assists Maiggic in Rapid Approval of PQQ Disodium Salt for Substantial Equivalence

Enzymatically converted rebaudioside M2 (RebM2)

● CIRS Assists Client in Receiving "No Questions" FDA GRAS Notice

Click here to view more about our successful cases.

7. Aligning Food and Feed Sectors to Deliver a Unified Solution for Human and Animal Needs

Modern ingredient innovation rarely stays confined to a single commercial application. A single novel molecule may span:

• Conventional Foods;
• Dietary Supplements / Health Foods;
• Special Dietary Uses;
• Animal Feed & Additives; and
• Pet Food.

CIRS Group seamlessly spans both Human Food Ingredient and Animal Feed Ingredient Compliance. This expertise enables companies aiming for "one ingredient, multi-scenario commercialization" to execute a unified assessment, testing strategy, and submission plan across human and animal applications.

8. Expertise in Synthetic Biology Regulatory Frameworks

Synthetic biology (SynBio) is driving the next generation of food and feed ingredients. Compared to traditional ingredients, fermentation-derived and bio-manufactured components face heightened regulatory scrutiny regarding strain safety, genetic constructs, impurity profiling, production process validation, and scientific equivalence.

CIRS Group possesses extensive experience in SynBio ingredient submissions (including HMOs, alternative proteins, bioconverted sweeteners, and carotenoids). CIRS could assist bio-manufacturers with:

• Determining optimal regulatory classification across global markets;
• Structuring production strain identity, stability, and safety dossiers;
• Establishing impurity profiles and technical specifications;
• Designing targeted safety and toxicology testing protocols; and
• Coordinating synchronized multi-jurisdictional submissions.

9. One-Stop Support Spanning Consultation, Testing, R&D & Data

CIRS Group provides an end-to-end service loop that reduces vendor management overhead, accelerates turnaround times, and ensures data integrity. Our services cover:

• Regulatory consulting;
• Technical dossier compilation;
• Toxicological evaluation & risk assessment;
• Laboratory testing coordination;
• R&D support; and
• Data service.

CIRS Group also maintains proprietary global regulatory databases, enabling real-time monitoring of regulatory updates, maximum residue limits (MRLs), and additive standard changes worldwide.

10. Multi-Industry Compliance Solutions

In addition to food and feed compliance services, CIRS Group provides compliance solutions across other industries, including chemical, cosmetic, medical devices, biocides, and agrochemicals. This broad footprint provides a holistic compliance perspective. For companies navigating overlapping requirements, such as active ingredients, food contact materials, sustainable packaging, and global labeling rules, CIRS Group delivers cohesive, enterprise-grade solutions.

Why Choose CIRS for Global Food and Feed Ingredient Registration?

Overall, CIRS Group has established a distinct and robust competitive advantage in global food and feed ingredients compliance, including:

• Comprehensive global network.
• Deep regulatory expertise.
• Multiple successful cases.
• Service network spans across major regulatory jurisdictions, including China, the US, and the EU.
• End-to-end solutions spanning food, feed, and pet food.
• One-Stop technical support and regulatory solutions.
• Tailored, multi-industry market entry strategies.

For companies looking to expand into China, the United States, the European Union, and other key international markets, partnering with CIRS Group means more than hiring a service provider. It means gaining a mature, highly professional, and globally aligned market access solution.

With our global footprint, expert technical team, deep toxicological capabilities, and successful cases, CIRS Group consistently delivers premium compliance support to businesses around the world.

Whether you require regulatory support for novel foods, new food additives, novel feed ingredients, or new feed additives, including US FDA GRAS notifications and EU Novel Food applications,CIRS Group is your trusted strategic partner.

Frequently Asked Questions for Industry

1. What specific services regarding new food ingredients does CIRS Group provide?

Our Services include, but are not limited to:

• China “Three New Foods application (new food additives, new food raw materials, and new food-related products”;
• US FDA GRAS notifications & Self-GRAS , U.S. NDI notification, and CAP;
• EU Novel food applications and food additive applications;
• UK novel food application;
• Australia/New Zealand (FSANZ) novel foods application;
• South Korea MFDS approvals;
• Japan MHLW applications,
• China New Feed and Feed Additives;
• U.S. Animal Food GRAS, AFIC, AAFCO SRIS;
• EU Feed Additive Applications; and
• Global pet food labeling reviews.

2. Can CIRS Group act as a local representative for overseas submissions?

Yes. With wholly-owned subsidiaries and full-time local teams in the U.S., Europe (Ireland/UK), Japan, and South Korea, CIRS Group can act as the local legal entity or foreign applicant agent required by regulatory bodies.

3. What makes CIRS Group’s toxicological team unique?

CIRS Group houses 24 Chinese certified toxicologists (DCST), 2 U.S. certified toxicologists (DABT), and 2 European registered toxicologists (ERT). It is worth mentioning that the DABT toxicologists are fully eligible to convene and chair independent GRAS Expert Panels and sign official GRAS determination conclusions.

4. Are there any successful cases?

CIRS Group has led successful submissions for D-Allulose, 2'-FL, 3'-SL, Fusarium venenatum mycoprotein, N-Acetylglucosamine (NAG), PQQ, Astaxanthin, precision-fermented Zeaxanthin, SAMe-DT, NMN , Recombinant Humanized Collagen, and various probiotics. [See links above]

5. Does CIRS Group handle animal feed and pet food compliance?

Yes. CIRS Group provides comprehensive services for China new feed ingredients, feed additives, U.S. Animal Food GRAS, FDA AFIC, AAFCO SRIS, pet food import compliance, and label review across major global markets.

6. Why should companies entrust a professional consulting agency for global ingredient registration?

Regulatory definitions, toxicology requirements, submission formats, and review timelines vary drastically between jurisdictions like the U.S., EU, China, and Asia-Pacific. A professional regulatory compliance agency prevents costly study re-runs, optimizes testing strategy, formats dossiers correctly, and bridges communication with regulatory authorities, dramatically reducing time-to-market.

Get In Touch

Whether you need compliance solutions for New Food Ingredients, New Food Additives, New Feed Ingredients, and New Feed Additives, CIRS Group can help you identify the correct regulatory route and build a practical approval strategy. Click to contact our food regulatory experts or get in touch with us via service@cirs-group.com.