Multi-jurisdictional bio-product registration

01Overview and value chain#

Markers EC: Novel-food, cosmetic & new-ingredient multi-jurisdiction registration | OECD: Bioeconomy policy & governance | Regulator: FDA (US), EFSA (EU)

Multi-jurisdictional bio-product registration is a B2B regulatory-services category that registers bio-based consumer products — novel foods, cosmetics, food-contact materials and new ingredients — across multiple national regimes simultaneously, distinct from biopharmaceutical drug-submission consulting because the products (foods, cosmetics, industrial ingredients) fall under entirely different regulatory frameworks than prescription drugs. Registrar Corp is the world’s largest FDA cosmetic-registration company with 30,000+ customers, offering comprehensive MoCRA (Modernization of Cosmetics Regulation Act) compliance solutions following the most significant changes to US cosmetics regulation in decades. Eurofins Regulatory Services supports clients navigating the EU Novel Food Regulation, including participation in EU-funded consortium work (SafeNov) aimed at accelerating novel-food approval timelines. Intertek helps clients navigate the changing US GRAS (Generally Recognized As Safe) landscape alongside deep expertise in functional-foods and food-contact-material (FCM) regulatory compliance. CIRS Group registers new cosmetic ingredients under China’s domestic filing and registration system, alongside its established chemical and food-ingredient registration practice. Freyr Solutions helps cosmetic brands expand globally by navigating the registration challenges that come with entering new national markets. TOXI PLAN, a French regulatory specialist, prepares Novel Food dossiers under EU regulation, guiding clients through the procedures required to secure EU market access for innovative food ingredients.

The key directions of multi-jurisdictional bio-product registration are:

1. Novel-food dossier preparation: compiling the safety and technical dossier required under regimes such as the EU Novel Food Regulation to gain approval for a new food ingredient.
2. Cosmetic facility and product registration: registering cosmetic manufacturing facilities and products with national authorities, including FDA facility registration under MoCRA and China’s cosmetic new-ingredient filing system.
3. New-ingredient notification and filing: navigating GRAS notifications, food-contact-material compliance and other new-ingredient filing pathways specific to each jurisdiction’s food and consumer-product law.
4. Multi-market expansion regulatory support: helping a bio-based consumer-product brand sequence its registration filings as it expands from one national market into several simultaneously.

Sectoral value chain#

[Product classification by jurisdiction] ──> [Dossier/notification preparation] ──> [Regulatory submission]
                                                                    │
                                                        (Cross-jurisdiction sequencing)
                                                                    │
              [Post-approval labeling compliance] <──── [Approval/registration outcome] <─── [Authority review & query response]

Value chain levels#

Cross-cutting technologies of the sector:

• Novel-food dossier preparation: the specific technical and safety-dossier practice required to secure approval for a new food ingredient under regimes such as the EU Novel Food Regulation.
• Cosmetic facility-registration services: registering cosmetic manufacturing facilities and products with national authorities under regimes such as US MoCRA and China’s ingredient-filing system.
• New-ingredient notification filing: navigating GRAS notifications and other jurisdiction-specific new-ingredient filing pathways for food and consumer products.

02US#

The United States hosts specialist firms focused specifically on FDA cosmetic and food-ingredient registration, several built around the compliance demands of recent legislative change.

Registrar Corp’s MoCRA-focused cosmetic-registration scale, Intertek’s GRAS and food-contact-material expertise#

• Registrar Corp: the world’s largest FDA cosmetic-registration company with 30,000+ customers, offering comprehensive MoCRA compliance solutions following the most significant changes to US cosmetics regulation in decades.
• Intertek: helps clients navigate the changing US GRAS landscape alongside deep expertise in functional-foods and food-contact-material regulatory compliance.

03CN#

China hosts a domestic regulatory-affairs firm with an established filing and registration practice specific to the country’s cosmetic new-ingredient and chemical/food-ingredient registration systems.

CIRS Group’s domestic cosmetic and ingredient-registration practice#

• CIRS Group: registers new cosmetic ingredients under China’s domestic filing and registration system, alongside its established chemical and food-ingredient registration practice.

04EU#

Europe hosts specialist Novel Food and regulatory-affairs firms navigating the EU’s distinct pre-market approval regime for innovative food ingredients.

Eurofins’ EU Novel Food consortium participation, TOXI PLAN’s dossier-preparation specialism#

• Eurofins Regulatory Services: supports clients navigating the EU Novel Food Regulation, including participation in EU-funded consortium work aimed at accelerating novel-food approval timelines.
• TOXI PLAN: a French regulatory specialist preparing Novel Food dossiers under EU regulation, guiding clients through the procedures required to secure EU market access for innovative food ingredients.

05Leading companies and research institutes#

06Tech stack and innovations#

The multi-jurisdictional bio-product registration stack combines classification and dossier-preparation expertise with jurisdiction-specific filing infrastructure:

1. Novel-food dossier preparation:
   • Firms such as TOXI PLAN and Eurofins Regulatory Services prepare the technical and safety dossiers required under the EU Novel Food Regulation, including EU-funded consortium work to accelerate approval timelines.
2. Cosmetic facility-registration services:
   • Registrar Corp and CIRS Group register cosmetic manufacturing facilities and products under jurisdiction-specific regimes (US MoCRA, China’s ingredient-filing system).
3. New-ingredient notification filing:
   • Intertek navigates GRAS notifications and food-contact-material compliance requirements specific to each jurisdiction’s food and consumer-product law.

07Value chains and production pipelines#

Industrial pipeline for a multi-jurisdiction bio-product registration#

┌───────────────────────────┐      ┌───────────────────────────┐
│ 1. Product classification   │ ───> │ 2. Dossier/notification     │
│    by jurisdiction               │      │    preparation                    │
└───────────────────────────┘      └───────────────────────────┘
                                                 │
                                                 ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 4. Authority review &       │ <─── │ 3. Regulatory submission    │
│    query response                │      │                                   │
└───────────────────────────┘      └───────────────────────────┘
              │
              ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 5. Approval/registration    │ ───> │ 6. Post-approval labeling   │
│    outcome                      │      │    compliance                     │
└───────────────────────────┘      └───────────────────────────┘

Stage 1: Product classification by jurisdiction

The regulatory-affairs firm determines how the bio-based product is classified (novel food, cosmetic, food-contact material) under each target jurisdiction’s framework.

Stage 2: Dossier/notification preparation

The safety, technical and labeling dossier or notification required for the classified product type is compiled for each jurisdiction.

Stage 3: Regulatory submission

The dossier or notification is filed with the relevant national authority.

Stage 4: Authority review and query response

The firm manages the authority’s review process, responding to any additional-information requests that arise.

Stage 5: Approval/registration outcome

The authority issues an approval, registration number or rejection for the product in that jurisdiction.

Stage 6: Post-approval labeling compliance

Product labeling and marketing claims are brought into compliance with the specific requirements of each jurisdiction where the product is now registered.