Create. Comply. Connect.

What is Trace One Regulatory Compliance software?

Trace One Regulatory Compliance is web-based software for food manufacturers. It helps teams monitor food laws, evaluate product formulas for selected markets, access regulatory documentation, get products to markets faster, and share compliance assessments across regulatory, quality, procurement, and packaging teams.

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  • Auchan
  • Barilla
  • Bacardi
  • Carrefour
  • General Mills
  • McCormick
  • Ghirardelli
  • Ferrero
  • Brown-Forman
  • Campari
  • ILLVA Saronno
  • Lindt & Sprüngli
  • Moet Hennessy
  • Tesco
  • Pastificio Garofalo
  • AB Mauri
  • Post Consumer Brands
  • Aryzta
  • Bauli
  • Biscuits Leclerc
  • Britannia Industries
  • Colussi Group
  • Dawn Foods
  • Eureden
  • Ingredion
  • Inner Mongolia Yili
  • OSI Group
  • Tata Consumer
  • MAPEI
  • Ahold Delhaize USA
  • Europastry
  • Glico
  • UNFI
  • Monoprix
  • Francap
  • Franprix
  • AAK
  • ElectroDepot
  • NAOS
  • Feihe

170+

Countries with regulatory coverage, as of Aug 2026

37,000+

Statutes in the Food Law Library globally

20,000+

 Restricted substance database

up to 70%

of compliance time saved by Trace One customers*

* metric provided by our customers

Quick Recap

  • Trace One Regulatory Compliance is web-based regulatory compliance software for food and beverage manufacturers. It helps teams monitor regulations, evaluate product formulas, and manage compliance documents across supported markets.
  • Main capabilities: REGDATA structured regulatory requirements, regulatory news monitoring, a food law library, market assessments, and integration with Trace One Devex PLM.
  • Regulatory affairs, quality, procurement, packaging, product development, and marketing teams share assessments and supporting information from one platform.

Trace One Regulatory Compliance at a glance

 

What the software does

Monitors regulations, evaluates product formulas, and manages compliance documents across supported markets.

Main capabilities

REGDATA, Food News Monitoring System, Food Law Library, compliance assessments, regulatory expert support, and regulatory compliance capabilities embedded within Trace One Devex PLM.

Who uses it

Regulatory affairs, quality, procurement, packaging, product development, and marketing teams collaborate on the same platform to one source of truth.

Measure Current figure
Country coverage Regulatory data for 170+ countries as of September 2026
Language availability Get essential insights from 50+ languages available in English
Statute volume 37,000+ statutes across 77 countries and six confederations
REGDATA scope Ingredient, additive rules, and 20,000+ restricted substances rules for 70+ countries

 

Why it matters

Why do food manufacturers use regulatory compliance software?

Food manufacturers sell the same product into markets with different ingredient rules, additive limits, labeling requirements, and packaging regulations. Checking each formula against each market by hand does not scale, and the rules change continuously. Regulatory compliance software holds the current rules, checks formulas against them, and records the result, so regulatory, quality, and procurement teams work from the same assessment.

Deployment model

Trace One Regulatory Compliance is a subscription-based, browser-accessed platform.

What the data actually is

Ingredient rules, additive limits, labeling requirements, regulatory compliance laws and documents, and regulatory news, all maintained by market.


 

Family at the supermarket shopping for some fruits

What are REGDATA, Trace One Copilot, and the other Trace One regulatory tools?

Stop switching between government websites, spreadsheets, internal documents, and disconnected systems. Trace One brings regulatory research, legislative monitoring, compliance assessments, and regulatory intelligence together in one platform.

Name What it is What it holds or does
REGDATA A regulatory database module Ingredient and additive rules, permitted levels, and restrictions for 70+ countries
Trace One Copilot An AI assistant for regulatory documents Summarizes and synthesizes stored regulatory documentation and drives tasks end-to-end.[L
Trace One Devex The product lifecycle management platform Formulation, specification, and packaging data that Regulatory Compliance checks against market rules
Food Law Library A document repository Full-text food legislation, guidance, and standards organized by market
Food News Monitoring System A regulatory news service Tracks regulatory changes, recalls, and enforcement actions by market
My Queries A saved-search feature Stores repeat regulatory questions and re-runs them against updated data
Smart Alerts A personalized regulatory alert feature Delivers updates on regulatory changes in your selected markets directly to your inbox

 

How does Trace One help food brands with regulatory compliance?

Browse expert analysis of food regulations, legislative updates, and compliance developments from key global markets. Stay informed about the changes that could impact your products, labels, and market access.

What tools are included in Trace One Regulatory Compliance?

REGDATA

Provides regulatory data on substances, including additives, contaminants, pesticides, and other regulated substances across global markets. Regulatory and R&D teams can use this data to check requirements for specific substances and run automated compliance assessments against the requirements of their target markets.

Food Law Library

Access full-text food legislation, guidance, and standards organized by market. Used by regulatory teams researching requirements and supporting compliance decisions.

Food News Monitoring System

Tracks published regulatory changes across covered markets and routes relevant items to the teams they affect. Used by regulatory watch and quality teams.

Does Trace One provide regulatory expert support?

Yes. In addition to its regulatory compliance software, Trace One provides access to multilingual regulatory experts and specialized partners for additional guidance and support.

Regulatory Consulting

Our multilingual regulatory experts specialize in navigating diverse food legislation across the world. Our consultancy services are customized to meet your needs, adding value at every stage of your product development process.

Specialized regulatory partners

Trace One works with partners that bring expertise in specific regulatory domains, both domestically and globally. Their areas of specialization range from safety regulations and labeling requirements to local market knowledge and industry insights.

What compliance tasks can Trace One Regulatory Compliance support?

  1. Research ingredient and additive requirements by market
    Use REGDATA to find substance rules, permitted levels, and restrictions for the markets where you plan to sell.

  2. Find and review regulatory documentation by market
    Use the Food Law Library to search food legislation, guidance, and standards by market and topic.

  3. Automate regulatory checks during product development
    Evaluate formulas against selected markets to identify whether they pass, fail, or require expert review.

  4. Monitor regulatory changes that could affect your products
    Track regulatory changes, recalls, and enforcement actions based on the markets and product categories relevant to your business.

  5. Assess product readiness for new markets
    Evaluate products market by market before launch to identify where requirements are met and where additional action or expert review is needed.

 

What can regulatory teams do with Trace One Regulatory Compliance?

Capability What a team does What the team gets
REGDATA Look up ingredient and additive rules for a target market A clear, traceable basis for the compliance decision, with the applicable rule, market, and date recorded
Formula checking Evaluate a formula against requirements in selected markets A pass, fail, or expert-review-required result for each market, so teams can identify compliance issues before launch
Regulatory news monitoring Select the markets and product categories relevant to the business Relevant regulatory changes, recalls, and enforcement actions filtered to the areas the team needs to monitor
Food Law Library Search full-text legislation, guidance, and standards by market The source regulatory documentation needed to research requirements and support compliance decisions
Trace One Copilot Ask questions about regulatory documents stored in the platform Answers with citations back to the source documents, making the underlying information easy to verify
Regulatory Compliance within Trace One Devex PLM Perform regulatory calculations and compliance assessments during product development Compliance checks based on the current product data, reducing reliance on exported copies and disconnected information

 

How does Trace One Regulatory Compliance compare with a manual approach?

Task Manual Approach With Trace One Regulatory Compliance
Researching ingredient and additive requirements Search multiple sources for ingredient and additive requirements in each target market Access substance rules, permitted levels, and restrictions by market in REGDATA
Checking a formula Compare ingredients against requirements for each target market in a spreadsheet Evaluate a formula against selected markets and identify where it passes, fails, or requires expert review
Finding regulatory documentation Search government websites and other sources for relevant legislation, guidance, and standards Search regulatory documentation by market and topic in the Food Law Library
Monitoring regulatory changes Subscribe to newsletters and government feeds then determine which changes are relevant Receive regulatory changes filtered to subscribed markets and product categories
Sharing the result Share spreadsheets and files between teams, creating multiple copies of the same assessment Give regulatory, quality, procurement, and packaging teams access to the same compliance assessment
Supporting compliance decisions Reconstruct the reasoning from email and file history at audit time The source text and the assessment are stored together within the platform

 

REGDATA
What is REGDATA?

REGDATA is the Trace One regulatory database module. It holds ingredient and additive rules, permitted levels, and restrictions for 70+ countries. When a rule is applied to a product, the rule, the market, and the date are recorded against that product, so the basis for an assessment is retrievable later rather than reconstructed.

Substance info
Compliance assessment_Per-Market

FORMULA CHECKS
How are formulas checked?

A formula is submitted once and evaluated against every selected market. Each market returns pass, fail, or expert-review-required, with the applicable rule and the source text attached to the result. Regulatory, quality, procurement, and packaging teams read the same stored assessment rather than separate copies.

Regulatory Watch
How are regulatory changes monitored?

The Food News Monitoring System tracks food news, recalls, and food safety updates by market. Customers subscribe to the markets and product categories that apply to them and receive filtered notifications rather than an unfiltered feed. My Queries stores repeat regulatory questions and re-runs them against updated data.

Food News
Queries

Food Law Library
How are documents stored and analyzed?

The Food Law Library holds full-text food legislation, guidance, and standards organized by market. Documents are searchable by market and by topic, and the source text supporting an assessment is attached to that assessment rather than stored separately from it.

Market readiness 
How are market assessments completed?

A team selects the target markets for a product and requests an assessment. The platform produces a market-by-market readiness result before launch rather than after, naming which markets the product is ready for, which it is not, and which require expert review.

Compliance assessment_failed

Regulatory Consulting 
What regulatory expert support does Trace One provide?

Trace One provides best-in-class support from a multilingual team of regulatory experts who help you navigate food compliance across global markets. Get expert guidance on market requirements, regulatory assessments, and complex compliance questions throughout the product development process.

Trace One Copilot 
How does Trace One Copilot answer questions about regulatory documents?

Trace One Copilot is an integrated, context aware intelligence embedded directly within the Trace One solutions platform. Its Regulatory Assistant helps teams quickly analyze regulatory documents by asking plain-language questions across one or multiple documents. It summarizes and synthesizes the information to provide contextualized insights, helping teams find key information and make confident decisions faster.

TOCopilot_screenshot1

Trace One Devex PLM
How does Trace One Regulatory Compliance work with Trace One Devex PLM?

Trace One Regulatory Compliance capabilities are embedded directly within Trace One Devex PLM, allowing teams to perform regulatory calculation and compliance checks as part of the product development process. This helps teams identify regulatory requirements and potential compliance issues while products are being developed, rather than checking them separately after development.

Which countries and regulatory data types are covered?

Whether you're launching into a new country or expanding an existing product line, quickly check the regulatory limits and legal documents available for each market using Trace One's interactive coverage map.

Check Regulatory Coverage Across 170+ Countries 

Whether you're launching into a new country or expanding an existing product line, quickly check the regulatory limits and legal documents available for each market using Trace One's interactive coverage map.

Where can I find key food regulatory updates by region?

Stay informed about key food regulatory developments across global markets. Trace One’s regulatory team identifies important changes, consultations, new requirements, and other developments for food manufacturers, with selected updates organized by region in our Food News blogs.

 

US Food Regulation Updates

Updates on US food safety, ingredients, labeling, packaging, and other regulatory requirements.

EU Food Regulation Updates

Developments across the European Union affecting ingredients, additives, labeling, food safety, contaminants, and other regulatory requirements.

Asia-Pacific Food Regulation Updates

Regulatory developments across Asia-Pacific markets affecting food products, ingredients, labeling, safety, and market access.

Canada Food Regulation Updates

Updates to Canadian food safety, ingredient, labeling, packaging, and other regulatory requirements.

UK Food Regulation Updates

Developments affecting UK food safety, ingredients, labeling, packaging, and other regulatory requirements.

Latin America Food Regulation Updates

Regulatory developments across Latin American markets affecting food products, ingredients, labeling, safety, and market access.

Australia and New Zealand Food Regulation Updates

Developments in food standards, ingredients, labeling, food safety, and other requirements across Australia and New Zealand.

Codex Food Regulation Updates

Developments in Codex Alimentarius food standards, guidelines, codes of practice, and other internationally relevant requirements.

How much could you save with Trace One Regulatory Compliance?

Discover how much time your team could save by reducing manual regulatory research, monitoring, and compliance assessments. Answer five quick questions to estimate potential efficiency gains and build your business case for Trace One Regulatory Compliance.

  • Personalized estimate in under 2 minutes

  • Based on your team's current regulatory workflow

  • Quantify potential time and efficiency gains

Calculate Your ROI →

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How is Trace One Regulatory Compliance implemented?

    • selerant-icon-two-color-discovery

      Discovery

      Trace One reviews your product portfolio, target markets, and current compliance process. You receive a scoped implementation plan naming the modules, markets, and data types in scope.

    • selerant-icon-two-color-mapping

      Mapping

      Your product records, formulas, and market list are mapped to the platform data model. You receive a mapped data set and a list of records that need cleanup before migration.

    • selerant-icon-two-color-implementation

      Implementation

      The platform is configured for your markets, product categories, and integrations, including Trace One Devex PLM where applicable. You receive a working environment loaded with your data.

    • selerant-icon-two-color-training

      Training

      Regulatory, quality, procurement, and packaging teams are trained on the workflows they own. You receive role-based training sessions and access to ongoing support.

How do regulatory, procurement, quality, and packaging teams use the platform?

Trace One maintains a database of 37,000+ statutes across 77 countries and six confederations. Each team asks a different question of the same product record.

Team The question they ask What they get
Regulatory affairs Is this formula permitted in these markets and what is the basis for that answer? A per-market result with the applicable rule and the source text attached
Procurement Is this ingredient permitted in the markets we sell into before I contract for it? An ingredient-level check against the target market list before the purchase decision
Quality management What changed in the regulations that apply to the products we already sell? Filtered regulatory change notifications for subscribed markets and product categories
Packaging Do the label and packaging meet the requirements in each destination market? Labeling and packaging requirements by market, held against the current product record
Product development Will this formulation clear regulatory review in the markets we are targeting? An assessment run during development rather than after the formula is locked
Marketing Which claims can we make about this product in each market? Market-specific claim and labeling constraints attached to the product record

 

End-to-end scenarios

  • Scenario 1: A new market is added to a launch plan

Trigger: Commercial adds [market] to the launch plan for an existing SKU.
Steps: Regulatory affairs selects the new market on the product record and requests an assessment. The formula is evaluated against that market. Ingredients that fail or require expert review are flagged, and procurement is notified of the affected inputs.
Outcome: A per-market readiness result before the launch date, with the applicable rule and source text attached.

  • Scenario 2: A regulation changes in a market you already sell into

Trigger: The Food News Monitoring System reports a change to an additive limit in [market].
Steps: The change arrives filtered to the subscribed market and product category. Quality re-runs the affected assessments against the updated rule. Products that no longer pass are listed with the specific ingredient at issue.
Outcome: A list of affected SKUs and the reformulation or labeling work each one requires.

  • Scenario 3: An auditor asks for the basis of a compliance decision

Trigger: An auditor requests evidence for a compliance decision made [N] months ago.
Steps: The stored assessment is retrieved from the product record. The rule that was applied, the market, the date, and the source text are all held with the result.
Outcome: The basis for the decision is produced from the record rather than reconstructed from email and file history.

FOOD REGULATORY COMPLIANCE USE CASES

What are the biggest regulatory challenges for food manufacturers?

Whether you're researching food regulations, monitoring legislative changes, assessing product compliance, or validating labels, Trace One helps food manufacturers simplify regulatory compliance across every stage of the product lifecycle.

Research Food Regulations

Access validated food regulations, additives, flavouring substances, contaminants, pesticides, and more from one searchable global database.

Validate Product Labels

Interpret global labelling requirements to help ensure ingredient lists, allergens, nutritional information, and claims meet market-specific regulations.

Monitor Regulatory Changes

Stay ahead of legislative changes with customized monitoring and Smart Alerts for the countries, ingredients, and product categories that matter most.

Launch Products into New Markets

Compare regulatory requirements across countries and identify opportunities for expansion with confidence.

Assess Product Compliance

Determine whether products meet country-specific regulatory requirements before launch using standardized compliance assessments.

Support Cross-Functional Teams

Provide Regulatory, Quality, R&D, and Packaging teams with one source of regulatory intelligence to improve collaboration and decision-making.

What results have customers achieved?

Food manufacturers use Trace One Regulatory Compliance to reduce time spent on regulatory work, accelerate assessments, and stay ahead of regulatory change across global markets.

Leading Global Dairy Company

7,200 hours saved annually and 50% faster time-to-market

By transforming its global regulatory compliance processes, a leading dairy company saved 7,200 hours of regulatory work annually, equivalent to 13 full-time employees, while reducing time-to-market by 50%.

Read the Case Study → 

Top 3 Global FMCG Company

Up to 80% faster regulatory assessments for new markets

By embedding regulatory data and food legislation monitoring into product development, one of the world's top three FMCG companies achieved 30% time savings for R&D and Regulatory teams and accelerated regulatory assessments for new markets by up to 80%.

Read the Case Study → 

Feihe Dairy

20+ hours saved every month on regulatory monitoring

Feihe Dairy uses Trace One Regulatory Compliance to centralize international regulatory intelligence, saving more than 20 hours each month on regulatory monitoring while supporting faster global expansion.

Read the Case Study → 

Milk bottles on factory production line

What customers say

“Trace One is a true accelerator that helps us advance and complete our overseas strategic planning. The most direct benefit is the shift from a passive 'firefighting' approach to a forward-looking compliance strategy.”

- Feihe Dairy

“Everybody in our business needs to monitor regulations and Trace One Regulatory Compliance is the perfect tool for real-time regulatory monitoring and for concentrating relevant information in one easy-to-access location.”

- A world leader in liquid food processing and packaging

“If you don’t have enough scientific background or knowledge to really understand a standard or to collect information, Trace One Regulatory Compliance gives you access to that data in a structured way. You can read the results and interact with technical knowledge, surpassing barriers.”

- Global food manufacturer

“Trace One Regulatory Compliance allows us to validate our go-to market priorities. It’s so easy to use, we think it’s the gold standard for global information and reporting for alcoholic beverage organizations.”

- Leading spirits company

"Trace One Regulatory Compliance offers us a comprehensive and easy-to-use tool for accessing worldwide food legislation and news monitoring. The user-friendly interface allows for smooth searching of the database and quick understanding both for experienced colleagues and those who are not frequent Trace One Regulatory Compliance users. The Trace One support desk is readily available for assistance. Trace One Regulatory Compliance is of great added value to our business and is highly recommended."

- Global Dairy Manufacturer

 

Frequently Asqued Questions

What is food regulatory compliance software?

Food regulatory compliance software holds the ingredient rules, additive limits, labeling requirements, and packaging regulations that apply in each market, checks product formulas against them, and stores the result. It gives regulatory, quality, procurement, and packaging teams one shared assessment rather than separate spreadsheets.

What does Trace One Regulatory Compliance do?

Trace One Regulatory Compliance is web-based software for food manufacturers. It monitors food laws by market, evaluates product formulas against selected markets, manages regulatory documents, and shares compliance assessments across regulatory, quality, procurement, and packaging teams.

Which countries does Trace One cover?

Trace One maintains regulatory data for 170+ countries. Coverage depth varies by data type and market. The coverage matrix on this page states which regulatory data types are maintained for each region so a buyer can check a specific market before contacting sales.

What information is included in REGDATA?

REGDATA is the regulatory database module. It holds ingredient and additive rules, permitted levels, and restrictions for 70+ countries. When a rule is applied to a product, the rule, the market, and the date are recorded against that product.

How often is regulatory information updated?

Update cadence varies by market and data type. Regulatory news monitoring runs continuously and delivers changes, recalls, and enforcement actions filtered to the markets and product categories a customer subscribes to.

Can Trace One check food formulas for multiple markets?

Yes. A formula is submitted once and evaluated against every selected market. Each market returns pass, fail, or expert-review-required, with the applicable rule and the source text attached to the result.

Can the platform monitor recalls and regulatory news?

Yes. The Food News Monitoring System tracks regulatory changes, recalls, and enforcement actions by market. Customers subscribe to the markets and product categories that apply to them and receive filtered notifications rather than an unfiltered feed.

How does Trace One Copilot answer questions about regulatory documents?

Trace One Copilot includes a Regulatory Assistant that helps teams quickly analyze regulatory documents by asking plain-language questions across one or multiple documents. It summarizes and synthesizes information to provide contextualized insights, helping teams find key information and make confident decisions faster.

Does Trace One provide source citations for compliance answers?

Yes. Assessments store the source text alongside the result, and Copilot answers return citations to the underlying documents. At audit time the basis for a decision is retrievable from the record rather than reconstructed from email history.

How does Trace One Regulatory Compliance work within Trace One Devex PLM?
Trace One Regulatory Compliance calculations and assessments are integrated directly into Trace One Devex PLM, enabling teams to check product compliance as part of the product development process. Trace One Devex is the product lifecycle management platform. Regulatory  requirements can be assessed against formulation and product data directly within Trace One Devex PLM, helping teams identify potential compliance issues as products are developed.
Which teams use the software?

Regulatory affairs, quality management, procurement, packaging, product development, and marketing. Each team asks a different question of the same product record, and each receives an answer scoped to the decision it owns.

How long does implementation take?

Implementation timelines vary based on your organization's needs and requirements. Trace One works with your team to define the appropriate implementation approach and provide the guidance and support needed to get started.

What training and support are included?

Trace One provides training and ongoing support to help teams get started and make effective use of the platform. The level of training and support can be tailored to your organization's needs.

Does the software replace regulatory or legal review?

No. The platform supports regulatory decision-making by holding the current rules, running checks, and recording the basis for each assessment. Formulas that require expert judgment return an expert-review-required result rather than a pass or a fail.

Request a demo

See Trace One Regulatory Compliance in action

Discover how Trace One Regulatory Compliance can help your team streamline regulatory research, assess products across target markets, monitor regulatory change, and make confident compliance decisions.

 

About Trace One

Trace One is a global provider of AI-native Product Lifecycle Management (PLM) and regulatory compliance software for the food & beverage, cosmetics & personal care, and specialty chemical industries. With more than 30 years of industry expertise, Trace One is the product development and compliance partner to over 9,000 brands worldwide, helping companies develop, launch, and manage remarkable products faster. Purpose-built for formula-based product development, the platform connects the entire product lifecycle from ideation to launch, with integrated regulatory intelligence spanning 170+ countries.