Can I assess the same SKU in multiple markets?
Yes, against any supported market. One formula is assessed against several market rule sets, and each market returns its own set of requirement statuses. The same formula can be compliant in one market and non-compliant in another, because the requirement sets differ rather than because the product changed.How do teams share and standardize assessments?
Regulatory teams use a consistent set of regulatory data and requirements for each selected market, helping standardize how product compliance is assessed across products and markets.
Assessment results can be shared with relevant stakeholders, helping regulatory teams communicate compliance findings across the business when needed.
When Trace One Regulatory Compliance is used within Trace One Devex PLM, compliance assessments are integrated directly into the product development process, allowing regulatory checks to be performed using formulation and product data within the PLM software.
When should a company run an SKU formula check?
- When launching an existing product in another country.
- When developing a new formula intended for more than one market.
- When reformulating after an ingredient or supplier change.
- When reviewing an additive level against a market requirement.
- When comparing one SKU across several markets before committing to a launch plan.
- When responding to a regulatory change that affects an existing formula.
- When quality, regulatory, and commercial teams need a documented status they can all work from.
How does PPWR affect food compliance assessment?
The European Packaging and Packaging Waste Regulation (PPWR) introduces new requirements for packaging across the European Union, including requirements affecting packaging design, materials, recyclability, and waste reduction.
Within Trace One Devex PLM, regulatory compliance capabilities are integrated into the product development process, allowing teams to consider PPWR requirements alongside product and packaging data. This helps teams identify relevant requirements earlier and incorporate regulatory considerations as products are developed for European markets.
The Food News Monitoring System also helps regulatory teams stay informed about PPWR developments and other regulatory changes that could affect their products and markets.
What the software supports, and what needs separate review
A formula check supports a regulatory decision rather than making it. The table below sets out what the software assesses and what still needs a separate review, which is also where a Requires review status goes.
| The software can support | Separate review may still be required for |
| Formula and ingredient rule checks against configured market requirements. | Legal interpretation of a requirement. |
| Additive and contaminant limit comparisons. | Laboratory or physical product testing. |
| Repeatable assessments across supported markets. | Complete label artwork approval, unless specifically supported. |
| Shared status reporting across teams. | Decisions based on missing or inaccurate input data. |
| Earlier identification of potential issues. | Final authorization by a regulator or a certifying body. |
Requirements for the United States market are published by the FDA, and an assessment compares entered formula data against those requirements rather than replacing them.
What countries and food companies does Trace One support?
Trace One Regulatory Compliance supports food manufacturers operating across global markets, with regulatory coverage spanning 170+ countries and essential insights from 50+ languages available in English.
| Coverage | Trace One Regulatory Compliance |
| 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 |
How do food and beverage companies use Trace One Regulatory Compliance?
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%.
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%.
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.
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Frequently Asked Questions
What is a food compliance assessment?
What is a market formula check?
A market formula check is a food compliance assessment that evaluates a product formula against the regulatory requirements of a selected market. Trace One automatically checks the relevant formula data against the applicable regulatory data and provides detailed assessment results by country, guideline, and substance.
What is an SKU formula check?
An SKU formula check is a food compliance assessment applied to a single stock keeping unit (SKU), or sellable product variant. It evaluates the product formula against the regulatory requirements of a selected market and provides detailed assessment results by country, guideline, and substance.
As a Regulatory Manager, how do I prepare a product for compliance testing?
To run a food compliance assessment, provide the target market, product category, substance, concentration, and unit of measurement. Trace One uses this information to automatically assess the formula against the applicable regulatory requirements for the selected market.
Is product compliance testing the same as laboratory testing?
No. A food compliance assessment evaluates product and formula data against the regulatory requirements of a selected market. Laboratory testing analyzes a physical product or sample. They serve different purposes within the regulatory compliance process.
Can I assess the same food formula in several countries?
Yes. The same food formula can be assessed against multiple supported markets. Each market is evaluated against its applicable regulatory requirements, allowing regulatory teams to compare compliance results across countries without repeating the assessment process manually.
What formula data is required to run an assessment?
To run a food compliance assessment, provide the formula, ingredients, additive levels, contaminant levels, and selected target market. Trace One uses this data to assess the formula against the applicable regulatory requirements for that market.
Can the software check food additives and contaminant levels?
Yes. Trace One Regulatory Compliance can assess food additives and contaminants as separate regulatory data types, comparing entered levels against the applicable requirements and limits for the selected market.
What do the assessment statuses mean
Compliance assessments in Trace One Regulatory Compliance return three statuses:
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Passed: The assessed requirement is met for the selected market based on the data provided.
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Failed: The assessed requirement is not met for the selected market based on the data provided.
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Requires review: The assessment requires further review to determine compliance with the applicable requirement.
How often is the regulatory content updated?
Content in Trace One Regulatory Compliance is continuously updated to reflect changes across supported markets, helping teams work with current information when conducting compliance assessments.
Which teams can access the assessment results?
What do common food compliance assessment terms mean?
| Term | Definition |
| Food compliance assessment | A comparison of a product formula against the requirements of a selected market, returning a status for each requirement assessed. |
| Market formula check | Another way to describe a Compliance Assessment, where a product formula is assessed against the regulatory requirements of a selected market. |
| Target market | The country or region where a product is intended to be sold. The selected market determines which regulatory requirements are applied during the compliance assessment. |
| Regulatory limit | A maximum or minimum value permitted for a substance in a product under the requirements of a selected market. |
| Additive | A substance added to a food product for a specific technical purpose. Permitted additives and permitted levels can vary by market and food category. |
| Contaminant | A substance present in a food product without being intentionally added. Applicable limits can vary by market and are assessed against the entered concentration. |
| Formula | The recipe for a product, including its ingredients and their quantities, together with the data attached to those ingredients. |
| Compliance status | The result returned for a single assessed requirement. Trace One returns three states rather than a binary pass or fail. |
| Product lifecycle | The sequence from formulation through launch, reformulation, and withdrawal. Regulatory assessment occurs at multiple points in it. |
| Recall risk | The likelihood that a product will need to be withdrawn from a market. Assessment reduces the chance of a known issue reaching market. It does not eliminate the risk. |
| FMCG | Fast moving consumer goods. The category covering food, beverage, cosmetics, and household products sold at high volume and short shelf cycles. |
| PLM | Product lifecycle management. Software for managing product data from concept through end of life. Regulatory compliance is one capability within it. |
Which Trace One tools support food regulatory compliance?
| Solution | Description |
|
Food Law Library |
Provides access to full-text food legislation, guidance, and standards organized by market, supporting regulatory research and compliance decisions. |
| REGDATA |
Provides regulatory data on substances, including additives, contaminants, pesticides, flavorings, and other regulated substances across global markets. It powers automated Compliance Assessments against target-market requirements. |
|
Food News Monitoring System |
Tracks regulatory developments across covered markets, helping regulatory teams stay informed about changes that could affect their products and markets. |
| Regulatory expert support |
Trace One’s multilingual regulatory experts and specialized partners can provide guidance on market requirements, assessments, and complex regulatory questions that require additional interpretation. |
|
Trace One Regulatory Compliance |
The broader regulatory compliance solution that brings together regulatory data, research, monitoring, and Compliance Assessment capabilities to support food regulatory teams across global markets. |
Where can regulatory teams learn more about food compliance management?
- FDA Food Guidance: Official FDA information on food ingredients, additives, contaminants, labeling, and other requirements affecting foods marketed in the United States.
- European Commission Food Additives Database: Official EU information for researching authorized food additives and their conditions of use.
- Codex Alimentarius: International food standards, guidelines, and codes of practice, including the General Standard for Food Additives.
- Trace One Regulatory Compliance: Learn how Trace One helps regulatory teams research requirements, run Compliance Assessments, and monitor regulatory developments across global markets.
- Trace One Food News: Explore regulatory updates and developments affecting food manufacturers across global markets.
How can I see a Compliance Assessment in Trace One?
See how Trace One Regulatory Compliance helps food and beverage manufacturers assess product formulas against the requirements of selected markets. Explore the platform at your own pace or request a personalized demonstration with the Trace One team..png?width=570&height=650&name=photo1%20(24).png)
Why Regulatory Compliance? Run instant compliance assessments. Increase speed-to-market.
Don’t comb through endless online searches for the most up-to-date documents and regulations. Trace One's Regulatory Compliance assessment tool helps regulatory, quality, and labeling teams save time and eliminate manual data entry with more immediate compliance checkpoints.
- Perform go/no-go assessments on recipes and ingredients.
- Visually identify if product attributes meet compliance standards with red, yellow, or green traffic lights.
Understand how food additives and contaminant levels affect product compliance during product innovation.