* metric provided by our customers
Quick recap
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What it is |
A regulatory compliance capability integrated directly into Trace One Devex PLM. |
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Who it is for |
Regulatory affairs, research and development, quality, and packaging teams at food and beverage, cosmetics, and specialty chemical manufacturers. |
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What it checks |
Formulas and sub-formulas, raw materials, packaging specifications, and labels against applicable regulatory requirements. |
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When it runs |
During product development and revision, with checks that can also be configured to run across multiple products at regular intervals. |
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What it produces |
Compliance assessment results based on the applicable requirements for each selected market, helping teams identify and address compliance issues during product development. |
What is Compliant Product Development?
Compliant Product Development means considering regulatory requirements throughout product development rather than waiting until the end of the process. In Trace One Devex PLM, teams can check formulas, sub-formulas, raw materials, packaging, and labels against applicable requirements as product information is created and updated. Products can also be checked against multiple target markets at the same time.
Regulatory compliance continues into labeling. Trace One Devex PLM can automate label creation using product data, including compiling ingredient statements, identifying allergens, providing nutritional information, and calculating values according to applicable legislative requirements. Labeling tools check guidelines and regulations across 14+ markets and regions to help teams generate appropriate, compliant labels.
By bringing regulatory checks and labeling into the product development workflow, teams can identify potential compliance issues earlier and reduce the manual work and repeated reviews associated with checking products only after development is complete.
What Compliant Product Development checks
What does the system evaluate?
Trace One Devex PLM can evaluate compliance at multiple levels of the product structure, including raw materials, sub-formulas, and finished formulas. Compliance calculations use regulatory data, ingredient composition, substance categorizations, restrictions, and limits to evaluate applicable requirements throughout the formulation hierarchy.
Trace One Devex PLM also supports packaging compliance and regulatory-compliant labeling, helping teams address requirements beyond the formula as part of the product development process.
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What is assessed |
What is checked |
What the assessment shows |
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Raw materials, sub-formulas, and finished formulas |
Regulatory requirements based on ingredient composition, substance categorizations, restrictions, and applicable limits. |
Compliance results at each level of the product structure, helping teams identify where potential compliance issues occur during formulation. |
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Packaging |
Packaging data such as materials, weight, recyclability, and recycled content against applicable packaging requirements.. |
Compliance information based on the packaging data and applicable requirements for the selected market. |
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Labels |
Ingredient statements, nutritional labels, allergen declarations, market-specific labeling requirements, and applicable regulatory labeling calculations and validations. |
Regulatory-compliant label content based on product data and the requirements of the selected market. |
Can teams assess formulation changes before making them?
Yes. Trace One Devex PLM supports “what-if” compliance assessments, allowing teams to evaluate hypothetical formulation changes and understand their potential compliance impact during product development.
When the checks run
Compliance checks can be performed throughout product development, helping teams evaluate compliance as formulations evolve rather than only checking the finished product before launch.
In Trace One Devex PLM, Teams can also configure checks to run at regular intervals across multiple products, providing ongoing compliance visibility across their product portfolio as requirements and product data change.
What does regulatory compliance coverage include?
Trace One Devex PLM supports compliance evaluation across ingredient permissibility, substance restrictions and concentration limits, and market-specific labeling requirements. Regulatory compliance assessments can be performed at the raw material, sub-formula, and finished formula levels, helping teams evaluate requirements throughout product development.
For labeling, Trace One Devex PLM supports regulatory calculations and validations for areas such as ingredient statements, nutritional information, allergen declarations, and market-specific label requirements.
How does regulatory data work inside Trace One Devex PLM?
Trace One Devex PLM brings regulatory data and product data together within the product development process. Compliance calculations use information such as ingredient composition, substance categorizations, restrictions, and applicable limits to evaluate raw materials, sub-formulas, and finished formulas against relevant requirements.
Because these checks take place within Trace One Devex PLM, teams can evaluate compliance using the product data they are already working with and maintain compliance visibility as formulations evolve.
Regulatory data also supports market-specific labeling calculations and validations, connecting compliance checks with the information needed to generate appropriate product labels.
How does a compliance evaluation run?
Trace One Devex PLM uses product and regulatory data to evaluate a formula against the requirements of its target markets. Teams can analyze multiple countries at the same time for regulatory rules covering additives, contaminants, pesticides, and other regulated substances.
Regulatory teams and formulators can perform initial recipe screens, check applicable limits, and review compliance and impact reports to understand whether a formulation meets relevant requirements across selected markets.
What can teams do when a compliance issue is identified?
Trace One Devex PLM helps teams move from identifying a regulatory issue to understanding its impact and taking action across affected formulas.
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Find: Select a substance or ingredient and identify the formulas in which it is used.
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Assess: Run assessments across multiple products to identify which formulas are affected by a regulatory requirement or change.
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Replace: Identify an alternative ingredient or substance and apply the replacement across impacted formulas.
What Compliant Product Development covers
Trace One Devex PLM brings regulatory data and compliance capabilities into product development, with functionality tailored to the requirements of different industries.
Food and beverage: labeling and regulatory calculations
Trace One Devex PLM helps food and beverage teams create accurate, market-specific label content using product data. It can compile ingredient statements, identify allergens, provide nutritional information, and calculate values according to applicable legislative requirements.
Product labeling tools support guidelines and regulations across markets and regions, helping teams generate appropriate labels for their target markets.
Cosmetics: ingredient statements and INCI calculations
For cosmetics and personal care products, Trace One Devex PLM can compile ingredient statements and perform INCI calculations using formulation data, helping teams prepare accurate product information in line with applicable legislative requirements.
Specialty chemicals: EHS compliance and SDS authoring
Trace One Devex PLM supports hazard classification and Safety Data Sheet (SDS) authoring across major markets, including the European Union, United States, and China. It uses official regulatory data, a harmonized database of substance classifications, and integrated regulatory content to support EHS compliance and SDS authoring.
How does Trace One Devex PLM connect to ERP and LIMS systems?
Trace One Devex PLM can connect with enterprise systems such as ERP and LIMS, helping product development teams work with relevant product, material, and testing data across their PLM processes. These integrations help reduce disconnected information and manual data entry.
How are formulas and sub-formulas evaluated against target markets?
A sub-formula is a formulation used as a component within another formula. Trace One Devex PLM supports regulatory compliance assessments at multiple levels of the product structure, including raw materials, sub-formulas, and finished formulas.
Compliance calculations use ingredient composition, substance categorizations, restrictions, and applicable limits to evaluate requirements throughout the formulation hierarchy. Teams can also evaluate products against multiple target markets at the same time to understand compliance during product development.
How does raw material data support compliance assessments?
Trace One Devex PLM uses raw material data as part of regulatory compliance assessments throughout the product structure. Regulatory data, ingredient composition, substance categorizations, restrictions, and applicable limits are used to evaluate raw materials and understand their compliance impact on sub-formulas and finished formulas.
How does Trace One Devex PLM support regulatory-compliant labeling?
Trace One Devex PLM uses product and formulation data to support market-specific labeling calculations and validations. Labeling capabilities include ingredient statements, nutritional information, allergen declarations, and other market-specific labeling requirements.
Teams can evaluate requirements across different target markets and use the resulting product data to generate appropriate labels.
How are compliant labels generated in Trace One Devex PLM?
Trace One Devex PLM helps automate label creation using product data and applicable legislative requirements. It can compile ingredient statements, identify allergens, provide nutritional information, and calculate required values, helping teams create accurate and consistent label content for their target markets.
How can the same ingredient produce different compliance results across markets?
The same ingredient can meet regulatory requirements in one market and fail to meet them in another. This example shows how a substance within a sub-formula can be assessed across two target markets and how teams can respond when an issue is identified.
| Step | What happens |
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| 1. Assess the formula | A finished product contains a sub-formula with a preservative at a defined concentration. |
| 2. Review market one | The preservative is permitted at or below a defined concentration. The resolved level sits under that limit, so the formula passes and the ingredient appears on the label under its required name. |
| 3. Review market two | The same preservative is restricted to a lower limit for this product category. The resolved level exceeds it, so the formula fails, and the failure names the ingredient, the level, the limit, and the governing rule. |
| 4. Find affected formulas | Select the substance and identify the other formulas in which it is used. |
| 5. Assess the wider impact | Run compliance assessments across multiple products to identify which formulas are also impacted. |
| 6. Replace the substance | Reformulate for market two, drop market two from the launch, or reduce the concentration in the sub-formula and re-run evaluation across every finished product that inherits it. |
Why it matters: The failure surfaces during formulation rather than at the regulatory review at the end of development, which is the difference between an adjustment and a reformulation cycle.
Seamless compliance Compliance early and often
Trace One Devex PLM includes an integrated regulatory solution to ensure product compliance. Embedded within the product lifecycle management platform, our regulatory solution supports users in evaluating recipes and comparing them against a harmonized database of regulations.
How do you run a compliance check, from formula to approval?
A compliance check runs in seven steps, from opening the formula through generating approved label content.
- Create or open the formula. The formula record holds the ingredient list, concentrations, and any nested sub-formulas.
- Select the target markets. Each market attaches its own rule set, and a product can carry a different result in each.
- Resolve the ingredient tree. Sub-formulas are flattened to final concentrations so every substance in the finished product is visible to the check.
- Run the evaluation. The rule set for each selected market is applied to the resolved list and a result is written per market.
- Review failures with their governing rules. Each failure names the ingredient, the concentration, the limit, and the rule, so the fix is specific rather than exploratory.
- Check claims and packaging. Marketing claims and the packaging specification are evaluated against the same market list in the same pass.
- Approve and generate outputs. On approval, label content, nutrition panels, INCI statements, and safety data sheets are generated from the approved record.
How does regulatory coverage vary by market?
Trace One Devex PLM supports regulatory compliance across multiple global markets, allowing teams to evaluate products against the requirements of multiple target markets at the same time.
Coverage varies by market, product category, and regulatory requirement. Depending on the product and industry, Trace One Devex PLM supports capabilities including formula compliance assessments, regulatory limits calculations, labeling calculations and validations, INCI calculations, hazard classification, and SDS authoring.
How does Trace One Devex PLM support PPWR compliance?
The Packaging and Packaging Waste Regulation (PPWR) introduces new requirements for packaging placed on the EU market. Trace One Devex PLM helps manufacturers prepare for and manage these requirements by centralizing packaging data, automating compliance assessments, and generating supporting documentation.
1. Build a PPWR-ready packaging data foundation
Centralize packaging data across materials, substances, components, and BOMs in a single source of truth. Maintain complete and up-to-date packaging information for products and packaging components. Improve data quality, traceability, and readiness for PPWR, EPR, and evolving sustainability requirements.
2. Automate PPWR compliance management
Automatically assess packaging against PPWR PFAS and heavy metals requirements at scale. Detect risks and non-compliant packaging earlier. Stay aligned with evolving regulations.
3. Generate audit-ready PPWR documentation
Automatically generate Declarations of Conformity (DoC). Maintain supporting evidence and full audit trails. Produce market-ready and multi-language outputs. Ensure end-to-end traceability and version control.
Who uses Compliant Product Development?
Trace One Devex PLM brings product development and compliance workflows together, giving different teams access to the information they need throughout the product lifecycle.
| Role | How they use Trace One Devex PLM | How it helps |
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| Research and Development | Create and revise formulas and sub-formulas, perform compliance assessments, and evaluate products across target markets. | Overcome data silos, formulate faster, and identify compliance issues earlier during product development. |
| Regulatory Affairs | Review compliance assessments, applicable limits, and market-specific requirements across products. | Identify where further review or action is needed and support compliance throughout product development with a comprehensive regulatory compliance framework. |
| Quality Management | Manage packaging data and evaluate applicable packaging requirements, including PPWR-related compliance capabilities. | Improve consistency and visibility across product information and support end-to-end quality management processes. |
| Packaging | Manage packaging data and evaluate applicable packaging requirements, including PPWR-related compliance capabilities. | Identify packaging compliance risks earlier and improve the data quality and traceability needed to support evolving packaging requirements. |
| Marketing & Innovation | Work with approved product information used to support market-specific labeling requirements. | Support requirements-driven product development and help ensure product and label information meets market requirements. |
| Procurement & Supply Chain | Work with raw material and ingredient information used throughout product development. | ingredient information used throughout product development. Improve visibility across materials and connect with Trace One Devex PLM supplier quality management to support wider supply chain processes. |
| IT | Connect Trace One Devex PLM with enterprise systems such as ERP and LIMS where required. | Reduce disconnected information and manual data entry through ERP integration with Trace One Devex PLM and connected product data. |
Expert-guided success How does a Trace One Devex PLM implementation work?
A Trace One Devex PLM implementation is tailored to the organization’s product data, regulatory requirements, workflows, and integrations.
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Discovery
Review existing product, formula, raw material, specification, and regulatory data, along with the processes and systems that need to be considered.
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Configuration
Configure Trace One Devex PLM around the organization’s requirements, including relevant regulatory content, product development processes, and approval workflows.
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Data migration and integration
Migrate and validate relevant existing product data and connect Trace One Devex PLM with enterprise systems such as ERP and LIMS where required.
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Go live and adoption
Prepare teams for launch with training and ongoing support to help users adopt Trace One Devex PLM within their day-to-day processes.
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How are customers using Trace One Devex PLM for Compliant Product Development?
A global leader in food and agriculture needed to manage increasing complexity across product development while keeping pace with evolving regulatory requirements and supporting collaboration across its global teams.
With Trace One Devex PLM, the company brought product development and regulatory compliance capabilities together within its PLM environment, helping teams manage products more efficiently while supporting compliance throughout the development process.
What do our customers have to say?
"[Trace One Devex PLM] saves time on compliance efforts because all of the information is in one place and shared across the company. Our staff members aren’t looking all over trying to figure out what they’re supposed to evaluate and then finding the data they need to do that."
- Manager of marketing systems, personal care company
Glossary
The terms and acronyms used on this page, defined.
| Term | Definition |
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| PLM (Product Lifecycle Management) | Software that manages a product from concept through formulation, specification, packaging, and launch in one system. |
| Formula | A set of ingredients and concentrations that make up a product. Recipe and formulation are used interchangeably with formula. A multi-formulation is a formula built from nested sub-formulas. |
| Sub-formula | A formula used as an ingredient inside another formula. Compliance must resolve through every level, which is why nesting matters. |
| INCI (International Nomenclature of Cosmetic Ingredients) | The standardized ingredient naming system required on cosmetic product labels in the EU and many other markets. |
| R&D (Research and Development) | The team that creates and revises formulas. The primary daily user of the formula record. |
| ERP (Enterprise Resource Planning) | The system of record for procurement, inventory, and finance. Devex PLM reads material and purchasing data from it. |
| LIMS (Laboratory Information Management System) | The system that holds laboratory test results. Devex PLM reads test data from it so a compliance result reflects the tests actually run. |
| SSOT (single source of truth) | One authoritative record that every team works from, rather than separate copies per department. |
| GS1 (Global Standards One) and GDSN (Global Data Synchronization Network) | The standards body and the data exchange network used to share product data with retailers. |
| GHS (Globally Harmonized System of Classification and Labelling of Chemicals) | The international system for classifying chemical hazards and generating safety data sheets. |
| SDS (safety data sheet) and EHS (environment, health, and safety) | The document type and the discipline covering chemical hazard communication. |
| Regulatory rule, jurisdiction, claim, standard of identity | The four objects a compliance check operates on. A rule applies in a jurisdiction, a claim is a marketing statement checked against rules, and a standard of identity defines what a product must contain to be called by a given name. |
Frequently Asked Questions
What is Compliant Product Development?
Compliant Product Development means considering regulatory requirements throughout product development rather than waiting until the end of the process. Trace One Devex PLM helps teams evaluate formulas, sub-formulas, raw materials, packaging, and labels against applicable requirements as products are developed.
Is Compliant Product Development a separate product or part of Devex PLM?
It is a capability inside Trace One Devex PLM, not a separate product. The regulatory content, the product data, and the evaluation engine sit in the same platform, which is why a compliance result is written onto the product record itself rather than produced by a separate tool and copied across.
Which regulatory databases does Trace One use?
The regulatory content layer is maintained against official sources for each jurisdiction covered, spanning ingredient permissibility, concentration limits, labeling requirements, and claim substantiation rules. [Named source list per market to be supplied]
Does Trace One support cosmetics regulatory compliance?
Yes. Devex PLM generates the INCI statement from the resolved formula in descending concentration order, applies the one percent threshold rule, and checks every ingredient against the restricted and prohibited substance annexes of Regulation (EC) No 1223/2009.
How does a formula compliance check work, step by step?
Open the formula, select the target markets, resolve the ingredient tree so nested sub-formulas reduce to final concentrations, run the evaluation, review each failure against the rule that governs it, check claims and packaging in the same pass, then approve and generate label content, nutrition panels, INCI statements, and safety data sheets.
What happens when an ingredient fails in one market but not another?
The formula carries a separate result per market. A failure names the ingredient, the resolved concentration, the limit, and the governing rule for that market. The team can reformulate for the failing market, drop it from the launch, or reduce the concentration in the sub-formula and re-run evaluation across every product that inherits it.
Can Trace One generate INCI statements and cosmetic labels?
Yes. The INCI statement is generated from the approved formula, and label content including the ingredient list, allergen statement, and claim set is generated from the approved formula and the rules of the destination market, so the label carries the same objects that passed evaluation.
How long does a Trace One implementation take?
An implementation runs in four phases: discovery, configuration, migration, and go live with adoption. Duration depends on the number of markets, product categories, and integrations in scope.
Is Trace One Devex PLM a fit for your compliance workflow?
Trace One Devex PLM is designed for food and beverage, cosmetics, and specialty chemicals manufacturers that want to bring regulatory compliance directly into product development.
See how your teams can evaluate formulas and sub-formulas against target markets, identify compliance issues earlier, assess requirements across multiple markets, and support regulatory-compliant labeling within Trace One Devex PLM.