More intelligent safety assessment

A cosmetic safety assessment is not simply a matter of checking ingredient concentrations against regulatory limits. PRIMS increasingly reflects the different layers of reasoning involved in assessing the safety and compliance of a cosmetic product.

The PRIMS analysis distinguishes between regulatory rules, systemic toxicity (Margin of Safety), sensitisation (NESIL), CIR assessments and IFRA requirements. Where professional judgement is required, authorised safety assessors can overrule relevant conclusions and record their reasoning.

A particularly important new development adds another layer of control to this process: PRIMS now monitors whether the data underlying an assessor’s decision has subsequently changed.

When an assessor overrides a conclusion, PRIMS records the date. If relevant underlying information is changed afterwards, the system compares the modification date with the date of the assessor’s decision. The assessor can generate a report to obtain an overview of which conclusions need to be reassessed based on changes that have occurred.

This creates a much stronger audit trail and helps safety assessors maintain assessments over time, rather than treating the Cosmetic Product Safety Report (CPSR) as a static document.

Regulatory compliance starts at raw-material level

Regulatory conditions do not always apply in the same way to a finished cosmetic product and to the raw material from which an ingredient originates.

PRIMS now distinguishes explicitly between Product Conditions and Raw Material Conditions within regulatory rules. Raw-material conditions can be assessed and confirmed directly at raw-material level, rather than having to repeat the same assessment for every product containing that material.

When a raw material has an active regulatory condition, PRIMS flags it for attention. Once the condition has been evaluated at raw-material level, that information becomes available to the product assessment.

For regulatory teams managing larger portfolios, this is an important efficiency gain. One properly maintained raw-material assessment can support the compliance process across multiple formulations and products.

Traceability that follows the complete product lifecycle

Cosmetic compliance is not only about knowing what is in a product today. Regulatory teams may also need to establish exactly what was in a product at an earlier point in its lifecycle.

PRIMS has therefore strengthened its historical traceability.

For superseded and discontinued products, users can now view the formula, raw materials and packaging components exactly as they existed for a specific product version in time.

This makes version history much more than an administrative record. It provides regulatory professionals with a reliable historical view of the actual product composition – valuable when investigating past compliance, answering customer or authority questions, or reviewing changes between product versions.

CPSRs with greater scientific traceability

PRIMS continues to deepen the connection between the underlying safety data and the Cosmetic Product Safety Report.

Literature references supporting toxicological data are incorporated into Appendix I of the CPSR, strengthening the scientific traceability between substance toxicological data, the assessment and its supporting sources.

PRIMS has also expanded the way safety assessors can work with CPSR information. Assessors can document comments supporting individual assessment conclusions, while the CPSR presents the different safety and regulatory considerations in a more structured way.

Another practical addition is the option to generate a Safety Assessment with percentage ranges alongside the version containing exact formulation percentages. Ingredient concentrations are presented as ranges in this report, while the exact-percentage assessment remains available in parallel.

This gives regulatory teams greater flexibility when sharing safety documentation while retaining the detailed formulation data needed for the underlying assessment.

Smarter handling of CIR safety qualifications

PRIMS has become more intelligent in areas where repetitive assessor input can be reduced without removing professional oversight.

A good example is the handling of CIR “Safe with Qualifications” conclusions.

Many CIR qualifications relate to whether a finished formulation is irritating and/or sensitising. PRIMS is using information recorded for the formula – for example, whether irritation or sensitisation is expected based on relevant data – together with the applicable CIR qualification to support the conclusion automatically.

The result is less repetitive confirmation for safety assessors while keeping the underlying assessment logic visible.

Better control of regulated constituents

Regulated constituents can originate from multiple ingredients and its raw materials, making their assessment considerably more complex than checking a single ingredient percentage.

PRIMS has further developed its handling of these substances. Within ingredient-based formulations, the system can identify when regulated-constituent information still needs to be entered and automatically calculate the total amount when the same constituent originates from several sources. The analysis also distinguishes between a confirmed zero and a value that has simply not yet been provided.

This distinction is small from a data-entry perspective but important from a regulatory perspective: “0%” and “unknown” do not mean the same thing.

It is another example of how PRIMS is designed around the realities of regulatory assessment rather than simply storing formulation data.

Keeping allergen and fragrance documentation under control

Preparing for changing fragrance-allergen requirements requires more than updating an ingredient list at the last moment. Brands need to know which fragrances, aromas and essential oils have sufficient documentation and which products are affected when information is missing.

PRIMS supports this process through dedicated reporting and documentation controls. The system can identify products and relevant raw materials for which extended allergen information is available or still missing, helping regulatory teams organise the transition to the requirements of EU Regulation 2023/1545.

PIF reporting has also been expanded so that missing IFRA statements and allergen lists can be identified as part of documentation completeness.

For brands with large portfolios, this turns a potentially manual product-by-product exercise into a manageable portfolio-level workflow.

More support for international cosmetic compliance

PRIMS is built to support regulatory work across markets, and this continues to expand.

Recent developments include additional support for Canadian substance information and Canadian-specific ingredient label names. Where the Canadian Ingredient label name differs from the EU Common Glossary Name, PRIMS can store the Canadian version and use it in the Canada Label Report.

PRIMS also continues to expand regulatory ingredient restrictions for individual US states (California, Colorado, Maine, Maryland, Minnesota, New York, Oregon, Vermont, Viginia and Washington).

PRIMS also supports specific labelling workflows for products falling under US OTC or Canadian Non-Prescription Drug requirements.

For international brands, this means product information can increasingly be managed from one regulatory data structure while still accounting for market-specific requirements.

One connected system with a single view

What connects these developments is not any single new feature. It is the way PRIMS brings formulation management, raw-material information, regulatory rules, toxicological data, safety assessment, product documentation, labelling and portfolio compliance together.

A regulatory condition can be assessed where it originates. A safety assessor’s decision remains connected to the data on which it was based. Historical product versions remain traceable. Missing documentation can be identified across a portfolio. And information captured once can support multiple regulatory and safety processes.

That is where the depth of PRIMS becomes most valuable: not simply storing more regulatory information, but helping regulatory professionals turn that information into controlled, traceable decisions throughout the cosmetic product lifecycle.

For PRIMS clients: keep an eye on the Info Center in your PRIMS dashboard for regular release updates, legislative insights and TRC guidance.

Not using PRIMS yet? Discover how PRIMS can help your regulatory and safety teams manage cosmetic product compliance, CPSRs, PIF documentation and portfolio data in one connected environment.