Cosmetics Product Safety, CPSR, PIF & Claims — From INCI Ingredients to Evidence-Backed Marketing

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated November 2025 • cosmetics product safety, CPSR, PIF, MoCRA, ISO 22716, INCI, preservative efficacy, stability studies, fragrance allergens & IFRA, cosmetic claims substantiation, manufacturing & QMS integration • Skin Care, Hair Care, Colour Cosmetics, Fragrance, Personal Care, OTC-like Cosmetics

Cosmetics product safety is no longer just a regulatory file in a drawer. It is the live connection between what you formulate (INCI ingredients and levels), what you actually manufacture (batches, lots, processes), what you promise on the label (claims, warnings, allergens) and what you can prove when regulators, retailers or litigators start asking questions.

On the regulatory side, that means building and maintaining a Cosmetic Product Safety Report (CPSR), a Product Information File (PIF), EU/UK notifications, MoCRA obligations and a web of specifications, test reports and decisions. On the operational side, it means making sure your MES/QMS/LIMS actually reflect what’s in the CPSR/PIF—and vice versa.

“If your CPSR and PIF say one thing, your batch records say another and your labels say a third, you don’t have cosmetic safety. You have paperwork risk.”

1) The regulatory landscape — EU/UK CPSR & PIF, US MoCRA and global overlap

Different jurisdictions use different acronyms, but the logic is similar: you must be able to show that each product is safe for its intended use and that you understand what is in it.

• CPSR – Cosmetic Product Safety Report. The CPSR is a structured assessment (usually Parts A and B) required under EU/UK cosmetic regulations. It pulls in toxicological profiles, margins of safety, impurity risks and exposure estimates.
• PIF – Product Information File. The PIF is the umbrella file kept readily accessible for authorities. It includes CPSR, product description, manufacturing method in line with GMP, proof of effect for claims and data on animal testing where relevant.
• MoCRA (US). The Modernization of Cosmetics Regulation Act (MoCRA) introduces new US requirements: facility registration, product listing, safety substantiation, adverse-event reporting and record-keeping.
• Global GMP & quality frameworks. ISO 22716 Cosmetics GMP and more general quality frameworks (e.g., ISO 9001, GMP/cGMP) underpin manufacturing discipline and documentation.

CPSR and PIF are the “brains” of cosmetic safety. GMP, MES, QMS and LIMS are the “muscles” and “nervous system” that put safety decisions into daily operations. You can’t afford to let those diverge.

2) Ingredients, INCI and specifications — knowing what you’re actually using

Everything in CPSR and PIF ultimately depends on the ingredients you use and how well you understand them.

• INCI – International Nomenclature of Cosmetic Ingredients. INCI names provide consistent ingredient identity across suppliers, labels and safety evaluations.
• Raw-material specifications. Each raw material should have a spec that defines identity, purity, active content, impurities and test methods (potentially referencing SDS, regulations, etc.).
• Supplier verification. Supplier verification of COAs and Supplier Quality Management (SQM) make sure that the materials arriving at the plant match the assumptions in the CPSR/PIF.

Any change in INCI composition, supplier, manufacturing process or impurity profile should trigger both a CPSR/PIF review and controlled changes in your formulation and MES/QMS configuration.

3) Microbial control & preservative efficacy

Microbial contamination is one of the most common failure modes in cosmetics. Your glossaries capture the key concepts:

• Microbial control in cosmetics manufacturing. Microbial control in cosmetics manufacturing covers hygienic design, cleaning and disinfection regimes, water-system management, air and surface monitoring, and staff hygiene.
• Preservative efficacy / challenge testing. Preservative efficacy challenge testing (e.g., ISO 11930) evaluates whether your preservation system can control defined challenge organisms over time. The results feed directly into CPSR and your accepted shelf life.

From an operational perspective, the manufacturing system must know which preservative system each recipe uses, which batches have been tested, and whether process deviations (e.g., water phase temperature, mixing time) might compromise preservation performance. This is where V5 MES and QMS link recipe, process data and lab results back into the product safety story.

4) Stability & compatibility studies

Cosmetic products change over time. Cosmetic stability & compatibility studies answer two questions:

• Stability. Does the formulation remain within spec for appearance, odour, pH, viscosity, microbiology, phase separation and active levels over shelf life under real and accelerated conditions?
• Compatibility. Is the formulation compatible with packaging (e.g., no leaching, swelling, softening, discolouration, loss of functional properties)?

Stability and compatibility findings should be encoded into manufacturing instructions (mixing order, shear, temperature limits, cooling profiles, fill temperatures) and into storage and distribution rules. If your MES ignores these constraints, you’re effectively manufacturing a different product than the one you “validated” in stability.

5) Fragrance, IFRA compliance & allergen disclosure

Fragrances bring both regulatory complexity and marketing value. You’ve documented this in multiple entries:

• Bulk fragrance concentrate control. Bulk fragrance concentrate control ensures that fragrance concentrates are handled as high-potency raw materials with controlled dosing, storage and traceability.
• IFRA compliance. IFRA compliance for fragrances ensures that fragrance levels and use contexts adhere to the relevant IFRA standard (Category, maximum concentration, restricted materials).
• Fragrance allergen disclosure. Fragrance allergen disclosure manages the labelling of listed fragrance allergens above threshold levels, per EU/UK and other regulations.

From a system perspective, your MES and label-control processes must know:

• Which formulations contain which fragrance oils and at what levels.
• Which IFRA category each product belongs to and which version of IFRA standards you are applying.
• Which allergens will appear on the INCI/ingredient list and when threshold changes or regulatory updates require label amendments.

This is another area where CPSR/PIF content and manufacturing reality must stay in lockstep if you want to avoid non-conformances and recall risk.

6) Cosmetic claims substantiation & evidence

Marketing often wants to move faster than safety or regulatory teams. Cosmetic claims substantiation is where you draw the line between aspiration and defensible reality.

• Claim types. Broad categories include performance claims (“moisturises for 24 hours”), sensory claims (“lightweight feel”), appearance claims (“reduces the appearance of fine lines”), “free-from” claims and “clean” / “natural” / “vegan” type claims.
• Evidence. Substantiation may be based on consumer use tests, instrumental measurements, clinical evaluations, literature, in vitro tests or ingredient supplier data—depending on risk and jurisdiction.
• Link to formulation and manufacturing. The product you release must match the product you tested: same key ingredients at similar levels, same critical process parameters affecting texture, deposition, film formation, etc.

If claims in the market outpace the CPSR/PIF and lab evidence, or if MES/ERP changes undermine the basis of your claims, you’re exposed. This is why V5 QMS and documentation can be used to link claims, tests and formulation data tightly together.

7) CPSR, PIF & MoCRA as “living files” tied to manufacturing data

Historically, CPSR and PIF lived as PDFs and binders—updated infrequently, often manually. With MoCRA and more aggressive market scrutiny, that’s no longer enough. A modern approach treats CPSR, PIF and MoCRA records as “living files” connected to:

• Formulation master data. Ingredients, INCI names, concentrations and specs, maintained in a central formulation/QMS system, not scattered spreadsheets.
• Manufacturing records. Batch records (eBMR), in-process controls, deviations and rework handling in MES, aligned with GMP expectations (ISO 22716, etc.).
• Lab and stability data. Micro, preservative challenge, stability and compatibility results managed in LIMS and referenced in CPSR/PIF and MoCRA safety substantiation.
• Complaints and adverse events. Linked to batches, markets and product configurations so that safety assessments and formulations can be updated when signals emerge.

V5’s job is not to replace CPSR/PIF documents, but to ensure the data those documents rely on is consistent, current and traceable back to specific batches and lots.

8) How V5 Traceability supports cosmetics product safety & CPSR/PIF reality

V5 Traceability provides the execution and quality backbone that cosmetics safety and regulatory teams need:

• Formulation & recipes in MES. V5 MES implements cosmetic formulations as executable recipes with controlled weighing, mixing, heating/cooling, addition orders and hold times that match CPSR/PIF assumptions.
• Ingredient & INCI control. Ingredients in V5 are tied to INCI identities, specs and suppliers, with lot-level lot traceability and COA checks.
• Micro & stability integration. V5 QMS and LIMS interfaces connect in-process and release testing, preservative challenge data and stability results directly to lot and batch records.
• Fragrance & allergen management. Fragrance concentrates and allergens are treated as controlled ingredients; dosage, IFRA constraints and allergen declarations map into manufacturing instructions and labels.
• Claims & documentation linkage. Claims, test reports and CPSR/PIF references can be linked via V5 QMS to formulations and batches, creating a traceable chain from marketing taglines back to evidence.

In short: V5 ensures your safety and regulatory files reflect what is really happening on the shop floor—and that the shop floor keeps following what the safety files expect.

FAQ — Cosmetics Product Safety, CPSR, PIF & Claims

Q1. What’s the difference between a CPSR and a PIF?
The CPSR is the formal safety assessment for a cosmetic product (toxicology, exposure, margins of safety, impurities). The PIF is the broader product information file required under EU/UK rules, which includes the CPSR plus product description, manufacturing method (GMP), claims evidence and certain testing records.

Q2. How does MoCRA change cosmetics product safety expectations in the US?
The Modernization of Cosmetics Regulation Act (MoCRA) introduces facility registration, product listing, safety substantiation and more detailed adverse-event reporting and record-keeping requirements. While the US historically relied heavily on voluntary programmes and self-regulation, MoCRA pushes manufacturers toward more formal safety documentation akin to CPSR/PIF expectations elsewhere.

Q3. Why are microbial control and preservative efficacy so central to cosmetics safety?
Cosmetics often contain water and nutrients that can support microbial growth. Microbial control in manufacturing reduces contamination risk, and preservative efficacy testing demonstrates that the product’s preservative system can control residual or introduced microorganisms over time. Failures in these areas drive recalls, complaints and safety concerns.

Q4. How do fragrance and IFRA compliance relate to CPSR and labels?
Fragrances contain complex mixtures, some of which have restrictions or allergen labelling requirements. IFRA compliance ensures that fragrance use levels meet safety and regulatory constraints, while fragrance allergen disclosure ensures required allergens appear on product labels when threshold levels are exceeded. This information feeds directly into CPSR risk assessments and PIF content.

Q5. What does “claims substantiation” mean in cosmetics?
Cosmetic claims substantiation means you have appropriate evidence to support what you say about a product—its effects, characteristics or benefits. That might include consumer use studies, clinical or instrumental tests, literature or other documented support. The product sold must be materially the same as the product tested for those claims to remain valid.

Q6. How can manufacturing systems like V5 support CPSR and PIF requirements?
Systems like V5 ensure that the ingredients, processes, tests and deviations recorded on the shop floor match what is described in the CPSR and PIF. They provide traceable batch records, lot-level data, micro and stability results, and controlled changes to formulations and processes. That makes it far easier for safety assessors and regulators to see that the documented safety case is reflected in real operations.

Related Reading (Glossary)
• Core Cosmetics Safety: CPSR | PIF | MoCRA | ISO 22716 Cosmetics GMP | INCI
• Micro, Preservation & Stability: Microbial Control in Cosmetics Manufacturing | Preservative Efficacy / Challenge Testing | Cosmetic Stability & Compatibility Studies
• Fragrance & Allergens: Bulk Fragrance Concentrate Control | IFRA Compliance for Fragrances | Fragrance Allergen Disclosure
• Claims & QMS: Cosmetic Claims Substantiation | Quality Management System (QMS) | Deviation / NC | CAPA
• V5 Platform: Cosmetics Manufacturing Industry Solution | V5 Solution Overview | V5 QMS | V5 MES | V5 Connect API