For brands operating in the European Union (EU), the Cosmetic Product Safety Report (CPSR) is the linchpin of compliance. It is the mandatory scientific document confirming a product is safe for human health. A common and critical question for manufacturers with product lines—such as scented soaps or multi-shade make-up—is when a single CPSR suffices and when each variation requires a distinct safety assessment. The answer lies not in marketing, but in chemistry.
The Core Principle: The Safety Assessor’s Formula
The EU Cosmetic Regulation (EC) No 1223/2009 mandates that every cosmetic product must have a safety assessment. This assessment is based on the product’s specific qualitative and quantitative composition (Part A of the CPSR). Therefore, the rule of thumb is simple: if the formula changes in a way that impacts the safety or toxicological profile, a new or updated CPSR is required.
The safety assessor is concerned with the base formula and any added ingredients, particularly those with known allergenic or restricted properties.
When One CPSR Covers Multiple Variations
A single CPSR can often cover multiple SKUs (stock-keeping units) if the core safety profile remains constant. This is common in two key scenarios:
1. Variation in Size or Packaging
If a product (e.g., a body lotion) is offered in different sizes (50ml vs. 250ml) or different packaging formats (a jar versus a pump bottle), and the formula and the packaging material remain identical, only one CPSR is needed. Changes in volume or container shape do not alter the ingredient safety assessment, provided the material itself does not introduce new safety concerns (e.g., impurities or migration).
2. Color Cosmetics with a “May Contain” List
For color cosmetics like eyeshadow palettes, blushers, or foundations, a single, comprehensive CPSR is often possible. This applies when:
- The Base Formula is Identical: All shades share the same matrix (emulsifiers, oils, waxes, preservatives, etc.).
- Pigments are Optional: The various colorants are the only difference between the shades and are included in a “May Contain” list on the label. The safety assessor reviews all potential colorants and ensures their combined use, or use at maximum permitted levels, remains safe, covering the entire range under one report.
When a Separate CPSR (or Assessment) is Required
Variations that introduce new chemical components or alter the overall exposure risk must be assessed separately.
1. Changing Scents (Fragrance/Aroma)
This is the most common reason for needing a distinct CPSR. A fragrance, whether synthetic or a natural essential oil blend, is a complex mixture of chemical compounds, many of which are known allergens.
- Impact on Safety: Different scents mean different chemical compositions and allergen profiles. Even if the base soap formula is identical, adding a “Rose” fragrance versus a “Lemon” fragrance introduces entirely different allergens and concentration limits.
- Legal Requirement: Because each distinct scent alters the toxicological and allergenic profile of the final product, each variation (e.g., “Lavender Soap” vs. “Peppermint Soap”) requires its own separate CPSR.
2. Changing Functional Ingredients or Ratios
If a variation involves altering ingredients beyond basic colorants, it constitutes a new product:
- Preservatives or UV Filters: Changing the preservative system or the type/concentration of UV filters requires a new CPSR, as these ingredients are highly regulated and directly impact microbial safety and consumer exposure.
- Active Ingredients: Creating a “Day Cream with Retinol” and a “Day Cream with Vitamin C” from the same base requires two separate CPSRs, as the active ingredients introduce different safety and efficacy assessments.
Conclusion for Responsible Persons
For Responsible Persons launching a product line, the key takeaway is to conduct a risk-based assessment focused on the formula’s change, not the product’s name. Variations in size pose little risk; variations in colorants can often be consolidated; but variations in scent (fragrance) or functional ingredients inherently alter the safety profile and necessitate a distinct CPSR for each unique formula to maintain legal compliance across the EU market.
