A separate CPSR is required whenever a cosmetic product variant changes the formulation in a way that affects its safety profile. Variations in fragrance, active ingredients, preservatives, or UV filters always require a new CPSR, while size changes usually do not.

For cosmetic brands operating in the European Union (EU), the Cosmetic Product Safety Report (CPSR) is the cornerstone of regulatory compliance. Under Regulation (EC) No 1223/2009, every cosmetic product placed on the EU market must be supported by a safety assessment demonstrating that it is safe for human health under normal or reasonably foreseeable conditions.

One of the most frequently asked questions by manufacturers and Responsible Persons is whether product variations—such as different scents, colors, or sizes—require separate CPSRs. The answer is not driven by marketing decisions or SKU numbers, but by changes in the product’s chemical composition and safety profile.

The Fundamental Rule: CPSR Is Formula-Based

A CPSR is prepared based on the qualitative and quantitative composition of a cosmetic product, as documented in Part A of the report. This means that the safety assessment is intrinsically linked to the exact formulation.

As a general principle:
If a variation changes the formulation in a way that may affect toxicology, allergen exposure, or overall consumer safety, a new or updated CPSR is required.

Safety assessors focus on the base formula and any ingredients that are restricted, sensitising, allergenic, or otherwise safety-critical.

When One CPSR Can Cover Multiple Variations

In certain situations, multiple product variants can be covered under a single CPSR, provided the overall safety profile remains unchanged.

Different Sizes or Packaging Formats

If the same cosmetic product is marketed in different sizes (for example, 50 ml and 250 ml) or in different packaging formats (such as a jar versus an airless pump), a single CPSR is generally sufficient.

This is valid as long as:

  • The formulation is identical
  • The packaging material is the same or equivalent
  • There is no new safety concern related to packaging interaction, such as substance migration or contamination risk

Changes in volume or container shape alone do not affect the toxicological assessment of the ingredients.

Colour Variations Using a “May Contain” Approach

For colour cosmetics such as foundations, eyeshadows, blushers, or lip products, one CPSR may cover multiple shades when specific conditions are met.

This is possible when:

  • All shades share the same base formulation (emollients, emulsifiers, preservatives, etc.)
  • The only variation is the pigment or colourant composition
  • All potential colourants are included in a “May Contain” (±) list on the label
  • The safety assessor evaluates all listed colourants at their maximum permitted concentrations

In this scenario, the CPSR assesses the worst-case exposure and can therefore justify safety for the entire shade range.

When a Separate CPSR Is Required

If a product variation introduces new substances or significantly alters exposure or toxicological risk, it must be assessed separately.

Different Scents or Fragrances

Changing the fragrance is the most common reason for requiring separate CPSRs.

Fragrances—whether synthetic perfumes or natural essential oil blends—are complex mixtures of chemical substances, many of which are known allergens or subject to concentration limits.

Each fragrance has:

  • A unique chemical composition
  • A different allergen profile
  • Different safety and labelling implications

As a result, even if the base formulation is identical, a product with a different scent represents a different safety profile. For example, a lavender soap and a citrus soap cannot share the same CPSR solely because their fragrance compositions differ.

Each scented variant therefore requires its own CPSR.

Changes to Functional or Active Ingredients

Any variation that affects functional ingredients automatically triggers the need for a new CPSR.

Examples include:

  • Changing the preservative system or preservative concentration
  • Using different UV filters or adjusting SPF-related ingredients
  • Adding or replacing active ingredients such as retinol, vitamin C, acids, or botanical extracts

These ingredients are often strictly regulated and have a direct impact on consumer exposure and risk assessment. Even small changes can significantly alter the toxicological evaluation.

Practical Takeaway for Responsible Persons

When managing a cosmetic product range, Responsible Persons should always assess variations from a safety and formulation perspective rather than a branding or marketing perspective.

In summary:

  • Different sizes do not require separate CPSRs
  • Colour variations can often be grouped under one CPSR if handled correctly
  • Different scents almost always require separate CPSRs
  • Any change to functional or active ingredients requires a new assessment

A risk-based, formula-focused approach is essential to ensure ongoing compliance with EU cosmetic legislation and to avoid regulatory issues during market surveillance or inspections.

This article is prepared by a qualified Cosmetic Safety Assessor with hands-on experience in CPSR preparation and EU cosmetic compliance under Regulation (EC) No 1223/2009.

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