Fragrance products are an important part of the cosmetics industry, offering consumers a way to express themselves, enhance personal grooming, and create memorable sensory experiences. While fine fragrance sprays tend to dominate the market, roll-on perfumes and solid perfumes have gained a loyal following due to their portability, targeted application, and unique formats.
From a regulatory perspective, however, these products are not simply “smaller” or “simpler” versions of a spray perfume. Their formulation characteristics, method of application, and packaging all influence how they are assessed under the EU Cosmetics Regulation (EC) No 1223/2009. In particular, they often intersect with ISO 29621 low-microbiological risk criteria, allergen labelling obligations under Regulation (EU) 2023/1545, and the requirements for a thorough Cosmetic Product Safety Report (CPSR) and Product Information File (PIF).
This guide will walk you through exactly what you need to know to launch a roll-on or solid perfume in the EU, from understanding their unique risk profiles to preparing compliant documentation, making correct label declarations, and structuring your workflow to avoid costly delays.
Why Do These Two Formats Require Specific Safety Considerations
Roll-on Perfumes: Direct Skin Contact, High Fragrance Load, Applicator Contamination Risk
Roll-on perfumes are typically packaged in bottles fitted with a rolling ball applicator. This allows for precise application to pulse points such as the wrists, neck, or behind the ears.
From a compliance standpoint, the key safety issue is direct and repeated contact between the applicator and the skin. Each time a consumer applies the perfume, there is a potential for skin microorganisms to transfer onto the ball and into the product reservoir. If the formulation does not have adequate antimicrobial properties or is not classified as low-risk under ISO 29621, this can lead to microbial growth over the product’s shelf life.
Another consideration is fragrance concentration. Roll-ons often contain a high percentage of ethanol or fragrance oils, which can increase dermal exposure to allergens. Since the EU’s allergen labelling thresholds for leave-on products are very low (0.001%), it is common for roll-ons to trigger multiple allergen declarations. Packaging design is also critical. A poorly sealed applicator can allow evaporation of alcohol, leading to reduced preservation efficacy over time.
Solid Perfumes: Wax/Oil Base, Prolonged Skin Contact, Low Water Activity Formulation
Solid perfumes are usually anhydrous formulations composed of waxes (e.g., beeswax, candelilla, and carnauba) and carrier oils (e.g., jojoba, sweet almond, and coconut oil), into which the fragrance is blended. Their very low water activity (aw) typically meets the ISO 29621 criteria for low-microbiological-risk products, making them eligible for preservative challenge test exemptions.
However, this does not mean they are automatically “safer”; solid perfumes are leave-on products with prolonged skin contact. The semi-solid format slows fragrance release, meaning allergens can accumulate on the skin over extended wear. Furthermore, the stability of the wax/oil base can be affected by temperature fluctuations, oxidation of carrier oils, and migration of fragrance molecules to the surface, all of which must be addressed in the safety assessment. Packaging should protect the product from dust, moisture, and heat while allowing easy, hygienic use.
The Legal Baseline: EU Cosmetics Regulation (EC) No. 1223/2009
What Makes Roll-On And Solid Perfumes “Cosmetics”: Scope & Responsibilities
Under Article 2 of the Regulation, a product is a cosmetic if it is intended to be placed in contact with the external parts of the human body for cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odors. Both roll-ons and solid perfumes are perfuming products and therefore subject to the full scope of the regulation.
Key responsibilities include:
- Ensuring the product does not pose a risk to human health under normal or reasonably foreseeable use.
- Designating a Responsible Person (RP) established in the EU to oversee compliance.
- Preparing and maintaining a PIF.
- Completing the CPNP notification before placing the product on the market.
- Complying with ingredient restrictions, labeling rules, and claims regulations.
PIF and the Cosmetic Product Safety Report (CPSR): Part A vs Part B
The Product Information File is the main compliance document that must be kept available to the right people for at least ten years after the last batch of the product is sold. The CPSR is a key part of the PIF:
Part A collects information about the facts, such as the formula, specifications for the raw materials, the manufacturing process, the packaging details, the stability and microbiological test results, and the exposure information.
Part B has the assessor’s expert safety opinion, which is backed up by the information in Part A.
Even if they have a low risk of microbes, both roll-ons and solid perfumes need a CPSR. The assessor must clearly explain why they are not testing for preservative efficacy and make sure that exposure to allergens stays within safe limits.
Role of the Responsible Person and CPNP notification (pre-market)
The RP must let the product know through the Cosmetic Product Notification Portal (CPNP) before it can be sold in the EU. This includes the product category, the formulation, the label artwork, and the product photo. The RP is the person in charge of safety and compliance and must answer any questions from the authorities. When it comes to fragrance products, where allergens and restricted substances are a big deal for regulators, it’s especially important to choose an experienced RP.
Low-Microbiological Risk Products And ISO 29621
Definition Of Low-Risk Cosmetics: Criteria Under ISO 29621
ISO 29621 provides you with how to find products that are not likely to help microbes grow. Roll-ons can qualify if they have a lot of alcohol in them (at least 20%) and are packaged in a way that keeps them clean. Solid perfumes often qualify because they don’t have any water in them and have a low water activity (aw < 0.75).
Other things to think about are
- Very high or low pH (out of the range for microbial growth).
- Formulation with a lot of non-water-based solvents.
- Primary packaging that protects against repeated contamination of the environment.
When Challenge Testing Can Be Exempted
If a product is classified as low-risk under ISO 29621, it may not have to go through preservative efficacy testing (ISO 11930). But this isn’t a hard-and-fast rule; the CPSR must include a strong reason for this, backed up by measurements of water activity, analysis of the formulation, and evaluation of the packaging.
Documentation Requirements For Exemption Under CPSR
The safety assessor must document:
- The scientific rationale for low-risk status.
- Measurement methods and results (e.g., aw meter readings).
- How packaging design supports low microbial risk
This information must be available in the PIF in case of inspection.
Building a CPSR for Roll-on and Solid Perfumes
Part A: Data to Collect
- Full quantitative formula, including fragrance breakdown.
- Supplier documentation for each raw material.
- Allergen calculations are based on fragrance composition.
- Water activity and pH measurements.
- Stability data (temperature, light, packaging interaction).
- Microbial quality data or low-risk justification.
Part B: Safety Assessment Methodology
- Review toxicological profiles for all ingredients.
- Calculate Margin of Safety (MoS) for each relevant substance.
- Evaluate aggregate dermal exposure, especially for allergens.
- Consider foreseeable misuse (e.g., applying the product to broken skin).
Linking Low-Microbial Risk Status to CPSR Conclusions
The assessor should explicitly link the low-risk justification to microbiological safety conclusions while confirming that allergen exposure and chemical safety remain within acceptable limits.
Practical Labelling & Claims Checklist
When it comes to EU compliance, your product label is far more than a design element; it is a legal document that conveys mandatory information to consumers and authorities alike. Every roll-on and solid perfume placed on the EU market must carry all the elements set out in Regulation (EC) No 1223/2009, presented clearly and indelibly on the container and packaging.
INCI and Allergens (Annex III)
The full ingredient list must be presented using INCI (International Nomenclature of Cosmetic Ingredients) names. For fragrance-heavy products like roll-ons and solid perfumes, special attention must be given to allergens. Under the amended Annex III following Regulation (EU) 2023/1545, any allergen present above the threshold concentration (0.001% for leave-on products) must be declared individually in the INCI list, following the official INCI spelling exactly. Failure to declare allergens is one of the most common non-compliance issues flagged during market surveillance.
Batch or Lot Number
Every unit must carry a batch or lot number for traceability purposes. This allows you, the Responsible Person, and authorities to trace and recall a specific production run if necessary. For very small containers, the batch number may appear on the outer packaging if it cannot fit on the immediate container.
Period After Opening (PAO) Symbol
For products with a shelf life longer than 30 months, the PAO symbol (open jar icon followed by the number of months) must indicate how long the product remains safe and effective after first opening. For roll-ons, PAO is particularly relevant since repeated contact between the applicator and skin can increase microbial contamination risk over time.
Warnings
Certain claims and product formats require specific warnings. Alcohol-based roll-ons may need flammability warnings, while certain fragrance ingredients restricted by Annex III may require specific cautionary statements.
Claims Compliance
Marketing claims, whether on the packaging, website, or social media, must comply with the EU Common Criteria for Cosmetic Claims. Phrases like “hypoallergenic” or “preservative-free” must be substantiated with robust evidence. With the expanded allergen list, products previously advertised as “allergen-free” may now be ineligible for that claim.
For example, if a solid perfume contains naturally occurring linalool from essential oils above the threshold, “allergen-free” becomes a misleading claim, even if no synthetic allergens are added. Such claims can not only result in regulatory penalties but also undermine consumer trust.
Multilingual Packaging & E-Commerce Listings
The EU’s single market allows for cross-border sales, which means multilingual packaging is common. However, all mandatory information, from ingredient lists to warnings, must be provided in the official language(s) of the countries where the product is sold.
Equally important is ensuring that your online product listings exactly match your physical packaging. Authorities can and do check e-commerce platforms for compliance. If your website lists a different INCI order or omits allergens compared to the packaging, you risk enforcement action. Consistency between your PIF, packaging, and online content is a must.
Compliance Workflow: From Concept to Market Launch
Achieving EU compliance is not just a final step before launch; it is a structured process that begins during product development.
- Assess microbial risk in the earliest formulation stage using ISO 29621 criteria. If the product is likely to qualify as low-microbial risk, gather the necessary measurements (e.g., water activity) and packaging specifications from the outset.
- Run allergen calculations based on your fragrance composition by Regulation (EU) 2023/1545 to determine if label updates will be necessary.
- Prepare the CPSR in two parts: Part A with all product data and Part B with the safety assessor’s conclusions.
- Compile the PIF with CPSR, manufacturing details, safety data, and proof of compliance with ingredient restrictions.
- Submit the CPNP notification before launch.
- Implement ongoing monitoring for IFRA amendments, SCCS opinions, and EU regulation updates, adjusting your formulas, labels, and documentation as needed.
Approaching compliance as a continuous process, not a one-time event, ensures your roll-on and solid perfumes remain legally marketable and safe throughout their life cycle.
Frequently Asked Questions
Q1. Are roll-on perfumes always considered low-microbiological risk under ISO 29621?
Not automatically. While a high ethanol content (≥20%) can contribute to low microbial risk, factors like packaging design, water activity, and contamination potential from the applicator must also be assessed.
Q2. Do solid perfumes need preservative challenge testing?
Often no, as their anhydrous nature and low water activity mean they do not support microbial growth. However, a safety assessor must document this in the CPSR, supported by measurement data.
Q3. What allergen labeling rules apply to roll-on and solid perfumes?
All allergens listed in Annex III of the Cosmetics Regulation must be declared if present above 0.001% in leave-on products. This includes both naturally occurring allergens from essential oils and synthetic fragrance components.
Q4. How should I calculate allergen concentrations?
Use the allergen breakdown from your fragrance supplier (often provided on the IFRA certificate), calculate the concentration in your final formula, and compare to the regulatory thresholds.
Q5. What happens if I omit allergens from my label?
Omitting required allergens is a regulatory breach and can result in fines, product recalls, and reputational damage. EU authorities routinely check fragrance products for undeclared allergens.
Conclusion
Bringing roll-on and solid perfumes to the EU market requires more than just great scent and packaging it means ensuring your products meet every detail of EU safety and labeling regulations. By addressing microbiological risk, allergen transparency, and thorough documentation from the start, you can launch with confidence.
At Certified Cosmetics, we help brands prepare CPSRs, compile PIFs, and review labels so they meet all EU requirements. Visit our CPSR & PIF services or explore our blog for more compliance insights.
