Safety is not only a regulatory checkpoint but also a fundamental component of consumer trust when it comes to eye-area cosmetics, such as mascaras and eyebrow products. Being one of the most delicate parts of the body, the eyes are especially susceptible to chemical reactions, irritation, and microbial contamination. Every cosmetic product that is put on the EU market must have a Cosmetic Product Safety Report (CPSR) in accordance with EU Regulation (EC) No 1223/2009. However, the standards are much more stringent for products used in the eye area. These formulations are subject to stricter safety requirements than the majority of other cosmetic types because they fall under Microbiological Risk Category 1. This blog will discuss the reasons behind the need for extra caution in the CPSR for mascara and eyebrow products, the actions that brands must take, and how the most recent SCCS guidance helps businesses release safe and compliant products.
The Rising Demand for Mascara and Eyebrow Products in the EU Market
Cosmetics for the eyebrows and mascara are staples of beauty regimens. Millions of customers throughout Europe use these products daily, ranging from brow gels and pencils to volumizing mascaras. Eye makeup is one of the best-performing categories in the EU cosmetics market, which is still expanding steadily.
Demand entails accountability. The stakes for consumer safety are raised by the frequent and personal use of these products. Whereas eyebrow products are applied near the skin’s surface and occasionally on broken or sensitive areas, mascaras are applied directly to eyelashes, frequently several times a day, in contrast to body lotions or perfumes. The risk of microbial growth or ingredient sensitivity is increased by this frequent contact. In order to ensure thorough microbiological, toxicological, and packaging assessments, regulators require that businesses preparing a CPSR for these products go above and beyond standard assessments.
Understanding CPSR Requirements for Eye-Area Products
The CPSR, which is required by EU law, is the scientific evidence that a cosmetic product is safe for human health when used normally and in a way that is reasonably foreseeable. It is separated into two main sections:
A comprehensive record of the product’s composition, raw materials, impurities, stability, compatibility with packaging, and microbiological quality is found in Part A: Safety Information for Cosmetic Products.
Part B: Safety Assessment of Cosmetic Products: A scientific analysis conducted by a certified safety assessor that includes toxicological profiles, Margin of Safety (MoS) computation, and a final conclusion verifying product safety.
Both sections need to consider the specific application risks associated with mascaras and eyebrow products. Cosmetics for the eye area must undergo more thorough testing due to their proximity to mucous membranes. Similar to the argument made in Certified Cosmetics’ blog post regarding whether or not every product variation requires a different CPSR, minor formulation adjustments, like changing a pigment or preservative, may necessitate a new CPSR.
Why Eye-Area Cosmetics Fall Into Microbiological Category 1
Depending on the application and user, the EU classifies cosmetics into microbiological categories. Cosmetics for the eye area inherently fall under Category 1, which also includes products for mucous membranes, products applied around the eyes, and products for infants under three. The increased sensitivity and risk connected to these areas are reflected in this classification.
The microbiological quality standards for cosmetics are established by ISO 17516. The restrictions are severe for Category 1 products:
≤ 100 CFU/g or mL of total aerobic mesophilic microorganisms.
Molds and yeasts: ≤ 10 CFU/g or mL
Pseudomonas aeruginosa, Candida albicans, and Staphylococcus aureus are completely absent.
There’s a good reason for these requirements. For instance, when mascara applicators are repeatedly dipped into the same tube, bacteria from the skin or eyelashes can re-enter the formula. Contamination is unavoidable in the absence of strong preservation and packaging design. In a similar vein, microorganisms may be absorbed by eyebrow gels, pomades, or pencils and then returned to the product. Data demonstrating the product’s ability to withstand microbial contamination over the course of its shelf life and Period After Opening (PAO) must thus be included in the CPSR.
Key Areas of Focus in a CPSR for Mascara and Eyebrow Products
Microbial Preservation and Challenge Testing
Although EU law strictly regulates the use of preservatives, they are crucial in preventing microbial contamination. Use of preservatives is restricted to those specified in Annex V of the EU Regulation. Manufacturers are required to perform preservative efficacy testing (PET), also referred to as a challenge test, in order to prove efficacy. In this test, known microorganisms are purposefully added to the product, and the effectiveness of the preservative system in getting rid of them over time is tracked. Strong challenge test results are essential for mascaras and eyebrow products, where contamination risk is especially high.
Applicator Hygiene
Just as crucial as the formula itself is the applicators’ cleanliness. Microbes can be carried by a mascara wand or brow spoolie, compromising the product in between applications. A CPSR must consider this risk by integrating preservative efficacy with packaging design (e.g., airtight closures). To reduce health risks, safety assessors frequently suggest consumer advice like unambiguous PAO labeling (such as “6M” or “12M”). Single-use applicators might be necessary in certain situations, particularly in formal settings like salons.
Ingredient Risk Assessment
Each component in the recipe needs to go through a thorough toxicological analysis. Assessors focus especially on the following when evaluating eye-area products:
Impurities like heavy metals must be kept within safe bounds, and only pigments approved in Annex IV may be used.
Common ingredients in mascaras, waxes and film-formers must not irritate eyes or trigger allergic reactions.
Preservatives: In addition to their antimicrobial properties, preservatives need to be assessed for possible irritation or sensitization.
Each substance’s Margin of Safety (MoS) must be determined by the safety assessor, who must also show that cumulative exposure stays well below thresholds of toxicological concern.
Step-by-Step Guide to Preparing a CPSR for Eye-Area Cosmetics
1) Review the formulation (Annex checks, impurities, allergens)
For each raw material, start by freezing the intended formula and creating a comprehensive ingredient dossier that includes the INCI name, function, purity specifications, residual solvents/moners, heavy-metal limits (particularly important for pigments), allergen profile, and whether any of the components are nanomaterials. Examine each material in relation to the annexes of the EU Cosmetics Regulation: Annex II (prohibited), Annex III (restricted), Annex IV (colorants), Annex V (preservatives), and Annex VI (UV filters). Colorant compliance and impurity limits are important for mascaras and eyebrow products; trace metal levels should be as low as is practically possible. Ensure that allergen disclosure complies with the Regulation, and confirm that the overall fragrance concentration is suitable for use in the eye area if any fragrance is included (which is uncommon in eye products but possible in brow items). Each ingredient’s maximum foreseeable concentration should be noted, and worst-case scenarios (such as “waterproof” versus regular formulas) should be specified, as these will inform exposure and safety calculations in the future.
2) Conduct microbiological testing (ISO limits, challenge/PET, in-use)
Since eye-area products fall under Microbiological Category 1, your test plan needs to show that they are highly resistant to contamination both during the shelf life and the Period After Opening (PAO). Run a preservative efficacy test (challenge test, e.g., ISO 11930) using the standard panel (usually S. aureus, P. aeruginosa, C. albicans, E. coli, and a mold like A. brasiliensis) with timepoints (e.g., 7/14/28 days) and predetermined acceptance criteria in addition to routine total count and specified-pathogen absence testing to the Category 1 limits. Add an “in-use” simulation, specifically for mascaras: dip the applicator repeatedly to simulate consumer use, then observe whether contamination builds up and whether the preservative “reserve” is still effective. Verify that the actual water activity still justifies the selected test scope even if the formula is low-water or anhydrous (such as some brow pomades). Reformulation (adjusting the preservative system, chelators, pH, and humectant level) or packaging modifications should be the result of any PET failure.
3) Evaluate packaging and applicators (compatibility, hygiene, migration)
Pack design has a significant impact on the microbiological robustness of eye-area products. To lessen air infiltration and applicator “backwash,” consider the wiper design, neck geometry, and closure torque for mascara. Examine how spoolies or brushes work with the bulk of brow gels or pomades and whether single-use or easily cleaned applicators are practical for professional settings. Use accelerated/real-time stability and run pack–formula compatibility to identify variations in viscosity, color, odor, pH, or the availability of preservatives. Conduct risk assessments for extractables and leachables (such as plasticizers, monomers, and printing inks) as appropriate, and confirm that possible migrants stay within safe bounds. Add labeling components like PAO, batch coding, and any ophthalmologist-tested evidence if you intend to back up such claims, along with drop/transport and seal-integrity checks for consumer safety. List all of the CPSR and PIF’s hygiene-by-design justifications.
4) Compile Part A (complete, decision-grade technical file)
A safety assessor must be able to replicate your logic in Part A. Allergen and impurity statements; raw material specifications and CoAs; microbiological quality data (Category 1 routine testing + PET/in-use results); stability reports (accelerated and real-time, including preservative stability across shelf life); packaging composition and compatibility outcomes; manufacturing GMP references; and reasonably foreseeable use and exposure scenarios (frequency, quantity per application, number of coats, typical user groups) are all included. Provide the necessary characterization and advance notice if any ingredient is a nanomaterial or has unique limitations. Clarity is the aim; an assessor shouldn’t have to make educated guesses or fill in blanks.
5) Prepare Part B (toxicological assessment, exposure, MoS)
By combining NOAEL/DNEL data, SED estimations (based on realistic and worst-case use, such as two to three mascara coats per eye daily), and cumulative exposure from multiple products, where applicable, a qualified safety assessor assesses the toxicological profile of each ingredient and the final product. Focus on local tolerance (eye irritation/corrosion potential, sensitization) and any phototoxicity issues if colorants or film formers may interact with light when used in the eye area. When conventional data is scarce, use SCCS-aligned methods (such as NAMs, TTC/iTTC, and NGRA) and clearly document your reasoning. Finish with a concise safety statement, usage guidelines (such as PAO), cautions like “do not share applicators,” and any labeling requirements resulting from allergies or limitations.
6) Assign shelf life, PAO, and consumer instructions (usability & risk control)
Convert your stability and in-use results into PAO and realistic shelf life (unopened) values. Reduce PAO or modify the design if in-use testing reveals preservative depletion or increasing counts following repeated dips. Give specific user instructions that reduce real-world risks, such as not sharing wands, tightly closing the cap, replacing after an eye infection, taking out contact lenses before using them if necessary, and stopping use if irritation develops. The assessor’s risk-management narrative and consumer safety are both supported by these guidelines.
7) Account for variations and change control (when a new CPSR is needed)
Determine which variations result in a new CPSR and which are covered by the same safety assessment. Generally speaking:
- If exposure and pigment identity/purity don’t significantly alter the risk profile, shade-only changes might stay under the same CPSR.
- A new or updated Part B, and frequently a new CPSR, is usually required for waterproof vs. regular preservative-system changes, packaging/applicator changes (new wiper, different closure), or significant percentage changes in key functional ingredients.
- Site/process modifications that may impact micro quality or stability necessitate partial reassessment and re-verification under GMP.
To make future edits auditable and the assessor’s thresholds clear, include a basic change-control matrix in the PIF.
8) Final pre-market checks (readiness review & PIF completeness)
Verify that your Product Information File (PIF) is complete and that all label information mandated by EU law aligns with the CPSR findings prior to notification and launch. This contains the PAO symbol, batch coding, INCI list, and any cautions or usage guidelines that may be required. The product shouldn’t be put on the EU market until these inspections are finished.
The Role of SCCS Notes of Guidance (12th Revision)
For safety assessors, the SCCS Notes of Guidance, 12th Revision, is an essential resource. They provide updated methods for assessing ingredients used in cosmetics, such as
- New Approach Methodologies (NAMs) that use computational models and in vitro testing in place of animal testing
- When data is scarce, the Threshold of Toxicological Concern (TTC and iTTC) is used to estimate safe exposure levels.
- Frameworks for Next Generation Risk Assessment (NGRA) for comprehensive safety assessments
These approaches guarantee more accurate safety evaluations for mascara and eyebrow products while complying with EU pledges to minimize animal testing. Incorporating SCCS guidelines into a CPSR enhances consumer trust in product safety while also proving compliance.
Frequently Asked Questions
Q1. Does each shade of mascara require its own CPSR?
Not always. The same CPSR might be applicable if the pigment only changes, and it has already been evaluated for safety. However, a new CPSR is needed if the formulation, applicator, or preservative system changes.
Q2. Which microbiological limits apply to eyebrow and mascara products?
These products must have ≤ 100 CFU/g of bacteria, ≤ 10 CFU/g of yeasts and molds, and be completely free of the designated pathogens to be classified as Category 1 cosmetics.
Q3. How can I make sure the applicator is clean?
This is achieved through the combination of consumer labeling (such as PAO symbols), efficient preservatives, and airtight packaging. Single-use applicators are advised in professional settings.
Q4. A CPSR can be prepared by whom?
Under EU law, the report can only be prepared and signed by a qualified safety assessor, usually a specialist in toxicology, microbiology, or a related field.
Q5. What function does the SCCS guidance serve?
The guidelines and procedures for assessing ingredient safety are described in the SCCS Notes of Guidance. In accordance with EU standards, they support assessors in applying consistent, scientifically sound evaluations.
Conclusion
Preparing a CPSR for mascara and eyebrow products requires a deeper level of scrutiny than most other cosmetics. With their classification under Category 1 microbiological risk, these products face strict safety limits to protect consumers from infection and irritation. Brands must prove preservative efficacy, assess applicator hygiene, evaluate ingredient safety, and apply SCCS methodologies in their assessments.
At Certified Cosmetics, we specialize in guiding brands through this process. Our experts prepare detailed CPSRs, conduct microbiological and stability testing, and provide regulatory support to ensure your eye-area products meet the highest EU standards. With our help, you can confidently launch mascaras and eyebrow products that are not only compliant but also trusted by consumers.
Explore our full range of CPSR services or browse more insights on our blog to learn how we can support your compliance journey.
