Shower gels and liquid soaps are among the most widely used cosmetic products, often considered everyday essentials. Because they are rinse-off and water-based, many assume they carry lower regulatory risks compared to leave-on formulations. However, under the EU Cosmetics Regulation (EC) No 1223/2009, there are no exemptions; these products must undergo the full Cosmetic Product Safety Report (CPSR) process. Preservatives, surfactants, and fragrance allergens all require careful safety assessment and documentation to meet compliance standards. In this blog, we’ll walk through the essentials of obtaining a CPSR for shower gels and liquid soaps, highlight common pitfalls, and explain how to prepare the necessary Product Information File (PIF).
Why Rinse-Off Products Don’t Get Exemptions: CPSR Is Mandatory
Because shower gels and liquid soaps are rinse-off products that are only applied to the skin for a brief period of time before being washed off, they are frequently regarded as “low-risk” cosmetics. Due to this perception, many small producers think they are not subject to stringent regulations. However, all cosmetics, whether rinse-off or leave-on, must have a complete Cosmetic Product Safety Report (CPSR) in accordance with EU Cosmetics Regulation (EC) No 1223/2009. Regardless of whether they are water-based or contain preservatives, liquid soaps and shower gels are not exempt.
This makes sense because, despite spending less time on the skin, rinse-off products still contain fragrances, preservatives, surfactants, and allergens that can irritate skin, trigger allergic reactions, or harm the environment. The Regulation’s Article 16 states unequivocally that rinse-off products are subject to all requirements. As a result, manufacturers are required to maintain a Product Information File (PIF), carry out a comprehensive safety assessment, and make sure that claims and labeling are accurate. The first step toward compliance for formulators and brands is acknowledging that shower gels and liquid soaps must pass the same stringent testing as creams and serums.
Key Components in CPSR for Shower Gels and Liquid Soaps
Preservatives: Ensuring Stability Against Microbial Growth
Due to their water-based nature, shower gels and liquid soaps are particularly vulnerable to microbial contamination. As a result, preservatives are necessary and not optional. The selected preservative system must be evaluated by the CPSR, who must show that it successfully inhibits the growth of bacteria, yeast, and mold throughout the product’s shelf life and while it is being used by the consumer. To demonstrate the system’s dependability, preservation efficacy testing, also known as a challenge test, is usually necessary.
Safety assessors must take consumer sensitivity, toxicological profile, and concentration into account because not all preservatives are created equal. Even commonly used preservatives, such as phenoxyethanol or blends of organic acids, need to be justified within the CPSR. Furthermore, since interactions can lessen efficacy, the assessor must determine whether the preservative is compatible with fragrances, surfactants, and other formulation ingredients. Although preservative systems for rinse-off products are typically more lenient than those for leave-on cosmetics, thorough testing and documentation are still necessary.
Surfactants: Balancing Cleanliness and Safety
Surfactants are the backbone of shower gels and liquid soaps. They create the foaming, cleansing action consumers expect, but they also raise safety concerns. Many surfactants are associated with skin dryness or irritation, especially with repeated use. The CPSR must evaluate the surfactant system, including its concentration, irritancy potential, and overall toxicological profile. Surfactants are also assessed for biodegradability, as environmental safety is part of compliance under EU regulation.
Formulators often combine primary surfactants like sodium lauryl ether sulfate (SLES) with milder co-surfactants such as betaines or glucosides to reduce irritation. The CPSR must provide evidence that the chosen blend achieves cleansing performance while minimizing adverse effects. In rinse-off products, the short contact time with the skin does mitigate some risks, but safety assessors still need to calculate a Margin of Safety (MoS) for the surfactant system to ensure consumer protection.
Allergens in Rinse-Off Products: Labeling and Concentration Limits
Many shower gels and liquid soaps have fragrance as a distinguishing feature, but it also introduces allergens that need to be carefully managed. According to EU law, certain fragrance allergens must be disclosed on the ingredient list if their presence exceeds 0.01% in rinse-off products. Often found in citrus or floral fragrances, limonene, linalool, and citronellol are common allergens.
By assessing the fragrance composition and making sure labeling conforms with Annex III of the Regulation, the CPSR must take allergen content into consideration. Cumulative exposure is another factor taken into account by safety assessors, particularly if users use several scented products daily. One common compliance hazard for brands is improperly declaring allergens. In addition to avoiding legal problems, transparent labeling fosters consumer trust with potentially ingredient-sensitive customers.
Compliance Pitfalls to Watch For
Underestimating preservative requirements
A common mistake among manufacturers is assuming that rinse-off products do not need robust preservative systems. While these products are washed off quickly, their high water content makes them prone to microbial growth. Without adequate preservatives, contamination can occur both in storage and during use, as water in the shower provides ideal conditions for microbial proliferation. Safety assessors routinely flag insufficient preservative justification as a compliance issue in CPSRs.
Neglecting surfactant irritancy and biodegradability issues
Another pitfall is overlooking the potential irritancy of surfactants. Even though rinse-off products spend less time on the skin, repeated use can strip the skin’s natural oils and cause dryness or irritation. The CPSR must demonstrate that the surfactant system is both effective and safe. Additionally, environmental compliance requires surfactants to be biodegradable. Failing to address biodegradability data or using outdated references can lead to gaps in the safety report.
Missing updated fragrance allergen labeling requirements
Fragrance allergens are a frequent cause of noncompliance. The EU regularly updates the list of allergens that must be declared on cosmetic labels. Failing to keep ingredient labels current with the latest requirements is a regulatory red flag. For manufacturers, it is not enough to list generic “parfum”; specific allergens must be identified above threshold levels. CPSRs must reflect accurate allergen data, and PIFs must include supporting documentation from fragrance suppliers.
Building a Solid CPSR & PIF for Rinse-Off Products
Structuring the safety report (Part A & Part B)
The product’s safety information is compiled in Part A of the CPSR, and the safety assessor’s findings are presented in Part B. Quantitative formulas, ingredient toxicological profiles, exposure scenario details, and the outcomes of stability and microbiological testing are all required in Part A for shower gels and liquid soaps. Thereafter, Part B must state that the product is safe for consumer use under typical and predictable circumstances, based on the assessor’s professional judgment.
Because consumers frequently use multiple wash products each day, assessors also consider cumulative exposure when evaluating rinse-off items. To ensure that even repeated use is safe, safe exposure levels across various scenarios must be calculated. Manufacturers exhibit professionalism and compliance by properly structuring the CPSR.
Required testing: microbiological, stability, and ingredient toxicology
Testing forms the backbone of the CPSR. Microbiological testing ensures that preservatives keep the product free from contamination. Stability testing verifies that the product maintains its safety, efficacy, and appearance over time and under different storage conditions. Toxicological assessment of each ingredient ensures that concentrations are within safe limits.
For rinse-off products, these tests are not optional. Regulators expect to see documented results included in the PIF. Inadequate or missing test data is one of the most common reasons for non-compliance. Manufacturers who invest in proper testing not only satisfy legal requirements but also gain confidence in the quality and longevity of their products.
Documenting the responsible person, GMP, and product labeling
The Responsible Person, the legal entity in charge of putting the product on the market, must be listed in the PIF along with the CPSR. Additionally, it must include evidence of Good Manufacturing Practices (GMP), which attests to the production’s adherence to accepted standards for quality and hygiene. Another crucial element is labeling, which needs to clearly include ingredient lists, batch codes, shelf life, warnings, and allergen declarations.
Small or new brands frequently undervalue these factors, despite the fact that they are crucial for compliance. Manufacturers demonstrate that their products fulfill the administrative and organizational requirements of EU cosmetics law in addition to safety regulations by meticulously documenting the Responsible Person, GMP, and labeling.
FAQ: Quick Answers for Shower Gel Safety & Compliance
Q1. Are shower gels regarded as safe cosmetics?
Indeed, but “low risk” does not imply exemption. According to EU law, they still need a complete CPSR and PIF.
Q2. Is a preservative required for all shower gels?
Indeed. They need to contain potent preservatives because they are water-based. Challenge testing demonstrates the effectiveness of the preservative.
Q3. Which regulations govern the labeling of liquid soaps for allergens?
Fragrance allergens must be disclosed on the label of rinse-off products if their concentration exceeds 0.01%.
Q4. Which tests are necessary to ensure compliance with CPSR?
Ingredients must undergo stability testing, microbiological testing, and toxicological evaluation.
Q5. Is it possible for a small artisan brand to sell at markets without submitting paperwork?
No. Before putting products on the market, all brands, regardless of size, must have a CPSR, PIF, and compliant labeling.
Conclusion & How Certified Cosmetics Can Help
Shower gels and liquid soaps may seem simple compared to leave-on cosmetics, but they are still subject to the full scope of EU cosmetics regulation. From preservatives and surfactants to allergens and labeling, every component must be assessed and documented in a Cosmetic Product Safety Report (CPSR). There are no exemptions for rinse-off products, and compliance under Article 16 requires rigorous testing, reporting, and record-keeping.
At Certified Cosmetics, we guide brands and manufacturers through every step of this process. Our team provides support with CPSR preparation, microbiological testing and stability testing, cosmetics labeling compliance, and PIF documentation. By partnering with us, you can be confident that your shower gels and liquid soaps meet regulatory standards and inspire consumer trust.
Explore more compliance insights on our blog or our CPSR services.
