Handmade soaps, whether cold process, melt & pour, or crafted from natural botanicals, are admired for their creativity, authenticity, and small-batch appeal. Yet despite their artisanal nature, these products are legally classified as cosmetics in the European Union and must adhere to the same rigorous safety requirements as industrially produced goods. That means every handmade soap, no matter how simple the recipe, requires a Cosmetic Product Safety Report (CPSR) and proper microbiological testing to ensure it is safe for consumers. In this blog, we’ll explore why handmade soaps fall under EU cosmetics law, what safety documentation is required, and how different types of soap bases come with unique compliance considerations.
The Importance of Safety for Small-Batch & Handmade Soaps
Recently, handmade soaps have become incredibly popular, particularly with customers who appreciate eco-friendly, artisanal, and natural personal care products. Although small-batch producers frequently highlight transparency, inventiveness, and craftsmanship, there is occasionally a misconception that “natural” equates to “safe.” In actuality, handmade soaps, whether made with natural botanicals, melt-and-pour bases, or cold processes, are subject to the same regulations as mass-produced cosmetics in the EU. This implies that for them to be sold legally, they must meet the same standards for safety documentation, testing, and compliance.
Because of their high pH, cold process soaps are generally more stable, but safety issues still exist. Soaps containing water-based ingredients such as milk, honey, aloe vera, or botanical infusions may be vulnerable to microbial growth, which could lead to spoiling and endanger consumers. Despite their convenience, melt-and-pour bases frequently contain humectants that hold onto moisture, which can foster the growth of microorganisms in the event that preservatives are not enough. Despite their apparent simplicity, even natural or minimally processed bars may contain plant-based ingredients that, if not handled correctly, can break down over time or cause microbial contamination.
This is why following regulations is crucial to making soap responsibly, especially when it comes to the Cosmetic Product Safety Report (CPSR) and microbiological testing. Through comprehension and implementation of these regulations, artisan producers not only fulfill their legal responsibilities but also enhance their reputation, safeguard their clientele, and establish enduring enterprises that can expand with assurance in the EU market.
Understanding EU Cosmetics Regulation & Article 11 in Soap Context
Definition of Soap as Cosmetic under Regulation EC 1223/2009
Under Regulation (EC) No 1223/2009, soap is legally considered a cosmetic product if it is marketed for cleansing or beautifying the skin. This definition encompasses virtually all cold process, melt & pour, and natural handmade bars intended for personal care. Some small-scale producers mistakenly believe that traditional soap making practices exempt them from regulation, but the law makes no distinction between artisanal and industrial production. If the product is intended for personal use on the skin, it is subject to the same regulatory framework as lotions, shampoos, or creams.
This classification has serious consequences. It requires soap makers to conduct safety assessments, maintain documentation, and comply with labeling requirements. Whether selling at a local market, online, or through retail stores, compliance ensures that consumers receive products that are not only enjoyable but also safe. Recognizing handmade soap as a cosmetic product under EU law is the foundation upon which all further compliance steps are built.
Soap Types & Their Specific Safety Considerations
Cold Process Soaps: High pH and Microbial Resistance; Do They Need Testing?
Many people consider cold process soaps to be the most “traditional” type of soap production. They create bars with naturally high pH levels (usually between 9 and 10) that are less conducive to microbial growth by saponifying oils and sodium hydroxide. Many soap producers think they are exempt from additional testing because of their innate microbial resistance. High-pH soaps are more stable than water-based cosmetics, it is true, but this does not mean that they are immune to microbiological testing or CPSR.
The microbiological risk rises dramatically when cold process soaps contain ingredients like goat’s milk, aloe vera, or honey. These organic ingredients can shorten the soap’s shelf life and reduce its resistance to microbial growth. Therefore, toxicological profiles of all ingredients, a rationale for the pH range, and the outcomes of microbial testing in cases where water-rich ingredients are present should all be included in a CPSR for cold process soaps. Testing offers documentation that supports compliance and proves consumer safety, even in cases where the risk of contamination is low.
Melt & Pour Soaps: Added Ingredients, Water-Based Formulations & Micro Testing
Melt & pour soaps use pre-manufactured bases that often contain glycerin and other humectants, which attract and retain water. This makes them particularly vulnerable to microbial growth, especially when crafters add botanicals, fragrances, or exfoliants. Because melt & pour bases are water-rich, they require preservatives and strict hygiene during production. Without adequate safeguards, these soaps can quickly develop microbial contamination, reducing shelf life and compromising safety.
Microbiological testing is therefore essential for melt-and-pour formulations. Challenge tests, microbial limit tests, and stability studies confirm whether preservatives are effective and whether the soap can withstand real-world use. In the CPSR, safety assessors must justify the chosen preservative system and assess how added ingredients influence microbial stability. For artisans, this means balancing creativity with compliance, ensuring that their products remain both appealing and safe.
Natural/Unrefined Bars: Botanicals, Water Content & Preservative Needs
Consumers who care about the environment are big fans of natural or minimally processed soaps. They have a unique character because they frequently contain unrefined oils, clays, botanicals, or essential oils. These ingredients, though, may present difficulties. For instance, unrefined oils may break down more quickly than refined ones, and botanicals may contain microbiological contamination from their natural habitat. Particularly at risk are soaps that contain fresh plant extracts or water-based infusions.
Microbiological testing is essential for natural bars in order to guarantee that contaminants are kept within acceptable bounds. Stability data must also be included in the CPSR to show that the safety of the product is not jeopardized over time by these natural ingredients. Although regulators demand the same degree of safety assurance as they would for synthetic formulations, consumers value the authenticity of natural soaps. Therefore, artisans have to balance upholding the authenticity of their products with adhering to stringent safety regulations.
Microbiological Testing & CPSR Documentation
When Is a Preservative System Required and How to Test It
Not all handmade soaps require a preservative system. Cold process bars with no water-based additives may not need one, as their high pH provides sufficient microbial resistance. However, any soap that incorporates water, fresh botanicals, or glycerin bases may require preservatives to remain safe. Safety assessors determine this on a case-by-case basis when compiling the CPSR.
Testing verifies whether a preservative system is effective. Challenge tests involve deliberately introducing microbes into a product to see if they are controlled over time, while microbial limit tests examine for contamination in finished batches. For soap makers, these tests provide evidence that their products remain safe across their shelf life and under typical usage conditions. Including results in the PIF strengthens compliance and protects consumers.
Appropriate Tests: Challenge Test, Microbial Limit Test, Stability
The three main categories of testing relevant to handmade soaps are:
- Challenge tests: Evaluate preservative system effectiveness.
- Microbial limit tests: Check finished products for contamination.
- Stability testing: Verifies how the product holds up over time in terms of appearance, odor, pH, and safety.
Each test contributes to a comprehensive safety profile. For cold process soaps, stability testing may focus on long-term pH consistency. For melt & pour or natural bars, microbial testing is particularly important. By combining these tests, artisans can build strong documentation for their CPSR and PIF, proving that their soaps meet EU safety standards.
Compiling Safety Assessment & PIF Documentation for Handmade Soaps
For small-scale producers, gathering documentation is frequently the most difficult step. The PIF arranges all relevant data, such as formulations, labels, and test results, while the CPSR offers the official safety evaluation. Regulatory review of both documents must be possible.
This entails keeping track of supplier details, documenting each batch, and arranging test results for presentation. A well-prepared PIF ensures professionalism and transparency, even though it may seem like an administrative burden. By demonstrating that their products adhere to the law, it also assists soap manufacturers in avoiding expensive disruptions like recalls or fines.
Practical Steps for Artisanal Soap Makers
Partnering with Qualified Safety Assessors for CPSR
One of the most effective ways for small-scale producers to achieve compliance is by working with qualified safety assessors. These professionals compile the CPSR, review formulations, and determine which tests are necessary. For artisans, partnering with experts saves time and ensures accuracy, allowing them to focus on creativity while still meeting regulatory standards.
Record-Keeping: Batch Logs, Supplier Details, Test Results
Good recordkeeping is a vital part of compliance. Soap makers should maintain batch logs documenting production dates, formulations, and any deviations from standard procedures. Supplier details must be recorded to ensure traceability of raw materials, while test results must be stored as part of the PIF. This systematic approach helps with compliance and improves quality control, ensuring consistency across products.
Labeling and Claims: Ensuring Transparency and Compliance
Labels must comply with EU requirements, including ingredient lists, responsible person details, batch numbers, and shelf-life information. Claims such as “natural,” “organic,” or “suitable for sensitive skin” must be substantiated with data in the PIF. Misleading or unsubstantiated claims are prohibited and may result in regulatory action. By focusing on accurate and transparent labeling, artisans build trust with consumers while meeting compliance obligations.
FAQ: Common Questions for CP, Melt & Pour, Natural Soap Producers
Q1. Is microbiological testing always necessary for cold process soaps?
This is not always the case. Their high pH provides natural microbial resistance if no water-based additives are used. Any additional liquids or botanicals, however, raise the requirement for testing.
Q2. For handmade soaps, why is a CPSR necessary?
Because a CPSR is required to demonstrate the safety of all cosmetics sold in the EU, regardless of production scale. This guarantees adherence to Regulation 1223/2009 and consumer protection.
Q3. How do preservatives function in handmade soaps?
In formulations that contain a lot of glycerin or water, preservatives guard against microbial contamination. A safety expert must determine their necessity based on the particular recipe.
Q4. How long is the Product Information File (PIF) required to be kept on file?
To ensure accountability and traceability, the PIF must be kept up to date for ten years following the last batch of a product being put on the market.
Q5. Can I sell soaps at a neighborhood market without a PIF or CPSR?
No. EU law must be followed no matter where or how the soap is sold. Artists run the risk of financial and legal repercussions when they sell without a CPSR and PIF.
Conclusion & How Certified Cosmetics Can Help
Whether they are cold-process, melt-and-pour, or natural bars, handmade soaps are adored for their individuality, inventiveness, and authenticity. The same legal requirements that apply to mass-produced goods also apply to regulated cosmetics. Thus, CPSR and microbiological testing compliance are crucial safety measures for consumer health and brand credibility rather than bureaucratic roadblocks. Craftspeople can confidently market their soaps while safeguarding themselves against legal or reputational risks by adhering to EU Regulation 1223/2009 and recording each step through the PIF.
We at Certified Cosmetics are experts at guiding soap manufacturers through these regulations. Our experience guarantees that your products are both compliant and ready for the market, from creating Cosmetic Product Safety Reports (CPSR) to carrying out microbiological testing and helping you with PIF documentation. Are you curious about the safety and compliance of handmade cosmetics? For more information, check out our blog, or get in touch with us right now to learn how we can help you on your soap-making path.
