A large proportion of people suffer from sensitive or atopic skin, and there is increasing demand for mild, skin-friendly products. In addition to comfort and hydration, people want to be sure that the products they use do not cause allergic reactions, redness or irritation. Products for sensitive skin are therefore viewed with extra scrutiny in the cosmetics industry.
This presents manufacturers with both opportunities and responsibilities. The difficulty lies in creating formulas that comply with strict EU cosmetics regulations while truly supporting the skin barrier. When it comes to sensitive skin, there is no room for error, so every ingredient, claim and test is more important than ever.
Sensitive and atopic skin in cosmetics
Sensitive skin, a general term used by consumers, is often characterized by redness, prickling or burning in response to certain substances, environmental factors or even basic care routines. It is a valid and growing niche market, even though it is not considered a medical condition. Cosmetics for sensitive skin are therefore expected to have soothing properties, reduce irritants and remove unnecessary allergens. On the other hand, atopic skin refers to skin prone to atopic dermatitis, a chronic inflammatory condition. In this case, it is super important to distinguish between medical and cosmetic care.
Cosmetics can help in the daily care of atopic skin by protecting the skin barrier and keeping the skin hydrated, but it cannot treat or cure atopic dermatitis itself. That boundary separates a conforming cosmetic product from a medicinal product under EU law. The importance of this distinction cannot be overemphasized. Products designed for customers with atopic skin should still be cosmetic in nature and supported by honest and open communication, even if they are looking for ways to care for their dry skin, itching or discomfort. In addition to ensuring regulatory compliance, this ensures credibility and trust with a particularly sensitive segment of the customer base.
Market relevance and growing demand
According to industry data, more than 50% of new products in specific skin care categories are aimed at caring for sensitive skin. Packaging often includes claims such as “hypoallergenic,” “fragrance-free” and “suitable for sensitive skin,” indicating how competitive the market has become. The need for customized solutions is further supported by the increasing incidence of atopic skin, which is partly attributed to urban lifestyles and the rising incidence of allergies.
This trend is driven by both consumers and regulations. Because vulnerable groups are more likely to be misled, authorities are closely monitoring claims in this area. Brands risk having their products withdrawn from the market, being fined and having their reputations damaged if they cannot substantiate their claims or if they confuse cosmetics and medicines.
The EU’s regulatory framework: where CPSR fits in
Every cosmetic product placed on the EU market must be supported by a Cosmetic Product Safety Report (CPSR) in accordance with Regulation (EC) No. 1223/2009. The CPSR is not a formality, but is the backbone of compliance and consumer protection.
- Part A: Cosmetic Product Safety Information contains the complete qualitative and quantitative composition, specifications of raw materials, impurities and traces, microbiological quality, packaging compatibility and toxicological profiles of each ingredient.
- Part B: Cosmetic Product Safety Assessment is prepared by a qualified safety assessor. This evaluates safety data, calculates safety margins (MoS) and concludes under what circumstances the product can be considered safe.
For high-risk categories, such as sensitive and atopic skin, reviewers are expected to make more conservative assumptions. That means lower allergen exposure thresholds, more stringent microbiological testing requirements, and more thorough scrutiny of preservatives and fragrances. The CPSR will become the evidence base not only for regulatory agencies, but also for substantiating marketing claims.
Claims for sensitive and atopic skin
Hypoallergenic: promise versus reality
Although “hypoallergenic” is a strong marketing term, it also has legal implications. Although not officially defined in the EU, it suggests that the product is made to reduce the likelihood of allergic reactions. To support this, brands must offer the following:
Evidence that high-risk allergens have been reduced or eliminated. That there are few side effects, as shown by clinical or dermatological tests. That the scientific data and claims are true. It is important to remember that “hypoallergenic” is not the same as “allergy-free. Brands should communicate carefully to avoid misleading customers. Dermatologically tested The term “dermatologically tested” is also commonly used. This should be supported by appropriate research, such as patch tests or Human Repeat Insult Patch Tests(HRIPT), performed on the finished product under dermatological supervision. The product information file (PIF) should include the procedures and findings of the study. Without supporting documentation, the claim is nonconforming. Staying on the cosmetic side When cosmetics enter the field of medicine, the most common compliance errors occur. Products with claims such as “treat eczema,” “cure dermatitis” or “prevent flare-ups” are considered medicinal. ‘Helps maintain hydration,’ ‘supports the skin barrier’ or ‘suitable for atopic skin’ are acceptable alternatives. These claims should be substantiated, but should be within aesthetic limits. CPSR considerations for high-risk formulations Ingredients to watch out for Formulations that are sensitive to or prone to atopic reactions should be given extra consideration:
Allergens in fragrances: the European Union requires the labeling of allergens in fragrances that exceed 0.001% in leave-ons and 0.01% in rinse-offs. The list of allergens was expanded by the 2023 regulatory update, meaning more compounds must now be listed.
Preservatives: Although consumers prefer products with few or no preservatives, microbiological safety must not be compromised. Challenge testing is imperative.
Irritants and penetration enhancers: In high-risk products, avoid using aggressive surfactants, strong acids or penetration enhancers, as these can destabilize the barrier.
Safety assessments and safety margins
Safety assessors may use lower thresholds for these groups to account for weakened skin barriers. Higher absorption rates and cumulative exposure to different products are taken into account when calculating safety margins (MoS). Children and other special groups require even more stringent assessments.
Microbiological quality and packaging
Packaging is essential when minimizing preservative content. Unit dosages, pumps and airless dispensers can reduce the risk of contamination. To maintain microbiological quality, CPSRs should describe how formulation and packaging are matched.
Formulation for sensitive and atopic skin
Choice of surfactants
Cleansers are the foundation of any skin care regime, but they can also be one of the main causes of irritation in people with sensitive or atopic skin. While conventional sulfate-based surfactants are effective in removing oil and dirt, they also deplete essential proteins and lipids, weakening the barrier. This loss of protection can cause redness, dryness and chronic discomfort in already fragile skin.
Formulators are increasingly using nonionic and amphoteric surfactants to reduce these risks. By cleansing without unnecessarily altering the natural lipid matrix, these milder substitutes keep skin hydrated and stronger. They produce cleansers that balance tolerance and effectiveness when combined with conditioning agents and active ingredients that support the barrier. The result is a strategic formulation approach that considers the physiology of sensitive skin, rather than just “gentle cleansing.”
In addition, surfactants in this category are often tailored to creamy, low-foaming textures. While these textures may not be as noticeable as foaming detergents, they provide a sense of comfort and softness, qualities that consumers with sensitive skin expect.
Balance between emollients, humectants and occlusives
For sensitive and atopic skin, moisturizers must provide more than just a temporary sense of calm. They must moisturize throughout the day, improve barrier function and restore comfort. To achieve this, emollients, humectants and occlusives must be carefully balanced, as each has a complementary function.
Emollients improve tactile softness, fill micro-cracks and smooth the skin’s surface. Water is drawn into the stratum corneum by humectants such as glycerin and hyaluronic acid, which plump the skin and reduce the feeling of tightness. Shea butter and petrolatum are examples of occlusive agents that form a barrier that retains moisture and protects against external irritants. When these three ingredients are well balanced, the product actively strengthens the skin’s defenses and provides hydration.
This balance is especially important for skin prone to atopic reactions. According to scientific research, one of the main characteristics of atopic dermatitis is impaired barrier function. A moisturizer containing these three ingredients can help with daily care by reducing dryness and maintaining resistance to environmental factors, even though cosmetics cannot cure the condition.
Trends in ‘free from’ and minimalism
In addition to the science behind the formulation, consumer psychology is also an important factor. Many people with sensitive or atopic skin naturally avoid products with long ingredient lists, believing them to be dangerous. Therefore, statements such as “free of,” for example, “fragrance-free,” “alcohol-free” or “dye-free” have become important indicators of safety.
Regulatory agencies warn that “free of” in itself is not an indication of tolerance, but the emotional comfort it provides cannot be ignored. For similar reasons, minimalist formulas, containing only essential ingredients, are becoming increasingly popular. They not only satisfy consumers’ growing need for “cleaner” and simpler beauty products, but also reduce the potential causes of irritation.
Brands face two challenges. First, they must ensure that product stability and shelf life are not compromised by minimalism. Second, they must openly explain these decisions and link them to the scientific rationale. When done effectively in a competitive market, this combination of clear communication and simplified wording creates strong customer confidence.
Replacing claims with evidence
Dermatological patch testing and HRIPT
Patch tests are often the first step in demonstrating tolerance, and cosmetic claims in the EU must be supported by reliable scientific data. In a dermatological patch test, volunteers’ skin is covered with small amounts of the product while looking for symptoms of irritation, redness or itching. The findings provide crucial confirmation that the product is unlikely to cause side effects under normal conditions of use. Human Repeat Insult Patch Tests (HRIPT), in which participants are repeatedly exposed to the product over a period of time, offer a more thorough evaluation by identifying possible sensitization that becomes apparent only after cumulative use.
In combination, these techniques provide both immediate and long-term information about a product’s safety profile. HRIPT results are especially important for high-risk categories such as products for sensitive and atopic skin because they show that the formula is well tolerated even after repeated exposure. In addition to promoting regulatory compliance, adding such studies to the Product Information File (PIF) gives brands solid evidence to support their claims if they are challenged.
Prick tests and instrumental assessments
Customers with sensitive skin often report subjective sensations such as burning or stinging, in addition to obvious irritation. In prickling tests, products are applied under carefully controlled conditions to volunteers with self-reported sensitive skin to specifically record these reactions. The results provide a clear perspective that patch tests may not be able to provide, allowing brands to back up statements such as “suitable for sensitive skin” with actual, consumer-relevant data.
Instrumental evaluations provide an impartial degree of legitimacy. The physiological performance of a product can be demonstrated by measurements of erythema index, transepidermal water loss (TEWL), hydration levels and skin barrier repair rates. For example, a moisturizer can legitimately claim to support barrier function if it significantly reduces TEWL. Brands can avoid the risk of marketing language being rejected as unsubstantiated by integrating subjective, clinical and instrumental evidence to provide a solid scientific basis for claims about sensitive skin.
Labeling and consumer communication
Transparent and compliant labeling is not only required by law but also a way to inspire confidence. Current allergen labeling regulations require INCI lists to be accurate and up-to-date. Allergens exceeding thresholds must be listed separately.
The wording on packaging and promotional materials is also critical. Consumer confidence is damaged and compliance is compromised when medical results are over-promised or implied. Instead, brands should prioritize truthfulness, clarity and scientific validation.
Frequently asked questions (FAQ)
V1. Can atopic dermatitis be treated with cosmetics?
No. Atopic dermatitis cannot be prevented, treated or cured with cosmetics. Cosmetics can only be advertised as suitable for skin prone to atopic acne.
V2. What is meant by “hypoallergenic”?
It means there is less chance of allergic reactions. To use it, you must show that you have chosen ingredients carefully and that there are few reactions.
V3. How can I prove that something is “dermatologically tested”?
The results of dermatologist-controlled patch or HRIPT studies are included in the PIF.
V4. Is a separate CPSR required for each product variant?
Yes. Any change in formula (fragrance, color, active ingredients) requires a different CPSR.
V5. What are the rules for listing allergens on labels?
Above the thresholds of 0.01% for rinse-off products and 0.001% for non-rinse-off products, fragrance allergens must be listed. The list of allergens that must be listed was expanded in the 2023 update.
V6. Are products for sensitive skin necessarily safer?
Not always. The same CPSR procedure must still be followed, and consumer monitoring, formulation design and evidence determine safety.
V7. Which tests support the claim that the product is “suitable for sensitive skin”?
Support can be obtained from consumer perception tests, TEWL measurements, excitation tests and dermatological tolerance studies.
Conclusion
Extra care must be taken when creating cosmetics for atopic or sensitive skin. These products must inspire confidence, provide comfort and maintain the skin’s barrier function without straying too far from the pharmaceutical world. Honest communication, careful ingredient selection and safety considerations are the first steps to finding that balance.
For DIYers, this means choosing mild, skin-friendly base ingredients, using high-quality oils and butters, and carefully testing your creations. Giving people confidence in the products they use every day is the goal of a well-made product for sensitive skin, not just a soothing texture. YouWish offers the cosmetic ingredients and advice you need to create safe and gentle formulas. With our selection of nourishing natural oils and fragrance-free base ingredients, you can let your creativity run wild while making high-quality products. Browse our collection now and create skin care products that truly care for your skin.
