It takes much more than just eye-catching hues, smooth textures, or creative packaging to introduce foundations and makeup to the European Union market. Every successful product is the result of a meticulously planned safety evaluation procedure intended to safeguard customers and ensure adherence to stringent EU laws. One of the most delicate cosmetic product categories is foundations, powders, lipsticks, and other pigmented leave-ons. They are applied directly to the face, remain on the skin for long periods of time, and often contain complex pigment blends that require careful toxicological analysis. The EU demands a careful approach to their safety because of this.
The Cosmetic Product Safety Report (CPSR), a legally mandated document that assesses whether a cosmetic product is safe under typical and reasonably foreseeable conditions of use, is at the center of this compliance pathway. Although all cosmetics must adhere to the CPSR, foundations and makeup present particular risks because of pigment limitations, heavy metal contaminants, and dermal exposure margins. The regulatory framework, particularly CPSR requirements, colorant regulations, and labeling obligations, will all be covered in this article. Referencing Certified Cosmetics’ own guidelines, we will also address the frequently perplexing question of whether each shade variation requires a separate CPSR. By the end, brands will know how to protect consumer trust and market access by aligning product development with Regulation (EC) No 1223/2009.
Why Foundations and Make-Up Require Stricter Assessments
Leave-On Formulations vs. Rinse-Off Products
Makeup and foundations are classified as leave-on products, which means that they stay on the skin for extended periods of time, typically eight to twelve hours per day, in contrast to shampoos and shower gels, which are rinsed off in a matter of minutes. The product’s safety profile is drastically changed by this extended exposure period. Long-term direct skin contact raises the risk of irritation, allergic reactions, and systemic absorption. Because of the much higher cumulative exposure over time, even ingredients that are deemed safe at specific concentrations in rinse-off products may need stricter limits in leave-on formulations. In order to demonstrate that the margin of safety is still acceptable, safety assessors must compute systemic exposure doses using the default values for facial application areas that the SCCS provides.
Consumer behavior is another crucial factor. In contrast to hair or body lotions, foundations are applied consistently to the same parts of the face every day, sometimes several times during the day. Although exposure estimates are rather simple due to this consistent and recurring use pattern, it also highlights the significance of conservative safety margins. The risk could become serious if contaminants or questionable ingredients were permitted to build up over years of use, even at extremely low concentrations. Because of this, every foundation and makeup product that is put on the market must undergo a thorough dermal exposure analysis.
The Role of Pigments and Impurities
At the core of makeup innovation are pigments, which enable companies to provide a variety of shades to satisfy the demands of customers around the world. Nonetheless, from a regulatory standpoint, pigments rank among the most hazardous categories of raw materials used in cosmetics. Only colorants listed in Annex IV are allowed for cosmetic use under Regulation (EC) No 1223/2009, and each pigment must fulfill strict purity requirements. This implies that not all pigments on the international market are appropriate for use in EU products, and that some shades that are widely sold in other countries might be restricted or outright forbidden in Europe. Therefore, when evaluating a foundation formula, a safety assessor must confirm that each pigment is approved for leave-on use and that its specifications align with those mandated by the regulation.
Unavoidable contaminants, especially heavy metals like lead, arsenic, cadmium, and mercury, can also be present in pigments. Although these substances are never purposefully added by manufacturers, they may show up as trace contaminants in synthetic or mined pigments. The EU mandates that businesses reduce impurities to “as low as technically achievable,” but it does not have set maximum limits for any of the heavy metals. This calls for batch-to-batch monitoring, supplier certificates of analysis, and laboratory testing. Foundations, which are worn every day and cover a lot of the face’s surface, need to show particularly stringent control over these contaminants. If authorities find unsafe levels, brands that don’t take this precaution run the risk of product recalls or harm to their reputation. Certified Cosmetics frequently assists customers by setting up authorized heavy metal testing and making sure all paperwork is prepared for the CPSR.
Application to Sensitive Facial Areas
The fact that foundation and makeup are meant to be applied to delicate body parts adds another layer of difficulty to safety evaluations. The face is more permeable because areas like the lips and eyelids have thinner skin. While some makeup products, such as concealers or highlighters, may be applied even closer to mucous membranes, foundation is frequently applied all the way up to the orbital area and around the mouth. The stakes are raised by this proximity: chemicals that might not be harmful on the forearm might act differently on more sensitive skin, causing irritation or sensitization.
Additionally, customers frequently layer several products on top of one another, including blush, concealer, primer, foundation, and setting powder. In addition to assessing cumulative dermal exposure from a single product, safety assessors also need to consider realistic consumer behavior. Therefore, a properly prepared CPSR looks at actual exposure scenarios and determines the margins of safety in accordance with them, rather than evaluating a foundation in a vacuum. This all-encompassing strategy guarantees that consumers’ daily activities, whether they involve applying a lot or little makeup, remain compliant with EU regulations.
Understanding the Regulatory Framework
Regulation (EC) No 1223/2009 at a Glance
Regulation (EC) No 1223/2009, which establishes a uniform set of regulations for all 27 EU member states, governs the European cosmetics industry. The EU imposes strict requirements on producers, importers, and distributors, in contrast to certain markets where cosmetics are not subject to strict regulations. Without a safety evaluation recorded in a CPSR and assembled in a Product Information File (PIF), no cosmetic may be marketed in the EU.
This rule goes beyond the general requirements for makeup and foundations. Only authorized Annex IV colorants may be used as pigments; formulations must be tested for dermal absorption levels, and safety assessors must verify that no prohibited substances are present. This implies that careful documentation is still necessary to ensure compliance, even for products that appear to have minor differences, like a new shade of foundation.
The Role of the Responsible Person (RP)
A Responsible Person (RP) is required to represent each cosmetic product sold in the EU. This could be an importer, a designated entity, or the EU manufacturer. In terms of safety, labeling, and notification via the Cosmetic Products Notification Portal (CPNP), the RP is ultimately legally responsible for making sure the product conforms with all regulations.
Selecting a qualified RP is essential for brands with locations outside of the EU. The RP serves as the main point of contact for regulatory bodies in addition to ensuring compliance. The RP is supposed to provide the complete PIF in a matter of hours if a foundation or make-up line is discovered during inspections. The EU’s stance that consumer protection comes first and accountability needs to be transparent is further supported by this centralized responsibility.
CPSR Requirements for Foundations and Make-Up
Part A: Product Safety Information
The CPSR is divided into two main sections. Part A compiles product safety information, which includes:
- Quantitative and qualitative composition: A full ingredient list with concentrations. For foundations, this often includes emulsifiers, humectants, preservatives, and complex pigment blends.
- Physical and chemical properties: Stability data, solubility, and interactions.
- Microbiological quality: Demonstration that the product resists microbial contamination during shelf life and use.
- Impurities, traces, and information about the packaging: For pigmented products, heavy metals such as lead, cadmium, arsenic, and mercury must be quantified and confirmed to fall within safe limits.
- Normal and reasonably foreseeable use: Expected frequency, amount applied, and potential exposure routes.
This section requires laboratory testing and detailed data collection. For make-up, dermal exposure calculations are critical since the products remain on the skin for extended hours. Safety assessors use default values provided by SCCS (Scientific Committee on Consumer Safety) for surface area exposure to confirm that the margin of safety remains acceptable.
Part B: Safety Assessment & Conclusion
Only qualified safety assessors, usually toxicologists or pharmacists with established credentials, write Part B of the CPSR. After reviewing dermal exposure levels, analyzing toxicological profiles of ingredients, and interpreting the raw data from Part A, the assessor renders a professional judgment regarding the safety of the product.
This involves determining whether heavy metal impurities are adequately controlled, whether repeated exposure from daily use is safe, and whether the concentration of specific pigments in pigmented foundations could present sensitization risks. The legal foundation of the product’s market authorization is this expert opinion, which the assessor has signed. The product cannot be lawfully sold in the EU without a Part B that complies.
Special Considerations for Pigmented Leave-On Products
Colorant Restrictions
The distinctive feature of makeup and foundations is their heavy reliance on pigments to produce a variety of shades. Only colorants specified in Annex IV of Regulation 1223/2009 may be used in accordance with EU law. In Europe, certain colorants that are widely used in other markets are strictly forbidden. Furthermore, because of increased exposure risks, some pigments that are approved for rinse-off products might not be allowed for leave-on applications like foundations.
Therefore, a company creating a foundation line needs to compare each pigment to Annex IV. When shade ranges grow into dozens of variations, this process can get complicated. Recalls or market entry restrictions may result from even trace amounts of non-compliant pigments. In client consultations, Certified Cosmetics highlights this point by helping brands choose approved pigments and recording compliance for every formulation.
Heavy Metal Impurities
The possible presence of heavy metals in pigmented cosmetics is one of the most urgent problems. Although lead, cadmium, and arsenic are not intentionally added by manufacturers, they can naturally be found in pigments that are mined. The EU mandates that heavy metal levels stay as low as is technically possible, but it does not formally set maximum limits for any of them.
Laboratory analysis verifying impurity control within safe thresholds is expected by safety assessors. The product will be taken off the market if authorities find levels that are unsafe. For this reason, a lot of brands regularly test raw pigments in batches to ensure consistency and demonstrate compliance. Foundations require particularly stringent impurity testing because they are applied to large facial areas daily.
Dermal Exposure & Risk Margins
Foundations and makeup stay on the skin for many hours, in contrast to rinse-off products that are quickly removed. Dermal exposure is greatly increased by this. To make sure that even cumulative, long-term use does not present health risks, safety assessors compute systemic exposure doses and margins of safety.
For instance, if iron oxides are present in a foundation as pigments, the assessor will consider both the potential for systemic absorption over years of use as well as the effects on the skin locally. The core of EU safety assessments is this risk-based methodology, which guarantees that consumer health is safeguarded even in situations with maximum exposure.
Labelling Obligations
INCI and Allergen Disclosure
According to EU law, a complete ingredient list using the International Nomenclature of Cosmetic Ingredients (INCI) must be displayed on all cosmetic products. When it comes to makeup, this entails disclosing pigments, preservatives, and fragrance allergies as appropriate. A “best before” date for goods with a shelf life of less than 30 months or a PAO (Period After Opening) symbol for items with a longer shelf life are examples of how products must demonstrate durability.
Allergens are especially significant. If fragrance allergen levels surpass the regulatory thresholds, even trace amounts must be reported. This calls for thorough investigation and precise labeling for foundations that contain fragrance in order to prevent deceiving customers.
The “May Contain:” Statement
Particularly for foundations and makeup with broad shade ranges, the “may contain” statement is pertinent. Manufacturers can list all potential pigments and use the “±” symbol or the phrase “May contain” to indicate that some shades include certain pigments while others do not, rather than printing separate ingredient lists for each variation.
This labeling method gives consumers transparency while streamlining packaging. It cannot, however, be used to mask non-compliance. After “May contain,” only pigments allowed in Annex IV may be seen. The same idea is emphasized in the labeling article on roll-on and solid perfumes from Certified Cosmetics: honesty and clarity in labeling safeguard the brand and the customer.
Cross-Product CPSR Considerations
Do You Need Separate CPSRs for Each Shade or Size?
Whether each shade variation needs its own CPSR is a question that makeup brands frequently ask. The degree to which the differences impact safety will determine the response. A safety assessor may determine that one CPSR can cover the whole range if different shades use the same base formulation with only slight variations in pigment, as long as impurities and safety data apply equally.
Separate CPSRs might be required, though, if concentrations differ greatly or if new pigments raise additional toxicological issues. In its article, “Do I need a separate CPSR for each scent, color, or size?” Certified Cosmetics discusses this subtlety and offers helpful guidance for brands navigating these murky waters.
Cutting corners is not an option, but preparing multiple CPSRs can be expensive. In the end, short-term savings are outweighed by consumer safety and regulatory compliance.
Advanced Topics: Nanomaterials & SCCS Guidance
Nanomaterial Use in Foundations
Nanomaterials present both opportunities and regulatory challenges. They can improve texture, coverage, and stability, but the EU applies heightened scrutiny. Any ingredient present in nanomaterial form must be explicitly notified in the CPNP, and “(nano)” must be included on the label. Safety assessors must evaluate unique toxicological profiles since nanomaterials may penetrate the skin differently.
Staying Updated with SCCS Guidance Notes
Safety assessors rely on Notes of Guidance published by the SCCS on a regular basis. These documents offer updated safety opinions, testing recommendations, and default exposure values. Because SCCS updates can change the acceptability of specific pigments or nanomaterials, brands need to be aware of these changes. By ensuring that clients’ CPSRs adhere to the most recent guidelines, Certified Cosmetics helps to prevent compliance lapses that might result in product withdrawal.
Post-Market Responsibilities
Cosmetovigilance and Adverse Event Reporting
Once a foundation is on store shelves, compliance doesn’t stop. Constant cosmetovigilance is mandated by EU law. The Responsible Person is responsible for keeping an eye out for negative reactions, looking into any significant negative effects, and reporting them to the appropriate authorities.
Every time new information affecting safety is discovered, such as through reformulation, supplier changes, or the emergence of toxicological issues, the PIF needs to be updated. Careful updates are essential for foundations and makeup, as the shades and pigment sources may alter over time. In order to guarantee that compliance is a continuous obligation rather than a one-time task, Certified Cosmetics helps brands maintain living documentation.
Frequently Asked Questions
Q1: Does each shade of foundation require its own CPSR?
Not all the time. One CPSR might be adequate if the base formulation stays the same and only pigment variations take place. Separate CPSRs are necessary, though, if pigments raise new toxicological issues. For more information on this topic, read the article from Certified Cosmetics.
Q2: What does the phrase “May contain:” on a cosmetic label mean?
Without printing separate lists for each SKU, it enables manufacturers to list possible pigments across shade ranges, offering transparency. Only if every pigment on the list is allowed by Annex IV is it valid.
Q3: Do EU foundations have to undergo heavy metal testing?
Indeed. Pigment impurities must be kept to “as low as technically achievable,” but intentional additions are prohibited. The CPSR anticipates laboratory analysis.
Q4: Can my makeup product contain nanomaterials?
Yes, but only after being specifically informed and marked as “(nano).” According to SCCS guidelines, a thorough safety assessment is necessary.
Q5: How long is the Product Information File (PIF) required to be kept on file?
After the final batch of the product is put on the EU market, the Responsible Person is required to keep the PIF for ten years.
Conclusion & How Certified Cosmetics Can Help
Safety evaluation for makeup and foundations is essential to consumer confidence and commercial success; it is not merely a legal requirement. Every detail counts, from label transparency and dermal exposure evaluations to pigment limitations and heavy metal testing. Only safe, compliant products are guaranteed to reach consumers by the EU’s stringent framework under Regulation (EC) No 1223/2009, but even seasoned brands may find it difficult to navigate this complexity.
Certified Cosmetics specializes in helping businesses navigate this procedure. Our professionals create customized CPSRs, carry out microbiological and heavy metal testing, assist with labeling compliance, and put together comprehensive PIFs. Our services guarantee that your products not only satisfy legal requirements but also stand out for their dependability and safety, whether you’re launching a single foundation or a full line of makeup.
Discover more about our Certified Cosmetics Blog and how our CPSR Services can help your brand succeed in the EU market.
