Cosmetics and personal care products are generally governed by the Cosmetics Regulation (EC) No 1223/2009, not the General Product Safety Regulation (EU) 2023/988 (GPSR), when they meet the legal definition of a cosmetic product. GPSR can still matter for borderline products, accessories, or situations where a product is not a cosmetic under EU law.
The key is classification: if a product is intended to be placed in contact with external parts of the human body or the teeth and oral mucosa mainly to clean, perfume, change appearance, protect, keep in good condition, or correct body odors, it typically falls under the EU cosmetics framework. If it claims to disinfect, treat, or prevent disease, different rules may apply.
The questions below break down which EU rules apply, how to classify products correctly, and what compliance steps usually follow.
Are cosmetics covered by the GPSR or the EU Cosmetics Regulation?
Cosmetics are primarily regulated under the Cosmetics Regulation (EC) No 1223/2009, which sets specific safety, labeling, and responsible party obligations for cosmetic products placed on the EU market. The GPSR is a horizontal safety law for consumer products and generally does not replace sector-specific rules like the EU cosmetics framework.
In practice, EU law uses a sector-specific, first approach: when a product qualifies as a cosmetic, the Cosmetics Regulation drives the core compliance requirements. That said, GPSR can still become relevant in a few common scenarios:
- Borderline products that do not clearly meet the cosmetic definition, or where claims push the product into another legal category
- Non-cosmetic items sold alongside cosmetics, such as certain beauty accessories, tools, or promotional items that are consumer products but not cosmetic substances or mixtures
- General safety expectations for consumer products where no more specific EU safety legislation applies to that item
For non-EU brands selling direct to EU consumers, the practical takeaway is simple: classify the product correctly first, then apply the right rule set. Misclassification is one of the fastest ways to trigger marketplace blocks or market surveillance questions.
What EU compliance requirements apply to cosmetics and personal care products?
EU cosmetics compliance is built around the Cosmetics Regulation (EC) No 1223/2009 and focuses on product safety substantiation, controlled ingredients, and clear consumer information. Typical requirements include a designated EU-based responsible entity for cosmetics, a safety assessment, a Product Information File, and compliant labeling, including ingredient listing and warnings where required.
While the detailed obligations depend on the exact product type and presentation, most cosmetic and personal care product compliance programs include the following building blocks:
- Product safety assessment performed by a qualified safety assessor, resulting in a Cosmetic Product Safety Report
- Product Information File maintained and kept available for authorities, typically including formulation, manufacturing method, safety data, and substantiation for claims
- Ingredient and substance controls aligned with annex restrictions, prohibited substances, and conditions of use
- Good Manufacturing Practice expectations, commonly aligned with ISO 22716 for cosmetics manufacturing
- Labeling and claims compliance, including INCI ingredient list, nominal content, durability or period after opening, precautions, batch or reference, and function when not obvious
- Notification through the EU cosmetics notification portal before placing the product on the market
For personal care products that are not cosmetics, such as certain disinfecting products or products with medical claims, the compliance route can shift to other EU frameworks. That is why the product claims, intended use, and presentation matter as much as the formula.
How do you tell if a product is a cosmetic, a biocide, or something else?
You can tell whether a product is a cosmetic, a biocide, or another regulated product by checking its intended purpose, claims, mode of action, and how consumers will use it. Cosmetics focus on cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odors, while biocides are intended to control harmful organisms through a biocidal action.
A practical way to classify is to review the product from the outside in, starting with what the consumer sees and expects, then confirming the technical reality behind it.
- Cosmetic indicators: claims like moisturizes, softens, deodorizes, perfumes, cleanses skin, improves appearance, or helps maintain skin in good condition
- Biocide indicators: claims like disinfects, kills bacteria, virucidal, sanitizes surfaces, antimicrobial protection with an intent to control harmful organisms
- Medical or therapeutic indicators: claims like treats eczema, heals acne, prevents disease, relieves symptoms, or other medical promises that can trigger medical device or medicinal product considerations
Borderline examples are common in 2026, especially for hand gels, acne products, anti-dandruff products, and products marketed with strong antimicrobial language. Even if a formula looks similar to a cosmetic, the claims and intended purpose can move it into a different legal category.
If you sell through online marketplaces, classification also affects what documentation platforms may request. A product described as disinfecting can attract scrutiny that a purely cosmetic positioning would not, even when the packaging and listing differ only by a few words.
How EARP helps with EU compliance for cosmetics and personal care products
We help non-EU manufacturers and sellers stay compliant by clarifying whether a product falls under the EU cosmetics regulation framework or the GPSR, then putting the right EU-based economic operator role in place for market access. We also support documentation readiness and authority-facing processes aligned with the Market Surveillance Regulation (EU) 2019/1020 (MSR), including the Responsible Person EU role as required for many non-EU supply chains.
- Product scope and classification support to reduce the risk of applying the wrong EU rule set
- EU Responsible Person services where required, structured as an economic operator function for marketplace and authority expectations
- Documentation checks and controlled storage so required safety and compliance materials are present, complete, and retrievable when requested
- Authority liaison processes to help manage requests efficiently and keep communication clear and consistent
- Risk communication under MSR by notifying risks to the manufacturer when identified, supporting timely corrective action
To confirm which rules apply to your specific cosmetics or personal care products and set up the right compliance path, review our EU compliance services and then reach out through our contact form to get started.
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