EU Cosmetics Documentation: What You Need and How to Get It

Getting your EU cosmetics documentation right is the single biggest factor in how quickly you reach compliance. The bottleneck is not the regulation itself — it is the documentation. Sellers know they need a CPSR and a CPNP notification, but when they start the process they discover that neither can be completed without a stack of supporting documents that they may never have heard of, let alone collected.

This guide covers every document required for EU cosmetics compliance, explains what each one is, why it matters, and where to source it. If you are preparing to sell cosmetics in the EU through Amazon, Shopify, or any other channel, this is your documentation roadmap.

The Full Quantitative and Qualitative Formula

This is the starting point for everything. Your product formula must list every ingredient with its exact percentage, totalling 100%. Each ingredient should be identified by both its trade name (the name your supplier uses) and its INCI name (the standardised International Nomenclature of Cosmetic Ingredients name used in EU cosmetics regulation).

The formula is needed for the CPSR — the safety assessor must know exactly what is in the product and in what concentrations to assess its safety. It is also needed for the CPNP notification, where either the exact formulation or a frame formulation must be submitted.

If you manufacture your own products, you should already have this. If you use a contract manufacturer or white-label supplier, request the full quantitative formula in writing. Some suppliers are reluctant to share exact percentages due to commercial confidentiality — but without them, a CPSR cannot be produced. This is non-negotiable under the regulation.

Safety Data Sheets (SDS)

A Safety Data Sheet — sometimes still referred to as an MSDS (Material Safety Data Sheet) — is a standardised document providing information about the hazards, handling, storage, and toxicological properties of a chemical substance or mixture. You need an SDS for every raw material in your product formulation.

The SDS is essential for the CPSR because it provides the toxicological data that the safety assessor uses to evaluate each ingredient's safety profile. Without SDS documents, the assessor cannot determine whether an ingredient poses a risk at the concentration used in your product.

SDS documents must come from your actual ingredient suppliers. A generic SDS downloaded from the internet for a similar ingredient from a different supplier is not sufficient — the composition, purity, and specifications may differ. When you purchase raw materials, request the SDS at the point of purchase. Most reputable suppliers provide them as standard.

If your supplier cannot or will not provide SDS documents, that is a red flag. Ingredient suppliers operating within the EU are legally required to provide SDS under REACH regulation. For suppliers outside the EU, you may need to request the documents specifically and follow up firmly.

Certificates of Analysis (CoA)

A Certificate of Analysis is a laboratory document confirming that a specific batch of a raw material meets its stated specifications. It typically includes identity testing, purity, heavy metal content, microbiological testing, and other parameters relevant to that ingredient.

CoAs serve as batch-level quality verification. While the SDS tells you about the substance in general terms, the CoA tells you about the specific batch you are using. The safety assessor reviews CoAs to confirm that the actual ingredients going into your product match their expected specifications.

CoAs should be requested from your ingredient suppliers for each batch of raw material you purchase. If you use a contract manufacturer, ask them for the CoAs for every ingredient in your formulation — they should have these on file from their own incoming goods checks if they are operating under GMP.

IFRA Certificate

If your product contains fragrance — whether a fragrance oil, essential oil blend, or parfum compound — you need an IFRA certificate from the fragrance supplier. IFRA stands for the International Fragrance Association, and the certificate confirms that the fragrance complies with IFRA standards for the product category in which it will be used.

Critically, the IFRA certificate also provides the allergen breakdown — a list of all allergenic substances present in the fragrance compound and their concentrations. This information is essential for two reasons. First, the safety assessor needs it for the CPSR to evaluate allergen exposure. Second, EU labelling law requires that 26 specific allergens must be individually declared on the product ingredient list when present above certain concentration thresholds (0.001% in leave-on products, 0.01% in rinse-off products).

Without an IFRA certificate, the safety assessor cannot complete the allergen section of the CPSR, and you cannot produce a compliant ingredient list for your label. Request the IFRA certificate from your fragrance supplier at the time of purchase. If they cannot provide one, consider changing supplier — a fragrance supplied without IFRA compliance certification is a compliance risk.

Stability Test Data

Stability testing demonstrates that your product remains safe and effective over its intended shelf life. Testing typically involves storing the product under various conditions — ambient temperature, elevated temperature (accelerated ageing), and sometimes freeze-thaw cycles — and testing periodically for changes in appearance, odour, pH, viscosity, and microbiological quality.

The CPSR must reference stability data because the safety assessor needs to confirm that the product does not degrade in a way that affects safety during its stated shelf life. If your product has a 24-month shelf life, you need stability data demonstrating the product remains within specification over that period (or accelerated data extrapolating to that period).

Stability testing is conducted by testing laboratories. If you are a small brand, your contract manufacturer may offer stability testing as part of their service. Otherwise, independent cosmetics testing laboratories in the UK can conduct stability programmes — budget £150 to £500 depending on the testing regime and duration. Stability testing takes time by definition; real-time testing for a 24-month shelf life takes 24 months, though accelerated testing at elevated temperatures can provide indicative data in 3 to 6 months.

Preservative Efficacy Testing (Challenge Test)

Any cosmetic product containing water must undergo preservative efficacy testing, commonly called a challenge test or PET (Preservative Efficacy Test). This test deliberately inoculates the product with specific microorganisms — typically bacteria, yeasts, and moulds — and measures whether the preservative system in the product kills them or prevents their growth over a defined period.

The standard method is ISO 11930, which specifies the test organisms, inoculation levels, and pass/fail criteria. Products must demonstrate adequate microbial reduction at defined time points (typically 7, 14, and 28 days) to pass.

If your product is anhydrous — an oil, a balm, a wax-based product with no water content — a challenge test is not required. But any product containing water, including emulsions, lotions, creams, gels, shampoos, and conditioners, must have one. The safety assessor cannot sign off the CPSR for a water-containing product without challenge test data confirming the preservative system works.

Budget £200 to £400 for a challenge test through a UK laboratory. Results typically take 4 to 6 weeks due to the incubation periods required.

Microbial Limits Testing

Separate from the challenge test, microbial limits testing checks the finished product for the presence of harmful microorganisms. While the challenge test confirms that the preservative system works in principle, microbial limits testing confirms that a specific batch of finished product is free from contamination.

The test checks for total aerobic mesophilic count, yeasts and moulds, and specific pathogens including Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Candida albicans. Results are compared against limits specified in ISO 17516.

This testing is typically conducted by the manufacturer as part of batch release under GMP. If you manufacture yourself, arrange testing through a laboratory for each production batch.

GMP Certificate or Statement

EU Cosmetics Regulation requires that cosmetic products are manufactured in accordance with Good Manufacturing Practice as set out in ISO 22716. You need to demonstrate GMP compliance through either a formal ISO 22716 certificate issued by an accredited certification body, or a signed GMP statement from the manufacturer confirming that production processes comply with the standard.

Large contract manufacturers typically hold ISO 22716 certification and can provide a copy of their certificate. Smaller manufacturers or home-based makers may not have formal certification but should be able to provide a GMP compliance statement detailing how their processes meet the standard's requirements for personnel, premises, equipment, raw materials, production, and quality control.

Product Photography and Label Artwork

The CPNP notification requires a clear photograph of the finished product and an image of the product label. The label image should show all mandatory information including the EU Responsible Person details, ingredient list, durability marking, batch number placement, and any precautions.

If your label artwork is not yet finalised, Eldris can review draft artwork as part of the packaging compliance guidance included in the service, ensuring your label meets all EU requirements before you go to print.

Conditional Documents

Depending on your product, you may also need SPF test data (for products making sun protection claims), claim substantiation data (for specific efficacy claims like "reduces wrinkles"), nanomaterial specifications (for products containing nanomaterials, which require notification 6 months before market placement), and CMR substance declarations if your product contains any substances classified as Carcinogenic, Mutagenic, or Reprotoxic.

Getting Your Documentation in Order

The most efficient approach is to collect all documentation before starting the CPSR process. Every missing document delays the safety assessment, and gaps discovered mid-process can add weeks to your timeline.

Eldris Cosmetics uses a guided document collection process that identifies exactly what you need for your specific product type and tracks what has been received, what is under review, and what is still outstanding. This front-loads the documentation work so that once the CPSR begins, it can proceed without interruption through to CPNP submission.

For a complete checklist tailored to your product type, see the documents required page, or get started with the full compliance service.