Selling Cosmetics in the EU

How to Start a Soap Business in the EU: Legal and Safety Requirements

Soap sold to clean the skin is a cosmetic under EU law. This launch roadmap covers GMP, the soap CPSR, INCI labelling quirks, CPNP notification and the Responsible Person for handmade brands.

Handmade soap bars curing on a wooden rack in a small artisan workshop

Soap is where many cosmetic founders begin: the materials are affordable, the craft can be learned at kitchen-table scale, and a well-made bar sells at markets and online alike. Before you start a soap business in the EU, though, one point must be clear: soap sold to clean the skin is a cosmetic under Regulation (EC) No 1223/2009, and the full framework applies — safety assessment, notification, labelling, traceability. There is no exemption for handmade or craft products.

Encouragingly, solid soap is one of the simplest cosmetics to bring into compliance: high pH and low water content make it microbiologically low-risk, so testing is often light and the paperwork manageable for a one-person workshop. This guide sets out the launch roadmap, from business basics and GMP through the soap CPSR and labelling to CPNP notification.

Key takeaways

  • Soap is a cosmetic under Regulation (EC) No 1223/2009 whenever its function is cleaning the skin — no handmade exemption exists.
  • Every formulation needs a CPSR signed by a qualified assessor before it can be sold.
  • High pH and low water activity mean many solid soaps qualify for the challenge-test exemption — the assessor makes that call.
  • GMP under ISO 22716 scales down to a home workshop: documented recipes, batch records and traceability are the core.
  • INCI labelling of saponified oils follows one of two conventions — salt names such as sodium olivate, or oils plus sodium hydroxide.
  • Before the first sale you need an EU Responsible Person and a CPNP notification for each product.

Soap is a cosmetic under EU law — and that shapes everything

Regulation (EC) No 1223/2009 defines a cosmetic as a substance or mixture applied to the external parts of the body with a view to, among other things, cleaning them. Handmade soap for washing hands or body sits squarely inside that definition; only soap marketed purely for household use — laundry bars, dish soap — falls under detergent legislation instead.

That classification triggers the whole framework: safety assessment before sale, a designated Responsible Person, a Product Information File (PIF) kept for ten years after the last batch, CPNP notification per product, and mandatory label particulars. Enforcement authorities do check craft sellers, so none of this can wait until the brand “gets bigger”.

Business basics: registration, insurance and your Responsible Person

Set up the commercial foundations first: register a legal entity or sole tradership in your member state, sort out VAT where applicable, and arrange product liability insurance — not an EU requirement as such, but many marketplaces and retailers ask for proof of cover.

Then comes the role the regulation cares about most: every cosmetic on the EU market must have a Responsible Person (RP) established within the EU. If you manufacture in the EU and sell under your own name, you are the RP by default — guaranteeing compliance, holding the PIF, handling CPNP notifications and cooperating with authorities. Founders outside the EU must appoint an RP by written mandate first. Either way, the RP’s name and address go on every label.

Good Manufacturing Practice in a small soap workshop

Article 8 requires Good Manufacturing Practice, presumed when you follow the harmonised standard ISO 22716 — written for factories, but it scales down sensibly. For a handmade soap workshop the essentials are a dedicated, cleanable making area, calibrated scales, documented master recipes, and a batch record for every make: date, quantities, supplier lot numbers, temperatures, cure dates and batch number.

Traceability must run both ways: from any bar back to the ingredient lots used, and from any lot forward to the batches it entered — that is what makes a targeted recall possible. Add a cleaning log, labelled storage and a quarantine rule, and you have a defensible GMP system.

Warning: Sodium hydroxide is a corrosive, CLP-classified raw material. Store it securely in its original labelled container, wear gloves and eye protection, and always add lye to water — never the reverse. Cured soap is not a lye hazard; the making stage is where the danger lies.

Your launch roadmap at a glance

Soap rewards planning, because its longest step — the cure — can run in parallel with the paperwork. Here is the sequence most handmade soap launches follow.

Step What it involves Typical timing
1. Register the business Legal entity, VAT where applicable, product liability insurance 1–2 weeks
2. Finalise recipes and suppliers Cosmetic-grade ingredients; specifications, allergen and IFRA documentation 2–4 weeks
3. Set up GMP and batch records Adapt ISO 22716 to your workshop; batch-sheet and traceability templates 1–2 weeks
4. Make and cure pilot batches Cold-process cure, pH checks, stability observations 4–8 weeks
5. Commission the soap CPSR Send the final formula and supplier documents to a qualified assessor 2–4 weeks, in parallel with the cure
6. Design compliant labels INCI list, allergens, RP name and address, batch code, nominal weight 1–2 weeks, overlapping
7. Notify on the CPNP Responsible Person submits each product before it goes on sale Days, once documents are ready
8. Launch and maintain the PIF Keep the PIF updated; retain for ten years after the last batch Ongoing

Run steps 5 and 6 while the pilot batches cure, and a realistic zero-to-launch timeline is three to four months — most of it waiting for soap, not consultants.

The soap CPSR: cure time, pH and the challenge-test exemption

The CPSR is the heart of soap compliance. Under Annex I, Part A gathers the safety data — exact formula, physico-chemical and microbiological specifications, packaging and toxicological profiles — and Part B is the assessment itself, signed by an assessor with a qualifying degree in pharmacy, toxicology, medicine or similar. You cannot write your own; commissioning a professional CPSR is a fixed early cost.

Soap is comparatively easy to assess. Its high pH and low water activity create an environment hostile to microbial growth — the reasoning codified in ISO 29621 for microbiologically low-risk products — so many solid soaps are granted the challenge-test exemption, sparing you preservation-efficacy testing. Our deep-dive on handmade soap safety, the CPSR and microbiological testing covers what testing may still apply.

Cold-process makers have one extra duty: saponification continues after moulding, so pH falls during the cure. Your specification should define the cure period (commonly four to six weeks) and the target pH of the finished bar, verified batch by batch — the assessor will expect this, and it doubles as a quality gate.

Note: The challenge-test exemption is the assessor’s decision, made on your specific formula — never self-declared. Fresh botanicals, milks, purées or a move to liquid soap change the risk profile and can bring testing back. Melt-and-pour makers still need their own CPSR for the finished product.

Labelling, INCI names and CPNP notification

Article 19 lists the mandatory particulars: RP name and address, nominal content, durability marking, batch number, function where not obvious, precautions, and the ingredients list headed “Ingredients”. For soap, the interesting part is the ingredients list.

The INCI quirk of saponified oils

Saponification transforms your oils, so the label can follow either of two accepted conventions: name the reaction products — the sodium salts of the fatty acids, such as Sodium Olivate and Sodium Cocoate — alongside Aqua and the Glycerin the reaction creates, or list the starting materials instead: Olea Europaea Fruit Oil, Aqua, Sodium Hydroxide. Both are accepted; pick one convention, apply it consistently across your range, and keep it aligned with your CPSR.

Fragrances, colourants and allergens

Every additive must be cosmetic-grade: colourants must appear in the regulation’s positive list (Annex IV) — craft glitters and candle dyes do not qualify — and fragrances need an IFRA certificate and an allergen declaration. Allergens above the rinse-off threshold must be named on the label, and the declarable list expands substantially from 2026 — check the new fragrance allergen labelling rules before printing labels in bulk.

Notify on the CPNP before the first sale

The final gate is the Cosmetic Products Notification Portal. The RP submits each product — formulation details, label and packaging artwork — before it goes on sale. The portal is free, and one notification covers the whole EU with no further national registrations. Fragrance or colour variants generally count as separate formulations; our CPNP notification service handles the submission end to end.

Bringing it all together

Handmade soap is one of the most achievable first products in cosmetics: the regulation is demanding, but soap’s chemistry works in your favour. Classify it correctly as a cosmetic, build a right-sized GMP system, commission a soap CPSR while your pilot batches cure, write the INCI list in one consistent convention, and notify on the CPNP before the first bar ships. Done in that order, soap compliance becomes routine. For the wider context, our pillar guide on how to legally sell cosmetics in the EU covers the full framework.

If you want the whole stack handled in one engagement, the Low-Risk Compliance Kit was built for exactly this kind of product: it bundles the CPSR, CPNP notification and label review at a price that reflects how straightforward low-risk products like solid soap are to assess. You supply the formula and supplier documents; we return a launch-ready file while your soap cures.

Frequently asked questions

Is handmade soap a cosmetic in the EU?

Yes — any soap sold to clean the skin is a cosmetic under Regulation (EC) No 1223/2009, however small your production. Only soap marketed purely for household use falls under detergent legislation instead.

Do I need a CPSR for every soap I sell?

Yes, every distinct formulation needs its own Cosmetic Product Safety Report signed by a qualified assessor before it goes on sale. Assessors commonly assess a range of similar soaps together, reducing the cost per product.

Does handmade soap need a challenge test or a preservative?

Usually not — the high pH and low water activity of solid soap make it microbiologically low-risk, so most bars need no preservative and qualify for the challenge-test exemption. The decision belongs to your safety assessor, and additions like milks or purées can change it.

Can I sell my soap before the CPNP notification is done?

No — CPNP notification must be completed before the product is placed on the market. The submission is free and quick once your CPSR and label are ready.

How do I list saponified oils in the INCI ingredients list?

Use one of the two accepted conventions: name the sodium salts (Sodium Olivate, Sodium Cocoate) with Aqua and Glycerin, or list the starting oils with Sodium Hydroxide. Apply one convention across your range, consistent with your CPSR.

How long does it take to make a handmade soap brand compliant?

Around three to four months from a standing start — most of it cure time, since the CPSR, label design and CPNP notification all run in parallel with the cure.