To sell a New Zealand or Australian skincare product in the European Union, you need three things in place before the first unit ships: an EU-based Responsible Person, a Cosmetic Product Safety Report signed by a qualified safety assessor, and a CPNP notification. Great Britain requires the same structure, but with a UK Responsible Person and an SCPN notification instead.
That is the whole answer in one paragraph. The detail underneath it is where most indie founders lose six months — so here is what each piece actually means, in the order you will meet it.
What does the EU actually require before your product can be sold?
EU cosmetics are governed by Regulation (EC) No 1223/2009, which has applied across all member states since 11 July 2013. It is a pre-market compliance regime, not a registration or approval one. Nobody grants you a licence. Instead, the law makes a named legal entity accountable for your product, and requires that entity to hold a complete evidence file before the product goes on sale.
In practice you need:
- A Responsible Person (RP) — a legal person or company established in one of the 27 EU member states.
- A Product Information File (PIF) — held at the RP's address and kept accessible for 10 years after the last batch is placed on the market.
- A Cosmetic Product Safety Report (CPSR) — Parts A and B, which sit inside the PIF.
- A CPNP notification — submitted through the EU's Cosmetic Product Notification Portal before the product is made available.
- GMP-compliant manufacturing — evidenced by a description of the manufacturing method in the PIF.
One CPNP notification covers all 27 member states. There is no further national-level notification once you have done it.
Who can be your EU Responsible Person if you're based in NZ or Australia?
Not you — at least not your NZ or Australian entity. The RP must be established inside the EU. If you have no EU company, you appoint someone: an EU distributor, an importer, a consultancy that offers RP services, or an agent. Whoever it is, the arrangement must be covered by a written mandate between you and them.
This is the decision most founders get wrong by making it too casually. Your RP is legally accountable to the authorities, holds your PIF, and is the contact point if anything goes wrong. If you appoint your distributor as RP and the relationship ends, your market access can end with it — and you may find your notification and your file sitting with someone who is no longer your partner. Many brands prefer an independent RP service precisely so the compliance asset stays theirs.
What goes into a CPSR, and who is allowed to sign it?
The CPSR has two parts. Part A is the safety information: the full quantitative formula, physicochemical and microbiological specifications, stability data, impurity and packaging-material information, exposure estimates, and the toxicological profile of every ingredient. Part B is the assessment itself — a reasoned conclusion on whether the product is safe for its intended use, plus any warnings needed on the label.
Part B cannot be signed by anyone. Article 10 requires a person holding a university-level qualification in pharmacy, toxicology, medicine or a similar discipline, or a qualification recognised as equivalent by an EU member state. If your assessor's degree is from outside the EU, it must be formally recognised by a member state body.
The practical implication for an indie brand: you cannot self-assess, and your assessor will only be as fast as your data is complete. Missing stability data, an unverified preservative system, or an ingredient with no supplier documentation will stop a CPSR dead. This is why we build the evidence base during formulation rather than retrofitting it — see our guides to cosmetic stability testing and preservative efficacy testing.
How is the UK different from the EU after Brexit?
Great Britain now runs a parallel regime. You need a UK-based Responsible Person and you notify through the UK's Submit Cosmetic Product Notification (SCPN) portal, under Schedule 34 of SI 2019/696. A CPNP notification does not cover Great Britain, and an SCPN notification does not cover the EU.
Northern Ireland is the exception that catches people out: it remains aligned with EU rules, so products placed on the NI market follow Regulation 1223/2009 and CPNP — while NI-based Responsible Persons also notify the GB regulator via SCPN.
The good news is that the technical dossier is largely shared. Your CPSR, PIF and GMP evidence do most of the work for both markets. What you duplicate is the RP appointment and the notification, not the science.
What is changing on fragrance allergen labelling in 2026?
Commission Regulation (EU) 2023/1545, published on 26 July 2023, significantly expanded the list of fragrance allergens that must be individually declared on the label — adding 56 new substances to the existing list.
Two dates matter:
- 31 July 2026 — products newly placed on the EU market must comply.
- 31 July 2028 — products already on the market must be brought into compliance.
If you are formulating a fragranced product for Europe right now, this is a live constraint, not a future one. It can force both a label redesign and, occasionally, a reformulation. It is also one of the reasons fragrance-free development has become a genuine export advantage rather than just a marketing position.
How does your NZ and Australian compliance work carry over?
More than you might expect, but not automatically. Your AICIS ingredient checks, your NZ Cosmetic Products Group Standard work, your stability and challenge test data and your GMP documentation all feed directly into the EU PIF. What does not carry over is the assessment itself, the RP appointment, the notification, and the labelling format — EU labels have their own requirements for ingredient nomenclature, period-after-opening or date of minimum durability, batch code, nominal content, and country of origin.
Two differences deserve flagging early. First, the EU has prohibited the marketing of cosmetics tested on animals since 2013, and your ingredient documentation needs to support that. Second, sunscreens are regulated as cosmetics in the EU, whereas in Australia many are therapeutic goods under the TGA — so an Australian SPF dossier does not map neatly onto an EU one. Our guides to Australian compliance and New Zealand cosmetic regulations cover the home-market side.
What does this cost, and how long does it take?
Be honest with yourself about sequencing: EU and UK entry is a post-launch move for most indie brands, not a launch-day one. A realistic path looks like formulating with export in mind, proving the product at home, then building the dossier once you have volume to justify it.
On our side, formulation development that is built export-ready starts from NZ$2,000–$5,000 on The Accelerator (4–6 months, semi-custom) or from NZ$4,000 on The Visionary (9–12 months, bespoke, with full IP transferred to you before manufacturing). Preservative efficacy testing is NZ$1,200 per formula. Minimum order quantities run from 100 to 500 units depending on pathway, so you are not committing to a container-load to test a market.
Third-party EU and UK costs — RP retainers, CPSR fees, notification support — are quoted per product and vary widely by provider and product type. Get two or three quotes before you budget, and get them before you finalise your formula, not after.
Frequently asked questions
Do I need a separate Responsible Person for the EU and the UK?
Yes. Great Britain requires a UK-established Responsible Person and SCPN notification; the EU requires an EU-established Responsible Person and CPNP notification. The underlying CPSR and Product Information File can largely be shared.
Can my New Zealand or Australian company be the Responsible Person?
No. The Responsible Person must be established within the EU, or within the UK for the Great Britain market. You appoint an EU or UK entity under a written mandate.
How long must I keep the Product Information File?
Ten years after the last batch of the product was placed on the market, kept accessible at the Responsible Person's address for competent authorities.
Who can sign the cosmetic product safety assessment?
A person holding a university-level qualification in pharmacy, toxicology, medicine or a similar discipline. Qualifications obtained outside the EU must be recognised by an EU member state body.
Does one CPNP notification cover all EU countries?
Yes. Once a product is notified via CPNP, no further national-level notification is required within the EU.
When do the new EU fragrance allergen labelling rules take effect?
31 July 2026 for products newly placed on the EU market, and 31 July 2028 for products already on the market.
Formulating with export in mind
The cheapest EU dossier is the one you did not have to reverse-engineer. If Europe or the UK is anywhere in your three-year plan, say so at the discovery stage — it changes ingredient selection, preservative strategy, packaging choices and the test schedule, and it costs far less to build in than to bolt on.
If you would like a straight answer on whether your current formula is export-viable, Ask The Chemist is a 30-minute consult from NZ$150. If you are ready to plan the full pathway, start a conversation with us — we work with indie brands across New Zealand and Australia, and we believe indie brands deserve a seat at the table in every market, not just their own.
This article is general information, not regulatory advice. Requirements change; confirm current obligations with your Responsible Person or a qualified regulatory consultant before placing product on the EU or UK market.
