GMP — Good Manufacturing Practice — is the documented system a cosmetic manufacturer uses to make every batch the same way, and to prove it afterwards. ISO 22716 is the international GMP standard written specifically for cosmetics. It is not legally mandatory in New Zealand or Australia, but retailers, distributors and export markets increasingly ask for it.
If you are choosing a formulator for your first product, GMP is one of the few questions that separates a real lab from a kitchen with good branding. Here is what the standard covers, where it is required, and how to check whether your manufacturer genuinely works to it.
What is ISO 22716, and what does it actually cover?
ISO 22716:2007 is the international standard titled Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices. It sets out how cosmetic products should be produced, controlled, stored and shipped.
In practice it covers:
- Personnel — training records, hygiene rules, who is authorised to do what
- Premises and equipment — cleaning schedules, maintenance, calibration, preventing cross-contamination
- Raw materials and packaging — supplier approval, incoming goods checks, quarantine, lot numbering
- Production — a written batch record for every batch, with the actual weights used, who made it, and when
- Finished products — release criteria, retained samples, storage conditions
- Quality control, deviations, complaints, recalls, subcontracting and internal audits
Two things it deliberately does not cover: research and development work, and distribution of finished products once they leave the manufacturer. So a lab can be doing excellent formulation work and still need a separate conversation about how the manufacturing batch will be documented.
Is GMP legally required for cosmetics in New Zealand and Australia?
Not directly — but the picture is different in every market you might sell into.
- New Zealand: cosmetics are regulated under the Cosmetic Products Group Standard, issued under the Hazardous Substances and New Organisms Act 1996 and administered by the Environmental Protection Authority. That standard governs ingredients, concentration limits and labelling. It does not mandate GMP certification. Cosmetics New Zealand runs a voluntary GMP certification scheme aligned to ISO 22716, with compliance monitoring through IANZ.
- Australia: AICIS (the Australian Industrial Chemicals Introduction Scheme, under the Industrial Chemicals Act 2019) regulates the introduction of the chemicals in your product. It does not set or enforce GMP requirements for cosmetic manufacturing.
- European Union: here it is mandatory. Article 8 of Regulation (EC) No 1223/2009 requires manufacture in accordance with cosmetic GMP. ISO 22716 is the harmonised standard, so manufacturing to it gives you a presumption of conformity, and a declaration of compliance for the manufacturing site goes into your Product Information File.
- United States: MoCRA requires the FDA to establish GMP regulations for cosmetic facilities. As of 2026 the final rule has still not been issued — it has slipped past the original 2024 and 2025 deadlines and now sits as a long-term action. Small businesses will get an additional three years to comply once the final rule lands.
So: optional at home, required for Europe, and coming for the US. If export is anywhere in your five-year plan, building the paperwork habit now is much cheaper than retrofitting it later.
Why do retailers and distributors ask for GMP if it isn't mandatory?
Because it is the cheapest proxy they have for "will this brand embarrass us." A buyer at a pharmacy chain, or a distributor taking you into a new market, cannot audit your formula. What they can ask for is evidence that batch three will behave like batch one, and that if something does go wrong you can identify exactly which units are affected and pull them. Without a batch record and lot traceability, a single customer complaint becomes a guess about your entire stock holding rather than a defined recall of 180 units.
What does GMP look like at small-batch scale?
This is where indie founders get discouraged — the standard reads as though it was written for a factory, because largely it was. At 100 to 500 units the principles still apply, but the implementation is proportionate. Realistically it means:
- Every raw material has a supplier, a lot number and a certificate of analysis on file
- Every batch has its own number and a record showing actual weights, not just the target formula
- A retained sample of each batch is kept and stored so it can be checked later
- Equipment cleaning between batches is written down, not remembered
- Finished batches are only released against defined criteria — appearance, pH, viscosity, microbiological result
None of that requires a cleanroom. It requires a system, and someone who insists on using it.
How do you check whether a manufacturer really works to GMP?
Ask for artefacts, not adjectives. Four questions for your discovery call:
- Can you show me a redacted batch record from a previous production run? A lab with a real system will have one to hand.
- What lot number will appear on my finished units, and how do I trace it back to raw materials?
- Do you retain samples, and for how long?
- What are your release criteria for my product, and who signs it off?
If the answers are vague, that is your answer. Note too that "GMP certified" and "GMP aligned" are different claims — certification means a third party has audited the site. Both can be legitimate; you just want to know which one you are buying.
Does GMP replace stability and safety testing?
No, and this is a common and expensive misunderstanding. GMP is about how consistently you make the product. It says nothing about whether the formula itself is stable, adequately preserved, or safe.
Those are separate pieces of work — accelerated stability testing and preservative efficacy (challenge) testing to ISO 11930, which runs at NZ$1,200 per formula. A perfectly GMP-manufactured batch of an under-preserved formula is still an under-preserved formula, made very consistently.
How we approach this at The INCI Lab
We are a small-batch studio in Auckland working with indie brands across New Zealand and Australia, so our documentation is built for the 100–500 unit range rather than the 50,000 unit one. Every raw material lot is logged with its supplier and certificate of analysis, every batch gets its own record and retained sample, and you receive a certificate of analysis with your finished units.
That paperwork travels with you. Because we transfer full formulation IP to you on The Visionary pathway before manufacturing, the batch documentation supports your Product Information File or export dossier rather than locking you to us.
If you want to talk through what your specific market needs, Ask The Chemist is a 30-minute consult starting from $150. If you already know what you want to make, The Accelerator runs 4–6 months from starting from $2,000, and The Visionary takes 9–12 months from starting from $4,000. You can compare all four routes on our services page.
Frequently asked questions
Is ISO 22716 certification required to sell cosmetics in New Zealand?
No. New Zealand regulates cosmetics through the Cosmetic Products Group Standard under the HSNO Act 1996, administered by the EPA, which covers ingredients and labelling rather than manufacturing systems. GMP certification is voluntary in New Zealand, though Cosmetics New Zealand operates a scheme aligned to ISO 22716.
Do I need GMP to sell my skincare in Australia?
Not as a legal requirement. AICIS regulates the introduction of the chemicals in your product, not the manufacturing standard of the facility. However, Australian retailers and distributors often ask for evidence of batch control as a condition of listing.
Do I need GMP to export cosmetics to the EU?
Yes. Article 8 of EU Regulation 1223/2009 requires manufacture in accordance with cosmetic GMP. Manufacturing to ISO 22716 gives a presumption of conformity, and a declaration of compliance for the manufacturing site is included in your Product Information File.
What is the difference between GMP certified and GMP compliant?
GMP certified means an independent third party has audited the site against the standard and issued a certificate. GMP compliant or GMP aligned means the manufacturer follows the principles without holding that external audit. Ask which one applies before you rely on it in a retailer submission.
Does GMP mean my formula has been tested for safety?
No. GMP governs manufacturing consistency and traceability only. Stability testing, preservative efficacy testing and safety assessment are separate pieces of work and are required regardless of how well the batch was made.
Can a small-batch manufacturer realistically work to GMP?
Yes. The standard scales down. At 100–500 units it means documented batch records, raw material lot traceability with certificates of analysis, retained samples, written cleaning procedures and defined release criteria — none of which require factory-scale infrastructure.
