Who actually regulates cosmetics in New Zealand — and it is not Medsafe

Published 6 August 2026Zane Hitchcox, editor

The error is not a small one. If you believe Medsafe vets skincare, you assume somebody read the file on the product in your hand before it reached the shelf. Nobody did. The system works the other way round: it fixes what may be in the bottle and reserves individual scrutiny for the moment a seller starts making medical promises.

The statute is about hazardous substances, not about beauty

Section 96B of the Hazardous Substances and New Organisms Act 1996 lets the Environmental Protection Authority issue a group standard: an instrument that identifies a group of hazardous substances or products and imposes on the whole identified group whatever obligations and restrictions the Authority "thinks fit for the purpose of setting EPA controls".⁴ Cosmetics are one of those groups. The instrument is the Cosmetic Products Group Standard 2020, issued under section 96B, carrying HSNO approval number HSR002552 and in force since 30 April 2021, with the current consolidated version effective 1 January 2026.¹

The consequence is unusual. Under section 96E(3) of the Act, a hazardous substance to which section 96B(2)(a) applies is deemed to have been approved by the Authority under section 29.¹ A cosmetic inside the scope of the Group Standard is therefore approved automatically, by fitting the description, and the importer simply uses HSR002552 as its approval number. No file is opened. No assessor reads the formula. The approval is a category, not a decision about your moisturiser.

Scope was widened by the 2024 amendment. Clauses 4(2)(a) and 4(2)(b) now cover both a cosmetic that is itself classified as hazardous and one that is not hazardous but contains a component that is.¹ The rules therefore capture any cosmetic containing a hazardous ingredient, even where the finished product is not hazardous.³ Products made only from non-hazardous ingredients fall outside the standard entirely.

The Schedules are the European rules, adopted by reference

Schedule 1 of the Group Standard carries the conditions, Schedule 2 the transitional provisions and Schedule 3 the definitions. Schedules 4 to 8 carry the ingredient lists, and the instrument's own explanatory note says they are based on the provisions of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.¹ The mapping is close to one-for-one. Schedule 4 is the prohibited list, Schedule 5 the restricted list, Schedule 6 permitted colourants, Schedule 7 permitted preservatives, Schedule 8 permitted UV filters — which is Article 14 of the European Regulation and its Annexes II, III, IV, V and VI in the same order.⁵ The 2024 amendment updated Schedules 4 to 8 specifically to realign them with the European rules.³

That fact cuts both ways. A shopper here gets a large ingredient-restriction regime without New Zealand running the toxicology itself, and also gets Europe's gaps on Europe's timetable, and only when the EPA next amends the Schedules. The instrument's own regulatory history shows how rarely that has happened. Before the 2024 decision, the last one to touch the ingredient Schedules was dated 29 June 2012, and it covered Schedules 4, 5 and 6. Five decisions came and went in the years between — aerosol site and storage conditions, a technical correction, two reissues of the whole standard, and the label requirements for fluoride toothpaste — and none of them touched Schedules 4 to 8.¹ A cosmetic bought here in December 2025 was screened against ingredient lists last realigned with Europe by a decision taken in 2012.

For colourants, preservatives and UV filters the standard runs a positive list, and it does so by exclusion: under clause 4(5)(e) to (g) a product falls outside the Group Standard altogether if it contains a colourant, preservative or UV filter that is not on the relevant Schedule, or is on it but used outside the stated conditions. The single written-in carve-out is for colouring agents intended solely to colour hair.¹ Article 14 of the European Regulation draws the same line with the same exception.⁵

The alignment is not total, and the breaks are the interesting part. Each of Schedules 4 to 8 ends in a second table of New Zealand-specific entries. Schedule 4's runs to exactly two items: methyl methacrylate, and PFAS. Schedule 8 keeps an additional list of UV filters permitted here, and against two of them the instrument prints its own explanation. 4-aminobenzoic acid stays permitted at up to 15% because, when the EU banned it as a UV filter, New Zealand kept it "in order to maintain regulatory consistency with Australia". Benzophenone-4 stays at 10% because the EU cut its limit to 5% and New Zealand did not follow, for the same stated reason.¹ Where Europe and Australia disagree, the instrument says in a footnote that it follows Australia.

What the label has to say, and what it may leave out

The labelling condition is clause 1 of Schedule 1. Ingredients present at 1% or more must be listed in descending order by volume or mass; ingredients below 1% may be listed in any order; colour additives may go in any order; and fragrance may be declared with the single word "fragrance" or "parfum" rather than by naming its components.¹ Ingredients may be declared by common chemical name or by International Nomenclature Cosmetic Ingredient name — INCI is permitted, not compelled.¹ Nanomaterials must be flagged with the word "nano" in brackets after the ingredient.¹ And clause 1(11) lets the whole scheme be bypassed: a label complying with the current cosmetic labelling rules of Australia, the United States, Canada, the United Kingdom or the European Union is accepted instead.¹

The one-per-cent line is where the ordering rule stops being informative, and the fragrance allowance is where a mixture of dozens of substances legally becomes one word. Both are features of the instrument, not sharp practice by a seller. Reading an ingredient list is mostly a matter of knowing which permission is being used.

New Zealand has no cosmetic product register

This is where the New Zealand regime diverges most sharply from the one it borrows its ingredient lists from. Under Article 13 of Regulation (EC) No 1223/2009 a responsible person must notify the European Commission electronically before placing a cosmetic on the market: product category and name, where the product information file is held, country of origin on import, contact details, any nanomaterials, any CMR substances of category 1A or 1B, and a frame formulation allowing for prompt medical treatment.⁵ Article 4 requires that a named person inside the Union be designated as responsible for the product.⁵

New Zealand requires none of that for cosmetics as such. The Group Standard has exactly one notification duty, condition 6 of Schedule 1, headed "Notification to the Authority": a person intending to import or manufacture a cosmetic containing nanomaterials must notify the Authority in writing at first import, giving the substance name, the approval number and the nature of the nanomaterials, and keep a record — and even that does not apply to nanomaterials used as approved colourants, preservatives or UV filters.¹ Separately, anyone importing or manufacturing a hazardous substance must give the EPA their business details through the hazardous substances reporting and notification portal within 30 days, and from 1 January 2026 must also supply their New Zealand Business Number and the relevant HSNO approval numbers.⁶ That is a register of businesses, not of products.

Enforcement is split, but less evenly than that phrase suggests. The EPA's published roles-and-responsibilities guidance makes the EPA the enforcing agency across all of New Zealand for classification and content controls — labelling, packaging and safety data sheets — for the equivalent conditions in group standards, and for the requirement that a substance have an approval before it is imported. WorkSafe New Zealand's HSNO role is narrower than its name implies: disposal and ecotoxic controls in workplaces not covered by another agency. The guidance works this through a cosmetic example. A shopper complains of itchy, burning eyes after a mascara whose label does not comply with the Group Standard; the EPA leads, the Ministry of Health supports because someone was hurt, and Trading Standards may help with a recall while not being a HSNO enforcement agency at all.⁷

The 2024 amendment, and why the dates are confusing

The EPA consulted between 2 March and 31 May 2023 and released its decision on 30 January 2024.⁸ The consolidated instrument dates that decision 25 January 2024, under application APP204297, effective 1 January 2026, with a further decision of 8 July 2025 correcting minor and technical errors.¹

The gap between decision and effect is the transitional schedule, and it explains most of the confusion in trade coverage. Schedule 2 allows a person to keep importing and manufacturing products meeting the pre-amendment conditions until 31 December 2025 and to keep supplying them until 31 December 2026; non-compliant stock must be disposed of by 30 June 2027.¹ The manufacturer's compliance date was the end of 2025, the new rules bit on 1 January 2026, and old stock leaves the shelf at the end of 2026 — three correct dates describing three different obligations.

PFAS: banned in New Zealand, still unassessed in the United States

The 2024 amendment phases per- and polyfluoroalkyl substances out of cosmetics. Schedule 2 clause 4 permits import and manufacture of PFAS-containing cosmetics until 31 December 2026 and supply until 31 December 2027; clause 5(2) requires disposal of all PFAS-containing cosmetics by 30 June 2028.¹ A parallel phase-out applies to the UV filter homosalate, whose maximum authorised concentration is cut to 10% at Schedule 8, Table 1, entry 3, and it runs to 30 June 2027, 30 June 2028 and 31 March 2029 for import, supply and disposal respectively.¹ Announcing the decision on 30 January 2024, the EPA described New Zealand as one of the first countries in the world to take this step, reasoning that the chemicals do not easily break down, can build up in the body and are toxic at high levels, and noted, citing international research, that PFAS are found in only a small number of products.⁹

The American contrast is recent. On 29 December 2025 the FDA published the PFAS report MoCRA required of it. Using mandatory product listing data it identified 51 PFAS in 1,744 cosmetic formulations and assessed the 25 most used, about 96% of intentionally added PFAS. Toxicological data for a majority were incomplete or unavailable; five appeared to present low safety concerns under intended conditions of use, one was flagged as a potential safety concern, and the safety of most could not be definitively established. No federal regulation specifically prohibits intentionally added PFAS in cosmetics.¹⁷ New Zealand's ban is precautionary in the strict sense: decided without, and still ahead of, a completed assessment.

Medsafe's jurisdiction begins at the claim

The Group Standard's explanatory note draws the line itself: it does not cover registered medicines under the Medicines Act 1981, or products intended for the treatment of medical conditions as defined under that Act where registration is required.¹ The EPA's guidance repeats it: medicines and medical devices are not covered by the Group Standard and are regulated by Medsafe.² Medsafe says the same from the other direction — categorisation is determined by a product's ingredients, its purpose for use and the manner in which it is presented in the market.¹⁰

Two definitions do the work. A medicine is a substance manufactured, imported, sold or supplied wholly or principally for administering to human beings for a therapeutic purpose. A related product, under section 94 of the Medicines Act 1981, is a cosmetic, dentifrice or food in respect of which a claim is made that it is effective for a therapeutic purpose that is not its principal one — the standard example being fluoride toothpaste, whose principal purpose is cleaning teeth.¹⁰ "Therapeutic purpose" is defined at section 4 of the Act and covers preventing, diagnosing, monitoring, alleviating, treating, curing or compensating for a disease, ailment, defect or injury, and influencing, inhibiting or modifying a physiological process.¹¹

The boundary matters more to a shopper than the agency names do, because the category is decided by the sentence on the front of the pack rather than the chemistry inside. A cream can be reformulated without changing its regulator, and change its regulator without being reformulated at all. That is why so much cosmetic language is engineered to sound clinical while stopping short of a therapeutic claim, a subject taken up in the words on cosmetic labels that have no legal definition.

Sunscreen is the product that keeps changing regimes

Sunscreen is the clearest case of one product sitting in different boxes in different countries. In New Zealand a primary sunscreen stays a cosmetic under the Group Standard — clause 1(5) of Schedule 1 expressly allows it to be labelled instead to an Australian therapeutic goods order¹ — but it is additionally subject to a mandatory product safety standard, enforced by the Commerce Commission, requiring compliance with the joint Australian and New Zealand sunscreen standard AS/NZS 2604, which also reaches insect repellents labelled SPF 4 or above and skincare labelled above SPF 15.¹² In the United States a sunscreen is an over-the-counter drug: the FDA says outright that some products regulated as cosmetics in Europe are regulated as drugs there, and gives sunscreens as its example.¹⁵ The numbers on the bottle are the subject of a separate article.

The United States: MoCRA added paperwork, not approval

The Modernization of Cosmetics Regulation Act of 2022 was enacted on 29 December 2022 as part of the Consolidated Appropriations Act, 2023, Public Law 117-328, and inserted sections 604 to 614 into the Federal Food, Drug, and Cosmetic Act: definitions, adverse events, good manufacturing practice, registration and product listing, safety substantiation, labeling, records, mandatory recall authority, small businesses, exemptions and preemption.¹⁴ The FDA calls it the most significant expansion of its cosmetics authority since the FD&C Act passed in 1938.¹³

What it obliges is real. Manufacturers and processors must register their facilities and renew biennially under section 607(a)(2).¹⁴ A responsible person must list every marketed cosmetic product with its ingredients and update annually; must report serious adverse events within 15 business days with the retail label attached, and any new medical information received within a year of that report within a further 15 business days; and must keep records supporting adequate substantiation of safety, though neither the statute nor FDA regulations prescribe particular tests.¹³ As of 30 June 2026 the FDA reported 16,398 unique active facility registrations and 1,298,361 unique active product listings.¹⁶

What MoCRA did not do is the part that matters for the comparison. Nowhere in sections 604 to 614 is there a power to refuse a cosmetic entry to the market. Section 608 requires a responsible person to ensure and keep records of "adequate substantiation of safety", and then defines that as evidence sufficient, among qualified experts, to support a reasonable certainty that the product is safe — a standard the company applies to itself, with no agency sign-off in the loop.¹⁴ The FDA says the consequence in its own words: it does not pre-approve cosmetic products or ingredients, with the important exception of some colour additives.¹⁵ Registration and listing, the agency adds, is neither a cosmetic approval program nor a promotional tool, and it issues no certificates for either.¹⁶

The two systems fail in opposite directions. New Zealand has a hard ingredient rulebook and almost no visibility of what is on the market. The United States now has extraordinary visibility — a million-plus listings — and no power to refuse any of them entry.

Australia regulates the chemical rather than the product

Australia takes a third route. The Australian Industrial Chemicals Introduction Scheme, established by section 140 of the Industrial Chemicals Act 2019 (No. 12 of 2019),¹⁹ regulates the importation and manufacture of the chemicals used in cosmetics rather than the finished products. AICIS describes the division as a process of exclusion: the Therapeutic Goods Administration takes chemicals in products that are medicines or marketed as having therapeutic effects, including most skin-whitening lotions and primary sunscreens, and AICIS takes the rest, treated as having an industrial use. Labelling and product safety sit with the ACCC. Importers must register before importing, with no minimum quantity, and every relevant chemical must be authorised under one of five categories — listed, exempted, reported, assessed or commercial evaluation.¹⁸

AICIS also makes a point that undercuts much marketing on both sides of the Tasman: almost all cosmetic ingredients are regulated as industrial chemicals, including nearly all of those described as natural or organic, such as oils, extracts and plant essences.¹⁸ The regulatory system has no category called natural. And asked which chemicals are allowed in cosmetics, AICIS answers that in Australia there is no single list of chemicals banned or restricted in products, pointing instead at the Poisons Standard.¹⁸ The thing a New Zealand cosmetic is measured against — a numbered, published set of ingredient Schedules — has no counterpart across the Tasman.

What this means standing in the aisle

Three conclusions follow, none of which requires trusting this page over the instruments it cites. No New Zealand agency has assessed the individual product you are holding, so an appeal to regulatory approval is empty. The regulated information is on the back, and it is ordered by volume or mass only down to one per cent — or in whatever order British or American labelling rules allow, if the seller prefers. And the front of the pack is where jurisdiction is decided: a claim that crosses into therapeutic territory does not make a product better, it makes it a different kind of legal object.

A complaint about a mislabelled or wrongly approved cosmetic goes to the EPA's hazardous substances compliance team.⁷ A complaint about a sunscreen's SPF goes to the Commerce Commission.¹² A complaint about a cosmetic making medical claims is Medsafe's.¹⁰ Knowing which is which is most of the practical value in understanding the system.