Cosmetic Regulatory Watch

Regulatory Watch is a subscription service in which Oxford Biosciences monitors every change to cosmetic ingredient law in each market an enrolled product is sold in, checks that change against the product’s actual formulation, and tells the brand whether that specific product is over the new line, by which date, and what to do about it. It is priced per product per year and quoted on request.

Scope

Regulatory Watch covers cosmetic ingredient law as it applies to the enrolled formula in each chosen market: prohibitions, concentration limits, conditions of use, labelling triggers, and nanomaterial and CMR status. It does not cover regulation that sits outside the formulation, such as facility registrations and FEI numbers under MoCRA, product listing formats and filings, general product safety filings, customs, tariffs and origin marking, VAT, company law, advertising codes, or organic, vegan and similar certification schemes. If a rule changes for an ingredient, we look at your formula and say whether your product is affected. That is the whole service, and it is deliberately narrow so that it can be done properly for every product enrolled.

The problem it solves

A product with a signed CPSR is compliant on the day the assessment is signed. From that day onward the law moves and the product does not. A brand selling in the EU and UK alone is tracking two diverging versions of the same Regulation: EU Regulation (EC) No 1223/2009, amended several times a year through Omnibus Regulations and targeted amendments to Annexes II to VI, and the UK’s retained Regulation 1223/2009 with substance restrictions in Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, which the UK amends on its own timetable and sometimes not at all. Add the further sixteen markets set out below and a mid-sized brand is exposed to eighteen moving ingredient rule sets, none of which changes on the same day as any other.

In practice most brands find out about a change in one of three ways: a retailer or distributor rejects a shipment, a marketplace delists a product, or a competitor quietly reformulates first. All three are late.

How it works

1. Enrolment. You tell us which products to watch and in which markets. If we hold the CPSR, we already have the formulation, the INCI list, the concentrations and the product category. If we do not, we take the formulation under NDA and enrol it in the same way. One CPSR is one product; where a CPSR covers a shade range, every shade’s colourant entries are watched under that one enrolment.

2. Monitoring. We track the primary legal instruments in each market directly: the Official Journal of the EU and the SCCS opinion pipeline, UK legislation.gov.uk and OPSS notices, the US Federal Register and state ingredient statutes, Canada Gazette and Hotlist revisions, ASEAN ACSB annex updates, GSO standards, NMPA and IECIC announcements, and the equivalent sources in every other enrolled market. We do not rely on secondary summaries or on other consultancies’ pages.

3. Formulation matching. Every published change is decomposed into the ingredient identity (INCI, CAS and CI number where relevant), the restriction type, the product categories and the compliance dates, then run against every enrolled formulation in the affected market.

4. Alert. If a product is affected, you receive a plain-language alert within 5 working days of publication. It states the instrument and its citation, the affected ingredient in your product, your concentration against the new limit, the compliance dates that apply, and one of the five recommended actions below.

5. Annual statement. If a product is not affected by a change, you hear nothing about it, and no digest is sent in weeks where nothing is affected; there is no Friday newsletter to skim. Instead, once a year each enrolled product receives a compliance statement listing every instrument reviewed against it in the period and confirming its status, so that the absence of alerts is recorded rather than assumed. Retailers, distributors and Responsible Persons increasingly ask for exactly this document.

The five recommended actions

Every alert closes with one of five actions, and each has a defined route through our other services:

Recommended action	What it means	How we help
No action	Your concentration is already within the new limit, or the change does not apply to your product type	Recorded on the annual statement
Label amendment	The formulation is unchanged but a declaration, warning or claim must change	Label Review, with the specific wording
CPSR update	The assessment must be re-issued to reflect the new limit, a new MoS calculation or a changed condition of use	CPSR Update at the published rate
Reformulation	The ingredient must be removed or reduced, and the product reassessed	Formulation support and a new CPSR
Market withdrawal	The product cannot lawfully remain on sale in that market after the making-available date	Notification amendment and RP guidance

Because we hold the CPSR and, where applicable, act as your Responsible Person, the alert and the fix are handled by the same people who assessed the product. There is no re-briefing and no second consultancy.

The two-date discipline

Nearly every EU and UK restriction carries two dates: the date after which a product may no longer be placed on the market (the first time it is made available in that market, in practice the date it leaves the manufacturer’s or importer’s control), and the date after which it may no longer be made available at all (the sell-through deadline for stock already in the chain). The gap between them is often 12 to 24 months and is the single most misunderstood point in cosmetic compliance. Brands that treat the first date as a recall deadline destroy stock they were entitled to sell. Brands that treat the second date as the only deadline ship non-compliant new batches.

Two instruments show the pattern in real time. Under Regulation (EU) 2023/1545 (fragrance allergens) the placing date of 31 July 2026 has passed and the making-available date of 31 July 2028 is live. Under Regulation (EU) 2024/996 (retinol and others) the placing date of 1 November 2025 has passed and the making-available date of 1 May 2027 is live. For an enrolled product the question is no longer “do we need to comply” but “how much compliant stock do we have and how long do we have to sell the rest”. Every Regulatory Watch alert states both dates separately and says which of your activities each one governs.

Fragrance materials: the highest-frequency risk

Fragrance is where the largest share of formulation-specific changes lands, for three reasons: fragrance compounds contain dozens of individual materials, those materials are the most frequently reviewed by the SCCS, and a fragrance house’s IFRA certificate tells you about IFRA Standards, not about what the law requires in a given market.

Allergen labelling. In the EU, Regulation (EU) 2023/1545 expanded the list of fragrance allergens requiring individual declaration from 26 to over 80 named substances and substance groups, declarable where present above 0.001% in leave-on and 0.01% in rinse-off products. The placing-on-the-market date, 31 July 2026, has passed: any product first supplied into the EU since then must already carry the expanded declaration. The live date is 31 July 2028, after which stock placed before the cut-off may no longer be made available anywhere in the chain. That is the date a brand with existing EU inventory is managing now, and the one that decides whether to relabel, sell through or withdraw. The UK has not mirrored this instrument, so a product sold in both markets carries two label positions and a decision about whether to harmonise upward. Regulatory Watch flags every enrolled product whose fragrance disclosure contains a listed allergen above threshold, states which of the two dates governs that product’s stock position, and quantifies the sell-through window.

Prohibitions and restrictions. Butylphenyl methylpropional (Lilial) was prohibited in the EU from 1 March 2022 under Regulation (EU) 2021/1902 and in the UK from 15 December 2022. Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC, Lyral), atranol and chloroatranol were prohibited under Regulation (EU) 2017/1410 with a two-stage timetable. Each was present in thousands of marketed fragrance compounds at the time. Brands that found out from the retailer rather than the Official Journal lost stock.

What the alert looks like for fragrance. Because we hold the fragrance disclosure from the CPSR, the alert names the material, states the percentage in the finished product, states the new limit or prohibition, and states whether the fragrance house will need to supply a revised compound or whether a label-only change is sufficient. We do not send you a list of 80 allergens and ask you to check.

Colourants: low frequency, high consequence

Colour changes are rarer than fragrance changes but far less forgiving, because a colourant is usually not substitutable without changing the product’s appearance, and because colour rules diverge sharply between markets.

In the EU and UK, permitted colourants are listed in Annex IV of Regulation 1223/2009 (Schedule 34 Part 4 in the UK), with conditions on field of application, purity criteria and, for certain entries, maximum concentrations. In the US, cosmetic colour additives are governed by 21 CFR Parts 73 and 74, with a closed list, use restrictions by product area, and batch certification for synthetic organic colours (the FD&C and D&C series). A colour permitted in the EU under a CI number may have no US listing at all, or may be permitted only for externally applied cosmetics and not for the eye area or lips. ASEAN, China and Japan each run their own positive lists.

Regulatory Watch checks each enrolled product’s colourant entries against every relevant list, flags changes to purity criteria and permitted fields of application, and is particularly attentive to the eye-area, lip and mucous-membrane restrictions that catch multi-market brands most often. Where a CPSR covers a shade range, every shade’s colourant entries are checked under the one enrolment, because the colourants are exactly what differ between shades. Hair dye substances under Annex III are treated the same way, as these receive some of the most frequent SCCS attention of any ingredient class.

Other ingredient classes under watch

• Preservatives (Annex V): for example the successive restrictions on methylisothiazolinone, now prohibited in leave-on products and limited to 0.0015% in rinse-off.
• UV filters (Annex VI): for example the Omnibus VII limits on homosalate, benzophenone-3 and octocrylene, which the UK has not mirrored.
• Retinoids and other Annex III entries: for example Regulation (EU) 2024/996, limiting retinol, retinyl acetate and retinyl palmitate to 0.05% retinol equivalent in body lotion and 0.3% in other products, with the making-available date of 1 May 2027 now the live one.
• Microplastics: for example Regulation (EU) 2023/2055 under REACH, with dates staggered by product type to 2035 and not mirrored in the UK.
• Nanomaterials: for example SCCS opinions that reclassify a nano form, with the notification consequences that follow.
• CMR substances: for example each Omnibus Regulation adding newly classified CMR substances to Annex II, often with short compliance windows.

Markets covered and what is monitored in each

European Union

Regulation (EU) 2023/1545

Fragrance allergens: placing ended 31 July 2026; making available ends 31 July 2028

The service covers the eighteen markets below. For each, we monitor the primary instrument and the regulator’s own publication channel, and we track the specific ways that market diverges from the EU baseline that most brand formulations were assessed against.

United Kingdom. Retained Regulation 1223/2009 as amended, with substance restrictions in Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. Monitored via legislation.gov.uk and OPSS. Notification via SCPN. Divergence is now the central risk: the UK has adopted some EU measures late (Lilial), some with different dates, and several not at all (the 2023 allergen list, microplastics, the Omnibus VII UV filter limits).

European Union. Regulation (EC) No 1223/2009 and its Annexes II to VI. Monitored via the Official Journal and the SCCS opinion pipeline, which gives 12 to 24 months’ visibility of what the next Omnibus will restrict. Notification via CPNP.

Norway. Regulation 1223/2009 applies through the EEA Agreement, transposed as the Norwegian cosmetics regulation (FOR-2013-04-08-391) and enforced by Mattilsynet. Each EU amendment takes effect in Norway only after an EEA Joint Committee decision, so Norwegian compliance dates can lag EU dates by months. We track the incorporation, not just the EU publication.

Switzerland. The Ordinance on Cosmetics (VKos, SR 817.023.31) under the Foodstuffs Act, administered by the FSVO. Its annexes follow the EU annexes but are updated on a Swiss timetable, so a substance restricted in the EU may remain permitted in Switzerland for a period, or vice versa. There is no Swiss notification database; compliance rests on the formulation itself.

Türkiye. The Cosmetic Regulation (Kozmetik Yönetmeliği), aligned with 1223/2009 and administered by TİTCK, with annex amendments published in the Resmî Gazete and notification through ÜTS. Alignment is close but not simultaneous, and the notification system requires updated ingredient data when a formulation changes.

United States. The FD&C Act as amended by MoCRA, with 21 CFR Parts 700 to 740 and the colour additive listings in Parts 73 and 74. Monitored via the Federal Register and FDA Cosmetics Direct. The federal ingredient framework is stable, but state law is not: the California Toxic-Free Cosmetics Act and the Washington Toxic-Free Cosmetics Act each prohibit named ingredient classes in products sold in those states, and further state bills follow every session. Colour additive listing and batch certification are tracked per colourant.

Canada. The Cosmetic Regulations under the Food and Drugs Act, the Cosmetic Ingredient Hotlist (prohibited and restricted substances) and Cosmetic Notification Form requirements, monitored via Canada Gazette and Health Canada notices. The 2024 amendments to the Cosmetic Regulations introduced mandatory disclosure of fragrance allergens on a phased timetable, giving Canada an allergen position that matches neither the EU nor the UK.

Mexico. The Ley General de Salud and its Reglamento, the COFEPRIS Acuerdo listing prohibited and restricted substances in perfumery and beauty products, and NOM-141-SSA1/SCFI-2012 on labelling. Monitored via the Diario Oficial de la Federación. Restricted-substance updates are irregular and are easily missed by brands relying on EU compliance alone.

Brazil. The Resolutions of the Collegiate Board (RDCs) of ANVISA that establish prohibited and restricted substances, permitted preservatives, colourants and UV filters, together with RDC 752/2022 on the definition, classification and regularisation of cosmetics. These track the Mercosur GMC resolutions and are published in the Diário Oficial da União. Brazil operates its own positive lists, so a colourant or filter permitted in the EU is not automatically permitted in Brazil.

Australia. Cosmetic ingredients are industrial chemicals under the Industrial Chemicals Act 2019, administered by AICIS, with scheduling under the Poisons Standard and mandatory ingredient labelling under the Consumer Goods (Cosmetics) Information Standard 2020. Sunscreens and products with SPF claims are therapeutic goods under the TGA and must be listed on the ARTG. AICIS evaluation outcomes and Poisons Standard amendments can change a substance’s status independently of any other market.

New Zealand. The Cosmetic Products Group Standard under the Hazardous Substances and New Organisms Act, administered by the EPA, whose schedules follow the EU annexes with a lag and are updated periodically. Sunscreens are separately regulated under the Sunscreen (Product Safety Standard) Act 2022, which made AS/NZS 2604 mandatory. New Zealand does not automatically adopt EU changes; each schedule update is a distinct instrument.

GCC. GSO 1943 (safety requirements for cosmetics and personal care products) with its annexes tracking the EU lists, GSO 2528 on claims, and national enforcement by the SFDA in Saudi Arabia (eCosma registration) and by ESMA and MOIAT in the UAE. GSO annex revisions and SFDA circulars are monitored directly; Halal and labelling requirements are flagged where a change affects an enrolled product.

ASEAN. The ASEAN Cosmetic Directive with Annexes II to VII, revised by the ASEAN Cosmetic Scientific Body and adopted by the ASEAN Cosmetic Committee, then enforced through national notification in each member state (Thai FDA, NPRA Malaysia, HSA Singapore, BPOM Indonesia, Philippine FDA, DAV Vietnam). ACD annex changes usually follow EU changes with a delay of one to three years and with their own transition dates.

China. The Cosmetics Supervision and Administration Regulation (CSAR) and its implementing measures, the Inventory of Existing Cosmetic Ingredients in China (IECIC), and the Safety and Technical Standards for Cosmetics (STSC), administered by the NMPA. China maintains its own positive lists for preservatives, colourants, UV filters and hair dyes, and its own prohibited list; an ingredient permitted in the EU but absent from the IECIC is a new ingredient requiring registration or filing. STSC revisions and NMPA announcements are monitored directly.

Japan. The Pharmaceutical and Medical Device Act and the Standards for Cosmetics (MHLW Notification No. 331 of 2000), comprising a negative list, a restricted list and positive lists for preservatives and UV absorbers, together with the tar colour ordinance (MHW Ordinance No. 30 of 1966). Products with functional claims fall under the separate quasi-drug regime. Japan’s colourant and preservative positive lists differ materially from the EU’s.

South Korea. The Cosmetics Act and the MFDS Regulation on Safety Standards for Cosmetics, with positive lists for preservatives, colourants and UV filters and a separate regime for functional cosmetics. MFDS amends the ingredient standards by notification several times a year, and these are monitored at source.

India. The Drugs and Cosmetics Act 1940 and the Cosmetics Rules 2020, administered by the CDSCO, which require import registration and apply the Bureau of Indian Standards specifications IS 4707 Part 1 (permitted colourants) and Part 2 (prohibited and restricted substances). BIS revisions to IS 4707 change what may be imported, and are not synchronised with any other market.

South Africa. The Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 and the Regulations relating to the labelling, advertising and composition of cosmetics (R.1469 of 2017), administered by the Department of Health, which reference the applicable SANS standards and the EU annex lists for composition. Updates arrive through Government Gazette notices and SANS revisions, both of which are monitored.

Where a brand enters a market not listed here, tell us and we will confirm coverage before enrolment.

Who Regulatory Watch is for

• Brands selling in more than one market, where divergence between the EU and UK alone makes manual tracking impractical.
• Brands with fragranced products, particularly fine fragrance, body care and candles with cosmetic claims.
• Colour cosmetics brands, where a single Annex IV or 21 CFR change can affect an entire shade range.
• Brands supplying retailers or marketplaces that require documented evidence of ongoing compliance.
• Contract manufacturers and private-label suppliers who need to notify their own customers of changes affecting shared formulations.
• Any brand whose CPSR was signed more than a year ago.

Who it is not for yet

A single unfragranced, uncoloured product sold in Great Britain only, with a CPSR signed in the last few months, has very little exposure and does not need watching yet. Enrol it when it gains a fragrance, a colourant or a second market, or when the CPSR passes its first anniversary. We would rather you enrolled the right products than all of them.

Pricing

Regulatory Watch is priced per product per year and quoted on request. One CPSR is one product: a shade range assessed under a single CPSR is one enrolment, with every shade’s colourant entries watched; a range assessed under separate CPSRs is enrolled per CPSR. There is no minimum number of products and no separate fee per market. Any resulting CPSR update, label review or reformulation is quoted separately at the published rate, and the alert will state that quotation.

How to enrol

Send us the list of products and markets, or tell us to enrol every product we hold a current CPSR for. Enrolment is confirmed within two working days, and the annual statement date is set from the enrolment date.