Global Market Access
From £149
Cosmetic regulatory documentation for markets beyond the EU and UK: Canada, Australia, New Zealand, ASEAN, the GCC and Latin America, prepared from the same evidence base by the assessor who signs our CPSRs.
- Canada: Health Canada Cosmetic Notification, Hotlist review and written compliance report (£395)
- Australia: AICIS Compliance Statement and Information Standard 2020 labelling assessment (£149)
- New Zealand: EPA Cosmetic Products Group Standard 2020 Compliance Statement (£179)
- ASEAN: Cosmetic Directive four-part PIF restructure and Annexes II to VII cross-reference (£249)
- GCC and Latin America (Brazil, Mexico, Argentina, Chile): quoted on application
Cosmetic regulation outside the EU and UK does not fall behind a single instrument. Each major market has its own framework, its own ingredient lists, its own language obligations, and its own enforcement posture. The credibility of a safety dossier rests on knowing all of them, and the work is led by the same qualified safety assessor who signs our EU and UK CPSRs, working from the same evidence base.
Where markets converge in substance, a single Product Information File can carry the additional jurisdiction-specific annexes that a multi-market product needs, rather than requiring a separate dossier for each. Where they diverge, the divergence is treated explicitly.
The markets we prepare
Canada. Cosmetic Notification Form preparation under the Food and Drugs Act and the Cosmetic Regulations (C.R.C., c. 869), with an ingredient-by-ingredient review against the Health Canada Cosmetic Ingredient Hotlist and a written compliance report. £395.
Australia. An AICIS Compliance Statement, with an Inventory cross-check on every ingredient, a use-restriction review, an assessment against the Consumer Goods (Cosmetics) Information Standard 2020, TGA jurisdiction confirmation, and an ACCC compliance note, for inclusion in the PIF as the Australia annex. £149, in addition to a CPSR engagement.
New Zealand. An EPA Cosmetic Products Group Standard 2020 Compliance Statement, cross-referencing every ingredient against Schedules 4 to 8 (as amended January 2026), with a PFAS phase-out attestation, IFRA fragrance verification, a nanomaterial notification check, and EPA HSNO approval confirmation. £179, in addition to a CPSR.
ASEAN. A Cosmetic Directive Documentation Package restructuring the safety dossier into the four-part ASEAN Product Information File format, cross-referenced against ASEAN Annexes II to VII, with an ASEAN-format safety assessment summary, IFRA verification, and GMP and Free Sale Certificate guidance. £249, in addition to a CPSR. Country-specific filing is a separate engagement and requires a Responsible Person registered in each ASEAN member state.
GCC and Latin America. The GCC Technical Regulation framework (Saudi Arabia, the United Arab Emirates, Bahrain, Kuwait, Oman and Qatar), and Latin American markets through the Mercosur common framework and individual filings for Brazil (ANVISA), Mexico (COFEPRIS), Argentina (ANMAT) and Chile (ISP). Quoted on application.
All fees are exclusive of VAT.
Frequently asked questions
Which international markets does Oxford Biosciences cover?
Beyond the EU and UK, Oxford Biosciences prepares the United States MoCRA Toxicological Risk Assessment (£395), the Canadian Health Canada Cosmetic Notification (£395), the Australian AICIS Compliance Statement (£149), the New Zealand EPA Group Standard Compliance Statement (£179), and the ASEAN Cosmetic Directive Documentation Package (£249), with GCC and Latin American markets (Brazil, Mexico, Argentina and Chile) quoted on application. Where markets share an evidence base, a single Product Information File carries the jurisdiction-specific annexes rather than requiring a separate dossier for each.
What is MoCRA?
MoCRA, the Modernization of Cosmetics Regulation Act 2022, is the first comprehensive federal cosmetics law in the United States. It amended the Federal Food, Drug, and Cosmetic Act to require registration of manufacturing facilities with the FDA, product listing, adequate substantiation of product safety, adverse event recordkeeping and reporting, and a named responsible person. Oxford Biosciences prepares the MoCRA-compliant Toxicological Risk Assessment that substantiates safety, with the relevant US state provisions addressed alongside it.