Regulatory Expertise
Global Export Support
Taking one product into many markets without rebuilding the dossier each time. We hold a master evidence base and adapt it to each jurisdiction's requirements, including Certificates of Free Sale, apostille and legalisation, and sworn translation.
Exporting a cosmetic is rarely a matter of one approval that travels. Most markets require their own registration or notification, their own Responsible Person or local representative, and documentation in their own format and language. The efficient way to handle that is to build the science once and adapt it many times, from a single master evidence base, rather than starting each country from scratch.
A master evidence base, adapted per market
We maintain a master evidence base for a product, the safety assessment and the supporting data, and map it onto each target market rather than rebuilding it. The work is to identify the gaps that actually matter and close them once: an ingredient permitted in one market but prohibited in another, a UV filter on one positive list but not the next, a preservative within limits in the EU but capped differently in China, or a claim acceptable in one market and restricted in another. The same core science is then adjusted to each market’s lists and format rather than commissioned again.
The per-region gap analysis
A gap analysis runs each formulation, label and claim set against the target market along four axes: the permitted and prohibited substance lists, the concentration limits and mandatory warnings, the claims rules, and the filing and local-representative mechanics. What the analysis turns up differs sharply by region.
In the EU and UK the two regimes were once identical and are now diverging, so a product sold in both is checked against both annex sets (the EU’s 2026 Omnibus changes against Great Britain’s SI 2026/23), needs a Responsible Person established in each, and is notified separately through CPNP and SCPN. Northern Ireland follows the EU rules under the Windsor Framework, so it is treated as an EU destination rather than a GB one.
North America has no single positive ingredient list to work to. The United States regulates cosmetic ingredients largely by outcome under MoCRA, with facility registration, product listing and safety substantiation, while sunscreens, anti-dandruff products and similar categories fall outside cosmetics altogether as over-the-counter drugs. Canada works differently again, against the Cosmetic Ingredient Hotlist of prohibited and restricted substances, with a Cosmetic Notification Form filed to Health Canada and bilingual English and French labelling.
In East Asia the gateways are the most demanding. China requires notification of general cosmetics and registration of special cosmetics through the NMPA, with ingredients checked against the Inventory of Existing Cosmetic Ingredients in China and any new ingredient run through its own approval and monitoring route. Japan operates positive and negative ingredient lists and a separate quasi-drug category for certain functional products, and South Korea reviews functional cosmetics through the MFDS. The ASEAN markets share the harmonised ASEAN Cosmetic Directive and its annexes, close to the EU lists but not identical, yet notification is still made state by state, to the NPRA in Malaysia, BPOM in Indonesia and the national authorities elsewhere, with halal expectations relevant in several of them.
The Gulf states register through national authorities such as the Saudi FDA against the GSO technical regulations, with Arabic labelling and, almost always, a legalised Certificate of Free Sale. South Asia centres on India, where imported cosmetics are registered with the CDSCO under the Cosmetics Rules. Oceania splits the question in two: Australia controls the introduction of cosmetic ingredients through AICIS while regulating sunscreens as therapeutic goods under the TGA, and New Zealand works to the EPA’s cosmetic products group standard. Across Latin America the pattern is national registration or notification, graded by risk, with Brazil’s ANVISA tiering products into lower-risk and higher-risk categories, and a legalised or apostilled Certificate of Free Sale required widely. Africa is the most heterogeneous of all, ranging from national registration with bodies such as Nigeria’s NAFDAC to markets that lean on standards and a Certificate of Free Sale, so each is assessed individually.
The fuller treatment of each sits on our jurisdiction pages for the EU, UK, North America, the GCC, ASEAN, East Asia, Oceania, South Asia, South America, Central America and Africa. The output of the gap analysis is a per-market action list: where the formulation passes as it stands, where a substance or concentration has to change, where a claim has to be dropped or re-evidenced, and which filing and representative each market needs.
Certificates of Free Sale
Many importing authorities, particularly across the Middle East, Asia, Africa and Latin America, require a Certificate of Free Sale before they will register an imported cosmetic or release it at the border. A Certificate of Free Sale is an official document confirming that the product is freely and legally sold in its country of origin and meets that country’s requirements. In the United Kingdom it is typically issued by the relevant authority or a chamber of commerce on evidence that the product is compliant and on sale. Because it is a foreign-facing document, it rarely travels as issued; it usually has to be authenticated for the destination.
Apostille, legalisation and translation
Authentication takes one of two routes. For a destination party to the 1961 Hague Apostille Convention, a single apostille certificate, issued in the UK by the Foreign, Commonwealth and Development Office, validates the document for use there. For a destination outside the convention, full consular legalisation is required: the document is notarised, legalised by the FCDO, and then legalised again by the destination country’s embassy or consulate. Either route can be preceded by notarisation and followed by a sworn or certified translation into the destination language. Each step adds time, and the requirements differ by country, which is why the chain is mapped before a launch rather than discovered during one.
Sequencing a multi-market launch
The value in handling export centrally is sequencing. The documentation chain, notification or registration, Certificate of Free Sale, apostille or legalisation, and translation, runs differently in each destination and on different timelines. We coordinate them so several markets proceed in parallel rather than one slow country at a time, and so a single delay, a pending legalisation or a translation in progress, does not hold up the markets that are ready.
How we help
We hold the master evidence base, run the per-market gap analysis against each jurisdiction’s lists, prepare the market-specific dossiers, and coordinate the Certificates of Free Sale, apostille or legalisation, and translations. Where a market requires a local Responsible Person or agent, we arrange or provide it as a separate engagement, so a brand can run a multi-market launch through one point of contact rather than assembling a different supplier in every country.
Relevant services
Global Markets
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.
Learn more →Responsible Person
From £149 · per product, per year
Oxford Biosciences acts as your Responsible Person in the UK and the EU under a single quality management system, holding the regulatory obligation: PIF maintenance, SCPN and CPNP notification, labelling oversight, and cosmetovigilance.
Learn more →CPSR
From £70 · 2 to 3 days
The Cosmetic Product Safety Report is the safety assessment required under Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product may be placed on the UK or EU market. Prepared and signed by a qualified safety assessor.
Learn more →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 a Responsible Person?
Every cosmetic product placed on the EU or UK market must have a Responsible Person established within that jurisdiction. Under Articles 4 and 5 of Regulation (EC) No 1223/2009, the Responsible Person is the legal entity that holds the regulatory obligation for the product: it maintains the Product Information File, makes the CPNP or SCPN notification, oversees labelling, and handles cosmetovigilance and contact with the competent authority. It is not simply a postal address. Oxford Biosciences acts as Responsible Person in both the UK and the EU under a single quality management system.
What is a CPSR?
A Cosmetic Product Safety Report (CPSR) is the safety assessment required by Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product is placed on the UK or EU market. Annex I sets out two parts: Part A, the cosmetic product safety information (composition, physico-chemical and microbiological characteristics, stability, exposure and the toxicological profile of each substance), and Part B, the safety assessment, in which a qualified assessor states and reasons the conclusion on safety. It is the pivotal scientific document held within the Product Information File.
What is a Certificate of Free Sale and when do I need one?
A Certificate of Free Sale confirms that a product is freely and legally sold in its country of origin. Many importing authorities require one before they will register or admit an imported cosmetic, often legalised or apostilled, and sometimes with a sworn translation.
What is the difference between an apostille and legalisation for export documents?
An apostille is a single certificate that authenticates a document for any country party to the 1961 Hague Apostille Convention. For countries outside the convention, full consular legalisation through the destination's embassy is needed instead, often after notarisation and government legalisation.
Can one safety assessment be used to sell a cosmetic in several countries?
The underlying safety science can be reused, but the filing cannot. A single master evidence base supports many markets, yet each needs its own assessment format, registration or notification, and usually its own local representative, with the formulation re-checked against that market's ingredient lists.