As UK businesses look to grow through international trade, one document often becomes crucial when exporting to certain markets: the Certificate of Free Sale (CFS). But what is a Certificate of Free Sale, exactly, and why might you need one?
In the UK, a Certificate of Free Sale confirms that a product is freely sold and complies with domestic health and safety laws. Although it’s not a standard export document for every product, it’s a key requirement in many countries that don’t have comparable regulatory standards. In particular, if you’re exporting healthcare products, cosmetics, food, drink, or medical devices, it’s likely that a CFS will be required by the importing authority. Often, the CFS will need notarisation and an apostille in order to be legally valid overseas.
In this guide, we’ll walk you through what a Certificate of Free Sale is, who may need one, how to get one, and how we can help with authentication processes.
What is a Certificate of Free Sale (CFS)?
A Certificate of Free Sale (CFS) is an official document that confirms a product can be legally sold in the open market of the UK. It certifies that the product complies with all relevant UK regulations, such as those set by the UK government or bodies like the Health and Safety Executive (HSE) or the Medicines and Healthcare products Regulatory Agency (MHRA).
Although sometimes referred to as an export certificate, a CFS or export statement, it’s important to note that a CFS is not an endorsement of a product’s quality. It simply shows that the product may be freely sold in the UK and therefore meets domestic regulatory requirements.
Importing countries − particularly those with developing or evolving regulatory authorities − often request a CFS to verify that the exported goods meet acceptable safety and health standards.
Common products requiring a CFS include:
- Cosmetics and food items
- Medical devices
- Pharmaceutical products
- Plant protection products
- Biocidal products (typically used to manage pests and microbes)
While not mandatory for all UK exports, a CFS is often necessary for entering foreign markets, especially when the importing country lacks its own product regulatory framework.
When Do You Need a Certificate of Free Sale for Exporting?
If you’re planning to export goods overseas, there’s a good chance you’ll be asked to present a CFS. Why might you need a certificate like this?
Importing authorities use the CFS to ensure that the products they’re receiving have already been approved for sale in their country of origin − in this case, the UK. This adds a layer of protection to their markets and helps prevent the import of unsafe or unregulated goods.
Here are some of the most common reasons you might need a Certificate of Free Sale:
- Product registration in the destination country
- Customs clearance
- Meeting health and safety requirements imposed by the importing authority
- As part of a free trade agreement (FTA) process
Certain regions, such as the Middle East, Asia, and Latin America, often request a CFS, especially for cosmetics, medical or healthcare products, and food and drink items.
Failing to present a required CFS can lead to serious consequences for your business, such as:
- Shipment delays
- Rejection by customs
- Additional fees or fines
- In some cases, the return or destruction of the goods
In short, having a CFS demonstrates that your products are legitimate, comply with UK health and safety standards, and are thus fit for sale in overseas markets.
What Information is Typically Included in a Certificate of Free Sale?
Although formats may vary slightly depending on the issuing body, a CFS typically includes the following:
- A unique certificate number
- The date of issue
- A description of the product(s)
- The name, address and VAT number of the manufacturer
- Occasionally the exporter or distributor’s details
- Confirmation that the products are freely sold in the UK
It’s important to note that some information − such as the manufacturer or exporter details − are often provided by the applicant and may not be independently verified by the issuing authority. This disclaimer is commonly included on certificates issued by bodies such as the Health and Safety Executive (HSE).
For medical devices, particularly those intended for sale within the EU, the CFS should also include:
- The Basic UDI-DI (Unique Device Identification – Device Identifier), where applicable
- The CE Certificate reference number, especially for devices above Class I that require notified body approval
If the product is regulated under UK law (post-Brexit), the UKCA mark and any relevant UK Approved Body number may also be referenced, depending on the export destination and local authority requirements.
Who Issues Certificates of Free Sale in the UK?
The authority responsible for issuing a CFS in the UK depends on the type of product. Here’s a breakdown:
Department for Business and Trade (DBT) – Issues CFS for general products not regulated by other specialist bodies. It also issues Certificates of Manufacture and Good Manufacturing Practice Certificates (for exporting cosmetics to China).
Health and Safety Executive (HSE) – Issues CFS and export statements for:
- Biocidal products
- Active substances under COPR (Control of Pesticides Regulations) or GB BPR (Great Britain Biocidal Products Regulation – the post-Brexit version of the European Union Biocidal Products Regulation)
- Plant protection products
Medicines and Healthcare products Regulatory Agency (MHRA) – Issues CFS for:
- Medicines
- Medical devices
- Note: A CFS is not issued for in-vitro diagnostic medical devices used for performance evaluation, as these are not yet fully authorised to be freely sold in the UK.
Rural Payments Agency (RPA) – Handles food, drink, and nutritional supplements.
Department of Health and Social Care (DHSC) – For medicinal products, although the MHRA typically leads for medicines.
Department for Environment, Food and Rural Affairs (Defra) – For veterinary medicines or products animals come into contact with.
Businesses are advised to identify the appropriate authority for their product category and apply for a certificate via the relevant channel.
Important Considerations for Cosmetics
Since the UK’s entry into the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) in July 2023, some rules have changed for cosmetic exports.
Under Article 19 of the Cosmetics Annex 8-D, a Certificate of Free Sale for cosmetics is no longer required for marketing or selling products in the following countries:
- Australia
- Brunei
- Chile
- Japan
- Malaysia
- New Zealand
- Peru
- Singapore
- Vietnam
However, Canada and Mexico are not yet ratified members, so a CFS is still needed when exporting cosmetics there. Exporters should monitor updates from the DBT regarding changes in requirements.
How to Apply for a Certificate of Free Sale in the UK
To apply for a Certificate of Free Sale, start by identifying the issuing authority relevant to your product:
- Visit GOV.UK to find information and access online forms
- Contact MHRA for medical devices (registration required via their online platform, DORS)
- Use HSE’s application portal for biocides and pesticides
- Approach RPA for food items and supplements
- Reach out to DBT if no specific authority applies
You’ll usually need to provide:
- Product details
- Manufacturer details
- Evidence of UK sale (e.g. invoices, packaging)
- A declaration that the information provided is entirely the responsibility of the applicant
Most CFSs are issued digitally, but they can be printed and presented with a seal if needed.
How We Can Help You with a CFS for Foreign Markets
Many foreign governments won’t accept a CFS unless it has been notarised and – in some cases – legalised with an apostille and (on occasion) further consularised / legalised by the destination country’s embassy or consulate in the UK.
At Notary.co.uk, we provide comprehensive support with your Certificate of Free Sale:
- We verify the authenticity of your CFS with the issuing body (e.g. MHRA)
- We issue a notarial certificate confirming authenticity
- We help you get a CFS or export document apostilled by the Foreign, Commonwealth & Development Office (FCDO)
- For non-Hague countries, we facilitate embassy legalisation / consularisation
- We offer standard and premium services, depending on your urgency
To begin the process, you’ll typically need the original CFS document, often received as a digital file from an issuing body like MHRA or HSE.
Let us guide you through this often complex but vital step in ensuring your products can reach international markets with regulatory compliance fully in place.
Conclusion
A Certificate of Free Sale is more than just a piece of paper − it’s a key to unlocking global opportunities for UK exporters. Whether you’re shipping medical devices, cosmetics, food, or pharmaceutical products, a CFS shows that your goods comply with UK standards and are suitable for sale abroad. Navigating the application and legalisation process can be daunting, especially when foreign markets demand additional authentication.
That’s where Notary.co.uk comes in. We make it simple to notarise, apostille, and legalise your business documents, such as your Certificate of Free Sale, so your business can grow internationally with confidence. Contact Notary.co.uk today to find out how we can help.