SPS

Dorian Rosca

Customs Manager

Biological material is frequently transported internationally, being a key part in the growth and development of the pharmaceutical and life science sector. As with all other cross-border freight, biological material is subject to customs formalities. 

Transporting biological material is typically for the purpose of scientific research, such as in clinical trials or in the research of infectious diseases. 

An example could be a science institute based in Britain, importing blood swabs from Africa to conduct research on a certain type of malaria. It can be human cells from a cancer patient being exported from the UK to a university in the US for scientific testing. There is a growing need for safe, efficient transport.

What is biological material?

Biological material is a broad term that refers to material derived from, or produced by, biological organisms and other living forms. Examples include blood/plasmids, bacteria, viruses, micro-organisms, genetically modified organisms (GMO), toxins of biological origin, seeds, fungi, and antibodies.

How to transport biological material?

When thinking of sending bio material, we need to consider customs, temperature and the routing path.

To find out the customs requirements for your material, you first need to identify what category your material falls under.

This is a necessity as all shipping must meet International Air Transport Association & role (IATA) requirements. IATA is the global regulatory organisation which decides the rules for transporting biological material and other items..

Here are the international IATA categories that need to be adhered to:

  • Category A –  
    • “Infectious substances, affecting humans” (UN 2814)
    • “Infectious substances, affecting animals” (UN 2900)
  • Category B – 
    • UN 3373, Biological substance
  • Genetically modified organisms (GMO) Class 9 –
    • UN 3245 Genetically modified microorganisms
  • Exempt substances  –
    • not subject to the regulatory requirements

Cat A material is, as defined by IATA, “an infectious substance, which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals”. Some examples are materials infected by HIV or COVID-19.

Cat B includes infectious substances that do not meet the criteria of category A. In addition to pathogens, this category includes human or animal material such as excreta, secreta, blood, tissue, and body parts transported for research, diagnosis, disease treatment or prevention.

Genetically modified organisms (GMO), or genetically modified microorganisms (GMM), are usually classified as either Cat A or Cat B. However, if there are alterations to the material that are not the result of natural reproduction, they are classified as ‘Miscellaneous Dangerous Goods’.

Exempt substances are specimens in which there is minimal likelihood that pathogens are present and are not subject to other provisions of regulations, provided they are marked with the words “exempt human specimen” or “exempt animal specimen”, and are packaged according to the IATA regulations. This is often overlooked in international shipping; senders are still marking exempt substances as Cat B.

Must-have customs requirements for transporting international material

You should contact clearBorder for advice before packaging and transporting biological material. Cat. A, infectious substances are highly regulated and compliance is crucial to avoid costly delays and penalties. 

The table below shows the minimum requirements to be considered for international shipping.

Shipping Biological material Cat A Cat B Exempt
Requirements
Packaging
Leakproof packaging Y Y Y
Rigid outer packaging Y Y Y
Cushioning/Absorbent materials Y Y
Package orientation label Y
UN Mark Y Y
Responsible person label Y
Proper shipping name Y Y
Exempt specimen label Y
Secondary packaging e.g. IATA 620 Y Y
Paperwork
Shipper & Consignee information Y Y Y
Customs invoice Y Y Y
IATA DG Dec or Multi-Modal Y
*Additional documents depending on the country intended for

Additional documentation and customs formalities may be required depending on the countries you are importing or exporting to. As an example, if you are sending biological material to the US, there is the requirement for an additional document called a Centers for Disease Control and Prevention(CDC) which will need to travel with the shipment, and even more additional documents such as a USDA statement and/or permit depending on what type of biomaterial is transported. You can contact clearBorder consulting. We will provide you with the relevant customs templates and advice to meet the destination country’s requirements.

Proper packaging and labelling are crucial for shipping biological materials, as the transit temperature directly impacts the success of a study. Temperature excursions can render the material unusable, wasting time and investment. For instance, a shipment of blood tubes on dry ice losing its cooling could render the blood expired and redundant for testing. Monitoring devices help ensure temperature compliance, preventing costly issues in pharmaceutical/biological sample deliveries.

Temperature Controlled transit

The table below shows the commonly used temperatures for shipping.

Temperature Purpose
Ambient The temperature of the surrounding environment. This can vary depending on the time of year or the geography. With ambient temperature, there is no safeguarding of a temperature range. On occasion, this is used for quick turnaround studies of blood or saliva swabs. It reduces the requirement for temperature control during transit. However, sometimes a fast end-to-end delivery is required to ensure the sample does not expire.
Controlled Ambient +15C to +25C Also known as room temperature, controlled ambient is commonly used in sending high value pharmaceutical drugs and in some studies of biological samples.
Refrigerated +2C to +8C While typically a less used option as of reduced long-term storage capability, refrigerated temperatures are optimal for short-term storage of frequently used biological reagents, such as enzymes and antibodies.
Frozen -15C to -25C This temperature range is utilised for many types of biological samples such as blood, tissue and cells. When material is frozen it preserves the material in such a way that analysis can take place a significant amount of time after the material was made available.
Dry Ice -20C to -80C Dry Ice shipping has much the same benefits of frozen shipping but is utilised more frequently. The ability to replenish dry ice can happen without the constant need for the use of a freeze room or harder to source frozen gel packs. The temperature can be maintained easily though different tranships and whereabouts of the shipment.
Deep frozen Dry Ice -60C to -80C Dry ice shipping and deep frozen dry ice shipping usually average below -70C, but when deep frozen dry ice is requested, more monitoring and regular replenishment should take place to safeguard colder temperatures. 
Cryogenic -150C to -190C Cryogenic storage is often deemed the gold standard for long-term storage of biological samples. At these extreme temperatures, all biological activity is suspended and no degradation occurs. Cryogenic freezing is ideal for sensitive samples and specimens. This is often used for transporting types of cells. Liquid nitrogen vapour is used to maintain this temperature range.

It is best to seek expert advice on finding the right temperature-controlled containers and transport courier/freight forwarder options who accommodate temperature controlled transit and minimise temperature excursions.

There are a range of reasons why you, your organisation, or a staff member might send biological materials. It could be groundbreaking scientific research and can help save lives.

Whatever the case, if you conduct cross-border operations and require some expert, independent advice on gaining the clearances you require, we are here to help.

Here at clearBorder, we offer training to help get your team border-ready. You can take advantage of our expert consultancy services for bespoke advice and practical guidance on ensuring your operations run smoothly, efficiently and profitably, both now and in the future. Just contact us today to speak to a member of our team.

 

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Why Digital SPS Compliance is a Growing Challenge for UK Food & Agri Exporters

International SPS compliance is undergoing a digital transformation. However, as countries move away from paper documentation toward electronic platforms, UK food and agricultural exporters also face new operational challenges. Each export market operates its own digital platform, complete with unique technical specifications and documentation standards. In this guide, we’ll explore the evolving challenges of digital SPS compliance. We’ll discuss the key issues businesses face with the UK’s digital compliance system, examine international certification requirements, and offer practical strategies to ensure compliance in different markets. Looking for clarity on digital SPS requirements? Contact clearBorder for a tailored consultation. Electronic Certificates: Modern SPS Solutions Digital sanitary and phytosanitary (SPS) compliance is changing how trading partners manage agricultural and food product certification. Many countries have shifted from paper documentation to electronic certificates, enabling faster processing and improved SPS compliance. Digital solutions allow users to secure, submit, and archive essential health and protection documents. This ensures compliance and enhances transparency in international trade. Major trading authorities worldwide now require electronic certification through various platforms. For businesses, digital SPS solutions make it easier to submit and store SPS certificates, but adapting to different systems across various markets can present many challenges. SPS Compliance: Digital Infrastructure in the UK In the UK, agricultural businesses are required to use the Export Health Certificate (EHC) Online system to obtain digital SPS certificates when exporting animals and animal products. An EHC confirms that animal exports meet the SPS requirements of the destination country. 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Technical problems include system downtime, slow resolution of queries, and difficulties in document retrieval. These issues are particularly challenging for smaller agricultural businesses, which have fewer employees to handle technical issues with SPS compliance. Many organisations also struggle to understand SPS documentation requirements and follow the appropriate guidelines. The situation is further complicated when exporters need to interact with multiple countries’ SPS systems, each with its own technical specifications and requirements. This complexity increases both operational costs and the risk of non-compliance. International SPS Certificates & Compliance Requirements Every country has its own digital SPS compliance system and SPS certificate requirements. The EU’s TRACES NT system is the most comprehensive SPS platform, requiring full digital certification for animal products, plants, and organic goods. All UK traders exporting to the EU must register and maintain active profiles, with certificates needing pre-notification and validation through the system. Other key international platforms include: PGA (United States): Exporters must use the Partner Government Agencies (PGA) system through US Customs and Border Protection. Digital submission of SPS certificates is required via the Automated Commercial Environment (ACE). Single Window (China): UK exporters must register on China’s Single Window platform. Digital copies of health certificates must be uploaded to the system before shipment. Original paper certificates are still required alongside digital submissions. NACCS (Japan): Exporters need to submit SPS certificates through the Nippon Automated Cargo and Port Consolidated System (NACCS). Pre-arrival notification is mandatory, with specific timeframes for different agricultural products. 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Cost & Operational Impact of Digital SPS Compliance Digital SPS compliance systems create substantial operational and financial burdens for UK exporters. For example, companies must invest in multiple software subscriptions, system upgrades, and technical infrastructure to meet varying international requirements. For smaller businesses, these costs can represent a significant portion of their operating budget. Staff need ongoing training to stay current with various digital systems and documentation rules. Companies must also manage their paperwork across different platforms, each with its own requirements for record-keeping and storage. This complexity often requires businesses to invest in specialised document management systems. These challenges can cause certification delays, potentially leading to delays at customs, increased storage costs, and compromised product shelf life. Building an Effective Compliance Strategy Digital SPS compliance requires a strategic approach. 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Expert Support to Improve Compliance At clearBorder, our trade specialists help UK businesses of all sizes navigate digital SPS compliance through specialised consulting and training.  Our expert team stays current with evolving SPS certificate requirements across key markets, including the EU, the US, and Asia. We also provide targeted advice to help businesses prepare for upcoming changes in digital certification.  Our tailored training courses help teams understand every aspect of international trade and SPS compliance. We give employees the tools and knowledge needed to stay up to date with SPS requirements, navigate digital systems efficiently, and ensure customs compliance. Our trade expertise is not limited to SPS compliance. The trade specialists at clearBorder help businesses improve every aspect of their international trade operations, including export control compliance, supply chain optimisation, and freight forwarding. 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Exporting Food Products To France From the UK? Read This First

Expanding to new markets can be an exciting opportunity for businesses,  but it can also be filled with challenges. Entering a new market requires careful consideration in many areas, from understanding local consumer preferences to establishing reliable distribution networks. Despite the geographical proximity, these considerations are just as important for UK businesses looking to export food products to France. In this guide, we’ll walk you through the essential aspects of exporting food products to France from the UK. We’ll explore some promising opportunities in the French market and explain the importance of understanding consumer preferences, regulatory requirements, and shipping strategies. Contact clearBorder for personalised advice on exporting to France from the UK. Opportunities in the French Food Market The French food market presents a wealth of opportunities for UK exporters. With France’s strong economy and proximity to the UK, exporting food products to France is a logical and potentially lucrative strategy for British businesses looking to expand their international presence. Known for their culinary sophistication, French consumers boast high spending power and a deep appreciation for quality, diverse food products. This creates an ideal environment for British businesses to introduce unique offerings. Specific food categories, such as artisanal cheeses, premium teas, and organic products, show particular growth potential. The “British” brand is also often associated with quality and tradition by French consumers. By leveraging this perception, UK businesses can differentiate their products in a competitive market. In France, there’s also a growing demand for healthy food options that are free from artificial additives, giving UK businesses that offer healthy food options a promising opportunity to enter the market. 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With our freight forwarding expertise, we can manage your entire supply chain efficiently and help you determine the most efficient shipping strategies to get your product to the French market. clearBorder’s consultancy services can help you determine the most efficient shipping methods and strategies. Understand French Customs and Import Procedures Navigating French customs and import procedures involves many steps. Here are some key considerations for UK companies exporting food products to France: UK businesses must obtain an Economic Operator Registration and Identification (EORI) number, which is essential for customs declarations and tracking shipments. As part of the customs clearance process, businesses must also submit a customs declaration, including detailed information about the goods, their origin, and their value. Import VAT is generally charged at 20% for most food products, though some items may qualify for reduced rates. 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As part of our export services, we also help with documentation preparation, customs declarations, and VAT registration. By working with clearBorder you can reduce the risk of costly delays, fines, or compliance issues. By leveraging our deep understanding of UK and French regulations, we can also help you anticipate issues and implement proactive solutions. Contact clearBorder to ensure smooth entry to the French market.

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Essential French Food Safety Standards for UK Businesses

France’s reputation for culinary excellence is matched by its rigorous approach to food safety and quality standards. This makes compliance not just a legal requirement, but a necessity for market entry and long-term success. In this article, we’ll discuss the French food safety standards and regulations that UK businesses need to know when exporting to France. From environmental considerations to consumer protection rules, this article will help you ensure your products meet all requirements and can be sold on the French market. Contact clearBorder for comprehensive support on French trade regulations.  France’s Reputation for High Food Standards France is renowned for its stringent food safety standards and culinary excellence. According to the 2022 Global Food Security Index, France ranks 6th globally in food quality and safety. But it’s not just the French government that prioritises food safety. In France, food is not just a necessity but a cultural cornerstone. The French treat food with reverence, which leads to this higher standard for food safety and quality. A 2019 Eurobarometer survey revealed that 60% of French consumers are personally interested in the topic of food safety, compared to the EU average of 41%. For UK businesses exporting food products to the French market, understanding and meeting French standards is not just a regulatory requirement but a key to gaining consumer trust and succeeding in the market. Overview of French Food Safety Agencies France’s food safety landscape is primarily governed by the French food safety agency known as ANSES. ANSES plays a crucial role in safeguarding consumer and public health. Its responsibilities extend beyond food safety to encompass environmental and occupational health risks. ANSES also conducts risk assessments, provides expert scientific opinions, and coordinates research activities. Working alongside ANSES, the Directorate General for Food (DGAL) oversees food safety policies and controls, while the Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) ensures fair trade practices and product conformity. These bodies collaborate to maintain France’s high food safety standards and ensure consumer health. Key Food Safety Regulations The Role of European Union Regulations EU-wide regulations form the foundation of French food safety standards. Several key EU regulations that directly impact food businesses operating in France include: General Food Law: Establishes the general principles and requirements of food law, including food safety, traceability, and risk analysis. Food Hygiene Package: A set of regulations that outline specific hygiene rules for food of animal origin and official controls. Food Information to Consumers Regulation: Outlines the requirements for food labelling, including mandatory nutrition declarations, allergen information, and origin labelling for certain products. Maximum Residue Levels (MRLs): Regulations on MRLs set the maximum levels of pesticide residues permitted in food and animal feed. While the UK has retained some EU legislation on food safety following Brexit, UK businesses face many new challenges when exporting food products to the EU. UK exporters must now comply with EU import requirements as a third country. This includes: Obtaining health certificates for products of animal origin Adhering to EU labelling standards Complying with EU rules on food additives, flavourings, and enzymes Meeting EU requirements for food contact materials France’s Food Safety Standards French food safety regulations are among the most stringent in Europe, often going beyond EU standards. For example, French regulations mandate more detailed traceability documentation for food products, requiring more comprehensive tracking of food origins and production processes compared to basic EU standards. Compared to UK standards, French regulations are often stricter in areas such as GMO restrictions and animal welfare requirements. UK businesses must receive authorisation from the DGPP (French Authority for Protection of Populations) to sell products in France, and demonstrate compliance with local regulations. The French government is always implementing new food safety standards as well. Upcoming changes include enhanced regulations on food contact materials, with France set to ban the use of bisphenol A (BPA) in all food packaging by 2025, a move that goes further than the EU’s current restrictions. UK businesses must stay up-to-date with both EU and French-specific regulations to ensure compliance and maintain market access. Failure to comply with these regulations can result in penalties, product recalls, and damage to brand reputation. With personalised trade consulting from clearBorder, UK businesses can understand all relevant French and EU regulations, ensuring smooth market entry and ongoing compliance. Environmental Considerations France also prioritises environmentally friendly practices in food production. For example, the AGEC law aims to reduce waste and promote a circular economy by banning single-use plastic packaging for fruits and vegetables. Animal health and welfare standards are also strict, with France often exceeding EU minimums. Plant health regulations are equally robust, with strict controls on pesticide use and GMO cultivation. For example, the Ecophyto II+ plan aims to reduce pesticide dependency while promoting alternative pest control methods. UK exporters must be aware of French environmental standards, as they impact production methods and the requirements for plant and animal products entering the French market. Consumer Protection Regulations France has stringent regulations regarding consumer protection and information in the food sector. Labelling requirements are comprehensive, mandating clear information on ingredients, allergens, nutritional content, and origin.  Advertising regulations also prohibit misleading claims and restrict the marketing of unhealthy foods to children. France’s traceability requirements are among the most rigorous in the EU, with the “one step back, one step forward” principle ensuring full supply chain visibility. Transparency is further enhanced by regulations that require disclosure of production methods and the use of GMOs. UK exporters must ensure full compliance with these regulations to operate in the French market. How to Stay Compliant with French Food Safety Standards To navigate the complex French food safety landscape, UK businesses must take a proactive approach. Businesses can stay informed about regulatory changes by consulting with official sources like ANSES or reaching out to industry associations. French partners can provide invaluable knowledge of French regulations and standards, facilitating smoother market entry and ongoing compliance. Businesses should also invest in robust quality control and assurance systems to consistently meet France’s high food safety standards. clearBorder provides tailored trade support to UK businesses, helping them comply with French and EU regulations. Our experts stay up to date on the latest regulatory changes and can assist with customs compliance, import and export controls, and freight forwarding.  With our extensive knowledge and experience in cross-border trade, we can identify potential issues and resolve them before they cause problems, saving you time and resources. Contact clearBorder today to ensure full compliance with French food standards.

Essential French Food Safety Standards for UK Businesses
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