FSSC 22000 for food supplements: what does the certification mean?

Food safety has been a top priority at BIOGENA for many years. BIOGENA has been certified to ISO 22000 since 2009. Since May 2025, our food safety management system has also been certified to the more comprehensive FSSC 22000 scheme within the defined scope.

This means that an independent certification body has confirmed that we meet the FSSC 22000 requirements for food safety.

For us, however, this certification is not the finish line, but rather another milestone in our quality concept – from the selection of raw materials through development and production to quality control.

You can find out more in our press release “BIOGENA receives FSSC 22000 certification”.

Under food law, food supplements are classified as foodstuffs. A structured safety and quality management system therefore plays a vital role, particularly for products containing vitamins, minerals, plant extracts or other concentrated ingredients.

This is not just about the finished product. What is crucial is the entire journey leading up to it: How are potential risks identified? How are they controlled? And, should the worst come to the worst, how can one trace what has happened to a specific batch?

If a deviation is detected in a raw material or a product batch, it must be clear which batch is affected and the route it has taken.

This is precisely where traceability comes into play. Raw materials, production batches and finished products are documented in such a way that relevant information can be traced along the production chain.

Food safety does not begin with the final inspection. FSSC 22000 starts much earlier: potential biological, chemical and physical hazards are systematically assessed and appropriate control measures are put in place.

These include, for example, guidelines on hygiene, cleaning, storage, pest control and the handling of raw materials. The aim is therefore to identify and control risks as far as possible before they become a problem.

The ingredients that end up in a product come from somewhere. That is why attention is also focused on suppliers, raw materials and outsourced services.

FSSC 22000 sets out relevant requirements for procurement processes and the control of externally supplied products and services. Requirements also apply to the methods and laboratories used for analyses carried out to verify or validate food safety.

FSSC 22000 certification is not based solely on self-declaration. Certification bodies carry out regular audits to check whether the requirements are actually being implemented.

And these audits may also take place unannounced. Within a three-year certification cycle, at least one surveillance audit must be carried out unannounced. This demonstrates whether the defined processes are not only prepared for the day of the audit, but also function effectively in day-to-day operations.

FSSC 22000 provides a rigorous and internationally recognised framework for food safety management.

However, a certificate tells only part of the story.

This is because other factors also play a role in the quality of a food supplement: Which raw materials are used? How are the formulations developed? What analyses are carried out? What additives and excipients are used? And what quality measures does a manufacturer implement beyond the requirements of certification?

For us at BIOGENA, FSSC 22000 is therefore part of a bigger picture. After all, quality does not arise at a single point, but through the interplay of many steps – from the scientific idea, through the raw materials and formulation, to production and analysis.

Our micronutrient supplements are produced in the BIOGENA GOOD HEALTH WORLD in Koppl near Salzburg – using traditional craftsmanship and with great attention to detail.

In doing so, we combine manual work with modern production technology: many stages of the process are deliberately carried out by experienced staff, whilst machines are used where particular precision is required.

This ensures that development, expertise in raw materials, production and quality management remain closely interlinked – and that key stages in the journey towards the finished supplement are fully traceable.

Quality should not merely be promised, but verifiable.

That is why every batch of our products is analysed. In addition to our internal quality processes, we also have batches tested by independent laboratories such as the LEFO Institute or Analytec.

Depending on the test plan, the focus is on different quality parameters – for example, nutrient content, heavy metals, microbiological purity or pesticides.

In this way, the analytical testing of the finished products complements our system-based food safety management system. To ensure maximum transparency, the laboratory results can be viewed at any time on the relevant product pages.

Before an idea can be turned into a finished product, one thing is essential above all else: the right raw materials.

BIOGENA relies on carefully selected and quality-assured premium and branded raw materials. It is not just a question of purity and quality. Bioavailability, scientific evidence and suitability for the specific formulation also play a role in the selection process.

After all, a well-designed product begins long before the first capsule is produced.

What does the formula really need? And what can we do without?

This philosophy underpins our micronutrient supplements. Since 2006, we have consistently avoided using numerous additives and excipients, provided they are not essential for the product in question.

These include, for example, artificial colours and flavourings, titanium dioxide and magnesium stearate. Unnecessary emulsifiers, binding agents, anti-caking agents and coating agents are also avoided wherever possible.

The aim: high-quality raw materials, well-thought-out formulations and as little as possible of anything that isn’t needed.

At BIOGENA, quality begins long before the first capsule is produced – namely with the question of what goes into it and why.

Our Quality & Science Team closely monitors the latest scientific findings on micronutrients, diagnostics and healthy lifestyles, and incorporates this knowledge into product development. In doing so, science, raw material selection, formulation development and practical feasibility all interplay. Our own product studies, as well as collaborations with laboratories, research institutions and therapy centres, complement this scientific approach.

After all, there is more to a good formulation than just a list of ingredients: it combines scientific findings with experience and expertise in raw materials.

For us, quality is not just a tick on a checklist. It is a process that is constantly evolving.

This is precisely what KAIZOGENA Q stands for – our holistic approach to quality, whose name is derived from the Japanese term Kaizen, the principle of continuous improvement.

Science, raw materials expertise, development, production, analysis and quality management are not viewed as separate stages, but as parts of a single, integrated system.

The philosophy behind this is not simply to meet standards, but to constantly question and refine our processes.

For us, excellence is not a state that is achieved once and then ticked off. It arises where quality is re-examined and refined every single day.

FSSC 22000 turns food safety into a structured process. Risk management, hygiene, traceability, supplier management, audits and continuous improvement are all interlinked – and are verified by independent certification bodies.

For BIOGENA, this certification is important additional proof of our commitment to food safety and traceable processes.

But our understanding of quality goes beyond that.

In-house production in Austria, independent batch testing, carefully selected premium raw materials, recipes stripped back to the essentials and scientifically-based product development complement the certified framework.

After all, ultimately, a single seal does not tell the whole story. It is the interplay of many steps – from the first raw material to the finished BIOGENA product.