FSSC 22000 for manufacturers of dietary supplements and functional foods

The market for dietary supplements and functional foods is growing in Poland and Europe at a rate of over ten per cent annually. Along with this growth, regulatory pressure and the expectations of trading partners towards manufacturers are increasing – more and more distributors, pharmacy chains and e-commerce platforms are requiring a documented food safety management system as a condition of cooperation. FSSC 22000 is the standard in this sector, addressing both market requirements and the specific challenges associated with the production of this category of products.

Dietary supplements and the scope of FSSC 22000 certification

The first question asked by dietary supplement manufacturers considering FSSC 22000 certification is one of scope – do supplements fall within the scope of the scheme at all, and if so, in which product category?

FSSC 22000 v6 provides a clear answer to this question. Dietary supplements classified as food under the national legislation of the country of manufacture are eligible for certification under Category C – covering the processing and production of foodstuffs stable at ambient temperature. This includes tablets, capsules, powders, liquids and other forms of supplements manufactured and packaged under production conditions. Important note: if a product is classified as a pharmaceutical or medical device under national law, it is not subject to FSSC 22000 certification – in such cases, the relevant standards are pharmaceutical GMP.

The relevant technical specification for manufacturers of Category C supplements is ISO/TS 22002-1, which sets out detailed PRP requirements for food production: facility infrastructure, pest control, staff hygiene, allergen management and cleaning. Manufacturers of liquid supplements or those requiring refrigeration may be subject to additional requirements depending on the specific nature of the process.

Specific challenges for manufacturers of dietary supplements and functional foods

The production of dietary supplements and functional foods involves several areas which, under FSSC 22000, require particular attention and are often the subject of non-conformities during audits.

1. Management of active ingredients and high-risk raw materials

Dietary supplements often contain ingredients with high biological activity – plant extracts, concentrated doses of vitamins, probiotics, enzymes and fatty acids. FSSC 22000 requires a detailed risk assessment to be carried out for each raw material, taking into account not only microbiological and chemical hazards, but also the risk of food fraud (food fraud). The market for supplement raw materials is particularly susceptible to fraud – dilution of extracts, substitution of plant species, and under-declared levels of active ingredients. The requirement for a vulnerability assessment is particularly important here and is scrutinised with special attention by auditors.

2. Allergen management

Dietary supplements very often contain allergens or are manufactured on production lines where the risk of cross-contamination is high – gelatine (an allergen for people with fish or beef allergies), lactose as a carrier, nuts or soya in plant-based products. FSSC 22000 requires a comprehensive allergen risk assessment, procedures to prevent cross-contamination, validation of cleaning processes and clear labelling. For manufacturers targeting consumers with special dietary requirements (vegetarians, vegans, people with coeliac disease), this is a particularly sensitive area.

3. Environmental monitoring

The requirement to monitor the production environment – particularly for environmental microorganisms such as Listeria – is a mandatory requirement under FSSC 22000 v6 for establishments producing ready-to-eat food. Supplements in the form of powders, capsules or tablets require a tailored monitoring programme that takes into account the specific characteristics of dry production environments.

4. Labelling and regulatory compliance

Supplement manufacturers operate in a highly regulated environment – Regulation 1169/2011 on consumer information, regulations on health and nutrition claims, and national registration requirements. FSSC 22000 requires that the management system ensures labelling complies with legal requirements and the declared composition. Non-conformities in this area – incorrect allergen declarations, incorrect nutritional values – are treated as serious non-conformities.

Why is FSSC 22000 gaining in importance in this sector?

For years, the dietary supplements market has operated without certification pressures comparable to those that have long shaped the conventional food market. This is changing. Three factors are driving increased interest in FSSC 22000 certification amongst manufacturers in this sector.

Firstly, the requirements of the distribution channel. Large pharmacy chains, chemists and e-commerce platforms are increasingly requiring supplement suppliers to have a documented food safety management system. In this context, FSSC 22000 certification serves as a means of eliminating the need for qualification audits for each individual customer.

Secondly, export expansion. Manufacturers targeting Western European markets – Germany, France, the Benelux countries and the United Kingdom – face expectations from distributors and trading partners regarding GFSI certification. FSSC 22000 is the most flexible and widely recognised choice in this regard.

Thirdly, growing interest from regulatory authorities. The Chief Sanitary Inspectorate and regulatory bodies in other EU countries are monitoring the supplements market ever more closely in terms of composition, labelling and production conditions. Possessing a certified food safety management system sends a clear signal to regulatory bodies that the manufacturer operates in a systematic and transparent manner.