Before you start reading - if you already have a product on the market with promises about the health effects of postbiotics, check your label. The chances that it contains prohibited claims are around 70%. I am not trying to scare you - I am simply saying what I see in practice.
What are postbiotics and why the law has stalled on them
Postbiotics are metabolites, cell wall fragments, and dead cells of probiotic bacteria. In other words, what remains after the bacterium multiplies and dies. They sound less glamorous than probiotics, but marketing has adapted. The problem is that EFSA - the European Food Safety Authority - has issued practically no Scientific Opinion confirming a direct impact of postbiotics on weight loss.
Regulation (EC) No 1924/2006 (this is our bible - the regulation on nutrition and health claims) requires for every health claim either an EFSA Scientific Opinion or at least three scientific publications from the last five years. With postbiotics? Research is growing, but it is scattered, concerns specific strains, specific doses. EFSA waits. And waits.
Expert Tip: Honestly? Early in my practice I thought a few good in vitro studies would be enough. Then I encountered a decision by the Chief Sanitary Inspectorate (GIS) that was brutal: "Cell studies are not sufficient for health claims in humans". It taught me a lesson - EFSA thinks differently from laboratory scientists.
Current status of postbiotics in EU regulations - where we stand today
Postbiotics do not have Novel Food status in the formal sense (Regulation (EU) 2015/2283) if they originate from traditional bacterial strains. But that does not mean you can write whatever you want. They are treated as food ingredients or supplements, depending on context.
- If the product is a supplement (Directive 2002/46/EC) - the postbiotic is an active ingredient and is subject to supplement labelling requirements
- If it is a functional food - it must meet the requirements of Regulation (EU) No 1169/2011 on consumer information
- Every claim about health effects - regardless of product category - must be approved or at least scientifically substantiated
- The Chief Sanitary Inspectorate (GIS) can issue a decision prohibiting distribution if it deems claims to be unauthorised (Regulation 1924/2006, Art. 28)
In practice: the Office of Competition and Consumer Protection (UOKiK) and the Chief Sanitary Inspectorate (GIS) view postbiotics sceptically because EFSA harmonisation is lacking. This means every inspection is a potential battle. I have seen GIS decisions from the last two years that prohibited claims such as "supports natural weight loss" or "accelerates metabolism". The justification? Insufficient scientific evidence.
What you can and cannot write - practical examples
This is the section my clients read three times. The difference between a permitted and prohibited claim is sometimes... one word.
- ❌ PROHIBITED: "Aids weight loss" - this is a health claim requiring an EFSA Scientific Opinion
- ✔ PERMITTED: "Contains postbiotics that support natural gut flora" - if you have research to support it
- ❌ PROHIBITED: "Accelerates metabolism" - this is a functional claim without an approved EFSA listing
- ✔ PERMITTED: "Postbiotics may support healthy gut function" - but only if you have scientific publications
- ❌ PROHIBITED: "Reduces appetite" - this is a health claim relating to weight loss
- ✔ PERMITTED: "Source of bacterial metabolites" - this is a neutral, descriptive statement
Expert Tip: A few years ago I had a client whose product stated "supports healthy body weight". Sounds innocent? The Chief Sanitary Inspectorate (GIS) deemed it a prohibited health claim. We changed it to "supports healthy metabolic function" - it passed. The difference? The first promise directly links to weight loss. The second speaks about a process, not an outcome.
Labelling and documentation requirements - what you need to prepare
If you want to be legally safe, prepare your documentation BEFORE sending the product to market. It will cost you, but significantly less than withdrawing a product or receiving a fine from UOKiK.
- A list of all claims you want to place on the packaging, label, and website
- For each claim: a list of scientific publications (peer-reviewed) supporting it - minimum 3 from the last 5 years
- A safety analysis report for the postbiotic (strain, origin, toxicology)
- Manufacturer documentation - certificates, purity tests, absence of contaminants
- If the claim relates to weight loss: an analysis of whether it is a health claim or a nutrition claim (this changes everything)
- A complete label in the language of every country you export to
Regulation (EC) No 1924/2006, Article 10, requires you to substantiate every claim. You bear the responsibility, not the Chief Sanitary Inspectorate (GIS). This means that if GIS challenges you - you must have the documents, not they must prove you are wrong.
Market potential in the EU - where EFSA awaits
The EU postbiotics market is growing. Estimates suggest 15-20% annual growth over the next 3-4 years. But this is growth in products, not growth in permitted claims. This is an important distinction.
EFSA has postbiotics on its radar. Over the past 18 months, it has received several applications for assessment of claims relating to postbiotics and gut health. But EFSA processes take time - on average 2-3 years. When they conclude, we will have clear guidelines. Until then - a grey zone.
- Germany and France: the postbiotics market is growing faster, but oversight by authorities is more restrictive
- Poland: UOKiK is cautious, but there is a lack of precedents - this could be an opportunity or a trap
- Scandinavia: FSA (Sweden) and tilsynet (Denmark) view postbiotics as Novel Food - requiring notification
- Italy: the Ministry of Health requires pre-notification for new postbiotics
Expert Tip: I recently spoke with a colleague from EFSA at a conference. He told me they are waiting for more high-quality clinical studies in humans. When they receive them, they may issue a Scientific Opinion. This means - if you invest in research now, you could be first with an approved Opinion in 2-3 years. This is a real competitive advantage.
Most common manufacturer mistakes - pitfalls I see every month
- Copying claims from probiotic products. Postbiotics are not the same. Claims approved for probiotics do not work for postbiotics.
- Writing about "weight loss" instead of "gut health". The first is a health claim, the second is a safer zone.
- Lack of scientific documentation. "We have research" is not the same as "we have peer-reviewed publications". One is marketing, the other is law.
- Ignoring differences between EU countries. A claim permitted in France may be prohibited in Poland.
- Placing claims on the website but not on the packaging. GIS and UOKiK look at both - it is one product.
- Thinking that "natural" means "legally safe". Natural postbiotics can have prohibited claims just as easily as synthetic ones.
From my experience, 60% of problems arise not because the product is bad, but because the communication is poorly done. This is good news - it can be fixed without changing the formulation.