Home › The Lab › Regulation October 2026
Regulation · Monitoring

Food supplement regulation: what changes in October 2026

New packaging rules, botanicals and red yeast rice heading for a ban, maximum vitamin levels in preparation, new EFSA opinions: autumn 2026 is busy. Here are the five topics to follow and what they mean for your brand.

By the Irati Production R&D team · Published 1 October 2026 · 7 min read

Food supplement formulation laboratory
Irati Production · Made in France
Key takeaways
  • Since 12 August 2026, the EU Packaging and Packaging Waste Regulation (PPWR) applies: PFAS limits and an EU declaration of conformity.
  • Rhubarb, senna, frangula and cascara preparations containing hydroxyanthracene derivatives are set to move to the list of prohibited substances.
  • The ban on monacolins from red yeast rice, voted on 13 May 2026, could be published in October 2026.
  • The Commission is preparing harmonised maximum levels for vitamins and minerals: consultation announced for Q3 2026, adoption targeted for Q1 2028.
  • EFSA has issued favourable opinions on new ingredients, including a first positive opinion on a purified CBD.

A busy regulatory autumn

Between mid-August and the end of September 2026, several EU texts came into application or moved close to adoption. Some affect every brand, such as packaging. Others target specific ingredients. For a food supplement brand, the stakes are simple: plan ahead so you never have to withdraw a product or reprint labels in a rush.

1. Packaging: the PPWR has applied since 12 August 2026

Regulation (EU) 2025/40 on packaging and packaging waste (PPWR) has applied since 12 August 2026. Two obligations directly affect food supplements. First, food-contact packaging can no longer be placed on the market above PFAS thresholds: 25 ppb for any individual PFAS measured by targeted analysis, 250 ppb for their sum and 50 ppm for total PFAS. Second, every packaging must be covered by an EU declaration of conformity. The Commission guidance published on 10 June 2026 states that a person who has a packaged product made under its own name or trademark is considered the manufacturer of the packaging. On 9 September 2026, the European federation EHPM called for a pragmatic implementation for the sector.

What it means for your brand. If you sell under your own brand, you are responsible for the compliance of your jars, pouches and sticks. Ask your suppliers for PFAS information and the data needed for the declaration of conformity. Packaging already placed on the market before 12 August 2026 can stay on shelves. New batches must comply.

2. Rhubarb, senna, frangula, cascara: heading for a ban

On 15 July 2026, the Commission sent the Council a draft regulation amending Annex III to Regulation (EC) No 1925/2006. It moves preparations of Rheum palmatum, Rheum officinale, Cassia senna, Rhamnus frangula and Rhamnus purshiana containing hydroxyanthracene derivatives (HADs) from Part C (under scrutiny) to Part A (prohibited). The text was endorsed by the Standing Committee (SCoPAFF) and is under scrutiny by the European Parliament and the Council until 15 October 2026. The draft allows products lawfully placed on the market before its entry into force to remain on sale for 12 months.

What it means for your brand. Digestive transit formulas based on senna, rhubarb, frangula bark or cascara are directly affected. Now is the time to list your SKUs, plan the end of sales and prepare a reformulation.

3. Red yeast rice: the monacolin ban takes shape

On 13 May 2026, Member States voted in favour of the draft regulation banning monacolins from red yeast rice in food. The text then goes through a three-month scrutiny by the European Parliament and the Council. According to an industry announcement published on 27 May 2026, publication in the Official Journal could take place in October 2026, with entry into force 20 days later and a stock clearance period until October 2027.

What it means for your brand. Food supplements containing monacolins now have an announced end date. Avoid launching new long production runs, adjust your stock and start working on a replacement formula now.

Food supplement capsules during quality control

4. Maximum levels of vitamins and minerals: the EU timetable

The European Commission has confirmed its timetable for harmonised maximum amounts of vitamins and minerals in food supplements and fortified foods: a revised draft open to public consultation in the third quarter of 2026 and adoption of the final act planned for the first quarter of 2028. Until then, each Member State applies its own rules. Luxembourg has just revised its national limits, reported on 10 September 2026: 50 µg per day for vitamin D and 1,000 mg for vitamin C.

What it means for your brand. High-dose formulas may need adjusting by 2028. Design new SKUs now with reasonable doses that work with French limits and with every country where you plan to sell.

5. Novel foods: new favourable EFSA opinions

Several ingredients have passed the scientific assessment stage. On 21 September 2026, the first favourable EFSA opinion on a purified CBD (at least 98% purity) was reported, with an intake considered safe of 2 mg per day for a 70 kg adult. On 11 September 2026, EFSA issued a positive opinion on S-acetyl glutathione, up to 300 mg per day for adults. In early September, a commensal bacterium, Anaerobutyricum soehngenii CH106, also received a favourable opinion. In each case, Commission authorisation and inclusion in the Union list are still required before any sale.

What it means for your brand. An EFSA opinion is not an authorisation. These ingredients cannot yet be sold as novel foods. You can, however, prepare your projects so you are ready as soon as the authorising regulations are published, following the conditions of use they will set.

Summary

Topic
Date
Impact
Packaging (PPWR): PFAS and EU declaration of conformity
Applies since 12 August 2026
Every brand: check packaging and collect supplier information
HAD botanicals (rhubarb, senna, frangula, cascara)
Scrutiny until 15 October 2026
Transit formulas: inventory, 12-month sell-off, reformulation
Monacolins from red yeast rice
Voted 13 May 2026, publication expected October 2026
Planned end of sales, replacement formula
Maximum levels of vitamins and minerals
Consultation Q3 2026, adoption targeted Q1 2028
High-dose formulas to watch
EFSA opinions: CBD, S-acetyl glutathione, A. soehngenii
September 2026
Opportunities to prepare, not yet authorised
For brands

Regulatory monitoring built into your project

At Irati Production, compliance is part of the service. Our regulatory team follows EU and French developments and applies them to your products.

  • Labelling and claims checked by our regulatory team
  • Formulas compliant with EU and French rules
  • Support when reformulation is needed
  • Made in France, on an ISO 22000 certified, FDA-registered site
  • Gummies, capsules, tablets, powders and sticks, functional drinks

Frequently asked questions

Does the PPWR apply to food supplements?

Yes. Jars, pouches and sticks are packaging. Since 12 August 2026, food-contact packaging must meet PFAS limits, and every packaging must be covered by an EU declaration of conformity.

Are senna and rhubarb already banned?

Not yet. The draft regulation is under scrutiny until 15 October 2026. It must then be adopted and published. The text allows 12 months to sell products lawfully placed on the market before its entry into force.

When will red yeast rice be banned?

Member States voted for the monacolin ban on 13 May 2026. Publication is expected in October 2026, with a stock clearance period announced until October 2027.

Can I use an ingredient that has a favourable EFSA opinion?

No, not until the Commission publishes the implementing regulation adding it to the Union list of novel foods, with its conditions of use.

Can Irati Production check the compliance of my range?

Yes. Our regulatory team checks formulas, labelling and claims for the products we manufacture. Contact us to discuss your project.

For information only, not legal advice. Sources: Regulation (EU) 2025/40 (PPWR); Commission Notice C/2026/3084, guidance document on Regulation (EU) 2025/40, published 10 June 2026 (eur-lex.europa.eu); Council of the European Union, document 11964/26 of 15 July 2026 (data.consilium.europa.eu); Regulation (EC) No 1925/2006; Complife Group, 7 September 2026; IGI Food Law, 1 June 2026; NutraIngredients, 9, 10, 11 and 21 September 2026; Valbiotis press release of 27 May 2026; LNE, PPWR PFAS thresholds.

Your project

A compliant range, made in France

Formulation, labelling, claims: we secure your project from start to finish. Let's talk.

Request a free quote