Key data
| Regulation | Commission Implementing Regulation (EU) 2026/1749 of 20 July 2026 |
|---|---|
| Modified standard | Implementing Regulation (EU) 2017/2470 (list of novel foods authorized in the EU) |
| Publication | 21 July 2026 |
| Entry into force | Not specified in the publication |
| Affected ingredient | Galacto-oligosaccharides (GOS) |
| Affected parties | Food, supplement and infant formula manufacturers using GOS |
| Category | European Regulation — directly applicable in all Member States |
| Year | 2026 |
Manufacturers of functional foods, nutritional supplements and infant formulas working with galacto-oligosaccharides (GOS) face a regulatory change. The Implementing Regulation (EU) 2026/1749, published on 21 July 2026, amends the annex of Regulation 2017/2470 — the official list of novel foods authorized in the EU — updating the conditions under which GOS can be incorporated into food products.
The change is significant: it affects both the food categories in which this ingredient can be used and the maximum permitted doses. And as with all European implementing regulations, it is directly applicable in all 27 Member States without requiring each country to transpose it into its national legislation.
What does this regulation establish?
Galacto-oligosaccharides are prebiotics of dairy origin. They are obtained from lactose and are used primarily for their effect on intestinal microbiota. Until now, their use was regulated by Regulation (EU) 2017/2470, which establishes the list of novel foods authorized in the European Union.
The new regulation amends the annex of that standard specifically with respect to GOS. The specific changes are:
| Regulated aspect | Previous situation (Regulation 2017/2470) | Situation after Regulation 2026/1749 |
|---|---|---|
| Authorized food categories | Previous categories listed in the 2017/2470 annex | Expansion to new food categories |
| Maximum permitted doses | Limits established in the original annex | Adjustment of applicable maximum levels |
| Labeling and technical documentation | Requirements of the previous framework | Possible need for update to reflect new conditions |
| Scope of application | Directly applicable throughout the EU | Directly applicable throughout the EU (without transposition) |
The regulation does not require Member States to convert it into national legislation: it enters into force on the date indicated by the regulation itself and directly binds all food sector operators in the EU.
Economic and operational impact
For companies already using GOS in their products, the most immediate impact is operational and documentary. This is not about banning an ingredient, but about updating the conditions of use, which can generate costs in several areas:
- Formulation review: If current GOS doses in a product exceed the new adjusted limits, reformulation will be necessary.
- Labeling update: Any change in conditions of use may require modifying product labeling information to reflect the new legal framework.
- Technical documentation: Product files, technical sheets and declarations of conformity must be updated to reference the new regulation.
- Market opportunity: The expansion of authorized categories opens the door to incorporating GOS in products where it was previously not permitted, which can be a competitive advantage for those who act quickly.
For companies not yet using GOS but waiting for regulatory expansion to incorporate them into new product lines, this regulation may be the enabling factor they needed.
Who does it affect?
- Infant formula manufacturers that already incorporate GOS as a prebiotic in their composition.
- Functional food manufacturers (enriched yogurts, cereals, functional beverages) that use or want to use GOS.
- Nutritional supplement manufacturers with GOS as an active or auxiliary ingredient.
- Food ingredient companies that supply GOS to final product manufacturers.
- R&D and Regulatory Affairs departments of any food sector company with presence in the EU.
- Importers and distributors of food products with GOS manufactured outside the EU but marketed within the European market.
Practical example
A Spanish nutritional supplement manufacturer has in its catalog a product with GOS formulated under Regulation 2017/2470. Following the publication of Regulation 2026/1749, its Regulatory Affairs team must do the following:
- Consult the new annex of Regulation 2017/2470 (already modified) to verify whether the product category in which it operates remains authorized and whether the GOS dose it uses is within the new adjusted limits.
- If the current dose exceeds the new maximum permitted, reformulate the product before the regulation's entry into force date.
- Update the product technical sheet and regulatory conformity declaration to reference Regulation 2026/1749.
- Review the labeling to ensure it correctly reflects the updated conditions of use.
On the other hand, if that same manufacturer was developing a new line of functional foods where GOS was not previously authorized, the expansion of categories may enable it to launch that product to market without needing an additional authorization procedure.
What should companies do now?
- Identify all catalog products containing GOS and verify in which food category they fall according to the new annex of the modified Regulation 2017/2470.
- Review the GOS doses used in each formulation and compare them with the new maximum levels established by Regulation 2026/1749.
- Update the technical documentation of each affected product: technical sheets, regulatory files and conformity declarations must reference the new regulation.
- Review the labeling of affected products to ensure compliance with updated conditions of use before the entry into force date.
- Evaluate opportunities for new product lines in categories that are now enabled for GOS use, if the company is interested in expanding its portfolio.
- Coordinate with GOS suppliers to ensure that the raw material they supply meets the technical specifications required by the new regulatory framework.
Frequently asked questions
What are galacto-oligosaccharides and why are they regulated as a "novel food"?
Galacto-oligosaccharides (GOS) are prebiotics of dairy origin obtained from lactose. They are classified as a "novel food" in the EU because their significant consumption by the European population occurred after 15 May 1997, the reference date of Regulation (EU) 2015/2283 on novel foods. This means that to market them in the EU they must be expressly authorized in the list of Regulation 2017/2470, which is precisely the regulation modified by Regulation 2026/1749.
Do I need to reformulate my GOS products after Regulation 2026/1749?
It depends. If the GOS doses you currently use are within the new adjusted limits and your product category remains authorized, you do not need to reformulate. If the dose exceeds the new maximum permitted or your category has changed conditions, you will need to adapt the formulation before the regulation's entry into force date. Reviewing the new annex of the modified Regulation 2017/2470 is the first mandatory step.
When does Regulation (EU) 2026/1749 enter into force?
The exact entry into force date has not been specified in the available information from the 21 July 2026 publication. European implementing regulations typically indicate their entry into force date in their final articles. It is recommended to consult the full text in the Official Journal of the EU to confirm this information.
Do I have to update the labeling of my GOS products?
Yes, potentially. The labeling and technical documentation of products containing GOS may require updating to reflect the new conditions of use established by Regulation 2026/1749. This applies to both products already on the market and those in development. Labeling review must be done before the regulation's entry into force date.
Does this regulation also apply to products imported from outside the EU that contain GOS?
Yes. Regulation 2026/1749 is directly applicable in all EU Member States and affects any food product marketed in the European market that contains GOS, regardless of its country of manufacture. Importers and distributors of GOS-containing products manufactured outside the EU must verify that those products comply with the new conditions of use before their commercialization in Europe.
Official source
Consult complete regulation at official source
Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202601749