Galacto-oligosaccharides: new use levels in the European Union
What are Galacto-oligosaccharides?
Galacto-oligosaccharides (GOS) are prebiotics, ingredients that trigger specific changes in the composition and/or activity of gastrointestinal microbiota, thus conferring benefits upon host (here: human) health. According to available clinical evidence, the beneficial effects of GOS embrace but are not limited to their supporting role in improving digestive health and the immune system's effectiveness.
For that reason, they have become one of the most interesting ingredients for food additives and supplements.
The EU legal framework
According to the current legal framework, the European Food Safety Authority (EFSA) characterised prebiotics as “novel foods” as they were not consumed “significantly” before May 1997. They are authorised for use in several foods, including infant formula and follow-on formula (Article 5 of Regulation (EC) No 258/97 of the European Parliament and the Council concerning novel foods and novel food ingredients), and further allowed in food supplements.
Increased upper limit as of 2022
On April 28, 2022, the European Commission issued Commission Implementing Regulation (EU) 2022/684, which establishes new increased upper limits for the use of galacto-oligosaccharide. As of May 18, 2022, an upper limit ratio of 45% (Kg. GOS/ Kg. Final Product) is allowed. However, the following conditions must apply:
- It must correspond to a maximum of 5,4 grams of GOS per serving;
- A maximum of three servings per day is allowed (adding up to 16,2 grams GOS daily intake);
- This limit excludes infants’ and young children’s food supplements.
Additionally, Commission Implementing Regulation (EU) 2022/684 extended the use of galacto-oligosaccharide to other foods, namely, dairy confectionary, cheese and processed cheese, butter and spreadable fats.
Moreover, Commission Implementing Regulation (EU) 2022/1381 of August 8, 2022, amended the conditions of use of galacto-oligosaccharide. It added the use as foods for special medical purposes as defined by Regulation (EU) No 609/2013, with maximal use level of 0,128 (expressed as ratio kg galacto-oligosaccharide/kg final food) and corresponding to a maximum of 8,25 g galacto-oligosaccharide/day.Get in touch
Alejandro Gutiérrez Ramos
Regulatory Affairs Department
- Davani-Davari, D., Negahdaripour, M., Karimzadeh, I., Seifan, M., Mohkam, M., & Masoumi, S. et al. (2 019). Prebiotics: Definition, Types, Sources, Mechanisms, and Clinical Applications. Foods, 8(3), 92. Retrieved on 20.06.2022 from https://doi.org/10.3390/foods8030092
- Mitmesser, S., & Combs, M. (2017). Prebiotics: Inulin and Other Oligosaccharides. The Microbiota In Gastrointestinal Pathophysiology. Retrieved on 20.06.2022, from https://www.sciencedirect.com/topics/biochemistry-genetics-and-molecular biology/galactooligosaccharide
- European Food Safety Authority. (2022). Novel food. Retrieved 20 June 2022, from https://www.efsa.europa.eu/en/topics/topic/novel-food.
- European Commission. (2017). Commission implementing regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. Retrieved on 24/08/2022 from https://eur-lex.europa.eu/eli/reg_impl/2017/2470/oj
- European Commission. (2022). Commission implementing regulation (EU) 2022/684 of 28 April 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food galacto-oligosaccharide. Retrieved on 24/08/2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2022.126.01.0010.01.ENG
- European Commission. (2022). Commission Implementing Regulation (EU) 2022/1381 of 8 August 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food galacto-oligosaccharide. Retrieved on 24/08/2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2022.126.01.0010.01.ENG