Changes to specifications of the novel food galacto-oligosaccharide

Commission Implementing Regulation (EU) 2024/1027 of 8 April 2024 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food galacto-oligosaccharide

Update

The EU has removed the requirement for a minimum level of galactose in galacto-oligosaccharide. This novel food ingredient will no longer have to contain a specific amount of galactose to be approved for use in foods.

Impacted Products

Food and beverage products including food supplements, dairy products, juice, cereal bars

What is changing?

The EU has removed the requirement for a minimum level of galactose in galacto-oligosaccharide. Previously this novel food ingredient had to contain at least 0.8% galactose (a type of sugar) based on its dry weight. Now this minimum requirement has been removed and galacto-oligosaccharide will no longer have to contain a specific amount of galactose to be approved for use in foods.

Why?

The company FrieslandCampina Ingredients requested to remove galactose from the specifications for galacto-oligosaccharide because additional purification steps in its production process remove monosaccharides like galactose to produce a higher purity product. The EU noted that galactose has a history of safe use in normal diets and does not raise safety concerns, so the specifications for galacto-oligosaccharide as a novel food do not need to require a certain level of galactose.

Timeline

The Regulation will enter into force on 28 April 2024.

Background

This Regulation updates the Annex to Implementing Regulation (EU) 2017/2470 which lists all authorised novel foods permitted on the EU market (see Union list of novel foods).

For further information on the EU novel foods authorisation process, see Novel foods explained.

Resources

Sources

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Regulation

Regulation (EU) 2024/1027 as regards the specifications of the novel food galacto-oligosaccharide

What is changing and why?

The EU has removed the requirement for a minimum level of galactose in galacto-oligosaccharide. Previously this novel food ingredient had to contain at least 0.8% galactose (a type of sugar). Now this minimum requirement has been removed and galacto-oligosaccharide no longer needs to contain a specific amount of galactose to be approved for use in foods. The EU noted that galactose has a history of safe use in normal diets and does not raise safety concerns.

Timeline

The Regulation will enter into force on 28 April 2024.

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