Amendment to specifications for the novel food galacto-oligosaccharide
European Union
Apr 10, 2024
With implementing Regulation (EU) 2024/1027 of 8 April 2024, the Commission amended Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food "galacto-oligosaccharide".
The amendment has been approved following the request to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 about the removal of the minimum level of galactose (currently 0.8% of the dry matter).
The applicant justified the request for the proposed change in the specifications of galacto-oligosaccharide by the introduction of additional purification steps in its production. The additional purification aims to remove monosaccharides like galactose to produce a higher purity galacto-oligosaccharide.
The Commission considers that the requested change in the specifications of galacto-oligosaccharide is not liable to have an effect on human health and that a safety evaluation by the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. Galactose has a history of safe use as a constituent of the normal diet when dairy products are consumed. As a result, it is authorised to be present in the novel food at minimal levels of 0,8% or more and without a maximum authorised level as it does not raise safety concerns. Thus, irrespective of the purification steps during the production, the specifications do not need to require a certain level of galactose in the novel food.
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