Date: 2021-06-04Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2021/900 of 3 June 2021 authorising a change of the conditions of use of the novel food ‘galacto-oligosaccharide’ under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2021/900 of June 3, 2021, modifies the conditions of use for the novel food galactooligosaccharide (GOS) by amending Implementing Regulation (EU) 2017/2470. This change follows an application from Yakult Pharmaceutical Industry Co., Ltd. and a safety assessment by the European Food Safety Authority (EFSA). The regulation entered into force on June 24, 2021, which was the twentieth day following its publication.
Key Points / Main Content:
* **Authorization and Union List:**
* The regulation amends the Union list of authorized novel foods regarding galactooligosaccharide (GOS).
* The amended entry includes specific conditions of use and labeling requirements.
* **Change in Conditions of Use:**
* The maximum use level of GOS in food supplements is increased from 0.333 kg GOS/kg food supplement to 0.450 kg GOS/kg food supplement for the general population, excluding infants and young children.
* The maximum serving is 3 servings a day with a maximum of 16.2g/day.
* **EFSA Opinion:**
* EFSA concluded that the proposed increase in the maximum use level of GOS in food supplements is safe under the specified conditions.
Impact Analysis:
European Commission:
Impact: Must ensure the regulation is applied and enforced across all Member States.
Action Required: Monitor the implementation and compliance with the amended conditions of use for galactooligosaccharide.
Yakult Pharmaceutical Industry Co., Ltd.:
Impact: Can market food supplements with increased levels of GOS (up to 0.450 kg GOS/kg food supplement) for the general population excluding infants and young children.
Action Required: Adjust product formulations and labeling to comply with the new maximum use levels and specific labeling requirements, ensuring exclusion of infants and young children.
Food Supplement Manufacturers:
Impact: Can use GOS in food supplements up to the new maximum level for the general population, excluding infants and young children.
Action Required: Reformulate products as needed and ensure labels comply with the updated requirements, especially regarding the exclusion of infants and young children.
Member States:
Impact: Responsible for enforcing the regulation within their territories.
Action Required: Update national regulations and conduct checks to ensure compliance with the new GOS usage conditions and labeling requirements.
Consumers (excluding infants and young children):
Impact: May be exposed to food supplements with higher levels of GOS.
Action Required: Be aware of the updated GOS content in food supplements and adhere to the recommended serving sizes.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation (EU) 2015/2283: A regulation of the European Parliament and of the Council on novel foods.
Commission Implementing Regulation (EU) 2017/2470: A Commission Implementing Regulation establishing a Union list of authorised novel foods.
galactooligosaccharide: A novel food ingredient whose conditions of use are being amended by the regulation.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Ursula VON DER LEYEN: The President of the European Commission.
Brussels: The city where the regulation was adopted.
4.6.2021 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 197/71
COMMISSION IMPLEMENTING REGULATION (EU) 2021/900
of 3 June 2021
authorising a change of the conditions of use of the novel food ‘galacto-oligosaccharide’ under
Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending
Commission Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing
Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC)
No 1852/2001(1), and in particular Article 12 thereof,
Whereas:
(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed
on the market within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470(2)
establishing a Union list of authorised novel foods was adopted.
(3) On 20 January 2014, the company Yakult Pharmaceutical Industry Co., Ltd. informed the Commission, pursuant to
Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council(3), of its intention to place on
the market ‘galacto-oligosaccharide’as a novel food to be used in a number of foods, including infant formula and
follow-on formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council(4).
Therefore, galacto-oligosaccharide was included in the Union list of novel foods.
(4) On 3 March 2020, the company Yakult Pharmaceutical Industry Co., Ltd. (‘the applicant’) submitted an application
to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 to change the conditions of use of the
novel food ‘galacto-oligosaccharide’. The applicant requested to increase the maximum use level of the novel food
galacto-oligosaccharide in food supplements from 0,333 kg GOS/kg food supplement (33,3 %) to 0,450 kg GOS/kg
food supplement (45,0 %) for the general population. During the application process, the applicant agreed to exclude
infants and young children from the request.
(5) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food
Safety Authority (‘the Authority’) on 18 June 2020, requesting it to provide a scientific opinion by carrying out an
assessment for the change of the conditions of use of galacto-oligosaccharide as a novel food.
(6) On 17 December 2020, the Authority adopted its scientific opinions on the ‘Safety of a change in the conditions of
use of galacto-oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU)
2015/2283’(5). This opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
(1) OJ L 327, 11.12.2015, p. 1.
(2) 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 (OJ L 351, 30.12.2017, p. 72).
(3) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel
foods ingredients (OJ L 43, 14.2.1997, p. 1).
(4) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young
children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC,
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament
and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).
(5) EFSA Journal 2021;19(1):6384.L 197/72 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 4.6.2021
(7) In its opinion, the Authority concluded that the proposed increase in the maximum use level of galacto-
oligosaccharide as a novel food in food supplements is safe under the proposed changes of the conditions of use.
(8) The opinion of the Authority gives sufficient grounds to establish that galacto-oligosaccharide under the proposed
conditions of use for the general population, excluding infants and young children, complies with Article 12(1) of
Regulation (EU) 2015/2283.
(9) The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
1. The entry in the Union list of authorised novel foods as provided for in Article 6 of Regulation (EU) 2015/2283 and
included in the Annex to Implementing Regulation (EU) 2017/2470, referring to the novel food galacto-oligosaccharide,
shall be amended as specified in the Annex to this Regulation.
2. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements
laid down in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 June 2021.
For the Commission
The President
Ursula VON DER LEYENANNEX
In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for the novel food ‘Galacto-oligosaccharide’is replaced by the following:
Additional specific labelling
Authorised novel food Conditions under which the novel food may be used Other requirements
requirements
Maximum levels (expressed as ratio kg galacto- Specified food category
oligosaccharide/kg final food)
Food Supplements as defined in Directive
0,333
2002/46/EC
0,450 (corresponding to 5,4 g galacto-
Food supplements as defined in Directive
oligosaccharide/serving; maximum 3 servings/day
2002/46/EC, excluding infants and young children
up to a maximum of 16,2 g/day)
Milk 0,020
Milk drinks 0,030
Meal replacement for weight control (as drinks) 0,020
Dairy analogue drinks 0,020
Yoghurt 0,033
Dairy based desserts 0,043
‘Galacto-oligosaccharide
Frozen dairy desserts 0,043
Fruit drinks and energy drinks 0,021
Infant meal replacement drinks 0,012
Baby juice 0,025
Baby yogurt drink 0,024
Baby dessert 0,027
Baby snack 0,143
Baby cereals 0,027
Drinks intended to meet the expenditure of intense
0,013 muscular effort especially for sportsmen
Juice 0,021
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197/73Fruit pie filling 0,059
Fruit preparations 0,125
Bars 0,125
Cereals 0,125
Infant formula and follow-on formula as defined in
0,008’
Regulation (EU) No 609/2013
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