Date: 2022-04-29Category: Not ApplicableState: Union GovernmentCountry: Europe
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 (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Regulation (EU) 2022/684 amends Implementing Regulation (EU) 2017/2470 regarding the conditions of use for the novel food galactooligosaccharide. It expands the permitted uses of galactooligosaccharide to include dairy confectionery, cheese and processed cheese, butter, and spreads for the general population. The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Amendment of Union List of Novel Foods:**
* The Annex to Implementing Regulation (EU) 2017/2470, which establishes the Union list of novel foods, is amended.
* The entry for galactooligosaccharide in Table 1 is replaced with updated conditions of use.
* **Extension of Use of Galactooligosaccharide:**
* Galactooligosaccharide's use is extended to dairy confectionery, cheese and processed cheese, butter and spreads intended for the general population.
* Maximum levels are specified for various food categories, including new additions like dairy confectionery (0.05 kg/kg), cheese and processed cheese (0.1 kg/kg), and butter and spreadable fats (0.1 kg/kg).
* **Specific Conditions of Use and Maximum Levels:**
* Maximum levels for galactooligosaccharide in various food categories are defined, such as 0.333 kg/kg in food supplements (Directive 2002/46/EC) and 0.008 kg/kg in infant formula and follow-on formula (Regulation (EU) No 609/2013).
* For food supplements (excluding infants and young children), the maximum level is 0.450 kg/kg, equivalent to 5.4g/serving, with a maximum of 3 servings/day up to 16.2g/day.
* **Scientific Opinion and Safety:**
* The European Food Safety Authority (EFSA) issued a scientific opinion concluding that galactooligosaccharide is safe under the proposed extension of use.
* The Authority assessed the safety of galactooligosaccharides composed of 57% galactooligosaccharide dry matter, lactose, and related saccharides.
* **Regulatory Basis:**
* The amendment is based on Regulation (EU) 2015/2283 on novel foods and considers the application submitted by Dairy Crest Ltd. (Saputo Dairy UK).
* The measures align with the opinion of the Standing Committee on Plants, Animals, Food and Feed.
Impact Analysis:
**Food Manufacturers:**
* *Impact:* Food manufacturers, particularly those producing dairy confectionery, cheese, processed cheese, butter, and spreads, are directly affected by the extended permitted uses of galactooligosaccharide.
* *Action Required:* They need to ensure compliance with the new maximum levels of galactooligosaccharide in their products and update labeling accordingly.
**Novel Food Producers/Suppliers (e.g., Saputo Dairy UK):**
* *Impact:* Producers and suppliers of galactooligosaccharide, such as Saputo Dairy UK, benefit from the expanded market opportunities.
* *Action Required:* They must ensure their product meets the required specifications and support food manufacturers in complying with the new regulations.
**European Food Safety Authority (EFSA):**
* *Impact:* EFSA is responsible for providing scientific opinions on the safety of novel foods.
* *Action Required:* Continue to monitor and assess any new data related to the safety of galactooligosaccharide.
**European Commission:**
* *Impact:* The Commission is responsible for implementing and enforcing the regulation.
* *Action Required:* Ensure the regulation is properly implemented and monitor compliance across Member States.
**Member States:**
* *Impact:* Member States are responsible for enforcing the regulation within their jurisdiction.
* *Action Required:* Update national regulations and ensure food businesses comply with the new rules.
**Consumers:**
* *Impact:* Consumers will have access to a wider range of food products containing galactooligosaccharide.
* *Action Required:* No direct action required, but should be aware of the presence of galactooligosaccharide in food products, particularly if they have specific dietary requirements.
Key Entities Referenced
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day business.
European Parliament: The directly elected parliamentary institution of the European Union with legislative, supervisory, and budgetary responsibilities.
Council of the European Union: A component of the EU legislature where ministers from each member state meet to negotiate and adopt laws.
Regulation (EU) 2015/2283: A European Union regulation on novel foods, governing the authorization and placing on the market of novel foods within the Union.
Implementing Regulation (EU) 2017/2470: A Commission Implementing Regulation that establishes the Union list of novel foods.
galactooligosaccharide: A novel food ingredient, the conditions of use of which are being amended by the regulation.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on risks associated with the food chain.
Saputo Dairy UK: Formerly Dairy Crest Ltd, the applicant company that requested the amendment of the conditions of use for galactooligosaccharide.
L 126/10 EN Official Journal of the European Union 29.4.2022
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
(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 of novel foods
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)has
established a Union list of novel foods.
(3) The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes galacto-oligosaccharide as
an authorised novel food.
(4) Pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council(3), galacto-
oligosaccharide has been authorised to be placed on the market 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).
(5) Commission Implementing Regulation (EU) 2021/900(5)authorised a change of the conditions of use of the novel
food galacto-oligosaccharide. In particular, the use level of the novel food galacto-oligosaccharide in food
supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council(6) was increased
from 0,333 kg galacto-oligosaccharide/kg of a food supplement (33,3 %) to 0,450 kg galacto-oligosaccharide/kg of
a food supplement (45,0 %) for the general population, excluding infants and young children.
(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) 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 (OJ L 197, 4.6.2021, p. 71).
(6) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the
Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).29.4.2022 EN Official Journal of the European Union L 126/11
(6) On 19 November 2019, the company Dairy Crest Ltd trading as Saputo Dairy UK (‘the applicant’) submitted an
application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 for an amendment of the
conditions of use of the novel food galacto-oligosaccharide. The applicant requested to extend the use of galacto-
oligosaccharide to dairy confectionary, cheese and processed cheese, butter and spreads intended for the general
population.
(7) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food
Safety Authority (‘the Authority’) on 21 December 2020, requesting it to provide a scientific opinion by carrying
out an assessment of the proposed extension of use of the novel food galacto-oligosaccharide.
(8) On 14 September 2021, the Authority adopted its scientific opinion on the ‘Safety of the extension of use of galacto-
oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/2283’(7) in accordance with Article 11 of
Regulation (EU) 2015/2283.
(9) In its scientific opinion, the Authority concluded that the novel food that is composed of ≥ 57 % galacto-
oligosaccharide dry matter, lactose and related saccharides, is safe under the proposed extension of use in dairy
confectionary, cheese and processed cheese, butter and spreads, and therefore it is appropriate to amend the
conditions of use of galacto-oligosaccharide.
(10) The information provided in the application and the Authority’s opinion gives sufficient grounds to establish that
the proposed changes to the conditions of use of the novel food are in accordance with Article 9 and Article 12(1)
of Regulation (EU) 2015/2283 and should be approved.
(11) The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(12) 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
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with 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, 28 April 2022.
For the Commission
The President
Ursula VON DER LEYEN
(7) EFSA Journal 2021;19(10):6844.ANNEX
In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘galacto-oligosaccharide’ is replaced by the following:
Additional specific
‘Authorised novel food Conditions under which the novel food may be used Other requirements Data protection
labelling 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
Food supplements as defined in Directive 0,450(corresponding to 5,4g galacto-oligo-
2002/46/EC, excluding infants and young saccharide/serving; maximum 3 servings/day
children up to a maximum of 16,2g/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
Galacto-
oligosaccharide Dairy based desserts 0,043
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
0,013
intense muscular effort especially for sportsmen
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Fruit pie filling 0,059
Fruit preparations 0,125
Bars 0,125
Cereals 0,125
Infant formula and follow-on formula as
0,008
defined in Regulation (EU) No 609/2013
Dairy confectionery 0,05
Cheese and processed cheese 0,1
Butter and spreadable fats 0,1’
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