G/SPS/N/GBR/20  
6 September 2022  
(22-6643) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  UNITED KINGDOM  
If applicable, name of local government involved:   
2. Agency responsible:  The UK Food Safety Authorities comprising of the Food Standards 
Agency (FSA) and Food Standards Scotland (FSS)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):   
Authorization of four novel food (NF) products and modification to the conditions of use 
of one novel food and specifications for its existing authorization.  
The four novel food products are:  
• 3'-Sialyllactose (3' -SL) sodium salt  
• 6'-Sialyllactose (6' -SL) sodium salt  
• Schizochytrium sp. (WZU477) oil  
• Schizochytrium sp. (FCC -3204)  oil. 
The modification of one novel food is:  
• 2'-Fucosyllactose/difucosyllactose mixture (2' -FL/DFL) (note this consists of a 
change to the conditions of use and specifications, not a new authorization).  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Authorization of four novel food products and a change 
to the conditions of use and specification for an existing authorization . Language(s):  
English . Number of pages:   
Full text of the legislation made available for England, Scotland and Wales, respectively.  
England: https://www.legislation.gov.uk/uksi/2022/619/introduction/made  
Scotland: https://www.legislation.gov.uk/en/ssi/2022/168/introduction/made  
Wales: https://www.legislation.gov.uk/wsi/2022/575/made  
6. Description of content:  The UK Food Safety Authorities are notifying Members of an 
authorization of four novel food products for use in the GB market and a change to the 
conditions of use of one novel food and its specification for an existing authorization.  
The authorizations cover novel food products to be u sed as components in infant follow -
on formula.  The following products are classified as "human -identical milk 
oligosaccharides (HiMOs)". The manufactured HiMOs are identical in structure to the same 
molecules present in breast milk.  
o 3'-Sialyllactose (3' -SL) sodium salt,  
o 6'-Sialyllactose (6' -SL) sodium salt.  G/SPS/N/GBR/20  
 
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  Terms for entry to the list of authorized novel foods:  
• Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products  
• Flavoured fermented milk -based products including heat-treaded products  
• Unflavoured fermented milk -based products  
• Beverages (flavoured drinks, excluding drinks with a pH less than 5)  
• Cereal bars  
• Infant formula as defined under Retained EU Regulation 609/2013  
• Follow -on formula as defined under Retained EU Regulation 609/2013  
• Processed cereal -based drinks and baby food for infants and young children as 
defined under Retained EU Regulation 609/2013  
• Milk-based drinks and similar products intended for young children  
• Total diet replacement foods for weight control as defined in Retained EU Regulation 
609/2013  
• Food for special medical purposes as defined under Retained EU Regulation 
609/2013 (only applicable to 3' -Sialyllactose (3' -SL) sodium salt)  
• Food supplements as defined in the Food Supplements Re gulation 2003 for England, 
excluding food supplements for infants and young children.  
o 2'-Fucosyllactose/difucosyllactose mixture (2' -FL/DFL) (note this consists of a change 
to the conditions of use and specifications, not a new authori zation)  
• Milk-based drinks and similar products intended for young children.  
The below products are Docosahexaenoic acid (DHA) rich oils derived from marine algae. 
DHA is mandatory in infant and follow -on formula in the UK under retained Commission 
Delegated Regulation 2016/1 27. 
o Schizochytrium sp. (WZU477) oil  
• Infant formula and follow -on formula as defined in retained Regulation (EU) No 
609/2013.  
o Schizochytrium sp. (FCC -3204) oil  
• Food supplements as defined in The Food Supplements Regulations 2003 for 
England, excluding food supplements for infants and young children  
• Infant and follow -on formula.  
These authorizations are made on the basis of the uses and specifications set out in the 
consultations linked in section 9.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius  Commission (e.g.  title or serial number of Codex 
standard or related text) : CXG-62-2007 - Working Principles for Risk Analysis 
for Food Safety for Application by Governments.  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Anim al Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  G/SPS/N/GBR/20  
 
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  [X] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:  
Full details of the applications for authorization of these Novel Food products are laid out 
in previous public consultations on the FS A and FSS websites, available here:  
FSA consultation on NF uses  
FSS consultation on NF uses  
The consultations also link to the FSA/FSS risk assessment on the uses.   
10. Proposed date of adoption (dd/mm/yy) : 20 May 2022  
Proposed date of publication (dd/mm/yy) : 20 May 2022  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 30 June 2022  
[X] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable.  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [  ] National Enquiry Point. Address, fax number and e -mail address 
(if av ailable) of other body:   
UK SPS Contact Point, Defra, Nobel House, London SW1P 3JR  
E-mail: UKSPS@defra.gov.uk  
13. Text(s) available from: [  ] National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
UK SPS Contact Point, Defra, Nobel House, London SW1P 3JR  
E-mail: UKSPS@defra.gov.uk