II 
(Non-legislative acts)  
REGULATIONS  
COMMISSION IMPLEMENTING REGULATION (EU) 2018/1023  
of 23 July 2018  
correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods  
(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 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 8 thereof,  
Whereas:  
(1) Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission is to establish, by 1 January 2018, the Union 
list of novel foods authorised or notified under Regulation (EC) No 258/97 of the European Parliament and of the 
Council (  2 ). 
(2) The Union list of novel foods authorised or notified under Regulation (EC) No 258/97 was established by 
Commission Implementing Regulation (EU) 2017/2470 (  3 ). 
(3) Pursuant to Article 36 of Regulation (EU) 2015/2283, the new novel food Regulation applies from 1 January 
2018. A number of products were authorised or notified under Regulation (EC) No 258/97 during the period 
between the Standing Committee vote on the Union list on 6 December 2017 and the date of application of 
Regulation (EU) 2015/2283 on 1 January 2018. These products should therefore be included in the Union list 
established through Implementing Regulation (EU) 2017/2470.  
(4) On 19 December 2017, the company Demethra Biotech S.r.l. notified the Commission that it placed the novel 
food ‘ Echinacea purpurea  extract from cell cultures’ on the Union market pursuant to Article 5 of Regulation (EC) 
No 258/97. This novel food was not included in the Union list. Therefore, a new entry should be added to Tables 
1 and 2 of the Annex to Implementing Regulation (EU) 2017/2470.  
(5) On 21 and 22 December 2017, two companies, DuPont Nutrition & Biosciences ApS and FrieslandCampina 
Nederland BV, notified the Commission that they placed the novel food ‘2'-Fucosyllactose (microbial source)’ on 
the Union market pursuant to Article 5 of Regulation (EC) No 258/97. ‘2'-Fucosyllactose (microbial source)’ was 
already included in the Annex to Implementing Regulation (EU) 2017/2470. Those new notifications modify the 
numerical values of several parameters listed in the specifications of this novel food and therefore, the entry 
‘2'-Fucosyllactose (microbial source)’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should 
be corrected accordingly.EN 24.7.2018 Official Journal of the European Union L 187/1  
( 1 ) OJ L 327, 11.12.2015, p. 1.  
( 2 ) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel 
food ingredients (OJ L 43, 14.2.1997, p. 1).  
( 3 ) 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). (6) On 20 December 2017, the company c-LEcta GmbH notified the Commission that it placed the novel food 
‘Trehalose’ on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. ‘Trehalose’ was included 
in the Annex to Implementing Regulation (EU) 2017/2470. That new notification concerns a new source of 
trehalose, sucrose. Therefore, the specifications of the entry ‘Trehalose’ in Table 2 of the Annex to Implementing 
Regulation (EU) 2017/2470 should be corrected accordingly.  
(7) After the publication of Implementing Regulation (EU) 2017/2470, a number of errors or omissions were noted 
concerning the specifications or the conditions of use of a number of authorised novel foods. Therefore, the Union 
list established in the Annex to Implementing Regulation (EU) 2017/2470 should be corrected.  
(8) The novel food ‘L-Alanyl-L-Glutamine’ was authorised under certain conditions of use pursuant to Article 5 of 
Regulation (EC) No 258/97. The category ‘Drinks intended to meet the expenditure of intense muscular effort 
especially for sportsmen’ was erroneously omitted. Therefore, a correction adding ‘Drinks intended to meet the 
expenditure of intense muscular effort especially for sportsmen’ as allowed food category in the entry ‘L-Alanyl-L- 
Glutamine’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.  
(9) The novel food ‘Glucosamine HCl’ was authorised under certain conditions of use pursuant to Article 5 of 
Regulation (EC) No 258/97. The food category ‘Milk-based drinks and similar products intended for young 
children’ was added erroneously and should be deleted from this entry. A correction in the entry ‘Glucosamine 
HCl’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is therefore necessary.  
(10) The novel food ‘Lacto- N-neotetraose’ was authorised under certain conditions of use and maximum levels by 
Commission Implementing Decision (EU) 2016/375 (  1 ). The wording ‘at concentrations up to 1,2 g/l’ was added 
erroneously and should be removed from the food category ‘Milk-based drinks and similar products intended for 
young children’ for this novel food. Therefore, a correction of the entry ‘Lacto- N-neotetraose’ in Table 1 of the 
Annex to Implementing Regulation (EU) 2017/2470 is necessary.  
(11) The novel food ‘Spermidine-rich wheat germ extract ( Triticum aestivum )’ was authorised under certain conditions of 
use for ‘adult population excluding pregnant and lactating women’ pursuant to Article 5 of Regulation (EC) No 
258/97. However, the exclusion of pregnant and lactating women erroneously did not feature in the Union list. In 
consequence, the correction of the entry ‘Spermidine-rich wheat germ extract ( Triticum aestivum )’ in Table 1 of the 
Annex to Implementing Regulation (EU) 2017/2470 is necessary.  
(12) The novel food ‘Antarctic Krill oil from  Euphausia superba ’ in Table 2 of the Annex to Implementing Regulation 
(EU) 2017/2470 erroneously omitted the following requirement, which should be added: ‘Oxidative stability: all 
food products containing Antarctic Krill oil from  Euphausia superba  should demonstrate oxidative stability by 
appropriate and recognised national/international test methodology (e.g. AOAC)’. Therefore, a correction of this 
entry in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.  
(13) The novel food ‘Antarctic Krill oil rich in phospholipids from  Euphausia superba ’ was authorised under certain 
conditions of use by the Finnish competent authorities (  2 ). The specifications erroneously added the following 
requirement: ‘Oxidative stability: all food products containing Antarctic Krill oil rich in phospholipids from  
Euphausia superba  should demonstrate oxidative stability by appropriate and recognised national/international 
test methodology (e.g. AOAC)’. This requirement should be removed. Therefore, a correction of the entry ‘Antarctic 
Krill oil rich in phospholipids from  Euphausia superba ’ in Table 2 of the Annex to Implementing Regulation (EU) 
2017/2470 is necessary.  
(14) The novel food ‘Chia seeds ( Salvia hispanica )’ was initially authorised under certain conditions of use by 
Commission Decision 2009/827/EC (  3 ). The specifications erroneously added the following requirement: ‘(EU: 
carbohydrates are available = sugar + starch)’. This requirement should be removed. Therefore, a correction of 
the entry ‘Chia seeds ( Salvia hispanica )’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is 
necessary.EN L 187/2 Official Journal of the European Union 24.7.2018  
( 1 ) Commission Implementing Decision (EU) 2016/375 of 11 March 2016 authorising the placing on the market of lacto-N-neotetraose 
as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 70, 16.3.2016, 
p. 22).  
( 2 ) Letter of 8 May 2015 (https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_ authorisation_2015_auth-letter_krill- oil_en.pdf)  
( 3 ) Commission Decision 2009/827/EC of 13 October 2009 authorising the placing on the market of Chia seed ( Salvia hispanica ) as 
novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 294, 11.11.2009, 
p. 14). (15) The novel food ‘Chitosan extract from fungi ( Agaricus bisporus ; Aspergillus niger )’ was initially authorised under 
certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The specifications erroneously added 
the following requirement: ‘Fat binding capacity 800 x 9 w/wet weight): pass’. This requirement should be replaced 
by ‘Fat binding capacity 800 x (w/w wet weight): pass’. Therefore, a correction of the entry ‘Chitosan extract from 
fungi ( Agaricus bisporus ; Aspergillus niger )’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is 
necessary.  
(16) The novel food ‘Citicoline’ was authorised under certain conditions of use by Commission Implementing Decision 
2014/423/EU (  1 ). In Table 2 of the Annex to Implementing Regulation (EU) 2017/2470, the specifications of the 
novel food ‘Citicoline’ refer to citicoline produced via either a synthetic or a microbial process. After the 
publication of that Regulation, it became clear that microbial process for the production of citicoline, also 
involved synthetic process. Thus, the specifications concerning ‘Citicoline’ in Table 2 of the Annex to Imple ­
menting Regulation (EU) 2017/2470 should be corrected to include only the microbial production process.  
(17) The novel food ‘ Echinacea angustifolia  extract from cell cultures’ was initially authorised under certain conditions of 
use pursuant to Article 5 of Regulation (EC) No 258/97. The specifications erroneously omitted the wording 
‘description/definition’. Therefore, a correction of the entry ‘ Echinacea angustifolia  extract from cell cultures’ in Table 
2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.  
(18) The novel food ‘Galacto-oligosaccharide’ is included in the Union list established by Implementing Regulation (EU) 
2017/2470. The following microbial sources  Pichia pastoris , Kluyveromyces lactis , Sporobolomyces singularis  and  Papi ­
liotrema terrestris  of the enzyme ‘ β-galactosidase’ were erroneously omitted in the specifications. Therefore, these 
sources of β-galactosidase should be added to the entry ‘Galacto-oligosaccharide’ in Table 2 of the Annex to 
Implementing Regulation (EU) 2017/2470.  
(19) The novel food ‘Vitamin K  2 (menaquinone)’ was initially authorised under certain conditions of use by Commission 
Decision 2009/345/EC (  2 ). The chemical definition of Vitamin K  2 was added to ‘specifications of microbiologically 
produced vitamin K  2 (menaquinone-7)’ but erroneously not added to ‘specifications of synthetic vitamin K  2 
(menaquinone-7)’. Therefore, a correction of the entry ‘Vitamin K  2 (menaquinone)’ in Table 2 of the Annex to 
Implementing Regulation (EU) 2017/2470 is necessary.  
(20) The novel food ‘Yeast beta-glucans’ was authorised under certain conditions of use by Commission Implementing 
Decision 2011/762/EU (  3 ). In the specifications, ‘Microbiological data’ and ‘heavy metals’ erroneously refer to the 
three forms of Yeast beta-glucans instead of to the form ‘Insoluble in water but dispersible in many liquid 
matrices’. Therefore, a correction of the entry ‘Yeast beta-glucans’ in Table 2 of the Annex to Implementing 
Regulation (EU) 2017/2470 is necessary.  
(21) The novel food ‘Phytosterols/phytostanols’ was authorised under certain conditions of use by Commission Decision 
2004/333/EC (  4 ). On 14 April 2016, the company BASF SE Human Nutrition, ENS/HR notified the Commission 
that it placed the novel food ‘Phytosterols/phytostanols’ on the Union market in the category ‘Food supplement’ 
pursuant to Article 5 of Regulation (EC) No 258/97. The category ‘Food supplement’ was erroneously omitted. 
Therefore, a correction adding ‘Food supplement’ as allowed food category in the entry ‘Phytosterols/phytostanols’ 
in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.  
(22) The novel food ‘Arachidonic acid-rich oil from the fungus  Mortierella alpina ’ was authorised under certain 
conditions of use by Commission Decision 2008/968/EC (  5 ). The following non-genetically modified strain ‘CBS 
210.32’ of the fungus  Mortierella alpina  was erroneously not included in the specifications. Therefore, this strain 
should be added to the entry ‘Arachidonic acid-rich oil from the fungus  Mortierella alpina ’ in Table 2 of the Annex 
to Implementing Regulation (EU) 2017/2470.EN 24.7.2018 Official Journal of the European Union L 187/3  
( 1 ) Commission Implementing Decision 2014/423/EU of 1 July 2014 authorising the placing on the market of citicoline as a novel fo od 
ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 196, 3.7.2014, p. 24).  
( 2 ) Commission Decision 2009/345/EC of 22 April 2009 authorising the placing on the market of Vitamin K  2 (menaquinone) from  
Bacillus subtilis  natto as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council 
(OJ L 105, 25.4.2009, p. 16).  
( 3 ) Commission Implementing Decision 2011/762/EU of 24 November 2011 authorising the placing on the market of yeast beta- 
glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 313, 
26.11.2011, p. 41).  
( 4 ) Commission Decision 2004/333/EC of 31 March 2004 authorising the placing on the market of yellow fat spreads, salad dressings , 
milk type products, fermented milk type products, soya drinks and cheese type products with added phytosterols/phytostanols as 
novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 105, 
14.4.2004, p. 40).  
( 5 ) Commission Decision 2008/968/EC of 12 December 2008 authorising the placing on the market of arachidonic acid-rich oil from  
Mortierella alpina  as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council 
(OJ L 344, 20.12.2008, p. 123). (23) The novel food ‘Epigallocatechin gallate as a purified extract from green tea leaves ( Camellia sinensis )’ was initially 
authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The food category 
‘Foods fortified in accordance with Regulation (EC) No 1925/2006’ was added erroneously and should be deleted 
from this entry. Furthermore, a correction adding ‘Foods’ to ‘food supplements as defined in Directive 2002/46/EC’ 
as the allowed food category in the entry ‘Epigallocatechin gallate as a purified extract from green tea leaves 
(Camellia sinensis )’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.  
(24) The novel food ‘Lycopene from tomatoes’ was authorised under certain conditions of use pursuant to Article 5 of 
Regulation (EC) No 258/97. The food category ‘Food supplement’ was omitted erroneously and should be added to 
this entry. Therefore, a correction adding ‘Food supplement’ as allowed food category in the entry ‘Lycopene from 
tomatoes’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.  
(25) In addition, after the publication of Implementing Regulation (EU) 2017/2470, several typographical errors have 
been identified in the Annex. While such typographic errors are usually corrected by a corrigendum, for the sake of 
clarity for economic operators and enforcement authorities, the correction of those typographical errors should be 
included in this correcting act.  
(26) Given the number of corrections, it is appropriate to replace the whole Annex to Implementing Regulation (EU) 
2017/2470.  
(27) 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 replaced by 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, 23 July 2018.  
For the Commission  
The President  
Jean-Claude JUNCKER  
______EN L 187/4 Official Journal of the European Union 24.7.2018 
ANNEX  
UNION LIST OF NOVEL FOODS  
Content of the list  
1. The Union list shall consist of Tables 1 and 2.  
2. Table 1 includes the authorised novel foods and contains the following information:  
Column 1: Authorised novel food  
Column 2: Conditions under which the novel food may be used. This column is further subdivided into two: 
Specified food category and Maximum levels  
Column 3: Additional specific labelling requirements  
Column 4: Other requirements  
3. Table 2 includes the specifications on novel foods and contains the following information:  
Column 1: Authorised novel food  
Column 2: SpecificationsEN 24.7.2018 Official Journal of the European Union L 187/5 EN L 187/6 Official Journal of the European Union 24.7.2018
 Table 1: Authorised novel foods  
Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
N-Acetyl-D-neuraminic acid  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘ N-acetyl-D-neur ­
aminic acid’ 
Food supplements containing  N-acetyl- 
D-neuraminic acid shall bear a 
statement that the food supplement 
should not be given to infants, young 
children and children under 10 years of 
age where they consume breast milk or 
other foods with added  N-acetyl-D- 
neuraminic acid within the same 
twenty four hour period.  Infant and follow-on formulae as 
defined by Regulation (EU) No 609/ 
2013 (1 ) 0,05 g/L of reconstituted formula  
Processed cereal-based foods and baby 
foods for infants and young children 
as defined by Regulation (EU) 
No 609/2013  0,05 g/kg for solid foods  
Foods for special medical purposes 
for infants and young children as 
defined by Regulation (EU) 
No 609/2013  In accordance with the particular 
nutritional requirements of the 
infants and young children for 
whom the products are intended but 
in any case not higher than the 
maximum levels specified for the 
category mentioned in the table 
corresponding to the products.  
Total diet replacement foods for 
weight control as defined by Regu ­
lation (EU) No 609/2013  0,2 g/L (drinks) 
1,7 g/kg (bars)  
Foods bearing statements on the 
absence or reduced presence of 
gluten in accordance with the 
requirements of Commission Imple ­
menting Regulation (EU) No 828/ 
2014 (2 ) 1,25 g/kg  
Unflavoured pasteurised and sterilised 
(including UHT) milk-based products  0,05 g/LEN 24.7.2018 Official Journal of the European Union L 187/7
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Unflavoured fermented milk-based 
products, heat treated after fermen ­
tation, flavoured fermented milk 
products including heat-treated 
products  0,05 g/L (beverages) 
0,4 g/kg (solids)  
Dairy analogues, including beverage 
whiteners  0,05 g/L (beverages) 
0,25 g/kg (solids)  
Cereal bars  0,5 g/kg  
Table top sweeteners  8,3 g/kg  
Fruit and vegetable-based drinks  0,05 g/L  
Flavoured drinks  0,05 g/L  
Speciality coffee, tea, herbal and fruit 
infusions, chicory; tea, herbal and 
fruit infusions and chicory extracts; 
tea, plant, fruit and cereal 
preparations for infusions  0,2 g/kg  
Food Supplements as defined in 
Directive 2002/46/EC (3 ) 300 mg/day for general population 
older than 10 years 
55 mg/day for infants 
130 mg/day for young children 
250 mg/day for children between 3 to 
10 years of age  
Adansonia digitata  (Baobab) 
dried fruit pulp  Not specified  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Baobab fruit 
pulp’EN L 187/8 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Ajuga reptans  extract from cell 
cultures  Specified food category  Maximum levels  
Food Supplements as defined in 
Directive 2002/46/EC  In line with normal use in food 
supplements of a similar extract of 
the flowering aerial parts of  Ajuga 
reptans  
L-Alanyl-L-Glutamine  Specified food category  Maximum levels  
Food Supplements as defined in 
Directive 2002/46/EC  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013 excluding foods for infants 
and young children  
Drinks intended to meet the 
expenditure of intense muscular 
effort especially for sportsmen  
Algal oil from the microalgae  
Ulkenia  sp.  Specified food category  Maximum levels of DHA  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Oil from the 
micro-algae  Ulkenia sp. ’ Bakery products (breads, rolls and 
sweet biscuits)  200 mg/100 g  
Cereal bars  500 mg/100 g  
Non-alcoholic beverages (including 
milk based beverages)  60 mg/100 ml  
Allanblackia  seed oil  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘ Allanblackia  seed 
oil’ Yellow fat spreads and cream based 
spreads  20 g/100 gEN 24.7.2018 Official Journal of the European Union L 187/9
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Aloe macroclada  Baker leaf 
extract  Specified food category  Maximum levels  
Food Supplements as defined in 
Directive 2002/46/EC  In line with normal use in food 
supplements of the similar gel 
derived  from Aloe vera  (L.) Burm.  
Antarctic Krill oil from  
Euphausia superba  Specified food category  Maximum levels of combined DHA and 
EPA  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Lipid extract 
from the crustacean Antarctic Krill 
(Euphausia superba )’ Dairy products except milk-based 
drinks  200 mg/100 g or for cheese products 
600 mg/100 g  
Dairy analogues except drinks  200 mg/100 g or for analogues to 
cheese products 600 mg/100 g  
Non-alcoholic beverages 
Milk-based drinks 
Dairy analogue drinks  80 mg/100 ml  
Spreadable fat and dressings  600 mg/100 g  
Cooking fats  360 mg/100 ml  
Breakfast cereals  500 mg/100 g  
Bakery products (breads, rolls and 
sweet biscuits)  200 mg/100 g  
Nutrition bars/cereal bars  500 mg/100 g  
Food Supplements as defined in 
Directive 2002/46/EC  3 000 mg/day for the general popu ­
lation 
450 mg/day for pregnant and 
lactating women  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intendedEN L 187/10 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  250 mg/meal  
Processed cereal-based food and baby 
food intended for infants and young 
children covered by Regulation (EU) 
No 609/2013  200 mg/100 ml  
Foods intended to meet the 
expenditure of intense muscular 
effort, especially for sportsmen  
Foods bearing statements on the 
absence or reduced presence of 
gluten in accordance with the 
requirements of Commission Imple ­
menting Regulation (EU) No 828/ 
2014  
Antarctic Krill oil rich in 
phospholipids from  Euphausia 
superba  Specified food category  Maximum levels of combined DHA and 
EPA  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Lipid extract 
from the crustacean Antarctic Krill 
(Euphausia superba )’ Dairy products except milk-based 
drinks  200 mg/100 g or for cheese products 
600 mg/100 g  
Dairy analogues except drinks  200 mg/100 g or for analogues to 
cheese products 600 mg/100 g  
Non-alcoholic beverages 
Milk-based drinks 
Dairy analogue drinks  80 mg/100 ml  
Spreadable fat and dressings  600 mg/100 g  
Cooking fats  360 mg/100 ml  
Breakfast cereals  500 mg/100 gEN 24.7.2018 Official Journal of the European Union L 187/11
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Bakery products (breads, rolls and 
sweet biscuits)  200 mg/100 g  
Nutrition bars/cereal bars  500 mg/100 g  
Food Supplements as defined in 
Directive 2002/46/EC  3 000 mg/day for the general popu ­
lation 
450 mg/day for pregnant and 
lactating women  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  250 mg/meal  
Processed cereal-based food and baby 
food intended for infants and young 
children covered by Regulation (EU) 
No 609/2013  200 mg/100 ml  
Foods intended to meet the 
expenditure of intense muscular 
effort, especially for sportsmen  
Foods bearing statements on the 
absence or reduced presence of 
gluten in accordance with the 
requirements of Commission Imple ­
menting Regulation (EU) No 828/ 
2014  
Arachidonic acid-rich oil from 
the fungus  Mortierella alpina  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Oil from  
Mortierella alpina ’ or ‘ Mortierella alpina  
oil’ Infant formula and follow-on formula 
as defined in Regulation (EU) No 609/ 
2013  In accordance with Regulation (EU) 
No 609/2013EN L 187/12 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Foods for special medical purposes 
for premature infants as defined in 
Regulation (EU) No 609/2013  In accordance with Regulation (EU) 
No 609/2013  
Argan oil from  Argania spinosa  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Argan oil’ and 
if used as seasoning ‘Vegetable oil 
only for seasoning’ shall be mentioned 
on the label  As seasonings  Not specified  
Food Supplements as defined in 
Directive 2002/46/EC  In line with normal food use of 
vegetable oils  
Astaxanthin-rich oleoresin 
from  Haematococcus pluvialis  
algae  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Astaxanthin’  Food Supplements as defined in 
Directive 2002/46/EC  40-80 mg/day of oleoresin, resulting 
in ≤ 8 mg astaxanthin per day  
Basil seeds ( Ocimum basilicum ) Specified food category  Maximum levels  
Fruit juice and fruit/vegetable blend 
beverages  3 g/200 ml for addition of whole basil 
seeds ( Ocimum basilicum ) 
Fermented black bean extract  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Fermented black 
bean (Soya) extract’’ or ‘Fermented Soya 
extract’  Food Supplements as defined in 
Directive 2002/46/EC  4,5 g/day  
Bovine lactoferrin  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Lactoferrin from 
cows’ milk’  Infant formula and follow-on formula 
as defined in Regulation (EU) 
No 609/2013 (ready to drink)  100 mg/100 ml  
Foods on dairy basis intended for 
young children (ready to eat/drink)  200 mg/100 g  
Processed cereal food (solid)  670 mg/100 g  
Foods for special medical purposes as 
defined in Regulation (EU) 
No 609/2013  Depending on the needs of the indi ­
vidual up to 3 g/dayEN 24.7.2018 Official Journal of the European Union L 187/13
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Beverages based on milk  200 mg/100 g  
Powdered drink mixes based on milk 
(ready to drink)  330 mg/100 g  
Beverages based on fermented milk 
(including yoghurt drinks)  50 mg/100 g  
Non-alcoholic drinks  120 mg/100 g  
Products based on yoghurt  80 mg/100 g  
Products based on cheese  2 000 mg/100 g  
Ice cream  130 mg/100 g  
Cakes and pastries  1 000 mg/100 g  
Candies  750 mg/100 g  
Chewing gum  3 000 mg/100 g  
Buglossoides arvensis  seed oil  Specified food category  Maximum levels of stearidonic acid (STA)  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Refined  Buglos ­
soides  oil’  Dairy products and analogues  250 mg/100 g  
75 mg/100 g for drinks  
Cheese and cheese products  750 mg/100 g  
Butter and other fat and oil emulsions 
including spreads (not for cooking or 
frying purposes)  750 mg/100 g  
Breakfast cereals  625 mg/100 g  
Food supplements as defined in 
Directive 2002/46/EC, excluding 
food supplements for infants and 
young children  500 mg/dayEN L 187/14 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013, excluding foods for special 
medical purposes intended for 
infants and young children  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  250 mg/meal  
Calanus finmarchicus  oil  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘oil from  Calanus 
finmarchicus  (crustacean)’  Food supplements as defined in 
Directive 2002/46/EC  2,3 g/day  
Chewing gum base 
(monomethoxypolyethylene 
glycol)  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Gum base 
(including 1,3-butadiene, 2-methyl- 
homopolymer, maleated, esters with 
polyethylene glycol mono-Me ether)’ 
or ‘Gum base (including CAS No: 
1246080-53-4)’  Chewing gum  8 %  
Chewing gum base (Methyl 
vinyl ether-maleic anhydride 
copolymer)  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Gum base 
(including methyl vinyl ether-maleic 
anhydride copolymer)’ or ‘Gum base 
(including CAS No 9011-16-9)’  Chewing gum  2 %  
Chia oil from  Salvia hispanica  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Chia oil ( Salvia 
hispanica )’ Fats and oils  10 %  
Pure chia oil  2 g/day  
Food Supplements as defined in 
Directive 2002/46/EC  2 g/dayEN 24.7.2018 Official Journal of the European Union L 187/15
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Chia seeds ( Salvia hispanica ) Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘Chia seeds 
(Salvia hispanica )’ 
2. Pre-packaged Chia ( Salvia hispanica ) 
seeds shall carry additional labelling 
to inform the consumer that the 
daily intake is no more than 15 g.  Bread products  5 % (whole or ground chia seeds)  
Baked products  10 % whole chia seeds  
Breakfast cereals  10 % whole chia seeds  
Fruit, nut and seed mixes  10 % whole chia seeds  
Fruit juice and fruit/vegetable blend 
beverages  15 g/day for addition of whole, 
mashed or ground chia seeds  
Pre-packaged Chia seed as such  15 g/day whole chia seeds  
Fruit spreads  1 % whole chia seeds  
Yoghurt  1,3 g whole chia seeds per 100 g of 
yoghurt or 4,3 g whole chia seeds per 
330 g of yoghurt (portion)  
Sterilised ready to eat meals based on 
cereal grains, pseudocereals grains 
and/or pulses  5 % whole chia seeds  
Chitin-glucan from  Aspergillus 
niger  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Chitin-glucan 
from  Aspergillus niger ’ Food Supplements as defined in 
Directive 2002/46/EC  5 g/day  
Chitin-glucan complex from  
Fomes fomentarius  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Chitin-glucan 
from  Fomes fomentarius ’ Food Supplements as defined in 
Directive 2002/46/EC  5 g/day  
Chitosan extract from fungi 
(Agaricus bisporus ; Aspergillus 
niger ) Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Chitosan extract 
from  Agaricus bisporus ’ or ‘Chitosan 
extract from  Aspergillus niger ’ Food Supplements as defined in 
Directive 2002/46/EC  In line with normal use in food 
supplements of chitosan from crusta ­
ceansEN L 187/16 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Chondroitin sulphate  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Chondroitin 
sulphate derived from microbial 
fermentation and sulphation’  Food supplements as defined in 
Directive 2002/46/EC for adult popu ­
lation, excluding pregnant and 
lactating women  1 200 mg/day  
Chromium Picolinate  Specified food category  Maximum levels of total chromium  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Chromium Picoli ­
nate’  Foods covered by Regulation (EU) 
No 609/2013  250 μg/day  
Foods fortified in accordance with 
Regulation (EC) No 1925/2006 (4 ) 
Cistus incanus  L. Pandalis herb  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘ Cistus incanus  L. 
Pandalis herb’  Herbal infusions  Intended daily intake: 3 g herbs/day 
(2 cups/day)  
Citicoline  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘Citicoline’ 
2. The labelling of foods containing 
citicoline shall bear a statement 
that the product is not intended to 
be consumed by children  Food Supplements as defined in 
Directive 2002/46/EC  500 mg/day  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  250 mg per serving and a maximum 
daily consumption level of 1 000 mg  
Clostridium butyricum  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘ Clostridium 
butyricum  MIYAIRI 588 (CBM 588)’ or 
‘Clostridium butyricum  (CBM 588)’  Food Supplements as defined in 
Directive 2002/46/EC  1,35 × 108 CFU/dayEN 24.7.2018 Official Journal of the European Union L 187/17
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Extract of defatted cocoa 
powder  Specified food category  Maximum levels  Consumers shall be instructed not to 
consume more than 600 mg poly ­
phenols corresponding to 1,1 g of 
extract of defatted cocoa powder per 
day Nutrition bars  1 g/day and 300 mg polyphenols 
corresponding to not more than 
550 mg of extract of defatted cocoa 
powder in one portion of food (or 
food supplement)  Milk based beverages  
Any other foods (including food 
supplements as defined in Directive 
2002/46/EC) which have become 
established vehicles for functional 
ingredients and which are typically 
positioned for consumption by 
health conscious adults  
Low fat cocoa extract  Specified food category  Maximum levels  Consumers shall be instructed not to 
consume more than 600 mg of cocoa 
flavanols per day  Foods including food supplements as 
defined in Directive 2002/46/EC  730 mg per serving and around 
1,2 g/day  
Coriander seed oil from  
Coriandrum sativum  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Coriander seed 
oil’ Food Supplements as defined in 
Directive 2002/46/EC  600 mg/day  
Crataegus pinnatifida  dried 
fruit  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘ Crataegus pinna ­
tifida  dried fruit’  Herbal infusions  In line with normal food use of  
Crataegus laevigata  
Jams and jellies in accordance with 
Directive 2001/113/EC (5 ) 
Compotes  
α-cyclodextrin  Not specified  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Alpha-cyclo ­
dextrin’ or ‘ α-cyclodextrin’EN L 187/18 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
γ-cyclodextrin  Not specified  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Gamma- 
Cyclodextrin’ or ‘ γ-Cyclodextrin’  
Dextran preparation produced 
by Leuconostoc mesenteroides  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Dextran’  Bakery products  5 %  
Diacylglycerol oil of plant 
origin  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Diacylglycerol 
oil of plant origin (at least 80 % 
diacylglycerols)’  Cooking oils  
Fat spreads  
Salad dressings  
Mayonnaise  
Meal replacement for weight control 
(as drinks)  
Bakery products  
Yoghurt type products  
Dihydrocapsiate (DHC)  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘Dihydrocap ­
siate’ 
2. Food supplements containing 
synthetic dihydrocapsiate will be 
labelled as ‘not intended for 
children up to 4.5 years’  Cereal bars  9 mg/100 g  
Biscuits, cookies and crackers  9 mg/100 g  
Rice based snacks  12 mg/100 g  
Carbonated drinks, dilutable drinks, 
fruit juice based beverages  1,5 mg/100 ml  
Vegetable drinks  2 mg/100 mlEN 24.7.2018 Official Journal of the European Union L 187/19
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Coffee based drinks, tea based drinks  1,5 mg/100 ml  
Flavoured water — still  1 mg/100 ml  
Precooked oatmeal cereal  2,5 mg/100 g  
Other cereals  4,5 mg/100 g  
Ice cream, dairy desserts  4 mg/100 g  
Pudding mixes (ready to eat)  2 mg/100 g  
Products based on yoghurt  2 mg/100 g  
Chocolate confectionery  7,5 mg/100 g  
Hard candy  27 mg/100 g  
Sugar-free gum  115 mg/100 g  
Whitener/creamer  40 mg/100 g  
Sweeteners  200 mg/100 g  
Soup (ready to eat)  1,1 mg/100 g  
Salad dressing  16 mg/100 g  
Vegetable protein  5 mg/100 g  
Ready to eat meals  3 mg/meal  
Meal replacements for weight control  3 mg/meal  
Meal replacement for weight control 
(as drinks)  1 mg/100 mlEN L 187/20 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Food Supplements as defined in 
Directive 2002/46/EC  3 mg/single intake 
9 mg/day  
Non-alcoholic powdered drink mixes  14,5 mg/kg equivalent to 1,5 mg/ 
100 ml  
Dried extract of  Lippia 
citriodora  from cell cultures  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘dried extract of  
Lippia citriodora  from cell cultures 
HTN® Vb’ Food Supplements as defined in 
Directive 2002/46/EC  In line with normal use in food 
supplements of a similar extract 
from the leaves of  Lippia citriodora  
Echinacea angustifolia  extract 
from cell cultures  Specified food category  Maximum levels  
Food Supplements as defined in 
Directive 2002/46/EC  In line with normal use in food 
supplements of a similar extract 
from the root of  Echinacea angustifolia  
Echinacea purpurea  extract 
from cell cultures  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘dried extract of  
Echinacea purpurea  from cell cultures 
HTN® Vb’ Food Supplements as defined in 
Directive 2002/46/EC  In line with normal use in food 
supplements of a similar extract 
from florets within the flower head 
of Echinacea purpurea  
Echium plantagineum  oil Specified food category  Maximum levels of stearidonic acid (STA)  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Refined echium 
oil’ Milk-based products and drinkable 
yoghurt products delivered in a 
single dose  250 mg/100 g; 75 mg/100 g for 
drinks  
Cheese preparations  750 mg/100 g  
Spreadable fat and dressings  750 mg/100 g  
Breakfast cereals  625 mg/100 g  
Food supplements as defined in 
Directive 2002/46/EC  500 mg/dayEN 24.7.2018 Official Journal of the European Union L 187/21
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  250 mg/meal  
Epigallocatechin gallate as a 
purified extract from green tea 
leaves ( Camellia sinensis ) Specified food category  Maximum levels  The labelling shall bear a statement that 
consumers should not consume more 
than 300 mg of extract per day  
Foods including food supplements as 
defined in Directive 2002/46/EC  150 mg of extract in one portion of 
food or food supplement  
L-ergothioneine  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘L-ergothioneine’  
Food supplements as defined in 
Directive 2002/46/EC  30 mg/day for general population 
(excluding pregnant and lactating 
women) 
20 mg/day for children older than 
3 years  
Ferric Sodium EDTA  Specified food category  Maximum levels (expressed as anhydrous 
EDTA)  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Ferric Sodium 
EDTA’  
Food supplements as defined in 
Directive 2002/46/EC  18 mg/day for children 
75 mg/day for adults  
Foods covered by Regulation (EU) 
No 609/2013  12 mg/100 g  
Foods fortified in accordance with 
Regulation (EC) No 1925/2006EN L 187/22 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Ferrous ammonium phosphate  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Ferrous 
ammonium phosphate’  Food supplements as defined in 
Directive 2002/46/EC  To be used in compliance with 
Directive 2002/46/EC, Regulation 
(EU) No 609/2013 and/or Regulation 
(EC) No 1925/2006  Foods covered by Regulation (EU) 
No 609/2013  
Foods fortified in accordance with 
Regulation (EC) No 1925/2006  
Fish peptides from  Sardinops 
sagax  Specified food category  Maximum levels fish peptide product  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Fish ( Sardinops 
sagax ) peptides’  Foods based on yoghurt, yoghurt 
drinks, fermented milk products, and 
powdered milk  0,48 g/100 g (ready to eat/drink)  
Flavoured water, and vegetable-based 
drinks  0,3 g/100 g (ready to drink)  
Breakfast cereals  2 g/100 g  
Soups, stews and soup powders  0,3 g/100 g (ready to eat)  
Flavonoids from  Glycyrrhiza 
glabra  Specified food category  Maximum levels of flavonoids from 
Glycyrrhiza glabra  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘Flavonoids 
from  Glycyrrhiza glabra L. ’ 
2. The labelling of the foods where the 
product was added as a novel food 
ingredient shall bear a statement 
that: 
(a) the product should not be 
consumed by pregnant and 
breast feeding women, children 
and young adolescents; and 
(b) people taking prescription drugs 
should only consume the 
product under medical super ­
vision;  Beverages containing 
flavonoids shall be 
presented to the final 
consumer as single 
portions.  Beverages based on milk  120 mg/day  
Beverages based on yoghurt  
Beverages based on fruit or vegetables  
Food Supplements as defined in 
Directive 2002/46/EC  120 mg/day  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013  120 mg/day  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  120 mg/dayEN 24.7.2018 Official Journal of the European Union L 187/23
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
(c) a maximum of 120 mg of 
flavonoids per day should be 
consumed. 
3. The amount of flavonoids in the 
final food shall be indicated on the 
labelling of the food containing it.  
Fucoidan extract from the 
seaweed  Fucus vesiculosus  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Fucoidan extract 
from seaweed  Fucus vesiculosus ’. Foods including food supplements as 
defined in Directive 2002/46/EC for 
the general population  250 mg/day  
Fucoidan extract from the 
seaweed  Undaria pinnatifida  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Fucoidan extract 
from seaweed Undaria pinnatifida’  Foods including food supplements as 
defined in Directive 2002/46/EC for 
the general population  250 mg/day  
2′-Fucosyllactose  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘2 ′-fucosyllac ­
tose’. 
2. The labelling of food supplements 
containing 2 ′-fucosyllactose shall 
bear a statement that the 
supplements should not be used if 
other foods with added 2 ′-fucosyl ­
lactose are consumed the same day. 
3. The labelling of food supplements 
containing 2 ′-fucosyllactose 
intended for young children shall 
bear a statement that the 
supplements should not be used if 
breast milk or other foods with 
added 2 ′-fucosyllactose are 
consumed the same day.  Unflavoured pasteurised and sterilised 
(including UHT) milk-based products  1,2 g/l  
Unflavoured fermented milk-based 
products  1,2 g/l beverages  
19,2 g/kg products other than 
beverages  
Flavoured fermented milk-based 
products including heat-treated 
products  1,2 g/l beverages  
19,2 g/kg products other than 
beverages  
Dairy analogues, including beverage 
whiteners  1,2 g/l beverages  
12 g/kg for products other than 
beverages  
400 g/kg for whitenerEN L 187/24 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Cereal bars  12 g/kg  
Table-top sweeteners  200 g/kg  
Infant formula as defined in 
Regulation (EU) No 609/2013  1,2 g/l alone or in combination with 
up to 0,6 g/l of lacto- N-neotetraose at 
a ratio of 2:1 in the final product 
ready for use, marketed as such or 
reconstituted as instructed by the 
manufacturer  
Follow-on formula as defined in 
Regulation (EU) No 609/2013  1,2 g/l alone or in combination with 
up to 0,6 g/l of lacto- N-neotetraose at 
a ratio of 2:1 in the final product 
ready for use, marketed as such or 
reconstituted as instructed by the 
manufacturer  
Processed cereal-based food and baby 
food for infants and young children 
as defined in Regulation (EU) No 609/ 
2013  12 g/kg for products other than 
beverages  
1,2 g/l for liquid food ready for use, 
marketed as such or reconstituted as 
instructed by the manufacturer  
Milk-based drinks and similar 
products intended for young children  1,2 g/l for milk-based drinks and 
similar products added alone or in 
combination with up to 0,6 g/l lacto-  
N-neotetraose, at a ratio of 2:1 in the 
final product ready for use, marketed 
as such or reconstituted as instructed 
by the manufacturer  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013  4,8 g/l for drinks  
40 g/kg for barsEN 24.7.2018 Official Journal of the European Union L 187/25
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Bread and pasta products bearing 
statements on the absence or 
reduced presence of gluten in 
accordance with the requirements of 
Commission Implementing Regu ­
lation (EU) No 828/2014  60 g/kg  
Flavoured drinks  1,2 g/l  
Coffee, tea (excluding black tea), 
herbal and fruit infusions, chicory; 
tea, herbal and fruit infusions and 
chicory extracts; tea, plant, fruit and 
cereal preparations for infusions, as 
well as mixes and instant mixes of 
these products  9,6 g/l — the maximum level refers to 
the products ready to use  
Food supplements as defined in 
Directive 2002/46/EC, excluding 
food supplements for infants  3,0 g/day for general population  
1,2 g/day for young children  
Galacto-oligosaccharide  Specified food category  Maximum levels (expressed as ratio kg 
galacto-oligosaccharide/kg final food)  
Food Supplements as defined in 
Directive 2002/46/EC  0,333  
Milk  0,020  
Milk drinks  0,030  
Meal replacement for weight control 
(as drinks)  0,020  
Dairy analogue drinks  0,020  
Yoghurt  0,033EN L 187/26 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Dairy based deserts  0,043  
Frozen dairy deserts  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 desert  0,027  
Baby snack  0,143  
Baby cereals  0,027  
Drinks intended to meet the 
expenditure of intense muscular 
effort especially for sportsmen  0,013  
Juice  0,021  
Fruit pie fillings  0,059  
Fruit preparations  0,125  
Bars  0,125  
Cereals  0,125  
Infant formula and follow-on formula 
as defined in Regulation (EU) No 609/ 
2013  0,008EN 24.7.2018 Official Journal of the European Union L 187/27
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Glucosamine HCl  Specified food category  Maximum levels  
Food Supplements as defined in 
Directive 2002/46/EC  In line with normal food use of gluco ­
samine from shell fish  
Foods covered by Regulation (EU) 
No 609/2013  
Meal replacement for weight control  
Foods intended to meet the 
expenditure of intense muscular 
effort, especially for sportsmen  
Foods bearing statements on the 
absence or reduced presence of 
gluten in accordance with the 
requirements of Commission Imple ­
menting Regulation (EU) No 828/ 
2014  
Glucosamine sulphate KCl  Specified food category  Maximum levels  
Food Supplements as defined in 
Directive 2002/46/EC  In line with normal food use of gluco ­
samine from shell fish  
Glucosamine sulphate NaCl  Specified food category  Maximum levels  
Food Supplements as defined in 
Directive 2002/46/EC  In line with normal food use of gluco ­
samine from shell fish  
Guar Gum  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘Guar Gum’. 
2. A specific mention of the possible 
risks of digestive discomfort linked 
to the exposure of children aged 
under 8 to guar gum must be 
visible on the label of any foodstuffs 
containing it.  Fresh dairy products such as yogurts, 
fermented milks, fresh cheeses and 
other dairy-based desserts.  1,5 g/100 g  
Fruit or vegetable-based liquid food ­
stuffs (of the ‘smoothie’ variety)  1,8 g/100 g  
Fruit or vegetable-based compotes  3,25 g/100 g  
Cereals accompanied by a dairy 
product, in packaging containing 
two compartments  10 g/100 g in the cereals 
None in the accompanying dairy 
productEN L 187/28 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
For example, ‘Excessive consumption 
of these products may cause 
digestive discomfort, especially for 
children under 8 years of age’. 
3. In the case of products with two 
compartments containing dairy and 
cereal products respectively, the 
instructions for use must clearly 
specify the need to mix the cereal 
and the dairy product before 
consumption, in order to take into 
account the potential risk of gastro- 
intestinal obstruction.  1 g/100 g in the product when ready 
to eat  
Heat-treated milk products 
fermented with  Bacteroides 
xylanisolvens  Specified food category  Maximum levels  
Fermented milk products (in liquid, 
semi-liquid and spray-dried powder 
forms)  
Hydroxytyrosol  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the food products 
containing it shall be ‘hydroxytyrosol’. 
The labelling of the food products 
containing hydroxytyrosol shall bear 
the following statements: 
(a) This food product should not be 
consumed by children under the 
age of three years, pregnant 
women, and lactating women; 
(b) This food product should not be 
used for cooking, baking or frying’  Fish and vegetable oils, (except olive 
oils and olive pomace oils as defined 
in Part VIII of Annex VII of Regu ­
lation (EU) No 1308/2013 (6 )), 
placed as such on the market  0,215 g/kg  
Spreadable fats as defined in Part VII 
of Annex VII of Regulation (EU) 
No 1308/2013, placed as such on 
the market  0,175 g/kg  
Ice Structuring Protein type III 
HPLC 12  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Ice Structuring 
Protein’  Edible ices  0,01 %EN 24.7.2018 Official Journal of the European Union L 187/29
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Aqueous extracts of dried 
leaves of  Ilex guayusa  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Extracts of dried 
leaves of  Ilex guayusa ’ Herbal infusions  In line with normal use in herbal 
infusions and food supplements of a 
similar aqueous extract of dried leaves 
of Ilex paraguariensis  Food Supplements as defined in 
Directive 2002/46/EC  
Isomalto-oligosaccharide  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘Isomaltooli ­
gosaccharide’. 
2. Foods containing the novel 
ingredient must be labelled as ‘a 
source of glucose’.  Energy-Reduced Soft Drinks  6,5 %  
Energy Drinks  5,0 %  
Foods intended to meet the 
expenditure of intense muscular 
efforts, especially for sportsmen 
(including isotonic drinks)  6,5 %  
Fruit Juices  5 %  
Processed Vegetables and Vegetable 
Juices  5 % 
Other Soft Drinks  5 %  
Cereals Bars  10 %  
Cookies, Biscuits  20 %  
Breakfast Cereal Bars  25 %  
Hard Candies  97 %  
Soft Candies/Chocolate Bars  25 %  
Meal replacement for weight control 
(as bars or milk based)  20 %EN L 187/30 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Isomaltulose  Not specified  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘Isomaltulose’. 
2. The designation of the novel food 
on the labelling shall be accom ­
panied by indication that the ‘Isom ­
altulose is a source of glucose and 
fructose’.  
Lactitol  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the food supplements 
containing it shall be ‘Lactitol’  Food Supplements as defined in 
Directive 2002/46/EC (capsules or 
tablets) intended for the adult popu ­
lation  20 g/day  
Lacto- N-neotetraose  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘lacto- N- 
neotetraose’. 
2. The labelling of food supplements 
containing lacto- N-neotetraose shall 
bear a statement that the 
supplements should not be used if 
other foods with added lacto- N- 
neotetraose are consumed the same 
day. 
3. The labelling of food supplements 
containing lacto- N-neotetraose 
intended for young children shall 
bear a statement that the 
supplements should not be used if 
breast milk or other foods with 
added lacto- N-neotetraose are 
consumed the same day.  Unflavoured pasteurised and sterilised 
(including UHT) milk-based products  0,6 g/l  
Unflavoured fermented milk-based 
products  0,6 g/l for beverages 
9,6 g/kg for products other than 
beverages  
Flavoured fermented milk-based 
products including heat-treated 
products  0,6 g/l for beverages 
9,6 g/kg for products other than 
beverages  
Dairy analogues, including beverage 
whiteners  0,6 g/l for beverages 
6 g/kg for products other than 
beverages 
200 g/kg for whitener  
Cereal bars  6 g/kg  
Table-top sweeteners  100 g/kgEN 24.7.2018 Official Journal of the European Union L 187/31
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Infant formula as defined in Regu ­
lation (EU) No 609/2013  0,6 g/l in combination with up to 
1,2 g/l of 2 ′-fucosyllactose at a ratio 
of 1:2 in the final product ready for 
use, marketed as such or reconstituted 
as instructed by the manufacturer  
Follow-on formula as defined in 
Regulation (EU) No 609/2013  0,6 g/l in combination with up to 
1,2 g/l of 2 ′-fucosyllactose at a ratio 
of 1:2 in the final product ready for 
use, marketed as such or reconstituted 
as instructed by the manufacturer  
Processed cereal-based food and baby 
food for infants and young children 
as defined in Regulation (EU) No 
609/2013  6 g/kg for products other than 
beverages 
0,6 g/l for liquid food ready for use, 
marketed as such or reconstituted as 
instructed by the manufacturer  
Milk-based drinks and similar 
products intended for young children  0,6 g/l for milk-based drinks and 
similar products added alone or in 
combination with 2 ′-fucosyllactose, 
at a ratio of 1:2 in the final product 
ready for use, marketed as such or 
reconstituted as instructed by the 
manufacturer  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013  2,4 g/l for drinks 
20 g/kg for bars  
Bread and pasta products bearing 
statements on the absence or 
reduced presence of gluten in 
accordance with the requirements of 
Commission Implementing Regu ­
lation (EU) No 828/2014  30 g/kgEN L 187/32 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Flavoured drinks  0,6 g/l  
Coffee, tea (excluding black tea), 
herbal and fruit infusions, chicory; 
tea, herbal and fruit infusions and 
chicory extracts; tea, plant, fruit and 
cereal preparations for infusions, as 
well as mixes and instant mixes of 
these products  4,8 g/l — the maximum level refers to 
the products ready to use  
Food supplements as defined in 
Directive 2002/46/EC, excluding 
food supplements for infants  1,5 g/day for general population 
0,6 g/day for young children  
Lucerne leaf extract from  
Medicago sativa  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Lucerne 
(Medicago sativa ) protein’ or ‘Alfalfa 
(Medicago sativa ) protein’.  Food supplements as defined in 
Directive 2002/46/EC  10 g/day  
Lycopene  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Lycopene’  Fruit/vegetable juice-based drinks 
(including concentrates)  2,5 mg/100 g  
Drinks intended to meet the 
expenditure of intense muscular 
effort especially for sportsmen  2,5 mg/100 g  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  8 mg/meal  
Breakfast cereals  5 mg/100 g  
Fats and dressings  10 mg/100 g  
Soups other than tomato soups  1 mg/100 g  
Bread (including crispy breads)  3 mg/100 gEN 24.7.2018 Official Journal of the European Union L 187/33
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Foods for special medical purposes as 
defined in Regulation (EU) No 
609/2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Food supplements as defined in 
Directive 2002/46/EC  15 mg/day  
Lycopene from  Blakeslea 
trispora  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Lycopene’  Fruit/vegetable juice-based drinks 
(including concentrates)  2,5 mg/100 g  
Drinks intended to meet the 
expenditure of intense muscular 
effort especially for sportsmen  2,5 mg/100 g  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  8 mg/meal  
Breakfast cereals  5 mg/100 g  
Fats and dressings  10 mg/100 g  
Soups other than tomato soups  1 mg/100 g  
Bread (including crispy breads)  3 mg/100 g  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Food supplements as defined in 
Directive 2002/46/EC  15 mg/dayEN L 187/34 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Lycopene from tomatoes  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Lycopene’  Fruit/vegetable juice-based drinks 
(including concentrates)  2,5 mg/100 g  
Drinks intended to meet the 
expenditure of intense muscular 
effort especially for sportsmen  2,5 mg/100 g  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  8 mg/meal  
Breakfast cereals  5 mg/100 g  
Fats and dressings  10 mg/100 g  
Soups other than tomato soups  1 mg/100 g  
Bread (including crispy breads)  3 mg/100 g  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Food supplements as defined in 
Directive 2002/46/EC  15 mg/day  
Lycopene oleoresin from 
tomatoes  Specified food category  Maximum levels of lycopene  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Lycopene 
oleoresin from tomatoes’  Fruit/vegetable juice-based drinks 
(including concentrates)  2,5 mg/100 g  
Drinks intended to meet the 
expenditure of intense muscular 
effort especially for sportsmen  2,5 mg/100 gEN 24.7.2018 Official Journal of the European Union L 187/35
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Total diet replacement for weight 
control covered by Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  8 mg/meal  
Breakfast cereals  5 mg/100 g  
Fats and dressings  10 mg/100 g  
Soups other than tomato soups  1 mg/100 g  
Bread (including crispy breads)  3 mg/100 g  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Magnesium citrate malate  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Magnesium 
citrate malate’  Food Supplements as defined in 
Directive 2002/46/EC  
Magnolia Bark Extract  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Magnolia Bark 
Extract’  Mints (confectionary products)  0,2 % for breath freshening purposes. 
Based on a 0,2 % maximum incor ­
poration level and a maximum 
gum/mint size of 1,5 g each, each 
gum or mint serving will contain no 
more than 3 mg of magnolia bark 
extract.  Chewing gum  
Maize-germ oil high in 
unsaponifiable matter  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Maize-germ oil 
extract’  Food Supplements as defined in 
Directive 2002/46/EC  2 g/day  
Chewing gum  2 %EN L 187/36 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Methylcellulose  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Methylcellulose’  Methylcellulose is not to 
be used in foods specially 
prepared for young 
children  Edible ices  2 %  
Flavoured drinks  
Flavoured or unflavoured fermented 
milk products  
Cold desserts (dairy, fat, fruit, cereal, 
egg-based products)  
Fruit preparations (pulps, purees or 
compotes)  
Soups and broths  
(6S)-5-methyltetrahydrofolic 
acid, glucosamine salt  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘(6S)-5-methyltet ­
rahydrofolic acid, glucosamine salt’ or 
‘5MTHF-glucosamine’  
Food Supplements as defined in 
Directive 2002/46/EC as a source of 
folate  
Monomethylsilanetriol 
(Organic Silicon)  Specified food category  Maximum levels of silicon  The designation of the novel food on 
the labelling of the food supplements 
containing it shall be ‘Organic silicon 
(monomethylsilanetriol)’  Food Supplements as defined in 
Directive 2002/46/EC for adult popu ­
lation (in liquid form)  10,40 mg/day  
Mycelial extract from Shiitake 
mushroom ( Lentinula edodes ) Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘extract from the 
mushroom  Lentinula edodes ’ or ‘extract 
from Shiitake mushroom’  Bread products  2 ml/100 g  
Soft drinks  0,5 ml/100 ml  
Ready prepared meals  2,5 ml per mealEN 24.7.2018 Official Journal of the European Union L 187/37
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Foods based on yoghurt  1,5 ml/100 ml  
Food supplements as defined in 
Directive 2002/46/EC  2,5 ml per day dose  
Noni fruit juice ( Morinda 
citrifolia ) Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Noni juice’ or 
‘Juice of  Morinda citrifolia ’ Pasteurised fruit and fruit nectar based 
drinks  30 ml with one serving (up to 100 % 
noni juice) 
or 
20 ml twice a day, not more than 
40 ml per day  
Noni fruit juice powder 
(Morinda citrifolia ) Food supplements as defined in 
Directive 2002/46/EC  6,6 g/day (equivalent to 30 ml of noni 
juice)  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Noni juice 
powder’ or ‘Juice powder of  Morinda 
citrifolia ’ 
Noni fruit puree and 
concentrate ( Morinda citrifolia ) Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be: 
For fruit puree: 
‘Morinda citrifolia  fruit puree’ or ‘Noni 
fruit puree’ 
For fruit concentrate: 
‘Morinda citrifolia  fruit concentrate’ or 
‘Noni fruit concentrate’  Fruit puree  
Candy/confectionery  45 g/100 g  
Cereal bars  53 g/100 g  
Powdered nutritional drink mixes (dry 
weight)  53 g/100 g  
Carbonated beverages  11 g/100 g  
Ice cream & sorbet  31 g/100 g  
Yoghurt  12 g/100 g  
Biscuits  53 g/100 g  
Buns, cakes and pastries  53 g/100 gEN L 187/38 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Breakfast cereals (wholegrain)  88 g/100 g  
Jams and jellies in accordance with 
Directive 2001/113/EC  133 g/100 g 
Based on pre-processing quantity to 
produce final 100 g product  
Sweet spreads, fillings and icings  31 g/100 g  
Savoury sauces, pickles, gravies and 
condiments  88 g/100 g  
Food Supplements as defined in 
Directive 2002/46/EC  26 g/day  
Fruit concentrate  
Candy/Confectionery  10 g/100 g  
Cereal bars  12 g/100 g  
Powdered nutritional drink mixes (dry 
weight)  12 g/100 g  
Carbonated beverages  3 g/100 g  
Ice cream & sorbet  7 g/100 g  
Yoghurt  3 g/100 g  
Biscuits  12 g/100 g  
Buns, cakes and pastries  12 g/100 g  
Breakfast cereals (wholegrain)  20 g/100 g  
Jams and jellies in accordance with 
Directive 2001/113/EC  30 g/100 g  
Sweet spreads, fillings and icings  7 g/100 gEN 24.7.2018 Official Journal of the European Union L 187/39
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Savoury sauces, pickles, gravies and 
condiments  20 g/100 g  
Food Supplements as defined in 
Directive 2002/46/EC  6 g/day  
Noni leaves ( Morinda citrifolia ) Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘Noni leaves’ 
or ‘leaves of  Morinda citrifolia ’. 
2. Instructions shall be given to the 
consumer that a cup of infusion 
should not be prepared with more 
than 1 g of dried and roasted leaves 
of Morinda citrifolia.  For the preparation of infusions  A cup of infusion to be consumed 
shall not be prepared with more 
than 1 g of dried and roasted leaves 
of Morinda citrifolia  
Noni fruit powder ( Morinda 
citrifolia ) Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Morinda citrifolia 
fruit powder’ or ‘Noni fruit powder’  Food Supplements as defined in 
Directive 2002/46/EC  2,4 g per/day  
Odontella aurita  microalgae  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘ Odontella aurita  
microalgae’  Flavoured pasta  1,5 %  
Fish soups  1 %  
Marine terrines  0,5 %  
Broth preparations  1 %  
Crackers  1,5 %  
Frozen breaded fish  1,5 %EN L 187/40 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Oil enriched with 
phytosterols/phytostanols  Specified food category  Maximum levels of phytosterols/ 
phytostanols  In accordance with Annex III.5 to 
Regulation (EU) No 1169/2011  
Spreadable fats as defined in Annex 
VII, Part VII and Appendix II, points 
B and C of Regulation (EU) No 
1308/2013, and excluding cooking 
and frying fats and spreads based on 
butter or other animal fat  1. The products containing the novel 
food ingredient shall be presented 
in such a manner that they can be 
easily divided into portions that 
contain either a maximum of 3 g 
(in case of one portion per day) or 
a maximum of 1 g (in case of three 
portions per day) of added phytos ­
terols/phytostanols. 
2. The amount of phytosterols/phy ­
tostanols added to a container of 
beverages shall not exceed 3 g. 
3. Salad dressings, mayonnaise and 
spicy sauces shall be packed as 
single portions.  Milk based products, such as products 
based on semi-skimmed and skimmed 
milk products, possibly with the 
addition of fruits and/or cereals, 
products based on fermented milk 
such as yoghurt and cheese based 
products (fat content ≤ 12 g per 
100 g), where possibly the milk fat 
has been reduced and the fat or 
protein has been partly or fully 
replaced by vegetable fat or protein  
Soya drinks  
Salad dressings, mayonnaise and spicy 
sauces  
Oil extracted from squids  Specified food category  Maximum levels of DHA and EPA 
combined  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Squid oil’.  
Dairy products except milk-based 
beverages  200 mg/100 g or for cheese products 
600 mg/100 g  
Dairy analogues except drinks  200 mg/100 g or for analogues to 
cheese products 600 mg/100 g  
Spreadable fat and dressings  600 mg/100 g  
Breakfast cereals  500 mg/100 g  
Bakery products (breads and bread 
rolls)  200 mg/100 gEN 24.7.2018 Official Journal of the European Union L 187/41
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Cereal bars  500 mg/100 g  
Non-alcoholic beverages (including 
milk-based beverages)  60 mg/100 ml  
Food Supplements as defined in 
Directive 2002/46/EC  3 000 mg/day for general population 
450 mg/day for pregnant and 
lactating women  
Foods for special medical purposes as 
defined in Regulation (EU) No 
609/2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products 
intended  
Total diet replacement for weight 
control defined in Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  200 mg/meal  
Pasteurised fruit-based 
preparations produced using 
high-pressure treatment  Specified food category  Maximum levels  The wording ‘pasteurised by high- 
pressure treatment’ shall be displayed 
next to the name of the fruit 
preparations as such and in any 
product in which it is used  Types of fruit: 
apple, apricot, banana, blackberry, 
blueberry, cherry, coconut, fig, grape, 
grapefruit, mandarin, mango, melon, 
peach, pear, pineapple, prune, rasp ­
berry, rhubarb, strawberry  
Phosphated maize starch  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Phosphated 
maize starch’  Baked bakery products  15 %  
Pasta  
Breakfast cereals  
Cereal bars  
Phosphatidylserine from fish 
phospholipids  Specified food category  Maximum levels of phosphatidylserine  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Fish phosphati ­
dylserine’  Beverages based on yoghurt  50 mg/100 ml  
Powders based on milk powders  3 500 mg/100 g (equivalent to 
40 mg/100 ml ready to drink)EN L 187/42 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Foods based on yoghurt  80 mg/100 g  
Cereal bars  350 mg/100 g  
Chocolate based confectionary  200 mg/100 g  
Foods for special medical purposes as 
defined in Regulation (EU) No 
609/2013  In compliance with Regulation (EU) 
No 609/2013  
Food supplements as defined in 
Directive 2002/46/EC  300 mg/day  
Phosphatidylserine from soya 
phospholipids  Specified food category  Maximum levels of phosphatidylserine  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Soya phosphati ­
dylserine’  Beverages based on yoghurt  50 mg/100 ml  
Powders based on milk powder  3,5 g/100 g (equivalent to 
40 mg/100 ml ready to drink)  
Foods based on yoghurt  80 mg/100 g  
Cereal bars  350 mg/100 g  
Chocolate based confectionary  200 mg/100 g  
Foods for special medical purposes as 
defined in Regulation (EU) No 
609/2013  In compliance with Regulation (EU) 
No 609/2013  
Phospholipid product 
containing equal amounts of 
phosphatidylserine and 
phosphatidic acid  Specified food category  Maximum levels of phosphatidylserine  The designation of the novel food on 
the labelling of the foodstuffs 
containing shall be ‘Soy phosphati ­
dylserine and phosphatidic acid’  The product is not 
intended to be marketed 
to pregnant or breast- 
feeding women  Breakfast cereals  80 mg/100 g  
Cereal bars  350 mg/100 g  
Foods based on yogurt  80 mg/100 g  
Soy-based yogurt-like products  80 mg/100 gEN 24.7.2018 Official Journal of the European Union L 187/43
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Yogurt based-drinks  50 mg/100 g  
Soy-based yogurt-like drinks  50 mg/100 g  
Powders based on milk powder  3,5 g/100 g (equivalent to 
40 mg/100 ml ready-to drink)  
Food Supplements as defined in 
Directive 2002/46/EC  800 mg/day  
Foods for special medical purposes as 
defined in Regulation (EU) No 
609/2013  In compliance with Regulation (EU) 
No 609/2013  
Phospholipides from egg yolk  Specified food category  Maximum levels  
Not specified  
Phytoglycogen  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Phytoglycogen’  Processed foods  25 %  
Phytosterols/phytostanols  Specified food category  Maximum levels  In accordance with Annex III.5 of 
Regulation (EU) No 1169/2011  
Rice drinks  1. They shall be presented in such a 
manner that they can be easily 
divided into portions that contain 
either a maximum of 3 g (in case 
of 1 portion/day) or a maximum 
of 1 g (in case of 3 portions/day) 
of added phytosterols/phytostanols. 
The amount of phytosterols/phy ­
tostanols added to a container of 
beverages shall not exceed 3 g. 
Salad dressings, mayonnaise and 
spicy sauces shall be packed as 
single portions  Rye bread with flour containing 
≥ 50 % rye (wholemeal rye flour, 
whole or cracked rye kernels and 
rye flakes) and ≤ 30 % wheat; and 
with ≤ 4 % added sugar but no fat 
added.  
Salad dressings, mayonnaise and spicy 
sauces.  
Soya drinkEN L 187/44 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Milk type products, such as semi- 
skimmed and skimmed milk type 
products, possibly with the addition 
of fruits and/or cereals, where 
possibly the milk fat has been 
reduced, or where milk fat and/or 
protein has been partly or fully 
replaced by vegetable fat and/or 
protein.  
Products based on fermented milk 
such as yoghurt and cheese type 
products (fat content < 12 % per 
100 g), where possibly the milk fat 
has been reduced, or where milk fat 
and/or protein has been partly or 
fully replaced by vegetable fat and/or 
protein  
Spreadable fats as defined in Annex 
VII, Part VII and Appendix II, points 
B and C of Regulation (EU) No 
1308/2013, and excluding cooking 
and frying fats and spreads based on 
butter or other animal fat.  
Food Supplements as defined in 
Directive 2002/46/EC  3 g/day  
Plum kernel oil  Specified food category  Maximum levels  
For frying and as seasoning  In line with normal food use of 
vegetable oils  
Potato proteins (coagulated) 
and hydrolysates thereof  Not specified  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Potato protein’EN 24.7.2018 Official Journal of the European Union L 187/45
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Prolyl oligopeptidase (enzyme 
preparation)  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Prolyl oligopepti ­
dase’  Food Supplements as defined in 
Directive 2002/46/EC for general 
adult population  120 PPU/day (2,7 g of enzyme 
preparation/day) (2 × 106 PPI/day) 
PPU – Prolyl Peptidase Units or 
Proline Protease Units 
PPI – Protease Picomole International  
Protein extract from pig 
kidneys  Specified food category  Maximum levels  
Food Supplements as defined in 
Directive 2002/46/EC  3 capsules/day; equalizing 12,6 mg 
pig kidney extract a day 
Diamine oxidase (DAO) content: 
0,9 mg/day (3 capsules with a 
content of DAO of 0,3 mg/capsule)  Food for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  
Rapeseed oil high in 
unsaponifiable matter  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Rapeseed oil 
extract’  Food Supplements as defined in 
Directive 2002/46/EC  1,5 g per portion recommended for 
daily consumption  
Rapeseed Protein  As a vegetable protein source in foods 
except in infant formula and follow- 
on formula  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘Rapeseed 
protein’. 
2. Any foodstuff containing ‘rapeseed 
protein’ shall bear a statement that 
this ingredient may cause allergic 
reaction to consumers who are 
allergic to mustard and products 
thereof. Where relevant, this 
statement shall appear in close 
proximity to the list of ingredients.EN L 187/46 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Trans-resveratrol  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the food 
supplements containing it shall be 
‘Trans -resveratrol’. 
2. The labelling of food supplements 
containing trans-resveratrol shall 
bear a statement that people using 
medicines should only consume the 
product under medical supervision.  Food Supplements as defined in 
Directive 2002/46/EC for adult popu ­
lation (capsule or tablet form)  150 mg/day  
Trans-resveratrol (microbial 
source)  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the food 
supplements containing it shall be 
‘Trans -resveratrol’. 
2. The labelling of food supplements 
containing trans-resveratrol shall 
bear a statement that people using 
medicines should only consume the 
product under medical supervision.  Food supplements as defined in 
Directive 2002/46/EC  In line with normal use in food 
supplements of resveratrol extracted 
from Japanese knotweed ( Fallopia 
japonica ) 
Rooster comb extract  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Rooster comb 
extract’ or ‘Cockerel comb extract’  Milk-based drinks  40 mg/100 g or mg/100 ml  
Milk based fermented drinks  80 mg/100 g or mg/100 ml  
Yoghurt-type products  65 mg/100 g or mg/100 ml  
Fromage frais  110 mg/100 g or mg/100 ml  
Sacha inchi oil from  Plukenetia 
volubilis  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Sacha inchi oil 
(Plukenetia volubilis)’  As for linseed oil  In line with normal food use of 
linseed oilEN 24.7.2018 Official Journal of the European Union L 187/47
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Salatrims  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘reduced 
energy fat (salatrims)’. 
2. There shall be a statement that 
excessive consumption may lead to 
gastro-intestinal disturbance. 
3. There shall be a statement that the 
products are not intended for use by 
children.  Bakery products and confectionary  
Schizochytrium sp.  oil rich in 
DHA and EPA  Specified food category  Maximum levels of DHA and EPA 
combined : The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘DHA and EPA- 
rich oil from the microalgae  Schizo ­
chytrium  sp.’  Food Supplements as defined in 
Directive 2002/46/EC for adult popu ­
lation excluding pregnant and 
lactating women  3 000 mg/day  
Food Supplements as defined in 
Directive 2002/46/EC for pregnant 
and lactating women  450 mg/day  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  250 mg/meal  
Milk-based drinks and similar 
products intended for young children  200 mg/100 g  
Processed cereal based food and baby 
food for infants and young children 
as defined in Regulation (EU) 
No 609/2013EN L 187/48 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Foods intended to meet the 
expenditure of intense muscular 
effort, especially for sportsmen  
Foods bearing statements on the 
absence or reduced presence of 
gluten in accordance with the 
requirements of Commission Imple ­
menting Regulation (EU) No 828/ 
2014  
Bakery Products (Breads, Rolls and 
Sweet Biscuits)  200 mg/100 g  
Breakfast Cereals  500 mg/100 g  
Cooking Fats  360 mg/100 g  
Dairy Analogues except drinks  600 mg/100 g for cheese; 
200 mg/100 g for soy and imitation 
milk products (excluding drinks)  
Dairy Products except milk-based 
drinks  600 mg/100 g for cheese; 
200 mg/100 g for milk products 
(including milk, fromage frais and 
yoghurt products; excluding drinks)  
Non-alcoholic Beverages (including 
dairy analogue and milk-based drinks)  80 mg/100 g  
Cereal/Nutrition Bars  500 mg/100 g  
Spreadable Fats and Dressings  600 mg/100 gEN 24.7.2018 Official Journal of the European Union L 187/49
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Schizochytrium  sp. (ATCC PTA- 
9695) oil  Specified food category  Maximum levels of DHA  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Oil from the 
microalgae  Schizochytrium  sp. (ATCC 
PTA-9695)’  Dairy products except milk-based 
drinks  200 mg/100 g or for cheese products 
600 mg/100 g  
Dairy analogues except drinks  200 mg/100 g or for analogues to 
cheese products 600 mg/100 g  
Spreadable fats and dressings  600 mg/100 g  
Breakfast cereals  500 mg/100 g  
Food Supplements as defined in 
Directive 2002/46/EC  250 mg DHA/day for general popu ­
lation  
450 mg DHA/day for pregnant and 
lactating women  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  250 mg/meal  
Milk-based drinks and similar 
products intended for young children  200 mg/100 g  
Foods intended to meet the 
expenditure of intense muscular 
effort, especially for sportsmen  
Foods bearing statements on the 
absence or reduced presence of 
gluten in accordance with the 
requirements of Commission Imple ­
menting Regulation (EU) No 
828/2014EN L 187/50 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Bakery products (breads,rolls, and, 
sweet biscuits)  200 mg/100 g  
Cereal bars  500 mg/100 g  
Cooking fats  360 mg/100 g  
Non-alcoholic beverages (including 
dairy analogue and milk-based drinks)  80 mg/100 ml  
Infant formula and follow-on formula 
as defined in Regulation (EU) 
No 609/2013  In accordance with Regulation (EU) 
No 609/2013  
Processed cereal-based foods and baby 
foods for infants and young children 
as defined in Regulation (EU) 
No 609/2013  200 mg/100 g  
Schizochytrium  sp. oil  Specified food category  Maximum levels of DHA  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Oil from the 
microalgae  Schizochytrium  sp.’  Dairy products except milk-based 
drinks  200 mg/100 g or for cheese products 
600 mg/100 g  
Dairy analogues except drinks  200 mg/100 g or for analogues to 
cheese products 600 mg/100 g  
Spreadable fats and dressings  600 mg/100 g  
Breakfast cereals  500 mg/100 gEN 24.7.2018 Official Journal of the European Union L 187/51
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Food Supplements as defined in 
Directive 2002/46/EC  250 mg DHA/day for general popu ­
lation  
450 mg DHA/day for pregnant and 
lactating women  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  250 mg/meal  
Milk-based drinks and similar 
products intended for young children  200 mg/100 g  
Processed cereal-based foods and baby 
foods for infants and young children 
as defined in Regulation (EU) 
No 609/2013  
Foods intended to meet the 
expenditure of intense muscular 
effort, especially for sportsmen  
Foods bearing statements on the 
absence or reduced presence of 
gluten in accordance with the 
requirements of Commission Imple ­
menting Regulation (EU) No 828/ 
2014  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Bakery products (breads, rolls and 
sweet biscuits)  200 mg/100 g  
Cereal bars  500 mg/100 g  
Cooking fats  360 mg/100 gEN L 187/52 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Non-alcoholic beverages (including 
dairy analogue and milk-based drinks)  80 mg/100 ml  
Schizochytrium  sp. (T18) oil  Specified food category  Maximum levels of DHA  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Oil from the 
microalgae  Schizochytrium  sp.’  Dairy products except milk-based 
drinks  200 mg/100 g or for cheese products 
600 mg/100 g  
Dairy analogues except drinks  200 mg/100 g or for analogues to 
cheese products 600 mg/100 g  
Spreadable fats and dressings  600 mg/100 g  
Breakfast cereals  500 mg/100 g  
Food Supplements as defined in 
Directive 2002/46/EC  250 mg DHA/day for general popu ­
lation  
450 mg DHA/day for pregnant and 
lactating women  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013 and meal replacements 
for weight control  250 mg/meal  
Milk-based drinks and similar 
products intended for young children  200 mg/100 g  
Foods intended to meet the 
expenditure of intense muscular 
effort, especially for sportsmen  
Foods bearing statements on the 
absence or reduced presence of 
gluten in accordance with the 
requirements of Commission Imple ­
menting Regulation (EU) No 828/ 
2014EN 24.7.2018 Official Journal of the European Union L 187/53
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Foods for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013  In accordance with the particular 
nutritional requirements of the 
persons for whom the products are 
intended  
Bakery products (breads, rolls and, 
sweet biscuits)  200 mg/100 g  
Cereal bars  500 mg/100 g  
Cooking fats  360 mg/100 g  
Non-alcoholic beverages (including 
dairy analogue and milk-based drinks)  80 mg/100 ml  
Infant formula and follow-on formula 
as defined in Regulation (EU) 
No 609/2013  In accordance with Regulation (EU) 
No 609/2013  
Processed cereal-based foods and baby 
foods for infants and young children 
as defined in Regulation (EU) 
No 609/2013  200 mg/100 g  
Fermented soybean extract  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘Fermented 
soybean extract’. 
2. The labelling of food supplements 
containing fermented soybean 
extract shall bear a statement that 
persons taking medication should 
only consume the product under 
medical supervision.  Food Supplements as defined in 
Directive 2002/46/EC (capsules, 
tablets or powder form) intended for 
the adult population, excluding 
pregnant and lactating women  100 mg/day  
Spermidine-rich wheat germ 
extract ( Triticum aestivum ) Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the food supplements 
containing it shall be ‘spermidine-rich 
wheat germ extract’  Food Supplements as defined in 
Directive 2002/46/EC intended for 
the adult population, excluding 
pregnant and lactating women  Equivalent of max. 6 mg/day sper ­
midineEN L 187/54 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Sucromalt  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘Sucromalt’. 
2. The designation of the novel food 
on the labelling shall be accom ­
panied by indication that the 
product is a source of glucose and 
fructose.  Not specified  
Sugar cane fibre  Specified food category  Maximum levels  
Bread  8 %  
Bakery goods  5 %  
Meat and muscle products  3 %  
Seasonings and spices  3 %  
Grated cheeses  2 %  
Special diet foods  5 %  
Sauces  2 %  
Beverages  5 %  
Sunflower oil extract  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Sunflower oil 
extract’  Food Supplements as defined in 
Directive 2002/46/EC  1,1 g/day  
Dried  Tetraselmis chuii  
microalgae  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Dried microalgae  
Tetraselmis chuii ’ or ‘Dried microalgae  
T. chuii ’ 
Food supplements containing dried 
microalgae  Tetraselmis chuii  shall bear 
the following statement: ‘Contains 
negligible amounts of iodine’  Sauces  20 % or 250mg/day  
Special salts  1 %  
Condiment  250 mg/day  
Food Supplements as defined in 
Directive 2002/46/EC  250 mg/dayEN 24.7.2018 Official Journal of the European Union L 187/55
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Therapon barcoo /Scortum  Intended use identical to that of the salmon, namely the preparation of 
culinary fish products and dishes, including cooked, raw, smoked and baked 
fish products  
D-Tagatose  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘D-Tagatose’. 
2. The labelling of any product where 
the level of D-Tagatose exceeds 15 g 
per serving and all beverages 
containing greater than 1 % 
D-Tagatose (as consumed) shall 
bear a statement ‘excessive 
consumption may produce laxative 
effects’.  Not specified  
Taxifolin-rich extract  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘taxifolin-rich 
extract’.  Food Supplements as defined in 
Directive 2002/46/EC intended for 
the general population, excluding 
infants, young children, children and 
adolescents younger than 14 years  100 mg/day  
Trehalose  Specified food category  Maximum levels  1. The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘Trehalose’ 
and shall be displayed on the 
labelling of the product as such or 
in the list of ingredients of food ­
stuffs containing it. 
2. The designation of the novel food 
on the labelling shall be accom ­
panied by indication that the ‘Tre ­
halose is a source of glucose’.  Not specifiedEN L 187/56 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
UV-treated mushrooms 
(Agaricus bisporus ) Specified food category  Maximum levels of vitamin D  2 
Mushrooms ( Agaricus bisporus ) 10 μg of vitamin D  2/100 g fresh 
weight  1. The designation on the label of the 
novel food as such or of the food ­
stuffs containing it shall be ‘UV- 
treated mushrooms ( Agaricus bispo ­
rus)’. 
2. The designation on the label of the 
novel food as such or of the food ­
stuffs containing it shall be accom ­
panied by indication that a ‘con ­
trolled light treatment was used to 
increase vitamin D levels’ or ‘UV 
treatment was used to increase 
vitamin D  2 levels’.  
UV-treated baker’s yeast 
(Saccharomyces cerevisiae ) Specified food category  Maximum levels of vitamin D  2 The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Vitamin D 
yeast’ or ‘Vitamin D  2 yeast’  Yeast-leavened breads and rolls  5 μg of vitamin D  2/100 g  
Yeast-leavened fine bakery wares  5 μg of vitamin D  2/100 g  
Food Supplements as defined in 
Directive 2002/46/EC  5 μg of vitamin D  2/day  
UV-treated bread  Specified food category  Maximum levels of vitamin D  2 The designation on the label of the 
novel food shall be accompanied by 
‘contains vitamin D produced by UV- 
treatment’  Yeast leavened bread and rolls 
(without toppings)  3 μg vitamin D  2/100 g  
UV-treated milk  Specified food category  Maximum levels of vitamin D  3 1. The designation on the label of the 
novel food shall be ‘UV-treated’. 
2. Where UV-treated milk contains an 
amount of vitamin D that is 
considered significant in accordance 
with Point 2 of Part A of Annex XIII 
to Regulation (EU) No 1169/2011 
of the European Parliament and of 
the Council, the designation for the 
labelling shall be accompanied by 
‘contains vitamin D produced by 
UV-treatment’ or ‘milk containing 
vitamin D resulting from UV-treat ­
ment’.  Pasteurised whole milk as defined in 
Regulation (EU) No 1308/2013 to be 
consumed as such  5-32 μg/kg for general population 
excluding infants  
Pasteurised semi-skimmed milk as 
defined in Regulation (EU) No 1308/ 
2013 to be consumed as such  1-15 μg/kg for general population 
excluding infantsEN 24.7.2018 Official Journal of the European Union L 187/57
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Vitamin K  2 (menaquinone)  To be used in compliance with Directive 2002/46/EC, Regulation (EU) No 
609/2013 and/or Regulation (EC) No 1925/2006  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Menaquinone’ 
or ‘Vitamin K  2’ 
Wheat bran extract  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Wheat bran 
extract’  The ‘Wheat Bran Extract’ 
may not be introduced 
onto the market as a 
food supplement or food 
supplement ingredient. 
Nor may it be added to 
infant formula.  Beer and substitutes  0,4 g/100 g  
Ready to eat cereals  9 g/100 g  
Dairy products  2,4 g/100 g  
Fruit and vegetable juices  0,6 g/100 g  
Soft drinks  0,6 g/100 g  
Meat preparations  2 g/100 g  
Yeast beta-glucans  Specified food category  Maximum levels of pure beta-glucans 
from yeast (Saccharomyces cervisiae)  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Yeast 
(Saccharomyces cerevisiae ) beta-glucans’  Food supplements as defined in 
Directive 2002/46/EC, excluding 
food supplements for infants and 
young children  1,275 g/day for children older than 
12 years and general adult population 
0,675 g/day for children younger than 
12 years  
Total diet replacement for weight 
control as defined in Regulation (EU) 
No 609/2013  1,275 g/day  
Food for special medical purposes as 
defined in Regulation (EU) No 609/ 
2013, excluding food for special 
medical purposes intended for 
infants and young children  1,275 g/day  
Beverages based on fruit and/or 
vegetable juices including concentrate 
and dehydrated juices  1,3 g/kgEN L 187/58 Official Journal of the European Union 24.7.2018
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Fruit-flavoured drinks  0,8 g/kg  
Cocoa beverages preparation powder  38,3 g/kg (powder)  
Other beverages  0,8 g/kg (ready to drink)  
7 g/kg (powder)  
Cereal bars  6 g/kg  
Breakfast cereals  15,3 g/kg  
Wholegrain and high fibre instant hot 
breakfast cereals  1,5 g/kg  
Cookie-type biscuits  6,7 g/kg  
Cracker-type biscuits  6,7 g/kg  
Milk based beverages  3,8 g/kg  
Fermented milk products  3,8 g/kg  
Milk product analogues  3,8 g/kg  
Dried milk/milk powder  25,5 g/kg  
Soups and soup mixes  0,9 g/kg (ready to eat)  
1,8 g/kg (condensed)  
6,3 g/kg (powder)  
Chocolate and confectionery  4 g/kg  
Protein bars and powders  19,1 g/kg  
Jam, marmalade and other fruit 
spreads  11,3 g/kgEN 24.7.2018 Official Journal of the European Union L 187/59
 Authorised novel food  Conditions under which the novel food may be used  Additional specific labelling requirements  Other requirements  
Zeaxanthin  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘synthetic zeaxan ­
thin’  Food Supplements as defined in 
Directive 2002/46/EC  2 mg/day  
Zinc L-pidolate  Specified food category  Maximum levels  The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be ‘Zinc L-pidolate’  Foods covered by Regulation (EU) 
No 609/2013  3 g/day  
Milk based drinks and similar 
products intended for young children  
Meal replacement for weight control  
Foods intended to meet the 
expenditure of intense muscular 
effort, especially for sportsmen  
Food bearing statement on the 
absence or reduced presence of 
gluten in accordance with the 
requirements of Commission Imple ­
menting Regulation (EU) No 828/ 
2014  
Food Supplements as defined in 
Directive 2002/46/EC  
(1 ) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and yo ung 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 2006/1 41/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). 
(2 ) Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to c onsumers on the absence or reduced presence of gluten in food 
(OJ L 228, 31.7.2014, p. 5). 
(3 ) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Me mber States relating to food supplements (OJ L 183, 12.7.2002, p. 51). 
(4 ) Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins an d minerals and of certain other substances to foods (OJ L 404, 
30.12.2006, p. 26). 
(5 ) Council Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut purée  intended for human consumption (OJ L 10, 12.1.2002, p. 67). 
(6 ) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisa tion of the markets in agricultural products and repealing Council 
Regulation (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) 1234/2007 (OJ L 347, 20.12.2013, p. 671).EN L 187/60 Official Journal of the European Union 24.7.2018
 Table 2: Specifications  
Authorised Novel Food  Specifications  
N-Acetyl-D-neuraminic acid  Description:  
N-Acetyl-D-neuraminic acid is a white to off-white crystalline powder  
Definition: 
Chemical name:  
IUPAC names:  
N-Acetyl-D-neuraminic acid (dihydrate) 
5-Acetamido-3,5-dideoxy-D-glycero-D-galacto-non-2-ulopyranosonic acid (dihydrate) 
Synonyms: 
Sialic acid (dihydrate)  
Chemical formula:  
C 11H 19NO  9 (acid) 
C 11H 23NO  11 (C 11H 19NO  9 * 2H  2O) (dihydrate)  
Molecular mass:  
309,3 Da (acid) 
345,3 (309,3 + 36,0) (dihydrate)  
CAS No.:  
131-48-6 (free acid) 
50795-27-2 (dihydrate)  
Specifications:  
Description: white to off-white crystalline powder 
pH (20 °C, 5 % solution): 1,7 – 2,5  
N-Acetyl-D-neuraminic acid (dihydrate): > 97,0 % 
Water (dihydrate calculates to 10,4 %): ≤ 12,5 % (w/w) 
Ash, sulphated: < 0,2 % (w/w) 
Acetic acid (as free acid and/or sodium acetate): < 0,5 % (w/w)  
Heavy Metals:  
Iron: < 20,0 mg/kg 
Lead: < 0,1 mg/kg 
Residual proteins: < 0,01 % (w/w)EN 24.7.2018 Official Journal of the European Union L 187/61
 Authorised Novel Food  Specifications  
Residual solvents:  
2-Propanol: < 0,1 % (w/w) 
Acetone: < 0,1 % (w/w) 
Ethyl acetate: < 0,1 % (w/w)  
Microbiological criteria:  
Salmonella:  Absence in 25 g 
Aerobic mesophilic total count:< 500 CFU/g 
Enterobacteriaceae: Absence in 10 g  
Cronobacter (Enterobacter) sakazakii:  Absence in 10 g  
Listeria monocytogenes:  Absence in 25 g  
Bacillus cereus:  < 50 CFU/g 
Yeasts: < 10 CFU/g 
Moulds: < 10 CFU/g 
Residual endotoxins: < 10 EU/mg 
CFU: Colony Forming Units; EU: Endotoxin Units.  
Adansonia digitata  (Baobab) 
dried fruit pulp  Description/Definition:  
The Baobab ( Adansonia digitata ) fruits are harvested from trees. The hard shells are cracked open and the pulp is separated from the seeds and the 
shell. This is milled, separated into coarse and fine lots (particle size 3 to 600 μ) and then packaged.  
Typical nutritional components:  
Moisture (loss on drying) (g/100 g): 4,5-13,7 
Protein (g/100 g): 1,8-9,3 
Fat (g/100 g): 0-1,6 
Total carbohydrate (g/100 g): 76,3-89,5 
Total sugars (as glucose): 15,2-36,5 
Sodium (mg/100 g): 0,1-25,2  
Analytical specifications:  
Foreign matter: Not more than 0,2 % 
Moisture (loss on drying) (g/100 g): 4,5-13,7 
Ash (g/100 g): 3,8-6,6EN L 187/62 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Ajuga reptans  extract from cell 
cultures  Description/Definition:  
Hydroalcoholic extract from  Ajuga reptans  L. tissue cultures which is substantially equivalent to extracts from flowering aerial parts of  Ajuga reptans  
obtained by traditional cultures.  
L-Alanyl-L-Glutamine  Description/Definition:  
L-Alanyl-L-Glutamine is produced by fermentation with a genetically modified strain of  Escherichia coli . During the fermentation process, the 
ingredient is secreted into the growth medium from which it is subsequently separated and purified to a concentration of > 98 % . 
Appearance: White crystalline powder 
Purity: > 98 % 
Infrared spectroscopy: Conformity with ref. standard 
Appearance of solution: Colourless and clear 
Assay (dry basis): 98-102 % 
Related substances (each): ≤ 0,2 % 
Residue on ignition: ≤ 0,1 % 
Loss on drying: ≤ 0,5 % 
Optical rotation: +9,0 - +11,0o 
pH (1 %; H  2O): 5,0-6,0 
Ammonium (NH  4): ≤ 0,020 % 
Chloride (Cl): ≤ 0,020 % 
Sulphate (SO  4): ≤ 0,020 %  
Microbiological criteria:  
Escherichia coli : Absence/g  
Algal oil from the microalgae  
Ulkenia  sp.  Description/Definition:  
Oil from the micro-algae  Ulkenia  sp. 
Acid value: ≤ 0,5 mg KOH/g 
Peroxide value (PV): ≤ 5,0 meq/kg oil 
Moisture and volatiles: ≤ 0,05 % 
Unsaponifiables: ≤ 4,5 % 
Trans-fatty acids: ≤ 1,0 % 
DHA content: ≥ 32 %EN 24.7.2018 Official Journal of the European Union L 187/63
 Authorised Novel Food  Specifications  
Allanblackia seed oil  Description/Definition:  
Allanblackia  seed oil is obtained from the seeds of the allanblackia species:  A. floribunda  (synonymous with  A. parviflora ) and  A. stuhlmannii.  
Composition of fatty acids:  
Lauric acid (C12:0): < 1,0 % 
Myristic acid (C14:0): < 1,0 % 
Palmitic acid (C16:0): < 2,0 % 
Palmitoleic acid (C16:1): < 1,0 % 
Stearic acid (C18:0): 45-58 % 
Oleic acid (C18:1): 40-51 % 
Linoleic acid (C18:2): < 1,0 % 
γ-Linolenic acid (C18:3): < 1,0 % 
Arachidic acid (C20:0): < 1,0 % 
Free fatty acids: max 0,1 %  
Characteristics:  
Trans fatty acids: max 0,5 % 
Peroxide value (PV): max 0,8 meq/kg 
Iodine value: < 46 g/100 g 
Unsaponifiable matter: max 1,0 % 
Saponification value: 185-198 mg KOH/g  
Aloe macroclada  Baker leaf 
extract  Description/Definition:  
Powdered gel extract derived from the leaves of  Aloe macroclada  Baker which is substantially equivalent to the same gel derived from  Aloe vera  (L.) 
Burm.f. leaves. 
Ash: 25 % 
Dietary fibres: 28,6 % 
Fat: 2,7 % 
Moisture: 4,7 % 
Polysaccharides: 9,5 % 
Protein: 1,63 % 
Glucose: 8,9 %EN L 187/64 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Antarctic Krill oil from  
Euphausia superba  Description/Definition:  
To produce lipid extract from Antarctic Krill ( Euphausia superba ) deep-frozen crushed krill or dried krill meal is subjected to lipid extraction with an 
approved extraction solvent (under Directive 2009/32/EC). Proteins and krill material are removed from the lipid extract by fil tration. The extraction 
solvents and residual water are removed by evaporation. 
Saponification value: ≤ 230 mg KOH/g 
Peroxide value (PV): ≤ 3 meq O  2/kg oil 
Oxidative stability: All food products containing Antarctic Krill oil from  Euphausia superba  should demonstrate oxidative stability by appropriate and 
recognised national/international test methodology (e.g. AOAC). 
Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °C 
Phospholipids: 35-50 % 
Trans-fatty acids: ≤ 1 % 
EPA (eicosapentaenoic acid): ≥ 9 % 
DHA (docosahexaenoic acid): ≥ 5 %  
Antarctic Krill oil rich in 
phospholipids from  Euphausia 
superba  Description/Definition:  
Oil rich in phospholipids is produced from Antarctic krill ( Euphausia superba ) by repeated solvent washings with an approved solvent (under Directive 
2009/32/EC) to increase phospholipid content of the oil. Solvents are removed from the final product by evaporation. 
Saponification value: ≤ 230 mg KOH/g 
Peroxide value (PV): ≤ 3 meq O  2/kg oil 
Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °C 
Phospholipids: ≥ 60 % 
Trans-fatty acids: ≤ 1 % 
EPA (eicosapentaenoic acid): ≥ 9 % 
DHA (docosahexaenoic acid): ≥ 5 %  
Arachidonic acid-rich oil from 
the fungus  Mortierella alpina  Description/Definition:  
The clear yellow arachidonic acid-rich oil is obtained by fermentation of the non-genetically modified strains IS-4, I49-N18, F JRK-MA01 and CBS 
210.32 of the fungus  Mortierella alpina  using a suitable liquid. The oil is then extracted from the biomass and purified. 
Arachidonic acid: ≥ 40 % by weight of the total fatty acid content 
Free fatty acids: ≤ 0,45 % of the total fatty acid content 
Trans fatty acids: ≤ 0,5 % of the total fatty acid content 
Unsaponifiable matter: ≤ 1,5 %EN 24.7.2018 Official Journal of the European Union L 187/65
 Authorised Novel Food  Specifications  
Peroxide value (PV): ≤ 5 meq/kg 
Anisidin value: ≤ 20 
Acid value: ≤ 1,0 KOH/g 
Moisture: ≤ 0,5 %  
Argan oil from  Argania spinosa  Description/Definition:  
Argan oil is the oil obtained by cold pressing of the almond like kernels of the fruits of  Argania spinosa  (L.) Skeels. Kernels may be roasted prior to 
pressing, but with no direct contact with a flame.  
Composition:  
Palmitic acid (C16:0): 12-15 % 
Stearic acid (C18:0): 5-7 % 
Oleic acid (C18:1): 43-50 % 
Linoleic acid (C18:2): 29-36 % 
Unsaponifiable matter: 0,3-2 % 
Total sterols: 100-500 mg/100 g 
Total tocopherols: 16-90 mg/100 g 
Oleic acidity: 0,2-1,5 % 
Peroxide value (PV): < 10 meq O  2/kg 
Astaxanthin-rich oleoresin 
from  Haematococcus pluvialis  
algae  Description/Definition:  
Astaxanthin is a carotenoid produced by  Haematococcus pluvialis  algae. Production methods for the growth of the algae are variable; using either closed 
systems exposed to sunlight or strictly controlled illuminated light; alternatively open ponds may be used. The algal cells are  harvested and dried; the 
oleoresin is extracted using either super critical CO  2 or a solvent (ethyl acetate). The Astaxanthin is diluted and standardized to 2,5 %, 5,0 %, 7,0 %, 
10 %, 15 % or 20 % using olive oil, safflower oil, Sunflower oil or MCT (Medium Chain Triglycerides).  
Composition of the Oleoresin:  
Fat: 42,2- 99 % 
Protein: 0,3-4,4 % 
Carbohydrate: 0-52,8 % 
Fibre: < 1,0 % 
Ash: 0,0-4,2 % 
Specification of Carotenoids w/w% 
Total Astaxanthins: 2,9-11,1 %EN L 187/66 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
9-cis-astaxanthin: 0,3-17,3 % 
13-cis-astaxanthin: 0,2-7,0 % 
Astaxanthin monoesters: 79,8-91,5 % 
Astaxanthin diesters: 0,16-19,0 % 
Β-Carotene: 0,01-0,3 % 
Lutein: 0-1,8 % 
Canthaxanthin: 0-1,30 %  
Microbiological criteria:  
Total aerobic bacteria: < 3 000 CFU/g 
Yeast and Moulds: < 100 CFU/g 
Coliforms: < 10 CFU/g  
E. coli : Negative  
Salmonella : Negative  
Staphylococcus : Negative  
Basil seeds ( Ocimum basilicum ) Description/Definition:  
Basil ( Ocimum basilicum  L.) belongs to the family ‘ Lamiaceae ’ within the order ‘Lamiales’. Post-harvest the seeds are cleaned mechanically. Flowers, 
leaves and other parts of the plant are removed. Highest level of purity of Basil seeds has to be ensured by filtering (optical , mechanical). Production 
process of fruit juice and fruit/vegetable blend beverages containing Basil seeds ( Ocimum basilicum  L.) includes seed pre-hydration and pasteurisation 
steps. Microbiological controls and monitoring systems are in place. 
Dry Matter: 94,1 % 
Protein: 20,7 % 
Fat: 24,4 % 
Carbohydrate: 1,7 % 
Dietary Fibre: 40,5 % (Method: AOAC 958,29) 
Ash: 6,78 %  
Fermented black bean extract  Description/Definition:  
Fermented black bean extract (Touchi extract) is a fine light-brown protein-rich powder obtained by water extraction of small s oybeans ( Glycine max 
(L.) Merr. ) fermented with  Aspergillus oryzae . The extract contains an α-glucosidase inhibitor.  
Characteristics:  
Fat: ≤ 1,0 % 
Protein: ≥ 55 %EN 24.7.2018 Official Journal of the European Union L 187/67
 Authorised Novel Food  Specifications  
Water: ≤ 7,0 % 
Ash: ≤ 10 % 
Carbohydrate: ≥ 20 % 
α-glucosidase inhibitory activity: IC50 min 0,025 mg/ml 
Soy isoflavone: ≤ 0,3 g/100 g  
Bovine lactoferrin  Description/Definition:  
Bovine lactoferrin is a protein that occurs naturally in cows’ milk. It is an iron-binding glycoprotein of approximately 77 kDa  and consists of a single 
polypeptide chain of 689 amino acids. 
Production process: Bovine lactoferrin is isolated from skimmed milk or cheese whey via ion exchange and subsequent ultra-filtr ation steps. Finally, it 
is dried by freeze drying or spraying and the large particles are sieved out. It is a virtually odourless, light pinkish powder . 
Physical-Chemical properties of Bovine lactoferrin:  
Moisture: < 4,5 % 
Ash: < 1,5 % 
Arsenic: < 2,0 mg/kg 
Iron: < 350 mg/kg 
Protein: > 93 % 
of which bovine lactoferrin: > 95 % 
of which other proteins: < 5,0 % 
pH (2 % solution, 20 °C): 5,2-7,2 
Solubility (2 % solution, 20 °C): complete  
Buglossoides arvensis  seed oil  Description/Definition:  
Refined Buglossoides oil is extracted from the seeds of  Buglossoides arvensis  (L.) I.M.Johnst 
Alpha-linolenic acid: ≥ 35 % w/w of total fatty acids 
Stearidonic acid: ≥ 15 % w/w of total fatty acids 
Linoleic acid: ≥ 8,0 % w/w of total fatty acids 
Trans fatty acids: ≤ 2,0 % w/w of total fatty acids 
Acid value: ≤ 0,6 mg KOH/g 
Peroxide value (PV): ≤ 5,0 meq O  2/kg 
Unsaponifiable content: ≤ 2,0 % 
Protein content (total nitrogen): ≤ 10 μg/ml 
Pyrrolizidine alkaloids: Not detectable with a detection limit of 4,0 μg/kgEN L 187/68 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Calanus finmarchicus  oil  Description/Definition:  
The novel food is ruby coloured, slightly viscous oil with a slight shellfish odour extracted from the crustacean (marine zoopl ankton)  Calanus 
finmarchicus . The ingredient consists primarily of wax esters (> 85 %) with minor amounts of triglycerides and other neutral lipids.  
Specifications:  
Water: < 1,0 % 
Wax esters: > 85 % 
Total fatty acids: > 46 % 
Eicosapentaenoic acid (EPA): > 3,0 % 
Docosahexaenoic acid (DHA): > 4,0 % 
Total fatty alcohols: > 28 % 
C20:1 n-9 fatty alcohol: > 9,0 % 
C22:1 n-11 fatty alcohol: > 12 % 
Trans fatty acids: < 1,0 % 
Astaxanthinesters: < 0,1 % 
Peroxide value (PV): < 3,0 meq. O  2/kg 
Chewing gum base 
(monomethoxypolyethylene 
glycol)  Description/Definition:  
The novel food ingredient is a synthetic polymer (Patent number WO2006016179). It consists of branched polymers of monomethoxyp olyethylene 
glycol (MPEG) grafted onto polyisoprene-graft-maleic anhydride (PIP-g-MA), and unreacted MPEG (less than 35 % by weight). 
White to off-white colour. 
CAS No.: 1246080-53-4  
Characteristics:  
Moisture: < 5,0 % 
Aluminium: < 3,0 mg/kg 
Lithium: < 0,5 mg/kg 
Nickel: < 0,5 mg/kg 
Residual anhydride: < 15 μmol/g 
Polydispersity index: < 1,4 
Isoprene: < 0,05 mg/kg 
Ethylene oxide: < 0,2 mg/kg 
Free maleic anhydride: < 0,1 %EN 24.7.2018 Official Journal of the European Union L 187/69
 Authorised Novel Food  Specifications  
Total oligomeres (less than 1 000 Dalton): ≤ 50 mg/kg 
Ethylene glycol: < 200 mg/kg 
Diethylene glycol: < 30 mg/kg 
Monoethylene glycol methyl ether: < 3,0 mg/kg 
Diethylene glycol methyl ether: < 4,0 mg/kg 
Triethylene glycol methyl ether: < 7,0 mg/kg 
1,4-Dioxane: < 2,0 mg/kg 
Formaldehyde: < 10 mg/kg  
Chewing gum base (Methyl 
vinyl ether-maleic anhydride 
copolymer)  Description/Definition:  
Methyl vinyl ether-maleic anhydride copolymer is an anhydrous copolymer of methyl vinyl ether and maleic anhydride. 
Free-flowing, white to white-off powder 
CAS No: 9011-16-9  
Purity:  
Assay value: At least 99,5 % in dry matter 
Specific viscosity (1 % MEK): 2-10 
Residual methyl vinyl ether: ≤ 150 ppm 
Residual maleic anhydride: ≤ 250 ppm 
Acetaldehyde: ≤ 500 ppm 
Methanol: ≤ 500 ppm 
Dilauroyl peroxide: ≤ 15 ppm 
Total heavy metals: ≤ 10 ppm  
Microbiological criteria:  
Total aerobic plate count: ≤ 500 CFU/g 
Mould/yeast: ≤ 500 CFU/g  
Escherichia coli : Negative to test  
Salmonella : Negative to test  
Staphylococcus aureus:  Negative to test  
Pseudomonas aeruginosa : Negative to testEN L 187/70 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Chia oil from  Salvia hispanica  Description/Definition:  
Chia oil is produced from Chia ( Salvia hispanica  L.) seeds (99,9 % pure) by cold pressing. No solvents are used and, once pressed, the oil is held in 
decantation tanks and a filtration process employed to remove impurities. It can also be produced by extraction with supercriti cal CO  2. 
Production process:  
Produced by cold pressing. No solvents are used and, once pressed, the oil is held in decantation tanks and a filtration proces s employed to remove 
impurities. 
Acidity expressed as oleic acid: ≤ 2,0 % 
Peroxide value (PV): ≤ 10 meq/kg 
Insoluble impurities: ≤ 0,05 % 
Alpha linolenic acid: ≥ 60 % 
Linoleic acid: 15-20 %  
Chia seeds ( Salvia hispanica ) Description/Definition:  
Chia ( Salvia hispanica  L.) is a summer annual herbaceous plant belonging to the  Labiatae  family. Post-harvest the seeds are cleaned mechanically. 
Flowers, leaves and other parts of the plant are removed. 
Dry matter: 90-97 % 
Protein: 15-26 % 
Fat: 18-39 % 
Carbohydrate (*): 18-43 % 
Crude Fibre(**): 18-43 % 
Ash: 3-7 %  
(*) Carbohydrates include the fibre value 
(**) Crude fibre is the part of fibre made mainly of indigestible cellulose, pentosans and lignin  
Production process:  
Production process of fruit juices and fruit juice blends beverages, containing Chia seeds, includes seed pre-hydration and pas teurisation steps. 
Microbiological controls and monitoring systems are in place.  
Chitin-glucan from  Aspergillus 
niger  Description/Definition:  
Chitin-glucan is obtained from the mycelium of  Aspergillus niger ; it is a slightly yellow, odourless, free-flowing powder. It has a dry matter content of 
90 % or more. 
Chitin-glucan is composed largely of two polysaccharides: 
— chitin, composed of repeating units of N-acetyl-D-glucosamine (CAS No: 1398-61-4), 
— beta (1, 3)-glucan, composed of repeating units of D-glucose (CAS No: 9041-22-9).EN 24.7.2018 Official Journal of the European Union L 187/71
 Authorised Novel Food  Specifications  
Loss on drying: ≤ 10 % 
Chitin-glucan: ≥ 90 % 
Ratio of chitin to glucan: 30:70 to 60:40 
Ash: ≤ 3,0 % 
Lipids: ≤ 1,0 % 
Proteins: ≤ 6,0 %  
Chitin-glucan complex from  
Fomes fomentarius  Description/Definition:  
Chitin-glucan complex is obtained from the cell walls of the fruit bodies of the fungus  Fomes fomentarius . It consists primarily of two polysaccharides: 
— Chitin, composed of repeating units of N-acetyl-D-glucosamine (CAS No: 1398-61-4); 
— Beta-(1,3)(1,6)-D-glucan, composed of repeating units of D-glucose (CAS No: 9041-22-9). 
The production process consists of several steps, including: cleaning, reduction in size and grinding, softening in water and h eating in an alkaline 
solution, washing, drying. No hydrolysis is applied during the production process. 
Appearance: Powder, odourless, flavourless, brown  
Purity:  
Moisture: ≤ 15 % 
Ash: ≤ 3,0 % 
Chitin-glucan: ≥ 90 % 
Ratio of chitin to glucan: 70:20 
Total carbohydrates, excluding glucans: ≤ 0,1 % 
Proteins: ≤ 2,0 % 
Lipids: ≤ 1,0 % 
Melanins: ≤ 8,3 % 
Additives: None 
pH: 6,7-7,5  
Heavy metals:  
Lead (ppm): ≤ 1,00 
Cadmium (ppm): ≤ 1,00 
Mercury (ppm): ≤ 0,03 
Arsenic (ppm): ≤ 0,20EN L 187/72 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Microbiological criteria:  
Total mesophilic bacteria: ≤ 103 /g 
Yeast and moulds: ≤ 103 /g 
Coliforms at 30 °C: ≤ 103 /g 
E. coli : ≤ 10/g  
Salmonella  and other pathogenic bacteria: Absence/25 g  
Chitosan extract from fungi 
(Agaricus bisporus ; Aspergillus 
niger ) Description/Definition:  
The chitosan extract (containing mainly poly(D-glucosamine)) is obtained from stems of  Agaricus bisporus  or from the mycelium of  Aspergillus niger . 
The patented production process consists of several steps, including: extraction and deacetylation (hydrolysis) in alkaline med ium, solubilisation in 
acidic medium, precipitation in alkaline medium, washing and drying. 
Synonym: Poly(D-glucosamine) 
Chitosan CAS number: 9012-76-4 
Chitosan formula: (C  6H 11NO  4) n 
Appearance: fine free-flowing powder 
Aspect: Off –white to slightly brownish 
Odour: Odourless  
Purity:  
Chitosan content (% w/w dry weight): ≥ 85 
Glucan content (% w/w dry weight): ≤ 15 
Loss on drying (% w/w dry weight): ≤ 10 
Viscosity (1 % in 1 % acetic acid): 1-15 
Degree of acetylation (in % mol/wet weight): 0-30 
Viscosity (1 % in 1 % acetic acid) (mPa.s): 1-14 for chitosan from Aspergillus niger; 12-25 for chitin from  Agaricus bisporus  
Ash (% w/w dry weight): ≤ 3,0 
Proteins (% w/w dry weight): ≤ 2,0 
Particle size: > 100 nm 
Tapped density (g/cm3 ): 0,7-1,0 
Fat binding capacity 800 × (w/w wet weight): passEN 24.7.2018 Official Journal of the European Union L 187/73
 Authorised Novel Food  Specifications  
Heavy metals:  
Mercury (ppm): ≤ 0,1 
Lead (ppm): ≤ 1,0 
Arsenic (ppm): ≤ 1,0 
Cadmium (ppm): ≤ 0,5  
Microbiological criteria:  
Aerobic count (CFU/g): ≤ 103 
Yeast and mould count (CFU/g): ≤ 103 
Escherichia coli  (CFU/g): ≤ 10 
Enterobacteriaceae (CFU/g): ≤ 10  
Salmonella : Absence/25g  
Listeria monocytogenes : Absence/25g  
Chondroitin sulphate  Description/Definition:  
Chondroitin sulphate (sodium salt) is a biosynthetic product. It is obtained by chemical sulphation of chondroitin derived from  fermentation by the 
bacterium  Escherichia coli  O5:K4:H4 strain U1-41 (ATCC 23502). 
Chondroitin sulphate (sodium salt) (% dry basis): 95-105 
MWw (weight avg.) (kDa): 5-12 
MWn (number avg.) (kDa): 4-11 
Dispersity (w  h/w 0,05): ≤ 0,7 
Sulphation pattern ( ΔDi-6S) (%): ≤ 85 
Loss on drying (%) (105 °C to constant weight): ≤ 10,0 
Residue on ignition (% dry basis): 20-30 
Protein (% dry basis): ≤ 0,5 
Endotoxins (EU/mg): ≤ 100 
Total organic impurities (mg/kg): ≤ 50  
Chromium Picolinate  Description/Definition:  
Chromium picolinate is a reddish free-flowing powder, slightly soluble in water at pH 7. The salt is also soluble in polar orga nic solvents. 
Chemical name: tris(2pyridinecarboxylato-N,O)chromium(III) or 2-pyridinecarboxylic acid chromium(III) salt 
CAS No.: 14639-25-9EN L 187/74 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Chemical formula: Cr(C  6H 4NO  2) 3 
Chemical characteristics: 
Chromium Picolinate: ≥ 95 % 
Chromium (III): 12-13 % 
Chromium (VI): not detected 
Water: ≤ 4,0 %  
Cistus incanus  L. Pandalis herb  Description:  
Cistus incanus  L. Pandalis herb; species belonging to the  Cistaceae  family and native to the Mediterranean region, Chalkidiki Peninsula.  
Composition:  
Moisture: 9–10 g/100 g herbs 
Protein: 6,1 g/100 g herbs 
Fat: 1,6 g/100 g herbs 
Carbohydrates: 50,1 g/100 g herbs 
Fiber: 27,1 g/100 g herbs 
Minerals: 4,4 g/100 g herbs 
Sodium: 0,18 g 
Potassium: 0,75 g 
Magnesium: 0,24 g 
Calcium: 1,0 g 
Iron: 65 mg 
Vitamin B  1: 3,0 μg 
Vitamin B  2: 30 μg 
Vitamin B  6: 54 μg 
Vitamin C: 28 mg 
Vitamin A: less than 0,1 mg 
Vitamin E: 40–50 mg 
Alpha-Tocopherol: 20–50 mg 
Beta and Gamma-Tocopherols: 2–15 mg 
Delta-Tocopherol: 0,1–2 mgEN 24.7.2018 Official Journal of the European Union L 187/75
 Authorised Novel Food  Specifications  
Citicoline  Description/Definition:  
Citicoline is produced by a microbial process. 
Citicoline is composed of cytosine, ribose, pyrophosphate and choline. 
White crystalline powder 
Chemical name: Choline cytidine 5 ′-pyrophosphate, Cytidine 5 ′-(trihydrogen diphosphate) P’-[2-(trimethylammonio)ethyl]ester inner salt 
Chemical formula: C  14H 26N 4O 11P 2 
Molecular weight: 488,32 g/mol 
CAS No.: 987-78-0 
pH (sample solution of 1 %): 2,5-3,5  
Purity:  
Assay value: ≥ 98 % of dry matter 
Loss on drying (100 °C for 4 hours): ≤ 5,0 % 
Ammonium: ≤ 0,05 % 
Arsenic: Not more than 2 ppm 
Free phosphoric acids: ≤ 0,1 % 
5′-Cytidylic acid: ≤ 1,0 %  
Microbiological criteria:  
Total plate count: ≤ 103 CFU/g 
Yeast and moulds: ≤ 102 CFU/g  
Escherichia coli : Absence in 1 g  
Clostridium butyricum  Description/Definition:  
Clostridium butyricum  (CBM-588) is a Gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium. 
Depository number FERM BP-2789  
Microbiological criteria:  
Total viable aerobic count: ≤ 103 CFU/g  
Escherichia coli : Not detected in 1 gEN L 187/76 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Staphylococcus aureus : Not detected in 1 g  
Pseudomonas aeruginosa : Not detected in 1 g 
Yeast and moulds: ≤ 102 CFU/g  
Extract of defatted cocoa 
powder  Cocoa ( Theobroma cacao  L.) Extract 
Appearance: Dark brown powder free of visible impurities 
Physical and chemical properties: 
Polyphenol content: Min 55,0 % GAE 
Theobromine content: Max 10,0 % 
Ash content: Max 5,0 % 
Moisture content: Max 8,0 % 
Bulk density: 0,40-0,55 g/cm3 
pH: 5,0-6,5 
Residual solvent: Max 500 ppm  
Low fat cocoa extract  Low fat Cocoa ( Theobroma cacao  L.) extract 
Appearance: Dark red to purple powder 
Cocoa extract, concentrate: Min 99 % 
Silicon dioxide (technological aid): Max 1,0 % 
Cocoa flavanols: Min. 300 mg/g 
— Epicatechin: Min. 45 mg/g 
Loss on drying: Max. 5,0 %  
Coriander seed oil from  
Coriandrum sativum  Description/Definition:  
Coriander seed oil is an oil containing glycerides of fatty acids that is produced from the seeds of the coriander plant  Coriandrum sativum  L. 
Slight yellow colour, bland taste 
CAS No.: 8008-52-4 
Composition of fatty acids: 
Palmitic acid (C16:0): 2-5 % 
Stearic acid (C18:0): < 1,5 % 
Petroselinic acid (cis-C18:1(n-12)): 60-75 % 
Oleic acid (cis-C18:1 (n-9)): 8-15 %EN 24.7.2018 Official Journal of the European Union L 187/77
 Authorised Novel Food  Specifications  
Linoleic acid (C18:2): 12-19 % 
α-Linolenic acid (C18:3): < 1,0 % 
Trans fatty acids: ≤ 1,0 %  
Purity:  
Refractive index (20 °C): 1,466-1,474 
Acid value: ≤ 2,5 mg KOH/g 
Peroxide value (PV): ≤ 5,0 meq/kg 
Iodine value: 88-110 units 
Saponification value: 186-200 mg KOH/g 
Unsaponifiable matter: ≤ 15 g/kg  
Crataegus pinnatifida  dried 
fruit  Description/Definition:  
Dried fruits of  Crataegus pinnatifida  species belonging to the  Rosaceae  family and native to north China and Korea.  
Composition:  
Dry matter: 80 % 
Carbohydrates: 55 g/kg fresh weight 
Fructose: 26,5–29,3 g/100 g 
Glucose: 25,5–28,1 g/100 g 
Vitamin C: 29,1 mg/100 g fresh weight 
Sodium: 2,9 g/100 g fresh weight 
Compotes are products obtained by thermal processing of the edible part of one or several species of fruits, whole or in pieces , sieved or not, without 
significant concentration. Sugars, water, cider, spices and lemon juice may be used.  
α-cyclodextrin  Description/Definition:  
A non-reducing cyclic saccharide consisting of six α-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase 
(CGTase, EC 2.4.1.19) on hydrolyzed starch. Recovery and purification of α-cyclodextrin may be carried out using one of the following procedures: 
precipitation of a complex of α-cyclodextrin with 1-decanol, dissolution in water at elevated temperature and re-precipitation, steam-stripping of the 
complexant, and crystallisation of α-cyclodextrin from the solution; or chromatography with ion-exchange or gel filtration followed by crystallisation 
of α-cyclodextrin from the purified mother liquor; or membrane separation methods such as ultra-filtration and reverse osmosis: Des cription: 
Virtually odourless, white or almost white crystalline solid. 
Synonyms: α-cyclodextrin, α-dextrin, cyclohexaamylose, cyclomaltohexaose, α-cycloamylase 
Chemical name: CyclohexaamyloseEN L 187/78 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
CAS No.: 10016-20-3 
Chemical formula: (C  6H 10O 5) 6 
Formula weight: 972,85 
Assay: ≥ 98 % (dry basis)  
Identification:  
Melting range: Decomposes above 278 °C 
Solubility: Freely soluble in water; very slightly soluble in ethanol 
Specific rotation: [ α] D25 : Between +145o and +151o (1 % solution) 
Chromatography: The retention time for the major peak in a liquid chromatogram of the sample corresponds to that for α-cyclodextrin in a 
chromatogram of reference α-cyclodextrin (available from  Consortium für Elektrochemische Industrie GmbH, München, Germany or Wacker Biochem Group, 
Adrian, MI, USA ) using the conditions described in the METHOD OF ASSAY  
Purity:  
Water: ≤ 11 % (Karl Fischer Method) 
Residual complexant: ≤ 20 mg/kg 
(1-decanol) 
Reducing substances: ≤ 0,5 % (as glucose) 
Sulphated ash: ≤ 0,1 % 
Lead: ≤ 0,5 mg/kg  
Method of assay:  
Determine by liquid chromatography using the following conditions: 
Sample solution: Weigh accurately about 100 mg of test sample into a 10 ml volumetric flask and add 8 ml of deionised water. Di ssolve the sample 
completely using an ultra-sonification bath (10-15 min) and dilute to the mark with purified deionised water. Filter through a 0,45-micrometer filter 
Reference solution: Weigh accurately about 100 mg of α-cyclodextrin into a 10 ml volumetric flask and add 8 ml of deionised water. Dissolve the 
sample completely using an ultra-sonification bath and dilute to the mark with purified deionised water. 
Chromatography: Liquid chromatograph equipped with a refractive index detector and an integrating recorder. 
Column and packing: Nucleosil-100-NH  2 (10 μm) ( Macherey & Nagel Co. Düren , Germany) or similar 
Length: 250 mm 
Diameter: 4 mm 
Temperature: 40 °C 
Mobile phase: acetonitrile/water (67/33, v/v) 
Flow rate: 2,0 ml/min 
Injection volume: 10 μlEN 24.7.2018 Official Journal of the European Union L 187/79
 Authorised Novel Food  Specifications  
Procedure: Inject the sample solution into the chromatograph, record the chromatogram, and measure the area of the α-CD peak. Calculate the 
percentage of α-cyclodextrin in the test sample as follows: 
% α-cyclodextrin (dry basis) = 100 × (A  S/A R) (W  R/W  S) 
where 
A S and A  R are the areas of the peaks due to α-cyclodextrin for the sample solution and reference solution, respectively. 
W S and W  R are the weights (mg) of the test sample and reference α-cyclodextrin, respectively, after correcting for water content.  
γ-cyclodextrin  Description/Definition:  
A non-reducing cyclic saccharide consisting of eight α-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase 
(CGTase, EC 2.4.1.19) on hydrolysed starch. Recovery and purification of γ-cyclodextrin may be carried out by precipitation of a complex of 
γ-cyclodextrin with 8-cyclohexadecen-1-one, dissolution of the complex with water and n-decane, steam-stripping of the aqueous p hase and recovery 
of gamma-CD from the solution by crystallisation. 
Virtually odourless, white or almost white crystalline solid 
Synonyms: γ-cyclodextrin, γ-dextrin, cyclooctaamylose, cyclomaltooctaose, γ-cycloamylase 
Chemical name: Cyclooctaamylose 
CAS number: 17465-86-0 
Chemical formula: (C  6H 10O 5) 8 
Assay: ≥ 98 % (dry basis)  
Identification:  
Melting range: Decomposes above 285 °C 
Solubility: Freely soluble in water; very slightly soluble in ethanol 
Specific rotation: [ α] D25 : between + 174o and + 180o (1 % solution)  
Purity:  
Water: ≤ 11 % 
Residual complexant (8-cyclohexadecen-1-one (CHDC)): ≤ 4 mg/kg 
Residual solvent (n-decane): ≤ 6mg/kg 
Reducing substances: ≤ 0,5 % (as glucose) 
Sulphated ash: ≤ 0,1 %  
Dextran preparation produced 
by Leuconostoc mesenteroides  1. Powdered form:  
Carbohydrates: 60 % with: (Dextran: 50 %, Mannitol: 0,5 %, Fructose: 0,3 %, Leucrose: 9,2 %) 
Protein: 6,5 % 
Lipid: 0,5 %EN L 187/80 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Lactic acid: 10 %Ethanol: traces 
Ash: 13 % 
Moisture: 10 % 
2. Liquid form:  
Carbohydrates: 12 % with: (Dextran: 6,9 %, Mannitol: 1,1 %, Fructose: 1,9 %, Leucrose: 2,2 %) 
Protein: 2,0 % 
Lipid: 0,1 % 
Lactic acid: 2,0 % 
Ethanol: 0,5 % 
Ash: 3,4 % 
Moisture: 80 %  
Diacylglycerol oil of plant 
origin  Description/Definition:  
Manufactured from glycerol and fatty acids derived from edible vegetable oils, in particular from soybean oil ( Glycine max ) or rapeseed oil ( Brassica 
campestris, Brassica napus ) using a specific enzyme.  
Acylglycerol Distribution:  
Diacylglycerols (DAG): ≥ 80 % 
1,3-Diacylglycerols (1,3-DAG): ≥ 50 % 
Triacylglycerols (TAG): ≤ 20 % 
Monoacylglycerols (MAG): ≤ 5,0 %  
Fatty Acid Composition (MAG, DAG, TAG):  
Oleic acid (C18:1): 20-65 % 
Linoleic acid (C18:2): 15-65 % 
Linolenic acid (C18:3): ≤ 15 % 
Saturated fatty acids: ≤ 10 %  
Others:  
Acid value: ≤ 0,5 mg KOH/g 
Moisture and volatile: ≤ 0,1 % 
Peroxide value (PV): ≤ 1,0 meq/kg 
Unsaponifiables: ≤ 2,0 % 
Trans fatty acids ≤ 1,0 % 
MAG = monoacylglycerols, DAG = diacylglycerols, TAG = triacylglycerolsEN 24.7.2018 Official Journal of the European Union L 187/81
 Authorised Novel Food  Specifications  
Dihydrocapsiate (DHC)  Description/Definition:  
Dihydrocapsiate is synthesised by enzyme-catalysed esterification of vanillyl alcohol and 8-methylnonanoic acid. Following the esterification dihydro ­
capsiate is extracted with n-hexane. 
Viscous to colourless to yellow liquid 
Chemical formula: C  18 H 28 O 4 
CAS No: 205687-03-2  
Physical-chemical properties:  
Dihydrocapsiate: > 94 % 
8-Methylnonanoic acid: < 6,0 % 
Vanillyl acohol: < 1,0 % 
Other synthesis related substances: < 2,0 %  
Dried extract of  Lippia 
citriodora  from cell cultures  Description/Definition:  
Dried extract of  Lippia citriodora  (Palau) Kunth from cell cultures HTN® Vb. 
Echinacea angustifolia  extract 
from cell cultures  Description/Definition:  
Extract of the roots of  Echinacea angustifolia  obtained from plant tissue culture which is substantially equivalent to a root extract from  Echinacea 
angustifolia  obtained in ethanol-water titrated to 4 % echinacoside.  
Echinacea purpurea  extract 
from cell cultures  Description/Definition:  
Dried extract of  Echinacea purpurea  from cell cultures HTN® Vb 
Echium plantagineum  oil Description/Definition:  
Echium oil is the pale yellow product obtained by refining oil extracted from the seeds of  Echium plantagineum  L. Stearidonic acid: ≥ 10 % w/w of 
total fatty acids 
Trans fatty acids: ≤ 2,0 % (w/w of total fatty acids) 
Acid value: ≤ 0,6 mg KOH/g 
Peroxide value (PV): ≤ 5,0 meq O  2/kg 
Unsaponifiable content: ≤ 2,0 % 
Protein content (total nitrogen): ≤ 20 μg/ml 
Pyrrolizidine alkaloids: Not detectable with a detection limit 4,0 μg/kgEN L 187/82 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Epigallocatechin gallate as a 
purified extract from green tea 
leaves ( Camellia sinensis ) Description/Definition:  
A highly purified extract from the leaves of green tea ( Camellia sinensis (L.) Kuntze ) in the form of a fine, off-white to pale pink powder. It is composed 
of a minimum of 90 % epigallo-catechin gallate (EGCG), and has a melting point between approx. 210 and 215 °C 
Appearance: off-white to pale pink powder 
Chemical name: polyphenol (-) epigallocatechin-3-gallate 
Synonyms: epigallocatechin gallate (EGCG) 
CAS No.: 989-51-5 
INCI name: epigallocatechin gallate 
Molecular mass: 458,4 g/mol 
Loss on drying: max 5,0 %  
Heavy metals:  
Arsenic: max 3,0 ppm 
Lead: max 5,0 ppm  
Assay:  
Min. 94 % EGCG (on dry material) 
max. 0,1 % caffeine 
Solubility: EGCG is fairly soluble in water, ethanol, methanol and acetone  
L-ergothioneine  Definition  
Chemical name (IUPAC): (2S)-3-(2-thioxo-2,3-dihydro-1 H-imidazol-4-yl)-2-(trimethylammonio)-Propanoate 
Chemical formula: C  9H 15N 3O 2S 
Molecular mass: 229,3 Da 
CAS No.: 497-30-3  
Parameter  Specification  Method  
Appearance  White powder  Visual  
Optical rotation  [ α] D ≥ (+) 122° (c = 1, H  2O)a) Polarimetry  
Chemical purity  ≥ 99,5 % 
≥ 99,0 %  HPLC [Eur. Ph. 2,2.29] 
1H-NMREN 24.7.2018 Official Journal of the European Union L 187/83
 Authorised Novel Food  Specifications  
Identification  Compliant with the structure 
C: 47,14 ± 0,4 % 
H: 6,59 ± 0,4 % 
N: 18,32 ± 0,4 %  1H-NMR 
Elemental analysis  
Total residual solvents 
(methanol, ethyl acetate, isopropanol, 
ethanol)  [Eur. Ph. 01/2008:50400] 
< 1 000 ppm  Gas chromatography 
[Eur. Ph. 01/2008:20424]  
Loss on drying  Internal standard < 0,5 %  [Eur. Ph. 01/2008:20232]  
Impurities  < 0,8 %  HPLC/GPC or 1H-NMR  
Heavy metalsb) c) 
Lead  < 3,0 ppm  ICP/AES  
Cadmium  < 1,0 ppm  (Pb, Cd)  
Mercury  < 0,1 ppm  Atomic fluorescence (Hg)  
Microbiological specificationsb) 
Total viable aerobic count (TVAC)  ≤ 1 x 103 CFU/g  [Eur. Ph. 01/2011:50104]  
Total yeast and mould count (TYMC)  ≤ 1 x 102 CFU/g  
Escherichia coli  Absence in 1 g  
Eur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-performance liquid chromatography; GPC:  gel 
permeation chromatography; ICP/AES: Inductively coupled plasma atomic emission spectroscopy; 
CFU: colony-forming units. 
a) Lit. [ α] D = (+) 126,6o (c = 1, H  2O) 
b) Analyses conducted on each batch 
c) Maximum levels in accordance with Regulation (EC) No 1881/2006EN L 187/84 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Ferric Sodium EDTA  Description/Definition:  
Ferric Sodium EDTA (ethylenediaminetetraacetic acid) is an odourless free-flowing, yellow to brown powder with a chemical purit y of more than 
99 % (w/w). It is freely soluble in water. 
Chemical formula: C  10H 12FeN  2NaO  8 * 3H  2O 
Chemical characteristics: 
pH of 1 % solution: 3,5-5,5 
Iron: 12,5-13,5 % 
Sodium: 5,5 % 
Water: 12,8 % 
Organic matter (CHNO): 68,4 % 
EDTA: 65,5-70,5 % 
Water insoluble matter: ≤ 0,1 % 
Nitrilo-triacetic acid: ≤ 0,1 %  
Ferrous ammonium phosphate  Description/Definition:  
Ferrous ammonium phosphate is a grey/green fine powder, practically insoluble in water and soluble in dilute mineral acids. 
CAS No.: 10101-60-7 
Chemical formula: FeNH  4PO  4 
Chemical characteristics: 
pH of 5 % suspension in water: 6,8-7,8 
Iron (total): ≥ 28 % 
Iron (II): 22-30 % (w/w) 
Iron (III): ≤ 7,0 % (w/w) 
Ammonia: 5-9 % (w/w) 
Water: ≤ 3,0 %  
Fish peptides from  Sardinops 
sagax  Description/Definition:  
The novel food ingredient is a peptide mixture, which is obtained by an alkaline protease-catalysed hydrolysis of fish ( Sardinops sagax ) muscle, 
subsequent isolation of the peptide fraction by column chromatography, concentration under vacuum and spray drying. 
Yellowish white powderEN 24.7.2018 Official Journal of the European Union L 187/85
 Authorised Novel Food  Specifications  
Peptides (1 ) (short chain peptides, dipeptides and tripeptides with a molecular weight of less than 2 kDa): ≥ 85 g/100 gVal-Tyr (dipeptide): 0,1- 
0,16 g/100 g 
Ash: ≤ 10 g/100 g 
Moisture: ≤ 8 g/100 g  
(1 ) Kjeldahl method  
Flavonoids from  Glycyrrhiza 
glabra  Description/Definition:  
Flavonoids derived from the roots or rootstock of  Glycyrrhiza glabra  L. are extracted with ethanol followed by further extraction of this ethanolic 
extract with medium-chain triglycerides. It is a dark-brown coloured liquid, containing 2,5 % to 3,5 % of glabridin. 
Moisture: < 0,5 % 
Ash: < 0,1 % 
Peroxide value (PV): < 0,5 meq/kg 
Glabridin: 2,5-3,5 % of fat 
Glycyrrhizinic acid: < 0,005 % 
Fat including polyphenol-type substances: ≥ 99 % 
Protein: < 0,1 % 
Carbohydrates: not detectable  
Fucoidan extract from the 
seaweed  Fucus vesiculosus  Description/Definition:  
Fucoidan from the seaweed  Fucus vesiculosus  is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic 
solvents. The resulting extract is concentrated and dried to yield the fucoidan extract with the following specifications: 
Off-white to brown powder 
Odour and Taste: Bland odour and taste 
Moisture: < 10 % (105 °C for 2 hours) 
pH value: 4,0-7,0 (1 % suspension at 25 °C)  
Heavy metals:  
Arsenic (inorganic): < 1,0 ppm 
Cadmium: < 3,0 ppm 
Lead: < 2,0 ppm 
Mercury: < 1,0 ppmEN L 187/86 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Microbiological criteria:  
Total aerobic microbial count: < 10 000 CFU/g 
Yeast and mould count: < 100 CFU/g 
Total enterobacteria count: Absence/g  
Escherichia coli : Absence/g  
Salmonella : Absence/10 g  
Staphylococcus aureus : Absence/g 
Composition of the two permitted types of extracts, based on the level of fucoidan:  
Extract 1:  
Fucoidan: 75-95 % 
Alginate: 2,0-5,5 % 
Polyphloroglucinol: 0,5-15 % 
Mannitol: 1-5 % 
Natural salts/Free Minerals: 0,5-2,5 % 
Other carbohydrates: 0,5-1,0 % 
Protein: 2,0-2,5 %  
Extract 2:  
Fucoidan: 60-65 % 
Alginate: 3,0-6,0 % 
Polyphloroglucinol: 20-30 % 
Mannitol: < 1,0 % 
Natural salts/Free Minerals: 0,5-2,0 % 
Other carbohydrates: 0,5-2,0 % 
Protein: 2,0-2,5 %  
Fucoidan extract from the 
seaweed  Undaria pinnatifida  Description/Definition:  
Fucoidan from seaweed  Undaria pinnatifida  is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic 
solvents. The resulting extract is concentrated and dried to yield the fucoidan extract with the following specifications: 
Off-white to brown powder 
Odour and Taste: Bland odour and tasteEN 24.7.2018 Official Journal of the European Union L 187/87
 Authorised Novel Food  Specifications  
Moisture: < 10 % (105 °C for 2 hours) 
pH value: 4,0-7,0 (1 % suspension at 25 °C)  
Heavy metals:  
Arsenic (inorganic): < 1,0 ppm 
Cadmium: < 3,0 ppm 
Lead: < 2,0 ppm 
Mercury: < 1,0 ppm  
Microbiology:  
Total aerobic microbial count: < 10 000 CFU/g 
Yeast and mould count: < 100 CFU/g 
Total enterobacteria count: Absence/g  
Escherichia coli : Absence/g  
Salmonella : Absence/10 g  
Staphylococcus aureus : Absence/g 
Composition of the two permitted types of extracts, based on the level of fucoidan:  
Extract 1:  
Fucoidan: 75-95 % 
Alginate: 2,0-6,5 % 
Polyphloroglucinol: 0,5-3,0 % 
Mannitol: 1-10 % 
Natural salts/Free Minerals: 0,5-1,0 % 
Other carbohydrates: 0,5-2,0 % 
Protein: 2,0-2,5 %  
Extract 2:  
Fucoidan: 50-55 % 
Alginate: 2,0-4,0 % 
Polyphloroglucinol: 1,0-3,0 % 
Mannitol: 25-35 % 
Natural salts/Free Minerals: 8-10 % 
Other carbohydrates: 0,5-2,0 % 
Protein: 1,0-1,5 %EN L 187/88 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
2′-Fucosyllactose 
(synthetic)  Definition:  
Chemical name: α-L-Fucopyranosyl-(1 →2)- β-D-galactopyranosyl-(1 →4)- D-glucopyranose 
Chemical formula: C  18H 32O 15 
CAS No: 41263-94-9 
Molecular weight: 488,44 g/mol  
Description:  
2′-fucosyllactose is a white to off-white powder that is produced by a chemical synthesis process.  
Purity:  
2'-Fucosyllactose: ≥ 95 % 
D-Lactose: ≤ 1,0 w/w % 
L-Fucose: ≤ 1,0 w/w % 
Difucosyl- D-lactose isomers: ≤ 1,0 w/w % 
2′-Fucosyl- D-lactulose: ≤ 0,6 w/w % 
pH (20 °C, 5 % solution): 3,2-7,0 
Water (%): ≤ 9,0 % 
Ash, sulphated: ≤ 0,2 % 
Acetic acid: ≤ 0,3 % 
Residual solvents (methanol, 2-propanol, methyl acetate, acetone): ≤ 50,0 mg/kg singly, ≤ 200,0 mg/kg in combination 
Residual proteins: ≤ 0,01 %  
Heavy Metals:  
Palladium: ≤ 0,1 mg/kg 
Nickel: ≤ 3,0 mg/kg  
Microbiological criteria:  
Aerobic mesophilic bacteria total count: ≤ 500 CFU/g 
Yeasts and Moulds: ≤ 10 CFU/g 
Residual endotoxins: ≤ 10 EU/mgEN 24.7.2018 Official Journal of the European Union L 187/89
 Authorised Novel Food  Specifications  
2'-Fucosyllactose 
(microbial source)  Definition:  
Chemical name: α-L-Fucopyranosyl-(1 →2)- β-D-galactopyranosyl-(1 →4)-D-glucopyranose 
Chemical formula: C  18H 32O 15 
CAS No: 41263-94-9 
Molecular weight: 488,44 g/mol  
Source:  
Genetically modified strain of  Escherichia coli  K-12  Source:  
Genetically modified strain of  Escherichia coli  BL21  
Description:  
2′-Fucosyllactose is a white to off-white powder that is produced by a 
microbial process.  
Purity:  
2'-Fucosyllactose: ≥ 90 % 
D-Lactose: ≤ 3,0 % 
L-Fucose: ≤ 2,0 
Difucosyl-D-lactose: ≤ 2,0 % 
2′-Fucosyl-D-lactulose: ≤ 1,0 % 
pH (20 °C, 5 % solution): 3,0-7,5 
Water: ≤ 9,0 % 
Sulphated ash: ≤ 2,0 % 
Acetic acid: ≤ 1,0 % 
Residual proteins: ≤ 0,01 %  
Microbiological criteria:  
Aerobic mesophilic bacteria total count: ≤ 3 000 CFU/g 
Yeasts: ≤ 100 CFU/g 
Moulds: ≤ 100 CFU/g 
Endotoxins: ≤ 10 EU/mg  Description:  
2′-Fucosyllactose is a white to off white powder and the liquid 
concentrate (45 % ± 5 % w/v) aqueous solution is a colourless 
to slight yellow clear aqueous solution. 2'-Fucosyllactose is 
produced by a microbiological process.  
Purity:  
2'-Fucosyllactose: ≥ 90 % 
Lactose: ≤ 5,0 % 
Fucose: ≤ 3,0 % 
3-Fucosyllactose: ≤ 5,0 % 
Fucosylgalactose: ≤ 3,0 % 
Difucosyllactose: ≤ 5,0 % 
Glucose: ≤ 3,0 % 
Galactose: ≤ 3,0 % 
Water: ≤ 9,0 % (powder) 
Ash, sulphated: ≤ 0,5 % (powder and liquid) 
Residual proteins: ≤ 0,01 % (powder and liquid)EN L 187/90 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Heavy Metals:  
Lead: ≤ 0,02 mg/kg (powder and liquid); 
Arsenic: ≤ 0,2 mg/kg (powder and liquid) 
Cadmium: ≤ 0,1 mg/kg (powder and liquid) 
Mercury: ≤ 0,5 mg/kg (powder and liquid)  
Microbiological criteria:  
Total plate count: ≤ 104 CFU/g (powder), ≤ 5 000 CFU/g (liquid) 
Yeasts and Moulds: ≤ 100 CFU/g (powder); ≤ 50 CFU/g (liquid) 
Enterobacteriaceae/Coliforms: absence in 11g (powder and liquid)  
Salmonella : negative/100 g (powder), negative/200 ml (liquid)  
Cronobacter : negative/100 g (powder), negative/200 ml (liquid) 
Endotoxins: ≤ 100 EU/g (powder), ≤ 100 EU/ml (liquid) 
Aflatoxin M1: ≤ 0,025 μg/kg (powder and liquid)  
Galacto-oligosaccharide  Description/Definition: 
Galacto-oligosaccharide is produced from milk lactose by an enzymatic process using β-galactosidases from  Aspergillus oryzae , 
Bifidobacterium bifidum, Pichia pastoris, Sporobolomyces singularis, Kluyveromyces lactis, Bacillus circulans, and Papiliotrema  terrestris . 
GOS: min 46 % Dry Matter (DM) 
Lactose: max 40 % DM 
Glucose: max 27 % DM 
Galactose: min 0,8 % DM 
Ash: max 4,0 % DM 
Protein: max 4,5 % DM 
Nitrite: max. 2 mg/kg  
Glucosamine HCl from  
Aspergillus niger  and 
genetically modified strain of  E. 
coli K-12  White crystalline odourless powder 
Molecular formula: C  6H 13NO  5 · HCl 
Relative molecular mass: 215,63 g/mol 
D-Glucosamine HCl 98,0-102,0 % of reference standard (HPLC) 
Specific rotation + 70,0o - + 73,0oEN 24.7.2018 Official Journal of the European Union L 187/91
 Authorised Novel Food  Specifications  
Glucosamine sulphate KCl 
from  Aspergillus niger  and 
genetically modified strain of  E. 
coli K-12  White crystalline odourless powder 
Molecular formula: (C  6H 14NO  5) 2SO  4 · 2KCl 
Relative molecular mass: 605,52 g/mol 
D-Glucosamine Sulphate 2KCl 98,0-102,0 % of reference standard (HPLC) 
Specific Rotation +50,0o to +52,0o 
Glucosamine sulphate NaCl 
from  Aspergillus niger  and 
genetically modified strain of  E. 
coli K-12  White crystalline odourless powder 
Molecular formula: (C  6H 14NO  5) 2SO  4 · 2NaCl 
Relative molecular mass: 573,31 g/mol 
D-Glucosamine HCl: 98-102 % of reference standard (HPLC) 
Specific Optical Rotation: +52o - +54o 
Guar Gum  Description/Definition:  
Native guar gum is the ground endosperm of seeds from natural strains of guar  Cyamopsis tetragonolobus  L. Taub. ( Leguminosae  family). It consists of a 
high molecular weight polysaccharide, primarily composed of galactopyranose and mannopyranose units combined through glycosidic  linkages, 
which may be described chemically as a galactomannan (galactomannan content not less than 75 %). 
Appearance: White to yellowish powder 
Molecular weight: Between 50 000 – 8 000 000 Daltons 
CAS number: 9000-30-0 
Einecs Number: 232-536-8 
Purity: As specified by Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to 
Regulation (EC) No 1333/2008 of the European Parliament and of the Council (1 ) & by Commission Implementing Regulation (EU) 2015/175 of 
5 February 2015 laying down special conditions applicable to the import of guar gum originating in or consigned from India due to contamination 
risks by pentachlorophenol and dioxins (2 ). 
Physico-chemical properties: 
Powder  
Shelf-life: 2 years 
Colour: White 
Odour: Light 
Average diameter of particles: 60-70 μm 
Moisture: Max 15 % 
Viscosity * at 1 hour —EN L 187/92 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Viscosity * at 2 hours: Min 3 600 mPa.s 
Viscosity * at 24 hours: Min 4 000 mPa.s 
Solubility: Soluble in hot and cold water 
pH for 10g/L, at 25 °C - 6-7,5  
Flakes  
Useful life: 1 year 
Colour: White/off white with absence or minimal presence of black spots 
Odour: Light 
Average diameter of particles: 1-10 mm 
Moisture: Max 15 % 
Viscosity * at 1 hour: Min 3 000 mPa.s 
Viscosity * at 2 hours — 
Viscosity * at 24 hours — 
Solubility — Soluble in hot and cold water 
pH for 10g/L, at 25 °C - 5-7,5  
(*) The measurements of viscosity are carried out under the following conditions: 1 %, 25 °C, 20 rpm  
Heat-treated milk products 
fermented with  Bacteroides 
xylanisolvens  Description/Definition:  
Heat-treated fermented milk products are produced with  Bacteroides xylanisolvens  (DSM 23964) as starter culture. 
Semi-skimmed milk (between 1,5 % and 1,8 % fat) or skimmed milk (0,5 % fat or less) is pasteurised or ultra-heat-treated before  starting the 
fermentation with  Bacteroides xylanisolvens  (DSM 23964). The resulting fermented milk product is homogenised and then heat-treated to inactivate  
Bacteroides xylanisolvens  (DSM 23964). The final product does not contain viable cells of  Bacteroides xylanisolvens  (DSM 23964)(1 ). 
(1 ) Modified DIN EN ISO 21528-2.  
Hydroxytyrosol  Description/Definition:  
Hydroxytyrosol is a pale yellow viscous liquid obtained by chemical synthesis 
Molecular formula: C  8H 10O 3 
Molecular weight: 154,6 g/mol 
CAS No: 10597-60-1 
Moisture ≤ 0,4 % 
Odour: CharacteristicEN 24.7.2018 Official Journal of the European Union L 187/93
 Authorised Novel Food  Specifications  
Taste: Slightly bitter 
Solubility (water): Miscible with water 
pH: 3,5-4,5 
Refractive Index: 1,571-1,575  
Purity:  
Hydroxytyrosol: ≥ 99 % 
Acetic acid: ≤ 0,4 % 
Hydroxytyrosol acetate: ≤ 0,3 % 
Sum of homovanillic acid, iso-homovanilic acid, and 3-methoxy-4hydroxyphenylglycol: ≤ 0,3 %  
Heavy Metals  
Lead: ≤ 0,03 mg/kg 
Cadmium: ≤ 0,01 mg/kg 
Mercury: ≤ 0,01 mg/kg  
Residual Solvents  
Ethyl acetate: ≤ 25,0 mg/kg 
Isopropanol: ≤ 2,50 mg/kg 
Methanol: ≤ 2,00 mg/kg 
Tetrahydrofuran: ≤ 0,01 mg/kg  
Ice Structuring Protein type III 
HPLC 12  Description/Definition:  
The Ice Structuring Protein (ISP) preparation is a light-brown liquid produced by submerged fermentation of a genetically-modif ied strain of food- 
grade baker’s yeast ( Saccharomyces cerevisiae ) in which a synthetic gene for the ISP has been inserted into the yeast’s genome. The protein is expressed 
and secreted into the growth medium where it is separated from the yeast cells by micro-filtration and concentrated by ultra-fi ltration. As a result, the 
yeast cells are not transferred into the ISP preparation as such or under an altered form. The ISP preparation consists of nati ve ISP, glycosylated ISP 
and proteins and peptides from the yeast and sugars as well as acids and salts commonly found in food. The concentrate is stabi lised with 10 mM 
citric acid buffer. 
Assay: ≥ 5 g/l active ISP 
pH: 2,5-3,5 
Ash: ≤ 2,0 % 
DNA: Not detectable  
Aqueous extract of dried leaves 
of Ilex guayusa  Description/Definition:  
Dark brown liquid. Aqueous extracts of dried leaves of  Ilex guayusa.EN L 187/94 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Composition:  
Protein: < 0,1 g/100 ml 
Fat: < 0,1 g/100 ml 
Carbohydrate: 0,2–0,3 g/100 ml 
Total sugars: < 0,2 g/100 ml 
Caffeine: 19,8–57,7 mg/100 ml 
Theobromine: 0,14–2,0 mg/100 ml 
Chlorogenic acids: 9,9–72,4 mg/100ml  
Isomalto-oligosaccharide  Powder:  
Solubility (water) (%): > 99 
Glucose (% dry basis): ≤ 5,0 
Isomaltose + DP3 to DP9 (% dry basis): ≥ 90 
Moisture (%): ≤ 4,0 
Sulphated ash(g/100 g): ≤ 0,3  
Heavy metals:  
Lead (mg/kg): ≤ 0,5 
Arsenic (mg/kg): ≤ 0,5  
Syrup:  
Dried solids (g/100 g): > 75 
Glucose (% dry basis): ≤ 5,0 
Isomaltose + DP3 to DP9 (% dry basis): ≥ 90 
pH: 4 - 6 
Sulphated ash(g/100 g): ≤ 0,3  
Heavy metals:  
Lead (mg/kg): ≤ 0,5 
Arsenic (mg/kg): ≤ 0,5  
Isomaltulose  Description/Definition:  
A reducing disaccharide that consists of one glucose and one fructose moiety linked by an alpha-1,6-glycosidic bond. It is obta ined from sucrose by 
an enzymatic process. The commercial product is the monohydrate. Appearance: Virtually odourless, white or almost white crystal s with a sweet tasteEN 24.7.2018 Official Journal of the European Union L 187/95
 Authorised Novel Food  Specifications  
Chemical name: 6-O- α-D-glucopyranosyl-D-fructofuranose, monohydrateCAS No.: 13718-94-0 
Chemical formula: C  12H 22O 11 · H 2O 
Structural formula
  
Formula weight: 360,3 (monohydrate)  
Purity:  
Assay: ≥ 98 % on the dry basis 
Loss on drying: ≤ 6,5 % (60 °C, 5 hours)  
Heavy metals:  
Lead: ≤ 0,1 mg/kg 
Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of s ample preparation 
may be based on the principles of the method described in FNP 5(1 ), ‘Instrumental methods’  
(1 ) Food and Nutrition Paper 5 Rev. 2 — Guide to specifications for general notices, general analytical techniques, identificatio n tests, test solutions and other reference 
materials (JECFA), 1991, 322 pp., English, ISBN 92-5-102991-1.  
Lactitol  Description/Definition:  
Crystalline powder or colourless solution manufactured via catalytic hydrogenation of lactose. Crystalline products occur in an hydrous, monohydrate 
and dihydrate forms. Nickel is used as a catalyst. 
Chemical name: 4-O- β-D-Galactopyranosyl-D-glucitol 
Chemical formula: C  12H 24O 11 
Molecular weight: 344,31 g/mol 
CAS No: 585-86-4EN L 187/96 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Purity:  
Solubility (in water): Very soluble in water 
Specific rotation [ α] D20 = + 13o to + 16o 
Assay: ≥ 95 % d.b (d.b — expressed on the dry weight basis) 
Water: ≤ 10,5 % 
Other polyols: ≤ 2,5 % d.b 
Reducing sugars: ≤ 0,2 % d.b 
Chlorides: ≤ 100 mg/kg d.b 
Sulphates: ≤ 200 mg/kg d.b 
Sulphated ash: ≤ 0,1 % d.b 
Nickel: ≤ 2,0 mg/kg d.b 
Arsenic: ≤ 3,0 mg/kg d.b 
Lead: ≤ 1,0 mg/kg d.b  
Lacto- N-neotetraose 
(synthetic)  Definition:  
Chemical name: β-D-Galactopyranosyl-(1 →4)-2-acetamido-2-deoxy- β-D-glucopyranosyl-(1 →3)- β-D-galactopyranosyl-(1 →4)- D-glucopyranose 
Chemical formula: C  26H 45NO  21 
CAS No: 13007-32-4 
Molecular weight: 707,63 g/mol  
Description:  
Lacto- N-neotetraose is a white to off-white powder. Produced by a chemical synthesis process and is isolated by crystallisation.  
Purity:  
Assay (water free): ≥ 96 % 
D-Lactose: ≤ 1,0 % 
Lacto-N-triose II: ≤ 0,3 % 
Lacto-N-neotetraose fructose isomer: ≤ 0,6 % 
pH (20 °C, 5 % solution): 5,0-7,0 
Water: ≤ 9,0 % 
Ash, sulphated: ≤ 0,4 % 
Acetic acid: ≤ 0,3 %EN 24.7.2018 Official Journal of the European Union L 187/97
 Authorised Novel Food  Specifications  
Residual solvents (methanol, 2-propanol, methyl acetate, acetone): ≤ 50 mg/kg singly, ≤ 200 mg/kg in combination 
Residual proteins: ≤ 0,01 % 
Palladium: ≤ 0,1 mg/kg 
Nickel: ≤ 3,0 mg/kg  
Microbiological criteria:  
Aerobic mesophilic bacteria total count: ≤ 500 CFU/g 
Yeasts: ≤ 10 CFU/g 
Moulds: ≤ 10 CFU/g 
Residual endotoxins: ≤ 10 EU/mg  
Lacto- N-neotetraose 
(microbial source)  Definition:  
Chemical name: β-D-Galactopyranosyl-(1 →4)-2-acetamido-2-deoxy- β-D-glucopyranosyl-(1 →3)- β-D-galactopyranosyl-(1 →4)-D-glucopyranose 
Chemical formula: C  26H 45NO  21 
CAS No: 13007-32-4 
Molecular weight: 707,63 g/mol  
Source:  
Genetically modified strain of  Escherichia coli  K-12  
Description:  
Lacto- N-neotetraose is a white to off-white powder that is produced by a microbiological process. Lacto- N-neotetraose is isolated by crystallisation.  
Purity:  
Assay (water free): ≥ 92 % 
D-Lactose: ≤ 3,0 % 
Lacto-N-triose II: ≤ 3,0 %  
para -Lacto-N-neohexaose: ≤ 3,0 % 
Lacto-N-neotetraose fructose isomer: ≤ 1,0 % 
pH (20 °C, 5 % solution): 4,0-7,0 
Water: ≤ 9,0 % 
Ash, sulphated: ≤ 0,4 % 
Residual solvents (methanol): ≤ 100 mg/kg 
Residual proteins: ≤ 0,01 %EN L 187/98 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Microbiological criteria:  
Aerobic mesophilic bacteria total count: ≤ 500 CFU/g 
Yeasts: ≤ 10 CFU/g 
Moulds: ≤ 10 CFU/g 
Residual endotoxins: ≤ 10 EU/mg  
Lucerne leaf extract from  
Medicago sativa  Description/Definition:  
The Lucerne ( Medicago sativa  L.) is processed within 2 hours after harvest. It is chopped and crushed. By passing through an oleaginous-type press, the 
Lucerne provides a fibrous residue and press juice (10 % of dry matter). The dry matter of this juice contains about 35 % of cr ude protein. The press 
juice (pH 5,8-6,2) is neutralised. Preheating and vapour injection allows coagulation of proteins associated with carotenoid an d chlorophyll pigments. 
The protein precipitate is separated by centrifugation and thereafter dried. After adding ascorbic acid the Lucerne protein con centrate is granulated 
and stored in inert gas or in cold storage.  
Composition:  
Protein: 45-60 % 
Fat: 9-11 % 
Free carbohydrates (soluble fibre): 1-2 % 
Polysaccharides (insoluble fibre): 11-15 % 
including cellulose: 2-3 % 
Minerals: 8-13 % 
Saponins: ≤ 1,4 % 
Isoflavones: ≤ 350 mg/kg 
Coumestrol: ≤ 100 mg/kg 
Phytates: ≤ 200 mg/kg 
L-canavanine: ≤ 4,5 mg/kg  
Lycopene  Description/Definition:  
Synthetic lycopene is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other c arotenoids used in 
food. Synthetic lycopene consists of ≥ 96 % lycopene and minor quantities of other related carotenoid components. Lycopene is presented either as a 
powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Antioxidative protection has to be ass ured. 
Chemical name: Lycopene 
CAS No.: 502-65-8 ( all-trans lycopene) 
Chemical formula: C  40H 56 
Formula weight: 536,85 DaEN 24.7.2018 Official Journal of the European Union L 187/99
 Authorised Novel Food  Specifications  
Lycopene from  Blakeslea 
trispora  Description/Definition:  
The purified lycopene from  Blakeslea trispora  consists of ≥ 95 % lycopene and ≤ 5 % other carotenoids. It is presented either as a powder in a suitable 
matrix or an oily dispersion. The colour is dark red or red-violet. Anti-oxidative protection has to be assured. 
Chemical name: Lycopene 
CAS No.: 502-65-8 (all trans lycopene) 
Chemical formula: C  40H 56 
Formula weight: 536,85 Da  
Lycopene from tomatoes  Description/Definition:  
The purified lycopene from tomatoes ( Lycopersicon esculantum  L.) consists of ≥ 95 % lycopene and ≤ 5 % other carotenoids. It is presented either as a 
powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Anti-oxidative protection has to be as sured. 
Chemical name: Lycopene 
CAS No.: 502-65-8 (all trans lycopene) 
Chemical formula: C  40H 56 
Formula weight: 536,85 Da  
Lycopene oleoresin from 
tomatoes  Description/Definition:  
Lycopene oleoresin from tomatoes is obtained by solvent extraction of ripe tomatoes ( Lycopersicon esculentum Mill. ) with subsequent removal of the 
solvent. It is a red to dark brown viscous, clear liquid. 
Total lycopene: 5-15 % 
Thereof trans-lycopene: 90-95 % 
Total carotenoids (calculated as lycopene): 6,5-16,5 % 
Other carotenoids: 1,75 % 
(Phytoene/phytofluene/ β-carotene): (0,5-0,75/0,4-0,65/0,2-0,35 %) 
Total tocopherols: 1,5-3,0 % 
Unsaponifiable matter: 13-20 % 
Total fatty acids: 60-75 % 
Water (Karl Fischer): ≤ 0,5 %  
Magnesium citrate malate  Description/Definition:  
Magnesium citrate malate is a white to yellowish-white, amorphous powder.EN L 187/100 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Chemical formula: Mg  5(C 6H 5O 7) 2(C 4H 4O 5) 2 
Chemical name: Pentamagnesium di-(2-hydroxybutanedioate)-di-(2- hydroxypropane-1,2,3-tricarboxylate) 
CAS No.: 1259381-40-2 
Molecular weight: 763,99 Daltons (anhydrous) 
Solubility: Freely soluble in water (about 20 g in 100 ml) 
Description of the physical state: Amorphous powder 
Assay magnesium: 12,0-15,0 % 
Loss on drying (120 °C/4 hours): ≤ 15 % 
Colour (solid): White to yellowish-white 
Colour (20 % aqueous solution): Colourless to yellowish 
Appearance (20 % aqueous solution): Clear solution 
pH (20 % aqueous solution): Approx. 6,0  
Impurities:  
Chloride: ≤ 0,05 % 
Sulphate: ≤ 0,05 % 
Arsenic: ≤ 3,0 ppm 
Lead: ≤ 2,0 ppm 
Cadmium: ≤ 1 ppm 
Mercury: ≤ 0,1 ppm  
Magnolia Bark Extract  Description/Definition:  
Magnolia bark extract is obtained from the bark of the plant  Magnolia officinalis  L. and produced with supercritical carbon dioxide. The bark is washed 
and oven dried to reduce moisture content before being crushed and extracted with supercritical carbon dioxide. The extract is dissolved in medical- 
grade ethanol and re-crystallised to yield magnolia bark extract. 
Magnolia bark extract is mainly composed of two phenolic compounds, magnolol and honokiol. 
Appearance: Light brownish powder  
Purity:  
Magnolol: ≥ 85,2 % 
Honokiol: ≥ 0,5 % 
Magnolol & Honokiol: ≥ 94 % 
Total Eudesmol: ≤ 2 % 
Moisture: 0,50 %EN 24.7.2018 Official Journal of the European Union L 187/101
 Authorised Novel Food  Specifications  
Heavy metals:  
Arsenic (ppm): ≤ 0,5 
Lead (ppm): ≤ 0,5 
Methyl eugenol (ppm): ≤ 10 
Tubocurarine (ppm): ≤ 2,0 
Total Alkaloid (ppm): ≤ 100  
Maize-germ oil high in 
unsaponifiable matter  Description/Definition:  
Maize-germ oil high in unsaponifiable matter is produced by vacuum distillation and it is different from refined maize-germ oil  in the concentration 
of the unsaponifiable fraction (1,2 g in refined maize-germ oil and 10 g in ‘maize-germ oil high in unsaponifiable matter’).  
Purity:  
Unsaponifiable matter: > 9,0 g/100 g 
Tocopherols: ≥ 1,3 g/100 g 
α-tocopherol (%): 10-25 % 
β-tocopherol (%): < 3,0 % 
γ-tocopherol (%): 68-89 % 
δ-tocopherol (%): < 7,0 % 
Sterols, triterpenic alcohols, methylsterols: > 6,5 g/100 g 
Fatty acids in triglycerides: 
palmitic acid: 10,0-20,0 % 
stearic acid: < 3,3 % 
oleic acid: 20,0-42,2 % 
linoleic acid: 34,0-65,6 % 
linolenic acid: < 2,0 % 
Acid value: ≤ 6,0 mg KOH/g 
Peroxide value (PV): ≤ 10 mEq O  2/kg 
Heavy metals:  
Iron (Fe): < 1 500 μg/kg 
Copper (Cu): < 100 μg/kg  
Impurities:  
Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 μg/kg 
Treatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons (PAH) are not enriched in the producti on of ‘maize-germ 
oil high in unsaponifiable matter’EN L 187/102 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Methylcellulose  Description/Definition:  
Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with me thyl groups. 
Chemical name: Methyl ether of cellulose 
Chemical formula: The polymers contain substituted anhydroglucose units with the following general formula: 
C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following: 
— H 
— CH  3 or 
— CH  2CH  3 
Molecular weight: Macromolecules: from about 20 000 (n about 100) up to about 380 000 g/mol (n about 2 000) 
Assay: Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH  3) and not more than 5 % of hydroxyethoxyl groups 
(-OCH  2CH  2OH) 
Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder. 
Solubility: Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol, ether and ch loroform. Soluble in glacial 
acetic acid.  
Purity:  
Loss on drying: ≤ 10 % (105 °C, 3 hours) 
Sulphated Ash: ≤ 1,5 % determined at 800 ± 25 °C 
pH: ≥ 5,0 and ≤ 8,0 (1 % colloidal solution)  
Heavy metals:  
Arsenic: ≤ 3,0 mg/kg 
Lead: ≤ 2,0 mg/kg 
Mercury: ≤ 1,0 mg/kg 
Cadmium: ≤ 1,0 mg/kg  
(6S)-5-methyltetrahydrofolic 
acid, glucosamine salt  Description/Definition:  
Chemical name: N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, gl ucosamine salt 
Chemical formula: C  32H 51N 9O 16 
Molecular weight: 817,80 g/mol (anhydrous) 
CAS No.: 1181972-37-1 
Appearance: Creamy to light-brown powderEN 24.7.2018 Official Journal of the European Union L 187/103
 Authorised Novel Food  Specifications  
Purity:  
Diastereoisomeric purity: At least 99 % of (6S)-5-methyltetrahydrofolic acid 
Glucosamine assay: 34-46 % in dry basis 
5-Methyltetrahydrofolic acid assay: 54-59 % in dry basis 
Water: ≤ 8,0 %  
Heavy metals:  
Lead: ≤ 2,0 ppm 
Cadmium: ≤ 1,0 ppm 
Mercury: ≤ 0,1 ppm 
Arsenic: ≤ 2,0 ppm 
Boron: ≤ 10 ppm  
Microbiological criteria:  
Total aerobic microbial count: ≤ 100 CFU/g 
Yeasts and moulds: ≤ 100 CFU/g  
Escherichia coli : Absence in 10g  
Monomethylsilanetriol 
(Organic Silicon)  Description/Definition:  
Chemical name: Silanetriol, 1-methyl- 
Chemical formula: CH  6O 3Si 
Molecular weight: 94,14 g/mol 
CAS No: 2445-53-6  
Purity:  
Organic Silicon (monomethylsilanetriol) preparation (aqueous solution): 
Acidity (pH): 6,4-6,8 
Silicon: 100-150 mg Si/l  
Heavy metals:  
Lead: ≤ 1,0 μg/l 
Mercury: ≤ 1,0 μg/l 
Cadmium: ≤ 1,0 μg/l 
Arsenic: ≤ 3,0 μg/l 
Solvents:  
Methanol: ≤ 5,0 mg/kg (residual presence)EN L 187/104 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Mycelial extract from Shiitake 
mushroom ( Lentinula edodes ) Description/Definition:  
The novel food ingredient is a sterile aqueous extract obtained from the mycelium of  Lentinula edodes  cultivated in a submerged fermentation. It is a 
light brown, slightly turbid liquid. 
Lentinan is a β-(1-3) β-(1-6)-D-glucan which has a molecular weight of approximately 5 × 105 Daltons, a degree of branching of 2/5 and a triple 
helical tertiary structure.  
Purity/Composition of the mycelial extract from  Lentinula edodes : 
Moisture: 98 % 
Dry matter: 2 % 
Free glucose: < 20 mg/ml 
Total protein(1 ): < 0,1 mg/ml 
N-containing constituents(2 ): < 10 mg/ml 
Lentinan: 0,8 – 1,2 mg/ml\  
(1 ) Bradford method 
(2 ) Kjeldahl method  
Noni fruit juice ( Morinda 
citrifolia ) Description/Definition:  
Noni fruits (fruits of  Morinda citrifolia  L.) are pressed. The obtained juice is pasteurised. An optional fermentation step before or after the pressing may 
occur. 
Rubiadin: ≤ 10 μg/kg 
Lucidin: ≤ 10 μg/kg  
Noni fruit juice powder 
(Morinda citrifolia ) Description/Definition:  
Seeds and skin of the sun-dried fruits of  Morinda citrifolia  are separated. The obtained pulp is filtered to separate juice from the flesh. Desiccation of 
the produced juice occurs in one or two ways: 
Either by atomisation using maize maltodextrins, this mixture is obtained by keeping the rates of inflow of the juice and malto dextrins constant 
Or by zeodratation or drying and then mixing with an excipient, this process allows the juice to be dried initially and then mi xed with maltodextrins 
(same amount as used in atomisation).  
Noni fruit puree and 
concentrate ( Morinda citrifolia ) Description/Definition:  
The fruits of  Morinda citrifolia  are harvested by hand. Seeds and skin may be separated mechanically from the pureed fruits. After pasteurisation, the 
puree is packaged in aseptic containers and stored under cold conditions.EN 24.7.2018 Official Journal of the European Union L 187/105
 Authorised Novel Food  Specifications  
Morinda citrifolia  concentrate is prepared from  M. citrifolia  puree by treatment with pectinolytic enzymes (50– 60 °C for 1-2 h). Then the puree is 
heated to inactivate the pectinases and then immediately cooled. The juice is separated in a decanter centrifuge. Afterwards th e juice is collected and 
pasteurised, prior to being concentrated in a vacuum evaporator from a brix of 6 to 8 to a brix of 49 to 51 in the final concen trate.  
Composition: 
Puree:  
Moisture: 89-93 % 
Protein: < 0,6 g/100 g 
Fat: ≤ 0,4 g/100 g 
Ash: < 1,0 g/100 g 
Total carbohydrates: 5-10 g/100 g 
Fructose: 0,5-3,82 g/100 g 
Glucose: 0,5-3,14 g/100 g 
Dietary fibre: < 0,5-3 g/100 g 
5,15-dimethylmorindol (1): ≤ 0,254 μg/ml 
Lucidin (1): Not detectable 
Alizarin (1): Not detectable 
Rubiadin (1): Not detectable  
Concentrate:  
Moisture: 48-53 % 
Protein: 3-3,5 g/100 g 
Fat: < 0,04 g/100 g 
Ash: 4,5-5,0 g/100 g 
Total carbohydrates: 37-45 g/100 g 
Fructose: 9-11 g/100 g 
Glucose: 9-11 g/100 g 
Dietary fibre: 1,5-5,0 g/100 g 
5,15-dimethylmorindol (1 ): ≤ 0,254 μg/ml  
(1 ) By an HPLC-UV method developed and validated for the analysis of anthraquinones in Morinda citrifolia puree and concentrate. L imits of detection: 2,5 ng/ml (5,15 dimethyl ­
morindol); 50,0 ng/ml (lucidin); 6,3 ng/ml (alizarin) and 62,5 ng/ml (rubiadin).EN L 187/106 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Noni leaves ( Morinda citrifolia ) Description/Definition:  
After cutting, the leaves of  Morinda citrifolia  are subject to drying and roasting steps. The product has a particle size ranging from broken leaves to 
coarse powder with fines. It is of greenish brown to brown colour.  
Purity/Composition:  
Moisture: < 5,2 % 
Protein: 17- 20 % 
Carbohydrate: 55-65 % 
Ash: 10-13 % 
Fat: 4-9 % 
Oxalic acid: < 0,14 % 
Tannic acid: < 2,7 % 
5,15-dimethylmorindol: < 47 mg/kg 
Rubiadin: non detectable, ≤ 10 μg/kg 
Lucidin: non detectable, ≤ 10 μg/kg  
Noni fruit powder ( Morinda 
citrifolia ) Description/Definition:  
Noni fruit powder is made from pulped noni ( Morinda citrifolia L.)  fruits by freeze-drying. Fruits are pulped and seeds are removed. After freeze-drying 
during which water is removed from noni fruits, the remaining noni pulp is milled to a powder and encapsulated.  
Purity/Composition  
Moisture: 5,3-9 % 
Protein: 3,8-4,8 g/100 g 
Fat: 1-2 g/100 g 
Ash: 4,6-5,7 g/100 g 
Total carbohydrates: 80-85 g/100 g 
Fructose: 20,4-22,5 g/100 g 
Glucose: 22-25 g/100 g 
Dietary fibre: 15,4-24,5 g/100 g 
5,15-dimethylmorindol (1 ): ≤ 2,0 μg/ml  
(1 ) By an HPLC-UV method developed and validated for the analysis of anthraquinones in Morinda citrifolia fruit powder. Limits of detection: 2,5 ng/ml (5,15 dimethylmorindol)EN 24.7.2018 Official Journal of the European Union L 187/107
 Authorised Novel Food  Specifications  
Odontella aurita  microalgae  Silicon: 3,3 %Crystalline silica: max 0,1-0,3 % as impurity  
Oil enriched with 
phytosterols/phytostanols  Description/Definition:  
Oil enriched with phytosterols/phytostanols is composed of an oil fraction and a phytosterol fraction.  
Acylglycerol Distribution:  
Free fatty acids (expressed as oleic acid): ≤ 2,0 % 
Monoacylglycerols (MAG): ≤ 10 % 
Diacylglycerols (DAG): ≤ 25 % 
Triacylglycerols (TAG): Making up the balance  
Phytosterol fraction:  
β-sitosterol: ≤ 80 % 
β-sitostanol: ≤ 15 % 
campesterol: ≤ 40 % 
campestanol: ≤ 5,0 % 
stigmasterol: ≤ 30 % 
brassicasterol ≤ 3,0 % 
other sterols/stanols: ≤ 3,0 %  
Others:  
Moisture and volatile: ≤ 0,5 % 
Peroxide value (PV): < 5,0 meq/kg 
Trans fatty acids: ≤ 1 % 
Contamination/Purity (GC-FID or equivalent method) of phytosterols/phytostanols: 
Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of contaminants , best ensured by a 
purity of more than 99 %.  
Oil extracted from squids  Acid value: ≤ 0,5 KOH/g oil 
Peroxide value (PV): ≤ 5 meq O  2/kg oil 
p-Anisidine value: ≤ 20 
Cold test at 0 °C: ≤ 3 hours 
Moisture: ≤ 0,1 % (w/w) 
Unsaponifiable matter: ≤ 5,0 %EN L 187/108 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Trans fatty acids: ≤ 1,0 % 
Docosahexaeonic acid: ≥ 20 % 
Eicosapentaenoic acid: ≥ 10 %  
Pasteurised fruit-based 
preparations produced using 
high-pressure treatment  Parameter  Target  Comments  
Fruit storage before high-pressure 
treatment  Minimum 15 days at – 20 °C  Fruit harvested and stored in conjunction with good/hygienic agri ­
cultural and manufacturing practices  
Fruit added  40 % to 60 % of thawed fruit  Fruit homogenised and added to other ingredients  
pH 3,2 to 4,2  
o Brix  7 to 42  Assured by added sugars  
a w < 0,95  Assured by added sugars  
Final storage  60 days maximum at + 5 °C maximum  Equivalent to storage regimen for conventionally processed product  
Phosphated maize starch  Description/Definition:  
Phosphated maize starch (phosphated distarch phosphate) is a chemically modified resistant starch derived from high amylose sta rch by combining 
chemical treatments to create phosphate cross-links between carbohydrate residues and esterified hydroxyl groups. 
The novel food ingredient is a white or nearly white powder. 
CAS No: 11120-02-8 
Chemical formula: (C  6H 10O 5) n [(C  6H 9O 5) 2PO  2H]x [(C  6H 9O 5)PO  3H 2]y 
n = number of glucose units; x, y = degrees of substitution 
The chemical characteristics of phosphated distarch phosphate: 
Loss on drying: 10-14 % 
pH: 4,5-7,5 
Dietary fibre: ≥ 70 % 
Starch: 7-14 % 
Protein: ≤ 0,8 % 
Lipids: ≤ 0,8 % 
Residual bound phosphorus: ≤ 0,4 % (as phosphorus) ‘high amylose maize’ as sourceEN 24.7.2018 Official Journal of the European Union L 187/109
 Authorised Novel Food  Specifications  
Phosphatidylserine from fish 
phospholipids  Description/Definition:  
The novel food ingredient is yellow to brown powder. Phosphatidylserine is obtained from fish phospholipids by an enzymatic tra nsphosphorylation 
with the amino acid L-serine.  
Specification of the phosphatidylserine product manufactured from fish phospholipids:  
Moisture: < 5,0 % 
Phospholipids: ≥ 75 % 
Phosphatidylserine: ≥ 35 % 
Glycerides: < 4,0 % 
Free L-serine: < 1,0 % 
Tocopherols: < 0,5 % (1 ) 
Peroxide value (PV): < 5,0 meq O  2/kg 
(1 ) Tocopherols may be added as antioxidants according to Commission Regulation (EU) No 1129/2011  
Phosphatidylserine from soya 
phospholipids  Description/Definition:  
The novel food ingredient is off-white to light yellow powder. It is also available in liquid form with a clear brown to orange  colour. The liquid form 
contains medium chain triacylglycerides (MCT) as a carrier. It contains lower levels of Phosphatidylserine due to the fact that  it includes significant 
amounts of oil (MCT). 
Phosphatidylserine from soya phospholipids is obtained through enzymatic transphosphatidylation of high-phosphatidylcholine soy bean lecithin with 
the amino acid L-serine. Phosphatidylserine consists of a glycerophosphate skeleton conjugated with two fatty acids and L-serin e via a phosphodiester 
linkage.  
Characteristics of Phosphatidylserine from soya phospholipids: 
Powder form:  
Moisture: < 2,0 % 
Phospholipids: ≥ 85 % 
Phosphatidylserine: ≥ 61 % 
Glycerides: < 2,0 % 
free L-serine: < 1,0 % 
Tocopherols: < 0,3 % 
Phytosterols: < 0,2 %  
Liquid form:  
Moisture: < 2,0 % 
Phospholipids: ≥ 25 %EN L 187/110 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Phosphatidylserine: ≥ 20 % 
Glycerides: not applicable 
free L-serine: < 1,0 % 
Tocopherols: < 0,3 % 
Phytosterols: < 0,2 %  
Phospholipid product 
containing equal amounts of 
phosphatidylserine and 
phosphatidic acid  Description/Definition:  
The product is manufactured through enzymatic conversion of soy lecithin. The phospholipid product is a highly concentrated, ye llow-brown powder 
form of phosphatidylserine and phosphatidic acid at an equal level.  
Specification of the product:  
Moisture: ≤ 2,0 % 
Total phospholipids: ≥ 70 % 
Phosphatidylserine: ≥ 20 % 
Phosphatidic acid: ≥ 20 % 
Glycerides: ≤ 1,0 % 
Free L-serine: ≤ 1,0 % 
Tocopherols: ≤ 0,3 % 
Phytosterols: ≤ 2,0 % 
Silicon dioxide is used with a maximum content of 1,0 %  
Phospholipides from egg yolk  85 % and 100 % pure Phospholipides from egg yolk  
Phytoglycogen  Description:  White to off-white powder which is an odourless, colourless, flavourless polysaccharide derived from non-GM sweet corn using 
conventional food processing techniques  
Definition:  Glucose polymer (C  6H 12O 6)n with linear linkages of α(1 – 4) glycosidic bonds branched every 8 to 12 glucose units by α(1 – 6) 
glycosidic bonds  
Specifications:  
Carbohydrates: 97 % 
Sugars: 0,5 % 
Fibre: 0,8 % 
Fat: 0,2 % 
Protein: 0,6 %EN 24.7.2018 Official Journal of the European Union L 187/111
 Authorised Novel Food  Specifications  
Phytosterols/phytostanols  Description/Definition:  
Phytosterols and phytostanols are sterols and stanols that are extracted from plants and may be presented as free sterols and s tanols or esterified with 
food grade fatty acids.  
Composition  (with GC-FID or equivalent method): 
β-sitosterol: < 81 % 
β-sitostanol: < 35 % 
campesterol: < 40 % 
campestanol: < 15 % 
stigmasterol: < 30 % 
brassicasterol: < 3,0 % 
other sterols/stanols: < 3,0 %  
Contamination/Purity  (GC-FID or equivalent method): 
Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of contaminants , best ensured by a 
purity of more than 99 % of the phytosterol/phytostanol ingredient.  
Plum kernel oil  Description/Definition:  
Plum kernel oil is a vegetable oil obtained by cold pressing of plum ( Prunus domestica ) kernels.  
Composition:  
Oleic acid (C18:1): 68 % 
Linoleic acid (C18:2): 23 % 
γ-Tocopherol:80 % of total tocopherols 
β-Sitosterol: 80-90 % of total sterols 
Triolein: 40-55 % of triglycerides 
Cyanhydric acid: maximum 5 mg/kg oil  
Potato proteins (coagulated) 
and hydrolysates thereof  Dry substance: ≥ 800 mg/g 
Protein (N * 6,25): ≥ 600 mg/g (dry substance) 
Ash: ≤ 400 mg/g (dry substance) 
Glycoalkaloid (total): ≤ 150 mg/kg 
Lysinoalanine (total): ≤ 500 mg/kg 
Lysinoalanine (free): ≤ 10 mg/kgEN L 187/112 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Prolyl oligopeptidase (enzyme 
preparation)  Specification of the enzyme:  
Systematic name: Prolyl oligopeptidase 
Synonyms: Prolyl endopeptidase, proline-specific endopeptidase, endoprolylpeptidase 
Molecular weight: 66 kDa 
Enzyme Commission number: EC 3.4.21.26 
CAS number: 72162-84-6 
Source: A genetically modified strain of  Aspergillus niger  (GEP-44)  
Description:  Prolyl oligopeptidase is available as an enzyme preparation containing approximately 30 % maltodextrin.  
Specifications of the enzyme preparation of prolyl oligopeptidase:  
Activity: > 580 000 PPI(1 )/g (> 34,8 PPU(2 )/g) 
Appearance: Microgranulate 
Colour: Off-white to orange yellowish. The colour may change from batch to batch 
Dry Matter: > 94 % 
Gluten: < 20 ppm  
Heavy metals:  
Lead: ≤ 1,0 mg/kg 
Arsenic: ≤ 1,0 mg/kg 
Cadmium: ≤ 0,5 mg/kg 
Mercury: ≤ 0,1 mg/kg  
Microbiological criteria:  
Total aerobic plate count: ≤ 103 CFU/g 
Total yeasts and moulds: ≤ 102 CFU/g 
Sulphite reducing anaerobes: ≤ 30 CFU/g  
Enterobacteriaceae : < 10 CFU/g  
Salmonella : Absence in 25 g  
Escherichia coli : Absence in 25 g  
Staphylococcus aureus : Absence in 10 g  
Pseudomonas aeruginosa : Absence in 10 g  
Listeria monocytogenes : Absence in 25 g 
Antimicrobial activity: AbsentEN 24.7.2018 Official Journal of the European Union L 187/113
 Authorised Novel Food  Specifications  
Mycotoxins: Below limits of detection: Aflatoxin B1, B2, G1, G2 (< 0,25 μg/kg), total Aflatoxins (< 2,0 μg/kg), Ochratoxin A (< 0,20 μg/kg), T-2 
Toxin (< 5 μg/kg), Zearalenone (< 2,5 μg/kg), Fumonisin B1 and B2 (< 2,5 μg/kg)  
(1 ) PPI – Protease Picomole International 
(2 ) PPU – Prolyl Peptidase Units or Proline Protease Units  
Protein extract from pig 
kidneys  Description/Definition:  
The protein extract is obtained from homogenised pig kidneys through a combination of salt precipitation and high speed centrif ugation. The 
obtained precipitate contains essentially proteins with 7 % of the enzyme diamine oxidase (enzyme nomenclature E.C. 1.4.3.22) a nd is resuspended in 
a physiologic buffer system. The obtained pig kidney extract is formulated as encapsulated enteric coated pellets to reach the active sites of digestion. 
Basic Product: 
Specification: pig kidney protein excerpt with natural content of Diamin oxidase (DAO): 
Physical condition: liquid 
Colour: brownish 
Appearance: slightly turbid solution 
pH value: 6,4-6,8 
Enzymatic activity: > 2 677 kHDU DAO/ml (DAO REA (DAO Radioextractionassay))  
Microbiological criteria:  
Brachyspira  spp.: negative (Real Time PCR)  
Listeria monocytogenes : negative (Real Time PCR)  
Staphylococcus aureus : < 100 CFU/g 
Influenza A: negative (Reverse Transcription Real Time PCR)  
Escherichia coli : < 10 CFU/g 
Total aerobic microbiological count: < 105 CFU/g 
Yeasts/moulds count: < 105 CFU/g  
Salmonella : Absence/10g 
Bile salt resistant enterobacteriaceae: < 104 CFU/g  
Final product:  
Specification pig kidney protein excerpt with natural content of DAO (E.C. 1.4.3.22) in an enteric coated formulation: 
Physical condition: solid 
Colour: yellow grayEN L 187/114 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Appearance: micropellets 
Enzymatic activity: 110-220 kHDU DAO/g pellet (DAO REA (DAO Radioextractionassay)) 
Acid stability 15 min 0,1M HCl followed by 60 min Borat pH = 9,0: > 68 kHDU DAO/g pellet (DAO REA (DAO Radioextractionassay)) 
Humidity: < 10 %  
Staphylococcus aureus : < 100 CFU/g  
Escherichia coli : < 10 CFU/g 
Total aerobic microbiological count: < 104 CFU/g 
Total combined yeasts/moulds count: < 103 CFU/g  
Salmonella : Absence/10g 
Bile salt resistant enterobacteriaceae: < 102 CFU/g  
Rapeseed oil high in 
unsaponifiable matter  Description/Definition:  
Rapeseed oil high in unsaponifiable matter’ is produced by vacuum distillation and it is different from refined rapeseed oil in  the concentration of the 
unsaponifiable fraction (1 g in refined rapeseed oil and 9 g in ‘rapeseed oil high in unsaponifiable matter’). There is a minor  reduction of triglycerides 
containing monounsaturated and polyunsaturated fatty acids.  
Purity:  
Unsaponifiable matter: > 7,0 g/100 g 
Tocopherols: > 0,8 g/100 g 
α-tocopherol (%): 30-50 % 
γ-tocopherol (%): 50-70 % 
δ-tocopherol (%): < 6,0 % 
Sterols, triterpenic alcohols, methylsterols: > 5,0 g/100 g  
Fatty acids in triglycerides:  
palmitic acid: 3-8 % 
stearic acid: 0,8-2,5 % 
oleic acid: 50-70 % 
linoleic acid: 15-28 % 
linolenic acid: 6-14 % 
erucic acid: < 2,0 % 
Acid value: ≤ 6,0 mg KOH/g 
Peroxide value (PV): ≤ 10 mEq O  2/kgEN 24.7.2018 Official Journal of the European Union L 187/115
 Authorised Novel Food  Specifications  
Heavy metals:  
Iron (Fe): < 1 000 μg/kg 
Copper (Cu): < 100 μg/kg  
Impurities:  
Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 μg/kg 
Treatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons (PAH) are not enriched in the producti on of ‘rapeseed oil 
high in unsaponifiable matter.  
Rapeseed Protein  Definition:  
Rapeseed protein is an aqueous protein-rich extract from rapeseed press cake originating from non-genetically modified  Brassica napus  L. and  Brassica 
rapa  L. 
Description:  
White to off-white, spray dried powder 
Total protein: ≥ 90 % 
Soluble protein: ≥ 85 % 
Moisture: ≤ 7,0 % 
Carbohydrates: ≤ 7,0 % 
Fat: ≤ 2,0 % 
Ash: ≤ 4,0 % 
Fibre: ≤ 0,5 % 
Total glucosinolates: ≤ 1 mmol/kg  
Purity:  
Total phytate: ≤ 1,5 % 
Lead: ≤ 0,5 mg/kg  
Microbiological criteria:  
Yeast and mould count: ≤ 100 CFU/g 
Aerobic bacteria count: ≤ 10 000 CFU/g 
Total coliform count: ≤ 10 CFU/g  
Escherichia coli:  Absence in 10 g  
Salmonella : Absence in 25 gEN L 187/116 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Trans-resveratrol  Description/Definition: 
Synthetic  Trans -resveratrol is off-white to beige crystals. 
Chemical name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol 
Chemical formula: C  14H 12O 3 
Molecular weight: 228,25 Da 
CAS No: 501-36-0  
Purity:  
Trans -resveratrol: ≥ 98 %-99 % 
Total by-products (related substances): ≤ 0,5 % 
Any single related substance: ≤ 0,1 % 
Sulphated ash: ≤ 0,1 % 
Loss on drying: ≤ 0,5 %  
Heavy metals:  
Lead: ≤ 1,0 ppm 
Mercury: ≤ 0,1 ppm 
Arsenic: ≤ 1,0 ppm  
Impurities:  
Diisopropylamine: ≤ 50 mg/kg  
Microbial source : A genetically modified strain of  Saccharomyces cerevisiae  
Appearance: Off-white to slight yellow powder 
Particle size: 100 % less than 62,23 μm 
Trans-resveratrol content: Min. 98 % w/w (dry weight basis) 
Ash: Max. 0,5 % w/w 
Moisture: Max. 3 % w/w  
Rooster comb extract  Description/Definition:  
Rooster comb extract is obtained from  Gallus gallus  by enzymatic hydrolysis of rooster comb and by subsequent filtration, concentration and 
precipitation steps. The principal constituents of rooster comb extract are the glycosaminoglycans hyaluronic acid, chondroitin  sulphate A and 
dermatan sulphate (chondroitin sulphate B). White or almost white hygroscopic powder. 
Hyaluronic acid: 60-80 % 
Chondroitin sulphate A: ≤ 5,0 %EN 24.7.2018 Official Journal of the European Union L 187/117
 Authorised Novel Food  Specifications  
Dermatan sulphate (chondroitin sulphate B): ≤ 25 % 
pH: 5,0-8,5  
Purity:  
Chlorides: ≤ 1,0 % 
Nitrogen: ≤ 8,0 % 
Loss on drying: (105 °C for 6 hours): ≤ 10 %  
Heavy metals:  
Mercury: ≤ 0,1 mg/kg 
Arsenic: ≤ 1,0 mg/kg 
Cadmium: ≤ 1,0 mg/kg 
Chromium: ≤ 10 mg/kg 
Lead: ≤ 0,5 mg/kg  
Microbiological criteria:  
Total viable aerobic count: ≤ 102 CFU/g  
Escherichia coli : Absence in 1 g  
Salmonella : Absence in 1 g  
Staphylococcus aureus : Absence in 1 g  
Pseudomonas aeruginosa : Absence in 1g  
Sacha Inchi oil from  Plukenetia 
volubilis  Description/Definition:  
Sacha inchi oil is a 100 % cold pressed vegetable oil obtained from the seeds of  Plukenetia volubiis  L. It is a transparent, fluid (liquid) and shiny oil at 
room temperature. It has a fruity, light, green vegetable taste without undesirable flavours. 
Aspect, limpidity, shine, colour: Fluid at room temperature, clean, shiny yellow gold 
Odour and taste: Fruity, vegetable without non acceptable taste or odour  
Purity:  
Water and Volatiles: < 0,2 g/100 g 
Impurities insoluble in hexane: < 0,05 g/100 g 
Oleic acidity: < 2,0 g/100 g 
Peroxide value (PV): < 15 meq O  2/kg 
Trans fatty acids: < 1,0 g/100 g 
Total unsaturated fatty acids: > 90 %EN L 187/118 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Omega 3 alpha linolenic acid (ALA): > 45 % 
Saturated fatty acids: < 10 % 
No trans fatty acids (< 0,5 %) 
No erucic acid (< 0,2 %) 
More than 50 % of tri-linolenin and di-linolenin-triglycerides 
Phytosterols composition and level 
No cholesterol (< 5,0 mg/100 g)  
Salatrims  Description/Definition:  
Salatrim is the internationally recognised acronym for (short and long chain acyl triglyceride molecules). Salatrim is prepared  by non-enzymatic inter- 
esterification of triacetin, tripropionin, tributyrin, or their mixtures with hydrogenated canola, soybean, cottonseed, or sunf lower oil. Description: 
Clear, slightly amber liquid to a light coloured waxy solid at room temperature. Free of particulate matter and of foreign or r ancid odour. 
Glycerol ester disribution: 
Triacylglycerols: > 87 % 
Diacylglycerols: ≤ 10 % 
Monoacylglycerols: ≤ 2,0 % 
Fatty acid composition: 
MOLE % LCFA (long chain fatty acids): 33-70 % 
MOLE % SCFA (short chain fatty acids): 30-67 % 
Saturated long chain fatty acids: < 70 % by weight 
Trans fatty acids: ≤ 1,0 % 
Free fatty acids as oleic acid: ≤ 0,5 % 
Triacylglycerol profile: 
Triesters (short/long of 0,5 to 2,0): ≥ 90 % 
Triesters (short/long = 0): ≤ 10 % 
Unsaponifiable material: ≤ 1,0 % 
Moisture: ≤ 0,3 % 
Ash: ≤ 0,1 % 
Colour: ≤ 3,5 Red (Lovibond) 
Peroxide value (PV): ≤ 2,0 Meq/KgEN 24.7.2018 Official Journal of the European Union L 187/119
 Authorised Novel Food  Specifications  
Schizochytrium sp.  oil rich in 
DHA and EPA  Acid value: ≤ 0,5 mg KOH/g 
Peroxide value (PV): ≤ 5,0 meq/kg oil 
Oxidative stability: All food products containing  Schizochytrium sp.  oil rich in DHA and EPA should demonstrate oxidative stability by appropriate and 
recognised national/international test methodology (e.g. AOAC) 
Moisture and volatiles: ≤ 0,05 % 
Unsaponifiables: ≤ 4,5 % 
Trans-fatty acids: ≤ 1 % 
DHA content: ≥ 22,5 % 
EPA content: ≥ 10 %  
Schizochytrium  sp. (ATCC PTA- 
9695) oil  Peroxide value (PV): ≤ 5,0 meq/kg oil 
Unsaponifiables: ≤ 3,5 % 
Trans-fatty acids: ≤ 2,0 % 
Free fatty acids: ≤ 0,4 % 
Docosapentaenoic acid (DPA) n-6: ≤ 7,5 % 
DHA content: ≥ 35 %  
Schizochytrium  sp. oil  Acid value: ≤ 0,5 mg KOH/g 
Peroxide value (PV): ≤ 5,0 meq/kg oil 
Moisture and volatiles: ≤ 0,05 % 
Unsaponifiables: ≤ 4,5 % 
Trans-fatty acids: ≤ 1,0 % 
DHA content: ≥ 32,0 %  
Schizochytrium  sp. (T18) oil  Acid value: ≤ 0,5 mg KOH/g 
Peroxide value (PV): ≤ 5,0 meq/kg oil 
Moisture and volatiles: ≤ 0,05 % 
Unsaponifiables: ≤ 3,5 % 
Trans-fatty acids: ≤ 2,0 % 
Free fatty acids: ≤ 0,4 % 
DHA content: ≥ 35 %EN L 187/120 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Fermented soybean extract  Description/Definition:  
Fermented soybean extract is an odourless milk-white coloured powder. It is comprised of 30 % fermented soybean extract powder and 70 % 
resistant dextrin (as carrier) from corn-starch, which is added during the processing. Vitamin K  2 is removed during the manufacturing process. 
Fermented soybean extract contains nattokinase isolated from natto, a foodstuff produced by the fermentation of non-genetically  modified soybeans 
(Glycine max  (L.)) with a selected strain of  Bacillus subtilis  var. natto. 
Nattokinase activity: 20 000 -28 000 Fibrin degradation unit/g(1 ) 
Identity: Confirmable 
Condition: No offensive taste or smell 
Loss on drying: ≤ 10 % 
Vitamin K  2: ≤ 0,1 mg/kg  
Heavy metals:  
Lead: ≤ 5,0 mg/kg 
Arsenic: ≤ 3,0 mg/kg  
Microbiological criteria:  
Total viable aerobic count: ≤ 103 CFU(3 )/g 
Yeast and mould: ≤ 102 CFU/g 
Coliforms: ≤ 30 CFU/g 
Spore-forming bacteria: ≤ 10 CFU/g  
Escherichia coli : Absence/25 g  
Salmonella : Absence/25 g  
Listeria : Absence/25 g  
(1 ) Assay method as described by Takaoka et al. (2010).  
Spermidine-rich wheat germ 
extract ( Triticum aestivum ) Description/Definition:  
Spermidine-rich wheat germ extract is obtained from non-fermented, non-sprouting wheat germs ( Triticum aestivum ) by the process of solid-liquid 
extraction targeting specifically, but not exclusively polyamines. 
Spermidine: 0,8-2,4 mg/g 
Spermine: 0,4-1,2 mg/g 
Spermidine trichloride < 0,1 μg/gEN 24.7.2018 Official Journal of the European Union L 187/121
 Authorised Novel Food  Specifications  
Putrescine: < 0,3 mg/g 
Cadaverine: < 0,1 μg/g 
Mycotoxins:  
Aflatoxins (total): < 0,4 μg/kg  
Microbiological criteria:  
Total aerobic bacteria: < 10 000 CFU/g 
Yeast and moulds: < 100 CFU/g  
Escherichia coli:  < 10 CFU/g  
Salmonella:  Absence/25g  
Listeria monocytogenes:  Absence/25g  
Sucromalt  Description/Definition:  
Sucromalt is a complex mixture of saccharides which is produced from sucrose and a starch hydrolysate by means of an enzymatic reaction. In this 
process, glucose units are attached to saccharides from the starch hydrolysate by means of an enzyme produced by the bacterium  Leuconostoc citreum  
or by means of a recombinant strain of the production organism  Bacillus licheniformis . The resulting oligosaccharides are characterised by the presence 
of α-(1 →6) and α-(l →3) glycosidic compounds. The overall product is syrup, in addition to these oligosaccharides, contains mainly fructose but also  
the disaccharide leucrose and other disaccharides. 
Total solids: 75-80 % 
Moisture: 20-25 % 
Sulphatase: Max 0,05 % 
pH: 3,5-6,0 
Conductivity < 200 (30 %) 
Nitrogen < 10 ppm 
Fructose: 35-45 % d.w. 
Leucrose: 7-15 % d.w. 
Other disaccharides: M ах 3 % 
Higher saccharides: 40-60 % d.w  
Sugar cane fibre  Description/Definition:  
Sugar Cane Fibre is derived from the dry cell wall or fibrous residue remaining after expression or extraction of sugar juice f rom sugar cane, of the 
Saccharum genotype. It consists primarily of cellulose and hemicellulose. 
The production process consists of several steps, including: chipping, alkaline digestion, removal of lignins and other non-cel lulosic components, 
bleaching of purified fibres, acid washing and neutralization.EN L 187/122 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Moisture: ≤ 7,0 % 
Ash: ≤ 0,3 % 
Total Dietary Fibre (AOAC) dry basis (all insoluble): ≥ 95 % 
of which: Hemicellulose (20-25 %) and cellulose (70-75 %) 
Silica (ppm): ≤ 200 
Protein: 0,0 % 
Fat: Trace 
pH: 4-7  
Heavy metals:  
Mercury (ppm): ≤ 0,1 
Lead (ppm): ≤ 1,0 
Arsenic (ppm): ≤ 1,0 
Cadmium (ppm): ≤ 0,1  
Microbiological criteria:  
Yeast and moulds (CFU/g): ≤ 1 000  
Salmonella : Absence  
Listeria monocytogenes : Absence  
Sunflower oil extract  Description/Definition:  
The sunflower extract is obtained by a concentration factor of 10 of the unsaponifiable fraction of refined sunflower oil extra cted from the seeds of 
the sunflower,  Helianthus Annuus  L. 
Composition:  
Oleic acid (C18:1): 20 % 
Linoleic acid (C18:2): 70 % 
Unsaponifiable matter: 8,0 % 
Phytosterols: 5,5 % 
Tocopherols: 1,1 %  
Dried  Tetraselmis chuii  
microalgae  Description/Definition:  
The dried product is obtained from the marine microalgae  Tetraselmis chuii , belonging to the  Chlorodendraceae  family, cultivated in sterile sea water in 
closed photobioreactors insulated from the outside air.EN 24.7.2018 Official Journal of the European Union L 187/123
 Authorised Novel Food  Specifications  
Purity/Composition:  
Identified by means of nuclear marker rDNA 18 S (sequence analysed no less than 1 600 base pairs) in the National Centre for Bi otechnology 
information (NCBI) database: Not less than 99,9 % 
Humidity: ≤ 7,0 % 
Proteins: 35-40 % 
Ashes: 14-16 % 
Carbohydrates: 30-32 % 
Fibre: 2-3 % 
Fat: 5-8 % 
Saturated fatty acids: 29-31 % of total fatty acids 
Monounsaturated fatty acids: 21-24 % of total fatty acids 
Polyunsaturated fatty acids: 44-49 % of total fatty acids 
Iodine: ≤ 15 mg/kg  
Therapon barcoo /Scortum  Description/Definition:  
Scortum/ Therapon barcoo  is a species of fish in the family Terapontidae. It is an endemic fresh water species from Australia. It is now reared in fish  
farms. 
Taxonomic Identification: Class: Actinopterygii > order: Perciformes > family: Terapontidae > genus:  Therapon  or Scortum barcoo  
Composition of fish flesh: 
Protein (%): 18-25 
Moisture (%): 65-75 
Ash (%): 0,5-2,0 
Energy (KJ/Kg): 6000-11500 
Carbohydrates (%): 0,0 
Fat (%): 5-15 
Fatty acids (mg FA/g fillet): 
Σ PUFA n-3: 1,2-20,0 
Σ PUFA n-6: 0,3-2,0 
PUFA n-3/n-6: 1,5-15,0 
Total omega 3 acids: 1,6-40,0 
Total omega 6 acids: 2,6-10,0EN L 187/124 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
D-Tagatose  Description/Definition:  
Tagatose is produced by isomerization of galactose by means of chemical or enzymatic conversion, or by epimerization of fructos e by means of 
enzymatic conversion. These are single-step conversions. 
Appearance: White or almost white crystals 
Chemical name: D-tagatose 
Synonym: D- lyxo-Hexulose 
CAS number: 87-81-0 
Chemical formula: C  6H 12O 6 
Formula weight: 180,16 (g/mol)  
Purity:  
Assay: ≥ 98 % on a dry weight basis 
Loss on drying: ≤ 0,5 % (102 °C, 2 hours) 
Specific Rotation: [ α] D20 : – 4 to – 5,6o (1 % aqueous solution)(1 ) 
Melting range: 133– 137 °C  
Heavy metals:  
Lead: ≤ 1,0 mg/kg(*)  
(*) Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on 
the principles of the method described in FNP 5. ‘Instrumental methods’(1 ). 
(1 ) Food and nutrition paper 5 Rev 2 – Guide to specifications for general notices, general analytical techniques, identification  tests, test solutions and other reference 
materials (JECFA) 1991, 307 p.; English – ISBN 92-5-102991-1  
Taxifolin-rich extract  Description:  
Taxifolin-rich extract from the wood of Dahurian Larch ( Larix gmelinii  (Rupr.) Rupr) is a white to pale-yellow powder that crystallizes from hot 
aqueous solutions.  
Definition:  
Chemical name: [(2R,3R)-2-(3,4 dihydroxyphenyl)-3,5,7-trihydroxy-2,3-dihydrochromen-4-one, also called (+) trans (2R,3R)- dihyd roquercetin] 
Chemical formula: C  15H 12O 7 
Molecular mass: 304,25 Da 
CAS No: 480-18-2  
Specifications:  
Physical parameter  
Moisture: ≤ 10 %EN 24.7.2018 Official Journal of the European Union L 187/125
 Authorised Novel Food  Specifications  
Compound analysis  
Taxifolin (m/m): ≥ 90,0 % of the dry weight  
Heavy Metals, Pesticide  
Lead: ≤ 0,5 mg/kg 
Arsenic: ≤ 0,02 mg/kg 
Cadmium: ≤ 0,5 mg/kg 
Mercury: ≤ 0,1 mg/kg 
Dichlorodiphenyltrichloroethane (DDT): ≤ 0,05 mg/kg  
Residual solvents  
Ethanol: < 5 000 mg/kg  
Microbiological criteria  
Total Plate Count (TPC): ≤ 104 CFU/g 
Enterobacteria: ≤ 100/g 
Yeast and Mould : ≤ 100 CFU/g  
Escherichia coli : Absence/1 g  
Salmonella : Absence/10 g  
Staphylococcus aureus : Absence/1 g  
Pseudomonas : Absence/1g  
Usual range of components of the Taxifolin-rich extract (as per dry substance)  
Extract component  Content, usual observed range (%)  
Taxifolin  90 – 93  
Aromadendrin  2,5 – 3,5  
Eriodictyol  0,1 – 0,3  
Quercetin  0,3 – 0,5  
Naringenin  0,2 – 0,3  
Kaempferol  0,01 – 0,1  
Pinocembrin  0,05 – 0,12  
Unidentified flavonoids  1 – 3  
Water(*)  1,5  
(*) Taxifolin in its hydrated form and during the drying process is a crystal. This results on the inclusion of water of crysta llisation in a quantity of 1,5 %.EN L 187/126 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Trehalose  Description/Definition:  
A non-reducing disaccharide that consists of two glucose moieties linkes by an α-1,1-glucosidic bond. It is obtained from liquefied starch or from 
sucrose by a multistep enzymatic process. The commercial product is the dihydrate. Virtually odourless, white or almost white c rystals with a sweet 
taste 
Synonyms: α,α-trehalose 
Chemical name: α-D-glucopyranosyl- α-D-glucopyranoside, dihydrate 
CAS No.: 6138-23-4 (dihydrate) 
Chemical formula: C  12H 22O 11 · 2H  2O (dihydrate) 
Formula weight: 378,33 (dihydrate) 
Assay: ≥ 98 % on the dry basis 
Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of s ample preparation 
may be based on the principles of the method described in FNP 5 (1), ‘Instrumental methods’  
Method of assay:  
Principle: trehalose is identified by liquid chromatography and quantified by comparison to a reference standard containing sta ndard trehalose 
Preparation of sample solution: weigh accurately about 3 g of dry sample into a 100 ml volumetric flask and add about 80 ml of purified, deionised 
water. Bring sample to complete dissolution and dilute to mark with purified deionised water. Filter through a 0,45 micron filt er 
Preparation of standard solution: dissolve accurately weighed quantities of dry standard reference trehalose in water to obtain  a solution having 
known concentration of about 30 mg of trehalose per ml. 
Apparatus: liquid chromatography equipped with a refractive index detector and integrating recorder 
Conditions: 
Column: Shodex Ionpack KS-801 (Showa Denko Co.) or equivalent 
— length: 300 mm 
— diameter: 10 mm 
— temperature: 50 °C 
Mobile phase: water 
flow rate: 0,4 ml/min 
Injection volume: 8 μl 
Procedure: inject separately equal volumes of the sample solution and the standard solution into the chromatograph. 
Record the chromatograms and measure the size of response of the trehalose peak 
Calculate the quantity, in mg, of trehalose in 1 ml of the sample solution by the following formula:EN 24.7.2018 Official Journal of the European Union L 187/127
 Authorised Novel Food  Specifications  
% trehalose = 100 × (R  U/R S) (W  S/W  U) 
where 
R S = peak area of trehalose in the standard preparation 
R U = peak area of trehalose in the sample preparation 
W S = weight in mg of trehalose in the standard preparation 
W U = weight of dry sample in mg  
Characteristics:  
Identification: 
Solubility: Freely soluble in water, very slightly soluble in ethanol 
Specific rotation: [ α] D20 = +179o (5 % aqueous solution, dihydrate), +199o (5 % aqueous solution, anhydrous substance) 
Melting point: 97 °C (dihydrate)  
Purity:  
Loss on drying: ≤ 1,5 % (60 °C, 5h) 
Total ash: ≤ 0,05 %  
Heavy metals:  
Lead: ≤ 1,0 mg/kg  
UV treated mushrooms 
(Agaricus bisporus ) Description/Definition:  
Commercially grown  Agaricus bisporus  to which UV light treatment is applied to harvested mushrooms. 
UV radiation: a process of radiation in ultraviolet light within the wavelength of 200-800 nm.  
Vitamin D  2: 
Chemical name: (3 β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol 
Synonym: Ergocalciferol 
CAS No: 50-14-6 
Molecular weight: 396,65 g/mol  
Contents:  
Vitamin D  2 in the final product: 5-10 μg/100 g fresh weight at the expiration of shelf life  
UV-treated baker’s yeast 
(Saccharomyces cerevisiae ) Description/Definition:  
Baker’s yeast ( Saccharomyces cerevisiae ) is treated with ultraviolet light to induce the conversion of ergosterol to vitamin D  2 (ergocalciferol). Vitamin D  2 
content in the yeast concentrate varies between 1 800 000-3 500 000 IU vitamin D/100 g (450-875 μg/g). 
Tan-coloured, free-flowing granulesEN L 187/128 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Vitamin D  2: 
Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol 
Synonym: Ergocalciferol 
CAS No.: 50-14-6 
Molecular weight: 396,65 g/mol  
Microbiological criteria for the yeast concentrate:  
Coliforms: ≤ 103 /g 
Escherichia coli : ≤ 10/g  
Salmonella : Absence in 25g  
UV-treated bread  Description/Definition:  
UV-treated bread is yeast leavened bread and rolls (without toppings) to which a treatment with ultraviolet radiation is applie d after baking in order 
to convert ergosterol to vitamin D  2 (ergocalciferol). 
UV radiation: A process of radiation in ultraviolet light within the wavelength of 240-315 nm for maximum of 5 seconds with ene rgy input of 
10-50 mJ/cm2 . 
Vitamin D  2: 
Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol 
Synonym: Ergocalciferol 
CAS No: 50-14-6 
Molecular weight: 396,65 g/mol  
Contents:  
Vitamin D  2 (ergocalciferol) in the final product: 0,75-3 μg/100 g(1 ) 
Yeast in dough: 1-5 g/100 g (2 ) 
(1 ) EN 12821, 2009, European Standard. 
(2 ) Recipe calculation.  
UV-treated milk  Description/Definition:  
UV-treated milk is cow’s milk (whole and semi-skimmed) to which a treatment with ultraviolet (UV) radiation via turbulent flow is applied after 
pasteurisation. The treatment of the pasteurised milk with UV radiation results in an increase in the vitamin D  3 (cholecalciferol) concentrations by 
conversion of 7-dehydrocholesterol to vitamin D  3. 
UV radiation: A process of radiation in ultraviolet light within the wavelength of 200-310 nm with energy input of 1 045 J/l.EN 24.7.2018 Official Journal of the European Union L 187/129
 Authorised Novel Food  Specifications  
Vitamin D  3: 
Chemical name: (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene ]ethylidene]-4- 
methylidenecyclohexan-1-ol 
Synonym: Cholecalciferol 
CAS No: 67-97-0 
Molecular weight: 384,6377 g/mol  
Contents:  
Vitamin D  3 in the final product: 
Whole milk(1 )0,5-3,2 μg/100 g(2 ) 
Semi-skimmed milk(1): 0,1–1,5 μg/100 g(2 ) 
(1 ) As defined by Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a c ommon organisation of the 
markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC)  No 1234/2007 (OJ L 347, 
20.12.2013, p. 671). 
(2 ) HPLC  
Vitamin K  2 (menaquinone)  This novel food is produced by a synthetic or microbiological process.Vitamin K  2 (2-methyl-3-all-trans-polyprenyl-1,4-naphthoquinones), or the 
menaquinone series, is a group of prenylated naphthoquinone derivatives. The number of isoprene residues, where 1 isoprene unit  consists of 5 
carbons comprising the side chain, is used to characterise the menaquinone homologues containing primarily MK-7 and to a smalle r extent MK-6. 
Vitamin K  2 (menaquinones) series with menaquinone-7 (MK-7)(n = 6) being C  46H 64O 2, menaquinone-6 (MK-6)(n = 5) being C  41H 56O 2 and 
menaquinone-4 (MK-4)(n = 3) being C  31H 40O 2. 
Chemical Name: (all-E)-2-(3,7,11,15,19,23,27-Heptamethyl-2,6,10,14,18,22,26-octacosaheptaenyl)-3-methyl-1,4-naphtalenedione 
CAS Number: 2124-57-4 
Molecular formula: C  46H 64O 2 
Molecular weight: 649 g/mol
EN L 187/130 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Specification of synthetic Vitamin K  2 (menaquinone-7)  
Appearance: Yellow powder 
Purity: Max 6,0 % cis-isomer, max 2,0 % other impurities 
Content: 97-102 % Menaquinone-7 (including at least 92 % all-trans Menaquinone-7)  
Specifications of microbiologically produced Vitamin K  2 (menaquinone-7)  
Source:  Bacillus subtilis  spp. natto and  Bacillus licheniformis  
Appearance: Yellow powder or oil suspension  
Wheat bran extract  Description/Definition:  
White crystalline powder obtained by enzymatic extraction from  Triticum aestivum  L. bran, rich in arabinoxylan oligosaccharides 
Dry matter: Min. 94 % 
Arabinoxylan oligosaccharides: Min 70 % of dry matter 
Average degree of polymerisation of arabinoxylan oligosaccharides: 3-8 
Ferulic acid (bound to arabinoxylan oligosaccharides): 1-3 % of dry matter 
Total poly/oligosaccharides: Min 90 % 
Protein: Max 2 % of dry matter 
Ash: Max 2 % of dry matter  
Microbiological parameters:  
Mesophilic bacteria – total count: Max 10 000/g 
Yeasts: Max 100/g 
Fungi: Max 100/g  
Salmonella : Absence in 25g  
Bacillus cereus : Max 1000/g  
Clostridium perfringens : Max 1000/g  
Yeast beta-glucans  Description/Definition:  
Beta-glucans are complex, high molecular mass (100–200 kDa) polysaccharides, found in the cell wall of many yeasts and cereals.  
The chemical name for ‘yeast beta-glucans’ is (1-3),(1-6)-ß-D-glucans. 
Beta-glucans consist of a backbone of ß-1-3-linked glucose residues that are branched by ß-1-6-linkages, to which chitin and ma nnoproteins are 
linked by ß-1-4-bonds.EN 24.7.2018 Official Journal of the European Union L 187/131
 Authorised Novel Food  Specifications  
Beta-glucans are isolated from yeast  Saccharomyces cerevisiae . 
The tertiary structure of the glucan cell wall of  Saccharomyces cerevisiae  consists of chains of ß-1,3-linked glucose residues, branched by ß-1,6-linkages, 
forming a backbone to which are linked chitin via ß-1,4- bonds, ß-1,6-glucans and some mannoproteins. 
This novel food is available in three different forms: soluble, insoluble and insoluble in water, but dispersible in many liqui d matrices.  
Chemical characteristics yeast ( Saccharomyces cerevisiae ) beta-glucans: 
Soluble form:  
Total carbohydrates: > 75 % 
Beta-glucans (1,3/1,6): > 75 % 
Ash: < 4,0 % 
Moisture: < 8,0 % 
Protein: < 3,5 % 
Fat: < 10 %  
Insoluble form:  
Total carbohydrates: > 70 % 
Beta-glucans (1,3/1,6): > 70 % 
Ash: ≤ 12 % 
Moisture: < 8,0 % 
Protein: < 10 % 
Fat: < 20 %  
Insoluble in water, but dispersible in many liquid matrices:  
(1,3)-(1,6)-ß-D-Glucans: > 80 % 
Ash: < 2,0 % 
Moisture: < 6,0 % 
Protein: < 4,0 % 
Total fat: < 3,0 %  
Microbiological data for insoluble in water, but dispersible in many liquid matrices:  
Total plate count: < 1 000 CFU/g 
Enterobacteriaceae: < 100 CFU/g 
Total coliforms: < 10 CFU/g 
Yeast: < 25 CFU/gEN L 187/132 Official Journal of the European Union 24.7.2018
 Authorised Novel Food  Specifications  
Mould: < 25 CFU/g  
Salmonella : Absence in 25 g  
Escherichia coli : Absence in 1 g  
Bacillus cereus : < 100 CFU/g  
Staphylococcus aureus : Absence in 1 g  
Heavy metals for insoluble in water, but dispersible in many liquid matrices:  
Lead: < 0,2 mg/g 
Arsenic: < 0,2 mg/g 
Mercury: < 0,1 mg/g 
Cadmium: < 0,1 mg/g  
Zeaxanthin  Description/Definition:  
Zeaxanthin is a naturally occurring xanthophyll pigment, it is an oxygenated carotenoid. 
The synthetic zeaxanthin is presented either as a spray-dried powder of gelatin or starch base (‘beadlets’) with added α-tocopherol and ascorbyl 
palmitate or as a corn oil suspension with added α-tocopherol. Synthetic zeaxanthin is produced by a multi-step chemical synthesis from smaller 
molecules. 
Orange-red crystalline powder with little or no odour. 
Chemical formula: C  40H 56O 2 
CAS No: 144-68-3 
Molecular weight: 568,9 daltons  
Physical-chemical properties:  
Loss on drying: < 0,2 %  
All-trans zeaxanthin: > 96 % 
Cis-zeaxanthin: < 2,0 % 
Other carotenoids: < 1,5 % 
Triphenylphosphine oxid (CAS No 791-28-6): < 50 mg/kg  
Zinc L-pidolate  Description/Definition:  
Zinc L-pidolate is a white to off-white powder, with characteristic odour. 
International non-proprietary name (INN): L-pyroglutamic acid, Zinc saltEN 24.7.2018 Official Journal of the European Union L 187/133
 Authorised Novel Food  Specifications  
Synonyms: Zinc 5-oxoproline, Zinc pyroglutamate, Zinc pyrrolidone carboxylate, Zinc PCA, L-Zinc pidolate 
CAS No.: 15454-75-8 
Molecular formula: (C  5 H 6 NO  3) 2 Zn 
Relative anhydrous molecular mass: 321,4 
Appearance: White to slightly white powder  
Purity:  
Zinc L-pidolate (purity): ≥ 98 % 
pH (10 % aqueous sol.): 5,0-6,0 
Specific rotation: 19,6o - 22,8o 
Water: ≤ 10,0 % 
Glutamic acid: < 2,0 %  
Heavy metals:  
Lead: ≤ 3,0 ppm 
Arsenic: ≤ 2,0 ppm 
Cadmium: ≤ 1,0 ppm 
Mercury: ≤ 0,1 ppm  
Microbiological criteria:  
Total viable mesophilic count: ≤ 1 000 CFU/g 
Yeasts and moulds: ≤ 100 CFU/g 
Pathogen: Absence  
(1 ) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and  III to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council (OJ L 83, 22.3.2012, p. 1). 
(2 ) Commission Implementing Regulation (EU) 2015/175 of 5 February 2015 laying down special conditions applicable to the import o f guar gum originating in or consigned from India due to contamination 
risks by pentachlorophenol and dioxins (OJ L 30, 6.2.2015, p. 10).