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Food Additives | Nutrition, Dietetic Products, Novel Food and Allergy

Risk assessment of «other substances»

Report no:

Ordered: 05.05.2015

Published: null

Main message:

The Norwegian Food Safety Authority (NFSA) requests the Norwegian Scientific Committee for Food Safety (VKM) to assess the safety of “other substances” found on the Norwegian market

«Other substances» are substances other than vitamins and minerals, with a nutritional and/or physiological effect on the body. “Other substances” are mainly added to food supplements, but these may also be added to other foods and beverages, such as sports products and energy drinks. Ingestion of these substances in high amounts presents a potential risk for consumers.

In 2011, food supplements containing “other substances” constituted more than 50% of the market share.

At EU level, other substances” remain largely unregulated. In order to ensure safe use of “other substances” many countries have regulated their use at a national level. Denmark for instance has a positive list i.e. a list of substances with maximal daily doses, permitted for use in food supplements and other foods.

The Norwegian Food Safety Authority (NFSA) has recommended the Norwegian Ministry for health and care services to regulate the addition of “other substances” to food supplements and other foods at a national level. NFSA has suggested using the Danish regulation as a model while establishing a national regulatory framework. NFSA has further suggested that the establishment of a list of substances with permitted maximal doses should be based on the products and substances found on the Norwegian market.

In preparation for an eventual regulation, NFSA has requested the Norwegian Scientific Committee for Food Safety (VKM) to assess the safety of “other substances” found on the Norwegian market. NFSA, in consultation with the industry, has compiled a list of “other substances” found in products marketed in Norway.

Only substances with a purity of minimum 50% or concentrated 40 times or more have been included in the list. Substances regulated by other legislations like those for novel foods, food additives, aromas, foods for special medical purposes, etc. have been excluded from the list.

Terms of Reference

NFSA has requested VKM to

  • Prepare a guidance document outlining the methodology to be used for the safety assessments of “other substances” (Phase 2).
  • Assess the safety of “other substances” (in accordance to the guidance document developed in Phase 2) at the doses specified (Phase 3).    
  • Safety assessments for “other substances” present in food supplements shall be carried out for a general population, ages 10 years and above.
  • Safety assessments for “other substances” present in energy drinks shall be carried out for a general population, ages 3 years and above. Drinking patterns reflecting a high acute intake, an average chronic intake and a high chronic intake should be assessed.

Substance

Daily doses in food supplements

Daily doses in other foods

Conjugated linoleic acid

3500 mg, 3250mg, 3000mg


Docosahexaenoic acid

1290 mg, 1050 mg


Docosapentaenoic acid

150 mg, 125 mg, 100 mg


Eicosapentaenoic acid

1825 mg, 1750 mg, 1500 mg


L-Alanine

4500 mg, 4250 mg, 4000 mg, 3750 mg, 3500 mg


L-Arginine

6800 mg, 6000 mg, 5500 mg, 5000 mg, 4500 mg, 4000 mg, 3500 mg, 3000 mg


L-Aspartic acid

5700 mg, 5000 mg, 4500 mg,

4000 mg, 3500 mg, 3000 mg


Beta-Alanine

2000 mg, 1500 mg, 1000 mg


L-Citrulline

2000 mg, 1500 mg, 1000 mg

 

L-Cystein

10 mg


L-Cystin

1000 mg, 750 mg, 500 mg, 250 mg


L-Glutamine

16000 mg, 15000 mg, 12000mg,

8000mg, 5000 mg, 3500 mg


L-Gutamic acid

5500 mg, 5000 mg, 4000 mg,

3000 mg, 2000 mg, 1000 mg


Glycine

650 mg, 500 mg, 300 mg, 100 mg,

50 mg, 20 mg


L-Histidine

600 mg, 550 mg


L-Isoleucine

2500 mg, 2000 mg, 1750 mg,

1500 mg


L-Leucine

5250 mg, 5000 mg, 4000 mg,

3000 mg, 2500 mg


L-Lysine

3000 mg, 2750 mg, 2500 mg,

2000 mg, 1000 mg


L-Methionine

700 mg, 600 mg, 500 mg, 300 mg,

200 mg


DL-Phenylalanine

75 mg, 50 mg


L-Phenylalanine

1000 mg, 750 mg, 500 mg, 250 mg,

100 mg


L-Proline

1800 mg, 1500 mg, 1000 mg, 500 mg,

50 mg


L-Serine

1750 mg, 1500 mg, 1250 mg,

1000 mg, 500 mg, 50 mg


L-Threonine

2400 mg, 2000 mg, 1500 mg,

1200 mg, 1000 mg


L-Tryptophan

450 mg, 300 mg, 250 mg


L-Tyrosine

2000 mg, 1750 mg, 1500 mg, 1250 mg


L-Valine

2500 mg, 2250 mg, 2000 mg,

1750 mg, 1500 mg


Arginine-alpha-ketoglutarate

2000 mg, 1000 mg


L-Carnitine

1500 mg


L-Carnitine-L-tartrate

2250 mg


Coenzyme Q10

100 mg


Collagen from fish

750 mg


Creatine

24000 mg, 10000 mg, 5000mg,

3000 mg


D-Ribose

6200 mg, 3100 mg


Glucuronolatone


24 mg/

100 ml

Inositol


10 mg/ 100 ml

Lecithin from sunflower

10100 mg


Taurine

2000 mg, 1000 mg

300, 350,

400 mg/

100 ml

Caffeine

300 mg, 100 mg

32 mg/ 100 ml

Curcumin

900 mg, 600 mg, 300 mg


Isoflavones from soy

80 mg, 40 mg


Lycopene

10 mg


Piperine from black pepper

1,5 mg


Inulin

3000 mg



Contact

Vitenskapskomiteen for mat og miljø

The Norwegian Scientific Committee for Food and Environment

T: +47 21 62 28 00
Send e-mail

The Norwegian Scientific Committee for Food and Environment

T: 21 62 28 00
@: vkm@vkm.no


P.O. Box 222 Skøyen
0213 Oslo

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