13.2 Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5)

GB food category, from assimilated Regulation (EC) No 1333/2008, Annex II, Part D, as at 28 June 2024.

In Great Britain an additive may be used only in the foods and under the conditions listed for them. Since 1 April 2025 those conditions are Annex II as it stood on 28 June 2024, read with the FSA and FSS register of authorisations. This page shows what is listed for this category. It does not infer anything from broader categories: where Annex II extends a broader category's provisions to its subcategories, it says so in that category's own listing. See the broader category 13.

Listed for this category

AdditiveMaximum levelConditionsCitation
Acesulfame potassium E950450 mg/kg or mg/l—Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Advantame E96910 mg/kg or mg/l—Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Agar E406quantum satis

only foods in tablet and coated tablet form.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Aspartame E9511,000 mg/kg or mg/l—Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Aspartame-acesulfame salt E962450 mg/kg or mg/l

Note (11): Limits are expressed as (a) acesulfame K equivalent or (b) aspartame equivalent. Note (49): The maximum usable levels are derived from the maximum usable levels for its constituent parts, aspartame (E 951) and acesulfame-K (E 950). Note (50): The levels for both E 951 and E 950 are not to be exceeded by use of the salt of aspartame-acesulfame, either alone or in combination with E 950 or E 951.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Calcium cyclamate INS 952(ii)400 mg/kg or mg/l

Authorised under E 952, Cyclamates. Note (51): Maximum usable levels are expressed in free acid.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 952, Cyclamates
Calcium saccharin E954200 mg/kg or mg/l

Authorised under E 954, Saccharins. Note (52): Maximum usable levels are expressed in free imide.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 954, Saccharins
Cyclamic acid INS 952(i)400 mg/kg or mg/l

Authorised under E 952, Cyclamates. Note (51): Maximum usable levels are expressed in free acid.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 952, Cyclamates
Cyclamic acid and its Na and Ca salts E952400 mg/kg or mg/l

Authorised under E 952, Cyclamates. Note (51): Maximum usable levels are expressed in free acid.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 952, Cyclamates
Enzymatically produced steviol glycosides E960c330 mg/kg or mg/l

Authorised under E 960c, Enzymatically produced steviol glycosides. Note (1): The additives may be added individually or in combination. Note (60): Expressed as steviol equivalents.

FSA/FSS Register of Food Additive Authorisations, E 960a–c conditions of use (19 February 2026), under E 960c, Enzymatically produced steviol glycosides
FD&C Yellow No. 6 E11010 mg/kg or mg/l

Note (61): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Lycopene E160d30 mg/kg or mg/l

Authorised under E 160d, Lycopene.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 160d, Lycopene
Lycopene, Blakeslea trispora INS 160d(iii)30 mg/kg or mg/l

Authorised under E 160d, Lycopene.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 160d, Lycopene
Lycopene, synthetic INS 160d(i)30 mg/kg or mg/l

Authorised under E 160d, Lycopene.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 160d, Lycopene
Lycopene, tomato INS 160d(ii)30 mg/kg or mg/l

Authorised under E 160d, Lycopene.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 160d, Lycopene
Neohesperidine DC E959100 mg/kg or mg/l—Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Neotame E96132 mg/kg or mg/l—Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Polyglycerol esters of fatty acids E4755,000 mg/kg or mg/l—Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Ponceau 4R (Cochineal red A) E12410 mg/kg or mg/l

Note (61): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Potassium saccharin E954200 mg/kg or mg/l

Authorised under E 954, Saccharins. Note (52): Maximum usable levels are expressed in free imide.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 954, Saccharins
Propylene glycol alginate E4051,200 mg/kg or mg/l—Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Propylene glycol esters of fatty acids E4771,000 mg/kg or mg/l—Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Quinoline yellow E10410 mg/kg or mg/l

Note (61): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)
Rebaudioside AM produced via enzymatic conversion of highly purified stevioside stevia leaf extracts E960c(iv)330 mg/kg or mg/l

Authorised under E 960c, Enzymatically produced steviol glycosides. Note (1): The additives may be added individually or in combination. Note (60): Expressed as steviol equivalents.

FSA/FSS Register of Food Additive Authorisations, E 960a–c conditions of use (19 February 2026), under E 960c, Enzymatically produced steviol glycosides
Rebaudioside D produced via enzymatic conversion of highly purified rebaudioside A stevia leaf extracts E960c(iii)330 mg/kg or mg/l

Authorised under E 960c, Enzymatically produced steviol glycosides. Note (1): The additives may be added individually or in combination. Note (60): Expressed as steviol equivalents.

FSA/FSS Register of Food Additive Authorisations, E 960a–c conditions of use (19 February 2026), under E 960c, Enzymatically produced steviol glycosides
Rebaudioside M from fermentation produced by Yarrowia lipolytica E960b(i)330 mg/kg or mg/l

Authorised under E 960b, Steviol glycosides from fermentation. Note (1): The additives may be added individually or in combination. Note (60): Expressed as steviol equivalents.

FSA/FSS Register of Food Additive Authorisations, E 960a–c conditions of use (19 February 2026), under E 960b, Steviol glycosides from fermentation
Rebaudioside M produced via enzymatic conversion of highly purified rebaudioside A stevia leaf extracts E960c(ii)330 mg/kg or mg/l

Authorised under E 960c, Enzymatically produced steviol glycosides. Note (1): The additives may be added individually or in combination. Note (60): Expressed as steviol equivalents.

FSA/FSS Register of Food Additive Authorisations, E 960a–c conditions of use (19 February 2026), under E 960c, Enzymatically produced steviol glycosides
Rebaudioside M produced via enzyme modification of steviol glycosides from stevia E960c(i)330 mg/kg or mg/l

Authorised under E 960c, Enzymatically produced steviol glycosides. Note (1): The additives may be added individually or in combination. Note (60): Expressed as steviol equivalents.

FSA/FSS Register of Food Additive Authorisations, E 960a–c conditions of use (19 February 2026), under E 960c, Enzymatically produced steviol glycosides
Saccharin E954200 mg/kg or mg/l

Authorised under E 954, Saccharins. Note (52): Maximum usable levels are expressed in free imide.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 954, Saccharins
Sodium cyclamate INS 952(iv)400 mg/kg or mg/l

Authorised under E 952, Cyclamates. Note (51): Maximum usable levels are expressed in free acid.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 952, Cyclamates
Sodium saccharin E954200 mg/kg or mg/l

Authorised under E 954, Saccharins. Note (52): Maximum usable levels are expressed in free imide.

Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 954, Saccharins
Steviol glycosides from fermentation E960b330 mg/kg or mg/l

Authorised under E 960b, Steviol glycosides from fermentation. Note (1): The additives may be added individually or in combination. Note (60): Expressed as steviol equivalents.

FSA/FSS Register of Food Additive Authorisations, E 960a–c conditions of use (19 February 2026), under E 960b, Steviol glycosides from fermentation
Steviol glycosides from Stevia rebaudiana Bertoni (Steviol glycosides from Stevia) E960330 mg/kg or mg/l

Note (1): The additives may be added individually or in combination. Note (60): Expressed as steviol equivalents.

FSA/FSS Register of Food Additive Authorisations, E 960a–c conditions of use (19 February 2026)
Sucralose E955400 mg/kg or mg/l—Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)

Permitted as members of an additive group

Annex II authorises some additives collectively. Each group below shares one set of conditions for this category.

E 200–213: Sorbic acid — sorbates; Benzoic acid — benzoates (SA + BA) — 6 additivesML = 1500. Note (1): The additives may be added individually or in combination. Note (2): The maximum level is applicable to the sum and the levels are expressed as the free acid.
E 338–341, E 343 and E 450 — 452: Phosphoric acid — phosphates — di-, tri- and polyphosphates — 26 additivesML = 5000. Note (1): The additives may be added individually or in combination. Note (4): The maximum level is expressed as P 2 O 5. E 450 (ix) is not included.
E 432–436: Polysorbates — 5 additivesML = 1000. Note (1): The additives may be added individually or in combination.
E 473–474: Sucrose esters of fatty acids, Sucroglycerides — 2 additivesML = 5000. Note (1): The additives may be added individually or in combination.
E 481–482: Stearoyl-2-lactylates — 2 additivesML = 2000. Note (1): The additives may be added individually or in combination.
E 491–495: Sorbitan esters — 5 additivesML = 5000. Note (1): The additives may be added individually or in combination.
Group I — 167 additivesquantum satis.
Group II: Food colours authorised at quantum satis — 25 additivesquantum satis.
Group III: Food colours with combined maximum limit — 14 additivesML = 50. Note (88): Maximum limit for aluminium coming from aluminium lakes of E 120 carminic acid, carmine 3 mg/kg only in liquid heat-treated products. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
Group IV: Polyols — 10 additivesquantum satis.