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Specifications of Food
Additives
A3.03

2019

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Commission Regulation (EU) 231/2012 adopted
revised specifications for all additives in one single list
and applied from: 1 December 2012.

This Regulation lays down specifications for all food

additives listed in Annexes II and III to (EC)
Regulation No 1333/2008 of the European Parliament
and of the Council

Applies to: Colours, Sweeteners and

Miscellaneous Additives 1

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In accordance with the additives Regulation,
Food additives must comply with the
approved specifications, which should include:

 Information to adequately identify the food

additive, including origin, and

 Description of the acceptable criteria of

purity

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Legislation

Takes into account

Specifications
Codex
Alimentarius
Food additives

Analytical
techniques

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The setting of specifications includes
detailing information on:

 Identity
 Purity

Is an essential part of

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Food additives listed in the specifications are
mainly defined by the following criteria:

 Description of their manufacture

 Chemical Characterization

 Minimum requirement for the content of the

principal functional component(s) of the
additive

 Maximum limits for undesirable impurities-

example heavy metals limits set for As, Pb, Hg 5
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The relative importance of the criteria Depends
of the
nature of
the
additive

Additives composed
largely of single • chemical purity
components

• description of the raw

Complex materials
materials e.g.
natural gums • method of manufacture

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 Specifications

Apply to the additive as marketed

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 Format of specifications

 Title, synonyms
 E Number
e.g. E 235
 Definition
 EINECS number natamycin
 chemical name
 chemical formula
 assay synonym:
 Description pimaricin
 identification 8
 purity DG SANTE policy
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 Format of specifications

Definition
 Chemical name

 Chemical formula E 235

 Assay “Content not less than

95 % on the anhydrous
basis”

EINECS=European INventory of Existing Commercial 9

chemical Substances DG SANTE policy

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 Format of specifications

Description

Identification Purity

• solubility in water • limits on impurities

• solubility in organic • e.g. heavy metals
solvents • microbiological purity
• colour reactions
• absorption spectra
• pH values

10

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Art.12 of Regulation (EC) 1333/2008

Changes in the
production methods
Food additives or starting materials
of the food additive if
significantly different

emphasis on
purity criteria safety evaluation by
EFSA

11

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 Some examples

Sweeteners Reg 231/2012 Acesulfame K

Miscellaneous FA Reg 231/2012 Natamycin

Colours Reg 231/2012 Beta-carotene

12

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 Reg 231/2012

Acesulfame K, E 950
Synonyms
Acesulfame potassium, potassium salt of 3,4- dihydro-6-methyl-1,2,3-
oxathiazin-4-one,2,2- dioxide
Definition
Chemical name
6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt
Einecs
259-715-3
Chemical formula
C 4 H 4 KNO 4 S
Molecular weight
201,24
Assay
Content not less than 99 % of C 4 H 4 KNO 4 S on the anhydrous basis
Description
Odourless, white, crystalline powder. Approximately 200 times as sweet as 13

sucrose DG SANTE policy

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 Reg 231/2012

Acesulfame K
Identification
A. Solubility
Very soluble in water, very slightly soluble in ethanol
B. Ultraviolet absorption
Maximum 227 ± 2 nm for a solution of 10 mg in 1 000 ml of water
C. Positive test for potassium
Passes test (test the residue obtained by igniting 2 g of the sample)
D. Precipitation test
Add a few drops of a 10 % solution of sodium cobalt nitrite to a solution of 0,2 g of the
sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced

Purity
Loss on drying
Not more than 1% (105oC, two hours)
Organic impurities
Passes test for 20 mg/kg of UV active components
Fluoride
Not more than 3 mg/kg
Lead 14
Not more than 1 mg/kg
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 Reg 231/2012

Natamycin, E 235
Synonyms
Pimaricin

Definition
Natamycin is a fungicide of the polyene macrolide group, and is produced by
natural strains of Streptomyces natalensis or of Streptococcus lactis
Einecs
231-683-5
Chemical formula
C 33 H 47 O 13 N
Molecular weight
665,74
Assay
Content not less than 95 % on the anhydrous basis

Description 15

White to creamy-white crystalline powder

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 Reg 231/2012

Natamycin E 235
Identification
A. Colour reactions
On adding a few crystals of natamycin on a spot plate, to a drop of: —
concentrated hydrochloric acid, a blue colour develops, — concentrated
phosphoric acid, a green colour develops, which changes into pale red after a
few minutes
B. Spectrometry
A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption
maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm
and exhibits minima at about 250 nm, 295,5 nm and 311 nm
C. pH
5,5 to 7,5 (1 % w/v solution in previously neutralised mixture of 20 parts
dimethylformamide and 80 parts of water)
D. Specific rotation
[α] D 20 = + 250 o to + 295 o (a 1 % w/v solution in glacial acetic acid, at 20 o
C and calculated with reference to the dried material)
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 Reg 231/2012

Natamycin E 235
Purity
Loss on drying
Not more than 8% (over P 2 O 5 , in vacuum at 600C to constant weight)
Sulphated ash
Not more than 0.5 %
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
Microbiological criteria: total viable count
Not more than 100/g

17

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 Reg 231/2012

Beta-carotene, E 160a
Description
Red to brownish-red crystals or crystalline powder

Identification
Spectrometry
Maximum in cyclohexane at 453 nm to 456 nm

Purity
Sulfated ash
Not more than 0,2 %
Subsidiary colouring matters
Carotenoids other than beta-carotene: not more than 3,0 % of total colouring
matters
Lead
Not more than 2 mg/kg

18

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 Reg 231/2012
Beta-carotene, E 160a
Synonyms
CI Food Orange 5

Definition
These specifications apply predominantly to all trans isomer of beta-carotene
together with minor amounts of other carotenoids. Diluted and stabilised
preparations may have different trans-cis isomer ratios.
Class Carotenoid
Colour Index No 40800
Einecs 230-636-6
Chemical names Beta-carotene, beta, beta-carotene
Chemical formula C 40 H 56
Molecular weight 536,88
Assay
Not less than 96% total colouring matters (expressed as beta-carotene) E 1 cm
1 % 2 500 at approximately by 440 nm to 457 nm in cyclohexane 19

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Recent amendments to Reg. (EU)
231/2012
Commission Regulation (EU) 2018/1481-Deletion of
the specifications for octyl gallate (E 311) and
dodecyl gallate (E 312)

Commission Regulation (EU) 2018/1472 –amending

specifications for Cochineal, Carminic acid,
Carmines (E 120)

New Name: ‘E 120 Carminic acid, Carmine’

 Limit set for the impurity 4-aminocarminic acid
(4-ACA)-Not more than 3 % relative to carminic
acid
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 Official control on FA
Principle that needs to be addressed

 The whole inspection will be based on the Food

Safety Management Systems in place (HACCP)

 Additives should be checked to ensure they meet

the specifications and purity criteria in Regulation
(EU) 231/2012
21

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 The Such information
responsibility for should be
having the whole supplied by the
documentation producer of the
on specifications
FBO Food additive to
for food FBOs buying and
additives using their
additives

If the FBO does not have the specifications for the additives
they are using in the manufacture of their food they should
request this information from their additive supplier.
22

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 Frequency of analyzing FA

 Controls should be carried out on a routine

basis according to a risk-based approach
presented by the FBO

 Controls should be reflective of the differing

batches of the Food Additive

23

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Documentation needed
during official controls

Producers
Distributors of a FA and foodstuffs
Sellers

24

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 Official samples

Taking samples is necessary in order to:

 Check the conformity of the Food

Additive

 Monitor production of the Food Additive

25

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 Thank you for your attention
AETS Consortium

Address : 17 av. André Marie Ampère, 64 140 Lons, France

Tel/fax: +33 5 59 72 43 23 / + 33 5 59 72 43 24
Email: contact@aets-consultants.com

Better Training for Safer Food

BTSF
European Commission
Consumers, Health and Food Executive Agency
DRB A3/042
L-2920 Luxembourg

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