Commission Regulation (EU) 2023/1329 of 29 June 2023 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of polyglycerol polyricinoleate (E 476) and the Annex to Commission Regulation (EU) No 231/2012 as regards specifications for glycerol (E 422), polyglycerol esters of fatty acids (E 475) and polyglycerol polyricinoleate (E 476) (Text with EEA relevance)

• CELEX: Regulation (EU) 2023/1329
• Articles: 6

Article 1

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.

Article 2

The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.

Article 3

The food additive glycerol (E 422) that has been lawfully placed on the market before 20 July 2023 and that does not comply with the maximum limits for arsenic, lead, mercury, cadmium or acrolein applicable from 20 July 2023 may be added to food in accordance with Annexes II and III to Regulation (EC) No 1333/2008 until 20 January 2024.

Foods containing the food additive glycerol (E 422) that has been lawfully placed on the market before 20 July 2023 and that does not comply with the maximum limits for arsenic, lead, mercury, cadmium or acrolein applicable from 20 July 2023 may continue to be placed on the market until 20 January 2024 and may continue to be marketed until their date of minimum durability or ‘use-by date’.

The food additive polyglycerol esters of fatty acids (E 475) that has been lawfully placed on the market before 20 July 2023 and that does not comply with the maximum limits for arsenic, lead, mercury, cadmium, the sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD), erucic acid or glycidyl fatty acids esters (expressed as glycidol) applicable from 20 July 2023 may be added to food in accordance with Annexes II and III to Regulation (EC) No 1333/2008 until 20 January 2024.

Foods containing the food additive polyglycerol esters of fatty acids (E 475) that has been lawfully placed on the market before 20 July 2023 and that does not comply with the maximum limits arsenic, lead, mercury, cadmium, the sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD), erucic acid or for glycidyl fatty acids esters (expressed as glycidol) applicable from 20 July 2023 may continue to be placed on the market until 20 January 2024 and may continue to be marketed until their date of minimum durability or ‘use-by date’.

The food additive polyglycerol esters of fatty acids (E 475) that has been lawfully placed on the market after 20 July 2023 and up to 20 January 2024 and that does not comply with the maximum limits for glycidyl fatty acids esters (expressed as glycidol) applicable from 20 January 2024 may be added to food in accordance with Annexes II and III to Regulation (EC) No 1333/2008 until the exhaustion of stocks.

Foods containing the food additive polyglycerol esters of fatty acids (E 475) that has been has been lawfully placed on the market after 20 July 2023 and up to 20 January 2024 and that does not comply with the maximum limits for glycidyl fatty acids esters (expressed as glycidol) applicable from 20 January 2024 may continue to be placed on the market and may continue to be marketed until their date of minimum durability or ‘use by date’.

The food additive polyglycerol polyricinoleate (E 476) that has been lawfully placed on the market before 20 July 2023 and that does not comply with the maximum limits for arsenic, lead, mercury, cadmium, the sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD) or glycidyl fatty acids esters (expressed as glycidol) applicable from 20 July 2023 may be added to food in accordance with Annexes II and III to Regulation (EC) No 1333/2008 until 20 January 2024.

Foods containing the food additive polyglycerol polyricinoleate (E 476) that has been lawfully placed on the market before 20 July 2023 and that does not comply with the maximum limits for arsenic, lead, mercury, cadmium, the sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD) or glycidyl fatty acids esters (expressed as glycidol) applicable from 20 July 2023 may continue to be placed on the market until 20 January 2024 and may continue to be marketed until their date of minimum durability or ‘use-by date’.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I

ANNEX I

Part E of Annex II to Regulation (EC) No 1333/2008 is amended as follows:

(1)

in Category 03 (Edible ices), the following entry is inserted after the entry for E 473–474:

‘E 476

Polyglycerol polyricinoleate

4 000

except sorbets’

(2)

in Category 12.6 (Sauces), the entry for E 476 (Polyglycerol polyricinoleate) is replaced by the following:

‘E 476

Polyglycerol polyricinoleate

4 000

only emulsified sauces with a fat content of less than 20 %

E 476

Polyglycerol polyricinoleate

8 000

only emulsified sauces with a fat content of 20 % or more’

ANNEX II

ANNEX II

The Annex to Regulation (EU) No 231/2012 is amended as follows:

(1)

the entry for food additive E 422 Glycerol is replaced by the following:

‘ E 422 GLYCEROL

Synonyms

Glycerin; Glycerine

Definition

Glycerol is obtained only from vegetable oils and fats, either directly or from the crude glycerol obtained as a by-product of biodiesel production and undergoes purification processes that involve distillation, and other clean up steps to obtain refined glycerol.

Einecs

200-289-5

Chemical name

1,2,3-propanetriol; Glycerol; Trihydroxypropane

Chemical formula

C 3 H 8 O 3

Molecular weight

92,10

Assay

Content not less than 98 % of glycerol on the anhydrous basis

Description

Clear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is neither harsh nor disagreeable

Identification

Specific gravity (25 °C/25 °C)

Not less than 1,257

Refractive index

[n] D

20 between 1,471 and 1,474

Purity

Water content

Not more than 5 % (Karl Fischer method)

Sulphated ash

Not more than 0,01 % determined at 800 ± 25 °C

Butanetriols

Not more than 0,2 %

Acrolein

Not more than 3 mg/kg

Fatty acids and esters

Not more than 0,1 % calculated as butyric acid

Chlorinated compounds

Not more than 30 mg/kg (as chlorine)

3-Monochloropropane-1,2-diol (3- MCPD)

Not more than 0,1 mg/kg

Arsenic

Not more than 0,1 mg/kg

Lead

Not more than 0,1 mg/kg

Mercury

Not more than 0,1 mg/kg

Cadmium

Not more than 0,1 mg/kg’

(2)

the entry for food additive E 475 Polyglycerol esters of fatty acids is replaced by the following:

‘ E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS

Synonyms

Polyglycerol fatty acid esters; Polyglycerin esters of fatty acid esters

Definition

Polyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol.

The polyglycerol is produced from glycerol complying with the specifications for E 422.

Einecs

Chemical name

Chemical formula

Molecular weight

Assay

Content of total fatty acid ester not less than 90 %

Description

Light yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids

Identification

Test for glycerol

Passes test

Test for polyglycerols

Passes test

Test for fatty acids

Passes test

Solubility

The esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oils

Purity

Sulphated ash

Not more than 0,5 % (800 ± 25 °C)

Acids other than fatty acids

Less than 1 %

Free fatty acids

Not more than 6 % estimated as oleic acid

Total glycerol and polyglycerol

Not less than 18 % and not more than 60 %

Free glycerol and polyglycerol

Not more than 7 %

Arsenic

Not more than 0,1 mg/kg

Lead

Not more than 0,3 mg/kg

Mercury

Not more than 0,1 mg/kg

Cadmium

Not more than 0,1 mg/kg

Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD

Not more than 2,5 mg/kg

Glycidyl fatty acid esters, expressed as glycidol

Not more than 10 mg/kg. This applies from 20 July 2023 until 20 January 2024.

Not more than 5 mg/kg. This applies from 20 January 2024.

Erucic acid

Not more than 2 %

Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

’;

(3)

the entry for food additive E 476 Polyglycerol polyricinoleate is replaced by the following:

‘ E 476 POLYGLYCEROL POLYRICINOLEATE

Synonyms

Glycerol esters of condensed castor oil fatty acids; Polyglycerol esters of polycondensed fatty acids from castor oil; Polyglycerol esters of interesterified ricinoleic acid; PGPR

Definition

Polyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids. Castor oil used for the production of polyglycerol polyricinoleate is free of ricin.

The polyglycerol is produced from glycerol complying with the specifications for E 422.

Einecs

Chemical name

Chemical formula

Molecular weight

Assay

Description

Clear, highly viscous liquid

Identification

Solubility

Insoluble in water and in ethanol; soluble in ether, hydrocarbons and halogenated hydrocarbons

Test for glycerol

Passes test

Test for polyglycerols

Passes test

Test for ricinoleic acid

Passes test

Refractive index

[n] D

65 between 1,4630 and 1,4665

Purity

Polyglycerols

The polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall contain not more than 10 % of polyglycerols equal to or higher than heptaglycerol

Hydroxyl value

Not less than 80 and not more than 100

Acid value

Not more than 6

Arsenic

Not more than 0,1 mg/kg

Lead

Not more than 0,1 mg/kg

Mercury

Not more than 0,1 mg/kg

Cadmium

Not more than 0,1 mg/kg

Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD)

Not more than 2,5 mg/kg

Glycidyl fatty acid esters (expressed as glycidol)

Not more than 1 mg/kg’