[Updated] EU’s Latest Amendment on Food Additive: Buffered Vinegar, Stearyl Tartrate, Nitrites and Nitrates

June 30, 2023: Polyglycerol Polyricinoleate (E 476), Glycerol (E 422), Polyglycerol Esters of Fatty Acids (E 475) and Polyglycerol Polyricinoleate (E 476)

As revealed by EU’s Official Journal on June 30, 2023, EU revises the use of polyglycerol polyricinoleate (E 476) as well as specifications for glycerol (E 422), polyglycerol esters of fatty acids (E 475) and polyglycerol polyricinoleate (E 476). As a result, Regulations (EC) No 1333/2008 on Food Additives and Regulations (EU) No 231/2012 Specifications for Food Additives are amended accordingly.

Major Revisions

1. Glycerol (E 422)

Reducing the maximum limits for toxic elements (arsenic, lead, mercury and cadmium)
Deleting requirements for acrolein and adding a maximum limit for acrolein “Not more than 3 mg/kg”
Modifying the definition of E 422

2. Polyglycerol esters of fatty acids (E 475)

Reducing the maximum limits for toxic elements
Including the maximum limits for impurities and constituents of safety concern
Modifying the definition of E 475

3. Polyglycerol polyricinoleate (E 476)

Authorizing E 476 in food category 03 ‘Edible ices’ at a maximum level of 4,000 mg/kg
Increasing the authorized maximum level of E476 in food category 12.6 ‘Sauces’ to 8,000 mg/kg for emulsified sauces with a fat content of 20 % or more
Reducing the maximum limits for toxic elements
Including the maximum limits for impurities of safety concern
Modifying the definition of E 476

Impact and transitional period

No.	Food additive	Food additives that can enjoy the transitional period	Transitional period for the food additive	Transitional period for foods containing such food additives
1	Glycerol (E 422)	The one that has been lawfully placed on the market before July 20, 2023, and not comply with the maximum limits for arsenic, lead, mercury, cadmium or acrolein applicable from July 20, 2023	May be added to food following Annexes II and III to Regulation (EC) No 1333/2008 until January 20, 2024	May continue to be placed on the market until January 20, 2024 and may continue to be marketed until their date of minimum durability or ‘use-by date’
2	Polyglycerol esters of fatty acids (E 475)	The one that has been lawfully placed on the market before July 20, 2023 and not comply with the maximum limits for arsenic, lead, mercury, cadmium, the sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, erucic acid or glycidyl fatty acids esters applicable from July 20, 2023	May be added to food following Annexes II and III to Regulation (EC) No 1333/2008 until January 20, 2024	May continue to be placed on the market until January 20, 2024 and may continue to be marketed until their date of minimum durability or ‘use-by date’
2	Polyglycerol esters of fatty acids (E 475)	The one that has been lawfully placed on the market after July 20, 2023 and up to January 20, 2024 and not comply with the maximum limits for glycidyl fatty acids esters applicable from January 20, 2024	May be added to food following Annexes II and III to Regulation (EC) No 1333/2008 until the exhaustion of stocks	May continue to be placed on the market and may continue to be marketed until their date of minimum durability or ‘use by date’
3	Polyglycerol polyricinoleate (E 476)	The one that has been lawfully placed on the market before July 20, 2023 and not comply with the maximum limits for arsenic, lead, mercury, cadmium, the sum of 3-MCPD and 3-MCPD fatty acid esters or glycidyl fatty acids esters applicable from July 20, 2023	May be added to food following Annexes II and III to Regulation (EC) No 1333/2008 until January 20, 2024	May continue to be placed on the market until January 20, 2024 and may continue to be marketed until their date of minimum durability or ‘use-by date’

Read more details at the official journal.

July 10, 2023: Mono- and Diglycerides of Fatty Acids (E 471)

On July 10, 2023, EU amends the specifications for mono- and diglycerides of fatty acids (E 471). Revisions include definition, maximum content of erucic acid, heavy metal, the sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, as well as glycidyl fatty acid esters.

Impact and transitional period

No.	Food additive	Situation	Transitional period for the food additive	Transitional period for foods containing such food additives
1	Mono- and diglycerides of fatty acids (E 471) that has been lawfully placed on the market before July 30, 2023	Not comply with the maximum limits for arsenic, lead, mercury, cadmium, 3-MCPD and 3-MCPD fatty acid esters, or erucic acid applicable from July 30, 2023	May be added to food as per relevant regulations* until January 30, 2024	Food may continue to be marketed until their date of minimum durability or ‘use-by date’.
2		Not comply with the maximum limits for glycidyl fatty acids esters applicable from July 30, 2023	May be added to food, except for foods for infants and young children, as per relevant regulations until January 30, 2024	A) Foods, except foods for infants and young children, may continue to be placed on the market until 30 January 2024 and may continue to be marketed until their date of minimum durability or ‘use-by date’. B) Foods for infants and young children may continue to be marketed until their date of minimum durability or ‘use-by date’.
3	E 471 that has been lawfully placed on the market after 30 July 2023 and up to 30 January 2024	Not comply with the maximum limits for glycidyl fatty acids esters applicable from January 30, 2024	May be added to food, except foods for infants and young children, as per Regulation (EC) No 1333/2008 until the exhaustion of stocks	Foods, except food for infants and young children may continue to be placed on the market and may continue to be marketed until their date of minimum durability or ‘use by date’.

*Relevant regulations refer to Regulation (EC) No 1333/2008 and Regulation (EU) 2023/915.

Read more details at the official journal.

September 29: Buffered Vinegar (E 267)

As revealed by an Official Journal issued on Sept 29, EU authorises the use of buffered vinegar for the first time as a preservative and acidity regulator, by adding the name of the substance and its condition of use to the Annex of Regulation (EC) No 1333/2008. For example, it can be used in whey cheese, canned or bottled fruit & vegetable, etc. Meanwhile, the specifications for buffered vinegar are newly included in the Annex of Regulation (EU) No 231/2012.

October 3: Stearyl Tartrate (E 483)

Due to the absence of appropriate toxicological data to confirm the safety of stearyl tartrate (E 483) as a food additive, EU deleted all information related to stearyl tartrate (E 483) from the Union list of authorized food additive, specified in Regulation (EC) No 1333/2008. As a result, Regulation (EU) No 231/2012 is revised accordingly as it stipulates the specifications of permitted food additives.

Foods containing stearyl tartrate (E 483) that have been lawfully placed on the market before 23 April 2024 may continue to be marketed until their date of minimum durability or use-by date. Read more at the Official Journal here.

October 9: Nitrites (E 249-250) and Nitrates (E 251-252)

Based on the new risk assessment, EU reduces the maximum amounts of nitrites and nitrates that may be added as food additives to foods and revises corresponding use conditions. Involved additives are potassium nitrite (E 249), sodium nitrite (E 250), sodium nitrate (E 251) and potassium nitrate (E 252). Affected categories include ripened cheese, whey cheese, dairy analogues, meat preparations, non-heat–treated meat products, heat-treated meat products, traditional immersion cured products, etc. At the same time, the maximum limits for lead, mercury and arsenic in thoses substances are lowered.

Implementation:

Foods not complying with the provisions laid down in Annex I and that have been lawfully placed on the market before the respective date of application may continue to be marketed until their date of minimum durability or use-by date.
The involved four food additives that have been lawfully placed on the market before 29 October 2023 and that do not comply with the maximum limits for lead, mercury and arsenic laid down in Annex II applicable from 29 October 2023 may be added to food in accordance with Annexes II and III to Regulation (EC) No 1333/2008 until 29 April 2024.
Foods containing the four food additives that have been lawfully placed on the market before 29 October 2023 and that do not comply with the maximum limits for lead, mercury and arsenic laid down in Annex II applicable from 29 October 2023 may continue to be placed on the market until 29 April 2024 and may continue to be marketed until their date of minimum durability or use-by date.

Read more at the Official Journal issed on October 9, 2023.