Stricter specifications for mono- and diglycerides of fatty acids (E 471)

Food additives
Food safety

Summary

The EU is introducing stricter specifications for mono- and diglycerides of fatty acids (E 471). It is lowering acceptable levels of toxic elements, establishing maximum limits for certain impurities, and adjusting the production process to decrease glycidyl fatty acid esters.

EU introduces stricter specifications for mono- and diglycerides of fatty acids (E 471)

Commission Regulation (EU) 2023/1428 of 7 July 2023 amending the Annex to Regulation (EU) No 231/2012 as regards mono- and diglycerides of fatty acids (E 471)

Update

Impacted Products

processed food products that use E 471, usually used as an emulsifier (e.g. in baked goods, dairy products, oils and fats, processed meats, confectionery, prepared meals and snacks)

What is changing?

This Regulation establishes stricter rules on the use of mono- and diglycerides of fatty acids (E 471) as food additives.

These include:

establishment of a maximum permitted content of erucic acid in the assay
reduction of maximum limits for arsenic, lead, mercury and cadmium
establishment of a maximum limit for the sum of 3-monochloropropane diol (3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD), and glycidyl fatty acids esters (expressed as glycidol), with stricter levels in foods for infants and young children

Details are given in the Annex to the Regulation.

Why?

The changes reflect concerns about findings of high levels of genotoxic and carcinogenic glycidyl fatty acid esters in E 471 (EFSA 2017, 2021) and recent amendments to legislation on contaminants.

Timeline

The new specifications apply from 30 July 2023. However, where E 471 has been lawfully placed on the EU market before that date, it may be added to food until 30 January 2024.

For glycidyl fatty acid esters, an intermediate maximum level is set between 30 July 2023 and 30 January 2024. In the case of foods for infants and young children, the new maximum level for glycidyl fatty acid esters applies from 30 July 2023.

What are the major implications for exporting countries?

These changes may have an impact on countries exporting food products containing E 471 to the EU market.

If exporting countries fail to comply with the new EU regulations, their products may be rejected at the EU border and prevented from entering the market. This could result in financial losses for exporters and a disruption of trade relations between the exporting country and the EU.

Recommended Actions

Suppliers of processed foods containing E 471 may need to adjust their manufacturing practices and/or safety and quality controls to meet the new requirements.

Resources

EFSA (2017) Re-evaluation of mono- and di-glycerides of fatty acids (E 471) as food additives. EFSA Journal, 15(11): 5045.

EFSA (2021) Opinion on the re‐evaluation of mono‐ and diglycerides of fatty acids (E 471) as food additive in foods for infants below 16 weeks of age and follow‐up of their re‐evaluation as food additives for uses in foods for all population groups. EFSA Journal, 19(11): 6885.

Commission Regulation (EU) 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.

Regulation (EC) 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings.

Sources

Commission Regulation (EU) 2023/1428 of 7 July 2023 amending the Annex to Regulation (EU) No 231/2012 as regards mono- and diglycerides of fatty acids (E 471)

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EU introduces stricter specifications for mono- and diglycerides of fatty acids (E 471)

Regulation (EU) 2023/1428

What is changing and why?

The EU is updating its regulations for mono- and diglycerides of fatty acids, also known as E 471. The new rules will reduce allowable levels of harmful substances like arsenic, lead, mercury and cadmium. They are also introducing stricter production methods to decrease the presence of glycidyl fatty acid esters. This comes after recent studies showed that E 471 has high levels of these esters, which are considered genotoxic and can cause cancer. The changes are in line with the EU's recent updates to its laws on contaminants.

Actions

Countries sending food products containing E 471 to the EU must follow the new rules. If not, the EU might block their products, leading to financial losses and trade issues. Food suppliers with E 471 should update their production and safety checks to meet these rules.

Timeline

The new rules for E 471 are operating from 30 July 2023. But if E 471 was legally on the EU market before then, it can be used in food until 30 January 2024. Between those dates there is a temporary limit for glycidyl fatty acid esters. For baby and toddler foods, the new limit begins on 30 July 2023.