Maximum levels of nitrites and nitrates lowered

Commission Regulation (EU) 2023/2108 of 6 October 2023 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards food additives nitrites (E 249–250) and nitrates (E 251–252)

Update

The EU is reducing the maximum limits of lead, mercury, and arsenic in both nitrites and nitrates, and lowering the maximum levels of nitrites and nitrates that may be used as food additives. The aim is to keep the level of nitrosamines as low as possible while ensuring microbiological safety.

Impacted Products

cheese, meat preparations, meat products, fishery products

What is changing?

The new Regulation:

• Sets new provisions specifically for traditional cured meat products (products category 08.3.4).
• Lowers the maximum limits for the presence of lead, mercury, and arsenic in nitrites (E 249 and E 250) and nitrates (E 251 and E 252) (Annex I).
• Lowers the maximum levels of nitrites and nitrates that may be used as food additives. For nitrites, the maximum levels may not be exceeded. For nitrates, products that exceed the new maximum levels can still be placed on the market, but food business operators should investigate the reasons for these higher levels.
• Expresses the revised maximum levels as nitrite and nitrate ions, in line with the acceptable daily intake (ADI) established by EFSA. (Maximum levels are currently expressed as sodium nitrite or sodium nitrate. The conversion factors are: current level × 0.67 for nitrites; and current level × 0.73 for nitrates.)

For details relating to cheese, see Table 2; for meat products, see Tables 2–6; and for fishery products, see Table 7.

Why?

Food additives used in processed foods are reassessed regularly. The European Commission decided to re-evaluate nitrites and nitrates as food additives for the following reasons.

• All food additives that were permitted in the EU before 20 January 2009 are subject to a new risk assessment by EFSA.
• In its scientific opinions re-evaluating the safety of nitrites and nitrates as food additives, EFSA (2017a, 2017b) found that overall dietary exposure could exceed the ADI, which may indicate a public health concern.
• In most EU Member States, nitrites are usually added to meat products at levels lower than the maximum permitted levels, without impacting microbiological safety. Because the levels are already lower in practice, reducing them in the legislation should be straightforward.
• In Denmark (Commission Decision 2021/741), and in organic meat production (Regulation 2021/1165), there is experience of using lower levels effectively.
• The rules on nitrates are less stringent (exceedances should be investigated but products may be placed on the market) because there is less concern about overexposure to nitrates than nitrites.

Timeline

The Regulation was published on 9 October 2023.

The new rules will apply as follows:

• Limits for lead, mercury, and arsenic: The new maximum limits for potassium nitrite (E 249), sodium nitrite (E 250), sodium nitrate (E 251), and potassium nitrate (E 252) apply from 29 October 2023. If food additives that do not comply with new limits were put on the EU market before 29 October, they may be used in food products until 29 April 2024. Foods put on the market before 29 April 2024 that contain non-compliant food additives may be marketed until their use-by date.
• Levels of nitrites/nitrates in food: The new levels will apply for meat and fishery products (see Tables 3–7) from 9 October 2025. For cheese, the application dates depend on the product concerned (see Table 2 for details). Meat, fishery, and cheese products that have been put on the market before these application dates may continue to be marketed until their use-by date.

What are the major implications for exporting countries?

Non-EU countries exporting meat, fish, and cheese products with added nitrites and nitrates will need to comply with the new lower levels as described in the Timeline.

Background

Regulation 1333/2008 (Annex II) lays down a Union list of food additives approved for use in foods, and their conditions of use.

Regulation 231/2012 lays down specifications for food additives in that Union list.

Potassium nitrite (E 249), sodium nitrite (E 250), sodium nitrate (E 251), and potassium nitrate (E 252) are used as additives for food preservation and food safety, particularly meat, fish, and cheese products. They also contribute to the characteristic taste and other properties of these products.

However, these substances can lead to the formation of nitrosamines, some of which are carcinogenic. There is a need to minimise the risk of nitrosamine formation while maintaining protective effects against bacteria, particularly Clostridium botulinum, which causes botulism.

The maximum levels of nitrites (E 249 and E 250) and nitrates (E 251 and E 252) in foods are usually expressed as the “added amount” rather than the residual amount. The use of maximum levels for both added and residual amounts is in line with the approach agreed by the Codex Committee on Food Additives (Codex 2019, para. 107).

EFSA assessed that the ADIs are 0.07 mg nitrite ion per kg body weight per day, and 3.7 mg nitrate ion per kg body weight per day.

Resources

Sources

Tables & Figures

Source: Regulation 2023/2108, Annex II

Source: Regulation 2023/2108, Annex I

Source: Regulation 2023/2108, Annex I

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Source: Regulation 2023/2108, Annex I

Source: Regulation 2023/2108, Annex I

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Source: Regulation 2023/2108, Annex I

Source: Regulation 2023/2108, Annex I