Draft Commission Regulation 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 the food additives nitrites (E 249-250) and nitrates (E 251-252) and Annexes

Update

The EU proposes to reduce the limits of lead, mercury and arsenic in both nitrites and nitrates, and to lower the maximum amounts 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

What is changing?

The EU proposes to:

• Extend the scope of products in the cured meat products category (08.3.4).
• Lower 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).
• Lower the maximum amounts of nitrites and nitrates that may be used as food additives.
• Express 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.)
• Establish maximum residual levels from all sources throughout the shelf-life of products (including food additives, natural presence and contamination, among others). For nitrates, products that exceed these new maximum residual levels can still be placed on the market, but food business operators should investigate the reasons for this excess (Annex II).

For details see AGRINFO Tables 1–7 below.

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 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.

Timeline

WTO consultation open until 19 September 2023.

Expected date of adoption and publication: third quarter 2023.

• The additives potassium nitrite (E 249), sodium nitrite (E 250), sodium nitrate (E 251) and/or potassium nitrate (E 252) exceeding the maximum limits for lead, mercury and arsenic (Annex II) may be added to food until 6 months after this Regulation enters into force.
• Foods to which the above substances have been added during that 6-month period can continue to be placed on the market within the 6 month period, and can be marketed until their use-by date.
• Foods already on the market, or placed on the market within 6 months after the Regulation enters into force, may continue to be marketed until their use-by date.

What are the major implications for exporting countries?

Non-EU countries exporting cheese, meat preparations and meat products with added nitrites and nitrates will need to comply with the new lower levels when the Regulation comes into force.

Recommended Actions

Comments or concerns about potential impacts can be submitted, via the National SPS notification authority of the country concerned, to the EU SPS Enquiry Point until 19 September 2023.

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 ADI for nitrites is 0.07 mg nitrite ion/kg body weight per day and of 3.7 mg nitrate ion/kg body weight per day.

Resources

Sources

Tables & Figures

Source: Annex II to the draft Regulation

Source: Annex I to the draft Regulation

Source: Annex I to the draft Regulation

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Source: Annex I to the draft Regulation

Source: Annex I to the draft Regulation

Source: Annex I to the draft Regulation

Source: Annex I to the draft Regulation