Changes in conditions of use of certain food additives
Published by AGRINFO on
Commission to review authorisations of certain food additives and set maximum use levels – WTO SPSconsultation
Draft Commission Regulation (EU) amending Annex II and Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the food additives tartaric acid (L(+)-) (E 334), sodium tartrates (E 335), potassium tartrates (E 336), sodium potassium tartrate (E 337) and calcium tartrate (E 354)
Update
The EU has informed the World Trade Organization (WTO) that it intends to review authorisations for tartaric acid (E 334), sodium tartrates (E 335), potassium tartrates (E 336), sodium potassium tartrate (E 337), and calcium tartrate (E 354) (G/SPS/N/EU/733). It also plans to set maximum levels for their use in a wide range of food products.
Impacted Products
Processed foods including baked goods, beverages, confectionery, desserts and jellies, heat-treated meat products, processed fruits, vegetables, and dairy products, processed fish and fishery products (including molluscs and crustaceans), table-top sweeteners, seasonings, condiments
What is changing?
For tartaric acid-tartrates (E 334–337 and E 354), the proposed group acceptable daily intake (ADI) is 240 mg/kg body weight per day, expressed as tartaric acid (EFSA 2020). These additives are removed from Group I (food additives other than colours and sweeteners without a specified ADI) and placed in a new group.
Their conditions of use are also being reviewed. For food categories where data were provided for review by the European Food Safety Authority (EFSA), maximum use levels for additives are proposed, and some inconsistencies regarding conditions of use in different categories will be removed. For food categories where no data were provided, authorisations for use will be withdrawn.
Table 1 summarises the changes outlined in the Draft Annex.
Why?
Food additives used in processed foods are reassessed regularly. The European Commission decided to re-evaluate E 334–E 337 and E 354 to ensure the safe use of these additives in food products. These reassessments, based on EFSA (2020) and industry input, aim to harmonise regulations and ensure the safe, informed use of additives based on current scientific and industry practices.
Timeline
Expected date of adoption: second quarter of 2024.
The Commission proposes a transitional period for products placed on the market before the date the new Regulation takes effect to allow food business operators, including small and medium enterprises, to adapt to the new conditions of use.
Foods containing these additives may remain on the market until their date of minimum durability or use-by date, even if they do not comply with the new rules, provided they have been lawfully placed on the market within 6 months after the Regulation enters into force.
What are the major implications for exporting countries?
Exporting countries must ensure that their food products meet the latest EU standards for food additives. This means adhering to the specific additives listed in Annexes II and III of Regulation 1333/2008, and their allowed quantities. Failure to comply could result in entry into the EU market being refused.
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 30 April 2024.
Background
Tartaric acid (E 334), sodium tartrates (E 335), potassium tartrates (E 336), sodium potassium tartrate (E 337), and calcium tartrate (E 354) are currently authorised for unrestricted use (at “quantum satis”; see note 1) as food additives other than colours and sweeteners (Regulation 1333/2008, Annex II, Part C, Group I).
Regulation 1333/2008 outlines the rules for assessment and approval of food additives within the European Union.
- List of Approved Food Additives (Annex II) specifies which food additives are allowed to be used in various categories of food products. Only the additives listed here are permitted for use, and they must be used according to the specified conditions.
- List for Specific Applications (Annex III) details which food additives can be used in the manufacturing of other food additives, enzymes, and flavourings. Additives must be used as outlined in this list to comply with the Regulation.
The European Commission’s Food Additives Database lists which additives may be used in which foods, and their conditions of use.
Regulation 1333/2008 also specifies the maximum allowable amounts that can be used in food products. These limits are determined based on two main principles:
- minimal necessary quantity: additives should be employed in the smallest quantity required to achieve their intended function, such as food preservation or flavour enhancement
- safety considerations: the applied quantities must ensure safety for all consumer groups, reflecting the ADI levels, particularly for populations with potentially higher consumption.
Note 1
Quantum satis is Latin for "as much as is enough". It means that the food additive can be used in a food product in any amount necessary to achieve the desired effect, without a specified upper limit, provided it is safe and in accordance with good manufacturing practices.
Resources
EFSA (2020) Re-evaluation of l(+)-tartaric acid (E 334), sodium tartrates (E 335), potassium tartrates (E 336), potassium sodium tartrate (E 337) and calcium tartrate (E 354) as food additives. EFSA Journal, 18(3): 6030.
Online resources from the European Commission:
Regulation (EC) No 1333/2008 on food additives
Sources
Draft Commission Regulation (EU) as regards the food additives tartaric acid (L(+)-) (E 334), sodium tartrates (E 335), potassium tartrates (E 336), sodium potassium tartrate (E 337) and calcium tartrate (E 354)
Tables & Figures
Source: Draft Annex
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.