[:uk]Commission Regulation (EU) 2024/2597 of 4 October 2024 brings amendments to existing EU legislation concerning the use and specifications of certain food additives, specifically sorbic acid (E 200), potassium sorbate (E 202), and propyl gallate (E 310).
**Amendments to Annex II of Regulation (EC) No 1333/2008:**
1. **Extended Use of Sorbic Acid and Potassium Sorbate:**
– **Food Category 16 Update:** In Part E of Annex II, under food category 16 (“Desserts excluding products covered in categories 1, 3, and 4”), the permitted use of sorbic acid (E 200) and potassium sorbate (E 202) at a maximum level of 1,000 mg/kg has been revised.
– **New Inclusion:** The previous allowance for these additives in “frugtgrød, rote Grütze, and pasha” has been expanded to include “fruit-flavoured water-based gelatine desserts.”
– **Usage Conditions:** The additives can now be used in these additional desserts at the specified maximum level, adhering to any specific notes or conditions outlined in the regulation.
**Amendments to the Annex of Regulation (EU) No 231/2012:**
1. **Sorbic Acid (E 200) Specifications:**
– **Description Update:**
– Sorbic acid is now described as “colourless needles or white free-flowing crystalline powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 °C.”
– **Purity Criteria Revised:**
– **Water Content:** Not more than 0.5% (determined by the Karl Fischer method).
– **Sulphated Ash:** Not more than 0.2%.
– **Aldehydes:** Not more than 0.1% (expressed as formaldehyde).
– **Arsenic:** Maximum limit reduced to 0.1 mg/kg.
– **Lead:** Maximum limit reduced to 0.1 mg/kg.
– **Mercury:** Maximum limit set at 0.01 mg/kg.
– **Zinc:** A new maximum limit established at 0.1 mg/kg.
2. **Potassium Sorbate (E 202) Specifications:**
– **Description Update:**
– Potassium sorbate is now described as “white crystalline powder or granules showing no change in colour after heating for 90 minutes at 105 °C,” acknowledging both powder and granular forms.
– **Purity Criteria Revised:**
– **Loss on Drying:** Not more than 1.0% (after drying at 105 °C for 3 hours).
– **Acidity or Alkalinity:** Not more than about 1.0% (calculated as sorbic acid or K₂CO₃).
– **Aldehydes:** Not more than 0.1%, calculated as formaldehyde.
– **Arsenic:** Maximum limit reduced to 0.1 mg/kg.
– **Lead:** Maximum limit reduced to 0.1 mg/kg.
– **Mercury:** Maximum limit set at 0.01 mg/kg.
– **Zinc:** A new maximum limit established at 0.1 mg/kg.
3. **Propyl Gallate (E 310) Specifications:**
– **Definition Included:**
– Propyl gallate is defined as being produced by the esterification of gallic acid with propanol, using sulphuric acid as a catalyst.
– Additional chemical identifiers provided:
– **Einecs Number:** 204-498-2.
– **Chemical Names:** Propyl gallate; Propyl ester of gallic acid; n-propyl ester of 3,4,5-trihydroxybenzoic acid.
– **Chemical Formula:** C₁₀H₁₂O₅.
– **Molecular Weight:** 212.20.
– **Assay:** Content not less than 98% on the anhydrous basis.
– **Purity Criteria Revised:**
– **Loss on Drying:** Not more than 0.5% (after drying at 110 °C for 4 hours).
– **Sulphated Ash:** Not more than 0.1%.
– **Free Acid:** Not more than 0.5% (expressed as gallic acid).
– **Specific Absorption in Ethanol:** At 275 nm, values should be not less than 485 and not more than 520.
– **Arsenic:** Maximum limit set at 0.1 mg/kg.
– **Lead:** Maximum limit reduced to 0.3 mg/kg.
– **Mercury:** Maximum limit set at 0.1 mg/kg.
– **Manufacturing Process Clarification:** The definition specifies that hydrochloric acid is not used as a catalyst, ensuring no chlorinated by-products are formed.
**Transitional Provisions:**
– **Implementation Date:** The new purity specifications and definitions for sorbic acid (E 200), potassium sorbate (E 202), and propyl gallate (E 310) will be applicable from 27 April 2025.
– **Existing Stocks of Additives:**
– Additives placed on the market before 27 April 2025 may continue to be used in foods according to the previous regulations until stocks are exhausted.
– **Foods Containing These Additives:**
– Foods that were lawfully placed on the market before 27 April 2025 and contain the specified additives can be marketed until their “date of minimum durability” or “use-by date.”
**Entry into Force:**
– **Effective Date:** The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
– **Specific Provisions Application:** Certain amendments (specified in points (1)(b), (2)(b), and (3) of Annex II) will apply starting from 27 April 2025.
**Regulation Adoption Details:**
– **Adoption Date:** 4 October 2024.
– **Authority:** The regulation was adopted by the European Commission.
– **Signatory:** Ursula von der Leyen, President of the European Commission.
**Summary of Key Changes:**
– **Extended Use in Desserts:** Sorbic acid and potassium sorbate can now be used as preservatives in fruit-flavoured water-based gelatine desserts, in addition to previously specified desserts.
– **Updated Specifications:** More stringent purity criteria for sorbic acid, potassium sorbate, and propyl gallate, including lower permissible levels of toxic elements and clarification of manufacturing processes.
– **Transitional Measures:** Businesses are given time to adapt to the new requirements, with provisions for the use of existing stocks and continued marketing of certain foods.[:]
