Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additivesnote, and in particular Article 10(3) and Article 14 thereof,Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavouringsnote, and in particular Article 7(5) thereof,Whereas:
(1)Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.
(2)Commission Regulation (EU) No 231/2012note lays down specifications for food additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.
(3)Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives and specifications for food additives may be updated either on the initiative of the Commission or following an application from a Member State or an interested party.
(4)In September 2016, an application was submitted to the Commission for the authorisation of use of curdlan as a gelling agent, firming agent, stabiliser and thickener in a broad variety of food categories. The application was subsequently made available to Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.
(5)Curdlan is a high molecular weight linear polysaccharide with thermal gelling properties, produced by fermentation from Rhizobium radiobacter biovar 1 strain NTK-u. It forms irreversible ‘high-set’ gels upon heating in aqueous suspension at temperatures above 80 °C and reversible ‘low-set’ gels, when heated in aqueous suspension at temperatures from 55 °C to 65 °C and then cooled at ≤ 40 °C. Curdlan is intended for use as a firming agent, gelling agent, stabiliser and thickener in a broad variety of foods to improve their textural properties, water-holding capacity and thermal stability, such as noodles, dumplings, processed meat products, fish pastes, cakes, sauces, soups, processed tofu and snacks.
(6)In the opinion published on 9 September 2024note, the European Food Safety Authority (‘the Authority’) evaluated the safety of the proposed use of curdlan as a food additive. Despite the limitations noted in the dataset, the Authority was able to assess the safety by applying the margin of exposure (MOE) approach and concluded that there is no safety concern for the use of curdlan as a food additive at the proposed uses and use levels.
(7)It is therefore appropriate to authorise the use of curdlan as a food additive and to assign E 424 as the E-number to that additive.
(8)The specifications for curdlan (E 424) should therefore be included in the Annex to Regulation (EU) No 231/2012, as this additive is included in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time.
(9)Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly.
(10)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1#
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.
Article 2#
The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.
Article 3#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Annex I
(1)in Part B, point 3 ‘Additives other than colours and sweeteners’, the following entry is inserted after the entry for food additive E 423, Octenyl succinic acid modified gum arabic:E 424 | Curdlan
(2)Part E is amended as follows:
(a)in category 01.7.5 (Processed cheese), the entry for E 424 (Curdlan) is inserted after the entry for E 338-452, Phosphoric acid – phosphates – di-, tri- and polyphosphates:| E 424 | Curdlan | 40000 | |
(aa)in category 10.2 (Processed eggs and egg products), the entry for E 424 (Curdlan) is inserted after the entry for E 392, Extracts of rosemary:| E 424 | Curdlan | 20000 | |
(b)in category 02.2.2 (Other fat and oil emulsions including spreads as defined by Regulation (EC) No 1234/2007 and liquid emulsions), the entry for E 424 (Curdlan) is inserted after the entry for E 405, Propane-1, 2-diol alginate:| E 424 | Curdlan | 50000 | |
(bb)in category 12.4 (Mustard), the entry for E 424 (Curdlan) is inserted before the entry for E 392, Extracts of rosemary:| E 424 | Curdlan | 30000 | |
(c)in category 03. (Edible ices),the entry for E 424 (Curdlan) is inserted after the entry for E 405, Propane-1, 2-diol alginate:| E 424 | Curdlan | 30000 | |
(cc)in category 12.5 (Soups and broths), the entry for E 424 (Curdlan) is inserted after the entry for E 392, Extracts of rosemary:| E 424 | Curdlan | 10000 | |
(d)in category 04.2.1 (Dried fruit and vegetables), the entry for E 424 (Curdlan) is inserted before the entry for E 907, Hydrogenated poly-1-decene:| E 424 | Curdlan | 50000 | | may not be used to produce dehydrated foods intended to rehydrate on ingestion
(dd)in category 12.6 (Sauces), the entry for E 424 (Curdlan) is inserted after the entry for E 392, Extracts of rosemary:| E 424 | Curdlan | 30000 | |
(e)In category 04.2.2 (Fruit and vegetables in vinegar, oil, or brine), the entry for E 424 (Curdlan) is inserted before the entry for E 579, Ferrous gluconate:| E 424 | Curdlan | 50000 | |
(ee)in category 12.7 (Salads and savoury based sandwich spreads), the entry for E 424 (Curdlan) is inserted after the entry for E 334-337 and E 354, Tartaric acid – tartrates:| E 424 | Curdlan | 30000 | |
(f)in category 04.2.3 (Canned or bottled fruit and vegetables), the entry for E 424 (Curdlan) is inserted after the entry for E 415, Xanthan gum:| E 424 | Curdlan | 50000 | | only chestnuts in liquid
(ff)in category 12.9 (Protein products, excluding products covered in category 1.8), the entry for E 424 (Curdlan) is inserted after the entry for E 338-452, Phosphoric acid – phosphates – di-, tri- and polyphosphates:| E 424 | Curdlan | 80000 | |
(g)in category 04.2.4.1 (Fruit and vegetable preparations excluding compote), the entry for E 424 (Curdlan) is inserted after the entry for E 405, Propane-1, 2-diol alginate:| E 424 | Curdlan | 50000 | |
(gg)in category 15.1 (Potato-, cereal-, flour- or starch-based snacks), the entry for E 424 (Curdlan) is inserted after the entry for E 416, Karaya gum:| E 424 | Curdlan | 10000 | |
(h)in category 04.2.5.3 (Other similar fruit or vegetable spreads), the entry for E 424 (Curdlan) is inserted after the entry for E 418, Gellan gum:| E 424 | Curdlan | 10000 | (32) |
(hh)in category 16 (Desserts excluding products covered in categories 1, 3 and 4), the entry for E 424 (Curdlan) is inserted after the entry for E 416, Karaya gum:| E 424 | Curdlan | 30000 | |
(i)in category 04.2.5.4 (Nut butters and nut spreads), the entry for E 424 (Curdlan) is inserted after the entry for E 392, Extracts of rosemary:| E 424 | Curdlan | 50000 | |
(j)in category 04.2.6 (Processed potato products), the entry for E 424 (Curdlan) is inserted after the entry for E 392, Extracts of rosemary:| E 424 | Curdlan | 50000 | |
(k)in category 05.1 (Cocoa and chocolate products as covered by Directive 2000/36/EC), the entry for E 424 (Curdlan) is inserted after the entry for E 422, Glycerol:| E 424 | Curdlan | 30000 | | only energy-reduced or with no added sugar
(l)in category 05.2 (Other confectionery including breath refreshening microsweets), the entry for E 424 (Curdlan) is inserted after the entry for E 405, Propane-1, 2-diol alginate:| E 424 | Curdlan | 50000 | | may not be used in jelly mini-cups, defined, for the purpose of this Regulation, as jelly confectionery of a firm consistence, contained in semi rigid mini-cups or mini-capsules, intended to be ingested in a single bite by exerting pressure on the mini-cups or mini-capsule to project the confectionery into the mouth; may not be used to produce dehydrated foods intended to rehydrate on ingestion
(m)in category 05.3 (Chewing gum), the entry for E 424 (Curdlan) is inserted after the entry for E 416, Karaya gum:| E 424 | Curdlan | 10000 | |
(n)in category 05.4 (Decorations, coatings and fillings, except fruit-based fillings covered by category 4.2.4), the entry for E 424 (Curdlan) is inserted after the entry for E 423, Octenyl succinic acid modified gum arabic:| E 424 | Curdlan | 5000 | |
(o)in category 06.3 (Breakfast cereals), the entry for E 424 (Curdlan) is inserted after the entry for E 338-452, Phosphoric acid – phosphates – di-, tri- and polyphosphates:| E 424 | Curdlan | 20000 | |
(p)in category 06.4.2 (Dry pasta), the entry for E 424 (Curdlan) is inserted after the entry for Group I Additives:| E 424 | Curdlan | 20000 | | only gluten-free pasta (as food specially produced to reduce the gluten content of gluten-containing ingredients or substitute the gluten-containing ingredients) and pasta intended for hypoproteic diets
(q)in category 06.4.4 (Potato gnocchi), the entry for E 424 (Curdlan) is inserted after the entry for E 330, Citric acid:| E 424 | Curdlan | 20000 | | except fresh refrigerated potato gnocchi
(r)in category 06.4.5 (Fillings of stuffed pasta (ravioli and similar), the entry for E 424 (Curdlan) is inserted after the entry for E 392, Extracts of rosemary:| E 424 | Curdlan | 20000 | |
(s)in category 06.5 (Noodles), the entry for E 424 (Curdlan) is inserted after the entry for E 338-452, Phosphoric acid – phosphates – di-, tri- and polyphosphates:| E 424 | Curdlan | 20000 | |
(t)in category 06.6 (Batters), the entry for E 424 (Curdlan) is inserted after the entry for E 338-452, Phosphoric acid – phosphates – di-, tri- and polyphosphates:| E 424 | Curdlan | 5000 | |
(u)in category 07.1 (Bread and rolls), the entry for E 424 (Curdlan) is inserted after the entry for E 338-452, Phosphoric acid – phosphates – di-, tri- and polyphosphates:| E 424 | Curdlan | 20000 | | except products in 7.1.1 and 7.1.2
(v)in category 07.2 (Fine bakery wares), the entry for E 424 (Curdlan) is inserted after the entry for E 338-452, Phosphoric acid – phosphates – di-, tri- and polyphosphates:| E 424 | Curdlan | 20000 | |
(w)in category 08.2 (Meat preparations as defined by Regulation (EC) No 853/2004), the entry for E 424 (Curdlan) is inserted after the entry for E 415, Xanthan gum:| E 424 | Curdlan | 20000 | | only preparations heat-treated before consumption in which ingredients have been injected; meat preparations heat-treated before consumption composed of meat parts that have been handled differently: minced, sliced or processed and that are combined together. Except bifteki, soutzoukaki, kebap, gyros and souvlaki
(x)in category 08.3.2 (Heat-treated meat products), the entry for E 424 (Curdlan) is inserted before the entry for E 427, Cassia gum:| E 424 | Curdlan | 20000 | | except foie gras, foie gras entier, blocs de foie gras, Libamáj, libamáj egészben, libamáj tömbben
(y)in category 08.3.3 (Casings and coatings and decorations for meat), the entry for E 424 (Curdlan) is inserted after the entry for E 339, Sodium phosphates:| E 424 | Curdlan | 20000 | |
(z)in category 09.2 (Processed fish and fishery products including mollusks and crustaceans), the entry for E 424 (Curdlan) is inserted before the entry for E 450, Diphosphates:| E 424 | Curdlan | 30000 | |
Annex II to Regulation (EC) No 1333/2008 is amended as follows:
Annex II
In the Annex to Regulation (EU) No 231/2012, the following entry is inserted after the entry for food additive E 423 OCTENYL SUCCINIC ACID MODIFIED GUM ARABIC:
E 424 CURDLANSynonyms | (1 → 3)-ß-d-GlucanDefinition | Curdlan is a high molecular weight polysaccharide consisting of β-1,3-linked glucose units, produced by pure-culture fermentation from a non-pathogenic and non-toxicogenic Rhizobium radiobacter biovar 1 strain NTK-u. Curdlan consists of β-(1,3)-linked glucose residues and has the unusual property of forming an elastic gel upon heating in its aqueous suspension. Crude curdlan is purified through several steps, which include alkaline dissolution and crystallisation in methanol. The crystallised solution is subjected to purification steps, i.e. centrifugation, washing and centrifugation once more. Then the product is dried, milled and sieved to obtain the final product.CAS number | 54724-00-4Chemical formula | H•(C6H10O5)n•OHAverage molecular weight | Not less than 1,4 × 106 DaAssay (calculated as anhydrous glucose) | Not less than 80 %Description | Odourless or almost odourless, white to nearly white powderIdentificationSolubility | Insoluble in water and ethanolSolubility in alkali | Passes testSuspend 0,2 g of the sample in 5 mL of water, add 1 mL of 3 N sodium hydroxide and shake. The sample dissolves.Gel formation | Heat a 2 % aqueous suspension of the sample in a boiling water bath for 10 min and cool. A firm gel forms.Precipitate formation with cupric tartrate | Passes testpH | Between 6,0-7,5 (1 % aqueous suspension)Gel strength | Not less than 600 g/cm2PurityLoss on drying | Not more than 10 %Residue on ignition | Not more than 6 %Sulfated ash | Not more than 6 %Nitrogen | Not more than 0,3 %Arsenic | Not more than 0,05 mg/kgLead | Not more than 0,2 mg/kgMethanol | Not more than 10 mg/kgMicrobiological criteriaTotal plate count | Not more than 1000 CFU/gColiforms | Absent in 1 gEscherichia coli | Absent in 1 g
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.