Download March 20, 2015 Supersedes: September 29, 2014 Food Additive

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Effective: March 20, 2015 Supersedes: September 29, 2014 Food Additive Status WALOCEL™ Sodium Carboxymethylcellulose Food and Premium Grade Products CLEAR+STABLE™ Sodium Carboxymethylcellulose Safety as Food Additives The safety of cellulose and cellulose derivatives, including sodium carboxymethylcellulose, as food additives has been extensively evaluated by regulatory bodies including the former EU Scientific Committee on Food (SCF), the WHO/FAO Joint Expert Committee on Food Additives, the US Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA). These evaluations led to these products being allocated an Acceptable Daily Intake (ADI) of “not specified”. This means that cellulose derivatives when used as food additives will not have adverse effects on human health at any point in a person’s life, even if they are consumed daily. This “not specified” ADI allows the derivatives to be used in processed foodstuffs at levels equal to Quantum Satis. In practice, this means that the use level for the additive corresponds with the level needed to achieve the desired technological effect. European Food Additive Compliance Status Dow’s food and pharma grade sodium carboxymethylcellulose products are compliant with Regulation (EC) No. 1333/2008 (as amended)1, of the European Parliament and of the Council of 16 December 2008 on food additives. This Regulation came into effect in the European Union on 20 January 2010. Sodium carboxymethylcellulose appears in Annex II to Regulation (EC) 1129/2011 (as amended)2 which is a list of additives authorized at Community level and giving conditions of use. Sodium carboxymethylcellulose is listed in: •
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Part B Table 3 which lists additives other than colours and sweeteners. Sodium carboxymethylcellulose is designated as E 466. Part C Group 1 which lists additives generally permitted for use at quantum satis levels in a wide range of foodstuffs. Part E Authorized food additives and conditions of use in food categories. The table attached in the Annex to this statement lists in which food categories E 466 can and cannot be used, along with any use restrictions. Where no restriction is given, E 466 can be used at quantum satis levels. Note that if E 466 is not listed in a specific category of interest, please contact us to discuss further as various principles, such as carry‐over, may be applicable. ®™Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow Page 1 of 12 The Annexes to Regulation 1333/2008 have applied as of 1st June 2013 and repeal Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners. When compared with Directive 95/2/EC, the regulatory status of E 466 remains unchanged in the new Annex II to Regulation 1333/2008. Dow’s WALOCEL and CLEAR+STABLE sodium carboxymethylcellulose food and premium grade products also comply with Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council. This Regulation repealed Directive 2008/84 on 1 December 2012. Regulation (EU) No 1274/2013 and impact on manufacturers of E466 On 6 December 2013, Commission Regulation (EU) No 1274/2013 amending and correcting Annexes II and III 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 certain food additives, was published in the Official Journal of the European Union. This Regulation enters into force on December 26th, 2014 and changes additives names and specifications relating to additives No E151, E460 and E466. What has changed in relation to E466? Prior to the publication of Regulation 1274/2013, E466 appears in Annexes II and III to Regulation 1333/20008 with three synonyms: • carboxymethylcellulose • sodium carboxymethylcellulose • cellulose gum In 2012, OFCA sent a proposal to the Commission requesting the removal of carboxymethylcellulose (CMC, free acid) as synonym for E466. The reasons for this being: •
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Carboxymethylcellulose has a different CAS number compared to sodium carboxymethylcellulose. Carboxymethylcellulose has not been evaluated by SCF or Jecfa as food additive. The WHO/FAO INS list does not include carboxymethylcellulose (no INS number). The WHO/FAO has already removed the abbreviation CMC from the list of synonyms in the Jecfa specification. Regulation 1274/2013 sees the removal of the synonym ‘carboxymethylcellulose’ from both Annex II and III to Regulation 1333/2008. 1 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives 2
Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives ®™Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow Page 2 of 12 If you have any questions or require further information, please contact us via our web site at http://dowwolff.custhelp.com/ (Answer Center, Ask a Question tab). This information is considered accurate and reliable as of the date appearing above and is presented in good faith. Because use conditions and applicable laws may differ from one location to another and may change with time, Recipient is responsible for determining whether the information in this document is appropriate for recipient’s use. Since Dow has no control over how this information may be ultimately used, all liability is expressly disclaimed and Dow assumes no obligation or liability therefore. No warranty, express or implied, is given nor is freedom from any patent owned by Dow or others to be inferred. ®™Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow Page 3 of 12 Annex – EU food categories per Annex II Part E to Regulation (EU) No 1129/2011 and the compliance status of sodium carboxymethylcellulose. SODIUM CARBOXYMETHYLCELLULOSE (E 466) Category Sub Number Category FOOD CATEGORY Listed Yes/No Restrictions 0 Food additives permitted in all categories of food 0 As above No 1 Dairy products and analogues 1.1 Unflavoured pasteurised and sterilised (including UHT) milk No 1.2 Unflavoured fermented milk products, including natural unflavoured buttermilk (excluding sterilised buttermilk) non‐heat‐
treated after fermentation Yes 1.3 Unflavoured fermented milk products, heat‐treated after fermentation Yes 1.4 Flavoured fermented milk products including heat‐treated products Yes 1.5 Dehydrated milk as defined by Directive 2001/114/EC No 1.6 Cream and cream powder 1.7 01.6.1 Unflavoured pasteurised cream (excluding reduced fat creams) No 01.6.2 Unflavoured live fermented cream products and substitute products with a fat content of less than 20 % Yes 01.6.3 Other creams Yes Cheese and cheese products 01.7.1 Unripened cheese excluding products falling in category 16 Yes Except mozzarella, and unflavoured live fermented unripened cheese 01.7.2 Ripened cheese No 01.7.3 Edible cheese rind No 01.7.4 Whey cheese No 01.7.5 Processed cheese Yes ®™Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow Page 4 of 12 1.8 01.7.6 Cheese products (excluding products Yes falling in category 16) Dairy analogues, including beverage whiteners Yes 2. Fats and oils and fat and oil emulsions 2.1 2.2 Fat and oil emulsions mainly of type water‐in‐oil 2.3 Fats and oils essentially free from water (excluding anhydrous milkfat) No 02.2.1 Butter and concentrated butter and butter oil and anhydrous milkfat No 02.2.2 Other fat and oil emulsions including Yes spreads as defined by Regulation (EC) No 1234/2007 and liquid emulsions Vegetable oil pan spray Yes As above Yes 3. Edible ices 3 4. Fruit and vegetables 4.1 4.2 04.2.5 Unprocessed fruit and vegetables 04.1.1 Entire fresh fruit and vegetables No 04.1.2 Peeled, cut and shredded fruit and vegetables No 04.1.3 Frozen fruit and vegetables No Processed fruit and vegetables 04.2.1 Dried fruit and vegetables Yes 04.2.2 Fruit and vegetables in vinegar, oil, or brine Yes 04.2.3 Canned or bottled fruit and vegetables No 04.2.4 Fruit and vegetable preparations, excluding products covered by 5.4 04.2.4.1 Fruit and vegetable preparations excluding compote Yes 04.2.4.2 Compote, excluding products covered by category 16 No Jam, jellies and marmalades and similar products ®™Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow Page 5 of 12 04.2.5.1 Extra jam and extra jelly as defined by Directive 2001/113/EC No 04.2.5.2 Jam, jellies and marmalades and sweetened chestnut puree as defined by Directive 2001/113/EC No 04.2.5.3 Other similar fruit or vegetable spreads No 04.2.5.4 Nut butters and nut spreads Yes 04.2.6 Processed potato products Yes 5. Confectionery 5.1 Cocoa and chocolate products as covered by Directive 2000/36/EC Yes Only energy‐reduced or with no added sugar 5.2 Other confectionery including breath refreshening microsweets Yes 5.3 Chewing gum Yes 5.4 Decorations, coatings and fillings, Yes except fruit based fillings covered by category 4.2.4 6. Cereals and cereal products 6.1 6.2 Whole, broken, or flaked grain Flours and other milled products and starches 06.2.1 Flours No 06.2.2 Starches Yes 6.3 Breakfast cereals 6.3 6.4 Pasta 6.5 No As above Yes 06.4.1 Fresh pasta No 06.4.2 Dry pasta Yes Only gluten free and/or pasta intended for hypoproteic diets in accordance with Directive 2009/39/EC 06.4.3 Fresh pre‐cooked pasta No 06.4.4 Potato gnocchi Yes 06.4.5 Fillings of stuffed pasta (ravioli and similar) Yes Noodles Yes ®™Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow Page 6 of 12 6.6 Batters Yes 6.7 Pre‐cooked or processed cereals Yes Bread and rolls
Yes
07.1.1 Bread prepared solely with the following ingredients: wheat flour, water, yeast or leaven, salt No 07.1.2 Pain courant français; Friss búzakenyér, fehér és félbarna kenyerek No Fine bakery wares Yes 7. Bakery wares 7.1 7.2 8. Meat 8.1 8.2 08.2.4 Unprocessed meat 08.1.1 Unprocessed meat other than meat preparations as defined by Regulation (EC) No 853/2004 No 08.1.2 Meat preparations as defined by Regulation (EC) No 853/2004 No Processed meat 08.2.1 Non‐heat‐treated processed meat Yes 08.2.2 Heat‐treated processed meat Yes except foie gras, foie gras entier, blocs de foie gras, Libamáj, libamáj egészben, libamáj tömbben 08.2.3 Casings and coatings and decorations for meat Yes Traditionally cured meat products with specific provisions concerning nitrites and nitrates 08.2.4.1 Traditional immersion cured products (Meat products cured by immersion in a curing solution containing nitrites and/or nitrates, salt and other components) No 08.2.4.2 Traditional dry cured products. (Dry curing process involves dry application of curing mixture containing nitrites and/or nitrates, salt and other components to the surface of the meat followed by a period of stabilisation/maturation). No ®™Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow Page 7 of 12 08.2.4.3 Other traditionally cured products. No (Immersion and dry cured processes used in combination or where nitrite and/or nitrate is included in a compound product or where the curing solution is injected into the product prior to cooking) 9. Fish and fisheries products 9.1 Unprocessed fish and fisheries products 09.1.1 Unprocessed fish No 09.1.2 Unprocessed molluscs and crustaceans No 9.2 Processed fish and fishery products including mollusks and crustaceans Yes 9.3 Fish roe Yes Only processed fish roe 10. Eggs and egg products 10.1 Unprocessed eggs No 10.2 Processed eggs and egg products Yes 11. Sugars, syrups, honey and table‐top sweeteners 11.1 Sugars and syrups as defined by Directive 2001/111/EC No 11.2 Other sugars and syrups Yes 11.3 Honey as defined in Directive 2001/110/EC N/A 11. 4 Table‐top sweeteners 11.4.1 Table‐top sweeteners in liquid form Yes 11.4.2 Table‐top sweeteners in powder form Yes 11.4.3 Table‐top sweeteners in tablets Yes 12 Salts, spices, soups, sauces, salads and protein products 12.1 Salt and salt substitutes 12.1.1 Salt No 12.1.2 Salt substitutes Yes ®™Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow Page 8 of 12 12.2 Herbs, spices, seasonings 12.2.1 Herbs and spices No 12.2.2 Seasonings and condiments Yes 12.3 Vinegars Yes 12.4 Mustard Yes 12.5 Soups and broths Yes 12.6 Sauces Yes 12.7 Salads and savoury based sandwich spreads Yes 12.8 Yeast and yeast products Yes 12.9 Protein products, excluding products Yes covered in category 1.8 13 Foods intended for particular nutritional uses as defined by Directive 2009/39/EC 13.1 Foods for infants and young children 13.1.1 Infant formulae as defined by Commission Directive 2006/141/EC ( 1 ) No 13.1.2 Follow‐on formulae as defined by Directive 2006/141/EC No 13.1.3 Processed cereal‐based foods and baby foods for infants and young children as defined by Commission Directive 2006/125/EC ( 2 ) No 13.1.4 Other foods for young children No 13.1.5 Dietary foods for infants and young children for special medical purposes as defined by Commission Directive 1999/21/EC ( 3 ) and special formulae for infants 13.1.5.1 Dietary foods for infants for special medical purposes and special formulae for infants Yes 13.1.5.2 Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC Yes ®™Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow Page 9 of 12 13.2 Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5) Yes 13.3 Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet) Yes 13.4 Foods suitable for people intolerant to gluten as defined by Commission Regulation (EC) No 41/2009 ( 4 ) Yes 14. Beverages 14.1 Non‐alcoholic beverages 14.1.1 Water, including natural mineral water as defined in Directive 2009/54/EC and spring water and all other bottled or packed waters No 14.1.2 Fruit juices as defined by Directive 2001/112/EC and vegetable juices Yes Only vegetable juices 14.1.3 Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products Yes 14.1.4 Flavoured drinks Yes 14.1.5 Coffee, tea, herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products 14.1.5.1 Coffee, coffee extracts No 14.1.5.2 Other Yes Excluding unflavoured leaf tea; including flavoured instant coffee ®™Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow Page 10 of 12 14.2 Alcoholic beverages, including alcohol‐free and low‐alcohol counterparts 14.2.1 Beer and malt beverages No 14.2.2 Wine and other products defined by Regulation (EEC) No 1234/2007, and alcohol‐free counterparts The use of additives is authorised in accordance with Regulation 1324/2007, Decision 2006/232/EC, Regulation 606/2009 and their implementing measures 14.2.3 Cider and perry Yes 14.2.4 Fruit wine and made wine Yes 14.2.5 Mead Yes 14.2.6 Spirit drinks as defined in Regulation (EC) No 110/2008 Yes Except whisky or whiskey 14.2.7 Aromatised wine‐based products as defined by Regulation (EEC) No 1601/91 14.2.7.1 Aromatised wines Yes 14.2.7.2 Aromatised wine‐based drinks Yes 14.2.7.3 Aromatised wine‐product cocktails Yes 14.2.8 Other alcoholic drinks including mixtures of alcoholic drinks with non‐alcoholic drinks and spirits with less than 15 % of alcohol Yes 15. Ready‐to‐eat savouries and snacks 15.1 Potato‐, cereal‐, flour‐ or starch‐
based snacks Yes 15.2 Processed nuts Yes 16. Desserts excluding products covered in categories 1, 3 and 4 16 As above Yes ®™Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow Page 11 of 12 17. Food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council ( 5 ) excluding food supplements for infants and young children 17.1 Food supplements supplied in a solid Yes form including capsules and tablets and similar forms, excluding chewable forms 17.2 Food supplements supplied in a liquid form Yes 17.3 Food supplements supplied in a syrup‐type or chewable form Yes 18. Processed foods not covered by categories 1 to 17, excluding foods for infants and young children 18 As above Yes ®™Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow Page 12 of 12