Regulation No. 292 establishing the Artificial Flavourings Permitted in Food, Maximum Limits by Food Groups, Requirements for Flavourings, Conditions and Methods for Use and Production and Special Requirements for Labelling of Such Substances

Establishment of List of Artificial Flavourings Permitted in Food, Maximum Limits by Food Groups, Requirements for Flavourings, Conditions and Methods for Use and Production and Special Requirements for Labelling of Such Substances Government of the Republic Regulation No. 292 of 6 October 1999 (RT1 I 1999, 74, 702), entered into force 1 January 1996, partially 1 January 2001, amended by the following Regulation: 22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424. Pursuant to subsection 17 (2) and subsection 38 (5) of the Food Act (RT I 1999, 30, 415; 58, 608), and having regard to the requirements of the Directives of the European Economic Communities 88/388/EEC (OJ L 184, 15.07.1988, p. 61) and 91/71/EEC (OJ L 42, 5.02.1991, p. 25), the Government of the Republic resolves: 1. The list of artificial flavourings permitted in food and used to impart odour or taste to food (hereinafter flavourings) and as raw material for production of flavourings according to the method for the production thereof: (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 1) natural flavouring substance which is obtained by traditional food-preparation processes, including drying, torrefaction and fermentation, from unprocessed or processed vegetable or animal raw material for food (hereinafter raw material for food) by appropriate physical processes, including distillation and solvent extraction, by enzymatic or micro-biological processes; (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 2) nature-identical flavouring substance which is obtained by chemical synthesis or is isolated from raw material for food by chemical processes and which is chemically identical to a substance present in raw material for food described in subclause 1) of this clause; (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 3) synthetic flavouring substance which is obtained by chemical synthesis and which is not chemically identical to a substance present in raw material for food described in subclause 1) of this clause; (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 4) natural flavouring preparation means a product with flavouring properties, except natural flavouring substance, which is obtained by appropriate physical, enzymatic or micro-biological processes raw material for food described in subclause 1) of this clause; (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 5) process flavouring means a product which is obtained according to good manufacturing practices by heating a mixture of ingredients as required, to temperature not exceeding 180 °C for a period not exceeding 15 minutes. The ingredients of the heated mixture need not necessarily have flavouring properties, but at least one must contain amino nitrogen and another must be a reducing sugar; 6) smoke flavouring means a smoke extract used in traditional smoking processes or added to food upon preparation thereof; 7) the mixture of substances specified in subclauses 1)-6) of this clause. 2. This Regulation does not apply to a substance which has exclusively a sweet, sour or salt taste, a substance of vegetable or animal origin having flavouring properties where it is not used as flavouring source, and an edible substance or product which is intended for consumption as such. (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 3. Flavourings shall not contain any element or substance in a quantity which is toxically dangerous to human health, including not more than 3 mg/kg of arsenic, 10 mg/kg of lead, 1 mg/kg of cadmium and 1 mg/kg of mercury. 4. Foodstuffs, substances for dissolving and diluting flavourings, technological aids and additives may be added to flavourings. 5. Substances provided for in the Annex to this Regulation may be naturally present in food or brought therein as a result of use of flavourings, but not upon pure addition of the specified substances. Upon use of flavourings, the requirements provided for in the Annex to this Regulation “Maximum Limits for Substances in Foodstuffs after Preparation by Food Groups” shall be observed. 6. Upon use of flavourings, the content of 3.4 benzopyrene in foodstuffs after preparation shall not exceed 0.03 µg/kg. 7. The labelling of flavourings shall be in compliance with the special requirements for labelling. In the case of flavourings to be sold or transferred in some other manner in Estonia, the required labelling information shall be presented in Estonian except in the case when the information is understandable to consumers in another language or presented in another manner. (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 8. The packaging of a flavouring intended for further handling, except retail, shall set out the following in a clearly visible, easily legible and indelible form: (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 1) the indication “lõhna- ja maitseaine” [“flavouring”] or a more specific name or description of the flavouring; 2) the list of groups of flavourings which include the substances in descending order of weight pursuant to clause 1 of this Regulation; 3) the name of the substance added to the flavouring for dissolving and diluting flavourings. If additives are added to a flavouring, the name of the category of the additive followed by the name of the additive or an internationally acknowledged number shall be set out on the packaging. The names of added substances and additives shall be set out on the packaging in descending order of weight; (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 4) the maximum quantity of each ingredient or group of ingredients in a mixture of flavourings if there exists a maximum limit to the content thereof in foodstuffs; 5) the indication “kasutamiseks toidus” [“for foodstuffs”] and more specific instructions for use; 6) an indication or mark identifying the batch in conformity with the requirements for the labelling of food; 7) the name and address of the manufacturer, packer or seller founded in a Member State of the European Union1; (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 8) the net quantity expressed in units of mass or volume. 9. Information provided for in subclauses 8 2), 3) and 4) of this Regulation may be presented in the accompanying documents of goods if the indication “Kasutamiseks toiduainetööstuses, mitte jaemüügiks” [“Intended for use in food industry and not for retail”] appears on a clearly visible surface of the packaging of flavourings. (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 10. The sales packaging of a flavouring intended for retail shall set out the following in a clearly visible, easily legible and indelible form: (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 1) the indication “lõhna- ja maitseaine” [“flavouring”] or a more specific name or description of the flavouring; 2) the indication “kasutamiseks toidus” [“for foodstuffs”] or more specific instructions for use; 3) the date of minimum durability in conformity with the requirements for the labelling of food; 4) the storage conditions, if these are necessary arising from the properties of the flavouring; 5) the instructions for use, if omission thereof would prevent appropriate use of the flavouring; 6) the net quantity expressed in units of mass or volume; 7) the name and address of the manufacturer, packer or seller founded in a Member State of the European Union1; (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 8) an indication or mark identifying the batch of food products in conformity with the requirements for labelling of food; 9) the flavourings in descending order of weight in the case of a mixture of flavourings with other substances, the name pursuant to subclause 1) of this clause, the names of other substances and, in the case of additives, the name of the category followed by the name of the additive or an internationally acknowledged number. 11. The word “looduslik” [“natural”] or other words having substantially the same meaning may be used only for flavourings in which the flavouring component contains a flavouring specified in subclauses 1 1) and 4) of this Regulation. (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 12. The word “looduslik” [“natural”] or other words having substantially the same meaning shall not be used for flavourings the name of which contains a reference to a foodstuff or a flavouring source and the flavouring component thereof has not been isolated by appropriate physical, enzymatic or microbiological processes or traditional food-preparation processes solely or almost solely from the foodstuff or the flavouring source concerned. 13. The Government of the Republic Regulation No. 156 of 14 July 1998 “Establishment of List of Artificial Flavourings, Manner of Use, Maximum Limits and Procedure for Labelling thereof”(RT I 1998, 67, 1075; 111, 1839) is repealed. 14. This Regulation enters into force on 1 January 2000, except clause 6 which enters into force on 1 January 2001. 1 For legal persons, the location and address shall be submitted, and for natural persons, the location and address of the person’s undertaking or another address through which the manufacturer, packer or seller founded in a Member State of the European Union can be contacted shall be submitted. (22.07.2004 entered into force 08.08.2004 - RT I 2004, 60, 424) 1 RT = Riigi Teataja = State Gazette Annex to Government of the Republic Regulation No. 292 of 6 October 1999 “Establishment of List of Artificial Flavourings Permitted in Food, Maximum Limits by Food Groups, Requirements for Flavourings, Conditions and Methods for Use and Production and Special Requirements for Labelling of Such Substances” Maximum Limits for Substances in Foodstuffs after Preparation by Food Groups Substance Maximum Limit in Foodstuffs after Preparation by Food Groups 1 2 1. Agaric acid 20 mg/kg; 100 mg/kg in alcoholic beverages and foodstuffs containing mushrooms 2. Aloin 0.1 mg/kg; 50 mg/kg in alcoholic beverages 3. Beta asarone 0.1 mg/kg; 1 mg/kg in seasonings used in snack foods, and in alcoholic beverages 4. Berberine 0.1 mg/kg; 10 mg/kg in alcoholic beverages 5. Coumarin 2 mg/kg; 10 mg/kg in caramel confectionery, 50 mg/kg in chewing gum and 10 mg/kg in alcoholic beverages 6. Hydrocyanic acid 1 mg/kg; 50 mg/kg in nougat, marzipan or its substitutes or similar products, 1 mg/% volume of alcohol in alcoholic beverages and 5 mg/kg in canned stone fruit 7. Hypericine 0.1 mg/kg; 10 mg/kg in alcoholic beverages and 1 mg/kg in confectionery 8. Pulegone 25 mg/kg; 100 mg/kg in beverages, 250 mg/kg in mint or peppermint flavoured beverages and 350 mg/kg in mint confectionery 9. Quassine 5 mg/kg; 10 mg/kg in confectionery in pastille and 50 mg/kg in alcoholic beverages 10. Safrole and isosafrole 1 mg/kg; 2 mg/kg in alcoholic beverages with not more than 25 % volume of alcohol, 5 mg/kg in alcoholic beverages with more than 25 % volume of alcohol and 15 mg/kg in foodstuffs containing mace and nutmeg 11. Santonin 0.1 mg/kg; 1 mg/kg in alcoholic beverages with more than 25 % volume of alcohol 12. Alpha and beta thuyone 0.5 mg/kg; 5 mg/kg in alcoholic beverages with not more than 25 % volume of alcohol, 10 mg/kg in alcoholic beverages with more than 25 % volume of alcohol and 25 mg/kg in foodstuffs containing preparations based on sage and 35 mg/kg in bitters