Food Improvement Agents Regulations Rhodri Evans
What is a food additive? Food additive means any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food whether or not it has a nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods.
Why Food Additives? Improve keeping quality -Preservatives (kill microorganisms) -Antioxidants (retard oxidation) Impart and enhance taste and appearance -Acids -Colours Provide consistency and texture -Emulsifiers -Stabilisers Meet specific nutritional requirements -Sweeteners
General criteria for the use of food additives: Technological need for their use Present no health hazard to the consumer They do not mislead the consumer Prior to food additives being authorised they are evaluated for their safety.
Existing EC Legal Framework Had Established:- Definition of food additives General Criteria for the use of additives Procedure for authorisation of additives generic authorisations Specified food categories in which additives can be used Maximum levels of additives Purity criteria for individual additives
EC Legal Framework for additives Framework Directive 89/107/EC Colours Directive 94/36/EC 42 Colours Purity Criteria 95/45/EC 4 amendments Sweeteners Directive 94/35/EC 3 amendments 15 Sweeteners Purity Criteria 95/31/EC 5 amendments Miscellaneous additives Directive 95/2/EC 6 amendments ~280 Additives Purity Criteria 96/77/EC 7 amendments Preservative Antioxidant Emulsifier Emulsifying salt Thickener Gelling agent Stabiliser Flavour enhancer Acid Acidity regulator Anti-caking agent Modified starch Raising agent Anti-foaming agent Glazing agent Flour treatment agent Firming agent Humectant Sequestrant Enzyme Bulking agent Propellant/packaging gas
Food Improvement Agents Package(FIAP) Regulation 1331/2008 establishing a common authorisation procedure for additives, enzymes and flavourings Regulation 1332/2008 on food enzymes Regulation 1333/2008 on food additives Regulation 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods
Didn t happen overnight Regulations first proposed by the Commission in July 2006 European Parliament - first reading vote July 2007 and 2 nd reading vote July 2008 Political Agreement in Council was reached on the 17 th Dec 2007 Common position adopted on the 10 th of March 2008 Regulations finally adopted on the 16 th of December 2008 and published on the 31 st of December 2008
Regulation 1331/2008 Common Authorisation Procedure
Common Authorisation Procedure (CAP) Create a simplified common approval procedure for additives, flavourings and enzymes, based on scientific opinions from the European Food Safety Authority (EFSA) EFSA opinion (9 months) will be followed by a risk management decision taken by the Commission (9 months). Comitology will speed up authorisation of new substances but also deletion from the list of substances where there is a safety concern. Authorisation by means of a Regulation will speed up the authorisation procedure. Includes procedural arrangements for updating the Community lists (adding, removing substances, adding or changing specifications or restrictions).
Emergencies (Art. 13) If the Member States or the Commission consider that a substance that has been authorised in accordance with the CAP poses a serious risk to human health, animal health or the environment, emergency measures must be adopted.
Regulation 1333/2008 Food additives
Additives Regulation This Regulation currently revokes and repeals the provisions of: Framework Directive on additives (89/107/EC) Sweeteners Directive (94/35/EC) Colours Directive (94/36/EC) Miscellaneous additives Directive (95/2/EC) with the exception of the annexes which will continue to apply until the Community list is adopted into annex II of the new Regulation. The Community list established by January 2011 Most provisions have applied since the 20/1/2010
Additives Regulation Simplification One single regulation on food additives: (colours, sweeteners and misc additives) Directly applicable in all Member States Introduction of comitology Simpler regulatory procedure for additive authorisation
Additives Regulation Consult EFSA for the safety evaluation of food additives Re-evaluation programme for all existing additives Review of food classification system Controls on additives in additives and enzymes
Additives Regulation Removes provision for National Authorisations Controls on GM additives Definition of processing aid remains unchanged Producers or users of additives should provide the Commission with the actual use of the food additive if requested
Additives Regulation General conditions for inclusion of additives in the Community list Present no health hazard at the level of use proposed Technological need Their use should not mislead the consumer Must have advantages and benefits to the consumer
Additives Regulation The Commission assisted by the SCoFCAH to review the current additive authorisations by the 20 th of January 2011 and transfer them into the annexes of the Regulation. Current authorisations continue to apply until this review is performed. Until the establishment of the Community lists of food additives the annexes to Directives 94/35/EC, 94/36/EC and 95/2/EC shall be amended by comitology.
Positive list of food additives Annex II of the Regulation will list foodstuffs and permitted additives (to be populated by comitology within 24 months of Regulation being adopted i.e. January 2011) The Regulation will list food additives in Annex II on the basis of the categories of food (i.e. Food Categorisation System) to which they may be added. Food additives which are permitted for use in foods under Directives 94/35/EC, 94/36/ and 95/2/EC and their conditions of use shall be entered into annex II of the Regulation following a review of their use The review shall not include a new risk assessment by EFSA
Food Categorisation System 1 Dairy 2 Fats and Oils 3 Edible Ices 4 Fruit and Vegetables 5 Confectionery 6 Cereals and Cereal Products 7 Bakery Wares 8 Meat and Meat Products 9 Fish and Fish Products 10 Eggs and Egg products 11 Sugars and Table Top Sweeteners (TTS) 12 Salt, Spices, Seasonings, Sauces etc. 13 PARNUTS 14 Beverages 15 Snacks 16 Desserts 17 Food Supplements
Additives Regulation: re-evaluation EFSA to re-evaluate all food additives which were authorised before the 20 th of January 2009 Commission have adopted a formal evaluation programme on food additives Regulation 257/2010 Criteria Procedure Order of Priority The re-evaluation of all food colours listed should be completed by the 30.6.2011 The re-evaluation of all additives other than colours and sweeteners by the 31.12.2018, with first priority for preservatives and antioxidants. The re-evaluation of all sweeteners by the 31.12.2020
Colours re-evaluation EFSA is systematically re-evaluating all of the currently permitted food additives and food colours are the first group of additives to be re-evaluated (synthetic colours reviewed by end of 2010). Recent EFSA opinions on food colours include: Amaranth (E 123)-26 th of July 2010 Curcumin (E 100)-7 th of July 2010 Brown FK (E 154) 21 st April 2010
Food Colours Re-evaluation Commission Regulation 884/2007/EC Suspended the use of Red 2G (E 128) in foods following an unfavourable EFSA opinion
EFSA review of Southampton Study Opinion published on the 7 th of March 2008 http://www.efsa.europa.eu/efsa/scientific_opinion/afc_ej660_mcc ann_study_op_en.pdf Colours involved: Tartrazine (E102), Quinoline Yellow (E104), Sunset Yellow FCF (E110), Carmoisine (E122), Ponceau 4R (E124), Allura Red (E129) and the preservative Sodium benzoate (E211)
Annex III of Additives Regulation Annex III -list of permitted additives in additives enzymes, flavourings (carriers will be transferred as above) Food additives in Annex III shall be listed on the basis of the food additives, food enzymes, food flavourings and nutrients or categories thereof to which they may be added
Regulation 1332/2008 Food Enzymes
Enzymes Regulation Harmonises controls on food enzymes across Member States for the first time Establishes a Community list of approved food enzymes and conditions for use in foods General requirements (safety, technological need, does not mislead the consumer) Provide labelling requirements for food enzymes Applies to all enzymes: processing aids & the 2 misc. additives Specifically excludes enzymes which are naturally present in food or added as live organisms
Regulation 1334/2008 Flavourings
Flavourings Regulation Luckily Joy Hardinge is here to talk about them..
Thank you for your attention!