Novel food technologies regulations

1. Novel food technologies regulations ‘On the road to Innovation Union: European food legislation’ Prof Brijesh K Tiwari PhD FIFST FRSC Food Chemistry and Technology, Teagasc Email: brijesh.tiwari@teagasc.ie FOODstars

2. Teagasc –Agriculture and Food Development Authority Animal and Grassland Research and Innovation Crops, Environment and Land Use Food Rural Economy and Development

3. Food production chain • Improved food quality • Valorisation of food processing by-products • Reduced energy and water consumption (clean and green solutions to key challenges faced by the food industry) • Employ new interventions for developing new food products underpinning key health, nutrition and wellness challenges

4. Novel food processing technologies Novel Food Processing Technologies Combination Thermal Electro-magnetic Biotechnological Mechanical

5. Selection and integration Commercial systems Mission Operations & Integration Technology Transition System Development Technology Development & Demonstration COMFORT ZONE Technology Research & Development Basic Research

6. Solid foods Liquid foods Selection of relevant technologies Model solutions Novel Technologies Microbial inactivation Yes No Integration Thermal processing High pressure processing Pulsed electric field Ozone applications Ultrasonics Light based technologies Ozone Cold plasma Airborne acoustics Light based technologies Conventional and Novel technologies No NOT SUITABLE Yes Process efficiency 1 – 2 log reductions Up to 5 log > 5 log Commercial validation

7. Key aspects with novel technologies 1 Microbial inactivation 2 Shelf life and quality 3 Nutritional 4 Packaging 5 Toxicological

8. Legislative Acts : EU vs National Acts

9. Legislative Acts : EU vs National Acts • Regulation • Binding legislative act • Mandatory in its entirety across the EU • Directive • sets out a goal that all EU countries must achieve • M-S decide how • Must be transposed to national legislation • Decision • Binding to whom it is addressed (e.g. a M-S or a company)

10. Timeline….

11. Timeline…. … this is not the end… • Regulation 2073/2005 Microbiological criteria for food safety & hygiene monitoring • Regulation 2074/2005 Implementing measures for certain products under the provisions of Reg 853/2004 • Regulation 931/2011 Traceability requirements

12. The EU Food Law at a glance

13. White Paper on Food Safety – Targets

14. EFSA

15. Novel food • Foods and food ingredients • with a new or intentionally modified primary molecular structure (eg, fat substitutes); • consisting of microorganisms, fungi or algae, or can be isolated from this (for example, microalgae oil); • consisting of plants or isolated (eg phytosterols), and isolated from animals food ingredients.

16. Novel food regulation Applies to foods and food ingredients which satisfy the description and fall into one of the following categories: • Foods and food ingredients • which present a new or modified primary molecular structure; • which consist of micro-organisms, fungi or algae; • which consist of or are isolated from plants and ingredients isolated from animals; • whose nutritional value, metabolism or level of undesirable substances has been significantly changed by the production process. http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm

17. Novel food regulation • Must be safe for consumers. • Must be properly labelled to not mislead consumers. • Can not be nutritionally disadvantageous. What the Novel Food Regulation does not cover The Regulation does not cover: • Food additives • Flavourings for use in foods • Extraction solvents used in the production of foods • GMOs for food and feed • If foods and/or food ingredients were used exclusively in food supplements, new uses in other foods require authorisationunder the Novel Food Regulation e.g. food fortification require authorisation.

18. Novel food legislation in Europe • Any food or food ingredient that falls within this definition must be authorized according to the Novel Food legislation, Regulation (EC) No 258/97 of the European Parliament and of the Council.  • To market a novel food or ingredient, companies must apply to a EU country authority for authorisation, presenting the scientific information and safety assessment report. • The competent authority decides if additional assessment is necessary. • It allows the marketing of the product if no additional assessment is necessary, and if the Commission and EU countries do not object. • Before approving, the Commission asks the Standing Committee on Food Chain and Animal Health for an opinion.

19. Novel food authorisation Authorisationcovers: • Conditionsofuse, • Designation ofnovelfoodornovelfoodingredient, • Specificationandlabellingrequirements.

20. Safeguard measures of Novel food • If a EU country considers a novel food or ingredient a risk to human or environmental health because of new information, it may suspend or temporarily restrict the marketing and use of any novel food or ingredient on their territory. • The country informs the Commission which either extends the national measures to all EU countries or asks that they are repealed. Regulation EC 258/97 – Article 12

21. Novel Food Catalogue • Lists products of plant and animal origin and other substances subject to the Novel Food Regulation, after EU countries and the Commission agree in the Novel Food Working Group. • It is non-exhaustive, and serves as orientation on whether a product will need authorisation under the Novel Food Regulation. • EU countries may restrict the marketing of a product through specific legislation. For information, businesses should address their national authorities. • If foods and/or food ingredients were used exclusively in food supplements, new uses in other foods require authorisation under the Novel Food Regulation.

22. Novel food notification • A novel food or ingredient may be marketed through a simplified procedure called "notification". • The company notifies the Commission about their marketing a novel food or ingredient based on the opinion of a food assessment body that has established "substantial equivalence". • The Commission sends decisions on a novel food or ingredient likely to affect public health to the Scientific Committee for Food.

23. Labeling of novel foods Requirements for labelling of novel food and ingredients are additional to the general EU requirements on food labelling. Where necessary, labelling of novel food and novel food ingredients may mention: • Characteristics - composition, nutritional value, intended use; • Materials which may affect the health of some individuals; • Materials that give rise to ethical concerns.

24. Novel food regulation (EU) • Originally also foods derived from genetically modified organisms, the so-called genetically modified foods, under the NF Regulation were under Novel food regulation. • Since April 2004, there now are own regulations for genetically modified organisms. • Even foods that have been produced using nanotechnology and cloned meat are considered to be novel and must be approved by the NFVO. • Additives and flavorings are not covered by the NFVO

25. Nutritional & Health Claim • A nutrition claim states or suggests that a food has beneficial nutritional properties, such as “low fat”, “no added sugar” and “high in fibre”. • A health claim is any statement on labels, advertising or other marketing products that health benefits can result from consuming a given food, for instance that a food can help reinforce the body’s natural defenses or enhance learning ability

26. EU Regulation 1924/2006

27. Classifications of claims

28. Traceability • Means the ability to trace and follow a food, at all stages of production • Traceability facilitates the identity, historyand source of a product • It does not make food safe, it is a management tool • It enables the assurance of food safety and allows action to be taken if food is found not to be safe, e.g. withdrawal or recall

29. Traceability – The “one up”/”one down” concept • Each stage in the food chain must • Identify what is received (raw materials from the previous stage in the chain) • Identify where product is sent (to the next stage in the chain) • Make information available on demand • Each stage in the food chain is responsible for the operations under their control • No requirement for whole chain traceability

30. Traceability – The “one up”/”one down” concept A stage in the food chain Make information available on demand

31. Traceability – Industry standards & practice • One up/one down concept plus link finished product to/from raw materials • Each food business operation must be able to trace and follow – All raw materials from source – Through all stages of production – To distribution of the finished product • Traceability is established from raw material to finished product and visa versa

32. Traceability – Regulation 931/2011 • From the 1st July 2012, the provisions set out in Regulation 931/2011  regarding the traceability requirements for unprocessed or processed food of animal origin will be applicable. • Sets the piece of information the FBO should provide to the competent authority upon request • an accurate description of the food • the volume or quantity of the food • the name and address of the food business operator from which the food has been dispatched • …….. • a reference identifying the lot, batch or consignment, as appropriate

33. Reg 178/2002 - The precautionary principle In specified circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection may be adopted, pending further scientific information for a more comprehensive risk assessment

34. Hygiene Pack • It is the current regime of hygiene rules • is often referred to as ‘The hygiene package’ • it aims to introduce consistency and clarity throughout the food production chain from 'farm to fork'.

35. Hygiene Pack The ‘hygiene package’ is comprised of rules on the following:

36. Regulation 852/2004 & HACCP requirements • All FBOs (production, processing and distribution of food) must put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles. • Food business operators must: • provide the competent authority with evidence of their compliance with the requirement to have procedures based on the HACCP principles taking account of the nature and size of the food business • ensure that any documents describing the procedures developed in accordance with this are up-to-date at all times • retain any other documents and records for an appropriate period

37. Regulation 852/2004 & HACCP requirements • For businesses undertaking low risk activities the prerequisite hygiene requirements (App II of Reg 852/2004) are sufficient • No need for establishment of a HACCP-based procedure (but it is desired) • Guidance document for implementation of HACCP

38. Regulation 852/2004 and requirements • Food Businesses must comply with the standards laid down in App II of Regulation 852/2004 • Chapter I: General requirements for food premises • Chapter II: Specific requirements in rooms where foodstuffs are prepared, treated or processed • Chapter III: Requirements for movable and/or temporary premises • Chapter IV: Transport - Containers used for transporting foodstuffs • Chapter V: Equipment with which food comes into contact • Chapter VI: Food waste • Chapter VII: Water supply • Chapter VIII: Personal Hygiene • Chapter IX: Provisions applicable to foodstuffs • Chapter X: Provisions applicable to the wrapping and packaging of foodstuffs • Chapter XI: Heat treatment • Chapter XII: Staff Training

39. Regulation 853/2004 • Lays down more specific hygiene requirements for foods of animal origin • Other issues • Registration or approval of establishments • Health and identification marking • Import of products of animal origin

40. Regulation 2073/2005 – Microbiological criteria • Food business operators shall: • Test against the values set for the criteria - take samples • Conduct studies in order to investigate compliance with the criteria throughout the shelf-life • Implement corrective actions- HACCP plan, food law and/or the instructions given by the competent authority • Take measures to find the cause of an unsatisfactory result in order to prevent the reoccurrence of unacceptable microbiological contamination • Microbiological analysis is done for verification purposes , ie to check that everything was done in such a way to obtain a safe product

41. Regulation 2073/2005 – Microbiological criteria • Food safety criterion • a limit above which a foodstuff should be considered unacceptably contaminated • It applies to products placed on the market • Salmonella, Listeria, etc • Process hygiene criterion • a limit indicating the acceptable functioning of a production process. • Such a criterion is not applicable to products placed on the market. • It sets an indicative contamination value above which corrective actions are required • E. coli, Coliforms, etc

42. Food additives Additive as defined by Regulation 1333/2008/EC: A ‘food additive’ shall mean 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 nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods

43. Food ingredient versus additive • An ingredient is a component of a food product which does not serve a technological function • An additive is a component of a food product which serves a technological function in the food product as defined by functional categories in Regulation 1333/2008/EC 

44. Categories of additivesRegulation 1333/2008/EC  ‘Functional class’ shall mean one of the categories set out in Annex I based on the technological function a food additive exerts in the foodstuff;

45. Labelling encapsulated ingredients • Labelling legislation for additives • Additive functional class and specific name or E-number • The following are not considered functional and as a result there is no requirement to label them as such*: • Carry-over additives • Processing aids • Substances used in the quantities strictly necessary as solvents for flavoring * Unless those components contain an allergen Encapsulated ingredients only name the active ingredient (and allergen if present)

46. Labelling Ingredients in descending order Active ingredients presented by class (name or E-Number) Example: Ice Cream Partially Reconstituted Skimmed Milk Concentrate, Sugar, Whey Powder (Milk), Palm Stearin, Palm Oil, Dextrose, Palm Kernel Oil, Emulsifier (Mono- and Di-Glycerides of Fatty Acids), Flavouring, Stabilisers (Guar Gum, Sodium Alginate), Colours (Beetroot Red, Beta-Carotene)

47. Additive database https://webgate.ec.europa.eu/sanco_foods/main/index.cfm

48. Additive database

49. Use of additives Categories (dairy, meat, confectionary….) Meat Category: permitted additives and maximum limits

50. Understanding legislation- example of phosphates in meat Phosphates serves many techno-functional properties in meat • Bind to Ca2+ in the meat cell • Dissociate acto-myosin complex (open cell) • Alkaline leading to increase in pH and movement from IEP • Increase protein solubilisation • Greater intracellular immobilised water = ↑ WHC, ↑ Juiciness, ↑ Yield • Chelating agents = ↓Oxidative Rancidity