EU hygiene legislation with regard to food ingredients and food additives

1. EU hygiene legislation with regard to food ingredients and food additives András Sebők Campden & Chorleywood Food Industry Development Institute, Hungary

2. Current EU Food Hygiene Legislation • General Food Hygiene Directive 93/43 EEC • 14 Directives for products of animal origin in compliance with the requirements laid down in • Regulation (EC) 1782002 on the general principles and requirements of food law.

3. Objective: • To ensure that all ingredients and food additives should not cause • excessive microbiological contamination, • physical contamination, • chemical contamination other than those, which are covered by the directives specific for food additives, colours, etc. of foodsuffs

4. General Food Hygiene Directive: 93/43 EEC • Based on the following principles: • obligation of food business operators to ensure safety of foods placed in the market • concept of industry self-control • use of HACCP based systems • development of codes of good hygiene practice • adoption of microbiological criteria and temperature control measures • monitoring of food hygiene by competent authorities

5. EU Food Hygiene LegislationConcept of industry self-control • General Directive on Food Hygiene – 93/43/EEC • Article 3 • Preventive food safety system based on HACCP principles • Article 5 • Member States shall encourage the development of guides to good hygiene practices which may be used voluntarily by food businesses. • The guides shall be developed by food business sectors and other parties such as appropriate authorities and consumer groups

6. EU Food Hygiene LegislationAnnex to General Hygiene DirectiveRequirements • General requirements for food premises • Specific for rooms used for preparation, treatment, processing • Moveable and temporary premises • Transport • Equipment • Food Waste • Water Supply • Personal Hygiene • Special Provisions • Training

7. Hygiene legislation – new regulations Five proposals • Hygiene of foodstuffs, Regulation (EC) No. 852/2004 • Specific hygiene rules (for food of animal origin)on hygiene of foodstuffs, Regulation (EC) No. 853/2004 • Rules for the organisation of official controls on products of animal origin intended for human consumpton, Regulation (EC) No. 854/2004 • Regulation (EC) No. 882/2004 official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules • Directive 2004/41/EC repealing existing Directives. • Adopted 26.04.2004. • Published in the Official Journal 30.04.2004. • Into effect 1stJanuary 2006

8. EU Hygiene Legislation and Guides • New regulations • Regulations not Directives • Consolidated requirements for all foods • Separate regulation for products of animal origin • HACCP based measures required • Risk assessment e.g. composite foods • Traceability • National guides for all types of foods

9. Control of hygiene of ingredients and food additives • Use of appropriate raw materials and ingredients free from excessive microbiological and foreign body contamination • Prevention of subsequent contamination or increase the level of contamination • Factory environmental standards • Personal hygiene • Temperature control • Product control • Removal / reduction of contamination to acceptable level through processing

10. Control of hazards -expectations of the users • Cascade-like approach – control of materials used • Specifications for finished products should match specifications for ingredients and additives • Chemical purity • Microbiological contamination • Foreign bodies • Allergens Declarations, certifications, test results provided • Control of operations: processing, warehousing, handling, storage and transport • Traceability (Regulation 178/2002) – mandatory from 01.01.2005.

11. Control of allergens in ingredients, additives • Identification of potential sources • evaluation of risks / HACCP system • Procedures for assuring traceability • to sources • between raw materials, ingredients, food additives and intermediate and finished products • Specifications – warranty declarations • Segregation of production of allergen containing and allergen free products to prevent cross contamination • adequate cleaning between product changes • Labelling

12. Cereals containing gluten Crustaceans Eggs Fish Peanuts Soybeans Nuts Celery Mustard Sesame seeds Sulfur dioxide and sulphites over 10 mg/kg, or 10 mg/l expressed as SO2 Indication of allergens • Directive 2003/89/EC and products thereof Some additives – preservatives and colours may cause allergy

13. GMO traceability • Much discussion: whether it is a food safety or quality / consumer information issue • Labelling requirements • Adequate control: traceability • identification of (potential) sources • specifications with warranty declarations • traceability of raw materials to intermediate and finished products and backwards • segregation of processing • labelling

14. Hygiene of manufacturing and handling of ingredients and food additives • Are procedures used in manufacture, storage and transport of ingredients, additives sufficient to • provide an adequate microbiological inactivation step • prevent cross contamination / recontamination • reduce water activity to prevent growth of surviving vegetative cells and spores • ensure storage temperature, which control growth of surviving vegetative cells and spores.

15. Major food safety aspects related to ingredients and additives • Properly controlled pre-processing steps • heat treatment • Filling and packaging • Control of foreign bodies • Time, temperature, humidity abuse • Contamination from damaged and soiled packaging • Contamination from pests at the site of the ingredient supplier and during transport • Contamination from cleaning chemicals and cleaning methods

16. Control of ingredients and additives at the users (1) • Control of purchased goods • Adequate control of all hazards by food safety management systems • HACCP / GHP • specifications • approved suppliers • risk based approval methods • evidences for verification and validation

17. Control of ingredients and additives at the users (2) • Appropriate storage facilities (time, temperature, humidity) • Segregated storage where necessary • Stock rotation • Separate deboxing and unwrappingarea from production • Prevention of cross contamination of heat treated ingredients by raw ingredients

18. Ingredients as sources of pathogens and toxins • Care with the use of - new ingredients - new ingredient sources - emergence of new pathogens - changing recipes • Caused by - changes to current practices - application of novel preservation and processing technology

19. Food Safety Management Systems: Good Hygiene Practice • GHP / GMP is not a system (in itself), it is a set of practices, essential to support HACCP programme, • An integral part of food safety system • Product / risk based information on correct food handling practices (hair covering, traceability, etc.) are widely known, but not consistently defined • HACCP has been much discussed, many conferences, published material – all has helped to move it forward; not the case with GMP / GHP Noordwijk Food Safety & HACCP Forum 3rd and 5th Meetings, 1999, 2002

20. Interpretation of GHP requirements • Lack of clarity on who finally decides on what is „necessary” or „appropriate” in GHP business owner, food control officer, auditor, customer or judge • (Neither) Codex (nor EU legislation) does not refer to the concept of „due diligence”, but its application is expected Noordwijk Food Safety & HACCP Forum 4th Meeting, 2001

21. Interpretation of requirements Voluntary, sector specific codes provide balanced, agreed reliable guidance

22. Interpretation of requirements A clear explanation is necessary • What is the minimum required by law • What is a recommendation for good practice • What is required by the customer

23. Good Hygienic Practice Good Hygienic Practice is the implementation of all those measures during the manufacture, storage and distribution of foods that ensure the minimisation or prevention of contamination of the food from external sources.

24. Business Support Programme of the CIAA • A project supported by the EU Phare Programme in 8 new EU member and 2 accession countries of the EU • A project led by the Federation of the European Food and During Industries (CIAA) • Supported by the EU Phare programme • Main objective: to contribute to food safety trough: • Reinforcing Business Representative Organisations in CEE countries • Supporting the CEEC food industries in the implementation of the EU acquis in the area of hygiene law, voluntary codes of Good Hygiene Practice and compliance with EU Food Law • Duration: 2003 – 2004, 18 months

25. Partners - Co-operations • CIAA (with the active participation of all 15 EU National F&D Federations) • 10 CEECs Enlargement Federations: Estonia Slovakia Latvia Hungary Lithuania Slovenia Poland Bulgaria Czech Republic Romania

26. Technical co-operating partners • CLITRAVI, the EU Meat industry association • EDA, the EU Dairy industry Association • SGF, the fruit juices QA Association • Campden & Chorleywood Hungary • GI Consulting – Austria

27. CIAA Business Support Programme • Four main actions: • Food safety • Supply chain and sustainable development • Strengthening of food and drink industry national federations • Food Law / Status Report

28. CIAA Business Support Programme • Food Safety Action: Diffusion of Good Hygiene Practices / HACCP methods in CEEC companies • Seminar in Brussels for influence groups, October 2003 (federations, government / authorities, industry opinion formers) • Train the trainers seminar in Prague for 30 national experts (January 2004) • Diffusion seminars in 10 countries (March- April 2004) • Trained national experts help more than 360 manufacturing companies in application of best practices, priorities: meat, dairy, fruit juice (March – October 2004) • Case studies (November 2004)