An International perspective on Best Practices in European Food Regulation – where has Europe got it right and why

Ric Hobby ILSI Taiwan April 2014

France Germany Italy Belgium Netherlands Luxembourg

1950

Denmark Ireland UK

1973

Greece

1981

Spain Portugal

1986

Austria Finland Sweden

1995

Cyprus Estonia Hungary Latvia Lithuania Malta Poland Slovakia Slovenia Czech Republic

2004

451 million

226 million

294 million

304 million

354 million

376 million

The Evolution of the European Union

Romania Bulgaria

2008

EU Expansion in Eastern Europe

Albania Macedonia

Turkey Ukraine Moldova

Bosnia-Herzegovina Serbia-Montenegro Croatia

2013

Now 500+ million and growing

The Evolution of EU Food Law and Nutrition Policy

• Phase I Common Agricultural Policy • Phase 2 Full Harmonisation • Phase 3 Food Safety • Phase 4 Nutrition

Phase 1 - Economically driven Common Agricultural Policy (CAP)

Phase 2 – Focus on the internal market

• “Full Harmonisation”

• Focus on Quality and Compositional Standards

• Vertical Directives aimed at harmonising all aspects of a product category, e.g. : – Honey / Chocolate / Sugar / Dried Milk / Fruit Juices / …

• Long and tedious process / Contrary to the rich cultural variety of the European Union – “Euro-sausage approach”

Phase 2 – Focus on the internal market

1985 White Paper on Completing the Internal Market

– “Minimum harmonisation”: Only those elements essential for health and safety

– Emphasis on “mutual recognition” of national regulations

and standards: – Especially relevant for food sector – EC Interpretative Communication on the Free

Movement of Foodstuffs within the European Community

Phase 2 – Focus on the internal market Principle of Mutual Recognition

– Free movement of goods should apply in cases where legislation has not been fully harmonised at EU level

– Each Member State is obliged to accept on its territory products that have been lawfully manufactured and/or marketed in one of the 28 EU Member States or in an EEA country (Iceland, Liechtenstein, and Norway)

– Member States may only restrict the importation and marketing of products where the restrictive measures are necessary for the

• the protection of public health, • the fairness of commercial transactions, • and the defence of the consumer, and • are proportionate

Phase 2 – Focus on the internal market Notification duty

• The Mandatory Notification of Technical Standards

– Directive 98/34/EC : • Laying down a procedure for the provision of

information in the field of technical standards […] • Scope : Technical specifications:

– Levels of quality, performance, safety – Dimensions – Terminology, symbols, labelling – Testing, testing methods – Conformity assessment procedures

Phase 3 – Food Safety 1997 Green Paper on Food Law

• 6 basic goals for Community Food Law: – to ensure a high level of protection of public health and safety, and of

consumer protection; – to ensure the free circulation of goods; – legislation to be based primarily on scientific evidence and risk

assessment; – to ensure the competitiveness of the European industry; – to place the primary responsibility for safe food with industry,

producers and suppliers, through self-checking provisions (so-called Hazard Analysis Critical Control Points systems or HACCP) backed up by official controls and appropriate enforcement;

– legislation to be coherent, rational, consistent, simpler, user-friendly and developed in full consultation with all interested parties.

Food safety in crisis Mad cow disease BSE – Bovine spongiform encephalopathy 188,000 cases CJD - Creutzfeldt Jakob Disease 280 cases

Escherichia coli E.Coli Thousands infected Many die

Salmonellosis Salmonella poisoning 100s thousands infected

Toxic oil syndrome Contaminated colza oil 600 die in Spain

Phase 3 – Food Safety 1999 White Paper on Food Law

• Establishment of the European Food [Safety] Authority.

• Coverage of the whole of the food chain, including animal feed production.

• Establishment of a high level of consumer health protection.

• Clearly attributing primary responsibility for safe food production to industry, producers and suppliers.

• Establishment of appropriate official controls at both national and European level.

Phase 3 – Food Safety 1999 White Paper on Food Law

• The ability to trace products through the whole food chain.

• The use of scientific advice to underpin Food Safety policy.

• The precautionary principle to be used where appropriate.

• The ability to take rapid, effective, safeguard measures in response to health emergencies throughout the food chain.

Phase 3 – Food Safety The European Food Safety Authority

• 84 legislative measures announced in 2002: – Most have been completed

• Food law Regulation / EFSA • Feed and Food Control • Hygiene • Nutrition and Health Claims • Addition of Vitamins, Minerals and other substances • Additives / Flavourings / Enzymes • Novel foods / Sports foods / Nutritional Labelling /

Pesticides

Phase 3 – Food Safety The European Food Safety Authority – The Authority must

• be guided by the best science to deliver independent and objective scientific advice on all aspects relating to food and feed safety, including animal health and welfare and plant protection;

• be independent of industrial and political interests, • be open to rigorous public scrutiny and to

communication and dialogue with consumers on food safety and health issues;

• be scientifically authoritative and work closely with national agencies and scientific bodies.

Phase 3 – Food Safety Food Control

• Uniform Food Safety Controls – European Commission’s inspection service shows wide

variations in how Community legislation is implemented and enforced.

• Food and Veterinary Office (FVO) established – The European Commission responsible for ensuring that

Community legislation is properly transposed, implemented and enforced by national authorities in the Member States.

– The control function is carried by the Commission's Food and Veterinary Office (FVO), which reports on its findings and makes recommendations

• Rapid Alert System for Food and Feed (RASFF) – Alert notifications / Information notifications / News

Phase 3 – Food Safety Consumer Information

– Consumers have the right to expect clear information on food quality and constituents, so that informed choices can be made.

– The importance of a balanced diet, and its impact on health.

– Full allergen labelling. – Rules for Nutrition [and Health] Claims. – Nutrition labelling revision.

Phase 3 – Food Safety Consumer Information

– General labelling Directive 2000/13/EC • Quantitative Ingredient Declaration (QUID) (Directive 97/4/EC) • Allergen labelling (Directive 2003/89/EC) • Meat (Directive 2001/101/EC)

– Nutritional labelling (Directive 98/498/EEC), now upgraded – Misleading and Comparative Advertising – Directive 2002/67/EC : foodstuffs containing quinine/caffeine – Directive 89/396/EEC : Lot code indication – Vertical directives

• Food supplements (Directive 2002/46/EC) • Dietetic foods (Directive 1989/389/EEC) • Chocolate (Directive 2000/36/EC) • Natural mineral waters (Directive 2003/40/EC) • Beef and beef products (Reg(EC) No 1760/2000)

– Regulation (EC) No 258/97 : Novel foods – Regulation (EC) No 1829/2003 : GMO – Regulation (EEC) No 2092/91: Organic production

Phase 3 – Food Safety Food Chain Approach

‘Farm to fork’ policy based on traceability: – A successful food policy demands the traceability of feed and

food and their ingredients. – Covering all sectors of the food chain, including feed production,

primary production, food processing, storage, transport and retail sale,

– Adequate procedures to withdraw feed and food from the market where a risk to the health of the consumer is present.

– Operators should also keep adequate records of suppliers of raw materials and ingredients so that the source of a problem can be identified.

– General Food law Regulation (178/2002): • Traceability rules (Art 18) • Procedures for recall (Art 19-20) • Notification duty (Art 19-20) • Rapid Alert System for Food and Feed (Art 50)

Phase 3 – Food Safety Traceability

Phase 3 – Food Safety Scientific risk analysis

– Risk Analysis must form the foundation on which food safety policy is based.

– The EU must base its food policy on the application of the three components of risk analysis:

RISK-ANALYSIS

RISK COMMUNICATION

RISK ASSESSMENT

RISK MANAGEMENT

Phase 3 – Food Safety Hygiene

A coordinated and holistic approach towards hygiene, based on:

– Auto control – Control of the auto control – HACCP

Hazard

Analysis

Critical

Control

Points

Phase 3 – Food Safety Contaminants and Residues

• “Contaminants” traditionally covers substances which are not intentionally added to food.

• environmental contamination; • agricultural practices, production, processing, storage,

packaging, transport or from fraudulent practices. • Some substances are found in food as a result of intentional

use. This concerns residues of pesticides in food of plant and animal origin and veterinary medicines in food of animal origin. – 400 of 1000 pesticides eliminated; – Establishment of maximum residue limits of these

substances in food and agricultural products; – Legislation on the radioactive contamination of food

Phase 3 – Food Safety Contaminants and Residues

Limits to be set: – Nitrates (lettuce and spinach) – Aflatoxins in nuts, dried fruit, cereals, spices and milk – Ochratoxin in cereal products and dried vine fruit – Patulin in apple juice – Deoxynivalenol, zearalenone, fumonisins in cereal-based

products – Lead, cadmium and mercury – Processing contaminants (3-MCPD) – Dioxins and PCB’s – Benzo(a)pyrene – Polycyclic aromatic hydrocarbons – Fusarium toxins

Phase 3 – Food Safety Novel foods

• Applies to the placing on the market of foods and food ingredients which have not hitherto been used for human consumption to a significant degree within the Community, prior to 15 May 1997.

• 1997 Regulation under revision for many years, with new 2014 proposal.

Phase 3 – Food Safety Additives, flavorings and enzymes

• Early 1990s law created positive lists of authorized additives – colors, sweeteners, flavors, enzymes, etc.

• Progressive safety review in the EU by EFSA and at global level by FAO’s JECFA

• Work on-going

Phase 3 – Food Safety Genetically Modified Organisms (GMOs)

• 2001 Authorisation procedures introduced for specific GM strains in crops;

• 2003 Authorisations introduced for GM food and feed, including labelling and traceability;

• 0.9% threshold set for adventitious contamination

Trials of GM crops bring new fears of 'Frankenstein' food By REBECCA ENGLISH, Daily Mail

Phase 3 – Food Safety Nutrition and Health Claims

• Main objectives

– To achieve a high level of consumer protection by providing further voluntary information, beyond the mandatory information foreseen by EU legislation;

– To improve the free movement of goods within the internal market;

– To increase legal security for economic operators;

– To ensure fair competition in the area of foods;

– To promote and protect innovation in the area of foods.

• European Parliament concern

– Impact on Small and Medium Sized Enterprises (SMEs)

Phase 3 – Food Safety Nutrition and Health Claims

• The implementation of the NHCR is a learning process

• Indications that none of the objectives will be met

• The broader impact – Innovation stifled; incentive for reformulation

rather than doing research; less research commissioned; peer review process undermined; trend toward research remaining unpublished.

– Massive economic damage likely to SMEs.

EU Register of Interests • Known as the Transparency register • Consumer right to know about European

institutions interaction with citizen’s associations, NGOs, businesses, trade and professional organizations, trade unions, think tanks, etc.

• Increasingly difficult to obtain a meeting in the European Parliament or European Commission without being registered.

Phase 4 – Nutrition EU Public Health Policy

– A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities;

– Community action, which shall complement national policies, shall be directed towards improving public health, preventing human illness and diseases, and obviating sources of danger to human health. […];

– Encourage cooperation between the Member States;

– The European Commission will promote coordination.

Phase 4 – Nutrition EU Health Organizations

• Executive Agency for the Public Health Program • European Centre for Disease Prevention and Control

(ECDC) • European Environment Agency (EEA) • European Monitoring Center for Drugs and Drugs

Addiction (EMCDDA) • European Agency for the Evaluation of Medicinal

Products (EMEA) • European Agency for Safety and Health at Work (EU-

OSHA) • European Food Safety Authority (EFSA) • European Chemicals Agency (ECHA)

Phase 4 – Nutrition Nutrition and Physical Activity

• Risk Factors for premature death: – Blood pressure – Cholesterol – Body Mass Index – Inadequate fruit and vegetable intake – Lack of physical activity – Excessive alcohol consumption – Tobacco

• Obesity: one of the most serious public health problems in Europe.

– Increased risk of chronic diseases such as cardiovascular disease, type 2 diabetes and certain cancers.

Thank you

Ric Hobby Vice President

Worldwide Regulatory, Government & Industry Affairs Herbalife International