Presentation by Ric Hobby, VP Regulatory, Government and Industry Affairs, Herbalife International at the International Life Sciences Institute Seminar in Taiwan, 2014

1. An International perspective on Best
Practices in European Food Regulation –
where has Europe got it right and why
Ric Hobby
ILSI Taiwan
April 2014

2. 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

3. Romania
Bulgaria
2008
EU Expansion in Eastern Europe
Albania
Macedonia
Turkey
Ukraine
Moldova
Bosnia-Herzegovina
Serbia-MontenegroCroatia
2013
Now 500+ million and growing

4. 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

5. Phase 1 - Economically driven
Common Agricultural Policy (CAP)

6. 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”

7. 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

8. 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

9. 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

10. 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.

11. 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

12. 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.

13. 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.

14. 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

15. 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.

16. 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

17. 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.

18. 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

19. 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)

20. Phase 3 – Food Safety
Traceability

21. 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

22. 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

23. 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

24. 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

25. 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.

26. 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

27. 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

28. 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)

29. 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.

30. 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.

31. 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.

32. 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)

33. 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.

34. Thank you
Ric Hobby
Vice President
Worldwide Regulatory, Government & Industry Affairs
Herbalife International