GLOBAL HARMONISATIONGLOBAL HARMONISATION

ofof

FOOD REGULATIONSFOOD REGULATIONS

andand

LEGISLATIONLEGISLATION

Huub Lelieveld

FOOD SAFETY REGULATIONSFOOD SAFETY REGULATIONS

ARE NEEDEDARE NEEDED

TO TO PROTECTPROTECT CONSUMERSCONSUMERS

BIOLOGICAL HAZARDS

•Verocytotoxin-producing Escherichia coli•1985 Canada: 73 cases, 17 fatal

•1996 Japan: 6000 cases, 3 fatal

•1996 Scotland: 500 cases, 21 fatal

•Campylobacter

•Salmonella1996 California: Odwalla® Apple Juice

10 cases, children, none fatal•Salmonella

•Listeria monocytogenes•1985 USA: 142 cases, 48 fatal

•1987/89 UK: 355 cases, 94 (of 252) fatal

•1992/93 France: 318 cases, 97 fatal

10 cases, children, none fatal

BIOLOGICAL HAZARDS

•1996 UK: Bovine Spongiform Encephalopathy (BSE)

Early in 1988 a middle level civil servant in the Ministry of Agriculture noted, “We do not know where this disease came from, we do not know how it is spread, and we do not know whether i t can be passed to humans. The last point seems to me the mo st worrying aspect of the problem. There is no evidence that th at people can be infected but we cannot say there is no risk.” Yet for the next eight

(Lord Phillips, chairman. The BSE inquiry Vol 1: findings and conclusions. London: Stationery Office; 2000. , HC 887-1.)

infected but we cannot say there is no risk.” Yet for the next eightyears expert committees, ministers, and civil servants - including two chief medical officers - reassured the public that there was no risk in eating beef.

CHEMICAL HAZARDS

•1994 Hungary: Lead oxide (Pb3O4) in paprika

THE EUROPEAN COMMISSION HAS ADOPTED MEASURES TO

STOP IMPORTS OF CHILLI AND CHILLI PRODUCTS WHICH

CONTAIN CARCINOGENIC RED CHEMICAL DYES. FROM NOW ON,

CHILLI AND CHILLI PRODUCTS INCLUDING CURRY POWDER CAN

CHEMICAL HAZARDS

•2003 China: Sudan red

ONLY BE IMPORTED INTO THE EU IF THEY ARE ACCOMPANIED BY

AN ANALYTICAL REPORT WHICH SHOWS THAT THEY DO NOT DO NOT

CONTAINCONTAIN SUDAN I, SUDAN II, SUDAN III OR SCARLET RED

(SUDAN IV). THE DYES ARE NOT FOUND NATURALLY IN FOOD AND

THE EU DOES NOT ALLOW THEM TO BE USED IN FOOD. ......

WHAT IS THE HEALTH RISK OF SUDAN I?

SUDAN I COULD CONTRIBUTE TO AN INCREASED RISK OF CANCER AND IT IS NOT

Sudan red, continued

INCREASED RISK OF CANCER AND IT IS NOT POSSIBLE TO IDENTIFY A SAFE LEVEL OR TO QUANTIFY THE RISK. HOWEVER, AT THE LEVELS PRESENT IN THESE FOOD PRODUCTS THE RISK IS LIKELY TO BE VERY SMALL.

THE THE ONLYONLY EVIDENCEEVIDENCE

RODENTS EATING DAILY 30 mg/kg BODY WEIGHT SUDAN RED FOR 2 YEARS DEVELOPED CANCER

Sudan red, continued

THIS WOULD MEAN FOR MAN 800 LITERWORCHESTER SAUCE EVERY DAY FOR 2 YEARS

April 11, 2005 - Elizabeth M. Whelan, president of the American Council on Science and Health

COSTS: £ 100,000,000

ZERO-TOLERANCE

EU 2001: DESTRUCTION OF FISH CONTAINING MINUTE

AMOUNTS OF CHLORAMPHENICOL.

ON 28 SEPTEMBER 2006, THE EUROPEAN COURT OF

JUSTICE, CONSIDERING THAT ZERO-TOLERANCEJUSTICE, CONSIDERING THAT ZERO-TOLERANCE

APPLIES TO FURAZOLIDONE AND CHLORAMPHENICOL,

RULED THAT EU COUNTRIES MUST SEIZE AND

DESTROY MEAT CONTAINING SUCH SUBSTANCES,

EVEN IF CONTAINING JUST PPBs (49 and 1.4 resp.).

CHORAMPHENICOL IS FREQUENTLY PRESCRIBED FOR HUMANS AND OTHER MAMMALS

IT IS PRODUCED IN NATURE (BY STREPTOMYCES VENEZUELAE)

ITS PRESENCE IN FOOD IS NOT EXCLUSIVELY DUE TO THE USE OF ANTIBIOTICS

EXAMPLE DOSE AS A MEDICIN(PER KG BODY WEIGHT PER DAY)

CHORAMPHENICOL: 25 mg

WHAT ABOUT WHAT ABOUT SALTSALT AND CANCER?AND CANCER?

DEFRA (UK) Expert Group on Vitamins and Minerals DEFRA (UK) Expert Group on Vitamins and Minerals Secretariat, Report March 2002 Secretariat, Report March 2002 ON SALT (NaCl)ON SALT (NaCl)

CARCINOGENICITYCARCINOGENICITY

78. The Committee on Medical Aspects of Food and Nutrition Policy stated that although most epidemiological studies indicated that higher intakes of salt were associated with higher risk of gastric cancer this does not generally relate to higher risk of gastric cancer this does not generally relate to foods commonly consumed in the UK (DH 1998).

DEFRA (UK) Expert Group on Vitamins and Minerals DEFRA (UK) Expert Group on Vitamins and Minerals Secretariat, Report March 2002 Secretariat, Report March 2002 ON SALT (NaCl) ON SALT (NaCl) [Continued]

80. A comparison of 136 incidences of gastric cancers with 151 age-comparable population controls in Puerto Rico found a strong odds ratio (3.34) and significant difference between cases and controls with regard to dietary salt exposure. Estimates for mean weekly salt exposure, based on the consumption of nine food items with high salt content consumption of nine food items with high salt content commonly consumed in Puerto Rico was 50.33 g (7.2 g per day) among the cancer patients and 29.81 g for the controls. The association remained positive and statistically significantafter adjusting for the confounding factors of gender, education and smoking habits (Nazario et al 1993).

DEFRA (UK) Expert Group on Vitamins and Minerals DEFRA (UK) Expert Group on Vitamins and Minerals Secretariat, Report March 2002 Secretariat, Report March 2002 ON SALT (NaCl) ON SALT (NaCl) [Continued]

154. Sodium chloride was determined to be a dose-dependent promoter of glandular stomach cancers in Wistar rats given an initiation dose of N-methyl-N’-nitro-Nnitrosoguanidine (MNNG) for eight weeks prior to exposure to 0, 2.5, 5 or 10% sodium chloride in their diet (Takahashi et al 1994).al 1994).

OF COURSE: UNNECESSARY ADDITIONS TO FOOD SHOULD NOT BE ALLOWED

AND THE USE OF SALT (NaCl) SHOULD NOT BE FORBIDDEN

RESOURCES, HOWEVER, SHOULD BE SPEND ON ISSUES THAT MAY HAVE A REALLY SERIOUS IMPACT ON FOOD SAFETY

CHEMICAL HAZARDS

•2007 China: Melamine in rice protein concentrates

Picture: Ariana Lindquist for The New York TimesPieces of melamine displayed by a worker. The melamine is ground into a powder and added to animal feed as a filler to keep costs low.

By DAVID BARBOZA and ALEXEI BARRIONUEVOPublished: April 30, 2007

PROCESSING HAZARDS

•2002: Acrylamide

A REACTION BETWEEN ASPARAGINE AND SUGAR AT ELEVATED TEMPERATURES RESULTS IN ACRYLAMIDE .

Mottram et al, Nature 419, 448-449 (2002).

Deep fat frying, baking, thermal sterilisation ....

Perhaps not as dangerous as suggested?

REGULATIONS ARE NEEDEDREGULATIONS ARE NEEDED

ARBITRARINESS AND PANICKING ARBITRARINESS AND PANICKING

MUST BE AVOIDEDMUST BE AVOIDEDMUST BE AVOIDEDMUST BE AVOIDED

SOUND SCIENCE MUST BE THE BASISSOUND SCIENCE MUST BE THE BASIS

DRIVERSDRIVERS

FORFORFORFOR

GLOBAL HARMONISATIONGLOBAL HARMONISATION

•GLOBAL DISPARITY IN FOOD SAFETY STANDARDS

•GLOBAL TRADE DISPUTES

•GLOBALLY BILLIONS OF TONS OF FOOD AT RISK OF

DESTRUCTION

•GLOBALLY 840 MILLION SUFFER UNDER-NUTRITION *•GLOBALLY 840 MILLION SUFFER UNDER-NUTRITION *

*Robert L. Thompson, ChairmanInternational Food & Agriculture Trade Policy Council

New Orleans, 19 July 2005

Regulatory TrendsAmong Industrialised Nations

1. Single agency focused on food

2. Use of risk analysis to design regulations (FSOs)

3. Recognition of the importance of the supply chain in addressing

food safety hazards (ISO22000)

4. HACCP system as basis for new regulations for microbial

pathogens in food (Juice HACCP)pathogens in food (Juice HACCP)

5. More stringent standards for many food safety hazards

6. New and more extensive standards for novel processing and

preservation techniques

7. Improving market performance in food safety through providing

information (to other countries)

• BSE

• Salmonella, E. Coli, Listeria monocytogenes

• Acrylamide, benzene, PCBs

• Avian influenza

• Sudan red, melamine

• Ochratoxin

FOOD SCARES (Fact, Fiction, Otherwise)

• Ochratoxin

DESTRUCTION OF FOODDESTRUCTION OF FOOD

POLITICAL SANCTIONS,POLITICAL SANCTIONS,

TARIFFS, HYSTERIATARIFFS, HYSTERIA

TOUGHER LEGISLATIONTOUGHER LEGISLATION

FOOD ADDITIVE REGULATIONSFOOD ADDITIVE REGULATIONS

SUBSTANCES THAT, WHEN ADDED TO THE FOOD, CAN BECOME PART OF THE FOOD OR ALTER ITS CHARACTERISTICS, WITH THE EXCEPTION OF MINERAL NUTRIENTS AND VITAMINS, (ADDED TO ENHANCE NUTRITIONAL VALUE), SPICES, SEASONINGS, FLAVORINGS, AGRICULTURAL CHEMICALS, AND SUBSTANCES ADDED TO THE PACKAGING MATERIAL.

FOOD ADDITIVE REGULATIONSFOOD ADDITIVE REGULATIONS

SUBSTANCES USED IN OR ON FOOD IN THE PROCESS OF MANUFACTURING FOOD, OR SUBSTANCES USED FOR THE PURPOSE OF PROCESSING OR PRESERVING FOOD.

NO NEED TO READ!

ANY SUBSTANCE THE INTENDED USE WHICH RESULTS OR MAY REASONABLY BE EXPECTED TO RESULT-DIRECTLY OR INDIRECTLYINITS BECOMING A COMPONENT OR OTHERWISE AFFECTING THE CHARACTERISTICS OF ANY FOOD.

FOOD ADDITIVE REGULATIONSFOOD ADDITIVE REGULATIONS

NO NEED TO READ!

FOOD ADDITIVE REGULATIONSFOOD ADDITIVE REGULATIONS

FOOD ADDITIVES ARE SUBSTANCES ADDED INTENTIONALLY TO FOODSTUFFS TO PERFORM CERTAIN TECHNOLOGICAL FUNCTIONS, FOR EXAMPLE TO COLOUR, TO SWEETEN OR TO PRESERVE. FOOD ADDITIVES ARE DEFINED IN COMMUNITY LEGISLATION AS "ANY SUBSTANCE NOT NORMALLY CONSUMED AS A FOOD IN ITSELF AND NOT NORMALLY USED AS A CHARACTERISTIC INGREDIENT OF FOOD

NO NEED TO READ!

NOT NORMALLY USED AS A CHARACTERISTIC INGREDIENT OF FOOD WHETHER OR NOT IT HAS NUTRITIVE VALUE, THE INTENTIONAL ADDITION OF WHICH T O FOOD FOR A TECHNOLOGICAL PURPOSE RESULTS IN IT OR ITS BY-PRODUCTS BECOMING DIRECTLY OR INDIRECTLY A COMPONENT OF SUCH FOODS". (FOR FULL DEFINITION SEE: ARTICLE 1(2) OF DIRECTIVE 89/107/EEC ).

ANY SUBSTANCE NOT NORMALLY CONSUMED AS A FOOD BY ITSELF AND NOT NORMALLY USED AS A TYPICAL INGREDIENT OF THE FOOD, WHETHER OR NOT IT HAS NUTRITIVE VALUE, THE INTENTIONAL ADDITION OF WHICH TO FOOD FOR A TECHNOLOGICAL (INCLUDING ORGANOLEPTIC) PURPOSE IN THE MANUFACTURE, PROCESSING, PREPARATION, TREATMENT, PACKING, PACKAGING, TRANSPORT OR HOLDING OF SUCH FOOD RESULTS, OR MAY BE REASONABLY

FOOD ADDITIVE REGULATIONSFOOD ADDITIVE REGULATIONS

HOLDING OF SUCH FOOD RESULTS, OR MAY BE REASONABLY EXPECTED TO RESULT, (DIRECTLY OR INDIRECTLY) IN IT OR ITS BY-PRODUCTS BECOMING A COMPONENT OF OR OTHERWISE AFFECTING THE CHARACTERISTICS OF SUCH FOODS. THE TERM DOES NOT INCLUDE CONTAMINANTS, OR SUBSTANCES ADDED TO FOOD FOR MAINTAINING OR IMPROVING NUTRITIONAL QUALITIES, OR SODIUM CHLORIDE

NO NEED TO READ!

REGULATIONS ARE NEEDED TO ASCERTAIN THAT FOOD IS SAFE

REGULATIONS SHOULD NOT HAMPER AVAILABILITY OF HEALTHY FOOD OR LEAD TO DESTRUCTION OF HEALTHY FOOD WHILE BILLIONS OF PEOPLE SUFFER FROM UNDERNOURISHMENTUNDERNOURISHMENT

REGRETTABLY, TOO OFTEN FOOD SAFETY MEASURES DO CAUSE SUCH EFFECTS

BACKGROUND USUALLY IS THAT REGULATORY MEASURES ARE DEVELOPED IN RESPONSE TO INCIDENTS

THEY ARE OFTEN BASED ON MISCONCEPTIONSSUCH AS TOXICITY (AND EQUALLY CARCINICITY SUCH AS TOXICITY (AND EQUALLY CARCINICITY AND ALLERGENICITY) IS ABSOLUTE AND THEREFORE THERE IS A ZERO TOLERANCE FOR POTENTIALLY TOXIC SUBSTANCES

“ALL SUBSTANCES ARE POISONS: THERE IS NONE WHICH IS NOT A POISON. THE RIGHT DOSE DIFFERENTIATES A POISON AND A REMEDY”

Paracelsus, before 1541.Paracelsus, before 1541.

EXAMPLE:EXAMPLE:

TOXICITY OF SOME VITAMINSVITAMINS

VITAMINEVITAMINERECOMMENDED DIETARY RECOMMENDED DIETARY

ALLOWANCEALLOWANCETOXICITY*TOXICITY*

ACUTEACUTE CHRONICCHRONIC

A

D

E

1-4Y: 2500 IU / 5+Y: 5000 IU

>1Y: 400 IU

1-4Y: 10 IU/ 5+Y: 30 IU

*IU PER KG BODYWEIGHT

25,000

unknown

4000

400

3000 for 7-9 weeks

EXAMPLE:EXAMPLE:

SELENIUMSELENIUM TOXICITY

AGE

0-6 MONTHS

7-12 MONTHS

TOLERABLE UPPER INTAKE

(::::g/day)

45

60

ADEQUATE OR RECOMMENDED

(::::g/day)

15

207-12 MONTHS

1-3 Y

4-8 Y

9-13 Y

14+ Y

60

90

150

280

400

20

20

30

40

55

8/1/2004 Office of Dietary Supplements, National Institutes of Health, USA

Substances - natural or not - although beneficial or even essential will be toxic above a certain concentration.

Total absence often may not be possible or undesirable.

Today detection* levels for most substances are well below the toxicity levels.

Requiring total absence (“zero tolerance”) therefore Requiring total absence (“zero tolerance”) therefore cannot be justified and would lead to either extremely expensive food, unaffordable to many or to no food at all.

* For many substances detection limitshave gone down from mg/kg to ng/kg

1000,0001000,000 MORE SENSITIVEMORE SENSITIVE

ABSENCE OF MICRO-ORGANISMS ...

EXAMPLEEXAMPLE

MICROBES ARE EVERYWHERE - THEY ARE ESSENTIAL FOR SUSTAINING THE PLANET

MICROBES MAY BE HARMFUL IF

• ABOVE CERTAIN CONTENTRATIONS

• ABLE TO MULTIPLY AND PRODUCE HARMFUL SUBSTANCES

• INFECTIOUS

MANY REGULATIONS REQUIRE THE ABSENCE OF CERTAIN MICROBES: ZEROZERO--TOLERANCETOLERANCE

IFT SUPPORTS RECOMMENDATIONS TO ELIMINATE THE ZERO TOLERANCE POLICY FOR FOOD THAT DOES NOT SUPPORT THE GROWTH OF L. MONOCYTOGENES, ALLOWING MORE EFFORTS AND RESOURCES TO BE FOCUSED ON AREAS THAT MAY HAVE A GREATER HEALTH BENEFIT.

IFT AGREES THAT ANALYSIS CLEARLY SHOWED THAT NOT ALL FOOD

PROGRESS ...PROGRESS ...

IFT AGREES THAT ANALYSIS CLEARLY SHOWED THAT NOT ALL FOOD REPRESENTS AN EQUAL RISK, AND THAT • REMOVAL OF A SMALL AMOUNT OF PRODUCT CONTAINING HIGH LEVELS OF L. MONOCYTOGENES WILL UNDOUBTEDLY HAVE AGREATER POSITIVE IMPACT ON PUBLIC HEALTH THAN

• REMOVING GREATER AMOUNTS OF PRODUCT CONTAINING LEVELSOF THE MICRO-ORGANISM SO LOW AS TO PRESENT VIRTUALLY NO

PUBLIC HEALTH RISK .

THE FOOD QUALITY PROTECTION ACT (FQPA) WAS PASSED UNANIMOUSLY BY CONGRESS IN JULY 1997, AND SIGNED INTO LAW IN AUGUST. THE ACT AMENDS TWO OTHER PIECES OF LEGISLATION. THESE ARE 1) THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (FFDCA), WHICH COVERS FOOD SAFETY AND TOLERANCES FOR PESTICIDES IN FOOD AND 2) THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA), WHICH SETS GUIDELINES FOR PESTICIDE REGISTRATION, CLASSIFICATION (GENERAL VERSUS RESTRICTED), AND USE , AS WELL AS APPLICATOR CERTIFICATION.

DELANEY IS DEAD: THE FQPA REPEALS THE DELANEY "ZERO TOLERANCE " CLAUSE FOR PESTICIDES. INSTEAD, THE DELANEY CLAUSE IS REPLACED WITH A SINGLE HEALTH BASED STANDARD FOR RAW AND PROCESSED FOODS. THE STANDARD REQUIRES THAT TOLERANCES ASSURE WITH "REASONABLE CERTAINTY THAT NO HARM WILL RESULT FROM AGGREGATE EXPOSURE ".

JUST READ

REDUCTION IN THE USE OF PESTICIDES WILL NOT EFFECTIVELY PREVENT DIET-RELATED CANCER. DIETS HIGH IN FRUITS AND VEGETABLES, WHICH ARE THE SOURCE OF MOST HUMAN EXPOSURES TO PESTICIDE RESIDUES, ARE ASSOCIATED WITH REDUCED RISK OF MANY TYPES OF CANCER. LESS USE OF SYNTHETIC PESTICIDES WOULD INCREASE COSTS OF FRUITS AND VEGETABLES AND, THUS, LIKELY REDUCE CONSUMPTION, ESPECIALLY AMONG PEOPLE WITH LOW INCOMES, WHO

SPEND A HIGHER PERCENTAGE OF THEIR INCOME ON FOOD.

Lois Swirsky Gold, Thomas H. Slone, Neela B. Manley and Bruce N. AmesThe Fraser Institute - Centre for Studies in Risk, Regulation and Environment

Vancouver, British Columbia, Canada, 2002

CARCINOGENICITY IN RODENTS OF NATURAL CHEMICALS IN ROASTED COFFEE

CARCINOGENS:CARCINOGENS:ACETALDEHYDE, BENZALDEHYDE, BENZENE, BENZOFURAN, BENZO(A)PYRENE, CAFFEIC ACID, CATECHOL, 1,2,5,6-DIBENZANTHRACENE, ETHANOL, ETHYLBENZENE, FORMALDEHYDE, FURAN, FURFURAL, HYDROGEN PEROXIDE, HYDROQUINONE, ISOPRENE, LIMONENE, 4-METHYL CATECHOL, STYRENE, TOLUENE, XYLENE

NONCARCINOGENS:NONCARCINOGENS:ACROLEIN, BIPHENYL, CHOLINE, EUGENOL, NICOTINAMIDE, NICOTINIC ACID,

Carcinogenic Potency Database (http://potency.berkeley.edu; Gold & al. 1999; Gold & Zeiger 1997).

Cited in: Lois Swirsky Gold, Thomas H. Slone, Neela B. Manley and Bruce N. AmesThe Fraser Institute - Centre for Studies in Risk, Regulation and Environment

Vancouver, British Columbia, Canada, 2002

PHENOL, PIPERIDINE

UNCERTAIN:UNCERTAIN:CAFFEINE

YET TO TESTYET TO TEST: ABOUT 1000 CHEMICALS

SINCE NO PLOT OF LAND IS FREE FROM ATTACK BY INSECTS, PLANTS NEED CHEMICAL DEFENSES - EITHER NATURAL OR SYNTHETIC - IN ORDER TO SURVIVE. THUS, THERE IS A TRADE-OFF BETWEEN NATURALLY OCCURRING AND SYNTHETIC PESTICIDES. ONE CONSEQUENCE OF DISPROPORTIONATE CONCERN ABOUT RESIDUES FROM SYNTHETIC PESTICIDES IS THAT SOME PLANT BREEDERS DEVELOP PLANTS THAT ARE MORE INSECT-RESISTANT BECAUSE THEY ARE HIGHER IN NATURALTOXINS.

A CASE STUDY ILLUSTRATES THE POTENTIAL HAZARDS OF THIS APPROACH TO PEST CONTROL. WHEN A MAJOR GROWER INTRODUCED A NEW VARIETY OF HIGHLY INSECT-RESISTANT CELERY INTO COMMERCE, PEOPLE WHO HANDLED THE CELERY DEVELOPED RASHES WHEN THEY WERE SUBSEQUENTLY EXPOSED TO SUNLIGHT. SOME DETECTIVE WORK FOUND THAT THE PEST-RESISTANT CELERY CONTAINED 6200 PARTS PER BILLION (PPB) OF CARCINOGENIC (AND MUTAGENIC) PSORALENS INSTEAD OF THE 800 PPB PRESENT IN COMMON CELERY (BERKLEY & AL. 1986; GOLD & AL. 1999; GOLD & AL. 1997B).

Lois Swirsky Gold, Thomas H. Slone, Neela B. Manley and Bruce N. AmesThe Fraser Institute - Centre for Studies in Risk, Regulation and Environment

Vancouver, British Columbia, Canada, 2002

IN OTHER WORDS:

REGULATIONS SHOULD BE BASED ON

RISK / BENEFIT ANALYSES

FOOD CONTACT EQUIPMENTFOOD CONTACT EQUIPMENT

CONSTRUCTION MATERIALSCONSTRUCTION MATERIALS

COMPONENTS

CONVEYOR BELTCONVEYOR BELT

STAINLESS STEEL + POLYMER MATERIALS + LUBRICANTS

POLYMERS

PLASTICISERS

CATALYST

STABILISER

FILLERS

PIGMENTS

Fe, Cr, Ni, C, Mo, Ti, etc.

OILS

ANTIMICROBIALS

ANTIOXIDANTS

RUST INHIBITOR

ANTI FOAM

VISCOSITY EXTENDER

200-250 MG IRON/KG BODY WEIGHT IS LETHAL.

NEVERTHELESS, WE ALSO GET ILL AND EVENTUALLY DIE IF WE DO NOT CONSUME

EXAMPLE:EXAMPLE:

IRONIRON TOXICITY

EVENTUALLY DIE IF WE DO NOT CONSUME ENOUGH IRON.

EXAMPLE:EXAMPLE:

MOLYBDENUMMOLYBDENUM TOXICITY

Deficiency symptoms include: anemia, fatigue, decreased urine formation, increased fatty acid oxidation, reduced life expectancy, tachycardia (increased heart rate), visual problems, male impotence, mouth and gum disorders, and cancer.Toxicity symptoms include: copper deficiency, gout, bone disease, diarrhea, anemia, decreased growth.

WHO (1993) ESTIMATED A DAILY REQUIREMENT FOR MOLYBDENUM OF BETWEEN 0.1 AND 0.3 MG/DAY FOR ADULTS.

WHO (1993) Guidelines for drinking water quality. Second edition. WHO, Geneva.

INTAKES OF 1 MG/DAY COULD BE ASSOCIATED WITH AN INCREASE IN GOUT-LIKE SYMPTOMS AND INCREASED SERUM URIC ACID LEVELS.

Kovalsky et al. (1961) Zhurnal Obshchei Biologii 22, 179-191(cited by Expert Group on Vitamins and Minerals 2003)

PRINCIPLE HYGIENIC DESIGNHYGIENIC DESIGN CRITERIA FOR THE PRODUCT CONTACT SIDE (EHEDG GUIDELINE NO. 8):

UNDER CONDITIONS OF USE MATERIALS MUST BE NON-TOXIC ...

HOW TO BE CERTAIN ABOUT

• THE COMPOSITION OF THE MATERIALS SUPPLIED?• THE COMPOSITION OF THE MATERIALS SUPPLIED?

• THE INTERACTION BETWEEN MATERIAL AND PRODUCT?

LEACHING, ABBRASION AND ELECTRO-CHEMISTRY MIGHT CAUSE UNACCEPTABLE CONTAMINATION OF THE FOOD PROCESSED

• DOES WELDING CHANGE THE STEEL COMPOSITION?

PRINCIPLE HYGIENIC DESIGNHYGIENIC DESIGN CRITERIA (EHEDG GUIDELINE NO. 8):

DEAD LEGS, GAPS AND CREVICES MUST BE AVOIDED...

• SOMETIMES REGULATORY PRESCRIPTIONS

REQUIRE THE PRESENCE OF DEAD LEGS

• SOMETIMES REGULATIONS REQUIRE BLOCK AND

BLEED VALVES IN STEAD OF DOUBLE-SEAT VALVES

3-A (USA) AND EHEDG ARE

WORKING TOGETHER.

OTHER REGIONS?

LOSS OFLOSS OF

COLOURCOLOUR -- TASTE TASTE -- NUTRIENTSNUTRIENTS

Genesis Juice CooperativeGenesis Juice CooperativeOregon, USAOregon, USA

PEFPEFCHAMBERCHAMBER

EUKARYOTIC CELL

Fe, Zn, ...Vitamins

AntioxidantsEtc.

UNCOOKEDUNCOOKED

Fe, Zn, ...Vitamins

AntioxidantsEtc.

EUKARYOTIC CELL

Fe, Zn, ...Vitamins

AntioxidantsEtc.

COOKEDCOOKED

Fe, Zn, ...Vitamins

AntioxidantsEtc.

Fe

Zn

Antioxidants

Vitamins

INFLUENCE OF HEATINFLUENCE OF HEAT

LOSS OF

• Vitamin C

• Thiamin, B6, B12, Folic acid

DENATURATION OF PROTEINS , incl. ENZYMESDENATURATION OF PROTEINS , incl. ENZYMES

• LIPASES

• LIPOGENASES

• HYDROLASES, TRYPSIN INHIBITORS

INFLUENCE OF HEAT INFLUENCE OF HEAT -- 22

CHEMICAL REACTIONS

• LIPID OXIDATION

• BREAKING DISULFIDE BRIDGES

• ALKALINE - ACID AMINOACID REACTIONS

• MAILLARD REACTIONS

Incl. ASPARAGINE + SUGAR ACRYLAMIDE*

• CROSS LINKING AMINO ACIDS

• ETC.

* Mottram, Nature 419, 448-449 (2002)

100OC

INFLUENCE OF INFLUENCE OF PEFPEF

EUKARYOTIC CELL

Fe, Zn, ...Vitamins

AntioxidantsEtc.

Fe, Zn, ...Vitamins

AntioxidantsEtc.

Fe

Zn

Antioxidants

Vitamins

INFLUENCE OF INFLUENCE OF PEFPEF

SALMON CELLSSALMON CELLS

CONTROL PEF TREATEDFrom: Gudmundsson & Hafsteinsson, TIFS 12(2001)122-128

INFLUENCE OF INFLUENCE OF PEFPEF

ONION CELLSONION CELLS

From: Mustafa Fincan, Thesis Lund University, 2003

CONTROL PEF TREATED

MILD

SEVERE HEAT TREATMENT

MILD TREATMENT

MILD MILD TREATMENT

MILD TREATMENT

INFLUENCE OF INFLUENCE OF PEFPEF

ELECTROCHEMICAL EFFECTS?

INFLUENCE OF INFLUENCE OF PEFPEF

ELECTRODES:

CATHODES

STAINLESS STEEL 316

ANODES

Cu 25%, W 75%

ROBBINS CHAMBER (USP 6,331,321 B1)

Cu 25%, W 75%

+ C, Mn, Si, Mo, N

INFLUENCE OF INFLUENCE OF HIGH PRESSUREHIGH PRESSURE

CHEMICAL REACTIONS

• LIPID OXIDATION DIFFERENT from effect of heat

• ASPARTAME BREAKS DOWN- forming aspartylphenylalanine and diketopiperazine *- forming aspartylphenylalanine and diketopiperazine *

• CHANGES IN Fe AVAILABILITY different from heat

* Butz et al., 1997; ADI = 7.5 mg/kg body weight

Commission informs applicant of decision

Free to market product

MS writes to applicant

European Commission

Dossier

MS* where product will be first marketed

Initial assessment completed

Objections?

Authorisation Procedure

Y

N

Day 0

Day 60Day 0

Day 90

EU NOVEL FOODS PROCESSEU NOVEL FOODS PROCESS

Standing Committee for Food

Objections resolved by QMV**

Summary report to other MS

Initial assessment to other MS

Comments / objections

Scientific Committee for Food

Day 60Day 0

*MS=Member State

** QMV = Qualified Majority Vote of MSs

Maurice Smith

THE SAFETY OF A NEW PROCESS MUST BE DEMONSTRATED

and

A SOUND RISK / BENEFIT ANALYSIS IS REQUIRED

IT SHOULD BE DONE FOLLOWING AN AGREED AND GLOBALLY RECOGNISED PROTOCOL

and and

NOT HAVE TO BE REPEATED MANY TIMESNOT HAVE TO BE REPEATED MANY TIMESWITH DIFFERENT PROTOCOLS

AND

GOALGOALGOALGOAL

“Achieving consensus on the science of

food regulations and legislation to ensure

the global availability of safe and

wholesome food products for all

consumers.”

2005-04-26 DRAFT

CHARTER

The goal of the initiative is to ensure the global availability of safe and wholesome food products for all consumers.

To achieve this, undue barriers to free trade that masquerade as food safety protections must be vanquished. Such barriers include safety protections must be vanquished. Such barriers include differences in regulations and legislation between countries globally. The international scientific community must, therefore, work towardsachieving global consensus on the science underpinning food regulations and legislation. This will be achieved through attainment of the following objectives:

1. Identifying relevant scientific organizations

2005-04-26 DRAFT

CHARTER

2. Inviting and encouraging the participation of these scientificsocieties in the global harmonization initiative and invitingtheir members to join in this activity in their field of expertise.

3. Identifying relevant non-scientific stakeholders

4. Establishing effective communication between non-scientificand scientific organizations.

2005-04-26 DRAFT

CHARTER

5. Inviting all stakeholders (organizations and individuals) toidentify and submit key issues requiring attention.

6. Prioritizing key issues with the subsequent formation of working groups to draft white papers or consensus statementsregarding the scientific validity of these issues.

7. Steering working groups to assess the best available evidenceand discuss their findings with the scientific community, workingtowards building consensus.

8. Publishing results on a per issue basis in journals, magazines and newspapers

2005-04-26 DRAFT

CHARTER

9. Publishing collections of resulting consensus statements in book form

10. Presenting results and participating in appropriate conferences

11. Making results available to all stakeholders, particularly 11. Making results available to all stakeholders, particularly those responsible for developing or amending regulations and legislation, global communicators, risk managers and assessors.

All of these will be done in an open, transparent manner, to avoid bias or the appearance of bias, political or otherwise.

GHI WILL NOT DIRECTLY CHANGE REGULATIONS, BUT INTENDS TO PROVIDE TOOLS FOR HARMONISED REGULATIONS

GHI WILL NOT REPEAT WHAT HAS BEEN DONE, BUT WILL COLLECT AND EVALUATE AVAILABLE DATA, TO PRODUCE DRAFT STATEMENTSDATA, TO PRODUCE DRAFT STATEMENTS

SCIENTIFIC INSTITUTIONAL MEMBERS

• SCIENTIFIC SOCIETIES

• FEDERATIONS OF SCIENTIFIC SOCIETIES

• UNIVERSITIES

• SCIENTIFIC RESEARCH INSTITUTES

TO SAFEGUARD SCIENTIFIC INTEGRITY, PRESSURE GROUPS OF ANY KIND CANNOT BECOME INSTITUTIONAL MEMBERS.

INDIVIDUAL SCIENTIFIC MEMBERS

INDIVIDUAL SCIENTISTS WHO SHALL BE ASKED FOR COMMENTS ON CONSENSUS STATEMENTS.

COMMENTS MUST ALWAYS BE ACCOMPANIED BY SOUND SCIENTIFIC EVIDENCE.SCIENTIFIC EVIDENCE.

TO ENABLE GLOBAL PARTICIPATION WITHOUT FINANCIAL HURDLES, INDIVIDUAL SCIENTIFIC MEMBERS WILL NOT PAY MEMBERSHIP FEES.

INDIVIDUAL SCIENTIFIC MEMBER QUALIFICATION

• NAMES AND TITLES • MAIL AND EMAIL ADDRESS • NATIONALITY • EDUCATION • MEMBERSHIP(S) OF SCIENTIFIC/PROFESSIONAL ORGANISATIONS • CURRENT POSITION • AREAS OF EXPERTISE • AREAS OF EXPERTISE • YEARS OF EXPERIENCE IN FOOD SCIENCE AND TECHNOLOGY • CV • STATEMENT ON WHY INTERESTED IN GHI / SCIENTIFIC CONSENSUS

http://www.globalharmonization.org/applicationform.htm

EXPERTS

INDIVIDUAL SCIENTIFIC MEMBERS WHO HAVE BEEN RECOGNISED AS EXPERTS IN PARTICULAR SCIENCE FIELDS, BASED ON EVIDENCE PROVIDED.

THEY WILL BE RESPONSIBLE FOR JUDGING SCIENTIFIC THEY WILL BE RESPONSIBLE FOR JUDGING SCIENTIFIC EVIDENCE AND JUDGING ANY COMMENTS RECEIVED AND NEED TO APPROVE CONCEPT CONSENSUS STATEMENTS.

EXPERT QUALIFICATION

TO QUALIFY AS AN EXPERT, CANDIDATES NEED TO PROVIDE

• NAME + CONTACT DETAILS

• EDUCATION DETAILS

• SCIENTIFIC EXPERTISE

• EXPERIENCE

• SUPPORTING LETTERS OF AT LEAST TWO PEERS WITH NO BUSINESS• SUPPORTING LETTERS OF AT LEAST TWO PEERS WITH NO BUSINESS

RELATION TO THE CANDIDATE (GHI RESERVES THE RIGHT TO SEEK

CONFIRMATION FROM PEERS)

• LIST OF PEER REVIEWED PUBLICATIONS

• ANY OTHER INFORMATION CONSIDERED TO BE RELEVANT

ALTHOUGH MEMBERSHIP IS RESTRICTED TO SCIENTIFIC ORGANISATIONS AND INDIVIDUAL SCIENTISTS, ISSUES FOR CONSIDERATION MAY BE FORWARDED BY ANY ORGANISATION, PRESSURE GROUP OR INDIVIDUAL

SCIENTIFIC CONSENSUS

SCIENTIFIC COMMITTEES WILL DEVELOP DRAFT CONSENSUS STATEMENTS THAT WILL BE CIRCULATED FOR COMMENTS

HAVING CONSIDERED COMMENTS AND OPINIONS RECEIVED, WHICH MAY BE AN ITERATIVE PROCESS, A FINAL DRAFT WILL BE PRODUCED FOR SUBMISSION TO A GROUP OF RELEVANT EXPERTSEXPERTS

THESE EXPERTS NEED TO AGREE ON THE CONSENSUS CONCLUSION OR PROVIDE REASONS WHY THE STATEMENT IS INCORRECT - IN WHICH CASE THE PROCESS MUST BE REPEATED

SCIENTIFIC CONSENSUS - continued

THE FINAL CONCLUSION WILL BE PUBLISHED AS THE CONSENSUS DOCUMENT ON THE PARTICULAR ISSUE

IF NO CONSENSUS IS OBTAINED, THE - SCIENTIFIC - REASONS WILL BE PUBLISHED AND THE RESEARCH NEEDED TO RESOLVE WILL BE PUBLISHED AND THE RESEARCH NEEDED TO RESOLVE THE ISSUE WILL BE INDICATED.

SUPERVISORY BOARDCONSISTING OF REPRESENTATIVES OF SCIENTIFIC ORGANIZATIONS AND STAKEHOLDERS

• TO GUARD THE IMPARTIALLITY AND INTEGRITY OF THE CONSENSUS PROCESS

• TO ELECT MEMBERS OF THE EXECUTIVE COMMITTEE

EXECUTIVE COMMITTEEELECTED BY THE SUPERVISORY BOARD

• TO MANAGE THE EXECUTION OF ACTIVITIES ACCORDING TO

THE CHARTER

• TO ELECT CO-CHAIRS

SECRETARIAT

CO-CHAIRSPART OF THE EXECUTIVE COMMITTEE

• TO ACT AS PRIMARY CONTACTS FOR WORKING GROUPS

PUBLIC RELATIONS OFFICER

UNPAID*

PAID WHEN POSSIBLESCIENTIFIC COMMITTEES• TO DEVELOP CONSENSUS STATEMENTS

* TRAVELLING EXPENSES TO BE

COVERED BY SCIENTIFIC ORGANIZATIONSEXPERTS

• TO APPROVE CONSENSUS STATEMENTS

LEGAL STATUSLEGAL STATUS

TO PROTECT IDENTITY, GOAL & PRINCIPLESIDENTITY, GOAL & PRINCIPLES

TO ENABLE EMPLOYMENT OF STAFF

ASSOCIATIONASSOCIATION

CONSTITUTION TO BE BASED ON THE CHARTERBASED ON THE CHARTER

BY-LAWS TO PUT DOWN OPERATION PRINCIPLES

VIENNA, AUSTRIA

HOSTED by BOKU or ICC

BY-LAWS TO PUT DOWN OPERATION PRINCIPLES

WEBSITE: WEBSITE: WWW.GLOBALHARMONI ZATION.ORG

WEBSITE BY

LOGO BY

2007 – OCTOBER 30-31: EXECUTIVE COMMITTEE MEETING, VIENNA, AUSTRIA

2007 – NOVEMBER 16: WORKSHOP LISBON, PORTUGAL

2008 – JANUARY: WORKSHOP IN INDIA

Thee First Trulie Accurate Mapp of the Worldeby Terry Pratchett & Stephen Briggs

Thank you for your patienceThank you for your patience