Doi:10.1016/j.tifs.2006.08.005

Trends in Food Science & Technology 18 (2007) S15eS19 limits went down and currently many substances may be de-tectable in nano- or even picograms per kg of product. In food regulations and practice this means that where absence of substances isrequired, the concentration must be between a million or abillion times lower than at the time the regulations were established. Governments have a duty to ensure that the law is maintained and so must food safety inspectors. Thismay have fundamentally unacceptable consequences, such as consumers being denied essential nutrients and food need-lessly being destroyed because it contains harmless concen- trations of legally forbidden substances. This happens whileit is known for 500 years that toxicity is a matter of concen-tration. Many compounds are essential for good health incertain concentrations while toxic in another higher concen- tration (‘‘All substances are poisons: there is none which is not a poison. The right dose differentiates a poison and aremedy.'' Paracelsus, 1493e1541).
aEnsahlaan 11, 3723 HT Bilthoven, The Netherlands (Tel.: D31 30 2253897; fax: D31 84 7468555; b4021 W. Bertona Street, Seattle, A total of 1.25 billion people live on less than US$1 WA 98199-1934, USA per day, of whom 840 million suffer under-nutritionor hunger (Robert L. Thompson, chairman Interna-tional Food & Agriculture Trade Policy Council, It is generally assumed around the world that food is safe. Food New Orleans, 19 July 2005).
must be safe, for its intended use for human consumption, butfood safety and regulatory measures should not unnecessarilyhamper the availability of human food or hamper the intro-duction of novel processing methods aimed at retaining the Toxicity of an essential nutrient natural healthy properties of food.
Consumption of 200e250 mg iron/kg body weight islethal. We get ill and eventually die if we do not con- The global availability of safe and wholesome sume enough iron.
Food safety regulations have been devised to protect the consumer. Substances that had harmed humans were listed Food preservation and desirable properties as toxic and therefore considered unacceptable in food. Ab- Because safe food must be available around the year, food sence of such substances merely meant undetectable by the and food products must be preserved. Traditionally this is methods available. At the time that most of the regulations done by lowering the water activity (drying, addition of sugar were developed, however, analytical techniques were not and salt), increasing acidity (by addition of e.g. citric or lactic well refined yet and absence usually meant less than a few acid, or by fermentation), by the addition of preserving milligrams per kg of product. Unintentionally, absence has chemicals (such as sorbic acid) or by heat treatments. To got a different meaning with time as with time, the detection limit damage to the food, combinations are used, for in-stance, with most jams (marmalades), where the additionof sugar and citric acid makes it possible to make the product * Corresponding author.
safe for consumption for very long periods of time by giving 0924-2244/$ - see front matter Ó 2006 Elsevier Ltd. All rights reserved.
doi:10.1016/j.tifs.2006.08.005 H. Lelieveld, L. Keener / Trends in Food Science & Technology 18 (2007) S15eS19 it a pasteurisation treatment instead of a far more severe ther-mal sterilisation treatment. For many products, however, such treatments are still harmful, adversely affecting flavour, Conveyor belts may consist of stainless steel, poly- colour and nutrients. For over a 100 years, scientists have mer materials and require lubrication. Consequently, been looking for alternatives that would stabilise the product depending on conditions of use, food might come in without losing its desirable properties. It is, however, only contact with a whole range of potential contaminants: rather recently that such technologies reached a state that Stainless steel: iron, chromium, nickel, molybde- commercial application has become a realistic option, num, titanium, .
mainly as the result of a vast amount of Polymer material: plasticisers, catalysts, stabilisers, dpartly governmen- fillers, pigments, dresearch. It has been demonstrated that many food products may be preserved by novel methods Lubricants: antimicrobials, antioxidants, rust inhib- with much less damage to the product than with the tradi- itors, anti-foaming agents, viscosity extenders.
tional methods, thus meeting consumer demands.
Risk communication Consequently, regulators and hence politicians, have to In the past two decennia, scientists became to under- be convinced that changes are needed. This is not easy as stand the relation between food consumed and health.
scientists often have difficulty with communication. They This lead to the identification of food constituents that re- like to use the scientifically correct wording and that may duced health risks. For instance, the discovery that plant easily be misunderstood. As Dr. Coughlin expressed it at stanols and plant sterols, as well as certain types of husks, a recent food safety conference (Orlando, June 2006), ‘‘un- all of natural plant origin, may effectively reduce the con- definable risk'' is likely to be perceived as ‘‘unavoidable centration of low-density lipoprotein (LDL) cholesterol in harm''. Because most people are not scientists, from an blood led to the developments of a range of new products electoral point of view it's easier to listen to the vox populi.
that fit in a healthy life style.
One of the manifestations or consequences of this reality isadoption of the precautionary principle within the EU. In Global harmonization short, this principle requires the provision of objective sci- Application of these insights, however, requires demon- entific data for purposes of demonstrating food safety stration that the products developed are safe. This self- where the public health status of a substance has been evidently is a fully justified requirement. The bad news, called into question; whether or not there is a long history however, is that due to the differences in regulations of the substance's safe use as food.
between nations, demonstration of safety may have to berepeated over and over again, depending on where the prod- ucts are produced, from where they or their ingredients ebenefit analysis originate or to where they are exported. The time and costs Reduction in the use of pesticides will not effectively pre- involved at least delay the availability of desirable products vent diet-related cancer. Diets high in fruits and vegeta- and in worse cases, products do not reach the market at all.
bles, which are the source of most human exposures to Having to prove safety only once, in a single country pesticide residues, are associated with reduced risk of according to globally agreed protocols, would significantly many types of cancer. Less use of synthetic pesticides reduce these hurdles and thereby also increase the interest would increase costs of fruits and vegetables and, thus, in further research into novel methods and ingredients.
likely reduce consumption, especially among people This requires that food safety regulations and legislation with low incomes, who spend a higher percentage of their have to be harmonised, globally. Food safety legislation income on food (Lois Swirsky Gold, Thomas H. Slone, often requires evidence produced by animal testing that Neela B. Manley and Bruce N. Ames, The Fraser Institu- is, mildly expressed, not popular. Apart from the debate tedCentre for Studies in Risk, Regulation and Environ- about how relevant animal testing really is to establish ment, Vancouver, British Columbia, Canada, 2002).
safety requirements for humans, having to do such testsonly once and the result being globally accepted wouldbe a significant step in a highly desirable direction.
It is not our intention to advocate carelessness or poor science in risk assessment. To the contrary, it is our positionthat any and all potential adverse effects that may have Food contact materials should not release toxic resulted from a new process should be subjected to the most careful scientific scrutiny. It is our view, however, Equipment manufacturers need to be certain about the that it is a waste of time and resources to require approval composition of the materials used for constructions in several countries, each demanding similar data produced intended for contact with food.
by different protocols. What is needed are globally agreedprotocols and a system to ensure that those protocols are H. Lelieveld, L. Keener / Trends in Food Science & Technology 18 (2007) S15eS19 followed accurately. Once checked and perhaps double Scientific consensus checked, the results should apply universally. Organisations It is realised that GHI on its own will not be able to or individuals, despite proven safety, who make statements change regulations anywheredlet alone globally. GHI calling into question the safety of a process, should be intends to establish whether global consensus is possible required to provide a sound scientific basis for their objec- on issues that buttress such regulations. This requires the tion or in support of their position.
participation of responsible food scientists from all over Similar questions and issues relating to food production the world and identification of experts. Publication of the and food safety are frequently raised about every aspect of results of the Global Harmonization Initiative will make the supply chain from farming to retail. For instance, does it more difficult to abuse science. By obtaining global the use of hormones and antibiotics affect the safety of the scientific consensus on food related issues, it will be hard meat? When is food kosher? Are all spices safe? Are micro- for antis to find scientists who are willing to support unjus- organisms used to ferment food always safe? Pesticides may tified statements. It will also be hard to counter or deny be essential to be able to produce enough food, when are they requests to governments for changes in regulations that safe and when harmful? Microbicides (fungicides, bacteri- are not based on sound scientific data.
cides), which are more harmful, microbicides or microbes? The intention is not to promote a ‘‘no'' or ‘‘yes'' for par- Pesticides or pests? On another front: what are food additives ticular cases, but to carefully review available evidence to and what are processing aids? Regrettably, at this moment in see whether or not a consensus statement on safety can be time, it depends on where you live. In short, the question is.
made. There may be issues where the ‘‘yes'' or ‘‘no'' de- ‘‘what is the balance between benefit and safety risk?'' pend on circumstances, e.g. the method of use or the useby certain populations. For instance, lactose is a natural con-stituent of bovine milk. While for some populations lactose is a harmless energy source, for other populations it is a toxicsubstance. Likewise, peanuts are a staple in the diets of bil- In 2001, the EU decided to destroy a large amount of lions of people around the world, whereas for thousands of fish containing minute amounts of chloramphenicol.
others they are a constant threat of anaphylaxis. In other Chloramphenicol is an antibiotic produced by Strepto- cases there may be lack of evidence either way. In such myces venezuelae that is frequently prescribed for cases research to obtain such evidence shall be proposed.
humans and other mammals. On 28 September 2006,the European Court of Justice, considering that zero-tolerance applies to furazolidone and chlorampheni- col, ruled that EU countries must seize and destroy It is realised that many organisations attempt to harmo- meat containing such substances, even if containing nise regulations and standards to which legislation refers.
These organisations include Codex Alimentarius (a jointUnited Nations and World Health Organization commis-sion), the World Trade Organisation (WTO), standardisa- The Global Harmonization Initiative tion organisations such as ISO and organisations such as It is for all those reasons discussed above that a few the European Food Safety Authority (EFSA). By far not years ago, scientists involved in various scientific organisa- all nations participate in these organisations and some tions, dealing with food science and technology, decided may be politically biased or perceived to be biased. Never- that it ought to be possible to harmonise food regulations theless, the GHI will not repeat work done. To the contrary, and legislation, i.e. having the same rules and food laws ev- where statements based on scientific evidence exist, they erywhere on the globe. In 2004 the International Division will be reviewed and most likely often be adopted as of IFT and the European Federation of Food Science and DRAFT consensus statements. Such statements may origi- Technology (EFFoST), in cooperation with Food Safety nate from organisations such as Codex Alimentarius, the Magazine and Elsevier Science launched the Global Har- International Commission for the Microbiological Specifi- monization Initiative (GHI) to try to eliminate differences cations for Food (ICMSF), the European Food Safety in regulations and legislation. Soon after this event, many Authority (EFSA), and the International Life Sciences other organisations have joined, including the International Institute (ILSI). The GHI therefore is very pleased with par- Union of Food Science and Technology (IUFoST), the Fed- ticipation of scientists involved in these and other organisa- eration of European Microbiological Societies (FEMS), the tions with similar goals.
Food Chemistry Division of the European Association for Meanwhile, there has been a range of GHI meetings, Chemical and Molecular Sciences (EuCheMS) and the Eu- including symposia and workshops, in places like Las ropean Hygienic Engineering and Design Group (EHEDG).
Vegas, Warsaw, Lisle, New Orleans, Hamburg, Sofia, In addition, scientific research organisations, such as the Orlando, Nantes, Cork and The Hague. Reports on these National Center for Food Safety & Technology (NCFST) events and presentations can be found on the web site in Chicago and food science & technology departments . This has resulted in a Charter of universities all over the world have joined.
(see below).

H. Lelieveld, L. Keener / Trends in Food Science & Technology 18 (2007) S15eS19 Current position The process to identify relevant scientific organisations Areas of expertise has been started. These organisations will be requested to Years of experience in food science and technology inform their members about the GHI and to invite them to join GHI as scientific members. To avoid any financial Statement on why interested in GHI and scientific hurdles, membership will be free, but to qualify, the follow- ing information must be provided: Names and titles GHI is not after obtaining consensuses between scientific Mail and email address organisations or any official bodies, but after consensuses be- Nationality (to ascertain that we shall have members in tween individual scientists, regardless of their affiliations.
This leads us to one of the most important but at the same time perhaps most difficult tasks for the GHI group: how to Membership(s) of scientific or professional organisations identify the real scientific experts and how to ensure that The goal of the initiative is to ensure the global availability of safe and wholesome foodproducts for all consumers. To achieve this, undue barriers to free trade that masquerade as food safety protectionsmust be vanquished. Such barriers include differences in regulations and legislation betweencountries 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 2. Inviting and encouraging the participation of these scientific societies in the global harmonization initiative and inviting their members to join in this activity in their field of expertise.
3. Identifying relevant non-scientific stakeholders4. Establishing effective communication between non-scientific and scientific organizations.
5. Inviting all stakeholders (organizations and individuals) to identify and submit key issues requiring attention.
6. Prioritizing key issues with the subsequent formation of working groups to draft white papers or consensus statements regarding the scientific validity of these issues.
7. Steering working groups to assess the best available evidence and discuss their findings with the scientific community, working towards building consensus. 8. Publishing results on a per issue basis in journals, magazines and newspapers9. Publishing collections of resulting consensus statements in book form 10. Presenting results and participating in appropriate conferences11. 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 ofbias, political or otherwise.

H. Lelieveld, L. Keener / Trends in Food Science & Technology 18 (2007) S15eS19 they will be able to participate in an independent way. Several for success, funds are required as staff will be needed to discussions took place on the identification of experts. The deal with the necessary correspondence and archiving.
initiative would fail if everybody could sign up as an expert Here, the GHI group faces a severe difficulty. Although on everything that he or she feels is something to be influ- stakeholders may play a role in providing issues and submit- enced. It is imperative that evidence of expertise is provided.
ting evidence, the GHI group needs to be independent of To qualify as an expert, therefore, candidates need to provide: stakeholders and therefore cannot and will not accept finan-cial support from either industry or governments. How then Name þ contact details to solve this problem? After considerable debate, it has Education details been decided that support from scientific organisations is es- Scientific expertise sential and need not affect impartiality. Recognising that sci- entific organisations are unlikely to have the funds to finance Supporting letters of at least two peers with no business the entire operation, these organisations may decide to attempt relation to the candidate to raise funds from, e.g. governments, industries, charities and List of peer-reviewed publications individual members in any way, to secure resources required.
Any other information considered to be relevant Provided, however, that the organisations will in no way pressthe GHI to focus on specific issues on the behalf of anypressure group. The GHI should be kept unaware of the Operation procedure stakeholders that provide financial support to the scientific Another activity that has been started is developing the organisations. The reason that stakeholders would support consensus ‘‘operation procedure''. The first step will have the initiative despite not being recognised as such should lay to be identification of issues and then prioritising them.
in the fact that they are stakeholders, i.e. they will eventually Proposed issues must be presented with justification and benefit from global harmonization of food regulations and any opinion of an issue must be accompanied by evidence.
legislation. In line with the GHI Charter, any funding In the follow-up of this process, we may depend on the avail- received by the GHI will be fully justified on the GHI web ability of experts as working parties need to be set up to eval- site and be open to inspection by participating scientific uate evidence provided. There will be a stage when a DRAFT consensus statement can be produced for circulation amongall other experts on the subject and for publication on the GHI web site. The next phase may be quite effort intensive To ensure that GHI will be able to operate professionally as replies need to be classified and evaluated and the process without losing impartiality, a GHI Foundation will be estab- may have to be repeated several times.
lished in Vienna, Austria, with the Charter as the core of theconstitution. Only employees will be paid. Of all others, only reasonable costs, such as for travelling, lodging and So far, all the GHI work is done by volunteers who believe teleconferencing will be funded. The structure of the orga- that the Initiative is worth the effort, but it is envisaged that nisations is presented below:

Source: http://www.globalharmonization.net/sites/default/files/pdf/articles/2007_TrendsFdSciTech_LelieveldKeener.pdf

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