Food Safety Magazine

Cover Story | December 2015/January 2016

The Harmonization of Food Safety Regulations

By Huub Lelieveld and Veslem√ły Andersen

The Harmonization of Food Safety Regulations

We cannot do without regulations in the way our food is produced and sold.

There are always people who have no scruples and just want to make money: those who make and sell food that has been manipulated to make it look or taste better so that a higher price can be asked. In other cases, companies may use processing aids that are very cheap so that the production costs are reduced; sometimes, they simply add materials to food that are not really ingredients but just chemicals, without caring about the consequences for the consumer.

However, there should not be unjustifiable differences in regulations between countries, because such differences may be used as tools to restrict the import of food: legalized protectionism. Justifiable differences are based on differences in eating habits between regions and sometimes on genetic differences between people. All food contains substances that can become toxic if the quantity consumed is large enough. While in certain parts of the world, food consumption is low and a toxic dose will never be consumed, in other parts, consumption of a staple food may be in large quantities and therefore may lead to health problems. Cassava, for instance, is a staple food in many parts of the world, such as Asia, but used very little in other parts, such as (Western) Europe. From a genetic point of view, in countries where (cow’s) milk consumption is unusual, people may lack the gene to produce galactosidase and therefore be unable to digest milk sugars, resulting in serious consequences when they unknowingly consume too many products that contain milk or lactose-containing derivatives. In most of Northern Europe, milk consumption is moderate to high, and lactose intolerance is low. In many Asian countries and in Latin America, a large part of the population is lactose intolerant, up to 100 percent. Therefore, food regulations must be harmonized but, at the same time, should take differences in eating habits and genetic variation into account. One of the best ways to achieve fair and intelligent harmonization of food regulations is to base them on science.

What Is the Scientific Basis of Food Regulations?
To the dismay of most scientists, regulations are not traditionally based on science. Those who have the most influence on the politicians who decide on laws may be ignorant of the science, but often they argue that the science is irrelevant or even castigate scientists as dishonest and acting solely in the interest of their industry. The politicians tend to do what is best for them; they want to keep their political positions. The general public does not read scientific publications, as they are mostly written in a scientific language they do not understand, and obtains its information from the mass media: television, newspapers and magazines. The mass media, however, do not earn income from good news; good news does not sell. It is the bad news that increases sales and television ratings. Scientists or pseudoscientists who claim that food is unsafe therefore get the most attention. The vast majority of conscientious scientists are often not heard; if they are and provide scientifically correct data, even in an understandable way, they tend to be accused of bias in favor of those who pay them—usually either the state or an industry. The consequence is absurdity in regulations because science is neglected. In many cases, the starting point is that “there is a chemical in the food” and the public demands that there should be no chemicals in food. That everything is a chemical does not matter. Professional “anti-organizations” publish statements such as “Did you know that 95% of shoppers fill their grocery carts with ingredients known to cause cancer? You’re probably one of these shoppers—which means you may be buying poison without even knowing it. And the results are devastating: cancer, diabetes, heart disease, depression, obesity, migraines and even worse.”[1] Just search for “chemicals in food are dangerous” on the Internet, and you will find an overwhelming number of such statements, without scientific substantiation. This is regrettable, because there are products that do contain chemicals that should not be there at the concentrations used and for which there is good scientific evidence to make such claims. The general public should be informed of these facts and perhaps should learn to discriminate between sense and nonsense, or at least to find which sources of information are science-based and reliable.

Understanding Toxicity
One of the greatest difficulties in advancing public support for science-based regulation is the public’s lack of understanding of toxicity. Paracelsus observed about 500 years ago that every substance can be toxic in large enough amounts, but that the same substances can be beneficial or curative if the concentration is right. In recent decades, an overwhelming amount of scientific evidence has been produced that substantiates Paracelsus’s observations.[2] Toxicity is not a matter of a substance on its own, but a matter of the dose, which determines whether it is harmless, beneficial or toxic. Regrettably, outside of scientific circles, “the dose makes the poison” is little understood and poorly communicated. Stating that food is contaminated by a toxic substance, without any evidence, is easy and makes most people sufficiently concerned to demand that the toxic substance be forbidden. Seriously concerned people with families will avoid the products because they do not want to expose their children to such substances. There are also people and organizations that make a living out of scaring people. The general population has no idea (yet) of what toxicity is and believes that if there is a chemical in the food, the food is dangerous. Individual pseudoscientists sometimes make a living by publicly stating that a food contains some chemical that is toxic and should thus be forbidden. We suspect that those who have had a scientific education do this against their better knowledge. Sometimes, they set up anti-organizations to make money from donations of concerned people. This concept is shown in Figure 1 (red line). In the past decade, an increasing number of politicians have learned that you would no longer be able to eat anything if that concept were maintained. Therefore, they switched to believing that the concentration plays a role, and they generally believe that if fewer than one in a million people suffers from a product containing a toxin, this is acceptable. Their philosophy is that harm increases with the concentration, as shown in Figure 1 (blue line). Toxicologists globally—with the exception perhaps of a few pseudoscientists—agree that there is a threshold below which there is no harm (Figure 1, black line). Actually, however, there can be harm if the dose is too low. Examples are vitamins and many minerals: Too much is bad for human health and can even be deadly, but an insufficient amount will make people ill (Figure 2). People know that the lack of oxygen for a few minutes is deadly, but oxygen is so toxic that we need antioxidants to prevent irreparable damage to our bodies. Many chemicals are essential in low amounts, but all, without exception, are harmful in excessive quantities, even water. This message should be understood by the general public to prevent misinformation and the demand for absurd regulations.

The minerals found in our food are by definition natural. Most chemicals in our food are also of natural origin or at least are also present in nature. Interestingly, many consumers are of the opinion that “natural” substances are safe and that they need to look for natural products only (organic or bioproducts). One needs to be aware that the world is full of naturally dangerous substances, such as the potentially poisonous substances in natural, unprocessed food. All food contains such substances and too much of such substances will harm human health. Potatoes, tomatoes and eggplants contain solanine. It is a deadly substance if consumed in too high amounts; nevertheless, these foods are considered healthy. They are, however, healthy only if not eaten is absurd quantities. The message here is that requiring the complete absence of certain substances (chemicals) in food is unrealistic; demanding a maximum concentration, however, makes much more sense, provided that the concentration is based on science and not on misinformation.

Deciphering Risks from Microorganisms
Legal requirements regarding the presence of microorganisms in food differ between countries. Nevertheless, such differences may lead to the needless destruction of food. As with chemicals, to require total absence (zero tolerance) on fresh products is unrealistic. The allowed concentration in fresh food should be science-based and, for some microbes, will be much lower than for others. Note that for in-pack sterilized products (e.g., those in jars and cans), the requirements may be very stringent and easy to control. For others that occur in nature, control can be a challenge.

For example, the potentially deadly botulinum toxin is natural and will be produced under circumstances favorable for the growth of Clostridium botulinum. In modern societies, it is also used as a medicine for very special applications and as a cosmetic—in harmlessly low amounts. In the past, C. botulinum was just a killer, because the anaerobic microbe found favorable conditions in cans that had been sterilized but were leaking just enough to suck in spores (and one is enough) of the microbe from the water used to cool the can after sterilization. One or a few spores of C. botulinum are harmless unless they have an opportunity to grow and multiply. Examples of other microbes that scare people and lead to the public demanding regulations for unrealistically low numbers of these microbes on fresh products are Staphylococcus aureus and Listeria monocytogenes. Pathogenic microbes are harmful only if the number ingested is too high, which may be the case if a product is kept at a temperature that allows the microbes to multiply for too long a time. Products that allow growth of such microbes have an ultimate consumption date at a specified temperature. Like C. botulinum, S. aureus is harmful mainly because of the production of toxin (enterotoxin) in the food. L. monocytogenes is harmful because it multiplies in the body, just like various Salmonella species. When ingested, they need to survive the acidic environment of the stomach, and therefore, just a few usually are not enough to cause illness. The resistance of microbes to the conditions in the stomach varies significantly, and their survival also depends on the food eaten, as it has an influence on the acidity of the stomach. As with chemicals, we need microbes, as certain types are essential for the digestion of the food we eat. The harmful dose of pathogenic microbes varies between the species and strains (Figure 3[3]) because of the mechanisms of pathogenesis. If bacteria act locally, the number of bacteria needed to cause an infection is much lower than with bacteria acting at a distance, which must grow to a certain number to sufficiently increase the diffusible molecules known as immune modulators. The ability of bacteria to be “smarter” than the host cell defenses is one of the most important factors in causing illness. The bacteria must modulate the host cell immune system to be able to grow before the host’s immune system takes over and destroys them. There are many pathogenic bacteria that cause severe diseases that react locally and can modulate the immune response in a short time. It is known, however, that most virulent bacteria, such as Bacillis anthracis and S. aureus, excrete immune modulators that work at a distance. In S. aureus, both local and diffusible immune modulators are responsible for its extreme virulence. In healthy people, there is a threshold number of pathogenic bacteria that the host immune system can cope with and destroy.

Requirements for Product Testing
As discussed, harmonization of food safety regulations is highly desirable. Harmonization, however, won’t be very effective if the methods of analysis used to verify compliance with such regulations are not harmonized as well. To establish the number of aerobic microbes in a product, many methods have been developed, such as spiral plating,[4] for which sophisticated equipment has been designed. It must be ascertained whether the results of the new methods are similar to those obtained with “standard plate count;” if not, it must be established which method is most accurate. This is very important because most of the regulations on microbiological safety are based on results obtained with traditional methods. The same applies to methods to detect the concentration of chemicals (direct and indirect food additives, pesticides, etc.) in food. The use of different methods may lead to the conclusion that a food meets the regulatory requirements in its country of origin but not in the country to which the product has been exported, even if these requirements have been harmonized. Another aspect of this issue is that for substances that are not allowed, one method may confirm absence, but a more sensitive method may confirm presence (this is also why absence should never be a requirement, harmonized or not, because the detection limit continuously decreases, and eventually no food will meet the requirement of absence of any substance).

A special case is establishing the genotoxicity of chemicals. Traditional methods have many disadvantages, of which the rate of false-positive and -negative results is high. Moreover, such methods require the use of test animals and take a long time. More recently, methods have been developed using human liver cells (HepG2) that are much more accurate (no false positives or negatives) and deliver results in less than a day.[5] Consequently, global harmonization based on this method will improve safety studies, avoid conflicts and save animals, time and costs.

Food Safety and Ethics
Consumers should be able to have confidence that the food products they buy are safe, particularly when the product is packed in a tamper-evident way. In case a product may be unsuitable for certain consumers, for example, because of an allergenic ingredient used, this should be labeled as such, which now is compulsory in many countries.

Regrettably, there are companies that would rather maximize profits than care about the health of their customers. Very well-known examples are the adulteration of milk with melamine and of wine with glycol. It is sad that in many cases of employees responsible for food quality and safety, when they discover conditions that may harm consumers but follow company procedures, they do not report the conditions to management because of the consequences of acting against policy. Although this is understandable if the employee has a family to support, such inaction can never be justified, because it leads to harm; the employee shares responsibility by not speaking up. When an employee has informed his superior that a product is not safe for consumption and this is ignored, he should try to get a hearing higher up in the hierarchy of the organization. If that fails, it is his duty to inform outside authorities. Understandably because of the consequences of such an action, it is very likely that such “whistleblowing” is not commonly done. Employers tend to have (many) more resources to defend themselves than does the employee against an angry employer. An employer may also accuse the employee of lying, with the sole intention to harm the company because of grudges, etc. The employee who does his duty eventually is likely to lose the case. If we want safe food, it is important to know when it is not safe; therefore, any employee who knows that food is unsafe should be able to speak up without reprisal. It is just as important that there be globally harmonized regulations to protect employees who conscientiously do what they should do, a global “whistleblowers act.” Readers are referred to an article on the subject, published in the June/July 2014 issue of Food Safety Magazine and still very relevant.[6]

What More Can Be Done Now?
One immediate action you can take is to become involved in a Global Harmonization Initiative (GHI) working group (WG). The goal of GHI is to promote sufficient safe and healthy food for all consumers. GHI focuses on globally harmonized regulations to achieve this goal. Such regulations would eliminate the selling of unsafe food as safe under false pretenses, limit the food that is destroyed because of differences in regulations and counter the notion that food safety is used as a means to prevent the import of foods, as hidden protectionism. The way GHI attempts to reach its goal is by setting up WGs, consisting of members from all over the globe, which work on specific issues. An example is the mycotoxin WG, which is developing proposals to draft certain globally compulsory measures to significantly reduce the mycotoxin problem. The education WG focuses on the globally compulsory training of food handlers. Encouragingly, there is also an ethics WG to address the above issue on whistleblowers and other ethical aspects of food production and processing. A survey of existing WGs can be found on the GHI website, and everybody who supports the goal of GHI and would like to contribute may write to

Readers interested in the subject of (lack of) harmonization of food regulations are referred to books on the subject published on behalf of GHI. The first one, published a few years ago,[7] discusses existing food regulations in the world and what may be done to harmonize them from chemical (toxicological) and microbiological points of view. The second book, to be published shortly,[8] is about the safety of traditional and ethnic foods. A series on the nutritional and health aspects of traditional and ethnic foods is under development; it is expected that the first volume will be published by the end of 2016. Another book under development and planned to be published in 2018 is entitled Harmonization of Food Standards Based on Risk Analysis.

If you are not a member of GHI but would like to help it achieve its goal, you are invited to join. The more members, the stronger the organization and the more GHI can do. Your membership will make a difference. Membership is free to qualified food scientists—microbiologists, food engineers, toxicologists, etc.—involved with the production, safety and quality of food. To join, go to

Food safety regulations are necessary to protect consumers and the food industry from unscrupulous as well as unskilled practices in food production. But differences in regulations between countries should be justifiable, based on differences in national diets and even tolerances for different food components. Unjustifiable differences can be used to impose de facto food protectionism in violation of international agreements. To prevent this, food safety regulations in different countries must be harmonized. The best basis for harmonizing regulations is science—utilizing up-to-date, validated knowledge of foodborne pathogens and especially toxicology. Harmonizing regulations on a scientific basis will provide a true understanding of risk while improving requirements for product testing and reducing food waste. Consumer confidence in the food system will grow as the global food supply network is seen to follow a uniform, science-based standard for ensuring safety. Industry can do much to advance consumer confidence by backing regulations that protect “whistleblowers” who report unsafe production practices in their companies. Food scientists can help harmonize food regulations by becoming active in a GHI WG. These WGs are currently tackling several food safety problems, from reducing mycotoxins in food to compulsory training of food handlers. The need for science in harmonizing regulations is as compelling as the need for regulations in ensuring safe food for consumers worldwide. 

Huub Lelieveld is president of the GHI.

Veslemøy Andersen is GHI’s ambassador for Norway.

2. Ames, BN and LS Gold. 1997. “The Causes and Prevention of Cancer: Gaining Perspective.” Environ Health Perspect 105(4):865–873.
3. Schmid-Hempel, P and SA Frank. 2007. “Pathogenesis, Virulence, and Infective Dose.” PLoS Pathog 3(10):e147.
4. Fung, DYC, “Rapid Microbiological Methods in Food Diagnostics,” in Advances in Food Diagnostics, eds. LML Nollet and F Toldrá (Oxford, UK: Blackwell Publishing, 2007), 131–154.
5. Darroudi, F, V Ehrlich, A Wuillot, T Dubois, S Knasmüller and V Mersch-Sunderman, “Testing for Food Safety using Competent Human Liver Cells,” in Ensuring Global Food Safety – Exploring Global Harmonization, eds. C Boisrobert, A Stjepanovic, S Oh and H Lelieveld (London: Academic Press/Elsevier London, 2010), 125–138.
6. Motarjemi, Y. 2014. “Whistleblowing: Food Safety and Fraud.” Food Safety Magazine 20(3):58–66.
7. Boisrobert, C, A Stjepanovic, S Oh and H Lelieveld, eds., Ensuring Global Food Safety – Exploring Global Harmonization (London: Academic Press/Elsevier, 2010).
8. Prakash, V, O Martín Belloso, L Keener, S Astley, S Braun, H McMahon and H Lelieveld, Regulating Safety of Traditional and Ethnic Foods (London: Academic Press/Elsevier, 2015).


Categories: Contamination Control: Chemical, Microbiological; Management: Best Practices, International; Regulatory: Guidelines, International Standards/Harmonization

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