Global Harmonization

By Lisa Lupo

The continuing globalization of the food chain provides consumers — at home and abroad — with an ever-expanding array of options in both the purchase of groceries and in dining out, along with the ability to purchase domestic brands with which they are familiar when traveling. But this same consumer benefit can cause challenges for the food industry in understanding and complying with all the food safety standards and regulations of countries to which they are exporting or from which they are importing goods. Understanding these difficulties, there are global organizations that are working to aid in the harmonization of standards and regulations to enable an increased meeting of minds between governments.

One of these is the Global Harmonization Initiative (GHI), an international non-profit network of individual scientists and scientific organizations dedicated to advancing the global harmonization of food safety standards and regulations through scientific consensus, education, and advocacy. The network engages and empowers food scientists and experts in industry, government, and academia to voice scientific consensus and make recommendations on food safety laws and regulations, globally. GHI Board President Huub Lelieveld and Vice President Larry Keener shared the organization’s thoughts and initiatives related to this harmonization.

1. Please discuss the Global Harmonization Initiative, its goals and initiatives in relation to the harmonization of global standards and regulations for food.

GHI, an Austrian-registered NGO, was founded in 2004 with the objective to eliminate non-science-based differences in food safety regulations. Differences in regulations often lead to needless destruction of healthy, safe foods and food ingredients. It hampers international trade and hinders the development of novel food processing technologies. This impediment to innovation results from the duplicitous nature of international regulatory schemes and because authorities require proof of safety following different requirements and differing end objectives while, at the same time, appearing to advocate for safe food.

2. How does harmonization provide value to the food manufacturing/processing industry?

Harmonized regulations would likely diminish disputes about safety at the borders between countries (and therefore minimize the destruction of food by authorities). Harmonization would also have a positive impact on the amount and cost of resources used to test and inspect foods seeking to confirm that they are safe. Likewise, there would be a reduction in unnecessary animal testing in many countries, encouraging innovation.

3. What changes are occurring in relation to harmonization?

A great deal of change is occurring at the moment, with much of it being driven by U.S. legislation. President Obama’s Food Safety Modernization Act (FSMA) both implicitly and explicitly demands harmonization. Because the U.S. is a large trading partner to much of the world, it is anticipated that these FSMA regulations will have a positive impact on harmonization.

4. What are the greatest challenge(s) to achieving global harmonization of standards and regulations?

Trade and commerce issues are the big impediments to achieving harmonization. Food safety is frequently used as a means for controlling trade and imposing taxes and tariffs. So long as there are differences in food laws and regulations, countries and companies will leverage this incongruence to achieve their business or national priorities. Unwillingness to admit errors in regulation also frequently is cited as a major challenge to harmonization. Sometimes the “errors” are there for political reasons, but that will not be admitted.

Also challenging are the differences in nomenclature that make regulators and politicians believe they talk about the same thing while the meaning of the words are different between countries. A good, and important, example is the definition of “food additives” which is very different between many countries.

Another, basically silly one, are the differences in meaning, e.g., of “parts per billion.” In UK English, a billion is 10 to the power of 12; in American English it is 10 to the power of 9. Similarly, for parts per trillion (which are concentrations of chemicals in food that governments do not want, usually for non-scientific reasons): in UK English, a trillion is 10 to the power of 18 and in American English it is 10 to the power of 12. Note, the difference is a factor of a million (10 to the power of 6 in both languages).

5. What advances have been made?

Many regulators have been made aware of the existence of such differences, of which most people had no idea. Many politicians still have no idea. The awareness, however, has led to authorities asking advise from GHI Ambassadors (which we have in many countries). The problems have been discussed in both papers and books authored by GHI membership (published by Elsevier on behalf of GHI). Moreover, the topic and messages have been presented on numerous occasions by GHI adherents at international conferences and congresses in many countries since our founding in 2004. For example, earlier this year we convened a symposium on harmonization at the World Food Congress in Dublin, Ireland.

6. Do you see any countries as more or less open to harmonization and/or cooperative than others?

We have noticed that some countries are more active than others, mostly depending on their interest in import and export of food products.

7. Few companies can operate completely within a single country (i.e., neither using imported nor exporting any ingredients, supplies, or product). As such, how do companies ensure their ingredients/finished products meet all the required standards and regulations?

Companies usually try to meet the legal requirements of both the exporting and the importing countries, but finding the data often is complex. For multinationals like Nestlé, Unilever, Mondelez, etc., it is simpler. Typically, small and medium sized enterprises (SMEs) do not have the manpower to sort this all out. Regulations tend to take thousands of pages and then, one must decipher what is meant by what is published. That is, companies need lawyers, regulatory specialists, and food safety experts to interpret the regulatory requirements. That is the reason that GHI has the Working Group, “Nomenclature.” This group proposes clear definitions in many languages to avoid such problems.

8. What is the best way or resource to find information relevant to specific countries?

Reviewing the regulations themselves. Because there are so many issues, we focus on acute ones. For a number of years, GHI members have provided presentations and written papers to discuss emerging regulatory changes and to compare existing legislation. We also find it is beneficial to monitor the activities of FDA, Codex, and EFSA.

9. How can companies keep up with changes?

Changes in regulations are always published. Our proposals will also be published. That is why we publish articles and books.

10. Until  harmonization is achieved, how can a food company simplify and standardize its quality systems and processes to meet what is still a vast array of global standards and regulations?

They have no choice than to continue with what they do now; there is no simple way. GHI is working on harmonization to make it simple, but that will take time. And let’s be clear, GHI understands that we cannot change laws and regulations. We know that our role is that of an influencer. We publish books and white papers and participate in international debate to provide objective science as the justification for harmonizing food safety legislation. 

11. How can food companies aid in the effort to achieve global harmonization?

Because GHI works impartially, it does not want any obligations to individual countries or companies; so GHI does not accept direct funding from governments or industries. Although hundreds of scientist volunteers around the world are cooperating in GHI, progress is fairly slow because there are no funds for travel or meetings. With face-to-face meetings, progress would be much faster. So there is now a separate organization, GHI-Financial, to which donations can be made. For information visit GHI’s website.

ABOUT GHI. Founded in 2004 as a joint activity of the Institute of Food Technologists (IFT) International Division and the European Federation of Food Science and Technology (EFFoST), the aim of GHI is to provide objective and fact-based advice that will help harmonize conflicting regulations and legal policies to eliminate trade barriers “that masquerade as food safety protections”; reduce needless destruction of safe foods; promote the global use of innovative food safety technologies; and lessen the potential for foodborne illness and pandemic outbreaks. For more information, visit http://www.globalharmonization.net.

The author is Editor of QA magazine. She can be reached at llupo@gie.net.