USP Hosts International Food Regulation Experts

Food safety has jumped front and center in the minds of consumers and governments around the world. From adulteration (melamine et al.) to microbial contamination (salmonella et al.), food crises are dominating the global marketplace. Considering these numerous issues facing food ingredients, the U.S. Pharmacopeia (USP), the new home to the Food Chemicals Codex (FCC), brought together numerous food standards regulators from various regions of the world to define issues, opportunities and solutions for food trade.

Held yesterday, Oct. 15, the Food Ingredients Workshop featured experts from USP, FDA, Health Canada, the Chinese Center for Disease Control and Prevention, Japan Food Additives Association and other experts working in Europe, South America, Australia/New Zealand and the Middle East.

Overall, the experts discussed the state of food standards and regulations in their region/country, especially on food safety issues. Specific attention was given to food additive and GRAS issues, as well as emerging technologies such as nanotechnology.

In fact, one of the surprises of the workshop was FDA's presentation, given by Annette McCarthy, Ph.D., CFSAN, which provided some insight on the agency's view of nanotechnology in food, one of the first times this position has been made public, according to James Griffiths, Ph.D., VP of Food & Dietary Supplements for USP. While not a mind-blowing revelation, FDA's view on nanotechnology definitely gave some early indication of what to expect, as McCarthy reported several interesting FDA viewpoints:

At this point, FDA is handling such ingredients on a case-by-case basis. McCarthy acknowledged that industry has requested more guidance on nanotechnology, but while such guidance is under consideration, FDA has decided to update existing guidance for new submissions to include nano-based considerations. For instance, with Food Contact Notifications (FCNs), McCarthy highlighted regulation indicating any manufacturing change to produce nanoscale particles would be a considered a significant change, if the nanoscale particles were not part of the original FCN.

For its efforts, FDA has partnered with the Woodrow Wilson Institute to explore any potential issues with nanotech food ingredients and active packaging.

Beyond nanostuff, FDA highlighted its recently announced efforts to approach food safety in global manner, including opening up field offices in others countries, namely China. This Beyond Our Borders initiative also includes India, Jordan, Europe and Latin America.

As the workshop turned to presentation from the international community, the information was fast and technical, albeit relatively general in scope. Health Canada outlined its initiatives, including research, on food chemicals, indicating a specific recent focus on toxins. The agency has plans to develop standards for selected natural toxins and create a Natural Toxins Reference Centre.

Europe has been a model for food-related standards, but it still faces some challenges in harmonizing efforts amongst European Union (EU) countries. The EU defines food or foodstuffs as any substance intended for ingestion, except medicinal products. Hmm, still a gray area there? While the EU seeks "free movement of safe and wholesome food" and has accomplished regulations for many nutrients, novel foods and health claims, its food safety association (EFSA) is still tackling newer issues such as allergens, nanotechnology and GMOs.

South of our own border, Mexico has a well-defined and organized food regulation system, centered on its COFEPRIS, its Federal Commission for the Protection against Sanitary Risk. In Mexico regulation, food, functional foods, nutraceuticals, dietary supplements and drugs are closely related. Among its current issues/priorities, COFEPRIS looks to define and classify food categories—herbal products, dietary supplements, etc.—address food safety issues, such as allergens, labeling and contaminants/adulterants, and address new technologies, including functional foods, GMOs and nanotechnologies. See a theme yet?

Way south of our border, the South Americans are banding together to form a trade bloc for free movement of goods between its member countries. Who knew of this Mercosur trade bloc? Full members currently include Argentina, Brazil, Paraguay and Uraguay, although Venezuela is knocking on the door. Chile, Peru, Bolivia, Columbia and Ecuador are non-active participants with no voting power, but could become members in the future if things work out.

In its drive for South American harmonization of food standards, Mercosur has taken a similar approach to many other global regions in turning to established standards for guidance. This includes Codex Alimentarius, EU Directive, U.S. FDA regulations and other South American and foreign regulations. The Mercosur regulations take a while to get approved, but thus far, there has been work done on labeling, food additives, processing aids, contaminants, pesticides and packaging materials.

While Mercosur was influenced by outside regulations and standards, their system is their own creation, and outside companies tackling this system need to mind Mercosur regs as well as the regs in each individual country in Mercosur. You're best bet? Speak Spanish and/or retain experts in each country, and filed all your petitions at the same in all the countries plus Mercosur itself. Sounds complex.

The Australia-New Zealand efforts at food standards also took direction from the EU, FDA, Codex and FAO/WHO JEFCA. However, food sector expert Simon Brooke-Taylor said it was important to determine what worked and didn’t' work for the Trans-Tasman initiative.

The food safety agency in Australia and New Zealand (FSANZ) developed the standards and provides advice on them, but the Ministerial Council sets policy and approves or rejects standards. Put simply, in this region, food must be safe and suitable, and must comply with a regulation where one exists. For food additives, processing aids, nutritive substances (including vitamins), novel foods, GMOs irradiated foods and labeling, there are regulations in palce. The more detailed review of food regulation shows current issues, such as how to deal with functional additives, new foods and technologies (nanotechnology), synthetic food colors, and surprise issues such as contamination and adulteration.

Its biggest effort appears to be in the area of allergens, including allegen labeling. Its Voluntary Incidental Trace Allergen Labelling (VITAL) initiative and its recently created (2005) Allergen Bureau are proof of the heavy attention Australia and New Zealand are paying to allergens in food.

North of this region is China and its areas of political control/influence. Junshi Chen, M.D., from the Institute of Nutrition and Food Safety, Chinese Disease Control and Prevention, braved his countries recent image and reputation problems and presentated his take on food regulation in China. Among the positives, he said China food regs and standards are fine, noting they are basically in compliance with international practices, including the Codex General Standard for Food Additives (GFSA). However, he admitted China has a lack of specification for almost half of the food additives approved for use, few specs for flavors and a positive list for packaging materials that hasn't been updated in more than 10 years.

On China's recent food safety crises, he insisted the adulteration cases "are not due to the illegal use of food additives, colors or processing aids. The problem is with bad companies in a system where the number of companies involved in the food trade far overwhelm the ability of the Chinese government to police and inspect. He further said, despite melamine problems, chemical hazards are not the number one food safety problem in China, but microbial hazard/contamination is at the forefront. He said risk analysis is the only efficient way to deal with any type of food safety issue.

One of the most interesting—and entertaining presentation was on the Middle East. Though not from the Middle East, P. Vincent hagerty, Ph.D., a consultant to WHO, FAO, USAID, EU and Dubai, has worked in middle east to help set up food standards and agencies, most recently in Egypt. He said flat-out that this region is far behind the western world and Asia, and has many obstacles to overcome before it can properly oversee food regulations and standards, especially food safety issues.

While Gulf Cooperation Countries—Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates (UAE)—got a more positive nod for progress on food trade and safety, Hagerty, called the efforts by Middle Eastern countries, for the most part, ineffective, inefficient, fragmented, outdated and inept. He expressed particular concern in Egypt, where he said those in charge of food regulation and oversight are more concerned with handouts or bribes than with establishing regulations to protect their citizens, culture and tourism income. He said the organizational structures of many of these countries are complex and weakly coordinated, and many don't see the value in treating all food the same, whether imported, exported or locally produced. He did say efforts such as USAID's in Egypt and elsewhere are making a difference, albeit slowly, but said one major barrier has been language; Arabic offers little , if any, vocabulary to describe new scientific and technical terms, especially nanotechnology.

Despite all these flaws, some countries in the Middle East are getting some aspects of food regulation correct, although there is a tendency for some countries to simply cut and past EU, FA or Codex standards, instead of creating standards that reflect the people, culture and other needs of its populations. Hagerty said the opportunity in this region is huge, as the countries generally have the income and desire for functional foods, dietary supplements and even new technologies.

All in all, there was too much to take in during this day-long workshop. Thankfully I have a handy workbook to review and tons of new contacts around the world for any upcoming stories on food safety or regulation. If you are interested in learning more about the workshop and its participants, contact the USP at (301) 881-0666 or visit USP.org for more information.