Why Food Regulatory Compliance Seems So Complicated and What Can Be Done to Simplify It

For the last decade or more, it seems as though every week there is a new regulation, directive, law or standard for food safety and labeling compliance.

For the last decade or more, it seems as though every week there is a new regulation, directive, law or standard for food safety and labeling compliance. For each new notification from the regulatory agencies it seems as though there are hundreds of pages of information to review. There is no inexpensive and readily available source for obtaining a summary for this information. Even when a summary is obtained, the requirements and language are not simple. The government agencies tend to change everything, even when it has been done the same way for decades. In addition to this, customers want more and more transparency of production and regulation compliance information each day. People in many companies are hired just to determine what the compliance requirements are, what needs to be done to remain in compliance and to provide this information to those that are requesting it. The cost of ensuring goods remain in compliance keeps rising, while sale prices do not rise at the same rate.

The reasons that regulation compliance appears to have become more complicated are as follows: We have better data collection today, so we know how, where and when people are becoming ill from food. We are also collecting this information faster. With this information, government agencies can change, improve and add programs to reduce these incidences. This adds to the complexity of the regulatory framework but after a period of time businesses adjust, so it no longer appears to be complicated. At least until the next change comes along.

For example, on May 14, 2015, the US Center for Disease Control reported its Foodnet data [1].  This data shows that there has been some progress in reducing foodborne illnesses. Shiga-toxin producing E. coli O157 has decreased 32% compared with the 2006-2008 data and 19% when compared to the last three years. The United States Department of Agriculture Food Safety Inspection Service has increased the scrutiny on beef products the last few years. The fundamental development of the regulatory change took place over 20 years ago and since then there have been changes implemented to improve the food safety culture. These regulations required HACCP programs and testing. At the point when this was instituted, such testing and certification was complicated for the industry. Now the industry views this as routine.   

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Each year we have more information on how certain ingredients affect our health. For example, we learned that saturated fats raise the level of Low-Density Lipoprotein (LDL) cholesterol in blood which, in turn, increases the risk of heart disease and stroke. In the 1980s, the food industry replaced many of the saturated fats that were in food formulas with trans fats. Trans fats unfortunately also increase the level of LDL cholesterol in the blood, increasing risk. In 1993, the US government required specific nutritional labeling in order to provide consumers with information allowing them to select foods that are good for them. In 2006, the US Food and Drug Administration required the listing of trans fat so consumers could have more information. Even at that time, the FDA stated that there was no safe level of trans fats. Recently, the FDA revoked the Generally Recognized as Safe status of partially hydrogenated oils, which are the primary source of trans fats, in order to help reduce incidences of heart disease. The Nutrition Labeling and Education Act seems complicated. A lot of testing and changes had to be made. Now a large number of countries have some sort of nutritional labeling requirements.

In the last 100 to 150 years, society has gone from a local base to a global one. Advances in transportation have made this possible. With this change came new foods, new ingredients and new problems. For example, consumers desire to have these products and ingredients from other countries available in their country. In response, the regulatory agencies have tried nationally to keep pace with other cultures’ accepted products, ingredients, innovations and adulterations. Of course, no one government can keep pace with these changes.

The Codex Alimentarius was established 50 years ago in an effort to keep uniform standards to increase freedom of trade between countries. This has worked to some degree, but unfortunately international attitudes still prevail, which add complications for regulatory compliance for many companies seeking to trade their products throughout the globe. For example, the sweetener cyclamates is approved by the Codex [2] and many countries of the world but is currently banned in the United States. This is an ingredient that can aid in sugar consumption reduction and provide products to consumers, such as diabetics, who can’t consume products with traditional sweeteners. Unfortunately, there are many other products and ingredients throughout the globe that suffer from this regulatory compliance complexity. Fortunately, this uniform standard is working, albeit slowly, because national governments are realizing that the problems regarding food safety need to be rectified on a global scale, and not just on a national one, as some of these restrictions are not really warranted. This reduces regulatory complexity, allowing local companies to explore the global marketplace.

Consumer preferences have gone virtually full circle as society has gone from fresh, local products to processed foods and back to fresh products again. This time, the source is global instead of local. The complication of food safety and import regulatory compliance almost stifles the sale of some products. How does one sell a product in one location where the product is being requested fresh or slightly processed because it is more beneficial, but where consumers lack the knowledge of proper cooking, cleaning or consumption practices of the product and who might suffer from the potential natural hazards of the product itself? On some of these items, regulations have been imposed to prevent entry into a country, or restrictions have been imposed on where these products can come from. Eventually, these restrictions are lifted or circumvented by companies selling these items, therefore simplifying a complex regulatory situation.

There are many regulatory restrictions to protect local and national businesses that add to the complexity of the situation. These restrictions are put in place in the name of food safety. Unfortunately for some industries, as soon as one restriction is removed, another is put into place, further complicating the situation. While short term benefits are typically seen by local or national businesses, eventually the product becomes more expensive or less available. As a result, consumers have to turn to other alternatives, reducing the market share for other product lines and sometimes having negative effects on consumer health. 

Since regulatory complexity isn’t going to disappear, it becomes a matter of simplifying in order to comply with the regulations. The unknown is complicated to all of us, and to tackle the unknown by oneself is difficult. Whether your company is a manufacturer, retailer, importer or distributor, all companies affected by the regulations are in the same situation. This is where banding together in associations and having the same programs is beneficial to all companies involved. 

These food associations have many abilities. They bring together experts in their particular field and assess regulations to provide feedback to their members in handling specific regulations. They publish summaries and offer presentations to develop an understanding of what needs to be achieved in order to foster regulatory compliance. Even before regulations are published, these associations communicate with government agencies in an effort to try to ensure that they are designed to increase food safety and marketability fairness while minimizing the impact they have on the industry they represent.

Government agencies understand that it is not just a matter of publishing regulations that the industry will instantly comply with. There is a realization that education must take place, even while they are enforcing the regulations.

Programs such as the Global Food Safety Initiative are designed to develop safe food operations, but also to promote fairness among the operations being reviewed against one consistent standard. These programs were developed by the industry to police themselves, to help their relationship with government, to avoid overregulating an industry that is already trying to resolve the problem, and to indirectly include these programs into the regulatory framework.

Third-party industry, whether it be certification bodies, testing laboratories, data or supplier chain management companies, regulatory information companies or others, want companies to expand their programs in order to increase their business. In order to do this, they provide information and tools to their customers to enable them to achieve compliance with regulations.

As shown by the discussion between the EU and the US during the process of working out the Transatlantic Trade and Investment Partnership [3], protection restrictions are probably the most difficult areas to foster agreement among governments and within industry. With clear agreements about what can and cannot be done, and where or how a particular product can be made, the regulation process can be simplified.

With publication of the first fundamental rules of the Food Safety Modernization Act, producers can rest at ease knowing that once the regulation is understood, and ways to comply with it are shown, the complexity of the situation disappears. While each new regulation seems to be frightening and complex, when we look back at them they are just another routine in the program to provide safety and quality food to the public. 


[1] http://www.cdc.gov/media/releases/2015/p0514-reducing-foodborne-infections.html

[2] http://www.codexalimentarius.net/gsfaonline/groups/details.html?id=71

[3] http://uk.reuters.com/article/2015/07/24/us-eu-usa-trade-cheese-idUKKCN0PY14B20150724