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What are the differences and similarities between FDA and S. Korea food contact legislation?

In the lead up to Global Food Contact 2016, we interviewed Joan Baughan, Partner at Keller and Heckman about the differences and similarities between FDA and S. Korea food contact legislation, and what are the key regulatory considerations for those launching products within the Asian market.

Joan Sylvain Baughan joined Keller and Heckman in 1991. She practices food and drug law, focusing on U.S. Food and Drug Administration (FDA) and comparable international regulation of food contact materials, drugs, cosmetics, and medical devices.

In addition to practicing in the firm's Washington office, Ms. Baughan spent three years counseling foreign and domestic clients from the firm's Brussels, Belgium office. While there, she developed an expertise in the regulation of food packaging materials and medicinal products under European Union and Member State legislation.

Smithers: How did Keller and Heckman begin specializing in food contact – what has been the secret of your success?

Joan Baughan: Keller and Heckman LLP has been a leader in advocating for those in the food packaging industry since the firm was founded in 1962. At that time, one of the firm’s founding partners, Jerome H. Heckman, already had almost a decade of experience representing clients in the plastics industry, and was General Counsel for The Society of the Plastics Industry, Inc. (SPI), on whose behalf he had fought vigorously to exclude food packaging materials from the same rigorous pre-clearance requirements applicable to direct food additives under the Food Additives Amendment of 1958. (Even at that time, Jerry Heckman was urging passage of a bill that would provide for a much simpler pre-clearance procedure for food packaging materials as compared to the procedure required for direct food additives.) Keller and Heckman LLP has been advocating for sensible regulation of food–contact materials, based on sound science, ever since. It’s no secret, but one of the many factors that has contributed to the firm’s success in this area is that Keller and Heckman recognizes the value of understanding the interplay between law and science. Keller and Heckman was the first law firm to hire a staff scientist (over 40 years ago) to assist the firm’s legal staff in representing clients in food contact matters, and our scientific staff today consists of 20 chemists and toxicologists. Our attorneys and scientists, working together in our offices in the Unites States, Europe, and Asia, are at the forefront of food contact regulatory matters and are well-respected both by industry and by regulatory authorities in virtually every jurisdiction around the globe.

Smithers: Food contact is a niche area of law, how did you get involved in food contact and what are the significant changes since you started your career?

Joan Baughan: I began handling food contact issues right when I started working at Keller and Heckman in 1991. I was hired to work as an attorney on Mr. Heckman’s “team,” which routinely handled food contact matters. I was a good fit for the team because of my scientific background.

The area of food contact legislation has exploded since the start of my career. Back in 1991, the only path to bringing about a specific U.S. Food and Drug Administration (FDA) clearance for a food contact substance that met the “food additive” definition was to file a Food Additive Petition with FDA and go through the laborious and time-consuming process (sometimes several years) of obtaining a regulatory clearance in the Code of Federal Regulations. In 1995, FDA’s Threshold of Regulation Rule was adopted, and this rule simplified the process for the use of food contact substances that met certain criteria (i.e., substances that are not carcinogens and do not contain impurities that are potent carcinogens, and whose intended use results in very low levels of dietary exposure). Then, finally, after decades of effort by Jerry Heckman, the system for clearing food contact substances was significantly modified − and simplified − with the implementation of the Food Contact Notification (FCN) program. (FDA’s final rules for the FCN program were adopted in 2002, but the Agency had begun accepting FCNs in lieu of Food Additive Petitions in 2000.) Under the FCN program, proprietary clearances for new food contact substances automatically become effective 120 days after an FCN is received by FDA unless the Agency specifically objects to the FCN before the 120 day period has elapsed.

Over the course of the last two decades (and more recently in some cases), many other jurisdictions throughout the world have adopted new or revised legislation governing food contact materials, and several of these jurisdictions have modeled their legislation, in part, on the principles that support FDA’s FCN program.

Smithers: What are the differences and similarities between FDA and S. Korea food contact legislation?

Joan Baughan: A major difference is that, while South Korea does have specific standards that different types of food contact materials must meet (for example, there are standards on several different types of resins, standards on paper, on cellophane, on rubber, on metal, etc.), there are no specific requirements with respect to adjuvants that may be used in these materials. That is, adjuvants that are used in food contact plastics or paper, for example, are not required to be specifically cleared in South Korea – they simply must be “safe,” and there are no well-defined, established criteria for making this determination. This may change in the future, but as of now, this is the system in South Korea. The most important similarity, of course, is that the primary goal of both systems (and essentially every other system for regulating food contact materials throughout the world) is to ensure that any material used in food contact applications is safe for that use.

Smithers: What advice do you have for attendees of the Global Food Contact conference who are new to South Korea and Asian markets? What are the key regulatory considerations if they are launching products within those markets?

Joan Baughan: It is very important for companies not to assume that, because their products are permitted for use in other jurisdictions such as the United States or the European Union, they likewise are permitted in South Korea or other Asian markets. The area of food contact legislation unfortunately is not harmonized globally. So, due diligence in learning about the requirements of each market of interest is a must!

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