is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Regulatory showdown?

Article-Regulatory showdown?

As the European Union works towards a Super-Regulation, governing all substances that come in contact with food, calls increase for harmonization between EU and FDA guidelines.

According to the U.S. Food and Drug Administration (FDA), substances that aren''t expected to become a component of a food stuff, or those that don''t pose a health risk, are cleared using analytical chemistry data and extrapolation to show they pose no toxicological concern.

In Europe, however, all materials present must be cleared using relatively exhaustive toxicological evaluations, regardless of the amount or likelihood of migration, according to Ralph Simmons, an attorney at Keller and Heckman LLP, a law firm that specializes in packaging law, especially as it relates to food contact.

"[Regulatory differences] are likely to get worse before they get better," Simmons says.

Setting a precedent

Much of the regulations currently surrounding food packaging in the U.S. came out the Food Additives Amendment of 1958, a modification of the 1938 Federal Food, Drug, and Cosmetic Act. Before 1958, the system was fairly self regulating, with manufacturers of packaging or packaging materials required by customers to show documentation from the FDA or the USDA that their materials were safe.

Early drafts of the law included provisions that required FDA preclearance of food additives with a definition of additives including materials used to produce, manufacture, pack, process, prepare, treat, transport, or hold food.

Soon, after outcry from the Society of the Plastics Industry and other trade groups, a separate measure was created to regulate indirect additives, including items like packaging, differently from direct food additives, which were actually introduced to food products on purpose. Moving forward, it was decided that packaging should be handled as it was in the past-through letter approvals from the FDA.

Soon, attention focused further upstream as chemicals used in the polymerization process, including catalysts, chain transfer agents, and surfactants, drew scrutiny. A "polymer doctrine" would soon exonerate such chemicals since they were deemed necessary to the polymerization process, but it did require clearance for functional additives like stabilizers, antioxidants, pigments, and lubricants.

Here and now

Most recently, the U.S. Congress passed a Food and Drug Administration Modernization and Accountability Act in 1997, but it changed little since it primarily targeted faster approval of direct food additives, like preservatives, rather than indirect additives like plastics packaging and its constituent chemicals.

Action in the EU is most likely more imminent, and when new laws come down, differences that require reconciliation seem likely, especially for companies looking to employ one packaging platform across continents. One current point of contention is migration, where, unlike the EU, the FDA offers some exemptions.

For instance, if a substance isn''t reasonably expected to become a component of the food, it can''t be regulated as an additive. Also, the FDA must find significant migration, with the standard being 50 parts/billion (ppb), or sometimes 10 ppb or less, depending on the substance''s toxicity or if it''s used in packaging with higher individual consumption rates like soft drinks, milk, or beer.

Dr. Philip Webb, a part of BASF''s product stewardship team, which seeks approval for food-contact substances, says the 1997 Modernization Act has sped up the approval process, with responses to the 22-page form coming in 120 days versus anywhere from 2 to 10 years, but it has posed some challenges.

"The amount of information and effort that has to go into preparation of the petition of notification is significantly greater for the submitter than it was before," Webb says, "so it''s still something of a trade off."

But in addition to faster overall turnaround, Webb says approval is now individual to companies. Previously, one company''s approval could be used by other companies making the same substance.

For a global company like BASF, differing standards in the EU compared to North America are handled on a regional basis, according to Webb, who used two recently approved additives-Uvinul 5050 light stabilizer and pigment Heliogen Green K 9360-as examples.

"[Approval] is market driven," Webb says. "Both of those products we were already selling for non-FDA applications, and it''s only when they''re put into polymers that are going to contact food that we have to worry about approval."

Tony Deligio [email protected]

Contact information

Keller and Heckman LLP

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.