Evaluating Novel Products Under Existing Regulations

Current regulations tend to conform to what the regulators know, because they want a consistent way of evaluating products. But what happens when your organization produces a ‘novel’ product that regulatory schemes don’t directly address?

Maryann Sanders, senior regulatory compliance specialist at Haley & Aldrich, raised this issue during a presentation at Product Stewardship 2017. She described fitting novel products into existing regulations as putting square pegs into round holes. When faced with this scenario, product stewards have two obvious options: 1) make the ‘hole’ bigger by stretching the regulation’s boundaries or 2) make the ‘peg’ a little smaller by adjusting your claims or limiting your market (i.e. from consumer to industrial).

To make the best determination, you have to really understand the regulatory requirements, particularly if the product will be sold globally. Sanders used a case study to illustrate how one company approached the problem.

The company developed a ‘green,’ cleaning product in the U.S., for distribution to Australia and New Zealand. She described it as a ‘novel’ product because it involved taking an existing product to a new market. The company’s goal was to minimize compositional variations and use the same label for all markets if possible.

In cases like this, you start by looking at exemptions. “That’s where regulatory flexibility really comes into play,” said Sanders. In Australia, for instance, the product was classified as a consumer product, which meant that it was not required to follow worker health and safety regulations.

The product was regulated under the Poison Standard. Classification and labeling (C&L) is based on the product type and associated schedules. The label wording varies from jurisdiction, but you might not have to use the exact claim if your label follows the appropriate intent of what’s listed in the Australia regulations, said Sanders.

Happily, In NZ, the act that regulates the product stipulates that if it’s compliant in the U.S., Australia or European Union, then it’s okay. “Those applicable exemptions will really make your life easier, if you can find them,” said Sanders.