FDA Amends Food Contact Notification Regulations

The U.S. Meals and Drug Administration (FDA) has issued a closing rule to amend laws 21 CFR 170.105 and 21 CFR 170.102 on how and when FDA could decide {that a} meals contact notification (FCN) is now not efficient. Making its administrative processes extra environment friendly by way of rulemaking is a part of FDA’s efforts to boost its method to meals chemical security.

An efficient FCN authorizes the usage of a meals contact substance from the producer or provider recognized within the FCN.

The brand new modifications will enhance the effectivity of FDA’s FCN program by permitting the company to find out an FCN is now not efficient for causes aside from security. The modifications additionally allow FDA to extra successfully reply to new data on the security and use of meals contact substances. A listing of efficient FCNs may be discovered on FDA’s web site.

Earlier than issuing the ultimate rule, FDA may solely decide that an FCN is now not efficient primarily based on security issues. As a part of the method, producers and suppliers may present why an FCN ought to proceed to be efficient after FDA would supply discover of its willpower that the FCN is now not efficient.

The ultimate rule issued at the moment offers extra flexibility and reduces redundancy within the company’s regulatory processes. Below the ultimate rule, FDA may decide that an FCN is now not efficient when the producer discontinues its use primarily based on causes aside from security; for instance, when the producer now not produces, provides, or makes use of the meals contact substance (known as abandonment). The ultimate rule additionally offers producers or suppliers a possibility to supply enter earlier than FDA determines that an FCN is now not efficient, which helps present the company with all related data earlier than making a willpower. Moreover, the ultimate rule permits FDA to declare an FCN now not efficient if it offers a duplicative authorization (for instance, the usage of the meals contact substance is already licensed by a meals additive regulation or the topic of an issued threshold of regulation exemption).  

The ultimate rule retains in place FDA’s capability to revoke an authorization primarily based on security issues. FDA can nonetheless declare an FCN now not efficient if the producer or provider doesn’t present the required knowledge or data to deal with our security issues. Additionally, FDA can nonetheless revoke authorizations primarily based on security issues even when the notifier decides to desert the licensed use.

As offered below FDA’s laws, the company will publish a discover of its willpower within the Federal Register, and the date of publication is when an FCN is now not efficient. When an FCN is now not efficient, the usage of the meals contact substance as described within the FCN is now not licensed.  As well as, FDA intends to replace its record of efficient FCNs on the company’s web site.