18 January 2018
FOCUS: Rules and regulations
in collaboration with FOOD CONTACT CENTER
DRAFT: NEW MUTUAL RECOGNITION REGULATION
The European Commission (EC) published a Draft proposal for a new Mutual Recognition Regulation, and has launched a public consultation on the draft on December 20, 2017. The objective of the new regulation is to improve the function of mutual recognition.
By way of background, the EC published an Inception Impact Assessment on the revision of the Mutual Recognition Regulation (EC) No 764/2008 in mid-2016. One of the policy options in that document was to revise the Mutual Recognition Regulation.
The draft Mutual Recognition Regulation clarifies the scope of mutual recognition and facilitates the ability to demonstrate that a product is already being lawfully marketed. It proposes a voluntary Mutual Recognition Declaration “to demonstrate to the competent authorities of the Member State of destination that the goods, or goods of that type, are lawfully marketed in another Member State”. Copies of the current proposal, along with an annex document and supporting documentation, can be assessed from the EC website.
U.S. FDA PUBLISHES ROADMAP TO FURTHER DEVELOP PREDICTIVE TOXICOLOGY METHODS FOR RISK ASSESSMENT
On December 6, 2017, the U.S. Food and Drug Administration (FDA) informed that its Toxicology Working Group has prepared a predictive toxicology roadmap, outlining “a six-part framework for integrating predictive toxicology methods into safety and risk assessments.” The roadmap calls for “research to identify data gaps and to support intramural and extramural research to ensure that the most promising technologies are developed, validated, and integrated into the product pipeline.” Predictive toxicology methods, such as organs on a chip or mathematical modeling, may improve FDA’s “ability to quickly and more accurately predict potential toxicities and reduce associated risks,” the agency stated.