Government Resolution No. 398 approving the Technical Regulation on Active and Intelligent Materials and Articles Intended to Come into Contact with Food.

This Resolution establishes requirements for active and intelligent materials and articles intended to come into contact with food. It defines the categories of materials and articles covered by the Regulation and sets the conditions under which they may be placed on the market, including requirements relating to their use, composition, labelling, and compliance with applicable food-contact material legislation.
The document provides rules on substances that may be used in active and intelligent components and requires the authorization of such substances by the National Food Agency. It establishes the conditions for inclusion in the list of authorized substances, specifies the information to be included in that list, and sets requirements governing the use of certain substances, including substances separated from food by a functional barrier and substances released from active materials and articles.
It further establishes requirements concerning labelling, declarations of compliance and supporting documentation. Business operators are required to issue declarations of compliance, maintain documentation demonstrating compliance with the applicable requirements, and make such documentation available to the competent authority upon request.