Regulation of active and intelligent packaging

In 2004 a new framework Regulation (EC) No 1935/2004 applicable to all materials intended to come into contact with foods was accepted. In this regulation, general requirements applicable to all food contact materials (FCM) are established. Specific provisions are included to allow the use of active and intelligent materials and articles, and a specific measure on active and intelligent materials was announced. In order to define the scope of 

If required in a specific measure, then relevant food contact materials (FCM) shall be accompanied with a declaration of compliance, while appropriate documents shall be provided to relevant authorities to demonstrate such compliance. As most of the requirements in the framework regulation are applicable to all FCM, active and intelligent materials are subject to these rules as they can be considered FCM. In some cases there may be no direct contact with the food, e.g., intelligent packaging positioned on the outside of the primary package, but they are subject to the framework regulation for the reliability of the information provided to the consumer. 

2 Draft regulation on active and intelligent materials and articles 

Finally the draft regulation requires that active and intelligent packagings are suitable and effective for the intended purpose and that the active and intelligent components are authorised. Authorisation will be granted after a positive opinion of the EFSA and will be valid only to the applicant for an authorisation. The authorisation will be valid for a period of ten years and may be renewed for another period of ten years. The authorisation will be published in a Decision to the applicant. In addition the active and intelligent components will be inserted in a list of authorised components. 

A requirement, in line with Regulation (EC) No 1935/2004, concerning a declaration of compliance and the availability of appropriate documentation, has been confirmed in the draft regulation. It means that for any active and intelligent material a statement shall be provided that certifies that the material is safe to be used in contact with food under specified conditions of contact. To support such a statement the certifier shall have documentation that can prove the validity of the certificated. These documents shall be available to relevant authorities for inspection. In many cases this will include analytical data on, e.g., migration, total release, and effectivity of the active and intelligent of active components. 

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