In accordance with Article 5 of EC Regulation No. 1935/2004, EC Regulation No. 450/2009 defines the specific requirements applicable to active and intelligent materials and packaging. This regulation supplements Article 4 of EC Regulation no. 1935/2004, which describes certain provisions to be complied with. These provisions are as follows:
- the authorization of active components on condition that they are authorized as food ingredients;
- the action of active or intelligent components on food, which must not mislead consumers;
- labeling, which must warn of the inedibility and action of active and intelligent components on foods.
The provisions of Regulation (EC) n°450/2009 are as follows:
- rules for authorizing substances that can be used in active or intelligent materials;
- the labelling provisions to be complied with;the written declaration of conformity and documentation to be kept by operators.
The new regulation came into force on June 19, 2009, except for the labelling and written declaration of conformity provisions applicable since December 19, 2009.
Application guidelines
These guidelines are intended for industry and specify how to submit applications for safety assessment of active and intelligent substances present in materials intended for contact with food. This publication follows the entry into force of Regulation (EC) No. 450/2009 on active intelligent materials and articles intended to come into contact with food.
These guidelines list the criteria that will be taken into account by EFSA when assessing the safety of active or intelligent substances, for example, their toxicological properties and the extent to which these substances, or their degradation products, can be transferred to food. The document also defines the types of data EFSA needs to conduct its assessments , including the physical or chemical characteristics of the substances concerned, as well as their manufacturing process and intended uses.