DECLARATION OF COMPLIANCE

VISCONEWS ISSUE #08 · Aug 2017

Manufacturers of food contact materials must provide a written declaration stating that their products comply with the rules applicable to them. This is what EC 1935/2004 says in Article 16. EU 10/2011 outlines concrete requirements for plastic FCM in Annex IV. To “permit an easy identification of the materials, articles or products from intermediate states of manufacture” (Article 15), each stage of production should provide a declaration of compliance (DoC) with the following information.

Data about business operator issuing the DoC

Data about Business Operator manufacturing the material

Identity of the material

Date of the DoC

Confirmation that the plastic materials comply to EC 1935/2004 and EU 10/2011

Information about the substances used or Degradation products thereof for which specific Migration Limits are laid down in Annex I or II of EU 10/2011

In case of dual use additive(s) confirmation that the substance respects the purity criteria of food additives

Conditions of use of the material: type of food for which it is intended to be put in contact, time and temperature of treatement and storage in contact with the food, ratio of food contact surface area to volume used to establish the compliance of the material

If a functional barrier is used: confirmation that the material complies with the requirements of Article 13(2), (3), (4) or Article 14(2) and (3) of EU 10/2011 Behind a functional barrier, non-authorized substances can be used. A Maximum Migration Level of 0,01 mg/kg (10ppb) in food is established. However, CMR substances are not covered by the functional

barrier concept. That means manufacturers have to confirm that behind

the functional barrier no CMR substances (mutagenic, carcinogenic or

toxic to reproduction) are used. EC 282/2008 finally specifies the

additional Information for recycled plastic in Annex I.

Confirmation that the recycling process has been authorized, including

its EC Register number

Declaration that the input material, the recycling process, and the recycled plastic meet the specifications for which the authorization has been granted