The EK Declaration
New EK Declaration forms from 2017
New EK forms must be used. These include the EK Declaration and the EK Documentation Summary. There are also a new revers side of the EK Declaration, and new guidance for the filling in of the forms. EK members may contact the EK secretariat for new forms and guidances: firstname.lastname@example.org.
Legal basis for the EK Declaration
The legal basis for the EK Declaration is the requirements for Compliance Declarations based on Appropriate Documentation given in Regulation (EC) No 10/2011 with updates (for details see belove), Reg (EC) No 1935/2004 and Reg (EC) No 2023/2006.
Documentation behind the EK- eclaration
Appropriate documentation to obtain an EK Declaration would be Declarations of Compliance, Food Contact Statements or Compliance Declarations from the producers of the raw materials and the food contact materials, and Supporting Documentation to demonstrate compliance. Important here are migration test results. For plastics materials the EU Directives and EU Regulations prevail. For materials not harmonised by EU, one may use the German BfR, the US FDA, or the Council of Europe resolutions, and if detailed national regulation is absent industry guidelines and standards can be used. Conformity with the restrictions listed in these regulations must be demonstrated; by testing, calculation, diffusion modelling, or reasoning.
EU regulations and Directives
For plastics materials use Regulation (EC) No 10/2011, No 1282/2011, No 1183/2012, No 202/2014, No 174/2015, No 1416/2016 and No 752/2017. Any Dual Use Additives used must be identified by E-number or CAS number.
All materials must comply with Reg (EC) No 1935/2004 and Reg (EC) No 2023/2006 and all materials must by followed with a Declaration of Compliance.
For paper and board use BfR-Empfehlung 36. For laminate adhesives use BfR-Empfehlung 28. For more details contact the EK secretariat.
Complete documentation from other independent labs
If the converter has already obtained a Compliance Declaration from an independent lab, including documentation, this may be used instead of the EK Declaration. However, because the testing labs just analyse what they are asked to test, it is not easy for the food industry to judge that all requirements of the regulation are included. Here the EK Secretariat may study the Compliance Declaration and the test report to verify its completeness. An EK Declaration can be registered at the end.
When documentation is accepted as appropriate, the EK Declaration is signed and stamped by the converter/supplier and the EK Secretariat. Copies are used by the converter/supplier towards the food industry and the retail chains.
The K Declaration is valid for two years.