Requirements, guidelines and recommendations

1) Framework Regulation

REGULATION (EC) No. 1935/2004 OF THE EUROPEAN PARLAMENT

Further information can be obtained here

Requirements of the framework regulation:

Materials and items are to be produced in accordance with good manufacturing practices, so that under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which would:

a) endanger human health; or
b) bring about an unacceptable change in the composition of the food; or
c) bring about a deterioration in the organoleptic characteristics thereof.

2) Plastics directive

DIRECTIVE 2002/72/EC

(plastic material and articles intended to come into contact with foodstuff)

Requirements from the plastics directive:

The following migration values have to be observed:

• Global migration value: 60 ppm [mg/(kg foodstuff)]
• Non-evaluated substances: 10 ppb [μg/(kg foodstuff)]
• Evaluated substances: specific migration limits (SMLs)

3) GMP – Regulation

Regulation (EC) No. 2023/2006 of December 22nd 2006

(Superior regulation which defines the requirements for single parties of the manufacturing and distribution process of food packaging)

The requirements on printing inks manufacturers were written down by EuPIA in the EuPIA GMP. Further information can be obtained here

4) EUPIA Guideline for printing inks

(Self commitment for the printing inks industry due to lack of official regulations for printing inks)

Further information can be obtained here

Requirements of the EUPIA Guideline for printing inks:

• Raw material exlusion list
• (no CMR raw materials, no toxic raw materials, no toxic heavy metals)
• Defined raw material selection scheme
  a) non-evaluated substances:<10 ppb (spec. migration)
  b) substances with three neg. mutagenity tests: < 50 ppb (spec. migration)
• Timetable to hit the limits for non evaluated substances  
  a) 50 ppb from December 2010 on
  b) 10 ppb from December 2015 on