background image
- Practical Guide -
Page 113 of 153
4.
Positive list
A positive list of approved substances and, if necessary, restrictions on their use has been
published in Annex II of Directive 83/229/EEC [A7].. Amendments on the limits for
derivatives of ethylene glycols (MEG/DEG) can be found in Directive 86/388/EEC [A10].
Directive 92/15/EEC [A13] introduced several changes to the list and added new substances.
Purity criteria (in the sense of 'good technical quality') are now stated in the Annex II of the
consolidated version, i.e. Directive 93/10/EEC [A18].
Restrictions in positive list
Some guidance in the determination of the restriction is given in Annex 1.
Colorants and adhesives
While colorants and adhesives for RCFs are not included in the published positive lists yet,
their use is authorised,
'provided that there is no trace of migration of the substances into or
onto foodstuffs, detectable by a method which shall be determined in accordance with the
procedure laid down in Article 10 of Directive 76/893/EEC'
(Article 2.2 of Directive
83/229/EEC). However, the Directive does not specify the method to be used. Therefore,
pending the establishment of a validated CEN method, it is useful to refer to the most
appropriate existing method proposed by industry in 1992 (see Annex II to Section 5 of
Chapter I)
The Framework Directive, the specific Directive or the amendments thereof provide
additional provisions directly or indirectly referring to this subject, such as that 'printed
surfaces of RCF shall not come into contact with the foodstuff' (Dir. 83/229/EEC, Art. 3), or
the possibility for a Member State to maintain or adopt a positive list of colouring matters or
adhesives.
Monoethylene and diethylene glycols (MEG/DEG)
MEG and DEG are included in the positive list of Directive 83/229/EEC with restrictions on
their use being amended by Directive 86/388/EEC. Tetraethylene glycol has been added to the
positive list by Directive 92/15/EEC. The restrictions have again been amended by Directive
93/10/EEC: migration is controlled by a compositional limit (QM) for the uncoated film.