Food Packaging Safety - Lists of Materials

The NAPIM Food Packaging Committee has prepared:

Please note that these lists have been prepared based on "positive" Inclusion listings (i.e. Swiss List, PIM, GIO), and "negative" Exclusion listings (i.e. IARC, Prop65, SVHC) and hybrid lists(General Substances, Nestles). See below for more detailed information

Swiss List
Swiss Ordinance RS 817.023.21 (2013) includes a list of substances that are permitted in inks used to print on food packages. The list includes both evaluated and non-evaluated substances. The non-evaluated substances are only permitted if they do not migrate to food at a level of 0.01 mg/kg or above. Swiss Ordinance List
Plastics Implementation Measure (PIM)

The EU Plastics Regulation, (EU) No. 10/2011does not apply to printing inks, per se, it may govern the use of printing ink in some applications. For example, the Plastics Regulation includes a positive list of substances permitted for use in food-contact plastic materials. While printing inks on plastics may consist of components other than those on that list, printing ink components that are on the positive list and have specific migration limits (SMLs) or other restrictions, should comply with those limitations when used on plastic articles covered by the Regulation.

The Plastics Regulation also has an overall migration limit (OML) of 60 mg/kg food or 10 mg/dm2 surface area, and any migration from printing inks must be taken into account when determining compliance of the finished article with the OML. Printing inks are not subject to the regulation's Declaration of Compliance (DoC) requirement, but adequate information must be passed on to enable the final manufacturer to ensure that applicable migration limits are met.

Neste's Guidance Note on Food Packaging Inks
The Nestlé Initiative on Packaging Safety and Compliance and addresses specifically the ink usage for decoration on packaging materials. This document equally applies to printing inks, lacquers, coatings and varnishes (shorten to “inks and varnishes” in the rest of this document). It specifies with more details the 4 Standards (Outer printing, UV printing, Inner printing and Ink-jet printing) of the Nestlé Standards on Materials in Contact with Food (GI-80.008) that are mandatory. This document aims at guiding further on the assessment of the composition of inks and varnishes, i.e. information received from packaging vendors via the Certificates of Compliance (CoC). The CoC provided by the converter is based on the composition declaration of the ink maker and varnish manufacturer.
General Chemicals List
This list of materials was compiled by ink manufacturers based on customer requests, generally known toxicity and regulatory concerns.
Substances of Very High Concern
This list is provided by the European Chemical Agency (ECHA). The identification of a substance as Substance of Very High Concern and its inclusion in the Candidate List is the first step of the authorisation procedure. Companies may have immediate legal obligations following such inclusion which are linked to the listed substance on its own, in preparations and articles. Further documentation or more detailed information on the identification process of substances of very high concern can be found on the web pages of ECHA's Member State Committee.
Chemicals classified by the International Agency for Research on Cancer. This listing included substances classified by IARC in Vols 1 - 117.
German Ink Ordinance
The Draft German Draft Ordinance on Printing Inks** when finalized EU Update, will amend the German Commodities Regulations. It establishes a positive list—with restrictions, specifications, and purity requirements—of monomers and other starting substances; colorants; solvents; additives; and photoinitiators. Substances not on the positive list may be used if they are not CMR (carcinogenic, mutagenic, or toxic to reproduction); do not migrate to food at a level of 10 ppb or above; and are on an "inventory list" that will be published by Germany's Federal Office on Consumer Protection and Food Safety (BVL). A DoC will be required for the printed food-contact material, the printing ink, and the substances intended to be used in the manufacture of the printing ink. Interestingly enough, the proposed Ordinance only applies to inks that are not used directly in contact with food. Presumably, those components used directly in contact with food are subject to other regulation at the EU or state level.
Listing of materials known to the state of California to cause cancer or reproductive toxicity. This listing is provided by California's Office of Environmental Health Hazard Assessment.
** September 2016 - EU Commission invites Germany to postpone ink ordinance The Commissioner informed Germany that in 2018 the Commission intends to adopt new Union legislation on printed food contact materials, including printing inks and commonly printed materials such and paper and board. The Commissioner has invited Germany to postpone the adoption of its draft legislation EU Commision letter