Swiss Printing Inks Ordinance Updated
Swiss Ordinance 817.023.21 on materials and articles will be updated as of February 1, 2024, by an amendment dated December 8, 2023. One significant change is that the Part B list (unevaluated substances) of the positive list in Annex 10 (Packaging Inks) will be deleted such that only the Part A list (evaluated substances) will remain. Unlisted substances may be used provided that they are not carcinogenic, mutagenic, or toxic to reproduction (See categories 1A, 1B, or 2 in Annex II, Chapter 1 of Swiss Ordinance 813.11 on protection against dangerous substances and preparations) and that their migration is non-detect at a detection limit of 0.01 mg/kg food or food simulant (if no detection limit is specified for certain substances or groups of substances).
Annex 10 still states that substances intentionally manufactured in nanoform may only be used in printing inks if they are authorized as such in Annex 2 (plastics) or Annex 10 (section 2.2.1). A new Table 3 is introduced in Annex 10 which contains a list of metals/elements mirroring that in Annex II of the Plastics Regulation (EU) No. 10/2011. In the same way as the Plastics Regulation, the salts of substances (for which ‘yes’ is indicated in column 2 in Table 3) of authorized acids, phenols, and alcohols may also be used subject to any applicable restrictions. An updated non-detect limit of 0.002 mg/kg food or food simulant) will also apply to the specific migration of certain primary aromatic amines (PAAs).
A declaration of compliance (DoC) will be required in Switzerland for substances used in the manufacture of printing inks, the printing inks themselves, and printed food contact materials and articles (FCMs) at marketing stages other than the retail stage. The information to be included in the DoC is set forth in a new Annex 15. This includes, for example, ‘adequate information’ relative to the substances used or their degradation or reaction products as well as impurities which should include, notably, the identity and amount of substances present in the material at each intermediate stage of manufacture that are likely to migrate from the final article to foodstuffs or food simulants. The Ordinance also details what supporting documentation should be maintained on file. The Swiss Federal Food Safety and Veterinary Office (FSVO) has indicated that it will publish a guidance document on the new provisions applicable to printing inks (at least in so far as they concern the DoC).
The amendment to the Ordinance is not confined to printing inks as the provisions, notably on plastics, silicones, and ceramics, will also be updated. The overall aim of the revision per the FSVO is to align the Swiss legislation more with that of the EU. For instance, it will align the provisions on plastics with the 15th amendment (Regulation (EU) 2020/1245) to the EU’s Plastics Regulation (EU) No. 10/2011. It updates the provisions applicable to recycled plastics (e.g., the DoC must confirm that the recycling process is authorized by the FSVO (and cite the authorization number) and that the recycled plastics comply with the EU’s Recycled Plastics Regulation (EU) 2022/1616)). For silicones, the table of metals reflecting that in Annex II of the Plastics Regulation and updated limits for PAAs will be introduced in line with the provisions as noted above for printing inks.
The amended Ordinance will also make it clear that materials in contact with drinking water are regulated by a different Ordinance (Ordinance 817.022.11, Ordinance on Drinking Water and Water from Publicly Accessible Bathing and Showering Facilities) than FCMs so that the control and evaluation procedures for materials in contact with drinking water are adequate in Switzerland. The FSVO noted that EU Member States such as France, Germany, and the Netherlands have specific review and evaluation procedures for materials in contact with drinking water and the rules are stricter than for FCMs.
Although the updated text will enter into force on February 1, 2024, there are some transitional provisions. Specifically, FCMs that are not compliant with Articles 35-35b (compositional requirements, DoC, and supporting documentation for printing inks) introduced by the amendment of December 8, 2023, may be imported, manufactured, and labelled in accordance with the pre-existing law until January 31, 2026, and provided to consumers until that date. Materials and articles that are not in compliance with other provisions of the amendment of December 8, 2023 may be imported, manufactured, and labelled in accordance with the pre-existing law until January 31, 2025. They can be provided to consumers until the exhaustion of stocks.
The amendment of December 8, 2023, to the Swiss Ordinance on Materials and Articles that will apply as from February 1, 2024, can be found Here.
The new annexes 2 (plastics), 9 (silicones) and 10 (packaging inks) can be found Here.