SGS : Switzerland Strengthens Ordinance on Food Contact Materials and Articles

SAFEGUARDS | FoodNO. 171/19

In December 2016, Switzerland published a new piece of legislation to establish requirements for, inter alia, 10 groups of food contact materials and articles (FCMs) as part of its new 'Food Law 2017' (SafeGuards 15/17). These FCMs are regulated under Ordinance of the Federal Department of Home Affairs on materials and articles intended to come into contact with foodstuffs (Ordinance on Materials and Articles ('the Ordinance'), RS 817.023.21 in German, French and Italian). The 10 categories of FCMs are:

1. Active and intelligent materials
2. Ceramics, glass, enamels and similar articles
3. Metals and alloys
4. Paper and cardboards
5. Paraffins, wax and dyes
6. Plastics (which also include epoxy resins)
7. Printing inks
8. Recycled plastics
9. Regenerated cellulose
10. Silicone

On November 5, 2019, Switzerland published Official Collection 2019 3371 (in German, French and Italian) to align 'the Ordinance' with many provisions on food contact materials and articles from the EU. These include provisions from the following pieces of legislation:

1. Regulation (EC) 1895/2005 'Certain epoxy derivatives' - relating to 2,2-bis(4-hydroxyphenyl) propane bis(2,3-epoxy(propyl) ether (BADGE, CAS 1675-54-3) and its derivatives, Novolac glycidyl ethers (NOGE) and bis (4-hdroxyphenyl)-methane bis (2,3-epoxypropyl) ether (BFDGE, CAS 29817-09-9)
2. Amendments to Regulation (EU) 10/2011 on food contact plastics, such as Regulation (EU) 2016/1416 (SafeGuards 147/16) and Regulation (EU) 2018/213 'Bisphenol A (BPA) in varnishes and coatings as regards to the use of that substance in food contact plastics' (SafeGuardS 21/18)

According to the amendment:

• Food contact materials and articles not complying with Annex 13 may be manufactured, imported, labeled and sold to consumers under the old law until May 31, 2020.
• Food contact materials and articles not complying with other provisions may remain on the market until stocks are exhausted

The latest amendment will become effective on December 1, 2019.

Highlights on major changes in the amendment are summarized in Table 1.

Amendment of October 23, 2019 to Ordinance of the Federal Department of Home Affairs on Materials and Articles Intended to Come into Contact with Foodstuffs (Ordinance on Materials and Articles, RS 817.023.21 of December 16, 2016) Official Collection 2019 3371, Number 99 of November 5, 2019, Federal Gazette
Item	Section	Highlight
1	Section 13a 'Varnishes and coatings'	Completely new section complementing Annex 13 (item 13 below)
2	Annex 2 'List of substances permitted for the manufacture of plastic materials and articles and related requirements'	New website for list
3	Annex 4, Table 1 'List of food simulants for food'	Specifying vegetable oils are to contain less than 1% unsaponifiable matter
4	Annex 4, Table 2 'Assignment of food simulants'	Assigning food simulants for migration tests for 'fresh or chilled fruit' and 'fresh or chilled vegetables'
5	Annex 4, Table 3 'Food simulant assignment for demonstrating compliance with overall migration'	Completely new table for assigning food simulants for overall migration
6	Annex 4, Section 2.2 'Rules for assessing compliance with migration limits'	New definition for 'Hot-filled' - any article with a temperature of not exceeding 100°C at the time of filling, after which the food cools to no more than 50°C within 60 minutes, or no more than 30°C within 150 minutes
7	Annex 4, Table 4 'Standardized conditions for testing overall migration'	Amending OM2 and OM3 by considering hot-filled conditions and formula for time Amending OM6 by inclusion of simulant D1 (50% ethanol)
8	Annex 4, Section 2.3.3 'Verification of compliance'	Verification of compliance for single-use and repeated use materials and articles
9	Annex 4, Table 7 'Selection of test temperature'	Addition of 2 temperature rules for testing above 175°C. These are for applications with worst foreseeable contact temperatures (T): 175°C < T≤200°C, and T > 200°C
10	Annex 4, Section 2.4.2.1.4 Specific conditions for contact time above 30 days at room temperature and below	Completely new set of conditions
11	Annex 9 'List of substances permitted for the manufacture of silicone materials and articles and related requirements'	New website for list
12	Annex 10 'List of substances permitted for the manufacture of packaging inks and related requirements'	New website for list
13	Annex 13 'Special requirements for varnishes and coatings'	Completely new annex complementing Section 13a (item 1 above) ≤ 9 mg/kg for sum of specific migration of BADGE, BADGE.H2O and BADGE.2H2O otherwise ≤ 9 mg/6 dm²* ≤ 1 mg/kg for sum of specific migration of BADGE.HCl, BADGE.2HCl and BADGE.H2O.HCl otherwise ≤ 1 mg/6 dm²* Prohibition of NOGE and BFDGE ≤ 0.05 mg/kg for BPA migration from varnished and coated FCMs BPA migration prohibited for food contact varnished or coated materials and articles for young children for food categories under Ordinance of the Department of Home Affairs on Foods for People with Special Nutritional Needs (RS 817.022.104 inGerman,FrenchandItalian)
14	Annex 14 'Declaration of conformity for varnishes and coatings'	New requirements specifying information for declarations of conformity (DoC)
*mg/6 dm² for the following: a) Containers and other articles, containing or intended to contain, less than 500 mL or grams or more than 10 L b) Materials and articles for which, due to their form, it is impracticable to estimate the relationship between the surface area of such materials and articles and the quantity of food in contact with c) Sheets and films that are not yet in contact with food d) Sheets and films containing less than 500 mL or grams or more than 10 L Points a to d above do not apply to food contact plastics intended to be brought into contact with or already in contact with food for infants and young children falling under Ordinance of the Department of Home Affairs of December 16, 2016 on Foods for People with Special Nutritional Needs (RS 817.022.104)

Table1

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