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Germany’s BFR Revises Recommendations for Several Types of Food Contact Material and Articles

SafeGuardSHardgoodsFebruary 09, 2023

SG 17/23

The German Federal Institute for Risk Assessment (BfR) has revised six Recommendations for food contact paper and board materials and articles and other commodities made of rubber and silicone. These Recommendations can be regarded as effective immediately.

In February 2023, Germany’s Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) issued six Recommendations for food contact silicone, rubber and paper and board materials and articles.

Highlights of these Recommendations are summarized in Table 1.

Recommendation dated February 1, 2023
Highlight
XV ‘Silicones’
(in German or English)
  • When compared to its 2020 version, adds footnote 16 for a website to the March 2022 BfR method for determining the release of volatile compounds in consumer goods made of silicone
XXI ‘Commodities Based on Natural and Synthetic Rubber’
(in German or English)
  • When compared to its April 2022 version, deletes food contact material (FCM) substance no. 569 (polyethylene glycol sorbitan monooleate) in table for processing aids
XXI/1 ‘Commodities based on natural and Synthetic Rubber in Contact with Food’
(in German or English)
  • When compared to its April 2022 version, two editorial changes to clarify the relevant sections in footnote a for cyclohexyl aminoacetate (CAS 7346-79-4) and pentamethylene-ammonium-N-pentamethylene-dithiocarbamate (CAS 98-77-1) in table for vulcanization accelerator
XXXVI ‘Paper and Board for Food Contact’
(in German or English)
  • Applies to single and multi-layered commodities (materials and articles) made of paper and paperboard, as well as fiber casting, which are intended to come into contact with food, including paper and paperboard which are intended to be used at temperatures up to 90 ºC
  • Provides a website for methods for testing commodities
  • Absence of preserving effect in finished products
  • ≤ 10 µg/L lead (cold water extract)
  • ≤ 5 µg/L cadmium (cold water extract)
  • ≤ 1.0 mg/kg aluminum migration (cold water extract)
  • A value of 5 on the evaluation scale for optical brightener migration (DIN EN 648)
  • ≤ 0.01 mg/kg (sum of the migration of primary aromatic amines, PAA)
  • ≤ 0.002 mg/kg for each PAA that is classified as carcinogenic category 1A and 1B under Regulation (EC) 1272/2008 (CLP Regulation)
  • ≤ 2 µg/L 1,3-dichloro-2-propanol (1,3-DCP, water extract)
  • ≤ 12 µg/L 3-monochloro-1,2-propanediol (3-MCPD, water extract)
  • Provides a list of substances with specifications which may be used in the manufacturing process. These include raw materials, production aids, special paper and refining agents, including:
    • ≤ 1.0 mg/dm² formaldehyde for adducts containing 70% benzyl alcohol and 30% formaldehyde
    • ≤ 0.5 µg/dm² (sum of 3:1 mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CMIT) and 2-methyl-4-isothiazolin-3-one (MIT)
    • ≤ 10 µg/dm² 1,2-benzisothiazolin-3-one (BIT)
    • ≤ 1.0 µg/dm² MIT
    • ≤ 1.5 mg/dm² glyoxal
    • ≤ 1.0 mg/dm² formaldehyde for urea-formaldehyde resins or melamine-formaldehyde resins
    • Grade 5 on gray scale for migration of colorants (DIN EN 646)
  • Table of restricted substances as an additional requirement for the use of recycled fibers as raw materials for the manufacture of paper (see Table 2 below)
XXXVI/1 ‘Cooking Paper, Hot Filter Paper and Filter Layers*’
(in German or English)

*Only applies to paper that come into contact with aqueous food
  • Applies to overall raw materials (Section I), overall production aids (Section II) and special raw materials and production aids (Section III) used in the manufacture of food contact paper, paperboard and board
  • ≤ 10 µg/L lead (hot water extract)
  • ≤ 5 µg/L cadmium (hot water extract)
  • ≤ 1.0 mg/kg aluminum migration (hot water extract)
  • ≤ 0.5 µg/dm² (sum of 3:1 mixture of CMIT and MIT, hot water extract)
  • ≤ 10 µg/dm² BIT (hot water extract)
  • ≤ 1.0 µg/dm² MIT (hot water extract)
  • ≤ 2 µg/L 1,3-DCP (cold water extract despite intended use)
  • ≤ 12 µg/L 3-MCPD (cold water extract despite intended use)
  • ≤ 15 µg/dm² 2-methyl-1,2-benzothiazol-3(2H)-one (MBT)
  • Absence of zone inhibition (antimicrobial agents)
XXXVI/2 ‘Paper and Paperboard for Baking Purposes’
(in German or English)
  • Applies to paper and paperboard that come into contact with food during baking. The paper and paperboard must be able to withstand a temperature of at least 220 ºC for the intended period of heating without decomposing
  • Applies to raw materials (Section I), production aids (Section II) and special raw materials and special paper refining agents (Section III) used in the manufacture of food contact paper, paperboard and board materials and articles
  • Contains Section IV for an additional set of substances for the manufacture of paper and board, including cardboard, materials and articles which are used in microwave ovens
  • Absence of preserving effect in finished products
  • ≤ 10 µg/L lead (hot water extract)
  • ≤ 5 µg/L cadmium (hot water extract)
  • ≤ 1.0 mg/kg aluminum migration (hot water extract)
  • ≤ 2 µg/L 1,3-DCP (cold water extract despite intended use)
  • ≤ 12 µg/L 3-MCPD (cold water extract despite intended use)
  • ≤ 0.5 µg/dm² (sum of 3:1 mixture of CMIT and MIT, hot water extract)
  • ≤ 10 µg/dm² BIT (hot water extract)
  • ≤ 1.0 µg/dm² MIT (hot water extract)
  • ≤ 1.0 mg/dm² formaldehyde for urea-formaldehyde resins or melamine-formaldehyde resins (hot water extract)
  • Unless specified, optical brighteners must not be used (Section IIIC)
  • Clarifies that finished products must not exceed a temperature of 150 ºC when used in a microwave oven

Table 1

Annex to Recommendation XXXVI ‘Paper and Board for Food Contact’, February 1, 2023

SubstanceContent in Finished Paper ProductMigration Limit
4,4’-Bis(dimethylamino)-benzophenone**---Not detected (ND, detection limit = 0.01 mg/kg)
Phthalates:
Diethylhexy phthalate (DEHP)
Di-n-butyl phthalate (DBP)
Diisobutyl phthalate (DIBP)
---1.5 mg/kg DEHP
0.3 mg/kg each of DBP and DIBP, and subject to no more than 0.3 mg/kg for the sum of DBP and DIBP
Benzophenone---0.6 mg/kg
Bisphenol A (BPA)**---0.05 mg/kg
Bisphenol S (BPS)**---0.05 mg/kg
Diisopropyl naphthaleneAs low as technically feasible---

**Verification of the specifications is only required if the finished product is intended to come into contact with moist and fatty food

Table 2

SGS technical experts have extensive knowledge and testing experience in materials and articles in contact with food. They work to ensure that your products meet the appropriate regulations for food contact materials, paving the way for compliance. From overall migration tests to expert advice on emerging regulations, compliance issues and documentation review, SGS is the partner to trust. In the end, it’s only trusted because it’s tested. Discover more on our website and read our brochure.

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