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German BfR revises 8 recommendations for food contact materials

Time：

2025-11-04

The German BfR has released 8 revised recommendations for food contact materials, covering products such as silicone, paper, and polyethylene terephthalate. The revised recommendations will take effect on October 1, 2025.

Recently, the German Federal Institute for Risk Assessment (BfR) released eight revised recommendations for food contact materials, covering products such as silicone, paper, and polyethylene terephthalate, and abolished one recommendation for food contact materials. The revised proposal has been effective since October 1, 2025.

Notice No. 229

XIV. Polymer dispersion

Last revised version as of April 1, 2022

In Part A, Section 2 d) Add the following items under the category of "emulsifier":

Sodium hexametaphosphate, maximum usage: 0.1 mg/dm2. The content of cyclic condensed phosphate (pyrophosphate) shall not exceed 8.0%. Sodium hexametaphosphate must comply with the requirements of EU Regulation (EU) 231/2012 regarding food additive E 452 (i).

In section A, except for the existing "1 Individual "and" 2 Introduce a list of additives outside the category of "production aids"

XV. Silicone

Last revised version as of September 1, 2024

Existing footnote 7 modified:

Wax and paraffin must comply with the requirements of Part 1 of Recommendation XXV 'Hard Paraffin, Microcrystalline Wax and its Mixtures with Wax, Resin and Plastic, and Natural Wax'.

XVII. Polyethylene terephthalate

Last revised version as of July 1, 2016

In point 1, add a new requirement for the entry "Low molecular weight diglycidyl ether of 4,4 '- dihydroxydiphenyl-2,2-propane (also known as bisphenol A diglycidyl ether), up to 2.0%": it must comply with the provisions of EU Regulation (EU) 2024/3190.

XXX. Conveyor belts made of Guta Bo glue and Balata glue

Last revised version as of September 1, 1984

Delete, not replaceable

XXXVI. Paper, cardboard, and cardstock used for food contact

Last revised version as of August 1, 2024

General requirements have changed, introducing new requirements: no acrylamide release shall be detected in finished products (paper, cardboard, and paperboard), with a detection limit of 0.01 mg/dm2 for food or food simulants.

Introduce new footnotes 8 and 9, as follows:

New footnote 8: "When testing according to EN 646, it is necessary to meet the gray sample card level 5 specified therein. New footnote 9: "When testing according to EN 648, it is necessary to achieve a rating level of 5.

Changes to the main text

Add new substances to the additive list

Add the following entries under A.I. fiber materials and C.IV. surface finishing and coating formulations:

Microfibrillated cellulose is produced by mechanical treatment of cellulose fibers, with or without the use of minerals from BfR recommendation XXXVI A.II (fillers). The fiber content in the grinding mixture is 80-100% (weight percentage). The proportion of fine particles after centrifugation shall not exceed 10%, and the average fiber width (quantity and size distribution) shall be greater than 20 nm. Enzymes shall not be used in the production of microfibrillated cellulose. ”

Add the following items under B.IV dehydration promoter and C.I wet strength agent:

-1,3-1,6-glucan, produced by enzymatic method, treated with 3-chloro-2-hydroxypropyltrimethylammonium chloride or glycidyl trimethylammonium chloride (specification of cationic glucan 17.29: epichlorohydrin, up to 1 mg/kg; Nitrogen, up to 3.0%, up to 0.3%, based on dry fiber materials

Add a new footnote 29:

The migration amount of cationic reagents 3-chloro-2-hydroxypropyltrimethylammonium chloride or glycidyl trimethylammonium chloride to food shall not exceed 0.15 μ g/kg. The maximum detection limit is 2 μ g/kg. The migration amount of the reaction product 2,3-dihydroxy-N, N, N-trimethyl-1-propylammonium chloride (CAS 34004-36-9) to food shall not exceed 5 mg/kg. The migration amount of the reaction product (1E) -3-hydroxy-N, N, N-trimethyl-1-propene-1-ammonium chloride (CAS 91725-36-9) to food shall not exceed 0.05 mg/kg. ”

The new footnote 29 will be added to the following other items in recommendation XXXVI and the items involved in XXXVI 1.2.3, while removing the restrictions on the use of (2,3-dihydroxypropyl) - trimethylammonium chloride and (3-hydroxypropenyl) - trimethylammonium chloride, thereby adjusting the specifications of cationic pectin.

B. I. Adhesive: 3.2.4.3, 3.2.4.4, 3.2.5, 3.2.6, 7.2, 22.3, 35, 36

C. IV Surface finishing and coating agents: 10.2, 45

C Special Paper Refiner Part Modification:

C. III. All previous entries under colorants and fluorescent whitening agents will be deleted and replaced with the following entries: a) colorants (not yet included); b) Fluorescent whitening agent: sulfonated stilbene derivative, up to 0.3%.

In addition, under C.IV, entry "1 Plastic has been adjusted. For the examples of "film" and "melt" listed after this entry, a reference to EU Regulation (EU) No. 10/2011 has been added; For the entry 'dispersion', a reference to BfR recommendation XIV (dispersion) has been added. The examples of "solution" and "varnish" have been removed.

Added the following two substances as new points 47 and 48:

47. Palmitoyl chloride, up to 4 mg/dm2, applied once on paper/cardboard coated with polyvinyl alcohol. Do not use in direct contact with acidic foods (pH<4.5).

48. Poly (2-ethyl-2-oxazoline), up to 7.4 mg/dm2.

Suggested testing methods for aromatic primary amines are provided:

http://www.bfr.bund.de/de/methodensammlung_papier_karton_und_pappe-32620.html

Changes to Appendix XXXVI

The section on the conditions for using recycled fibers as paper raw materials, footnote 32, has been removed and the following paragraph has been added to the main text:

Recycled fibers from Class 5.01 (DIN EN 643), as well as paper, cardboard, and paperboard from household waste and similar commercial waste, mixed packaging waste, and commercial waste, shall not be used. However, the following exceptions apply: Class 5.01, 5.02, 5.03 (DIN EN 643) from selectively collected mixed packaging waste and Class 5.14 (DIN EN 643) from selectively collected waste may be used, but not for the production of paper, cardboard, and paperboard in direct contact with food or for primary packaging. In the total recycled paper, only a maximum of 12.5% of the recycled fibers generated from the above categories are allowed to be used. In addition, the processing must include the following process steps: I) dry sorting based on NIR (near-infrared), II) using a separated water circulation system to remove pollutants and microorganisms, and III) a process step for reducing bacterial load, which includes heating the recovered fibers before use in paper production. ”

In addition, in the table in Appendix XXXVI, the original bisphenol A migration guidance value of 50 μ g/kg for food has been deleted and replaced with the following paragraph:

At the EU level, discussions are currently underway on how to address the entry of bisphenol A and other bisphenol A into food, particularly through the recycling of food contact materials made from paper/cardboard, within the framework of a monitoring proposal by the European Commission. Collect data about its existence and determine a threshold in this context, beyond which an investigation must be conducted to determine the source of entry. This threshold can be used as a reference (currently under discussion: 0.01 mg/kg food). Before concluding the discussion at the European level, BfR suggests that the migration of bisphenol A from paper and cardboard food contact materials to food should be minimized in this context. It is possible to display the migration amount of bisphenol A in water extracts, but it cannot display any values that do not meet the threshold, as water extracts often lead to a significant overestimation of bisphenol A release. ”

Change the requirements for MOAH below the table:

For dry, non fatty foods with large surfaces, such as flour, coarse flour, rice, breakfast grains, breadcrumbs, sugar, and salt, special consideration must be given to volatile and hydrophobic substances, such as aromatic mineral oils and hydrocarbons MOAH, which migrate through the gas phase.

XXXVI/1. Cooking and Heating Filter Paper and Filter Layer

Last revised version as of August 1, 2024

General requirement change, introducing new requirement: Acrylamide release must not be detected in finished products (paper, cardboard, and cardstock), with a detection limit of 0.01 mg/dm2 for food or food simulants

The modification of fiber materials and additives is the same as XXXVI

XXXVI/2. Paper, cardboard, and cardstock used for baking purposes

Last revised version as of August 1, 2024

The modification of fiber materials and additives is the same as XXXVI

XXXVI/3. Cellulose fiber based absorbent pads for food packaging

Last revised version as of September 1, 2019

The modification of fiber materials and additives is the same as XXXVI

XLIV. Artificial intestine casing

Last revised version as of November 1, 2014

Footnote 10 will be adjusted to the following new title based on suggestion XXV:

Hard paraffin wax, microcrystalline wax, and their mixtures with wax, resin, and plastic, as well as natural wax

Suggestions for Enterprises

This update particularly reflects the close alignment between BfR and regulatory dynamics at the EU level, especially in the areas of Bisphenol A (BPA) and Mineral Oil Aromatic Hydrocarbons (MOAH) that have recently received much attention:

Regarding BPA: BfR, the old guidance value has been removed and instead cited the ongoing discussion by the European Commission (currently discussing a threshold of 0.01 mg/kg), and it is required that BPA migration should be "as low as possible" (ALARA) before this;

Regarding MOAH: BfR, it is explicitly required that "there shall be no detectable migration", and its basis is directly referenced from the report of the Permanent Committee of the European Commission. In addition, the revision also includes setting a new limit of "no detectable" acrylamide and stricter requirements for the use of recycled fibers.

Given the crucial reference position of BfR in EU paper product compliance, it is recommended that relevant companies immediately review their supply chains to address new challenges.

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