Question 

Do the EU or German (BfR) authorities consider digester additives, used in pulp digesters, as part of the food contact regulation?   There is no specific section of BfR XXXVI, which appears to apply to this process. 

Answer 

The regulation of food-contact paper is not harmonized in the European Union (EU), therefore, at the EU level, paper and board materials are only subject to the general requirements set forth in the Framework Regulation (EC) No 1935/2004 and Regulation (EC) No 2023/2006 on Good Manufacturing Practice. However, paper and board also must comply with the appropriate laws of each of the EU Member States, subject to the principle of mutual recognition.

The German Federal institute for Risk Assessment—or Bundesinstitute fur Risikobewertung (BfR)—Recommendations on paper and paperboard, while not legally binding, are widely respected by industry throughout the EU. BfR Recommendation XXXVI includes a positive list of additives permitted for use in food-contact paper.  However, only substances that are intended to have a function in the final paper are required to be included in the positive list, unless they are biocides/preservatives, which are subject to BfR listing (regardless of whether they function in the paper additive or in the final paper).

Paragraph 2(b) of the current pre-amble to Rec. 36 states: "[s]ubstances that are used for manufacturing of paper raw materials listed in section A . . . are not subject to this BfR Recommendation."  Notably, Section A lists pulp and pulp fillers. Therefore, pulping or digester additives would not require a listing on Rec. 36, provided that they have no technical effect in the final paper.  They do, of course, remain subject to the Framework Regulation’s overall safety requirement, and thus, to the extent that residual levels of these substances remain in the final paper, they must be evaluated for their safety.