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EU's New Biocidal Regulation Applies to Food-Contact Materials

The European Union's (EU) Biocidal Products Regulation (BPR) (Regulation (EU) No. 528/2012), which entered into force on September 1, 2013, includes food-contact materials and articles in its scope. This is in contrast to the Biocidal Products Directive (BPD), which specifically excluded food-contact materials and articles. The BPD was repealed by the BPR.

The BPR defines a treated article as: "[A]ny substance, mixture or article which has been treated with, or intentionally incorporates, one of more biocidal products." Following a transition period, a "treated article" cannot be placed on the market in the EU unless all active substances contained in the biocidal products used to treat it are approved for the relevant product-type.

The European Commission is currently preparing a Note for Guidance, Frequently asked question on treated articles (CA-Sept13-Doc.5.1.e ) that was updated in September 2013. The document explains that while a treated article with biocidal function always has a biocidal property, a treated article without biocidal function can also have a biocidal property. One of the examples provided is the use of an antimicrobial product to prevent deterioration of plasticized PVC.

Active substances in residues on an imported product that was subjected to a biocidal treatment during the production process or some part of the manufacturing process does not have to be approved when the article is placed on the EU market, according to the draft document. An example provided is paper containing traces of a slimicide that was applied to the printing equipment. "In this case the biocide is not used to treat the article, and is not intentionally incorporated into the article. Therefore it does not have to be approved when the article is placed on the EU market," stated the EC in the document.

The last revised version of the above Note for Guidance is available on the EC's website.