27 September 2019
Food Contact News
EU AUTHORIZES NEW SUBSTANCE IN PLASTIC FCMs
European Commission amends EU 10/2011 regulation on plastic food contact materials, authorizes use of poly((R)-3-hydroxybutyrate-co- (R)-3-hydroxyhexanoate) for contact with dry or solid foods
On August 8, 2019, the European Commission (EC) amended EU Regulation No. 10/2011 on plastic materials and articles intended to come into contact with food. The amendment authorizes the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (CAS 147398- 31-0) to be used either alone or blended with other polymers that come into contact with dry or solid foods for less than 6 months at room temperature or below. This includes hot filling and short heating phases. The authorization corresponds to migration testing that makes use of simulant E in Table 2 of Annex III of the EU No. 10/2011 regulation. The amendment also “requires that the total migration of all oligomers with a molecular weight below 1 000 Da does not exceed 5.0 mg/kg food or food simulant.”
U.S. AND EU APPROACHES TO DEFINING AND EVALUATING IMPURITIES AND NIAS IN FOOD CONTACT MATERIALS
Keller and Heckman article discusses existing regulations related to non-intentionally added substances (NIAS); compares EU and U.S. approaches, outlines risk assessment steps
On August 21, 2019, the law firm Keller and Heckman LLP (KH) published an article discussing non-intentionally added substances (NIAS) in food contact materials (FCM) and the existing general safety requirements US and European regulations that relate to them. In the U.S., existing Good Manufacturing Practice (GMP) regulations define purity requirements for food contact substances. KH explains that under this regulation “all foreseeable impurities based on the manufacturing process—such as residual monomers, starting reactants, aids to polymerization, catalysts, and products of incomplete reaction—should be considered.” Notable is that U.S law considers oligomers as being part of the polymer, which “is in contrast to EU law.” Title 21 of the Code of Federal Regulations (CFR) also provides limits for some expected impurities for food contact substances approved as indirect food additives. In the EU, GMP must also be followed for manufacturing FCMs. In the EU’s plastics regulation No 10/2011, the term NIAS is defined as an “impurity in the substances used or reaction intermediates formed during the production process or a decomposition or reaction products.” Any specific migration limits set within the regulation’s positive list of monomers and additives must be followed.