On June 10, 2020, the European Food Safety Authority (EFSA) Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) published a scientific opinion outlining the prioritization of substances without an assigned specific migration limit (SML) within the EU Regulation No 10/2011 on plastic materials and articles intended to come into contact with food. The set of 451 substances had previously been regulated by a generic SML of 60 mg/kg food, however, the introduction of new EU Regulation No 2016/1416 led to the deletion of generic SMLs and therefore required the substances to be re-examined.

EFSA was requested to “identify those substances requiring an SML to ensure the authorization is sufficiently protective to health, grouping them in high, medium and low priority to serve as the basis for future re‐evaluations of individual substances.” Using existing hazard assessments for the substances, a developed prioritization procedure was applied. Following the prioritization:

  • 3 substances were placed in the high priority group, including salicylic acid (FCM 121, CAS 69-72-7), styrene (FCM 193, CAS 100-42-5) and lauric acid, vinyl ester (FCM 436, CAS 2146‐71‐6);
  • 102 were placed in the medium priority group;
  • 179 were placed into the low priority group;
  • 89 were found to not need a migration limit since an earlier evaluation determined that an Acceptable Daily Intake (ADI) is not needed or the substances are controlled by other existing restrictions;
  • 78 were eliminated as having been previously evaluated as food contact substances.

Read More

Keller and Heckman LLP (July 1, 2020). “EFSA Prioritizes Substances without an SML for Re-evaluation.”


EFSA CEP Panel (June 10, 2020). “Review and priority setting for substances that are listed without a specific migration limit in Table 1 of Annex 1 of Regulation 10/2011 on plastic materials and articles intended to come into contact with food.”