As you may have read, the European Commission adopted a proposal to strengthen the regulation on the use of BPA in food contact materials.
Where does this decision come from?
In January 2015, the European Food Safety Authority (EFSA) published its scientific opinion on the safety of BPA. In its assessment, EFSA covered exposure from food sources along with exposure from a range of other potential sources, and considered all age groups of the population. The Authority concluded that BPA poses no health risk to consumers because current exposure is too low to cause harm.
Based on new data and methodologies, EFSA lowered the estimated daily safe exposure level, known as the tolerable daily intake (TDI). The TDI was made temporary, pending results from a two-year study by the U.S. National Toxicology Program which is expected to become available in 2018. EFSA found that the highest estimates for aggregated exposure to BPA from both dietary and non-dietary sources are 3 to 5 times lower than the TDI, depending on the age group. Based on the EFSA opinion, the European Commission translated the new TDI into a new Specific Migration Limit (SML) and in turn notified to the World Trade Organisation (WTO) a draft Regulation that proposes the implementation of this new SML for BPA in food contact materials.
TDI, SML – what do they stand for?
- The Tolerable Daily Intake or “TDI” is a safety threshold aimed at ensuring consumer protection: it is the maximum amount of a substance to which any individual can be exposed every day of his/her life, through all possible sources, without any risk to his/her health. The TDI is usually expressed in micrograms of substance ingested per kilogram of body weight per day. In establishing the TDI, EFSA took the margins of safety into account. The current TDI for BPA was established in January 2015 by EFSA at a threshold of 4 micrograms per kg/day. This threshold is 12.5 times lower than the previous TDI of 50 micrograms per kg/day.
- The Specific Migration Limit or “SML” is the maximum permitted amount of a substance migrating from the packaging into food. This limit ensures that the food contact material does not pose a risk to human health. It is derived from the TDI, and is calculated in micrograms of BPA per kilogram of food. The SML is an essential tool in order to make sure the TDI is respected for all consumers, including the most sensitive populations.
What is new?
Following the risk assessment provided by EFSA and the new TDI for BPA, the new Regulation introduces a new SML of 0.05 mg of BPA per kg of food. It is applying the conventional exposure assumption and uses additionally an allocation factor to take into account other (non-dietary) sources of exposure. At the same time, the new SML would not only apply to plastic materials in food contact (as is currently the case), but also to coatings and varnishes, thus covering for the first time the overwhelming majority of all BPA-based materials in food contact applications. When it officially enters into force, all major uses of BPA in food contact materials (e.g. plastic bottles, food and drink cans etc.) will be covered and will have to comply with the new SML value.