The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) said there was considerable uncertainty in exposure estimates for non-dietary sources but hardly any around dietary estimates.
EFSA said new data and refined methodologies mean a reduction in the safe level of BPA from 50 micrograms per kilogram of body weight per day (μg/kg of bw/day) to 4 μg/kg of bw/day.
To read the full scientific opinion and lay summary please click here.
TDI lowering rationale
Highest estimates for dietary exposure and for exposure from various sources are three to five times lower than the new TDI.
Uncertainties around potential health effects on the mammary gland, reproductive, metabolic, neurobehavioural and immune systems have been quantified and factored in to the TDI.
The CEF panel concluded high doses of BPA (hundreds of times above the TDI) are likely to adversely affect the kidney and liver and it may also cause effects on the mammary gland in animals.
EFSA will reconsider the temporary TDI when the results of long-term research by the US National Toxicology Program are available in two to three years.
France has banned BPA from all packaging, containers and utensils intended for direct contact with food from the start of the year.
However, last month the US Food and Drug Administration (FDA) said that it is safe at current levels but pointed to safety assessments that are ongoing which may change its viewpoint.
Dr Trine Husøy is a member of EFSA’s CEF panel and chair of the BPA working group.
Husøy said it decided to re-evaluate BPA because of the number of research studies in recent years.
Studies indicating BPA as the cause of other health effects were less conclusive, said Dr Husøy.
“Effects on the reproductive, nervous, immune, metabolic and cardiovascular systems, as well as in the development of cancer are not considered likely at present but they could not be excluded on the available evidence,” she said.
“So, they add to the overall uncertainty about BPA-related hazards and therefore have been considered in the assessment.”
The panel also assessed unexpected responses to different doses, such as the so-called low dose effect (known as ‘non-monotonic dose-response’ or NMDR relationships).
They concluded that available data does not provide evidence of such relationships for the health effects considered.
Reaching the decision
As part of a three step process, EFSA provisionally concluded that for all population groups diet is the major source of exposure and it is lower than previously estimated, in a draft scientific opinion.
This was the first review since 2006 and the first to cover dietary and non-dietary sources.
It recommended the current tolerable daily intake (TDI) be lowered from 50 µg/kg bw/ day (or 0.05 mg/kg/bw/day) to 5 µg/kg bw/day (0.005 mg/kg/bw/day), in another draft scientific opinion.
However, the agency said the health risk is low because the highest estimates for combined oral and non-oral exposure are 3-5 times lower than the temporary TDI, depending on the age group.
The CEF panel identified likely effects on the liver and kidney and on the mammary gland linked to exposure to the chemical.
BPA-based epoxyphenolic resins are used as protective linings for food and beverage cans and may be used upstream in manufacturing of some raw materials, used to produce food contact materials.
Use is subject to a specific migration limit SML of 0.6 mg/kg and was banned in 2011 for the manufacture of polycarbonate infant feeding bottles in the EU.