EFSA – No consumer health risk from bisphenol A exposure

EFSA’s comprehensive re-evaluation of bisphenol A (BPA) exposure and toxicity concludes that BPA poses no health risk to consumers of any age group (including unborn children, infants and adolescents) at current exposure levels. Exposure from the diet or from a combination of sources (diet, dust, cosmetics and thermal paper) is considerably under the safe level (the “tolerable daily intake” or TDI).

Although new data and refined methodologies have led EFSA’s experts to considerably reduce 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, the highest estimates for dietary exposure and for exposure from a combination of sources (called “aggregated exposure” in EFSA’s opinion) are three to five times lower than the new TDI.

Uncertainties surrounding potential health effects of BPA on the mammary gland, reproductive, metabolic, neurobehavioural and immune systems have been quantified and factored in to the calculation of the TDI. In addition, the TDI is temporary pending the outcome of a long-term study in rats, which will help to reduce these uncertainties.

You can find the full opinion and the toxicological/exposure assessments HERE.

BPA is a controversial chemical compound used in the manufacture of food contact materials such as re-usable plastic tableware and can coatings (mainly protective linings). Another widespread use of BPA is in thermal paper commonly used in till/cash register receipts. Residues of BPA can migrate into food and beverages and be ingested by the consumer; BPA from other sources including thermal paper, cosmetics and dust can be absorbed through the skin and by inhalation.

Despite the positive outcomes of many scientific opinions, BPA is banned in many countries for the use in baby bottles and in France, since 1st January 2015, is prohibited for use in all food contact materials.

A recent study is advacing he hypothesis that some substitutes of BPA could be even more dangerous than this substance.

Written Q&A to EU Commission – High levels of Bisphenol A in widely consumed food

◊ E-011591/2011: Written question to the Commission by Nikolaos Salavrakos(EFD), Member of the European Parliament:

According to scientists at Harvard University, canned food and refreshments stored in plastic bottles contain excessively high levels of the chemical bisphenol A, which is linked to cancer and cardiovascular and sexual maturation problems. The scientists found that some food packaging contains 1.000 times higher levels of bisphenol A than fresh food. In their article published in the Journal of the American Medical Association they found to their astonishment that eating a tin of soup a day for a total of five days was enough for levels of bisphenol A in urine to soar by 1.221 %. ‘We’ve known for a while that drinking beverages that have been stored in hard plastics can increase the amount of BPA in your body,’ Jenny Carwile, the study’s lead author, said in the statement. ‘This study suggests that canned foods may be an even greater concern, especially given their wide use.’

Furthermore, an independent study by the American Food Standards Agency (FSA) has shown that 37 of 62 well-known products found on supermarket shelves which were examined contain this dangerous chemical substance.

In view of the above, will the Commission say:

Is it aware of the dangers posed by this particular substance and, in so far as it considers that citizens should be protected, what action does it intend to take?

Answer given by Mr Dalli on behalf of the Commission

(27 January 2012)

Currently the use of Bisphenol A is banned in baby bottles and authorised in plastic food contact materials(1) with a migration limit of 0.6 mg per kilogram food on the basis of the risk assessment by the European Food Safety Authority (EFSA). The use of Bisphenol A in cans is regulated at national level. On 1 December 2011 EFSA published its statement(2) on Bisphenol A in which it overall considers that the information in the report published by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) does not change the views that the Panel expressed in 2010(3), which confirmed the previously set tolerable daily intake of 0.05 mg Bisphenol A per kg body weight per day. 

Following the EFSA advice, the Commission position in relation to Bisphenol A in food contact materials remains unchanged. The Commission will review its position by the end of 2012 once EFSA has assessed the final ANSES risk assessment and the results from the ongoing low dose studies.

(1) Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food, OJ L 12, 15.1.2011, p. 1.

(2) http://www.efsa.europa.eu/en/efsajournal/pub/2475.htm

(3) http://www.efsa.europa.eu/en/efsajournal/pub/1829.htm


In 2012 EFSA have not changed its view. Now, EFSA have launched a public consultation on the draft opinion on bisphenol A (BPA), which will be closed for comments on 15th September 2013. The final adoption of the opinion is foreseen for the year 2014.