Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 111/2/19

22 January 2010

Dear Sirs,

Commercial Information Circular No. 43/2010

US : Update on Bisphenol A for Use in Food Contact Applications

The US Food and Drug Administration (FDA) has recently posted to its website a document entitled "Update on Bisphenol A for Use in Food Contact Applications" providing updated information on its current perspective on bisphenol A (BPA); interim public health recommendations; and the regulatory framework for BPA. A copy (pdf format) of the document is appended to this circular for reference.

DETAILS

2. BPA is an industrial chemical used in many consumer products, including reusable water bottles and baby bottles. It is also found in epoxy resins, which act as a protective lining on the inside of metal-based food and beverage cans. These uses of BPA are subject to premarket approval by FDA as indirect food additives or food contact substances. In recent years, concerns have been raised about BPA's safety. In August 2008, FDA released a draft report finding that BPA remains safe in food contact materials. On 15 January 2010, the FDA issued an interim update on BPA providing information on its current perspective on BPA; interim public health recommendations; and the regulatory framework for BPA.

Current perspective on BPA

3. In the document, FDA states that studies employing standardised toxicity tests have thus far supported the safety of current low levels of human exposure to BPA. However, on the basis of results from recent studies using novel approaches to test for subtle effects, both the National Toxicology Program at the US National Institutes of Health and FDA have some concern about the potential effects of BPA on the brain, behaviour, and prostate gland in fetuses, infants, and young children. In cooperation with the National Toxicology Program, FDA's National Center for Toxicological Research is carrying out in-depth studies to answer key questions and clarify uncertainties about the risks of BPA.

Interim public health recommendations

4. At this interim stage, FDA supports reasonable steps to reduce exposure of infants to BPA in the food supply such as (i) supporting the industry's actions to stop producing BPA-containing baby bottles and infant feeding cups for the US market; (ii) facilitating the development of alternatives to BPA for the linings of infant formula cans; and (iii) supporting efforts to replace BPA or minimize BPA levels in other food can linings. 
   
   

5. In addition, FDA will (i) work with industry to support and evaluate manufacturing practices and alternative substances that could reduce exposure to other populations; (ii) seek further public comment and external input on the science surrounding BPA; and (iii) support recommendations from the US Department of Health and Human Services for infant feeding and food preparation to reduce exposure to BPA. 
   

Regulatory framework for BPA

6. Current BPA food contact uses were approved in the 1960s. Once a food additive is approved, any manufacturer of food or food packaging may use the food additive in accordance with the regulation. There is no requirement to notify FDA of that use. Given concern about BPA and the ongoing evaluation of and studies on its safety, FDA is supporting a shift to a more robust regulatory framework for oversight of BPA. 
   
   

7. Since 2000, FDA has regulated new food contact substances through the Food Contact Substance Notification Program. Under this program, amongst others, FDA receives notification from each manufacturer of the basis for the safe use of a food contact substance, detailing the conditions of the substance's use, allowing FDA and public to know how much is being used, and for what applications. FDA will encourage manufacturers to voluntarily submit a food contact notification for their currently marketed uses of BPA-containing materials. Details of the Program are available at
   http://www.fda.gov/Food/FoodIngredientsPackaging/
   FoodContactSubstancesFCS/ucm064161.htm
   
   

8. Traders are advised to regularly visit the FDA website which is available at http://www.fda.gov/Food/FoodIngredientsPackaging/ucm166145.htm for the latest information on BPA.
   

ENQUIRIES

9. For enquiries concerning the content of this circular, please contact the undersigned at 2398 5682.

Yours faithfully,

(Miss Bonny CHAO)

for Director-General of Trade and Industry