Update on the Food Directorate's Risk Management Commitments for Bisphenol A as Part of Canada's Chemicals Management Plan

September 2012

Table of Contents

Background

The Food Directorate's Bureau of Chemical Safety (BCS), is responsible for ensuring that chemicals are not present in foods at levels that may cause adverse health effects.

Since the publication of the Food Directorate's Bisphenol A (BPA) health risk assessment in 2008, BCS has been actively engaged in facilitating efforts to reduce exposure to BPA for infants and newborns through the consumption of infant formula products.

BPA was included in Batch 2 of the Challenge under the  Chemicals Management Plan (CMP) carried out by Health Canada and Environment Canada. On October 18, 2008, the Government of Canada released its final assessment report, including the Government's proposed risk management strategies, to ensure that Canadian exposure to BPA is kept as low as reasonably, achievable, particularly for newborns and infants.

The Bureau is actively engaged in addressing the following Government commitments, first announced on April 18, 2008 and reiterated on October 18, 2008, which fall under its mandate:

Risk Management Commitment Updates

Commitment 1: To support industry in developing a "Code of Practice" to reduce levels of BPA in infant formula can linings.

The objective of the "Code of Practice" was to reduce the levels of BPA in infant formula by applying the ALARA (As Low As Reasonably Achievable) principle.

In 2010, the North American Metal Packaging Alliance (NAMPA) and various North American infant formula manufacturers, in collaboration with Health Canada's Food Directorate and the Center for Food Safety and Applied Nutrition (CFSAN) of the United States Food and Drug Administration (US FDA), conducted a research study on the can manufacturing process to identify key parameters that may be modified in order to reduce BPA migration without jeopardizing the safety of the infant formula products or compromising the final package integrity. The results of this study suggested that the impact of the eight tested parameters, which included baking temperature, can type and can size, on BPA migration was minimal. This is due to the fact that the levels of BPA in liquid ready-to-consume infant formula were already extremely low (parts per billion). In addition, industry has provided evidence to Health Canada that BPA levels in infant formula could already be considered as "ALARA", given the can coating technology available at that time the risk management commitment was announced.

Considering that the can coating industry has already developed various alternative BPA-free can coatings which are currently available on the market and that the infant formula manufacturers are phasing out the use of BPA-containing packaging materials, the Food Directorate is satisfied that current industry practices will continue to reduce the already low levels of BPA in infant formula products.

Commitment 2: To facilitate the assessment of proposed industry alternatives to BPA for use in infant formula can coatings.

Health Canada's Food Directorate supports efforts being made by manufacturers working to develop BPA-free can coatings. In this regard, the assessment of pre-market submissions of BPA-free food packaging materials for infant formula is treated as a high priority. A number of BPA-free can coatings have been assessed and deemed acceptable for packaging of liquid infant formula.

Commitment 3: To set migration targets for BPA in infant formula cans.

Migration limits are normally set on the basis of conclusions of a health risk assessment. The Food Directorate has conducted several health risk assessments of BPA exposure from food sources and has previously concluded that current dietary exposure to BPA through food packaging uses is not expected to pose a health risk to the general population, including newborns and young children. The most recent assessment incorporated a probabilistic exposure component that provided a more refined and detailed assessment of dietary exposure to BPA among Canadians. This assessment is based on the collective results of various surveys conducted by Health Canada's scientists to measure levels of BPA in a variety of foods. The most recent dietary intake estimates for both the general population and infants are lower than those estimated in the assessment of August 2008. These estimates are also in general agreement with exposure estimates based on the results of Canadian biomonitoring studies that examined total BPA concentrations in urine. Based on all results to date, Health Canada's Food Directorate continues to maintain that current BPA exposure from food packaging uses is not expected to pose a health risk. This conclusion is consistent with those of food regulatory agencies in other countries, including notably the United States, the European Union and Japan.

Considering that the infant formula manufacturers have demonstrated that they have already achieved BPA levels consistent with the ALARA principle and that the can coating industry has already developed a number of alternative BPA-free can coatings, the Food Directorate no longer identifies a need to set migration targets for BPA in infant formula.

Commitment 4: To continue to review pre-market submissions for infant formula packaging to ensure the lowest levels of BPA achievable.

Although the Industry emphasis has been on requesting pre-market reviews for infant formula can linings which are BPA-free, the Food Directorate would continue to apply the ALARA principle when evaluating all BPA-based packaging materials for infant formula.

Commitment 5: To explore setting migration targets for canned foods in general.

Health Canada is supportive of efforts being made by manufacturers working to develop BPA-free packaging alternatives. Such alternative coatings are becoming available and are expected to be broadly used in food packaging applications in the foreseeable future. In addition, more recent dietary exposure estimations indicate that the actual BPA exposure is lower than previously estimated. Therefore, as noted above under commitment 3, Health Canada's Food Directorate no longer considers it necessary to set migration targets for BPA in canned foods.

Commitment 6: To gather additional occurrence data on BPA in order to fill information gaps in the current exposure assessment knowledge base.

Health Canada's Food Directorate has conducted a number of surveys to measure the levels of BPA in food and beverages and continues to update its assessment of the health significance of current levels of BPA in foods available on the Canadian market. These Surveys have filled previously identified knowledge gaps and has allowed Health Canada's Food Directorate to update its exposure assessment of BPA from food sources.

Similar to commitment 1, current BPA levels in retail food are considered to be ALARA. Further, it is anticipated in the foreseeable future that alternative BPA-free can coatings will begin appearing on the market and will gradually replace most of the existing can coatings which use BPA. As such, the Food Directorate considers that this commitment has been met.

Commitment 7: To facilitate the assessment of proposed industry alternatives to BPA used in can coatings.

Health Canada's Food Directorate continues to place a high priority on the timely evaluation of pre-market submissions for BPA-free can coatings. As these alternative coatings become commercially available, they are anticipated to gradually be used in the packaging of more foods for the general population.

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