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16/09/18: BPA rules in European Union now in force

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New rules that tighten restrictions on the use of bisphenol A (BPA) in food contact materials in the European Union have entered into force this month.

The regulation lowers the specific migration limit (SML), which is the amount of the substance that can migrate from food contact materials (FCMs) into the food, from 0.6 mg of BPA per kg of food to 0.05 mg/kg. This migration limit has been strengthened 12-fold.

It prohibits the use of BPA in polycarbonate drinking cups or bottles intended for infants and young children, up to three years old and also applies to varnishes and coatings. Articles placed on the market before Sept. 6 may remain until stocks run out. BPA was prohibited in polycarbonate infant feeding bottles in mid-2011.

The European Commission avoided a total ban as it said there was insufficient information on alternative substances with more assessment needed on their safety and effectiveness before BPA could be replaced.

The chemical is largely used to manufacture hard, durable plastic including polycarbonate, for food contact applications such as water dispensers, moulding equipment and some reusable drink or food containers. It is also applied in the manufacture of epoxy resins and in coatings used to line food and drink cans. Figures from the start of this year estimated that BPA-based coatings are used in around 80 per cent of metal cans.

Denmark and Belgium have a ban on BPA in food contact materials for infants and young children; Sweden banned it in coatings and varnishes in FCMs intended for infants and young children, and France banned the chemical in all FCMs (except industrial equipment such as pipes and tanks) in January 2015.

The European Commission said differences between national laws affect the functioning of the internal market for FCMs and pose challenges to third-country exporters.

In 2015, a European Food Safety Authority (EFSA) opinion concluded BPA poses no health risk to consumers of any age group from current levels of dietary exposure. The agency set a temporary tolerable daily intake of 4 micrograms per kg of body weight.

EFSA’s Panel on Food Contact Materials, Enzymes and Processing Aids is re-assessing the potential hazards of BPA in food and reviewing this temporary safe level with the results of the assessment expected in 2020.

EFSA wants data for the hazard assessment until a deadline of 15 October 2018. All relevant new studies and data on the substance published since 31 December 2012 can be submitted to the agency for possible inclusion in the BPA review.

The assessment will include results of the U.S. Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA) project by the National Institute of Environmental Health Sciences (NIEHS) and U.S. Food and Drug Administration (FDA).

A draft report published earlier this year was used by the FDA to conclude that BPA is safe for currently authorized uses in food containers and packaging. However, another part of the work is expected this month and a report integrating findings from both of them is planned for 2019.

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