In the EU, general principles of safety and inertness for Food Contact Materials are laid down in Regulation (EC) 1935/2004. The Regulation provides the legal basis for setting specific measures for specific materials (e.g. plastics). It also provides the procedure to perform safety assessments of substances used to manufacture food contact materials which involves the European Food Safety Authority (EFSA). EFSA is an independent scientific panel that advises the European Commission on food safety matters. The safety assessments provided by EFSA inform EU decisions on risk management measures.
In January 2015, the European Food Safety Authority (EFSA) published its most recent comprehensive scientific opinion on the safety of Bisphenol A (BPA). It combines the authority´s assessment of both exposure and health aspects and considers comments received from national authorities and stakeholders following extensive engagement and consultation. The new assessment covers exposure from food sources along with exposure from a range of other potential sources, and considers all age groups of the population. The overall conclusion is that BPA poses no risk to human health from foodstuffs because current levels of exposure are well below the t-TDI of 4 μg/kg of bw/day. This also applies to pregnant women and to the elderly.
In addition, EFSA’s experts concluded that the health concern from the aggregated exposure to BPA from foodstuff, toys, dust, cosmetics and thermal paper is also below the t-TDI of 4 μg/kg bw/day. The uncertainty in the exposure estimate from toys, dust, cosmetics and thermal paper is considerable due to the very limited availability of data.
EFSA reduced the tolerable daily intake (TDI) for BPA from 50 micrograms per kilogram of body weight per day (µg/kg bw/day) to 4 µg/kg bw/day. In deriving this new TDI, EFSA quantified remaining uncertainties about potential effects of BPA on the mammary gland, reproductive, neurological, immune and metabolic systems in laboratory animals by applying an extra factor of six.
By setting a temporary TDI, EFSA committed to the re-evaluation of BPA when a two-year study by the U.S. National Toxicology Program becomes available in 2017. This intention was reconfirmed by EFSA in April 2016. A scientific protocol for a structured literature search and a transparent review of all the new scientific evidence that became available since 2012 and was not included in EFSA’s previous assessment will be developed. Public stakeholder consultation will be invited on the protocol, which is a predefined written procedural method for the collection, extraction and appraisal of data, by early 2017. EFSA announced the final scientific opinion for completion in 2018.
Following the risk assessment provided by EFSA, the European Commission published in November 2015 a roadmap entitled “Proposal for a new measure on Bisphenol A (BPA) in food contact materials”. The European Commission is currently in the process of adopting a new draft measure on BPA in food contact materials, which would lower the current Specific Migration Limit (the permitted amount of BPA which may migrate into food) based on the EFSA opinion. It is applying the conventional exposure assumption and uses additionally an allocation factor to take into account other sources of exposure. At the same time, the scope of the measure will be broadened, so that the new SML would not only apply to plastic materials, but also to coatings and varnishes. With this measure, all major uses of BPA in food contact materials will be covered and will have to comply with the new SML value.
The decision about the measure has been announced for autumn 2016. A transitional period of 6 months from the date of entry into force of the Regulation would apply, whereby food contact materials complying with the current SML can still be placed on the market and remain on the market until exhaustion of stocks.
Once such a consistent EU-harmonised regulation would be in place, the Commission indicated it would have to address current national restrictions against BPA in food contact – i.e. against the ban in France, and some further restrictions, e.g. in Denmark, Belgium, Sweden.
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