Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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Commission e-News, 14 February 2018
The Commission has published today a new Regulation that significantly tightens the restrictions on the use of BPA in food contact materials. It lowers the regulatory limit (specific migration limit or 'SML'), which is the amount allowed to migrate from the plastic material into food while keeping it safe, and extends this restriction to coating materials, which are used to line food and drink cans. The new Regulation also extends the ban from 2011 on the use of BPA in baby bottles by prohibiting the use of BPA to manufacture infant 'sippy' cups as well as the migration of BPA from coated materials containing food intended for infants and children 0–3 year olds. The new Regulation will apply from 6 September 2018.
See: Commission Regulation (EU) 2018/213 of 12 February 2018 on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials (OJ L41, 14.2.2018, page 6)
The Commission has also published the following (dated February 2018):
Questions and Answers
What is BPA?
Bisphenol A (BPA) is a chemical largely used to manufacture hard, durable plastic including polycarbonate, which is used in food contact applications such as water dispensers, moulding equipment and certain reusable drink or food containers. It is also employed in the manufacture of epoxy resins and therefore in coatings used to line food and drink cans. BPA is additionally used in many other consumer goods such as thermal receipt paper, toys and CDs, as well as in medical devices.
What are the health concerns about BPA?
Some studies suggest that BPA has a range of different possible health effects, including endocrine disrupting properties which are relevant to humans. In 2015, the European Food Safety Authority (EFSA) published an opinion that concluded on a lower Tolerable Daily Intake (TDI), which triggers the lowering of the specific migration limit (SML) of BPA into the food set out in the EU legislation. EFSA however stated that BPA poses no health risk to consumers of any age group from current levels of dietary exposure and poses a low health concern for consumers from all sources, including thermal receipt paper.
But hasn't the European Chemicals Agency (ECHA) recently decided BPA is an endocrine disruptor?
Both ECHA and EFSA agree that there is evidence that BPA has endocrine disrupting properties. However, whereas ECHA has assessed BPA based on its hazard properties that may be relevant to humans or to the environment, EFSA has specifically assessed BPA separately concerning the risk from its presence in food, taking into account all possible health effects, including endocrine disrupting properties as well as exposure to BPA.
Why doesn't the Commission just ban BPA from food contact materials completely?
Following extensive discussion with the Member States, the Commission has adopted on 12 February a measure which sets a much stricter limit for the amount of BPA allowed to migrate from plastic food contact materials and has extended this limit to food and drink cans to reduce exposure to BPA and to provide a high level of protection for consumers. It has also added further prohibitions on BPA in food contact materials for infants and young children. The work conducted by EFSA has taken into account uncertainties and all of the potential likely effects that BPA may have and incorporated these into its risk assessment. At the present time, there is also insufficient information on replacement substances and more assessment would need to be done on their safety and effectiveness before BPA could be totally replaced.
What food contact materials use BPA?
BPA is used in a number of food contact applications. It is used to make polycarbonate plastic, which is hard and durable and is therefore produced for articles that are intended to be reused, such as water dispensers, moulding equipment for confectionary products for example, or for some kitchenware items like drinks bottles or plastic containers. It is also used to manufacture coatings for food and drink cans. BPA is not however used to make flexible plastic packaging, such as that used for single use water bottles or food wrapping.
Is BPA tackled in areas other than food contact materials?
Yes: as BPA is used in a number of applications, restrictions also exist in other areas. Under REACH, in addition to the identification of BPA as a Substance of Very High Concern (SVHC), a new restriction for BPA present in thermal paper will apply from 2020. Stricter threshold values have also been introduced for toys and in the workplace, whilst exemptions will need to be requested in the future on its use in medical devices.
As part of the EU framework programme for research and innovation Horizon 2020, the European Human Biomonitoring Initiative has been set up to investigate whether levels of exposure to chemicals such as BPA are of concern for the health of the European populations and whether BPA substitutes are safe. The results will feed into policy-making at national and EU levels.
The Commission also plans to undertake a new strategy in the future to minimise exposure of EU citizens to endocrine disruptors, including from food packaging.
What are the next steps for BPA in food contact materials?
The Commission has mandated EFSA to undertake a full re-evaluation of BPA again on the basis of the results of anticipated new studies and scientific data to address the remaining uncertainties. This work is due to start in spring 2018 and once completed, the Commission will assess the findings and decide what if any further action is necessary to protect consumers as regards BPA in food contact materials.
