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Legislation

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Brussels considers migration limit for BPA in FCMs

Chemical Watch reports that The European Commission is considering whether to propose a specific migration limit (SML) for bisphenol A in food contact materials (FCMs).

But it believes a ban is unnecessary because the European Food Safety Authority (Efsa) says the levels consumers are exposed to are well below the recommended safety threshold.

It is taking the step in response to the adoption, by some member states, of bans on the use of BPA in certain FCMs.

Denmark and Belgium have introduced national bans on its use in FCMs for infants and young children; Sweden has introduced a ban in coatings and varnishes for FCMs for infants and young children; and France has banned it in all food packaging, containers and utensils (CW 18 September 2015).

According to a “roadmap” document, issued by the Commission food safety directorate, DG Sante, last Friday, these national laws have made companies uncertain of which products, that use and contain BPA, can be placed on the market, since they are different from the rules set at EU level.

FCM manufacturers are investigating alternatives, says the roadmap, with trials ongoing for 90% of those packed food products for which BPA is used in FCMs. But the national laws have not allowed FCM manufacturers enough time to complete their testing and evaluation programmes.

The EU food contact materials Regulation requires the Commission to decide, following an opinion from Efsa, whether such national measures are necessary and whether it will support or decline them.

Last January, Efsa significantly lowered its tolerable daily intake (TDI) level for BPA from 50 to 4 micrograms per kilogram of bodyweight, after taking into account non-dietary sources of exposure (CW 22 January 2015). A new SML is therefore warranted on the basis of the new TDI.

In the FCMs sector, BPA, says the roadmap, is mainly used in polycarbonate water coolers and chocolate moulds, and in epoxy resin in coatings for metal food and beverage cans, jar or bottle caps. It can also be present in printing inks, adhesives and recycled paper or board.

The roadmap says tightening the SML for BPA in plastic FCMs would give producers of such materials one harmonised set of rules. It would also be easy for them to comply with because migration levels are well below the current SML. Introducing such for FCM coatings and varnishes would have similar benefits and also be possible to comply with.

However, an SML for paper and board, which acquires BPA from the recycling of thermal paper, would probably increase costs and cause difficulties in the supply chain for industry because there are large variations in levels in paper.

Head of BfR outlines risk assessment challenges for FCMs

Chemical Watch reports that delegates at a conference in Luxembourg, last week, heard how new developments in food contact materials (FCMs) may affect risk assessment methodology in the EU.

The conference was hosted by the Luxembourg government in its current role of president of the Council of the EU.

In his presentation, professor Andreas Hensel, president of the German Federal Institute for Risk Assessment (BfR), said food packaging challenges "may require new approaches in risk assessment”.

The challenges, he said, include new technologies, such as ‘active’ and ‘intelligent’ packaging, nanomaterials, the demands of recycling, endocrine active substances and changing migration rules. Some of these will result in the use of novel materials and new chemical exposures. Others will mean different assumptions to be made in calculating exposures.

Active packaging controls the environment inside the packaging, for example, by moisture and gas absorption, and even gas generation. Intelligent packaging responds to the external environment perhaps by indicating when storage temperatures have been exceeded.

Developing nanomaterial packaging technologies was also mentioned by Beate Kettlitz, director of food policy, science and R&D at industry body FoodDrinkEurope. These include the:

  • addition of nano clays to biopolymers, such as PLA, to compensate for its deficiencies as a moisture barrier and its weak mechanical properties;
  • addition of nano clays to traditional polymers for enhancing gas barrier properties;
  • addition of nanoparticles to coatings for antimicrobial or corrosion resistant surfaces; and
  • nanostructured coatings for the enhancement of barrier properties.

Dr Georges Kass, deputy head of the European Food Safety Authority's food packaging unit, said the draft scientific opinion the authority endorsed on recent developments in the safety assessment of chemicals in food, may affect the agency's evaluation of FCMs (CW 9 July 2015). The consultation on the draft opinion closed on 7 October.

The document puts the case for revising the 2001 Scientific Committee on Food guidelines, and changing the way consumer exposure is estimated:

  • it suggests three food consumption categories, which are approximately 9, 5 and 1.2 times higher than the current default scenario of 17 grams/kg body weight per day. Using this would give a higher level of protection. But special exposure scenarios might be used if consumer consumption were lower;
  • the amount of toxicity data needed from manufacturers should be related to expected consumer exposure. Genotoxicity testing should always be required, even if migration leads to low exposure, but, beyond this, two threshold levels of exposure are proposed as triggers for additional toxicity data: 1.5 and 80μg/kg body weight per day; and
  • more focus is needed on migrating substances in finished materials and articles, the draft opinion maintains. For non-intended added substances (Nias), such as impurities, reaction products and oligomers, the same approach could be used as for authorised substances. In principle, the same degree of safety should be warranted for all migrating substances. But non-testing methods could be taken into account on a case-by-case basis for priority setting and for toxicological assessment of Nias
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