Head of BfR Outlines Risk Assessment Challenges for FCMs

« New chemicals and exposure estimates may affect methodologies, says Hensel
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. 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 80 μg/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. »


Sources:
Article by Philip Lightowlers
https://chemicalwatch.com/42867/head-of-bfr-outlines-risk-assessment-challenges-for-fcms
Conference details : http://www.securite-alimentaire.public.lu/actualites/evenements/2015/septembre/Conference—Food-Contact-Materials/index.html?highlight=materiaux
EFSA consultation : http://www.efsa.europa.eu/en/consultations/call/150707

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