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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

Consultation on China RoHS Proposal ends on 17 June 2015

Young & Global Partners reports that on 18 May 2015, the Measures on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Products (电器电子产品有害物质限制使用管理办法) was re-published by the Ministry of Industry and Information Technology for public consultation, which will end on 17 June 2015. The proposal Measures of 18 May 2015 is another version of the China RoHS proposal after the 4 June 2012 China RoHS II proposal (电子电气产品污染控制管理办法). 

The draft China RoHS proposal of 18 May 2015 would be applicable to the production, sale, and import of electrical and electronic products, and, accordingly, there would not be an exclusion for products that are intended for export (presumably to help ensure that exported products meet the RoHS restrictions imposed by other countries).

The scope of products would be expanded to "electrical and electronic products" excluding power generation, transmission and distribution equipment. The definition of "Electrical and electronic products" refers to devices and accessory products which function by means of current or electromagnetic fields. The definition utilizes the same voltage limits used by the EU RoHS Directive - rated working electrical voltages of no more than 1500 volts direct current and 1000 volts alternating current.

Hazardous substances are defined as the six original RoHS substances, with a seventh entry for other hazardous substances to restrict further substances.

The marking and labelling obligations (e.g., "environmental protection use period") and the table identifying harmful substances and their location in the product would remain. The requirements for the table of hazardous substances would be expanded with clarification.

A Catalog (
) would list products that are subject to substance restrictions. The catalog would be developed and maintained by the Ministry of Industry and Information Technology (MIIT) in consultation with other departments.

A conformity assessment system would be established for ensuring restricted substance conformity of products that are listed in the compliance management catalog, which would replace the CCC certification.

Packaging for all manufactured or imported electrical and electronic products would have to meet all applicable standards and laws. Manufacturers and importers should adopt the use of materials that are non-hazardous, easily biodegradable and/or facilitate recycling/reuse.

The draft is available from the MIIT (in Chinese) and from YGP ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it ). The public comment period ends June 17, 2015.

The previous China RoHS II proposal of 4 June 2002: a) further clarified the definition on "Electrical and Electronic Equipment" (电子电气产品) by virtually adopting the definition of the EU RoHS Directive; b) clarified the definition of "hazardous substances", e.g., from "lead" to "lead and its compounds"; c) provide more authority to the Ministry of Industry and Information Technology to coordinate implementation of China RoHS issues; d) introduction of "product compliance assessment system" on electrical and electronic equipment; e) The Ministry of Industry and Information Technology and the Certification and Accreditation Administration of China will establish "product compliance assessment system". The revised China RoHS II Proposal of 4 June 2012 is under consultation until 10 July 2012.


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