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FPF Workshop 2017: Save the date!

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On October 5, 2017, the Food Packaging Forum (FPF) will hold its fifth annual workshop on “Scientific challenges in the risk assessment of food contact materials (FCMs)” in Zurich, Switzerland.

This one-day workshop features high profile speakers and provides an ideal platform for engaging in inspiring discussions with different stakeholders. Save the date for this unique event in the FCM world to get up to speed on recent developments in science, business, advocacy, and regulation! As in previous years, the fifth FPF workshop is also an excellent opportunity for networking.

Scientific topics to be addressed at this year’s workshop include prioritization strategies for the toxicological assessment of non-intentionally added substances (NIAS) (FPF reported), and accumulation and toxicity of mineral oils in humans (FPF reported). Sharing results from scientific studies on these topics, respectively, will be Melissa van Bossuyt from the Scientific Institute of Public Health, Belgium, and Jean-Pierre Cravedi from the French National Institute for Agricultural Research (INRA) and the European Food Safety Authority’s (EFSA) Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel).

Benoit Schilter, head of the food safety research department at Nestlé Research Center, Switzerland, will highlight the application of bioassays for safety testing of FCMs (FPF reported). James Huang, director, food contact materials safety at The Coca-Cola Company, U.S., will talk about packaging safety at Coca-Cola.

Further, Maricel Maffini, independent consultant, U.S., will focus on recent food additives petitions to the U.S. Food and Drug Administration (FDA), filed by various U.S.-based public interest groups on FCM safety.

A detailed program will be provided shortly and registration will open in May 2017 – both to be available on the event website. As a novelty, the FPF will provide access to a live webcast of this year’s workshop for a minimal registration fee. Participants who cannot attend the workshop in person, may thus still follow the speaker presentations, Q&A’s, and the podium discussion.


EFSA: 4th FIP network meeting on FCMs

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In the beginning of March 2017, the European Food Safety Authority (EFSA) published the latest meeting minutes of its Food Ingredients and Packaging (FIP) Scientific Network on food contact materials (FCMs). The fourth FIP-FCM meeting involved the “Group of interest on coatings” and was held on February 16, 2017 by phone conference.

After the presentations given by the Council of Europe, the European Commission’s (EC) Joint Research Centre, and EU Member States (MS), the meeting participants discussed the differences, commonalities, and challenges regarding the evaluation methods for coatings. All participating MS confirmed willingness to be members of EFSA’s interest group on coatings. The leadership of the group was assigned to the Netherlands. The group will propose an action plan, define objectives, and provide a timeline for the next meetings. According to the meeting minutes, an event report of the meeting, containing further details, will be published at a later stage. A short summary of the presentations is provided here:

The Council of Europe (CoE) reported on its activities on coatings. In 2004 the CoE adopted a resolution on coatings and in 2009 last updated the corresponding Technical Document No.1. The Technical Document contains two lists of monomers and two lists of additives to be used in the manufacture of coatings for food contact. The CoE noted that both the resolution and Technical Document on coatings should be updated to include e.g. guidance on migration testing methods and restrictions for commonly found non-intentionally added substances (NIAS).

The EC’s Joint Research Centre (JRC) presented its baseline study on non-harmonized FCMs (FPF reported). The presentation focused on the area of coatings and reported on national regulatory frameworks specific to this sector. The JRC informed that “excluding substances authorized for use in plastics that are common to Member States, there is little convergence amongst the lists [of substances for coatings] developed at national level or between the national lists and the CoE list.”

MS Slovenia described that “there is no evaluation of substances prior to authorization and no national legislation” regarding coatings in the country. Coatings of samples from official controls are evaluated according to the plastics FCM regulation (EU) No 10/2011 and the CoE’s practical guide for metals and alloys. If concentrations exceed specific migration or release limits (SMLs, SRLs), or if substances are listed as carcinogenic, mutagenic, or reprotoxic (CMRs), exposure assessment is carried out using EFSA’s Comprehensive European Food Consumption Database and performing risk characterization. A recent study by Slovenian scientists measuring the release of titanium dioxide nanoparticles from non-stick frying pans was also presented (FPF reported).

MS the Netherlands informed that its legislation on coatings includes general provisions as well as positive lists of substances to be used for coatings. The legislation covers “all coatings, on any substrate, including these [sic!] on metals and paper and board, but excluding adhesive layers, printing inks, coatings on regenerated cellulose, and coatings not in direct contact with food.” In an upcoming update of the chapter on coatings in the ‘Packaging and Utensils Regulation,’ four types of coatings will be considered: General purpose coatings, solvent-free wax coatings, metallic coatings, and temperature resistant coatings. Separate positive lists will apply for each type of coating and a Declaration of Compliance (DoC) will be needed.

MS Italy explained that coatings are regulated by the Ministerial Decree 21.3.1973 (DM 21.3.73 and amendments), however no specific national guidelines for the safety assessment of coatings are included in the legislation. The EU positive list of substances for plastics ((EU) No 10/2011) and the Ministerial Decree’s positive list of polymers as well as the list of new substances other than those used for plastics are currently considered for coatings. Corresponding overall and specific migration limits (OMLs, SMLs) are applied. Italy further noted that “NIAS are under the responsibility of the business operator who has to perform the risk assessment.”

MS Belgium informed that in September 2016, a Royal Decree on varnishes and coatings intended for food contact was published, describing the substances authorized for intentional use (FPF reported). New substances are subject to evaluation by the Belgian Superior Health Council, however no applications have been received yet. The Decree further lays out the testing conditions for overall and specific migration.

Read more

EFSA (March 2017). “EFSA scientific network for the cooperation and harmonization of risk assessment of food contact materials – the ‘EFSA FCM Network’ – Minutes of the 4th meeting – Group of interest on coatings.(pdf)

Conference report: Towards a non-toxic future

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In March 2017 the Danish Ministry for the Environment and Food published the report of the conference entitled “Towards a non-toxic future.” The conference was held on November 24, 2016 in Ringstedt, Denmark (FPF reported). The aim of the conference was to gather different experts and stakeholders to help develop policy recommendations for the European Commission’s “non-toxic environment strategy” that will set the agenda for regulating chemicals after 2020. A series of workshops were held focusing on four specific topics: 1) Endocrine disruptors, 2) chemicals mixtures, 3) substances in articles and imported products, and 4) processing contaminants in the food industry. The conference report summarizes the key messages developed during the workshops. General messages of the conference include:

1) Consumers should not have to worry about chemicals in everyday products. Therefore, communication with consumers, as well as up and down the supply chain needs to be improved.
2) Existing EU chemicals legislation (i.e. REACH and CLP regulations) provide baseline protection and their implementation and enforcement must be a priority.
3) The magnitude of the risk posed by chemicals to human health and the environment must be recognized.

Read more

Ministry of Environment and Food of Denmark (2017). “Towards a non-toxic future – Report from the conference.(pdf)

EU plastic converters discuss risk assessment of FCMs

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On April 20-21, 2017 in Brussels, Belgium, the European Plastic Converters Association (EuPC), together with Polymer Comply Europe (PCE), held a Food Contact Plastics Seminar themed “Assessing and managing risks: Recent and upcoming developments” (FPF reported). The program featured five thematic sessions with speakers from research organizations, industry associations, food and packaging companies, and regulatory authorities, including the European Commission (EC).

Dario Danelli from packaging company Sealed Air commented on the European Food Safety Authority’s (EFSA) opinion on the safety assessment of FCMs that was published in January 2016 (FPF reported). He highlighted that the opinion bases the estimation of consumers’ exposure to chemicals migrating from FCMs entirely on dietary intake data, but does not consider packaging use factors. This approach is likely to yield a large overestimation of exposure and hence does not present a system more realistic than the ‘EU cube’ (i.e. consumption of 1 kg food per person (60 kg), in contact with 6 dm2 of packaging, with 100% migration of target substance), Danelli judged. However, he sees EFSA’s opinion as a valuable step in the development of a new exposure-based legislation approach for all FCMs.

Sebastian Gierisch from the European Printing Inks Association (EuPIA) presented the association’s approach to addressing and managing risks of printing inks for FCMs. In November 2016, EuPIA published the third edition of its exclusion policy for printing inks. The policy applies generally to printing inks and by default excludes the use of toxic (e.g. carcinogenic, mutagenic, reprotoxic) raw materials. The policy is built on hazard-based criteria; however, it includes elements of risk assessment in case of reclassification of substances that cannot readily be substituted. In March 2016, EuPIA also updated its Good Manufacturing Practice (GMP) for printing inks used for FCMs (FPF reported). Most recently, in January 2017, EuPIA published a guidance for the risk assessment of non-intentionally added substances (NIAS) and non-listed substances (NLS) migrating from printing inks used for FCMs. Lastly, Gierisch informed about EuPIA’s Statement of Composition (SOC) template, aiming to ensure adequate information exchange in the supply chain.

Bastiaan Schupp from the European Commission’s (EC) Directorate-General for Health and Food Safety (DG SANTE) reported on the state of play regarding the plastics FCM regulation (EU) No 10/2011. He noted that there are not many new announcements since his presentation at the conference on “Plastics and paper in food contact (Smithers Pira)” in December 2016 (FPF reported). Nevertheless, he informed that the EC aims to publish the 7th amendment to the plastics regulation in the second quarter of 2017 and the 8th amendment is under preparation. The tentative timeline for the ex-post evaluation of the FCM framework regulation (EC) No 1935/2004 is as follows: Preparation of the study in the second quarter of 2017; work by the external contractor in the third and fourth quarter of 2017; discussion, conclusion, and way forward from the study in the first quarter of 2018. The Union Measure for printed FCMs is expected to be adopted by mid-2018. Regarding DG SANTE’s consultation on information in the supply chain (FPF reported), Schupp reported that around 230 responses have been received from industry and EU Member States, as well 68 from associations. The evaluation of the survey is in progress.

Read more

EuPC (2017). “Food Contact Plastics Seminar – Assessing and managing risks: Recent and upcoming developments.(pdf)

Optimizing analytics for quantification of unknown substances

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An article published on April 10, 2017 in the peer-reviewed journal Analytica Chimica Acta proposed a framework for semi-quantification of unknown substances and known substances for which an authentic reference standard is not available. The study was authored by Eelco Pieke and colleagues from the Research Group for Analytical Food Chemistry, National Food Institute, Technical University of Denmark.

Mass spectrometry-based chemical analytics often rely on the so-called targeted approaches. There, a set of analytes of interest are being identified and quantified against their respective authentic reference standards, and the methods used are a priori optimized specifically for these analytes. Such targeted methods leave “very little room for unknown substances,” the authors emphasized. However, chemical risk assessment often seeks to prioritize multiple compounds based on their concentration. Many of these compounds may lack authentic reference standards, and their chemical identity may even be completely unknown. In such a situation, screening and semi-quantification may be carried out more efficiently by using an untargeted method, such as the one proposed and evaluated in their study.

As a proof-of-concept, the authors analyzed the responses of 17 marker analytes with chemically diverse structures. Each of these analytes was semi-quantified using a different analyte as a reference marker, and the outcomes were assessed under various conditions in order to investigate the influence of various instrumentation parameters and analytical approaches on the method performance. For example, the authors found that selecting the quantification marker based on retention time differences provided for a better quantification compared to selections based on accurate mass differences. The predictions obtained with an optimized method had error range with a maximum of factor three.

The optimized method was then successfully applied to an extract of a paperboard food contact material, where it allowed to semi-quantify over 300 unknown substances. With this, the authors demonstrated that, even without substance identification and lacking any authentic standards, their method “was able to estimate the concentration of a virtually unlimited number of compounds thereby providing valuable data to prioritize compounds in risk assessment studies.”

Read more

Emma Davies (May 18, 2017). “Danish team estimates levels of unknown chemicals in complex mixtures.Chemical Watch

Reference

Pieke, E., et al. (2017). “A framework to estimate concentrations of potentially unknown substances by semi-quantification in liquid chromatography electrospray ionization mass spectrometry.Analytica Chimica Acta (published April 10, 2017).

FPF Workshop 2017: Program and registration online

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The program of the Food Packaging Forum’s (FPF) fifth annual workshop, taking place on October 5, 2017 in Zurich, Switzerland, is now available online. The workshop is entitled “Scientific challenges in the risk assessment of food contact materials” and features high profile speakers representing different stakeholders in the field of food contact materials (FCMs). Join us for this unique event in the FCMs world and learn about recent developments in science, business, advocacy, and regulation! This year’s workshop can also be followed via live webcast for a minimal registration fee.

Registration for both the workshop and the live webcast is now open. Please register before September 28, 2017.

International food contact compliance conference

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On September 20-22, 2017 The Italian Institute of Packaging will hold the fourth International Conference on Food Contact Compliance in Baveno, Italy. The first conference day will focus on food contact materials (FCMs) without harmonized regulation at EU-level (e.g. adhesives, coatings, paper, and cardboard). Also, biodegradable plastic FCMs, non-intentionally added substances (NIAS), and mineral oils will be topics of discussion. The second day will inform about FCM regulations in the EU, the U.S., China, Mercosur, India, Russia, and Japan. The third day will be dedicated to the European Food Safety Authority’s (EFSA) future approach to safety assessment of FCMs, printed FCMs, and the regulatory status of bisphenol A (CAS 80-05-7) in the EU and the U.S..

The full conference program and registration are available on the event website.

Read more

The Italian Institute of Packaging (June 17, 2017). “International conference food contact compliance.

In vitro testing of FCMs: Current science and future challenges

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On July 14, 2017 a new scientific study entitled “In vitro toxicity testing of food contact materials: State-of-the-art and future challenges” was published in the peer-reviewed journal Comprehensive Reviews in Food Science and Food Safety. The authors Ksenia Groh and Jane Muncke from the Food Packaging Forum (FPF), Zurich, Switzerland, reviewed the scientific literature describing the use of alternative bioassays for testing the toxicity of food contact materials (FCMs) and food contact articles (FCAs), and discussed future research needs and challenges for broader implementation of this promising approach to ensuring safety of FCMs and FCAs.

Toxicological testing of FCMs is currently focused on single substances and usually only a few toxicological endpoints, most prominently genotoxicity. However, people are commonly exposed to mixtures of substances migrating from FCMs/FCAs into food, which may potentially induce a variety of toxic effects. Moreover, finished FCAs usually contain non-intentionally added substances (NIAS), which present a unique challenge to risk assessment, since in many cases these substances are not available as a pure chemical to carry out the necessary testing, or their chemical identity may even be unknown (FPF reported).

Nonetheless, regulation requires that all substances, including NIAS, that may migrate from FCMs/FCAs into food, should undergo risk assessment. One option to improve the toxicological testing of FCMs/FCAs would be to test their overall migrates or extracts, as this would allow understanding the joint effects of all chemicals present in a mixture. Rapid and cost-effective non-animal-based bioassays would be an ideal tool for such testing, since these assays usually present a rapid and more cost-effective alternative to traditional animal-based toxicological testing.

As the review summarizes, non-animal tests that have been applied for FCMs/FCAs assessment so far included most often various in vitro bioassays, performed with use of cell cultures derived from organs of human or other mammals. Plant cells and unicellular organisms such as bacteria and yeast have also been used, along with tests employing small multicellular organisms such as crustacean larvae or zebrafish embryos. Three main endpoints assessed most often included cytotoxicity, genotoxicity, and endocrine disruption potential, the latter mainly focused on estrogenic and androgenic effects.

As the review authors concluded, a non-animal bioassay-based approach to testing FCMs/FCAs safety is in principle feasible. However, a few remaining challenges should be solved before it can be applied more broadly. The first challenge concerns the procedure for obtaining representative samples, which should be optimized, standardized, and harmonized. Two approaches to sample preparation, extraction-based and migration-based, are available, and the former approach appears to be the most pragmatic.

Another area requiring attention concerns the choice of in vitro bioassays to perform the testing. These assays should have sufficient sensitivity and specificity, and they should also have a clear human health relevance. The significant body of research on chemical exposures’ contribution to the etiology of non-communicable diseases of public concern should be taken into consideration when choosing the most appropriate assays for FCMs/FCAs testing, and agreeing on their interpretation.

Reference

Groh, K., and Muncke, J. (2017). “In vitro toxicity testing of food contact materials : State-of-the-art and future challenges.Comprehensive Reviews in Food Science and Food Safety (published July 14, 2017).


EU assesses chemicals of potential concern

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In an article published on August 18, 2017, regulatory news provider Chemical Watch reported that EU Member States (MS) have started to perform risk management option analyses (RMOAs) for substances listed under the European Chemicals Agency’s (ECHA) public activities coordination tool (PACT).

Currently, France is assessing bisphenol A (BPA, CAS 80-05-7) which was identified as a substance of very high concern due to its reprotoxic and endocrine disrupting properties (FPF reported). The Netherlands are conducting a RMOA for penta-1,3-diene (CAS 504-60-9) because of concerns related to the environment and human health. Germany intends to assess decamethylcyclopentasiloxane (D5, CAS 541-02-6) and octamethylcyclotetrasiloxane (D4, CAS 556-67-2) due to potential persistent, bioaccumulative, and toxic (PBT) properties. Denmark intends to evaluate perfluorobutanoic acid (PFBA, CAS 375-22-4) and its salts and precursors because of suspected PBT and carcinogenic, mutagenic, and reprotoxic (CMR) properties.

BPA is included as monomer in the Union List of substances authorized for use in plastic FCMs (Annex I of Regulation (EU) No 10/2011) and listed in the FACET inventory of food contact materials (FCMs), as well as in the ESCO working group list of non-plastic FCMs. Penta-1,3-diene is included in the ESCO and FACET lists; the cyclic siloxanes D4 and D5 are listed in the FACET inventory and are typical non-intentionally added substances (NIAS) in silicones used in contact with food.

Read more

Chemical Watch (August 18, 2017). “EU member states begin RMOAs of new substances.

Risk assessment of FCMs: Overview of key scientific challenges

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On September 11, 2017, scientists from the Food Packaging Forum (FPF), together with experts from its Scientific Advisory Board, published a new commentary article in the scientific peer-reviewed journal Environmental Health Perspectives. The article gives an overview of existing regulatory requirements in the U.S. and Europe for establishing the safety of food contact materials and articles (FCMs and FCAs). Thereby, both legislative frameworks require detailed knowledge on the chemical composition of FCMs and FCAs, and chemical risk assessment is then performed for known substances that migrate into foods. However, the chemical identity of many migrating food contact chemicals (FCCs) is unknown, as they also include non-intentionally added substances (NIAS) – impurities, unintended reaction by-products, or breakdown products. As a consequence, conventional risk assessment cannot be performed for all FCCs, and conclusions about an FCA’s safety are not possible if not all FCCs are known.

What is more, for some known and authorized FCCs regulatory compliance cannot be controlled because analytical standards are unavailable. Such standards are necessary for establishing chemical analytical measurement methods and calibrating analytical equipment. However, no analytical standards are available for almost half of all substances authorized in Europe for the intentional use in plastic FCMs and FCAs.

The commentary article discusses further knowledge gaps, and also provides recommendations on how shortcomings of the current regulatory situation can be overcome.

Reference

Muncke, J. et al. (2017). “Scientific challenges in the risk assessment of food contact materials.Environmental Health Perspectives (published online September 11, 2017).

Conference on NIAS and mineral oils

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On March 28-29, 2018, the Italian Institute of Packaging will host a conference on ”NIAS and mineral oils in food contact materials: Regulatory and analytical affairs“ in Munich, Germany. The first session of the conference “addresses the regulatory approach to NIAS, in light of current scientific knowledge, focusing in particular on risk assessment.” The second session focuses on mineral oils and “aims to update the framework of knowledge on the subject and to also illustrate the rules that are about to be implemented, as well as look into what analytical bases are prevailing in the context of the European market.” The full conference program and registration are available on the event website.

Read more

The Italian Institute of Packaging (2018). “Conference NIAS and mineral oils in food contact materials: Regulatory and analytical affairs.(pdf)

FPF webinar on prioritization of unknown substances

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On February 8, 2018, at 02:00 pm CET (Central European Time), the Food Packaging Forum (FPF) will hold a public webinar on prioritization of unknown substances in food contact articles.

Different food contact materials (FCMs) such as plastics, metals, or paper and board bring about a cocktail of unknown chemicals in food likely never intended for consumption. The health risk associated with these chemicals is poorly understood while regulation is lacking. Therefore, methods are needed to prioritize unknown compounds for risk assessment.

Guest speaker Eelco Nicolaas Pieke, PhD candidate at the National Food Institute of the Technical University of Denmark (DTU Food), performed research on quantifying, identifying, and prioritizing chemical contaminants in paper and board FCMs (FPF reported). He will present his research group’s findings on developing comprehensive analytical strategies that permit exploring unknown chemicals, illustrated on the example of paper and board FCMs.

For more information and registration, please visit the event website.

Webinar on managing NIAS in the EU and U.S.

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On January 30, 2018, at 04:00 pm CET, the quality assurance company Intertek is holding a webinar entitled “The impact of the EU NIAS regulations on the U.S. FDA final articles indirect food additives compliance.” The webinar addresses “key elements of the regulations” covering non-intentionally added substances (NIAS), as well as challenges in the identification and quantification of NIAS. Further, toxicological risk assessment of NIAS to evaluate “potential health risk associated with the final material or article in accordance with internationally recognized scientific principles” will be discussed. Registration is available on the event website.

Read more

Intertek (2018). “The impact of the EU NIAS regulations on the U.S. FDA final articles indirect food additives compliance.

FPF speaker spotlight: Martin Scheringer

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On October 5, 2017, the Food Packaging Forum (FPF) held its fifth annual workshop in Zurich, Switzerland, focusing on “Scientific challenges in the risk assessment of food contact materials.

Prof. Dr. Martin Scheringer, Professor of Environmental Chemistry at Masaryk University, Czech Republic, summarized the main challenges in risk assessing food contact materials (FCMs), for example dealing with non-intentionally added substances (NIAS) (FPF reported). In a short interview, he highlighted that FCMs would have to be redesigned to reduce their chemical complexity and the number of chemicals used in their manufacture. Watch his speaker spotlight on YouTube or on the 2017 FPF Workshop website.

Prof. Dr. Scheringer’s entire presentation at the 2017 FPF Workshop can be found here.

FPF webinar on prioritizing unknown substances: Video online

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On February 8, 2018, the Food Packaging Forum (FPF) held a public webinar on prioritization of unknown substances in food contact articles.

Guest speaker Eelco Nicolaas Pieke, PhD candidate at the National Food Institute of the Technical University of Denmark (DTU Food), presented his research group’s findings on developing comprehensive analytical strategies that permit exploring unknown chemicals, illustrated on the example of paper and board food contact materials (FCMs) (FPF reported). After the presentation, there was time for questions from the audience.

The video recording of the webinar as well as Mr. Pieke’s presentation slides are now available on the event website.


International food contact compliance conference

0
0

On September 20-22, 2017 The Italian Institute of Packaging will hold the fourth International Conference on Food Contact Compliance in Baveno, Italy. The first conference day will focus on food contact materials (FCMs) without harmonized regulation at EU-level (e.g. adhesives, coatings, paper, and cardboard). Also, biodegradable plastic FCMs, non-intentionally added substances (NIAS), and mineral oils will be topics of discussion. The second day will inform about FCM regulations in the EU, the U.S., China, Mercosur, India, Russia, and Japan. The third day will be dedicated to the European Food Safety Authority’s (EFSA) future approach to safety assessment of FCMs, printed FCMs, and the regulatory status of bisphenol A (CAS 80-05-7) in the EU and the U.S..

The full conference program and registration are available on the event website.

Read more

The Italian Institute of Packaging (June 17, 2017). “International conference food contact compliance.

In vitro testing of FCMs: Current science and future challenges

0
0

On July 14, 2017 a new scientific study entitled “In vitro toxicity testing of food contact materials: State-of-the-art and future challenges” was published in the peer-reviewed journal Comprehensive Reviews in Food Science and Food Safety. The authors Ksenia Groh and Jane Muncke from the Food Packaging Forum (FPF), Zurich, Switzerland, reviewed the scientific literature describing the use of alternative bioassays for testing the toxicity of food contact materials (FCMs) and food contact articles (FCAs), and discussed future research needs and challenges for broader implementation of this promising approach to ensuring safety of FCMs and FCAs.

Toxicological testing of FCMs is currently focused on single substances and usually only a few toxicological endpoints, most prominently genotoxicity. However, people are commonly exposed to mixtures of substances migrating from FCMs/FCAs into food, which may potentially induce a variety of toxic effects. Moreover, finished FCAs usually contain non-intentionally added substances (NIAS), which present a unique challenge to risk assessment, since in many cases these substances are not available as a pure chemical to carry out the necessary testing, or their chemical identity may even be unknown (FPF reported).

Nonetheless, regulation requires that all substances, including NIAS, that may migrate from FCMs/FCAs into food, should undergo risk assessment. One option to improve the toxicological testing of FCMs/FCAs would be to test their overall migrates or extracts, as this would allow understanding the joint effects of all chemicals present in a mixture. Rapid and cost-effective non-animal-based bioassays would be an ideal tool for such testing, since these assays usually present a rapid and more cost-effective alternative to traditional animal-based toxicological testing.

As the review summarizes, non-animal tests that have been applied for FCMs/FCAs assessment so far included most often various in vitro bioassays, performed with use of cell cultures derived from organs of human or other mammals. Plant cells and unicellular organisms such as bacteria and yeast have also been used, along with tests employing small multicellular organisms such as crustacean larvae or zebrafish embryos. Three main endpoints assessed most often included cytotoxicity, genotoxicity, and endocrine disruption potential, the latter mainly focused on estrogenic and androgenic effects.

As the review authors concluded, a non-animal bioassay-based approach to testing FCMs/FCAs safety is in principle feasible. However, a few remaining challenges should be solved before it can be applied more broadly. The first challenge concerns the procedure for obtaining representative samples, which should be optimized, standardized, and harmonized. Two approaches to sample preparation, extraction-based and migration-based, are available, and the former approach appears to be the most pragmatic.

Another area requiring attention concerns the choice of in vitro bioassays to perform the testing. These assays should have sufficient sensitivity and specificity, and they should also have a clear human health relevance. The significant body of research on chemical exposures’ contribution to the etiology of non-communicable diseases of public concern should be taken into consideration when choosing the most appropriate assays for FCMs/FCAs testing, and agreeing on their interpretation.

Reference

Groh, K., and Muncke, J. (2017). “In vitro toxicity testing of food contact materials : State-of-the-art and future challenges.Comprehensive Reviews in Food Science and Food Safety (published July 14, 2017).

EU assesses chemicals of potential concern

0
0

In an article published on August 18, 2017, regulatory news provider Chemical Watch reported that EU Member States (MS) have started to perform risk management option analyses (RMOAs) for substances listed under the European Chemicals Agency’s (ECHA) public activities coordination tool (PACT).

Currently, France is assessing bisphenol A (BPA, CAS 80-05-7) which was identified as a substance of very high concern due to its reprotoxic and endocrine disrupting properties (FPF reported). The Netherlands are conducting a RMOA for penta-1,3-diene (CAS 504-60-9) because of concerns related to the environment and human health. Germany intends to assess decamethylcyclopentasiloxane (D5, CAS 541-02-6) and octamethylcyclotetrasiloxane (D4, CAS 556-67-2) due to potential persistent, bioaccumulative, and toxic (PBT) properties. Denmark intends to evaluate perfluorobutanoic acid (PFBA, CAS 375-22-4) and its salts and precursors because of suspected PBT and carcinogenic, mutagenic, and reprotoxic (CMR) properties.

BPA is included as monomer in the Union List of substances authorized for use in plastic FCMs (Annex I of Regulation (EU) No 10/2011) and listed in the FACET inventory of food contact materials (FCMs), as well as in the ESCO working group list of non-plastic FCMs. Penta-1,3-diene is included in the ESCO and FACET lists; the cyclic siloxanes D4 and D5 are listed in the FACET inventory and are typical non-intentionally added substances (NIAS) in silicones used in contact with food.

Read more

Chemical Watch (August 18, 2017). “EU member states begin RMOAs of new substances.

Risk assessment of FCMs: Overview of key scientific challenges

0
0

On September 11, 2017, scientists from the Food Packaging Forum (FPF), together with experts from its Scientific Advisory Board, published a new commentary article in the scientific peer-reviewed journal Environmental Health Perspectives. The article gives an overview of existing regulatory requirements in the U.S. and Europe for establishing the safety of food contact materials and articles (FCMs and FCAs). Thereby, both legislative frameworks require detailed knowledge on the chemical composition of FCMs and FCAs, and chemical risk assessment is then performed for known substances that migrate into foods. However, the chemical identity of many migrating food contact chemicals (FCCs) is unknown, as they also include non-intentionally added substances (NIAS) – impurities, unintended reaction by-products, or breakdown products. As a consequence, conventional risk assessment cannot be performed for all FCCs, and conclusions about an FCA’s safety are not possible if not all FCCs are known.

What is more, for some known and authorized FCCs regulatory compliance cannot be controlled because analytical standards are unavailable. Such standards are necessary for establishing chemical analytical measurement methods and calibrating analytical equipment. However, no analytical standards are available for almost half of all substances authorized in Europe for the intentional use in plastic FCMs and FCAs.

The commentary article discusses further knowledge gaps, and also provides recommendations on how shortcomings of the current regulatory situation can be overcome.

Reference

Muncke, J. et al. (2017). “Scientific challenges in the risk assessment of food contact materials.Environmental Health Perspectives (published online September 11, 2017).

FPF speaker spotlight: Martin Scheringer

0
0

On October 5, 2017, the Food Packaging Forum (FPF) held its fifth annual workshop in Zurich, Switzerland, focusing on “Scientific challenges in the risk assessment of food contact materials.

Prof. Dr. Martin Scheringer, Professor of Environmental Chemistry at Masaryk University, Czech Republic, summarized the main challenges in risk assessing food contact materials (FCMs), for example dealing with non-intentionally added substances (NIAS) (FPF reported). In a short interview, he highlighted that FCMs would have to be redesigned to reduce their chemical complexity and the number of chemicals used in their manufacture. Watch his speaker spotlight on YouTube or on the 2017 FPF Workshop website.

Prof. Dr. Scheringer’s entire presentation at the 2017 FPF Workshop can be found here.

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