In an article published on October 12, 2018, in the peer-reviewed journal Food Additives & Contaminants: Part A, Maria Hoppe and colleagues from the Fraunhofer institute for Process Engineering and Packaging IVV, Freising, Germany, characterized the oligomer composition of polyethylene furanoate (PEF) polymer intended for food contact. The scientists studied “PEF granulate . . . provided by Corbion (Gorinchem, the Netherlands” and performed extraction for 24 hours with either acetonitrile at 40 °C or dichloromethane at room temperature.

The scientists identified 20 linear and cyclic oligomers in PEF extracts, which they further divided into four groups. Oligomers from the first group, containing “cyclic oligomers consisting of furandicarboxylic acid, monoethylene glycol units and one diethylene glycol unit,” accounted for 87% of the total oligomer content. Oligomers from the groups II and III, also cyclic, accounted for 12% and 1%, respectively. Linear oligomers, assigned into group IV, represented less than 0.05% of the total oligomer content. The scientists conclude that their study “demonstrate[s] that oligomers are abundant in the PEF material and are potential migrants to foods.” The quantification of migrating oligomers will be the subject of future studies, using the sensitive analytical method proposed here.

PEF is a polyester analogous to polyethylene terephthalate (PET) (FPF reported). Based on the sourcing possibilities for its monomers, PEF could potentially be a “100% bio-based polyester.” As a food contact material, its primary applications are planned to include “bottles for soft drinks, water, alcoholic beverages and fruit juices,” thus potentially replacing PET in some applications (FPF reported). The scientific opinion by the European Food Safety Authority (EFSA) issued in 2014 for one of the co-monomers of PEF, furan-2,5-dicarboxylic acid (CAS 3238-40-2), concluded that there would be no safety concern if “the migration of the substance itself does not exceed 5 mg/kg food and migration of the oligomers less than 1000 Da does not exceed 50 µg/kg.”

References

Hoppe, M., et al. (2018). “Oligomers in polyethylene furanoate – identification and quantification approach via LC-UV LC-MS response ratio.” Food Additives & Contaminants: Part A (published October 12, 2018).

EFSA (2014). “Scientific Opinion on the safety assessment of the substance, furan-2,5-dicarboxylic acid, CAS No 3238-40-2, for use in food contact materials.” EFSA Journal 12:3866.

An article published on April 2, 2018, in the peer-reviewed journal Food Additives & Contaminants: Part A, reported on the assessment of non-intentionally added substances (NIAS) in polyphenylsulfone (PPSU) polymer intended for baby bottles. PPSU is “a polyether plastic formally composed of bisphenol S (BPS, CAS 80-09-1) and 4,4’-dihydroxybiphenyl (DHBP, CAS 92-88-6), which both have slight endocrine activities in in vitro tests.”

Martin Eckardt and colleagues from the Food Chemistry and Food and Skin Contact Materials, Technische Universität Dresden, Dresden, Germany, analyzed “five types of PPSU baby bottles from different brands as well as corresponding raw materials from different manufacturers.” Their approach followed three steps, namely (1) determination of “chemical structure, total oligomer content and hydrolytic stability” of the polymer, (2) “determination of extractables focusing on monomers, monomer derivatives, linear and cyclic oligomers below 1,000 Da and residual solvent,” and (3) “risk assessment on migration-related substances in accordance to European Union plastics regulation No. 10/2011 based on triplicate consecutive migration experiments using official milk simulant 50% ethanol” for two hours at 70 °C.

Different PPSU samples showed “significant variations . . . with regard to polymer and oligomer chain end groups (methoxylation, chlorination),” but “total oligomer content below 1000 Da was similar (mean about 0.48%).” The cyclic tetramer was the most abundant oligomer, reaching about 1200 mg/kg polymer in all PPSU samples. Concentration of BPS in all samples was below 0.3 mg/kg polymer, while DHBP residues “ranged between 1.7 and 15.5 mg/kg polymer.” In addition, residual solvent sulfolane (CAS 126-33-0) was determined at the concentrations up to 1300 mg/kg polymer. Migration tests did not show any exceedance of specific migration limits “neither . . . for listed substances nor for thresholds of toxicological concern for non-listed substances (monomer derivatives, oligomers).” Therefore, the authors conclude that “no concerns exist regarding migration of polymer-related substances from PPSU baby bottles.”

Reference

Eckardt, M., et al. (2018). “Polyphenylsulfone (PPSU) for baby bottles: a comprehensive assessment on polymer-related non-intentionally added substances (NIAS).” Food Additives & Contaminants: Part A 35:1421-1437.

In an article published on October 25, 2018, regulatory news provider Chemical Watch informed that “important players in the manufacture, import and downstream use of photoinitiators” plan to form a trade group that should serve as “a public and unified voice” for this industry, presented as “the Photoinitiators Platform.” The interested companies include “Europe’s largest producer of the substances used in coatings and inks, including those for sensitive packaging applications.”  

A spokesperson explained that the incentives for “join[ing] forces” included the fact that “ECHA is now looking into substances in a category approach, . . . as opposed to individual substances,” as well as “a demand from downstream users for more communication on toxicology.” In light of the upcoming review of food contact materials (FCM) regulation in the EU (FPF reported), there is a particular focus on “the potential of intentionally and non-intentionally added substances (IAS/NIAS) to migrate through packaging substances into food.” 

Read more 

Chemical Watch (October 26, 2018). “Photoinitiators to form trade group to handle REACH, FCM issues.”

On October 4, 2018, researchers from the Food Packaging Forum (FPF) and its partners in the MAVA-funded research project published an article entitled “Overview of known plastic packaging-associated chemicals and their hazards” in the peer-reviewed journal Science of The Total Environment. The final, open access version of the article was released on October 29, 2018. The publication presents the Database of Chemicals associated with Plastic Packaging (CPPdb) that was developed in the scope of the project Hazardous Chemicals in Plastic Packaging (HCPP) (FPF reported).

As a next step in the project, two case studies were carried out prioritizing hazardous chemicals associated with plastic packaging according to their impact on human health and the environment (FPF reported). Five phthalates were identified for further assessment: Benzyl butyl phthalate (BBP, CAS 85-68-7), dibutyl phthalate (DBP, CAS 84-74-2), diisobutyl phthalate (DiBP, CAS 84-69-5), bis(2-ethylhexyl) phthalate (DEHP, CAS 117-81-7), and dicyclohexyl phthalate (DCHP, CAS 84-61-7).

References

Groh, K., et al. (2018). “Overview of known plastic packaging-associated chemicals and their hazards.” Science of The Total Environment (published online October 4, 2018).

Groh, K., et al. (2018). “Database of chemicals associated with Plastic Packaging (CPPdb).” DOI: 10.5281/zenodo.1287773

An article published on November 9, 2018, in the peer-reviewed journal Food and Chemical Toxicology, reported on the “risk assessment for migration of styrene oligomers into food from polystyrene food containers.” Heinz-Peter Gelbke from the consultancy CinTox, France, together with nine other consultants and industrial scientists, addressed dimers and trimers of styrene (CAS 100-42-5) as “important potential components” of non-intentionally added substances (NIAS) in “polystyrene used for food packaging.” Risk assessment of NIAS is required by the Commission Regulation (EU) No 10/2011 on food contact plastics. 

The authors summarized that these substances are “not genotoxic in vitro [(FPF reported)], and there is good evidence that they are not endocrine disruptors.” They performed hazard characterization using the Threshold of Toxicological Concern (TTC) approach and “the No Adverse Effect Level (NOAEL) of 1 mg/kg bw/d in an oral rat study during pregnancy and lactation.”  To derive the “likely human exposure,” they relied on the concentrations measured in food simulants or food and performed “the probabilistic FACET [(Flavours, Additives, and food Contact materials Exposure Task)] exposure estimation based on dimer and trimer concentrations in polystyrene and their potential for migration.” 

The margin of safety, calculated “as the relation of potential consumer exposure and the ‘safe’ exposure level,” was “above 1” in all cases “apart from migration with 95% ethanol which is no longer recommended as an official food simulant for overall migration into fatty food.” Based on their analysis, the authors concluded that dimers and trimers of styrene migrating from polystyrene food packaging “present a low risk for consumers.”

References 

Gelbke, H.-P., et al. (2018). “Risk assessment for migration of styrene oligomers into food from polystyrene food containers.” Food and Chemical Toxicology (published November 9, 2018). 

Gelbke, H.-P., et al. (2018). “Oligomers of styrene are not endocrine disruptors.” Critical Reviews in Toxicology 48:471-499. 

Nakai, M., et al. (2014). “Genotoxicity of styrene oligomers extracted from polystyrene intended for use in contact with food.” Toxicology Reports 1:1175-1180.

On March 19-20, 2019, regulatory news provider Chemical Watch will hold the 2019 food contact regulations USA conference in Washington, D.C., U.S.. The second edition of this conference will feature “a team of outstanding speakers from North and South America to offer the latest developments in federal and state level-legislation along with global FCM regulations.” Topics such as non-intentionally added substances (NIAS), California’s Proposition 65, and per- and polyfluoroalkyl substances (PFASs) will be discussed. The full program and registration are available on the event website.

Read more

Chemical Watch (2018). “Food contact regulations USA 2019.”

On October 31, 2018, the European branch of the International Life Sciences Institute (ILSI Europe) published a report on “adhesives for food packaging applications.” The report, authored by adhesives expert Monika Toenniessen from Henkel AG & Co. KGaA, was commissioned by the ILSI’s Packaging Materials task force. It is the tenth report in ILSI Europe’s Packaging Materials series, initiated in 2000.

The new report provides “an overview of the variety of adhesives that can be used in food packaging, . . . taking into account the complexity . . . of possible applications.” It describes “typical ingredients,” “behaviors,” and “typical applications” of food packaging adhesives. With this, the report aims to assist the reader “in choosing the right adhesive for his or her individual application.” The report also “provides an overview of the food contact legislation relevant for food packaging adhesives, together with guidance on the evaluation of adhesives intended for food contact applications.”

Read more

ILSI Europe (October 31, 2018). “Packaging Materials 10: Adhesives for food packaging applications.”

ILSI Packaging Materials Task Force (2018). “Scientifically addressing the main challenges in the safety and quality of food contact & packaging materials.”

Reference

Monika Toenniessen (October 31, 2018). “Packaging Materials 10. Adhesives for food packaging applications.” ILSI Europe (pdf)

The annual “Plastics and paper in contact with foodstuffs” Smithers Pira conference took place on December 4-6, 2017 in Vienna, Austria. Speakers from industry, authorities, consultancies, and non-governmental organizations presented recent developments regarding the regulation of food contact materials (FCMs) in Europe, the U.S., and India.

The first day started with keynote speaker Bernard Hegarty, director of enforcement policy at the Food Safety Authority of Ireland, asking “Who will guard the guards themselves?” (“Quis custodiet ipsos custodes?”). Hegarty related this question to official controls of FCMs and explained the roles of FCM manufacturers, food industry, Member States (MS), and the European Commission (EC) in providing safe food. Therefore, he referred to the European legislation on official controls to ensure the application of food and feed law (Regulation (EC) No 882/2004, repealed by (EU) 2017/625). In short, industry has to demonstrate the safety of food which shall then be verified by MS. The role of the EC is to control the enforcement activities of MS. Examples of three recent audit reports from Slovakia, Portugal, and Lithuania illustrated how the EC evaluated the existing systems for official controls of FCMs. Finally, Hegarty concluded that weak official controls result in “less evidence of absence of harms from migration” but support “more an absence of evidence.”

Dario Dainelli, senior regulatory advisor at Polymer Comply Europe (PCE), stated that the current legislation does not provide a solution for all types of FCMs. As a reaction, he presented a plastic industry vision for FCM legislation in 2025, under which risks of all FCMs shall be addressed, based on a protocol agreed upon by all stakeholders and a uniform approach applicable for all substances and all FCMs. Since the capacity of the European Food Safety Authority (EFSA) is limited, Dainelli identified the need for recognition of self-assessment by industry. The PCE envisions an introduction of a transparent registry containing, e.g., toxicity data and exposure limits, and allowing for data sharing. Risk assessment authorities shall have the option to review and validate the entries of such a register which shall ideally be based on standardized data. However, the information available in the register shall not replace a declaration of compliance (DoC). Although data generation may be conducted by different stakeholders, industry shall remain liable for the content, Dainelli proposed. In addition, audits by enforcement authorities shall be foreseen.

Jeff Keithline, partner at Keller and Heckman LLP, gave an overview on state and local restrictions for packaging in the U.S.. At first, he introduced the amendment of the warning requirements under California Proposition 65 that became operative on August 30, 2018. It requires businesses to provide warnings about significant exposures to listed chemicals causing cancer, birth defects or reproductive harm. Businesses not providing such warnings may run the risk of being sued and having to pay high fines. Keithline summarized further legislations impacting the use of packaging, e.g., the Model Toxics in Packaging Regulation aims at reducing lead, mercury, cadmium and hexavalent chromium in packaging, whereas the California Rigid Plastic Packaging Container (RPPC) law shall facilitate the reuse and recycling of rigid plastic packaging containers. The RPPC law imposes a general requirement of 25% recycled content for all rigid plastic packaging containers but exempts, amongst others, items containing food.

Antonio Nespoli, Global Quality & Food Safety Governance Director at Barilla, focused on the assessment of equipment and tools coming into contact with food. Measures to improve the compliance of tools and equipment at Barilla include training of purchasing and engineering staff, recruitment of consultants, risk assessment of production lines, and sharing of drafts of declaration of compliance.

On the second day of the conference, Tjoena Siere, Consultant Food Contact Materials and Legislation at AdFoPack, informed about the update of the Dutch Regulation on coatings (FPF reported) and presented test design developed for overall migration testing of acrylic adhesives using olive oil as food simulant. According to the new protocol, the use of reversible pouches provided with two back liners allowed total immersion of the test specimen. Adhering oil was removed by dripping and quick immersion in n-pentane, because blotting would not work for adhesives.

The need for harmonized legislation for materials in contact with drinking water was highlighted by Miguel Angel Prieto Arranz, Food Contacts Additives (FCA) Group Sector Manager at the European Chemical Industry Council. A variety of items which are in contact with drinking water, e.g., pipes, hoses, pumps, taps, valves, are regulated under the Drinking Water Directive 98/83/EC (DWD), which is currently under revision, and the Construction Products Regulation (EU) No 305/2011 (CPR). Many national provisions and certification schemes lead to a fragmentation of the internal market, Arranz explained. To promote EU-wide harmonized provisions for drinking water, a joint industry group representing 30 associations was formed. This group supports the European Parliament plenary position on harmonization of materials and products in contact with drinking water (FPF reported).

Martin Kanert, Executive Manager at the European Printing Ink Association (EuPIA), introduced the Packaging Ink Joint Industry Task Force (PIJITF) that has been established to produce “safely packaged food” and to maintain “high levels of consumer confidence in food safety.” Kanert summarized some documents published by EuPIA to support its members in the risk assessment of printed FCMs. Transparent, defined and well-documented processes as well as audits by authorities shall help to manage risk assessment of substances and compliance work, Kanert stated.

Hervé Simian, Senior Specialist for Packaging Quality & Safety at the Nestlé Research Center, guided the audience through the complex issue of analyzing mineral oils in food. He presented a decision tree developed by Nestlé to help determine whether food is contaminated with mineral oil hydrocarbons (MOHs) or related substances. Difficulties in quantification of MOHs were illustrated by inter-laboratory comparisons that led to non-aligned results (FPF reported).

Ian Schofield, Own Label and Packaging Manager at Iceland Foods, presented the Iceland’s efforts to remove plastics from all their products. The media response that followed the announcement in January 2018 was very positive, Schofield emphasized (FPF reported). Then he went through a list of actions and requirements that need to be addressed to reach this aim by 2023 and finished by discussing some examples of plastic packaging which would be easy (e.g., egg boxes) or difficult (e.g., milk bottles) to replace.

A proposed draft amendment to the Plastics Recycling Regulation (EC) No 282/2008 was covered by Christa Hametner, Senior Expert for Consumer Goods at the Austrian Agency for Health and Food Safety, and Martin Policar, Regulatory Compliance Specialist at PCE. The amendment specifically addresses recycled materials behind a functional barrier as well as chemical recycling. Furthermore, it includes material-specific rules for scrap and offcuts in closed loop processes. Such processes shall not be subject to authorization by the EC but need to be registered and monitored. After a consultation period the draft amendment has been put on hold due to the high number of comments obtained. Both experts also informed that the EC’s authorization decisions for plastic recycling processes that have been assessed by EFSA are expected to be published in the beginning of 2019.

Emma Bradley, Head of the Food Safety and Quality program at Fera Science, gave a historical overview of non-intentionally added substances (NIAS) and summarized the current state of knowledge. The debate on NIAS started in the early 1990s. Since then, advances in analytics, instrumentation and databases allowed steadily improving qualitative and quantitative analyses of NIAS, Bradley stated. Likewise, communication has improved over this period. However, Bradley estimates that prediction of NIAS will never be complete.

A reform of the EU regulations on chemicals in FCMs was addressed by Michael Warhurst, Executive Director at CHEM Trust. In his presentation, he focused on the lack of regular reviews in the FCM legislation, the use of outdated data for risk assessment, the absence of harmonized regulation for many types of FCMs, the missing links between the FCM legislation and the European Chemicals Regulation REACH, as well as insufficient transparency of legislative processes (FPF reported). Warhurst highlighted grouping of chemicals as opportunity to avoid ‘regretful substitutions.’ In view of the European elections in 2019 and the ongoing evaluation of the FCM regulation (FPF reported), “we are at an important moment with a chance to modernize the FCM regulatory system, in line with other EU chemicals and product regulation,” Warhurst concluded.

Read more

P&P 2018

Michael Warhurst (December 6, 2018). “Reform of the EU regulations on chemicals in food contact materials.” CHEM Trust

An article published on November 2, 2018, in the peer-reviewed Journal of Chromatography A, reported on the “determination of non-volatile components of a biodegradable food packaging material based on polyester and polylactic acid (PLA)” and their migration to food simulants. Margarita Aznar and colleagues from the Analytical Chemistry Department, GUIA Group, University of Zaragoza, Spain, analyzed pellets and films made of a “blend of PLA and a biodegradable fossil-based polyester,” provided by an unrevealed “packaging company.”

The scientists first optimized a novel dissolution/precipitation methodology with “dichloromethane/ethanol used as solvent/antisolvent system” to perform representative extractions of pellets and films. The non-volatile substances in the extracts were then analyzed by a mass spectrometry-based method. Further, non-volatile substances were studied in the migrates obtained by total immersion of film samples in three different food simulants, 10% and 95% ethanol as well as 3% acetic acid.

In total, 37 compounds were detected in all the experiments in total. Among these, 23 compounds were detected in pellet samples. In the extracts of film samples, only 19 out of these 23 compounds could be detected, and “no new compounds” were observed. Thus, “the extrusion process from pellets to film did not generate any new compound but some of them disappeared,” the authors concluded. In the film migrates, only 14 out of the 19 compounds seen in film extracts could be detected. However, 14 new compounds, mostly linear PLA oligomers, were observed. These substances were “probably generated from the reaction between the components of the packaging material and the simulants.”

Four cyclic oligomers “coming from the polyester part of the blend” had the highest intensity in pellet extracts as well as in all subsequent experiments, implying “that the polyester part of the blend had a critical role in the risk assessment of this kind of materials.” These oligomers were composed of adipic acid (CAS 124-04-9), phthalic acid (CAS 88-99-3), and butanediol (CAS 513-85-9).

Among the compounds detected in pellets with “medium intensity,” the scientists highlighted “PLA cyclic oligomers” composed of lactic acid (CAS 50-21-5), two “plasticizers with adipate structure,” a glycol “probably used as PLA plasticizer” and a “compound with piperidine structure . . . probably used as light stabilizer.” The cyclic oligomers were also detected in film extracts but not in the migrates, “probably because they reacted with food simulants, inducing a cycle opening and formation of new compounds,” i.e. linear oligomers.

The compounds detected with “the lowest intensities” included “some plasticizers, PLA oligomers and compounds defined as indirect additives to food contact materials by the U.S. Food and Drug Administration.”

The authors conclude that “in addition to the screening in the [extracts of] film samples, a screening study in the migration solutions is necessary in order to have a comprehensive information about the migrants present in the food simulants.” They further inform that “a future quantification of the compounds detected would also establishing a correct risk assessment of the material.”

Reference

Aznar, M., et al. (2018). “Determination of non-volatile components of a biodegradable food packaging material based on polyester and polylactic acid (PLA) and its migration to food simulants.” Journal of Chromatography A (published November 2, 2018).

An article published on December 5, 2018, in the peer-reviewed journal PLoS One, reported on the chemical migration from plastic food contact articles (FCAs) “collected from the Chinese national product supervisory inspection from 2016 to 2017.” The study was performed by Shasha Qian and colleagues from the Nanjing Institute of Supervision & Testing on Product Quality, National Supervision & Testing Centre for Food & Food Additives, Jiangsu Center of Supervision & Testing on Green Degradable Material Quality, Nanjing, China.

Migration experiments were carried out using hexane as food simulant and following the procedures outlined in the Chinese guideline GB5009.156. First, several target compounds were quantified to examine compliance with regulatory specific migration limits (SML). Then, a detailed analysis of “unknown chemical migrants” by gas chromatography-mass spectrometry (GC-MS) was performed in 120 samples randomly picked from the pool of generally-compliant products, i.e., products with an overall migration below 10 mg/dm² and migration of target contaminants below their respective specific migration limits. These samples “covered all authorized categories of plastic FCM [(food contact material)] products in China, including bottles, disposable plastic tableware, plastic drink bottles, plastic wrap bags, packing bags” and others, the authors summarized. The FCMs analyzed included “poly(ethylene terephthalate) (PET), polyethylene (PE), polycarbonate (PC), polypropylene (PP), low-density polyethylene plastics (LDPE), melamine-formaldehyde (MF), polystyrene (PS) and biaxially oriented polypropylene/low density polyethylene (BOPP/LDPE).”

The analyzed chromatograms revealed “dozens or hundreds of different components,” the authors informed. Among these, the scientists were able to identify “nearly 100” compounds, of which “only 13% [were] included in the permitted list of Commission Regulation EU No 10/2011.” This means that “most of the identified migrants were not imposed to safety evaluation tests,” the authors noted. The authors classified all detected migrants into “11 categories: alkanes, amides, esters, alcohols, alkenes, acids, phenols, siloxanes, aldehydes, ethers and other substances” and summarized that “the alkane and phenolic substances were found almost in all FCM products.” PET products showed “significantly lower” amount of migrating chemical substances compared to other materials. The substance squalene (CAS 111-02-4) was found only in the PP material.

The authors further retrieved the “toxicology data of all chemicals” and observed that “most substances were of low toxicity.” The three “chemicals of concern” highlighted by the authors were bis(2-ethylhexyl) adipate (DEHA, CAS 103-23-1), bis(2-ethylhexyl) phthalate (DEHP, CAS 117-81-7), and stearamide (CAS 124-26-5). Subsequently, a quantitative analysis was performed for these three substances. The substance 2,4-di-tert-butylphenol (2,4-DTBP, CAS 96-76-4) was also quantified, despite “not [being] involved in any priority list,” because it was found “in all types of FCM” analyzed. This compound is “widely used as an intermediate for the preparation of antioxidants, UV stabilizers and in manufacturing of pharmaceuticals and fragrances,” the authors summarized.

The detected concentrations of DEHA and DEHP were below their respective SMLs of 18 mg/kg and 1.5 mg/kg. DEHA was namely detected in three types of FCMs, PP, BOPP/LDPE, and PE, at 3.32±0.59, 3.51±1.02 and 3.78±0.21 mg/kg, respectively. DEHP was detected in all FCMs except for PET and PS, with the highest concentration of 0.29±0.03 mg/kg detected in PP products, followed by BOPP/LDPE (0.24±0.02 mg/kg), PC (0.24±0.01 mg/kg) and PE (0.17±0.00 mg/kg) products. MF products had very low DEHP concentrations of 0.01±0.00 mg/kg.

Stearamide was also “under the recommended limit” of 60 mg/kg, the three FCMs with detectable concentrations being BOPP/LDPE (39.76±17.39 mg/kg), PE (20.57±13.27 mg/kg), and PP(14.07±1.64 mg/kg).

2,4-DTBP could be quantified in all analyzed FCMs except MF. The highest level was seen in BOPP/LDPE products (45.57±31.51 mg/kg), followed by PE (25.56±22.21 mg/kg), PS (3.91±1.67 mg/kg), PP (2.43±0.82 mg/kg), PET (1.34±0.35 mg/kg), and PC (1.26±0.39 mg/kg) products.

The authors concluded that their results imply “that plastic FCMs . . . [are] not so ‘inert’ as they [are] usually considered, and further safety evaluation should be performed toward the complete identification of new substances in FCM products.”

Reference

Qian, S., et al. (2018). “Detection and quantification analysis of chemical migrants in plastic food contact products.” PLoS One 13(12): e0208467.

In an article published on January 8, 2019, by regulatory news provider Chemical Watch, Anna Watson, head of advocacy at the non-governmental organization (NGO) CHEM Trust, summarized the first outcomes of a research project on chemicals in plastic packaging jointly carried out by several NGOs and academic scientists. The partners compiled the Database of Chemicals associated with Plastic Packaging (CPPdb) and analyzed the hazards of these chemicals (FPF reported). Prioritization case studies identified several phthalates as urgent substitution candidates (FPF reported).

As the study “has exposed how difficult it is to get hold of chemical-use information,” Watson calls for “more transparency from the industry on the chemicals they are using to produce plastic packaging.” She further says that “industry must move away from using groups of known hazardous substances such as phthalates” and bisphenols (FPF reported). She believes that “industry can rise to this challenge” and discusses the Food Packaging Product Stewardship Considerations published in March 2018 by several food and packaging companies (FPF reported) as an example of a proactive industry initiative.

Watson concludes by highlighting the challenges in risk assessment of non-intentionally added substances (NIAS). She calls on the industry to “use fewer chemicals and ensure production processes are controlled in such a way that NIAS are identified and appropriately assessed for their health and environmental impacts.”

Read more

Anna Watson (January 8, 2019). “NGO PLATFORM: The hidden hazards of chemicals in plastics.” Chemical Watch

An article published on January 3, 2018, in the peer-reviewed journal Trends in Food Science & Technology, reviewed “analytical approaches for the identification of non-intentionally added substances [(NIAS)] in paper and board food contact materials” (FCMs).  

Ruud Peters and colleagues from the RIKILT – Wageningen University & Research, the Netherlands, summarized that NIAS in FCMs can be comprised of “reaction by-products, oligomers, degradation processes, chemical reactions between packaging materials and foodstuff, or . . . impurities from the raw materials.” In paper and board FCMs, NIAS are “mostly components from printing inks, adhesives, sizing agents and surface coatings,” and “recycled paper contains overall more NIAS than fresh [(virgin)] paper” (FPF reported).  

Both targeted and untargeted analysis methods can be applied for NIAS analysis. Furthermore, “the potential toxicity of NIAS present in the mixture” can be assessed by bioassays (FPF reported), and “a combination of bioassays and chemical analysis . . . [can] . . . direct the identification of unknown bioactive NIAS in complex mixtures like those from paper and board FCM” (FPF reported). 

The authors noted that “future research is required into the selection of bioassays since these should not only be sensitive enough for detecting all compounds of concern but should also have a relevance with human health” (FPF reported). 

Reference 

Peters, R.J.B., et al. (2019). “Review of analytical approaches for the identification of non-intentionally added substances in paper and board food contact materials.” Trends in Food Science & Technology (published January 3, 2019).  

On March 8, 2017 the Austrian Research Institute for Chemistry and Technology (OFI) is holding an information event on bioassays for food contact materials (FCMs) in Vienna, Austria. The event will cover the legal background for FCMs, the application of the Threshold Of Toxicological Concern (TTC) for unknown non-intentionally added substances (NIAS), the strategy of a food manufacturer regarding the application of in vitro bioassays for FCMs, and OFI’s results from an in vitro bioassay analysis of marketed samples. The event also marks the kick-off meeting of OFI’s project “MigraTox,” which will focus on the development, validation, and standardization of in vitro bioassay methods for the analysis of food packaging migrates. The event is free of charge. A detailed program and registration are available online.

Read more

OFI (February 2017). “Invitation – Kick-off meeting project MigraTox and information event bioassays for food contact materials.” (pdf)

In an article published on February 21, 2017 the European polyethylene terephthalate (PET) industry association Petcore Europe announced that it has joined forces with the European Federation of Bottled Water (EFBW) and Soft Drink Europe (UNESDA) to drive compliance with the regulation on food contact plastics (EU) No 10/2011 regarding non-intentionally added substances (NIAS). The industry associations have signed a non-disclosure agreement “to work together as an integrated bottle value chain from virgin PET to preforms, bottles and r-PET,” Petcore Europe informed. The newly formed PET Industry NIAS Group (PING) “will evaluate NIAS test methods, risk assessment and produce an industry wide accepted process,” Petcore Europe further explained. PING commits to finding solutions to reduce or remove any identified unacceptable risk.

Read more

Petcore Europe (February 21, 2017). “PET bottles value chain joins forces to deliver European NIAS compliance.”

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.

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 4^th meeting – Group of interest on coatings.” (pdf)

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)

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 7^th amendment to the plastics regulation in the second quarter of 2017 and the 8^th 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)

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).

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.