Tags: chemicals, FCM, food contact materials, food packaging
Think all materials which come into contact with food are tightly regulated? Think again. [Click here to download print-friendly PDF]
EU food packaging
laws: mind the gap
Food contact materials in the EU are not regulated under the REACH chemical laws but instead by legislation which came into force in November 2004, governing “materials and articles intended to come into contact with food”.
According to this law, Regulation (EC) No. 1935/2004, no food contact materials shall “transfer their constituents to food in quantities which could … endanger human health”. To ensure this, the legislation defined a process that could lead to comprehensive EU regulation of the 17 different food contact materials (FCMs), including positive lists of chemicals which are allowed to be used in FCMs, and limits on impurities.
So far, however, the EU has only finalised regulation of six of the total of 17 groups of FCMs. For example, the specific regulation EC10/2011 [correction: original post said “EC1/2011”] describes a positive list of chemicals which can be used in plastics (there are currently 982 which are permitted, as of time of writing).
In addition to plastics, there are also regulations for recycled plastics, regenerated cellulose film (viscose – also seen in many 1970s shirts), printed surfaces, to some extent ceramics (for which heavy metal migration is regulated), “active and intelligent” packaging which e.g. releases substances to preserve food (which have to treated in the same way as food additives), and epoxy resin derivatives relating specifically to their use in coated materials, plastics and adhesives.
However, what this essentially means is there are still no EU-wide specific rules covering: adhesives; cork; rubbers; glass; metals and alloys; paper and board; printing inks; silicones; textiles; varnishes and coatings; waxes; and wood. Individual countries will have some regulations, but these vary in terms of their scope and level of protection.
This presents a particular problem for cardboard and paper packaging. Imagine you are drinking coffee out of a disposable cardboard cup: it is made from card (no harmonised regulation) which may even have been recycled (no harmonised regulation); it will have a waterproof coating (no harmonised regulation); the edges of the sheet of card used to make the cup will have been glued together and the base also glued in place (no harmonised regulation).
The plastic safety lid for the cup should be covered by harmonised regulation, but how effectively the regulation is enforced is still an open question and there are serious doubts about black plastics used as FCMs, as we have pointed out in a previous article.
The inks colouring and branding the outside of the cup should also be covered and cannot come into direct contact with the contents of the cup – but be warned, the EU does not have a positive list for permitted inks, so in the event that they do migrate through the cup (inks have been known to pass through food packaging) or are transmitted as part of the packaging assembly, filling or storing processes, there is very little known about the risks to health they pose (in Europe, only Switzerland has a positive inks list, and even there not all compounds have been adequately tested for safety).
This is an acknowledged problem. In November 2014, the European Food Safety Authority (EFSA) held a workshop on chemicals in FCM. Their feature story on this workshop described the weakness of the current regulatory system in Europe, stating: “Did you know that plastics and some ceramics used in food contact materials are regulated at European level and evaluated by EFSA for safety but a wide range of other materials – coatings, paper and board, adhesives, printing inks and rubber – are not?”
So there is a gap in the regulation. The worrying thing is that, as a result, a number of hazardous substances may indeed be being used in food contact materials. For example, in 2014 researchers identified 175 potentially hazardous substances (chemicals which are carcinogenic, mutagenic or reprotoxic; endocrine disruptors; and chemicals which are persistent or biocumulative) which are being used legally in the production of food contact materials in the EU and US (Geueke et al. 2014). This included 21 SVHCs, of which six are scheduled for phase-out under REACH.
Pizza boxes. The Danish Consumer Council recently analysed chemicals in pizza boxes, finding hormone disrupting chemicals such as nonylphenol and phthalates, which would not be permitted in plastic FCMs and thought to be present because of the use of recycled paper in the boxes. The German NGO Food Watch has found mineral oils in rice, pasta and cornflakes. This emphasises the need for proper controls on chemicals in recycled materials, as we previously discussed here.
This is just the chemicals we can list because we know about them. The rest, largely coming from oligomers, reaction products and impurities, are known as “non-intentionally added substances” (NIAS). According to the Food Packaging Forum, citing as many as 95-98% of the chemicals which migrate from can coatings and 60-90% of those from polypropylene are NIAS (numbers from Grob 2014) [correction: link to source of numbers added]. And according to Konrad Grob, an FCM expert at Kantonales Labor Zürich, there are much higher concentrations of chemicals migrating from food contact materials in food than there are pesticide residues, in a complex mixture which he believes means that the requirements of safety legislation are not (and cannot) be met at the moment.
A way forward?
In spite of both awareness and apparent scale of the problem, there do not appear to be any current plans to harmonise EU FCM regulation. In September at an EU Presidency FCM conference, Acting Director of DG Health’s Safety of the Food Chain Directorate, Dr Michael Flueh said: “Commission President Juncker wants us to focus on the big things, such as modernising and simplifying regulation… Mutual recognition is the pillar of the single market and we aim to improve mutual recognition rather than engage in further harmonisation.”
It is difficult to interpret exactly what this is supposed to mean. Germany is currently discussing introducing rules for inks on food packaging; mutual recognition would then either require all of the EU to adopt German rules, or require Germany to accept food packaging that breaks its rules. Since the former seems extremely unlikely to happen and the latter equally so, harmonisation would be the route for addressing this problem anyway. So the most recent EU proposal is either impossible, or requires harmonisation anyway.
Generic problems. Overall, there are thousands of chemicals used in food contact materials (there are over 5000 in inks alone), yet there are only around 1000 chemicals on the EU’s approved list, because most materials are not covered by harmonised EU regulations. Of the chemicals which are permitted, EFSA says “there is a lack of detailed science information” about the health risks they might pose, such as endocrine disrupting potential, and none of the chemicals have been risk assessed as mixtures. And that is before we even start talking about NIAS, which seem to be the biggest source of potential but unquantified health risk from FCMs.
The demand for a harmonised approach is being made by industry as well. Official notes from an EU Presidency workshop on FCMs, held in October this year, say: “For industry, harmonised rules at EU-level were clearly preferable. It was stated that divergent MS rules and risk assessments would hinder rather than foster the functioning of the internal market.” Contrary to the current line from the Commission, rather than being unimportant and complex, harmonisation would appear to simplify the problem, modernise the regulation and free up the internal market, and therefore be in tune with rather than counter to Juncker’s regulatory objectives.
EU Commission’s Joint Research Centre is at least starting an analysis of the problem, finally publishing in June this year the terms of reference for its investigation. The EU Parliament has also begun its own inquiry into the regulation of food contact materials. Conducted by the Environment, Public Health and Food Safety Committee (Envi), the inquiry will investigate how well current regulations protect consumers and identify any gaps which might need to be reassessed.
On matters of more dubious benefit, proposals have been put forward to address the NIAS issue using Thresholds of Toxicological Concern (TTCs), which are essentially a way of agreeing on the point at which chemicals in FCMs can be ignored rather than subject to risk assessment and potential regulatory scrutiny. While convenient and simple to implement, TTCs present a host of problems when it comes to understanding how well they will actually prevent NIAS causing harm to health – concerns we have covered before (see here, here and here.)
The Food Packaging Forum has submitted a critical response to the most recent TTC proposals, put forward by EFSA, which have suggested that the concept should even be extended to chemicals for which the structure is unknown. It should also be noted that even if TTCs were effective, according to Grob’s research there are many NIAS which exceed TTC limits.
Overall, EU food packaging laws are an incomplete patchwork of dubious effectiveness. Even if the “EU system for FCM regulation is one of the best in the world”, as was recently claimed by Chantal Bruetschy from the Commission’s DG for Health and Consumers, it is still a far cry from what is needed. Hopefully, reforms will be forthcoming.
December 2015 News Bulletin
Obesogens. Low doses of environmental chemicals can make animals gain weight. Whether they do the same to humans is a thorny issue.
EFSA and Member States vs. IARC on Glyphosate: Has Science Won? Superbly detailed analysis of how IARC and EFSA came to different conclusions on the carcinogenicity of glyphosate. A good deal seems to rest firstly on a technicality, that EFSA only looked at pure glyphosate thereby rendering all real-world exposure studies irrelevant to their evaluation, and secondly on privileged access to three animal studies which nobody else can see.
Contaminating Our Bodies With Everyday Products. “It’s frustrating to see the same story over and over,” Professor Woodruff said. “Animal studies, in vitro tests or early human studies show that chemical A causes adverse effects. The chemical industry says, ‘Those are bad studies, show me the human evidence.’ The human evidence takes years and requires that people get sick. We should not have to use the public as guinea pigs.”
MEPs call for ban on recycled plastics containing DEHP. MEPs have passed a non-binding Resolution demanding that the European Commission does not authorise the recycling of plastics containing the phthalate plasticiser DEHP.
Leading breast cancer journal article makes the case for prevention. Environmental exposures offer one of the greatest opportunities to reduce breast cancer risk, according to a recent article published in Breast Diseases: A Year Book Quarterly, an interdisciplinary publication for medical professionals. While both scientific literature and mainstream media tend to focus breast cancer research and coverage on primary genetic mutations, these account for just five-to-seven percent of breast cancer risk.
December 2015 Science Bulletin
Pesticides, Parkinson’s Disease | Association of Parkinson’s Disease and Its Subtypes with Agricultural Pesticide Exposures in Men: A Case-Control Study in France. This study helps to better characterize different aspects of pesticide exposure associated with PD, and shows a significant association of pesticides with tremor-dominant PD in men, the most typical PD presentation.
Pesticides, puberty | Prepubertal Serum Concentrations of Organochlorine Pesticides and Age at Sexual Maturity in Russian Boys. Higher prepubertal serum HCB and βHCH concentrations were associated with a later age at attainment of sexual maturity. Only the highest quartile of serum p,p´-DDE was associated with later pubic hair maturation.
BPA, genital malformations | Bisphenol A and other phenols in human placenta from children with cryptorchidism or hypospadias. The aim of this case-control study was to explore the relationship between exposure to non-persistent EDCs during pregnancy and male genital development. The multivariable regression analyses indicated a statistically significant association between exposure to BPA and propyl-PB and the risk of malformations [adjusted odd ratio (95% CIs) in the third tertile of exposure: 7.2 (1.5-35.5) and 6.4 (1.2-35.5) for BPA and propyl-PB, respectively].
PFCs, birth weight | Association between perfluorinated compound concentrations in cord serum and birth weight using multiple regression models. Seven PFASs were found in cord serum, PFOA and PFOS being dominant, with mean concentrations of 1.11 and 0.87 ng/mL, respectively. The adjusted birth weight changes (natural log) were -0.14 (95% confidence interval -0.33 to 0.03) for PFOS and -0.03 (95% confidence interval -0.25 to 0.18) for PFOA. None of the PFASs were statistically associated with birth weight in this population.
EDCs, human health | EDC-2: The Endocrine Society’s Second Scientific Statement on Endocrine-Disrupting Chemicals. The Endocrine Society’s Second Scientific Statement on EDCs in full.
Male reproductive health | Male Reproductive Disorders and Fertility Trends: Influences of Environment and Genetic Susceptibility. Based on our review of genetic and environmental factors, we conclude that environmental exposures arising from modern lifestyle, rather than genetics, are the most important factors in the observed trends. These environmental factors might act either directly or via epigenetic mechanisms. In the latter case, the effects of exposures might have an impact for several generations post-exposure. In conclusion, there is an urgent need to prioritize research in reproductive physiology and pathophysiology, particularly in highly industrialized countries facing decreasing populations.