Under the recommendation then, a material could be regulated as a nanomaterial if it contained as little as one percent to as much as 50 percent of nanomaterial content. But the definition is further qualified in a way that makes it unclear what would be regulated. The industry also lobbied successfully to include in the definition naturally occurring nanomaterials, e. The recommended definition must be approved by the European Parliament and Council for use in legislation and rulemaking.
Once approved the definition must be reviewed, in light of new scientific information, by December That process is outlined here specifically for setting food-additive standards. Then risk assessment challenges of nano-silicon dioxide will be used to illustrate some of the difficulties that agri-nanotechnological standards may face in a trade policy context. Finally we will consider, from the viewpoint of food safety, both the advantages and disadvantages of Codex agri-nanotechnology standards.
The Codex standards setting process, as diagrammed in Understanding Codex , seems straight forward enough. Among the standards is the online data base of the General Standard for Food Additives, which lists over 1, standards, including those for macro-scale silicon dioxide and titanium dioxide. According to a recent Pew Foundation report, additives are about half of the 10, substances that the FDA allows in food.
In practice though, the process is not quite so straight-forward. The first hurdle is to gather a critical mass of Codex members to launch a proposal for a standard. In some cases, one company, such as Monsanto, demanding that one member, such as the United States, propose a standard, such as recombinant Bovine Growth Hormone, suffices to start work.
More often, a number of countries with trade interests in a product affected by a standard will combine to propose a standard setting project document. Typically the Commission assigns work on a standard to a committee, which reports the status of its work to the Commission and to other committees that request such reporting.
Work on the ingredients of a food nanocoating probably would be assigned to the Committee on Food Additives, a general subject committee. For example, since the mass of nanoparticles is not very relevant to dose metrics to measure toxicological exposure, the Committee on Methods of Sampling and Analysis CCMAS might want to propose a standard on particle size distribution for an ENM, rather than try to adjust a mass based standard originally developed for the macro-sized counterpart of the ENM.
The Committee could then consider how to develop guidance on nano-particle number and surface area to arrive at a dose exposure for an ENM. The Codex Committee on Food Labeling might proposed a labeling guidance text for ENMs, once the Committee on Food Additives had agreed on a standard or even while the standard was in process. How would the Committee proceed with its work? The Executive Committee that reviews standards project proposals their meetings are now audio-archived on the new Codex website ensures that the proposals conform to terms in the Codex Procedural Manual, such as the definition of a food additive, and the pre-ambular requirements of the General Standards for Food Additives.
A decision-tree diagram from the General Standards for Food Additives shows how the Committee on Food Additives would approach the first two steps of the general eight step Codex standards elaboration procedure. JECFA risk assessments can be contentious, particularly if many of the scientific studies reviewed for the risk assessment are industry studies. Second, the discussion on whether there is a technical justification for advancing a standard can be contentious, particularly if the risk assessment is controversial.
In the case of non-controversial standards, agreement on a draft standard in the committee can go straight to the Commission for approval at Step 8 of the eight-step process. Although standards are generally approved by consensus, voting is allowed in cases of highly controversial standards.
If an ENM is not added to a food or feed, but, for example, is used to coat the surface of a food processing machine, Codex may decide that there is no need for expert risk assessment on which to base a numerically defined standard.
Instead a guideline could be written about nanocoating food processing machinery that would incorporate a testing protocol about ENM residues on the processed food. Such a guideline is likely to be less controversial than the development of a standard for a nano-scaled food additive.
Such controversies, if of sufficient commercial importance to the proponents of the standard, could also result in the launching of a trade dispute at the WTO. Their study estimates the presence and intake of nanosilica in 27 food products that are labeled as containing a non-nano synthetic amorphous silica.
The percentage of nano-silica relative to all silica concentrations in these foods ranged widely, from 33 percent in an instant asparagus soup to four percent in a steak house rub. Estimating the human intake of nanosilica via food involves development of a laboratory simulacrum of human digestion for average concentrations and portion sizes of specific food products with nano-silica. If nanosilica dissolves and is excreted as non-nano silica, then no harm to human health from consuming nanosilica in food is anticipated.
It is not clear how the silica is absorbed and if these effects are caused by nanosilica particles, dissolved silica or a combination of these two. Without going further into the details of their research, suffice it to say that this difficulty and others would have to be reported in a critical mass of peer-reviewed studies in order for JECFA to agree on a risk assessment that would be a recommendation to Codex for a nano-silica standard.
Despite the painstaking care of the researchers, the lack of scientific understanding and publicly available data about how nanosilica is absorbed in the gastro-intestinal system made it impossible to complete a risk assessment with the high degree of certainty required for standard-setting. Any consideration of whether Codex standards and guidance texts on agri-nanotechnology will protect consumers is subject to at least three assumptions; 1. Presently none of these assumptions are valid.
What motivations or pressures will begin to make these assumptions valid? Transnational agribusiness corporations deny that they are commercializing nano-foods. The panel did not call for unregulated ENMs in food and food packaging to be pulled from the shelves. An interim strategy for legal commercialization could be to seek agri-nanotechnology standards for generic food ingredients and food packaging materials not tied to a branded food.
It is well possible that ENMs applied in generic foods, such as bananas, or to food packaging, could be in commerce for perhaps a decade before Codex agrees on a food additive standard for an ingredient in a food nanocoating. But until standards are publicly debated and agreed, consumers will be exposed to the possibility of chronically ingesting ENMs that will not receive government oversight unless there is an outbreak of acute toxicity that can be traced back to consumption of ENMs.
Whether the quality and quantity of peer-reviewed studies is sufficient to ensure a non-controversial and widely accepted standard cannot be forecast with any certainty. However, it does seem likely that a Codex standard or guidance text on ENMs in food packaging materials or on food contact surfaces could become the first Codex agri-nanotechnology product, particularly if peer-reviewed studies show that ENMs incorporated into food packaging do not migrate from the packaging material to the food packaged.
The implementation and enforcement fate of any agreed Codex standards or guidance texts is less certain. This exchange of information may result in revisions to WTO member food safety laws, to avoid WTO trade dispute challenges to those standards.
Given the subordination of Codex standards to trade rules and policy, can Codex standards help make agri-nanotechnology products safe for consumers? Codex member state positions are generally the result of a dialogue between food industry representatives and government officials, some of whom move into the food industry following government service. However, consumer organization interventions can be influential and even decisive, particularly if there is a disagreement among member governments.
For example, the refusal of Codex to approve a ractopamine standard demanded by the United States on behalf of Dow Elanco, was due in part to the work of Consumers International. The Codex ideal was that standards developed using the best available science would be adopted by developing countries to improve their food safety and food security both domestically and in internationally traded food and agriculture products.
There is a Codex fund to enable the participation of developing country delegates who otherwise might not be able to afford to go to the more than 30 Codex committee meetings a year. FAO and WHO have programs to advise, but not finance, developing country implementation of standards. However, FAO and WHO have been in budget crises for more than a decade, so the contribution of standards to protecting consumer health in developing countries is difficult to measure.
The Codex Executive Committee proposal in February for FAO and WHO to adequately fund its joint expert committees for risk assessment 50 reflects just one aspect of that funding crisis. Codex standards are part of the rules that facilitate trade, along with customs rules, labeling rules, tariffs etc.
If a WTO member blocks a food import, by using a standard which does not conform to the Codex standard, Codex standards may become commercial diplomacy tools used to overcome importing country resistance to a product without going through the expensive and lengthy WTO dispute settlement and authorized retaliation process. The barriers to using the SPS Agreement to block an imported food, plant or animal products are considerable. Because precaution is characterized as inherent, there is no specificity about the application of precautionary measures.
Given the likely impending or existing commercialization of foods with ENMs, both Codex and the WTO will have to evolve to set relevant standards and use standards evidence that provides a wide berth for the uncertainties and insuffiency of scientific evidence about ENMs in food and food packaging materials. Despite its limitations, Codex is the appropriate venue to begin to develop multilateral standards on this rapidly evolving technology.
This article has surveyed the process of and a few challenges to Codex standard-setting for ENMs, both generic challenges and ones specific to nanosilica in food packaging. Even if there were more research and hence more publicly reviewable data on the gastro-intestinal effects of chronic exposure to inorganic ENMs, particularly metal oxides, it would not be easy to initiate, much less complete, standards and guidance texts on agri-nanotechnology.
Rather, nanotechnology poses systemic challenges to the numerical definitions of Codex standards, and their relevance to the protection of consumer health. For example, since the mass of an ENM is too small to provide a useful indicator of how much of a nano-metal oxide can bio-accumulate before it becomes a hazard to human health, then nano versions of all the metal oxide additives in the Codex list may need to be agreed.
Guidance texts on food inspection and certification systems, on sampling and testing for agri-nanotechnology products, and on other issues likely would also require some revision. Advanced Search. Skip to main content. Authors James D. Abstract Recent studies have shown that nanoparticles, which are approximately 1 to billionths of a meter in size, present unique health and environmental risks. Citation James D. Select an issue: All Issues Vol.
Digital Commons.
0コメント