Forthcoming 12th Session of the Codex Alimentarius Committee on Contaminants and Toxins in Food (12-16 March 2018, Utrecht, The Netherlands)

Many limits are expected to be lowered for heavy metals in several food categories and various discussions are foreseen on industrial and environmental contaminants and related codes of practices for their reduction, and the committee is to explore a new approach about low levels of contamination of the food chain with various chemicals.

World Food Regulation Review, Vol. 27, Number 9, February 2018 — The forthcoming 12th meeting of the Codex Alimentarius Committee on Contaminants (and Toxins) in Foods (CCCF12) has a loaded agenda, including the adoption of new and revised maximum tolerable levels for contaminants and toxins, such as lead, cadmium, methyl mercury, total aflatoxins, and ochratoxin A in several foods. CCCF12 will also consider the adoption of two codes of practices concerning the reduction of (i) dioxins, PCB-like dioxins, and (ii) 3-MCPD and glycidyl esters in refined vegetable oils and derived products, especially in infant formulas. In addition, for the first time, CCCF12 will discuss a new guidance for risk analysis of the inadvertent low level presence of chemicals in food. 

Furthermore, CCCF12 will review several discussion papers paving the way to continue working on other maximum levels (i.e. hydrocyanic acid, lead, aflatoxins and sterigmatocystin) as well as a code of practice for the prevention and reduction of cadmium in cocoa (beans). Last, CCCF12 will address possible actions, based on feedback from other Codex bodies, including the outcome of the last relevant FAO/WHO Joint Expert Meeting on Food Additives (JECFA)[1].
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The 12th session of the Codex Alimentarius Committee on Contaminants (and Toxins) in foods (CCCF) will be held in Utrecht (The Netherlands) from 12 to 16 March 2018. CCCF is the Codex Alimentarius horizontal committee in charge of the update of the General Standard on Contaminants and Toxins in Foods and therefore one of the most important committees in establishing tolerable levels for environmentally and industrially-sourced contaminants in foods, as low as reasonably (i.e. technically and economically) achievable to ensure acceptable protection of consumer health while ensuring fair practices in international trade of such foods[4].

CCCF12 will take important decisions on regulatory limits for foods in international trade of lead, cadmium, methyl mercury, aflatoxins, ochratoxin A

• Lead

CCCF12 will consider the inclusion into the Codex Alimentarius General Standard in Contaminants and Toxins in Food (GSCTF)[5] of new maximum tolerable limits (MLs) of lead in several foods: (a) lowering the ML for (i) grape juice from 0.05 mg/kg to 0.04 mg/kg (20% reduction), (ii) processed tomato concentrates from 1.5 mg/kg (currently 0.05 mg/kg at Step 5) to 0.08 mg/kg (about 47% reduction), (iii) mango chutney from 1 mg/kg to 0.3 mg/kg (70% reduction), (iv) wine from 0.2 mg/kg to 0.05 mg/kg (75% reduction), (v) food grade salt from 2 mg/kg to 1 mg/kg (50% reduction), (vi) fat spreads and blended spreads from 0.1 mg/kg to 0.04 mg/kg (60% reduction), (vii) edible fats and oils from 0.1 mg/kg to 0.07 mg/kg (30% reduction); and (b) to include canned brassica vegetables in the canned vegetables category with a ML of 0.1 mg/kg; and, (c) establishing an ML for fresh farmed mushrooms [common mushrooms (Agaricus bisporous), shiitake mushrooms (Lentinula edodes), and oyster mushrooms (Pleurotus)] of 0.2 mg/kg.

• Cadmium

CCCF12 will also review various proposals for establishing maximum tolerable levels (MLs) for Cadmium in chocolate products and other cocoa products. Suggested levels range from 0.40 to 1.00 microgram per kilogram (µg/kg or ppb) in chocolate products, from 0.4 to 1.2 µg/kg in dry mixtures of cocoa and sugars, and 0.4 µg/kg in cocoa powder intended for the final consumer. Note that the number of significant figures after the comma for each level is very important in terms of methods of analysis robustness. Those MLs are meant to be applicable to both the GSCTF standard and Codex commodity standards regulating these foods.

• Methyl mercury in fish including associated sampling plans

CCCF12 will reconsider the recommendations from an inter-session electronic working group (EWG) to adopt specific revised MLs for methyl mercury in fish – by far the primary source of methyl mercury responsible for the neurological Chisso-Minamata syndrome. The EWG recommends two different bases for the establishment of such MLs in various carnivore fish species (as these fishes are at the top of the food chain in oceans and are most likely to concentrate the highest levels of methyl mercury): either on the 95th percentile or on the immediate next higher amount leading to less than 5% rejection of lots. The two different bases though lead to quite negligible differences in the suggested ML values (thereafter the suggested levels are reported as [P95]/[<5%], as follows: (a) 1.1/1.2 mg/kg (i.e. ppm) for all tunas or 1.3/1.4 mg/kg for Bigeye and Bluefin tunas and 0.7/0.8 mg/kg for tuna other than Bigeye and Bluefin; (b) 1.5/1.5 mg/kg for Alfonsino, (c) 1.6/1.7 mg/kg for Marlin or 4.5/4.6 mg/kg for Marlin (based on Blue marlin, unspecified), (d) 0.7/0.8 mg/kg or no ML at all for Amberjack; (e) 1.5/1.6 mg/kg for Sharks; and, (f) 2.3/2.4 mg/kg for Swordfish. The working document also describes the associated sampling plans which are fundamental in terms on how the analytical results are obtained and compared to the future MLs.

• Total aflatoxins limit in ready-to-eat peanuts and associated sampling plan

CCCF12 will again review this long-standing and contentious issue on the CCCF agenda. An inter-session EWG led by India recommends the adoption of an ML for total aflatoxins of 10 micrograms per kilogram (µg/kg or ppb) in ready-to-eat peanuts for the final consumer. This proposed maximum limit value remains a very sensitive issue for ready-to-eat peanuts producing countries, as various climate and prophylactic conditions may lead to different capacities to prevent growers from limiting the developments of the moulds producing those aflatoxins and matching that suggested limit (especially the B1 type, one of the most carcinogenic aflatoxins for human liver, especially for the vulnerable group of humans carrying hepatitis B virus). The other source of tension is linked to different limits set at national levels. Most of the producing countries (but not all and that’s where the competitive advantage may well be) are not ready to accept a lower level for total aflatoxins in ready-to-eat peanuts in the Codex Alimentarius, as it may force those countries to subsequently lower their national regulatory maximum level (this is a WTO/SPS issue, as for all contaminants) and put an extra burden on their national producers wishing to export on the global market. Future will tell whether any compromise may be reached out on this economically very sensitive issue.

• Total Aflatoxins and Ochratoxin Alimits in some culinary herbs and spices

CCCF12 is to review the recommendations of the inter-session EWG led by India on limits in Nutmeg, Chili and Paprika, Ginger, Pepper and Turmeric for (a) total aflatoxins at 20 or 30 micrograms per kilogram (µg/kg or ppb), whereby those values seem still open for negotiation and for (b) Ochratoxin Aat 20 µg/kg, where that value is a firm recommended level by the EWG. This is related also to the role of India as the host (and chairing) country of the Codex Committee on Culinary Herbs and Spices, developing vertical Codex commodity/food standards on these foods.

Codes of practices for the reduction of the presence of industrial or environmental contaminants
In addition, CCCF12 is exploring ways to develop two new Codex Codes of Practice for the prevention and reduction of the contamination of the food chain by substances, coming either from environmental sources (such as dioxins) or neo-formed chemicals during processing (such as 3-MCPD and refining of vegetable oils). The development of such codes may be a valuable risk management alternative to establishing maximum tolerable levels. These codes are also necessary complementary tools useful to comply with already existing and any future possible maximum tolerable levels.

• Dioxins, PCB-like dioxins (DL-PCB), non-PCB dioxin like substances (NDL-PCB)

The working document is not yet available at the time of going to press. However, CCCF12 is going to review the recommendations of an inter-session EWG led by the European Union to update the existing recommended practices to prevent the contamination of the food chain with Dioxins and PCB-like dioxins. The document is expected to add new mitigation measures related to e.g. cooking practice and carry-over from feed to food, and to add new measures to those already detailed in the discussion paper discussed at the 11th session of CCCF. Those measures did include the following recommendations (quoted from CCCF11 corresponding working document):

(a) Inclusion of the outcome of the risk assessment performed by JECFA80 in 2015 on NDL-PCBs toxicity as well as the provisions derived from the Stockholm Convention related to PCBs under source directed measures.

(b) Reducing measures applicable to DL-PCBs also applicable to NDL-PCBs.

(c) If necessary, completion of the Code of Practice for the Prevention and Reduction of Dioxin and Dioxin-like PCB Contamination in Food and Feeds (CAC/RCP 62-2006) with specific measures for the prevention and reduction of NDL-PCBs in feed and food.

(d) Inclusion of information on specific analytical methods/requirements for NDL-PCBs.

(e) Inclusion of specific recommendations provided on (direct) drying techniques and traceability of the supply chain of fats and oils as experience has shown that these sources could result in unacceptable levels of dioxins and PCBs in feed and food.

(f) Inclusion of relevant recent information on the carry-over of dioxins and PCBs from feed into food of animal origin.

(g) Inclusion of cooking practices reducing the presence of dioxins and PCBs in food.

• 3-MCPDE and Glycidyl esters in refined vegetable oils and their products thereof, with special focus on infant formulas.

CCCF12 will consider a series of mitigation measures developed by the edible vegetable oil industry in the past few years to minimize the presence of 3-MCPDE and glycidyl esters of fatty acids, which were recently further evaluated by the European Food Safety Authority[6].

The working document was elaborated by an inter-session EWG led by the USA and co-chaired by the EU and Malaysia. It contains the full text of a possible Codex Code of Practice which covers better agricultural practices, sourcing recommendations about raw edible oils, the processing and refining of such edible oils, and other recommendations for the controlled use of carefully selected fats and oils in infant formulas. The draft Code of Practice also includes two specific annexes, describing in detail the various mitigation measures for each important key steps of the oil refining processing and the adaptation thereof to each type of oil and fat manufacturing plant. It has yet to be seen how far the CCCF12 may review the document (in part, fully, or not at all due to lack of time). The recommendations for infant formulas primarily emphasize the need to select carefully edible oils not containing 3-MCPDE and glycidyl esters of fatty acids or in minimized amounts.

Proposed draft guidelines to define the risk analysis principles about the inadvertent low level presence of chemicals in foods: is it a way to change the paradigm of zero tolerance on presence of banned chemicals? Or a confession of a lack of capacity to control certain pollutants already in the food chain? Or simply to challenge the “below limit of analytical detection (LOD)” going lower and lower with analytical methods improvements? or a way to cover up or smoothen anything else not laid out clearly yet in the paper?

The working document contains a complete first draft of the future guidelines for risk analysis of chemicals inadvertently present in food at low levels. This text has been developed by an inter-session EWG led by New Zealand and the Netherlands. CCCF12 will consider (a) the establishment of a definition of an emerging contaminant, (b) the use of a cut-off value as an initial risk management step (i.e. a kind of alert guidance level triggering action), (c) internationally agreed rapid risk assessment methodology to be used by countries, (d) the exclusion of feed from the proposed draft guidelines scope, (e) the request to JECFA to propose appropriate cut-off values and specific questions for those risk assessment experts and (f) the definition of the role JECFA may play in the identification and review of the above-mentioned rapid risk assessment methodology.

As laid out into the working document, these guidelines are triggered by scientific progress on the automatic lowering of the limit of detection of analytical methods subject to constant technical improvements. These progresses in analytical chemistry have accelerated in the recent past in such a way that now presence of chemical residues and other chemicals can be demonstrated in the food supply chain at very low levels. These improved analytical methodologies may then show the presence of substances undesirable in the food chain, at much lower levels than the established (national, regional or international) regulatory limits or identify their presence whereas previously they were considered as “absent” with older methods having higher LODs.

The working document is emphasizing the concept of Threshold of Toxicological Concerns as a primary screening tool. It provides for several interesting examples of chemical types which may fall under the definition of emerging contaminant: e.g. (i) Greenhouse gas mitigation technology such as chemicals used to address specific environmental and climate change-related issues, including agriculture nitrification and urease inhibitors, which have not been anticipated to be present in food; (ii) Emerging contaminants from materials used during processing of food such as non-regulated packaging materials and printing inks; or oils/lubricants/resins used as manufacturing maintenance compounds; (iii) Emerging natural toxins such as newly characterised mycotoxins or food crop phytotoxins; (iv) Environmental contaminants such as corrosion inhibitors, flame retardants and musks/fragrances.

These draft guidelines may pave the way to address issues not covered by any specific Codex Committee regulations, such as issues related to food contact material migrations to food, presence of microplastics, wide spread mineral hydrocarbons from environmental or industrial sources, e.g., used as free-flow and anti-dust agent on grains crops in storage silos, ports, etc…). But these guidelines may also be relevant beyond the “contaminant” scope as it may cover the presence of residues of undesirable veterinary drugs, pesticide residues, or genetically modified transformation event at the level of traces as well. The document can be summarized with the decision-tree included in the Annex 1 of the proposed draft guidelines, reproduced in Figure 1, below.

 For sure, this agenda item will constitute an important piece of the CCCF12 outcomes.

 Discussion papers on possible new work

• Hydrocyanic acid and mycotoxins in cassava and products thereof

The discussion paper was not available at the time of going to press. This paper will review the recommendations of the inter-session EWG led by Nigeria regarding the need for including a specific maximum tolerance limit for hydrocyanic acid in cassava and products derived thereof (i.e. fermented cassava products and cassava flour) into the Codex GSCTF. Regarding mycotoxins in cassava and derived products thereof, the discussion paper will present the data available on the levels of presence of these mycotoxins throughout Africa so that CCCF12 may assess the level of risks and provide some guidance back to the Codex FAO/WHO Regional Coordinating Committee for Africa.

• Other Lead limits

The final working document was also not available at the time of going to press of this article. This paper was prepared by an inter-session EWG led by Brazil to make priority recommendations to CCCF12 to develop new maximum tolerable levels to a wider scope of foods. However, based on the second-round draft document, it seemed clear that the intent is to cover a much wider scope of food products where maximum tolerable limits may be recommended as new work.

This discussion paper indicates a total shift in the paradigm for regulating lead limits in the food chain. For decades, the approach favored by CCCF and national regulators has been to focus on those foods contributing the most to the dietary exposure of lead, while the discussion paper aims at a code of practice for the reduction and prevention suggesting lead limit in a much wider range of foods, some of them arguably contributing insignificantly to lead dietary exposure.

The discussion paper suggests several prioritization criteria for approval by CCCF12. Based on those criteria, Brazil-led EWG recommends the tiered-approach for the development of new maximum tolerable levels for lead in three groups of food categories as follows (the presenting order also seems to matter) 

High priority group: (i) cereal-based food for infants and young children; (ii) fruit juice and herbal tea for infants and young children; (iii) canned baby food, (iv) tea and herbs/fruits for infusions, (v) food supplements, (vi) Cocoa and cocoa products, (vii) seafood (except fish), (viii) dried fruits, (ix) processed fish.

Intermediate priority group: (i) eggs, (ii) algae and seaweeds, (iii) nuts and oilseeds, (iv) sugar and confectionery (excluding cocoa), (v) flours and starches, (vi) dried vegetables, (vii) spices and aromatic herbs (to be likely addressed jointly with the CCCHS), (viii) alcoholic beverages (except wine), (ix) coffee and coffee-based beverages.

Low priority group: (i) stalk vegetables, (ii) vegetable juice (likely to be addressed jointly with CCPFV), (iii) ice cream, and (iv) non-alcoholic beverages. 

The discussion paper calls upon Codex Members to submit more data of lead occurrences in the above prioritized food categories to feed the WHO GEMS/Foods database. It also calls for Codex Members to flag up any other food category which may be relevant to be added to the priority lists based on data to be communicated to WHO (and FAO).

• Aflatoxins and sterigmatocystin in cereals

The working document includes a project document for consideration by CCCF12 suggesting the development of specific maximum presence levels for aflatoxins (including aflatoxin B1) and sterigmatocystin, for e.g. sorghum, rice and wheat and their derived products thereof. More specifically, the discussion paper recommends to CCCF12 develop (a) a maximum tolerable level for aflatoxins in cereal, cereal-based products and food for infants and small children; (b) specific maximum tolerable levels for other cereal food groups if data available at the time show it is essential to do so; (c) encourage standards development organizations to provide a validated method of analysis for sterigmatocystin; and, (d) discuss whether there are specific management practices for sterigmatocystin in cereals, intended to be included as an annex to the revised Code of practice for the prevention and reduction of mycotoxin contamination in cereals.

• Prevention and reduction of cadmium in cocoa (beans)

An inter-session EWG led by Peru to revise the discussion paper on the development of a Code of Practice for the prevention and reduction of the presence of cadmium in cocoa and in cocoa-derived products. The code of practice aims at focusing primarily on good agriculture practices and identification of potential sources of cadmium, both naturally present in soils where cocoa plantations are located or due to industrial pollution. The discussion paper emphasizes the need to cost-benefit assessment before implementing any stringent risk management measures. The discussion paper insists also on accompanying the training of cocoa farmers, growers, collectors and traders to the issue of Cadmium. It insists on a progressive implementation of any available mitigation measure and further research on other possible mitigation measures. The discussion paper flags up the need to improve primary production and processing, in improving infrastructures and equipment used for the fermentation and the drying process with modules adapted to tropical environment conditions. The lack of laboratories officially accredited for cadmium testing is also underlined as a limiting factor for the good implementation of mitigation measures. CCCF12 is invited to consider a process whereby it would regularly survey validated best practices (i.e. “on farm assessments that gave good results and were profitable”) to improve the discussion on the future Codex Code of Practice, and ideally conduct such a preliminary survey prior to starting a new work on developing such a Code of Practice. It is expected that the guidelines and research on mitigation measures performed by the Food And Agriculture Organization of the United Nations (FAO) would be a great help in that regard. 

CCCF12 to endorse provisions for contaminants included in Codex food standards elaborated by Codex Commodity Committees

CCCF12 is asked to respond to the Codex Alimentarius Commission on whether the maximum tolerable levels for the contaminants regulated in the Codex GSCTF applicable to cereals do or do not apply to Quinoa (as Quinoa is subject to a Codex commodity standard) and if not, what levels would apply then.

CCCF12 Priorities for future work of JECFA on contaminants

The CCCF12 will reconvene an in-session working group to discuss a list of further priorities for JECFA review and what type of work to be carried out. For example, CCCF11 last year asked JECFA to proceed to full evaluations of (i) dioxins, (ii) arsenic (inorganic), (iii) scopoletin (in relation to Noni Juice consumption), (iv) ergot alkaloids, (v) ciguatoxins, and (vi) an updated risk assessment, including exposure assessment, of mycotoxins trichothecenes (T2 and HT2). 

More details about CCCF12 outcome will be present in WFRR’s March issue.

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[1] JECFA is the international risk assessment body dealing with contaminants and toxins (as well as veterinary drugs residues) in foods, in addition to food additives, but with different experts and meetings.

[2] Food Engineer, Regulatory and Scientific Counsellor at Keller and Heckman LLP.

[3] Food Law Attorney & Partner at Keller and Heckman LLP.

[4] Neither CCCF nor CCFA regulate any specific and overall migration limit for any chemical used as technical ingredient in food contact materials (themselves largely unregulated at the Codex level). This has been a void area of work at the international level, and by the Codex alimentarius Commission, up to now.

[5] See latest version of the GSCTF (i.e. CODEX STAN 193).

[6] EFSA opinion on MCPD and Glycidyl esters of fatty acids published in March 2016 and corrected in January 2018 available at https://www.efsa.europa.eu/en/efsajournal/pub/4426. EFSA also published in January 2018 a new risk assessment of these neo-formed chemicals, adopted in November 2017 and available at https://www.efsa.europa.eu/en/efsajournal/pub/5083.