The controversial ‘split level’ approach

Section 4 of the Annex to the draft Regulation sets the new maximum levels (in μg/kg) of 3-MCPD, 3-MCPD fatty acid esters and glycidyl fatty acid esters in vegetable oils and fats, fish oils and oils from other marine organisms placed on the market for the final consumer or for use as an ingredient in food falling within the following categories, with the exception of virgin olive oils.

Initially, the Commission had considered two different approaches for the setting of the new maximum levels. Option 1 was a ‘split level’ approach, in which certain oils would have a lower maximum level, while other oils, which may have difficulties complying with the lower maximum level, would have a higher maximum. Option 2 consisted of a single but higher maximum level. Option 2 might have resulted in certain oils, with typically high levels of 3-MCPD esters, being removed from the market. Under both scenarios, the maximum level for 3-MCPD in refined palm oil was set at 2,500 µg/kg. Under the ‘split limit’ approach, only palm oil and refined olive oil was proposed to be subject to the maximum level of 2,500 µg/kg. This could have been interpreted as implying that such vegetable oils are ‘worse’ than other vegetable oils for which a lower limit was proposed.

In the draft Regulation, the Commission opted for the ‘split level’ approach, in which certain oils would be subject to a lower maximum level and other oils be subject to a higher maximum. More specifically, for oils and fats from coconut, maize, rapeseed, sunflower, soybean, palm kernel, as well as olive oils (composed of refined olive oil and virgin olive oil) and mixtures of oils and fats with oils and fats only from this category, the maximum level of 3-MCPD is set at 1,250 μg/kg. For other vegetable oils (including pomace olive oils), fish oils, and oils from other marine organisms and mixtures of oils and fats with oils and fats only from this category, the maximum level of 3-MCPD is set at 2,500 μg/kg. This category would include refined palm oil.

Although there are many reasons speaking against it, the Commission has indeed chosen the ‘split level’ approach. Most importantly, from a scientific perspective, there is no justification for it. Arguably, split maximum levels raise unnecessary concerns by consumers related to usage and consumption of oils from the ‘other vegetable oils’ category (which includes refined palm oil). This might lead to a significant impact for suppliers and users of those oils. In fact, the content of 3-MCPD is not simply connected to the type of oil used, but is actually mainly due to the quality and freshness of the raw material, as well as to the process parameters followed.

A single maximum limit of 2,500 µg/kg would appropriately address the conclusions of the EFSA opinion from January 2018, which provided that the established TDI of 2 μg/kg bw per day is not exceeded in the adult population and, hence, stated that consumption levels of 3-MCPDE in food are considered safe for most consumers, but that there is a potential health concern among high consumers in younger age groups. Based on the EFSA opinion, there does not appear to be a need to also set lower levels for oil and fats from coconut, maize, rapeseed, sunflower, soybean and palm kernel and mixtures of oils and fats with oils and fats only from this category.

As regards the general decision at which level the maximum levels should be set, Commission Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs, provides that “Maximum levels should be set at a strict level which is reasonably achievable by following good agricultural, fishery and manufacturing practices and taking into account the risk related to the consumption of the food. In the case of contaminants which are considered to be genotoxic carcinogens or in cases where current exposure of the population or of vulnerable groups in the population is close to or exceeds the tolerable intake, maximum levels should be set at a level which is as low as reasonably achievable (ALARA). Such approaches ensure that food business operators apply measures to prevent and reduce the contamination as far as possible in order to protect public health”.

While glycidol is genotoxic, for 3-MCPD and its esters there is no scientific evidence. Based on this and the EFSA opinion, both from a health and consumer point of view, there is neither a justification nor a possible explanation to set the different levels.

The discriminatory exclusion of virgin olive oils from the scope

Virgin olive oils are prominently and solely excluded from the scope of the draft Regulation. Recital 4 to the draft regulation states that, “as virgin olive oils do not contain glycidyl fatty acid esters, 3-MCPD and its fatty acid esters, it is appropriate that neither these new maximum levels for 3-MCPD and its fatty acid esters or the existing maximum level for glycidyl fatty acid esters apply to virgin oils”. The exclusion from the scope must be seen as a concession towards olive oil producing EU Members States such as France, Greece, Italy, Portugal, and Spain.

Virgin olive oils’ are defined in Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products as “oils obtained from the fruit of the olive tree solely by mechanical or other physical means under conditions that do not lead to alterations in the oil, which have not undergone any treatment other than washing, decantation, centrifugation or filtration, to the exclusion of oils obtained using solvents or using adjuvants having a chemical or biochemical action, or by re-esterification process and any mixture with oils of other kinds”. It is obvious that a ‘cold-pressed’ oil from a fruit does not contain process contaminants like 3-MCPD, which are generated by refining at high temperatures. Similar to excluding virgin olive oil from the scope of the regulation, other ‘virgin’ oils, including ‘virgin’ palm oil, could have been excluded from the scope. However, the EU does not provide for such EU production standard or categories other than for olive oil.

Problems in the case of ‘fake’ virgin olive oil should also not be ignored. On 4 May 2019, for example, the European Parliament reported that experts from Europol’s Intellectual Property Crime Coordinated Coalition had supported the Italian police and the Tribunal of Darmstadt (Germany) in the arrest of 20 individuals and the seizure of 150,000 litres of fake olive oil. The criminals had modified the colour of low-quality oils to sell them on the Italian and German markets as extra virgin olive oil. To an oil intended to be placed on the EU market as ‘extra virgin olive oil’, the maximum levels of 3-MCPD do not apply and consumers might be unaware of what they would actually be consuming, as well as the associated risks.

A new Codex Alimentarius Code of Practice to reduce 3-MCPD esters and glycidyl esters

On the basis of WTO law, regulations by WTO Members should be based on international standards if such standards exist in the relevant legal area. Importantly, the Codex Alimentarius General Standard for Contaminants and Toxins in Food and Feed (CODEX STAN 193-1995) does not provide for maximum levels for 3-MCPD and 3-MCPD esters. In its notification, the EU states that the proposed measure complies with the relevant international standard, namely the Codex Alimentarius Commission Code of Practice for the Reduction of 3-Monochloropropane-1,2- Diol Esters (3-MCPDEs) and Glycidyl Esters (GEs) in Refined Oils and Food Products Made with Refined Oil (CXC 79-2019).

This Code of Practice for the reduction of 3-MCPD esters and glycidyl esters (GE) in refined oils and food products made with refined oils has been adopted by the Codex Alimentarius Commission in July 2019. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) had determined, given the potential health concerns associated with 3-MCPD esters and glycidyl esters, that it was important to reduce exposure particularly in infant formula.

The Code of Practice is intended to reduce consumers’ exposure to 3-MCPD esters and glycidyl esters by lowering the levels of these contaminants in refined oils and products made from refined oils. More specifically, it intends to provide national and local authorities, producers, manufacturers, and other relevant bodies with guidance to prevent and reduce the formation of 3-MCPD esters and glycidyl esters in refined oils and food products made with refined oils.

The preparation of the Code of Practice was led by the United States, together with Malaysia and Indonesia. The Code of Practice provides farmers and processors with recommendations for methods to reduce 3-MCPD esters and glycidyl esters during agricultural production of vegetable oils, oil milling and refining of vegetable and fish oils, treatment of oils post refining, and selection and use of refined oils in products made with refined oils. Such mitigation measures are supposed to help reduce consumer exposures to 3-MCPD esters and glycidyl esters.

Efforts made by oil producers have already led to decreases of the level of 3-MCPD esters in their oil, but scientific knowledge regarding the generation of 3-MCPD esters in oil refining still appears to be incomplete. The mitigation of 3-MCPD esters is a complex issue requiring more research, process modifications and industrial trials, namely regarding the reduction of precursors in crude oils and on each production steps (i.e., degumming, neutralisation, washing, bleaching and deodorisation).

Implications for Malaysia

In 2018, Malaysia produced 19.5 million tonnes of palm oil and the Malaysian palm oil industry supports the livelihood of 650,000 smallholders in the country, plus countless other individuals. The development of Codex standards and other texts, such as the Code of Practice, are of crucial importance in facilitating global trade in fats and oils, including palm oil.

A representative of the Food Safety and Quality Division, within Malaysia’s Ministry of Health, underlined that the Code of Practice would “be used as a guideline in the Malaysian oil palm industry to ensure food safety and quality along the supply chain”. Malaysia, as the second major producer of palm oil in the world, already accords high priority to food safety and quality, as most of its palm oil is being used as an ingredient for food and cosmetic products. The Government of Malaysia underlined that it was “committed to evaluating several technologies to reduce the formation of 3-MCPDE and GE” and that the implementation of the Code of Practice,together with suitable technologies, will ensure that palm oil products will comply with requirements of the importing countries”.

The Code of Practice provides all countries with guidance to prevent and reduce the formation of 3-MCPD esters and glycidyl esters in refined oils, in order to produce safe and high quality products for human consumption. This approach will ensure that products are of the same standard and will be accepted by all importing countries through fair practices in trade, without discrimination. According to the Government of Malaysia, Malaysia has “already taken all the necessary measures” to ensure that the Code of Practice be implemented.

Next steps

The WTO SPS Agreement requires WTO Members to “notify changes in their sanitary or phytosanitary measures” and that such notifications are to “take place at an early stage, when amendments can still be introduced and comments taken into account” and that WTO Members are to “allow reasonable time for other Members to make comments in writing, discuss these comments upon request, and take the comments and the results of the discussions into account”. The EU has invited other WTO Members to submit comments on the draft Regulation by 24 April 2020. In its notification, the EU notes that the adoption of the regulation is foreseen for June 2020 and that it would then enter into force on 1 January 2021. Affected countries, such as Malaysia, should consider using this final opportunity to contribute to the EU legislative process.

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