In the EU, palm oil might soon be subject to strict maximum levels for certain process contaminants. More specifically, the EU is currently in the process of setting new maximum levels for 3-MCPD and its esters in vegetable oils and fats and fish oils, infant formula and follow-on formula, and foods for special medical purposes intended for infants and young children, as well as for glycidyl esters in fish oils.
For almost one year and a half, the European Commission has been debating the relevant levels with EU Member States, as well as with stakeholders. In mid-February 2020, the EU’s Standing Committee on Plants, Animals, Food and Feed appears to have given a favourable opinion and, shortly thereafter, on 24 February 2020, the EU notified a draft Commission Regulation (EU) amending Regulation (EC) No 1881/2006 as regards maximum levels of 3-monochloropropane diol (3-MCPD), 3-MCPD fatty acid esters and glycidyl fatty acid esters in certain foods to the World Trade Organization’s (WTO) Committee on Sanitary and Phytosanitary Measures (SPS Committee).
The Malaysian palm oil industry, supported by the Government of Malaysia, has long been working on the progressive reduction of such process contaminants and is committed to further evaluating several technologies to reduce the formation of 3-MCPD and 3-MCPD esters.
In parallel, the implementation of a new Codex Alimentarius Code of Practice, together with suitable technologies, will play an important role in ensuring that palm oil products comply with requirements of palm oil-importing countries. Malaysia, the second-biggest producer and exporter of palm oil in the world, already announced that it would enforce regulations to ensure that, by 2021, when the new EU rules become effective, its palm oil meet the new food safety standards set by the EU. Following consultations with industry stakeholders, Ministry of Primary Industries announced that Malaysia’s palm oil industry had been instructed to adhere to the new EU maximum level for 3-MCPD esters by 2021, so as to avoid any negative implications for this key element of Malaysia’s economy.
The issue of 3-MCPD and 3-MCPD esters
The chemical 3-monochloropropane diol (3-MCPD) and the related 3-MCPD esters (i.e., a fat-soluble form of 3-MCPD) are food processing contaminants found in some processed foods and vegetable oils. 3-MCPD and its esters are formed unintentionally, in particular during oil refining processes at temperatures of about 200°C or higher.
In May 2016, the European Food Safety Authority (EFSA) had published a scientific opinion on ‘Risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food’. The assessment by the EFSA on the presence of 3-MCPD, its esters and the other process contaminant ‘glycidyl fatty acid esters’ (GE) in vegetable oils, including palm oil, had important repercussions in the media and it was even simplistically claimed that palm oil caused cancer. The EFSA concluded that “Esters of 3- and 2-MCPD and glycidyl esters were found at the highest levels in palm oil/fat, but most vegetable oil/fats contain substantial quantities”.
The EFSA also stated that, “despite some positive genotoxicity tests in vitro, there is no evidence that 3-MCPD is genotoxic in vivo in any organ tested, including the kidney and testis”. The EFSA also explicitly recognised the food industry’s efforts in reducing the amount of such process contaminants by changing production methods. However, it is clear that additional scientific research is needed.
In January 2018, the EFSA published an update of its risk assessment for 3-MCPD. The updated risk assessment increased the ‘safety levels’ or, in more scientific terms, the ‘tolerable daily intake’ (i.e., an estimate of the amount of a substance in food that can be taken-in daily over a lifetime without appreciable health risk) of 3-MPCD.
The EU’s draft Regulation
Following the EFSA’s opinion in 2016, the Commission initiated discussions within the relevant EU Committee gathering Commission and EU Member States’ experts on the issue of additional maximum levels for 3-MCPD-esters in vegetable oils and fats and fish oils, infant formula and follow-on formula, and foods for special medical purposes intended for infants and young children, as well as for glycidyl esters in fish oils with the aim of protecting public health. These discussions have culminated in the adoption of a draft Regulation, which, on 24 February 2020, the EU notified to the WTO SPS Committee.
EU maximum levels for contaminants are based on Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food. The Annex to Commission Regulation (EC) No 1881/2006 on maximum levels for certain contaminants in foodstuffs already sets out maximum levels for 3-MCPD and glycidyl fatty acid esters, when used in foodstuffs. Regulation (EC) No 1881/2006 would be amended by the new measure.
The EU’s draft Regulation notes that, on 21 November 2017, the EFSA’s Scientific Panel on Contaminants in the Food Chain (CONTAM Panel) adopted a scientific opinion on an update of its assessment of the risks for human health related to the presence of 3-MCPD and its fatty acid esters in food published in 2016, in view of the scientific divergence identified concerning the establishment of the tolerable daily intake (TDI) in a report by the Joint FAO/WHO Expert Committee on Food Additives and Contaminants. The CONTAM Panel’s opinion established an updated tolerable daily intake of 2 μg/kg body weight per day for 3-MCPD and its fatty acid esters. It noted that this TDI is not exceeded in the adult population. However, a slight exceedance of the TDI was observed in the case of high consumers within the younger age groups and, in particular, in case of infants receiving only infant formula.
The draft Regulation states that “it is appropriate to establish maximum levels for the presence of 3-MCPD and its fatty acid esters in vegetable oils and fats placed on the market for the final consumer or for use as an ingredient in food”. The introduction also affirms 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 draft Regulation sets out that food business operators should be granted enough time to adapt their production processes and that, therefore, it is appropriate that the maximum levels for 3-MCPD and its fatty acid esters, and the new maximum levels of glycidyl esters in young child formula and fish oil and oils from other marine organisms, only apply from 1 January 2021.
Furthermore, the draft Regulation considers it appropriate to allow products not complying with the maximum levels for 3-MCPD and its fatty acid esters, and placed on the market before that date, to remain on the market until their date of minimum durability or use-by-date. However, given that glycidyl fatty acid esters are genotoxic carcinogens, and consequently their presence is a higher risk for public health, products not complying with the new maximum levels for glycidyl fatty acid esters, and placed on the market before 1 January 2021, would only be allowed to remain on the market until 30 June 2021.