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European regulation of mineral oil hydrocarbons: The story so far

Article-European regulation of mineral oil hydrocarbons: The story so far

An EU-wide restriction of harmful mineral oils in food products is overdue, with campaigners calling for a zero-tolerance approach. In anticipation of the update, we give a round-up of the regulatory landscape concerning mineral oils.

New EFSA opinion expected soon

Last year, the EU confirmed it would restrict mineral oils in all food products. However, the agreement is not yet legally binding, meaning that individual member states can choose whether to enforce the constraints or not.

The European Food Safety Authority (EFSA) was asked to update its scientific opinion on exposure assessment and risk characterisation, published in 2012, by the end of 2022; the new opinion is expected to be published soon.

“Once the new EFSA opinion [is] available, it will be evaluated whether changes are needed for the requirements for certain additives (eg microcrystalline wax – E905) or food contact materials,” said Efi Leontopoulou, manager of scientific and regulatory affairs at EAS Strategies, a consultancy specialising in regulation and policy of the food, nutrition, and health sectors.

It comes as campaigners have raised concerns about the possible presence of mineral oils of saturated hydrocarbons (MOSH) and mineral oils of aromatic hydrocarbons (MOAH) in food due to their potentially carcinogenic and genotoxic nature.

Mineral oils can migrate into food from packaging

“Mineral oil hydrocarbons (MOH) are chemical compounds derived mainly from crude oil, but also produced synthetically from coal, natural gas, and biomass,” said Leontopoulou.

“MOH can be present in food through environmental contamination, lubricants for machinery used during harvesting and food production, processing aids, food additives and food contact materials.”

Asked about the adverse effects associated with MOH intake, Leontopoulou said: “MOAH may act as genotoxic carcinogens, while some MOSH can accumulate in human tissue and may cause adverse effects in the liver.”

She outlined the foods most affected as being “animal fat, bread and rolls, fine bakery ware [biscuits and cakes], breakfast cereals, confectionery (including chocolate) and cocoa, fish meat and fish products (canned fish), grains for human consumption, ices and desserts, oilseeds, pasta, products derived from cereals, pulses, sausages, tree nuts, and vegetable oils”.

Examples of serious food safety recalls involving mineral oils include Delhaize BIO brand hazelnut spread, which was recalled in Belgium in January 2022 because of MOAH contamination concerns, and Auchan Pouce beef stock cubes, which were recalled in France in December 2021 due to a “packaging defect that can lead to the migration of contaminants beyond acceptable thresholds”.

Leontopoulou added: “As migration from food contact materials such as paper and board packaging is suspected to contribute significantly to the total exposure, monitoring should include pre-packaged food, the packaging material and the presence of functional barriers, and equipment used for storage and processing. Certain parameters may increase the migration of MOH from packaging into food, such as storage time and storage conditions.”

EU regulation: A fractured landscape

Leontopoulou said: “To date, only infant formula has been the subject of a European decision, with a contamination threshold of 1 mg MOAH per kg of product set in 2020. However, there is no firm rule prohibiting contamination of other foods.”

In April 2022, the EU Standing Committee on Plants, Animals, Food and Feed released a statement wherein member states agreed to withdraw and, if necessary, recall products when the sum of the concentrations of MOAH in food reached or exceeded the following maximum limits of quantification (LOQs): 0.5 mg/kg for dry foods with a low fat/oil content (≤4% fat/oil); 1 mg/kg for foods with a higher fat/oil content (>4% fat/oil); and 2 mg/kg for fats/oils.

However, at a meeting the following October, the Commission and member states made some amendments to that statement, Leontopoulou explained.

“The scope covers all foods: the limits will be applied to the products ‘as sold’, regardless of the source of MOAH,” she said. “The total MOAH concentration covers the fraction of MOAH ≥C10 to ≤C50 [hydrocarbon chain length].

“The member states also agreed to further specify the fat content of the products to which the limits of 1 and 2 mg/kg are applicable: 0.5 mg/kg for dry foods with a low fat/oil content (≤4% fat/oil); 1 mg/kg for foods with a higher fat/oil content (>4% fat/oil, ≤50% fat/oil); [and] 2 mg/kg for fats/ oils or foods with > 50% fat/oil.”

Member states move to limit mineral oil exposure

Leontopoulou also outlined some national initiatives to regulate MOHs.

In April 2022, France published an order pertaining to substances contained in mineral oils the use of which is prohibited on packaging and for printing to the public.

The Dutch authorities contacted industry players in October last year requesting data on the MOAH results and the LOQ of the analysis method used, with the intention of using this data in developing its enforcement policy.

Around the same time, Food Federation Germany published a joint recommendation on the use of “benchmark values” for contents of MOH.