Mineral oil hydrocarbons in food

Draft Commission Regulation amending Regulation (EU) 2023/915 as regards maximum levels of mineral oil aromatic hydrocarbons in food

Draft Annex [PLAN/2023/2345 ANNEX CIS]

Update

The European Union (EU) has notified the World Trade Organization Sanitary and Phytosanitary Measures (WTO SPS) Committee (G/SPS/N/EU/930) that it intends to set maximum permitted limits (maximum levels) of mineral oil aromatic hydrocarbons (MOAH) in certain foods that will apply from 1 January 2027.

The foods affected by the proposal are oilseeds, oil fruits, animal and vegetable fats and oils, tree nuts, pulses, cereal grains and products derived from cereals, milk, dairy products, cocoa beans and cocoa products, confectionary, spices, dried herbs, teas and herbal infusions, foods for infants and young children, food supplements, and food additives.

For further background on the proposed new measures, see these AGRINFO resources:

• Guide with further information on mineral oil hydrocarbons (MOH), their origins and effects, the EU’s regulatory intentions, the sectors most affected, and actions required to prepare for compliance with new rules (available in English, French, Spanish, and Portuguese)
• Video recordings of MOH webinars (in English, French, Spanish, and Portuguese)
• Questions and answers arising from the webinars (in English, French, Spanish, and Portuguese).

Please note that these resources were produced before the notification of this proposal, and should be read together with the details below on the new proposal.

What is changing?

The EU is proposing to set maximum levels for mineral oil aromatic hydrocarbons (MOAH) as set out in Table 1.

The rules today

There are currently no maximum levels for MOAH under EU law. EU Member States have agreed a common approach to controlling food containing MOAH, as set out in a joint statement in the Summary Report of 21 April 2022: when MOAH are found during official controls of food, Member States should “withdraw and, if necessary, [...] recall products from the market” when the limit of quantification (LOQ) is exceeded.

These LOQs are:

• 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)
• 2 mg/kg for fats/oils or foods with >50% fat/oil.

While not set in EU law, this agreed approach helps EU Member States to ensure that food is safe, as required by the General Food Law Regulation 178/2002 (Art. 14).

Currently no EU limits are in place for mineral oil saturated hydrocarbons (MOSH). There are discussions on establishing indicative levels for MOSH rather than maximum levels. These levels will not be thresholds for removing products from the market, but will be values that trigger investigations of the sources of contamination, and the application of mitigation measures.

In response to questions raised by stakeholders, the European Commission has published frequently asked questions (FAQs) on the draft regulatory measures on MOH in food (European Commission 2024).

Why?

In 2023, the European Food Safety Authority (EFSA) updated its risk assessment on MOH in food (EFSA 2023). The regulatory focus is mainly on MOAH, which have potential genotoxic and carcinogenic activity.

There is also discussion about MOSH, which bioaccumulate in various organs. EFSA considers that, according to present knowledge, the current exposure to MOSH does not raise concerns for human health (EFSA 2023). However, the consequences of long-term accumulation of MOSH have not yet been investigated and remain uncertain.

Maximum levels for contaminants are set taking into account the maximum levels that can be met according to the best available practices. This is known as the “ALARA” (as low as reasonably achievable) principle. Maximum levels are generally set at the LOQ. However, for certain foods it has been demonstrated that, even if good practices are applied, meeting a maximum level at the LOQ cannot be achieved. For these products, timetables have been set (see Table 1) for lowering the maximum levels.

Timeline

The new maximum levels are expected to apply from 1 January 2027, except in the specific cases listed in Table 1 where a later application date applies.

What are the major implications for exporting countries?

There are numerous potential sources of MOAH, and testing for them is complex. Although controls for mineral oils are already in place in the EU, setting maximum levels is likely to mean buyers will request suppliers to demonstrate compliance with the new levels. In the short term, there may be significant work required in many value chains to identify sources of MOAH and strategies to prevent their presence. This in turn may require an increase in analytical capacity to test for MOAH.

Recommended Actions

Competent authorities of countries that are members of the WTO can submit comments on the EU’s proposal by emailing the EU SPS Enquiry Point until 10 May 2026.

Suppliers of food in all sectors should increase monitoring of MOAH to identify any presence of these substances in their products. When MOAH or MOSH are identified in food, suppliers should check all steps of the supply process, identify the sources of contamination, and develop measures to avoid further contamination of their production. Guidance is available on preventing the transfer of undesired MOAH into food (FoodDrink Europe 2018).

In many non-EU countries, the capacity for analysing MOAH may be limited. The European Commission’s Joint Research Centre (JRC) has published Guidance on sampling, analysis, and data reporting for monitoring MOH in food and food contact materials (Bratinova et al. 2023).

Currently, no EU limits are in place for MOSH in food. However, some EU Member States have established national benchmark levels, so food business operators are recommended to also monitor foods for MOSH and develop measures to prevent contamination.

Background

Mineral oil hydrocarbons

Mineral oil hydrocarbons fall into two main classes:

• mineral oil saturated hydrocarbons (MOSH)
• mineral oil aromatic hydrocarbons (MOAH).

Mineral oil hydrocarbons enter the food chain at various points: through environmental contamination during harvesting, through accidental contact with lubricants during processing, or as a result of migration from food contact materials. Recycled paperboard may contain residues of printing ink solvents that can easily migrate to food.

For more information see the European Commission webpage Mineral Oil Hydrocarbons (MOH).

Analysis of MOAH

The analyses for MOAH in food are typically carried out by coupling liquid and gas chromatography with subsequent flame ionisation detection (LC-GC-FID). However, in cases where naturally occurring/biogenic substances interfere with the analysis, a confirmatory analysis with two-dimensional gas chromatography (GCxGC) is needed to confirm the concentration of MOAH (Bratinova et al. 2023).

Resources

Sources

Tables & Figures

Source: based on Draft Annex [PLAN/2023/2345 ANNEX CIS]