Latest and Final MOH Regulation Proposal Released by European Commission

GOED has just learned that the European Commission’s latest version of the proposal amending Regulation (EU) 2013/915 as regards maximum levels of mineral oil hydrocarbons in food (SANTE PLAN 2023/2345 Rev.7) has been released. It has also issued the associated Commission Recommendation on the monitoring of mineral oil hydrocarbons in food (SANTE PLAN 2023-2727-Rev5), and the proposal amending Regulation (EC) No 333/2007 as regards the methods of sampling and analysis for the control of levels of mineral oil hydrocarbons in foodstuffs (SANTE PLAN 2023 2726 Rev.6). Copies of the documents can be found here.

Maximum Levels (MLs)

In the Annex to “SANTE PLAN 2023/2345 Rev.7,” section 5 outlines the proposed maximum levels (MLs) for MOAH (≥C10 to ≤C50) for a range of food types. The most relevant categories for GOED members are:

• Section 5.5.2.5 - “Oils from Fishery Products and Algae,” with a ML of 10,0 mg/kg from 1 January 2027, and 5,0 mg/kg from 1 January 2030.
• Section 5.5.12 - “Food supplements,” with a ML of 10,0 mg/kg from 1 January 2027, and 5,0 mg/kg from 1 January 2030.
• Section 5.5.11 - “Infant formulae, follow-on formulae, young-child formulae, food for special medical purposes intended for infants and young children, baby food, processed cereal-based food for infants and young children, and drinks for infants and young children placed on the market and labelled as such.”:
  • Products with < 4% fat/oil content, with a ML of 0,50 mg/kg
  • Products with ≥ 4% and ≤ 50% fat/oil content, with a ML of 1,0 mg/kg
  • Products with ≥ 50% fat/oil content, with a ML of 2,0 mg/kg
    Note: for this category, the fat/oil content refers to the declared fat/oil content or, in absence of a declared fat/oil content, to the fat/oil content as determined by the competent authority.

• Section 5.5.2.6 - “Oils and fats other than those listed in previous categories,” with a ML of 4,0 mg/kg from 1 January 2027, and 2,0 mg/kg from 1 January 2028.
• For food additives that are produced from food sources, the foods that are used as a source shall comply with the MLs set out in this regulation.

There is no explicit mention of crude unrefined oils, or some exemption in case refining can be guaranteed to be carried out within the EU. Strictly taken, GOED believes that the proposed regulation will also be applicable to crude unrefined oils with the same ML of 10,0 mg/kg (and reduced to 5,0 mg/kg in 2030).

Blends of oils are not mentioned explicitly. If blends are in the form of a dietary supplement, i.e. a finished product, the ML of 10,0 mg/kg would be applicable.

There is no mention of an indicative limit for MOSH in this regulation, but it can be found in the document pertaining to the requirements for sampling and analysis (see below).

The proposed regulation mentions that foods placed on the market before 1 January 2027 may remain on the market until their use-by-date.

Monitoring of MOH in Foods

In SANTE PLAN 2023-2727-Rev5, the EC provides general recommendations and specific advice to Food Business Operators (FBOs). Some highlights of particular interest to GOED members are:

• The EC recommends that monitoring of both MOSH and MOAH in food is continued until 2029.
• While EFSA concluded that the current exposure to MOSH does not raise health concerns, the available margin for a safe exposure is limited. Therefore, the monitoring of the presence of MOSH in food and the application of mitigation measures should also be continued.
• The sampling procedures and the analyses should be performed in accordance with the requirements for sampling and analysis in Regulation (EC) No 333/2007.
• It is recommended to validate analysis methods for MOSH and MOAH in food on the basis of comprehensive gas chromatography (GC×GC) to distinguish the presence of MOSH and MOAH from other co-extracted and possibly interfering compounds.
• Indicative limits for MOSH for products that are relevant to GOED members are as follows:
  • Section 6a: 50,0 mg/kg for oil produced from fishery products and algae, and products derived from these fats and oils
  • Section 6c: 15,0 mg/kg for food supplements
  • Section 6f: 1,0 mg/kg for liquid infant and follow-on formulae, drinks for infants and young children placed on the market and labelled as such.
• Where MOSH and MOAH are detected in food in concentrations above indicative levels or MLs, FBOs should carry out further investigations to determine the possible sources of contamination. It is recommended to retain samples of the ingredients and food contact materials for further analysis, and implement the necessary measures to avoid the contamination of food with MOH. FBOs should provide monitoring data to the food authorities on a regular basis. There is no mention of food withdrawals related to exceeding an indicative level for MOSH.

Sampling and Analysis

Regarding SANTE PLAN 2023 2726 Rev.6, MOH is included as one of the listed contaminants alongside previously regulated contaminants (lead, cadmium, mercury, inorganic tin, inorganic arsenic, nickel, 3-monochloropropane-1,2-diol (3-MCPD), 3-MCPD fatty acid esters, glycidyl fatty acid esters, polycyclic aromatic hydrocarbons (PAH), and perchlorate). The following points published in the associated Annex may be of particular importance to GOED members:

• Language is introduced regarding the need to avoid cross-contamination and introduction of interferences of materials used during sampling, sample storage and sample transmission, as well as the loss of analytes by adsorption, and damage during transit.
• It is stated that the analysis of MOH should be carried out according to the JRC Guidance on sampling, analysis and data reporting for the monitoring of MOH in food and food contact materials. If other procedures are followed, equal performance of those procedures shall be ensured.
• A reagent blank analysis shall be included during sample analysis for each sequence of samples.
• Specific performance criteria for methods of analysis are specified, namely: 
  • Specificity: Analytical methods shall demonstrate the ability to reliably and consistently quantify MOSH and MOAH, excluding either co-extracted and possibly interfering compounds that may be present. When needed, characterization of interferences shall be done on the basis of two-dimensional gas chromatography (GC x GC).
  • Recovery: 70-120%
  • Reproducibility: < 20% (for certain products that contain endogenous interfering substances, the reproducibility can be higher than 20%)
  • Limit of Quantification (LOQ): A new category has been created for spices, dried herbs, food supplements, essential oil and oils produced from fishery products and algae, for which the LOQ should be ≤ 5,0 mg/kg.

In GOED’s view, the creation of a new category for which a higher LOQ is applicable denotes the recognition by the EC that specific commodities such as marine oils suffer from matrix interference in the analytical methods used for quantification of MOSH and MOAH. This is also reflected in the new language regarding avoiding cross-contamination with interfering substances. It is interesting to note the apparent convergence of the new LOQ with the proposed ML for MOAH of 5,0 mg/kg to be enforced in 2030 (a sharpening of the 10,0 mg/kg ML that is expected to be enforced in January 2027). For MOAH, the current harmonized action limits agreed upon by individual EU MS always refer to the allowable levels having to be below the attainable LOQ, for example ≤ 2,0 mg/kg MOAH for fats/oils with > 50% fat content, i.e. in line with the EC intention of managing contaminants according to its ALARA “as low as reasonably achievable" principle.

Importantly, according to our information to date, this is a final version of the proposed regulation and no open consultation is planned by the EC for receiving further input. The SCoPAFF (Standing Committee on Plants Animals and Foods) will issue a final vote in November of this year. GOED will evaluate whether a direct communication to the EC is warranted, asking for any additional clarifications or providing specific points of information about our sector, such as an argument against the ML applying to crude unrefined oils, clarification regarding blends of oils of different origin, a definition of “fishery products” or substantiation of natural interferences found in the oils. If you have any comments or questions about the proposed regulation, please contact Gerard Bannenberg.

GOED last reported on MOH in the 24 March 2025 GOED Current and will inform members as soon as it learns more.