The EU’s Standing Committee on Plants, Animals, Food and Feed (SC PAFF) voted on the MOAH and MOSH restrictions last month following a 2023 safety opinion from the European Food Safety Authority (EFSA) regarding potential genotoxic and carcinogenic risks.
The recommendations impact any food supplement which involves extraction processes and fatty carriers, or which contain dried botanicals, mushrooms, or cocoa. Notable effected categories will include fish oils, liposoluble extracts, botanical ingredients that are high in natural fats, oils or resins, and fat-soluble vitamin supplements such as vitamins A, D and E.
The regulation is being phased in, setting a 10.0 mg/kg maximum tolerated MOAH level for food supplements from January 2027, which will be reduced to 5.0 mg/kg from January 2030.
Ulrike Van den Houte, communications & regulatory affairs director at be-sup, the federation for the food supplement industry in Belgium representing more than 160 members, said meeting the new limits will be a significant challenge for some in the industry.
“Based on feedback we have received from our members in the past, we are aware that the proposed limits may prove challenging for certain operators within the food supplements sector,” she said, adding that the greatest challenge would likely be identifying contamination sources.
The European Commission (EC) has granted a three-year exemption for crude fish oils (and specific marine/algae oils) destined for refinement as MOAH can be removed during the refining process. This will also provide the industry time to invest in specialized refining and testing equipment.
A spokesperson for The Global Organization for EPA and DHA Omega-3s (GOED) said the organization was “supportive of the maximum limits and monitoring requirements”, adding that it is “reasonably satisfied that crude oils destined for refining received a three-year exemption”.
“We are confident our member companies can meet the 10 mg/kg limit for MOAH that will go into effect in January,” the spokesperson said. “GOED will continue to work with its members to further improve the mitigation of MOH throughout the entire EPA/DHA omega-3 value chain.”
What are MOAH and MOSH?
Mineral Oil Hydrocarbons (MOH) comprise a broad group of compounds that may originate from, among other sources, lubricants, packaging materials, processing aids, additives and environmental contamination.
They are divided into two main types: mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH).
In the context of food safety and mineral oil contamination, aromatic rings are the defining structural difference between MOSH and MOAH.
MOSH contain no aromatic rings. They are primarily long, open hydrocarbon chains (paraffins) or saturated rings (naphthenes). While they can accumulate in human tissue over time, they are generally considered non-genotoxic.
MOAH contain aromatic rings—chemical loops which make the molecules highly reactive and easily absorbed by the body.
The new MOAH limits are based on EFSA’s conclusion that MOAH containing three or more aromatic rings are of particular toxicological concern due to their potential genotoxic and carcinogenic properties.
Large-scale monitoring
Although MOSH are considered non-genotoxic, EFSA concluded the margin of safety remains limited. Therefore the European Commission (EC) has opted to implement a large-scale monitoring program between 2026, and 2029 and food supplements are explicitly included among the product categories subject to monitoring.
For food supplements, an indicative level of 15 mg/kg MOSH has been established. As this is not a legally-binding limit, exceeding it does not automatically prevent a product from being placed on the market.
Where this level is exceeded, competent authorities are expected to work with the operator to investigate the origin of the contamination and identify corrective measures.
In addition, the EC is introducing new analytical requirements for food supplements, including the use of analytical methods capable of achieving a limit of quantification (LOQ) of no more than 5.0 mg/kg for both MOAH and MOSH.
Specific requirements will also be introduced for sampling, sample storage, sample transport, analytical quality control and prevention of contamination during analysis.
Where elevated levels are detected, the Commission expects companies to conduct a systematic assessment of the entire production chain and implement appropriate preventive measures.
Priorities for industry
Although the first legal MOAH limit will not come into force until January 2027, Van den Houte advised that companies begin assessing the presence of MOAH and MOSH in their products now.
She specified key priorities for the coming period include evaluating whether existing analytical methods are sufficiently sensitive, establishing baseline levels for relevant products, identifying potential sources of contamination, engaging suppliers regarding their control measures, assessing whether packaging materials and manufacturing processes may present risks, and developing a strategy to comply with the new MOAH limit by 2027.
“Companies that begin evaluating their MOAH and MOSH profiles now will be best placed to comply with future European requirements in a timely manner,” she said. “At the same time, practical experience from across the sector will be crucial in assessing the real-world impact of this new legislation.”
In order to fully understand the impacts of the regulations and which operators will be most impacted, be-sup is inviting its members to confidentially report any exceedances of the future MOAH limits or elevated MOSH levels.
“This information will help be-sup to better identify recurring sources of contamination, map technical challenges within the sector, assess the feasibility of the new requirements, compare experiences across companies and more effectively represent the sector’s interests in discussions with Belgian and European authorities,” Van den Houte said.
