Phosphatidylserine MOSH and MOAH Testing Review for US and EU Buyers

A quality team sourcing bulk phosphatidylserine (PS) usually meets MOSH and MOAH for the first time during a packaging or contaminant review, not during routine purchasing. The direct answer: mineral oil hydrocarbons (MOH) are not currently controlled through fixed US or EU maximum levels for PS, so the buyer's job is to verify the supplier's raw-material controls, packaging declaration, processing-aid policy, and any batch MOSH/MOAH data, and to set documented acceptance criteria before approval. The question is not whether every COA must show a MOSH/MOAH row; it is whether the supplier can show a reasoned, documented position for the exact product and packaging being quoted.

This review is written for ingredient importers, distributors, supplement manufacturers, functional food brands, and quality teams in North America and Europe. It explains what MOSH and MOAH are, why they matter for a lecithin-derived powder, where the EU and US stand today, and which checks turn a mineral oil review into evidence. This is a contaminant and document-review discussion, not a medical discussion.

Where Nutranexa is mentioned, only verified public facts are used. Nutranexa identifies itself as Shandong Baianrui Biopharmaceutical Co., Ltd., founded in 2013, operating a 110,000+ m2 campus, and primarily serving export markets in Europe and North America. Its public PS product pages list soy PS and sunflower PS, sample COA evidence is shown on the Quality & R&D page, and its published minimum order is 25 kg with 25 kg net per drum.

The Direct Answer Buyers Need First

Run this five-point map before approving a PS supplier or accepting a batch:

What MOSH and MOAH Are: Two Families, One Contaminant Class

Mineral oil hydrocarbons are complex mixtures derived mainly from crude oil, and also produced synthetically from coal, natural gas, and biomass. They are grouped into two families that behave differently in the body and in the lab:

• MOSH (mineral oil saturated hydrocarbons). Straight and branched alkanes and alkylated cycloalkanes. Some MOSH fractions can accumulate in human tissue, which is why EFSA's 2012 opinion noted possible liver effects from accumulated material.
• MOAH (mineral oil aromatic hydrocarbons). Alkylated aromatic compounds, including three-or-more-ring structures. EFSA's 2012 opinion stated that some MOAH may act as genotoxic carcinogens; the concern is specifically the three-or-more-ring fraction.

The distinction matters because food-grade mineral oils are refined so that MOAH is minimised, and IARC classifies untreated and mildly treated mineral oils as Group 1 carcinogens while highly refined oils are not. That is why "mineral oil" as a general phrase is misleading: the risk question is about the aromatic fraction, the carbon range, and the refining quality, not the word itself.

In 2023, EFSA updated its risk assessment. The panel concluded that present dietary exposure to MOSH does not raise concern for human health for all age groups, using a margin-of-exposure approach. For MOAH with three or more aromatic rings, the update concluded it is extremely likely that dietary exposure is a concern for toddlers and likely a concern for other age groups. The practical buyer takeaway: MOSH is a quality and monitoring topic, while MOAH is the fraction buyers should treat with the most care, particularly in products intended for children.

Why Mineral Oil Hydrocarbons Matter for Lecithin-Derived PS

PS produced through bio-enzymatic conversion from natural lecithin and L-serine is a phospholipid-rich dry powder. MOH are not a natural property of the ingredient; they can enter the supply chain from outside sources:

• Raw material. Lecithin is derived from vegetable oils, and EFSA's monitoring found the highest MOH levels in vegetable oils among the commodities studied. If the oil crop or lecithin processing introduces mineral oil, traces can follow the raw material into the PS process.
• Processing. Machine lubricants, release agents, and other processing aids used during harvesting, extraction, refining, or powder handling can transfer MOH if they are not food-grade and controlled.
• Packaging. Paper and board packaging is a suspected major contributor to MOH exposure, and migration increases with storage time and warmer conditions. A powder can also pick up hydrocarbons from inks, adhesives, recycled fibres, or a liner that is not declared food-grade.
• Environment. Background contamination named in the EU monitoring recommendation.

For a sealed dry powder the practical exposure route is usually smaller than for fatty foods, but the review still applies: the emphasis shifts to packaging declaration, processing aids, and raw-material data rather than per-lot finished-goods testing.

Where MOH Can Enter a PS Supply Chain: Source Map

EU Context: Monitoring Before Maximum Levels

The EU does not currently set harmonised maximum levels for MOSH or MOAH in food. Regulation (EU) 2023/915 sets maximum levels for a defined list of contaminants in food; mineral oil hydrocarbons are not on that list as of this article's date. What exists instead is a monitoring framework:

• Commission Recommendation (EU) 2017/84 asked member states to monitor MOH in food and in food-contact materials, covering commodities such as vegetable oils, grains, and bakery products. It notes that MOH can enter food through environmental contamination, machinery lubricants, processing aids, food additives, and food-contact materials, and that migration from paper and board packaging is suspected to contribute significantly to exposure.
• The JRC guidance (first edition 2019, second edition 2023) was developed to support that monitoring. It describes how samples should be taken, which analytical approaches are suitable (on-line HPLC-GC-FID is the core technique), and how results should be reported, including in mg/kg across defined carbon ranges.
• No EU maximum level for PS. Because PS is an ingredient for food supplements and functional foods rather than a food additive with an EU specification, an EU-wide MOSH/MOAH limit does not apply to it. The closest obligation is general food safety under Regulation (EC) No 178/2002: food placed on the market must not be unsafe.

For an EU buyer, the practical consequence is that a supplier cannot simply cite a European maximum level as proof. The supplier must show either batch data or a documented risk position: raw-material controls, food-grade processing aids, packaging declaration, and a commitment to test when the risk profile justifies it.

US Context: Food-Grade Mineral Oil Rules and the Adulteration Standard

In the United States, the regulatory picture is different in form but similar in outcome: food-grade mineral oils are permitted for defined uses, and there is no FDA maximum level for MOSH or MOAH in food as such.

• 21 CFR 172.878 permits white mineral oil as a direct food additive for defined uses, with purity specifications from the United States Pharmacopeia. Uses include a release agent, binder, and lubricant in capsules and tablets at not more than 0.6 percent, and a dust-control agent for grains at low levels. The point for buyers: FDA has evaluated food-grade white mineral oil for specific uses, not set a general MOSH/MOAH limit for ingredients.
• 21 CFR 178.3620 permits mineral oil as a component of nonfood articles intended for food contact, such as process equipment, with white mineral oil meeting the 172.878 specifications or technical white mineral oil meeting ultraviolet absorbance limits.
• The general adulteration standard. Under section 402 of the Federal Food, Drug, and Cosmetic Act, food is adulterated if it contains a poisonous or deleterious substance that may render it injurious to health. In the absence of a numeric MOSH/MOAH limit, FDA enforcement relies on that standard, which is why document-based supplier control is the practical tool.

For a US buyer, the review mirrors the EU one: confirm the packaging and processing-aid declarations, review any batch data with method context, and put an acceptance criterion in the specification or supplier quality agreement. The supplier quality agreement review shows where such criteria belong.

What a MOSH/MOAH Review Should Include

Keep the review proportional: a documented position with periodic testing is defensible for many dry powder ingredients, while a refusal to answer packaging questions is not.

How to Read a MOSH/MOAH Report or Declaration

When a supplier provides MOSH/MOAH data, read it with the JRC reporting logic in mind:

• Units and basis. Results are reported in mg/kg of product. Confirm whether the value is total MOSH and total MOAH or split into carbon ranges.
• Carbon ranges. Reports commonly split results into fractions such as C10-C16, C16-C20, C20-C25, C25-C35, and C35-C50, because risk and accumulation behaviour differ by chain length.
• Limit of quantification. A result of "below LOQ" is only meaningful with the LOQ stated; a laboratory following the JRC guidance should be able to state it.
• Method. On-line HPLC-GC-FID is the reference approach; a report should name the method and the standard or guidance followed.
• MOAH detail. Because three-or-more-ring MOAH carry the health concern, ask whether MOAH is reported as a total or characterised further. For products intended for children's formulas, more detail is justified.

If the finished PS COA does not include MOSH/MOAH, that is acceptable only when the supplier's documented position covers raw materials, processing, and packaging, and the buyer agrees the residual risk does not justify per-batch testing. The general approach to reading a PS COA is covered in the COA and specification review, and the third-party testing review explains when independent laboratory verification is the right next step.

Supplier Questions and Acceptance Criteria

Add these questions to your supplier questionnaire:

1. Which food-contact materials contact the PS powder, from drum to liner to bag? Provide the declaration for the exact quoted product.
2. Are all lubricants and release agents in the production and packing lines food-grade? Which ones, and where are they controlled?
3. Do you monitor MOSH or MOAH in the lecithin raw material or the finished PS powder? If yes, provide method, units, carbon ranges, LOQ, and recent batch data. If no, what is your documented risk position?
4. What is your MOAH policy for three-or-more-ring fractions, and would you test if the destination market or application requires it?
5. Will you notify us of any change in packaging, raw-material source, or processing that could affect MOH results?
6. Can the COA or a supporting certificate include the agreed MOH acceptance criterion on request?

For acceptance criteria, agree on something measurable: for example, MOAH below the laboratory LOQ using a JRC-aligned method, or a documented threshold for total MOSH and MOAH that your quality team accepts based on the application and target consumer. Do not copy a number from another product; set the criterion for your PS formula and market. The supplier onboarding and repeat-order change control workflows show how criteria stay current after the first order.

Need current PS specifications, COA samples, packaging declarations, and document support for your MOH review? Request the specification and document evidence with your source preference, target assay, application, and destination market.

Conclusion

MOSH and MOAH are not a one-row check; they are a supply-chain review that combines raw materials, processing aids, packaging, and document control. In both the US and the EU, there is no fixed MOSH/MOAH maximum level for PS today, so the quality decision belongs to the buyer and the supplier: agree on the packaging declaration, the processing-aid policy, the monitoring position, and a measurable acceptance criterion, then keep the evidence in the lot file. For a lecithin-derived dry powder, the practical answer is usually a documented risk position plus periodic data, not testing every drum, and MOAH with three or more aromatic rings deserves the most attention.

FAQ

What are MOSH and MOAH in food ingredients?

Mineral oil hydrocarbons (MOH) are complex mixtures of saturated hydrocarbons (MOSH) and aromatic hydrocarbons (MOAH) derived mainly from crude oil. MOSH can accumulate in human tissue, while some three-or-more-ring MOAH may act as genotoxic carcinogens, which is why the aromatic fraction receives the most regulatory attention.

Does the EU set a maximum level for MOSH or MOAH in phosphatidylserine?

No. As of this article's date, Regulation (EU) 2023/915 does not include maximum levels for MOSH or MOAH, and PS is an ingredient rather than a food additive with an EU specification. The EU framework is monitoring-based: Commission Recommendation (EU) 2017/84 and the JRC guidance define how MOH data should be generated and reported.

Does the FDA regulate MOSH or MOAH in food ingredients?

FDA does not set a specific maximum level for MOSH or MOAH in food. Food-grade white mineral oil is permitted for defined direct uses under 21 CFR 172.878 and for food-contact uses under 21 CFR 178.3620, and the general adulteration standard in section 402 of the FD&C Act applies. Buyers therefore rely on documented supplier controls and acceptance criteria.

Why could mineral oil hydrocarbons appear in lecithin-derived PS?

The main routes are vegetable-oil-derived raw materials, non-food-grade processing aids and lubricants, food-contact packaging such as paper and board, and environmental background. For a sealed dry powder, packaging declaration and processing-aid controls are usually the highest-value review points.

Should every PS COA show MOSH and MOAH results?

Not necessarily. Many dry powder COAs do not include a MOSH/MOAH row, which is acceptable when the supplier documents raw-material, processing, and packaging controls and the buyer agrees on the residual risk. When data is provided, it should include method, units, carbon ranges, and limit of quantification.

What should I request from a PS supplier for an MOH review?

Request the packaging declaration for the exact quoted product, a food-grade processing-aid statement, the raw-material monitoring position, any batch MOSH/MOAH data with method and LOQ, and a written commitment to notify you of packaging or process changes. Then set a measurable acceptance criterion in the specification or quality agreement.

Sources

• EFSA: Scientific Opinion on Mineral Oil Hydrocarbons in Food (EFSA Journal 2012;10(6):2704)
• EFSA: Update of the Risk Assessment of Mineral Oil Hydrocarbons in Food (EFSA Journal 2023;21(9):8215)
• EUR-Lex: Commission Recommendation (EU) 2017/84 on the monitoring of mineral oil hydrocarbons in food and food contact materials
• JRC: Guidance on sampling, analysis and data reporting for the monitoring of mineral oil hydrocarbons in food and food contact materials (2019)
• EUR-Lex: Regulation (EU) 2023/915 on maximum levels for certain contaminants in food
• EUR-Lex: Regulation (EC) No 178/2002 laying down the general principles of food law
• eCFR: 21 CFR 172.878 - White mineral oil
• eCFR: 21 CFR 178.3620 - Mineral oil (food-contact articles)
• IARC Monographs Volume 100F: Mineral Oils, Untreated and Mildly Treated (Group 1) and Highly Refined Oils (Group 3)
• US Code: 21 U.S.C. 342 - Adulterated Food (FD&C Act section 402)

Recommended next steps

• Review the Phosphatidylserine product page.
• Compare Soy PS and Sunflower PS.
• Check manufacturing proof and Quality & R&D.