Phosphatidylserine EU Product Liability Guide

The new EU Product Liability Directive, Directive (EU) 2024/2853, starts applying on 9 December 2026 to products placed on the market or put into service from that date, replacing the 1985 directive on liability for defective products. The direct answer is that PS-containing food supplements are products in scope, and the EU-established importer is a primary liable operator when the manufacturer sits outside the EU - so preparation belongs at the sourcing and contracting stage, not after a complaint arrives. That means mapping who is liable for what, building a lot-level evidence file from specification and COA to finished product, agreeing supplier warranties and indemnities, and checking product-liability insurance before the cutover.

This guide is operational procurement and risk-management preparation, not legal advice; confirm the national rules in force in the destination member state.

What Changes on 9 December 2026

Directive (EU) 2024/2853 was adopted on 23 October 2024, published in the Official Journal on 18 November 2024, and entered into force on 8 December 2024. Member states must transpose it into national law by 9 December 2026, and from that date it replaces Council Directive 85/374/EEC. The new rules apply to products placed on the market or put into service on or after 9 December 2026; products placed on the market earlier remain governed by the national rules that transposed the old directive.

Three design choices matter for an ingredient buyer:

Strict liability stays. The injured person does not need to prove fault or negligence. They need to show that the product was defective, that damage occurred, and that the defect caused the damage.
The scope is broader than in 1985. The Directive covers all movable products, expressly including software and digital products. There is no exclusion for food, so food supplements are in scope.
The EU-based defendant is guaranteed by design. The liability cascade is structured so that an injured person can almost always find an operator established in the EU to claim against, even when the manufacturer is in a third country.

Because the Directive applies per product at the moment of placing on the market, a PS batch released into the EU in 2027 will sit under the new national rules. The contract, evidence file, and insurance review should be in place before the first post-cutover shipment, not after it.

Why a PS Supplement Is a Product in Scope

Under the Directive, a "product" is any movable item, including items integrated into or interconnected with another movable or immovable item. A food supplement containing phosphatidylserine is a movable product, and the ingredient itself - the PS powder in a 25 kg drum - is also one. The Directive does not carve food out of its scope; processed foods such as supplements have been covered by EU product liability rules for decades, and the new regime continues that coverage while broadening what counts as compensable damage.

What counts as damage

The Directive covers damage to natural persons:

Damage category	What it includes	Buyer relevance
Death and personal injury	Physical injury, and medically recognised damage to psychological health	Consumer injury from a defective supplement
Damage to property	Damage to or destruction of property, including data, that is not used for professional purposes	No EUR 500 minimum value for consumer property claims
Defective product itself	Excluded from property damage	The failed batch is a contractual issue, not a liability claim

Two changes raise practical exposure. The old EUR 500 minimum threshold for property-damage claims is removed, so small-value claims become actionable, and member states can no longer cap liability for death or personal injury. For a supplement importer, exposure changes at the batch level, not only for large recalls.

The defect standard

A product is defective when it does not provide the safety that a person is entitled to expect, taking into account:

the presentation of the product, including instructions, warnings, and labelling;
reasonably foreseeable use and misuse;
the time when the product was placed on the market or put into service;
applicable product safety requirements, including the manufacturer's or importer's recall obligations.

The fact that a better product is later placed on the market does not, by itself, make the earlier product defective. This matters for ingredient buyers because the defect question is assessed against the labelling, specification, and intended use of the finished product - not against the COA alone.

Who Can Be Liable in a PS Supply Chain

The Directive allocates liability across operators rather than treating "the supplier" as a single party. For a bulk PS import, map each role before the first post-cutover order:

Operator	Liability position under the Directive	Typical party in a PS import
Manufacturer	Primary liable operator for the defective product	The Chinese ingredient producer, for the ingredient it manufactures
Component manufacturer	Liable where a defective component integrated under its control renders the product defective	A lecithin or packaging component producer where applicable
Importer into the EU	Treated as a liable operator on the same footing when the manufacturer is outside the EU	The EU-established importer buying PS from China
Apparent manufacturer	Any operator that puts its name, trademark, or distinguishing feature on the product is treated as a manufacturer	A brand that private-labels or rebrands the supplement
Authorised representative	Fills the EU-based-defendant gap where no importer is established	Possible in some distribution models
Fulfilment service provider	Liable when no EU-based manufacturer, importer, or authorised representative can be identified	Logistics operators in specific fulfilment arrangements
Distributor	Subsidiary liability: must identify the EU-based operator or its own supplier within one month of a request, or become liable	Distributors, wholesalers, and repackers
Online platform	May be treated as a distributor where it presents the product or trader as acting under its authority or control	Marketplaces selling finished supplements

The single most important line for a European buyer is the importer row. When a Chinese manufacturer sells PS to an EU importer, the importer is the operator the injured person can sue in the EU without first litigating abroad. If the same buyer also puts its own brand on a finished supplement, it becomes the apparent manufacturer for that product as well - a second, independent liability position. A distributor that resells the ingredient has subsidiary exposure if it cannot identify its own supplier within the one-month window, so supplier identity belongs in the commercial file, not only in customs records.

The Evidence Rules That Raise the Stakes for Buyers

The Directive changes how evidence works in claims, and that change lands on document control. Courts may order a claimant or defendant to disclose relevant evidence when the claim is plausible, necessary, and proportionate, with confidentiality measures for trade secrets. If a defendant fails to disclose evidence it controls, the court can apply a rebuttable presumption that the product was defective, and the Directive also provides for presumptions on causation.

For an ingredient buyer, the file you keep today is the evidence you would disclose tomorrow. A PS shipment without a lot-linked COA, specification version, packing list, and batch record is not just a quality gap - it is a liability gap, because the presumption can operate against the operator that cannot show what the batch was.

Limitation and long-stop periods

Two time limits shape how long records must be kept:

A three-year limitation period runs from when the injured person became aware, or ought to have become aware, of the damage, the defect, and the identity of the liable operator.
A ten-year long-stop extinguishes rights from the date the product was placed on the market or put into service, extended to 25 years for latent personal injury where the injured person could not have become aware earlier.

The practical rule is to keep the lot-level file as long as finished products built from a PS batch remain on the market, plus the limitation window - in practice, several years beyond the last sale, and longer where a product is marketed for years. That argues for the same retention discipline you already apply to lot traceability e reserve samples.

Six Steps to Prepare Before December 2026

Use a fixed preparation workflow so the liability file is complete before the cutover:

Map your legal role. Write down, for every product you place on the EU market from December 2026, whether you are manufacturer, importer, apparent manufacturer, distributor, or fulfilment operator. One company can hold two roles.
Lock the identification chain. Capture the manufacturer's legal name and address, your own EU importer identity, and the upstream supplier for every batch. One month is the identification window for distributors; do not leave it to a request.
Build the lot-level evidence file. For each PS lot, keep the specification version, current COA, packing list, invoice, batch release records, storage records, and finished-product test results. Connect them through the same lot reference from drum to dispatch.
Update supplier contracts. Add warranties that the ingredient meets the agreed specification and applicable EU requirements, an obligation to notify safety or compliance issues, document access for claims, and an indemnity that survives delivery and reflects the December 2026 cutover.
Review insurance. Confirm whether your product-liability cover extends to supplements imported after the cutover, whether the insurer is aware of the new regime, and whether manufacturer indemnities and insurance are in place upstream.
Test the incident response. Rehearse what happens when a consumer or authority reports a problem: which file you open, who responds, how you notify upstream, and how you coordinate with RASFF monitoring.

The purchase-order specification review locks acceptance criteria at order time; the liability file proves what was delivered, tested, and released for every lot that reaches the market.

What to Request From Your PS Supplier

Add these items to the qualification and contract file for a European PS order:

Request	Why it matters for product liability
Legal entity and facility identification	Confirms who is the manufacturer for liability mapping and the identification chain
Current specification with version and date	Sets the acceptance baseline the finished product and claims will be judged against
Lot-linked COA	Shows the delivered batch met the agreed specification at release
Batch and production records summary	Supports the defect and causation analysis if a claim arises
Informações de embalagem e armazenamento	Documents the product's presentation and expected storage conditions
Arquivos de conformidade específicos do mercado, quando relevante	Supports the safety-requirement element of the defect standard
Notification commitment	Contractual obligation to inform you of safety issues, complaints, or regulatory actions
Indemnity and insurance position	Allocates upstream risk and shows what the manufacturer stands behind

Request these for the exact quoted route - general PS, soy PS, or sunflower PS - because the specification and source identity differ by route. Written, named documents are easier to defend than a statement that the product "meets EU standards." Re-check the answers on annual review cycles.

Need current PS specifications, COA evidence, batch documentation, and packaging details to start this file? Contact Nutranexa with your destination market, source preference, target grade, and annual volume so the review starts from the exact quoted configuration.

Red Flags and Hold Points

Slow the order when the liability file cannot be completed:

No named legal manufacturer, or a manufacturer identity that changes between quotation and shipment.
A COA or specification that cannot be tied to a specific lot and drum set.
Refusal to warrant the specification in the supply contract or to commit to safety notifications.
No insurance visibility, or a policy that excludes imported ingredients or supplements.
The distributor cannot identify the upstream supplier from the order documents alone.
Compliance files that are generic "export standard" statements instead of lot- and route-specific records.

Record the gap and the decision - approve, approve with conditions, hold, or reject - in the supplier file. The supplier quality agreement is the right place to convert the red-flag questions into contract language before the December 2026 cutover.

How Verified Nutranexa Facts Fit This Workflow

Nutranexa is a functional food ingredient manufacturer focused on phosphatidylserine, soy PS, sunflower PS, and soluble soybean polysaccharide. The primary manufacturing entity, Shandong Baianrui Biopharmaceutical Co., Ltd., was founded in 2013 and operates a 110,000+ m2 production campus, with a primary export focus in Europe and North America. For PS, the published baseline is a 25 kg MOQ with 25 kg net per drum.

Those facts support the preparation file in a practical way. A fixed 25 kg drum baseline keeps the lot unit simple: one drum, one lot reference, one COA to reconcile with the packing list and release records. Nutranexa provides PS COA and specification evidence, factory and packaging imagery, and dispatch imagery for buyer review, supported by Qualidade e P&D e manufacturing context. Buyers should request the current specification, COA, and batch documentation for the exact quoted route from the sales team and complete their own importer-side role mapping, contract, and insurance review. Nothing on this page claims that any Nutranexa document satisfies the Product Liability Directive; that depends on the exact batch, finished product, destination market, and operator role.

Perguntas frequentes

When does the new EU Product Liability Directive apply?

Directive (EU) 2024/2853 was published on 18 November 2024 and must be transposed by member states by 9 December 2026. It applies to products placed on the market or put into service on or after 9 December 2026, replacing the national rules that transposed Directive 85/374/EEC.

Does the Product Liability Directive apply to food supplements?

Yes. The Directive applies to all movable products and does not exclude food. A food supplement containing phosphatidylserine is a product in scope, and the PS ingredient itself is a movable product. What varies by member state is the national transposition, so confirm the rules in force in the destination country.

Who can be held liable for a defective imported food supplement in the EU?

The manufacturer is the primary liable operator. Where the manufacturer is outside the EU, the importer established in the EU is liable; an operator that puts its own name or trademark on the product is treated as the manufacturer; fulfilment service providers fill the gap where no EU operator can be identified; and distributors become liable if they fail to identify an EU operator or their own supplier within one month of a request.

Is an importer treated as a producer under the new rules?

Under the Directive's role structure, the EU-established importer is a liable operator on the same footing when the manufacturer is based outside the EU. If the importer also brands the finished supplement, it is additionally treated as the apparent manufacturer for that product.

How long can a product liability claim be brought after a supplement is placed on the market?

Claims are generally subject to a three-year limitation period from when the injured person became aware, or ought to have become aware, of the damage, the defect, and the liable operator, and rights are extinguished ten years after the product was placed on the market - extended to 25 years for latent personal injury. Keep lot-level records accordingly.

Conclusion

The December 2026 cutover changes product liability from a legal abstraction into a procurement task for every European PS buyer. The importer is the EU-based liable operator for a Chinese-origin ingredient, and the evidence file - specification, lot-linked COA, batch and release records, contract warranties, and insurance - is what the new disclosure and presumption rules will test. Map your role, lock the identification chain, build the lot-level file, and update contracts before the first post-cutover shipment.

Fontes

Contato de vendas

Contact Nutranexa to request current PS specifications, COA evidence, batch documentation, factory and dispatch imagery, and the exact 25 kg drum configuration for the soy or sunflower route you are evaluating for Europe. Share your destination market, source preference, target grade, and annual volume so the sales team can confirm the current technical file for your liability-preparation review.

Próximas etapas recomendadas

Revise o Phosphatidylserine página do produto.
Comparar Soy PS e Sunflower PS.
Verifique prova de fabricação e Qualidade e P&D.

Entre em contato com o departamento de vendas para obter documentos do produto

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