EUDR for pharma and nutraceutical makers: palm, soya, cocoa

Most of the palm, soya and cocoa excipients a pharma or nutraceutical manufacturer buys are EUDR relevant products, and nothing about a pharmacopoeial grade changes that. The one real exception: since 18 September 2026, several palm-derived excipient entries in Annex I — glycerol, stearic acid and its salts (including magnesium stearate), and a few others — are excluded "to the extent" the batch is used to manufacture a licensed medicinal product. That exclusion does not reach soya or cocoa derivatives, and it does not reach nutraceuticals or food supplements, which are not medicinal products in EU law.

Which excipients are in scope, and where the exclusion cuts in

Annex I of Regulation (EU) 2023/1115 lists specific CN codes under each regulated commodity. For the ingredients this sector actually buys:

Ingredient	Commodity / CN basis	In scope for a licensed medicine	In scope for a nutraceutical or supplement
Crude or refined palm oil, palm kernel oil	Oil palm (CN 1511, 1513)	Yes — no exclusion on the oil itself	Yes
Glycerol, ≥95% purity, palm-derived	Oil palm (CN 2905 45)	No, where used to manufacture the medicine	Yes
Stearic or palmitic acid and their salts (incl. magnesium, calcium, zinc stearate), palm-derived	Oil palm (CN 2915 70)	No, where used to manufacture the medicine	Yes
Industrial stearic acid, industrial oleic acid, palm-derived	Oil palm (CN 3823 11 00, 3823 12 00)	No, where used to manufacture the medicine	Yes
Hydrogenated palm oils, further fatty alcohols, soap bars — added by (EU) 2026/2102	Oil palm, several new entries	Mixed — some carry the same exclusion, from 30 December 2027	Yes, from 30 December 2027
Soya-bean oil, oilcake and meal	Soya (CN 1507, 2304)	Yes — no exclusion	Yes
Soya lecithin	Classified separately (CN 2923 20), not an Annex I soya entry	Not in scope either way	Not in scope either way
Cocoa butter, cocoa powder	Cocoa (CN 1804, 1805)	Yes — no exclusion	Yes
Gelatine capsule shells	No Annex I entry	Not in scope either way	Not in scope either way

The pattern that catches this sector out is the same one that catches cosmetics formulators: Annex I follows the customs code a batch is classified under, not how pharmacopoeial the ingredient looks on a certificate of analysis. What changed under the December 2025 amendment covers that principle in general terms; what is specific to pharma and nutraceutical buyers is the medicinal-products exclusion below, which applies only to some palm entries and only to some of what you make.

What the medicinal-products exclusion actually says

Commission Delegated Regulation (EU) 2026/2102, which recast Annex I and entered into force on 18 September 2026, added wording to several palm oil derivative entries excluding them "to the extent" the goods are used in the manufacture of a medicinal product within the meaning of Directive 2001/83/EC (human medicinal products), Regulation (EC) No 726/2004 (centralised EU marketing authorisation) or Regulation (EU) 2019/6 (veterinary medicinal products). This sits alongside, not instead of, the Annex I recast covered in the full list of 2026/2102 changes.

Two things about how it is written matter in practice:

• It is written into individual CN entries, not a single blanket carve-out. The exclusion appears against glycerol (CN 2905 45), palmitic and stearic acid and their salts and esters (CN 2915 70), industrial stearic acid (CN 3823 11 00), industrial oleic acid (CN 3823 12 00), and several of the newly added palm entries that apply from 30 December 2027, including hydrogenated and chemically modified palm oils and a further set of fatty alcohols, amines, soap forms and chemical preparations. It does not appear against crude or refined palm oil itself, nor against any soya or cocoa entry.
• It runs on end use, not on who you are. The word "to the extent" means the same batch of palm-derived stearic acid can be outside EUDR scope when it goes into a licensed medicine and inside scope when an identical batch, from the same production run, goes into a food supplement, a cosmetic or an unlicensed wellness product. The exclusion travels with what the material is actually used for, not with the buyer's sector.

Why this does not help a nutraceutical formulation

A "medicinal product" under Directive 2001/83/EC is a licensed medicine — something authorised for human use under that Directive or the centralised procedure, or a licensed veterinary product under Regulation (EU) 2019/6. Food supplements, nutraceuticals, fortified foods and most wellness products are not medicinal products under EU law, however they are marketed or however close their formulation sits to a pharmaceutical one. A capsule containing palm-derived magnesium stearate sold as a food supplement gets no exclusion at all; the identical lubricant grade sold into a licensed pharmaceutical batch does, provided the record shows that end use.

This means a contract manufacturer or excipient distributor serving both pharma and nutraceutical customers from the same stock cannot apply the exclusion across the board. It has to be able to show, batch by batch, which volume went to a licensed medicinal use and which did not — because only the first gets the exclusion, and a competent authority checking the due diligence record will ask for that distinction, not accept a general statement that the company "serves the pharma sector."

Stearates specifically

CN 2915 70 covers palmitic and stearic acid and their salts and esters — which settles a question that is easy to get wrong by reading only the oil and fatty-acid entries. Magnesium stearate, calcium stearate and zinc stearate, when made from palm-derived stearic acid, fall under this entry and are Annex I products in their own right. Since September 2026 they also carry the medicinal exclusion described above. The same stearate sold for tablet lubrication in a food supplement has no such exclusion; the one sold into a licensed medicine does, if the supplier can show it. Ask your excipient supplier which CN classification the batch carries and whether it has tracked the medicinal-use exclusion against that specific lot — a statement that the product is "pharma grade" is not the same as a customs classification or an end-use record.

Gelatine capsules are not an EUDR question at all

Gelatine, whether bovine or porcine, has never had an entry of its own in Annex I. The only cattle-related entries Annex I ever carried were raw hides, tanned hides and leather, and those were removed from scope entirely by the same September 2026 recast, as covered in the Annex I changes. Gelatine was never within reach of that entry in the first place, because it sits under a different customs code. A capsule manufacturer sourcing gelatine shells has no EUDR exposure on that input, whatever the animal source, and no exclusion to track either.

Soya and cocoa derivatives get no equivalent carve-out

Soya-bean oil, soya oilcake and meal (CN 1507, 2304) and cocoa butter and powder (CN 1804, 1805) have no medicinal-products exclusion anywhere in Annex I, before or after the 2026 recast. EUDR for soya in animal feed and EUDR for cocoa and chocolate makers cover the scope of those two commodities in more general terms; nothing in either changes for a pharmaceutical end use. A manufacturer using cocoa butter as a suppository base or soya oil in a softgel fill owes exactly the same due diligence as a confectioner or a feed mill buying the same material, with no pharma-specific relief.

Who owes the due diligence statement

Regulation (EU) 2025/2650 put the due diligence statement on whoever first places the Annex I product on the EU market, not on every business that later handles it. For a pharma or nutraceutical supply chain, that is usually one of:

• An API or excipient importer bringing palm oil, soya oil, cocoa butter or their in-scope derivatives into the EU directly from a non-EU producer. This is the primary operator, and the statement is theirs to file for whichever volume does not qualify for the medicinal exclusion.
• A pharmaceutical-grade excipient distributor who imports in bulk and resells to formulators — also a primary operator on what it imports itself, and the one who has to maintain the batch-level record separating medicinal from non-medicinal end use.
• A finished-dose or finished-supplement manufacturer buying an already-compliant excipient from an EU distributor who filed the statement upstream. This is a downstream operator, and the obligation is to record the reference number passed down, not file a fresh statement for the same material.

A manufacturer that assumes a distributor has handled this, when the distributor in fact imports on a drop-ship or back-to-back basis with no EU due diligence of its own, has not complied. Ask the question for each excipient line separately — a single formulation can combine palm, soya and cocoa inputs bought through different channels, with different exclusion positions.

Deadlines for a pharma or nutraceutical manufacturer

Your business	Already-listed palm, soya and cocoa derivatives	Palm entries added by (EU) 2026/2102
Large or medium operator or trader	30 December 2026	30 December 2027
Micro or small operator, product previously under the EU Timber Regulation	30 December 2026	30 December 2027
Micro or small operator, otherwise	30 June 2027	30 December 2027

The medicinal-products exclusion does not change these dates. It changes whether the obligation exists at all for a given batch's end use; where it does not apply — soya, cocoa, non-medicinal palm use, or palm use not yet supported by an end-use record — the normal dates above apply in full. Size is set by Directive 2013/34/EU thresholds: broadly, micro is up to 10 staff and €900,000 turnover, small up to 50 staff and €10 million turnover, medium up to 250 staff and €50 million turnover, large above that. The full deadline breakdown covers how the two dates interact with role and product history.

Origin and risk tier

The main producing countries for these three commodities — Indonesia and Malaysia for palm, Brazil for soya, Côte d'Ivoire and Ghana for cocoa — all sit in the EUDR's default standard risk tier under Implementing Regulation (EU) 2025/1093. None is benchmarked low risk, and none is on the high-risk list. Standard risk carries a 3% competent authority checking rate and does not qualify for the reduced simplified due diligence available for low-risk origins. Country benchmarking explained covers what the risk tier changes about the due diligence itself, which applies in full to whatever share of your palm, soya or cocoa purchases does not benefit from the medicinal exclusion.

What to ask your excipient and API suppliers now

• What CN code does this excipient carry on the import declaration — specifically, does a stearate fall under CN 2915 70, and does a glycerol grade sit at or above the 95% purity threshold in CN 2905 45?
• If you supply the same grade into both pharma and nutraceutical or cosmetic channels, how do you track which batches were used to manufacture a licensed medicinal product and which were not?
• Can you produce that batch-level record if a competent authority asks for it, rather than a general statement that the product is "pharmaceutical grade"?
• Are you the business first placing this ingredient on the EU market, or is someone upstream of you the primary operator — and if so, what is their due diligence statement reference number?

Check what the EUDR requires of your specific ingredients and role rather than assuming a medicinal end use or a pharmacopoeial grade has taken an ingredient out of scope on its own.