Tuna Histamine Limits: Indonesia 2025 Complete Export Guide

A practical, step-by-step EU-compliant n=9 histamine sampling plan for Indonesian tuna exporters in 2025. What to sample, how many units, acceptance rules (m=100/M=200 mg/kg), lab vs rapid kits, how to define a ‘lot,’ and the documentation EU border control actually checks.

We’ve gone from nervous, last‑minute releases to consistent EU border clearance using a simple, disciplined histamine program. The same playbook works for most Indonesian tuna plants if you commit to the n=9 standard and document it well.

Here’s the exact system we use and recommend for 2025.

The three pillars of fast, reliable EU compliance

Define the lot correctly. Keep it homogeneous by species, product form, production date, vessel/trip, size grade and packaging. Don’t mix Bigeye loins with Yellowfin saku in one lot, and don’t stretch a lot across multiple production dates.
Sample and test to the letter. Use the EU’s n=9, c=2 plan with the m=100/M=200 mg/kg acceptance rules. Pull the nine units from across the stack, not one corner.
Prove it on paper. EU BCPs increasingly want raw data. Your CoA should show all nine results, the mean, your lot definition, and the method/lab accreditation. Attach your sampling record. Then there are fewer questions on arrival.

Week 1–2: Set up your lot definition and SOP

We start here because most histamine “failures” trace back to messy lot definitions.

Lot definition. One lot = a single product specification produced under uniform conditions. For example: “Yellowfin saku, 2–3 kg, sashimi spec, produced 14 Jan 2025, vessel ABC-21, cartons 001–420.” That’s a good lot. “All Yellowfin from January” is not.
Forms to consider. Tuna forms behave differently. Yellowfin Saku (Sushi Grade) and Yellowfin Steak are typically harvested from many fish. Bigeye Loin might be more traceable to fewer fish. Ground or cubes like Yellowfin Ground Meat (IQF) and Skipjack Cube (WGGS / IQF) need extra vigilance because of mixing.
Written SOP. Spell out how you randomize, how you label, and how samples move to the lab. We include a one‑page “Lot Sampling Record” with date/time, sampler name, carton IDs, and a simple grid of results 1–9.

Practical takeaway: If you can’t describe the lot in one sentence, it’s probably too broad for a valid n=9 test.

Week 3–6: Run and validate the n=9 sampling plan

Here’s the heart of it. We follow the EU rules in Regulation (EC) No 2073/2005.

How many units? n=9, c=2. Take nine sample units per lot.
Acceptance rules. EU histamine limits are m=100 mg/kg and M=200 mg/kg. A lot passes when: (a) the mean of the nine results is ≤ 100 mg/kg, (b) a maximum of two results may fall between 100 and 200 mg/kg, and (c) no single result is ≥ 200 mg/kg. That mean requirement trips people up.
Where to sample. Choose nine cartons spread across the stack. We alternate top/middle/bottom and front/middle/back. From each carton, take one unit that represents the product form: a saku block, a steak, a loin cut, or about 50–100 g taken from the center of a cube/ground pack.
Sample size and handling. We submit 50–100 g per unit to allow duplicates if needed. Keep at -18°C. If you must portion at 0–4°C, work fast and refreeze immediately. Label each bag “Lot, Unit #, Date.”
Individual vs composite. For final EU lot release, test nine individual units. Composites are fine for intake screening, but they don’t meet the c=2 and mean criteria.
Method and lab. Use an ISO/IEC 17025 accredited lab with a validated method such as HPLC-UV or LC-MS. Enzymatic/spectrophotometric methods can be valid if the lab is accredited for them. In Indonesia, look for KAN-accredited labs that reference 2073/2005 on the report.
Turnaround time. Typical TAT is 24–72 hours. We sample two to three days before stuffing so we’re not gambling at the loading door.

Example. Suppose your nine results for Yellowfin saku are: 42, 58, 67, 91, 102, 109, 114, 121, 135 mg/kg. Mean is 93 mg/kg. Two results are between 100 and 200. None ≥ 200. The lot passes. If the mean were 108, the same set would fail even with no result ≥ 200.

Practical takeaway: Ask your lab to report all nine values and the mean right on the CoA. Many EU BCPs have started asking for raw data in the last six months.

Week 7–12: Scale and optimize your release program

Once the SOP runs smoothly, we automate what we can and keep the risk controls where they matter.

Frequency. EU compliance is per lot, not per day or per container. If a container has three lots, you’ll have three n=9 sets. Don’t “share” nine units across multiple lots.
Temperature and time. Histamine is a time-temperature story. We tie our sampling schedule to cold‑chain checks at receiving and during processing. Three out of five plants we’ve helped reduced borderline results simply by tightening blast-freezer loading and monitoring core temps.
Rapid kits. We use lateral‑flow or enzymatic rapid kits as in‑process screens at receiving and trimming. They’re great for quick decisions. But for EU documentation, we rely on ISO 17025 lab CoAs.

Need help mapping your exact lot structure to the n=9 plan or choosing a KAN-accredited lab with 48‑hour TAT? Just Contact us on whatsapp. We can share the sampling record template we use internally.

The questions buyers and auditors actually ask

What is the EU histamine limit for tuna exports?

For fishery products from species associated with high histidine, including tuna, the limit uses m=100 mg/kg and M=200 mg/kg with an n=9, c=2 sampling plan. The lot passes only if the mean of the nine is ≤ 100 mg/kg, at most two results fall between 100 and 200 mg/kg, and none is ≥ 200 mg/kg.

How many units do I test per lot under n=9 c=2?

Nine units per lot. Not per container and not per day unless day equals lot. Pull units from across the stack to reflect the whole lot.

Can I composite subsamples, or must I test nine individual units?

For EU lot release, test nine individual units. Composites may be used for internal screening only. They can mask highs and won’t satisfy the c=2 and mean criteria.

Do rapid histamine kits satisfy EU import requirements, or do I need ISO 17025 lab results?

Rapid kits are useful for HACCP checks but won’t carry you through an EU border check. Use an ISO/IEC 17025 accredited lab and ensure the CoA shows method, accreditation scope, and all nine values with the mean.

How should I define a ‘lot’ in a tuna plant?

One lot per unique spec and production run. Practical examples we use: “Yellowfin steak, 6–8 oz, 14 Jan, vessel ABC-21, cartons 1–280,” or “Bigeye loin, sashimi, 15 Jan, vessel XYZ-09, cartons 1–150.” Avoid mixing species, forms, or dates. If you’re shipping mixed items, create separate lots and CoAs. This keeps EU BCP questions to a minimum.

What happens if one of the nine is over 100 mg/kg but below 200 mg/kg?

You can have up to two such results and still pass if the mean of nine is ≤ 100 mg/kg. If any single result is ≥ 200 mg/kg, the lot fails. If the mean exceeds 100 mg/kg, the lot fails even if all nine are < 200 mg/kg.

What documents should accompany my shipment to pass EU border checks for histamine?

CoA from an ISO 17025 lab showing nine results and the mean, method and accreditation.
Your Lot Sampling Record referencing carton IDs and dates.
Health/Zoosanitary Certificate issued by BKIPM, linked to the lot(s).
Catch certificate and traceability documents as required by the EU IUU rules.
CHED-P in TRACES NT prepared by the importer’s agent.

We’ve found that providing the nine raw results upfront reduces detention time if the BCP decides to sample.

The five mistakes that kill shipments

Testing per container, not per lot. Containers often mix lots. EU criteria are lot-based.
Composite-only testing. It’s fine for screening. It’s not acceptable for final release.
Ignoring the mean rule. Two allowed between 100 and 200 doesn’t help if your mean creeps above 100.
Sampling from the same corner. Spread your nine across the stack and layers. Risk isn’t evenly distributed.
Shipping before the CoA is in hand. If your lab TAT is tight, sample earlier. We’ve adjusted cutting plans to allow a 48‑hour window without delaying stuffing.

Resources and next steps

If you’re aligning multiple tuna SKUs to EU n=9, start with your three highest-volume items. For most Indonesian exporters, that’s usually Yellowfin Steak, Yellowfin Saku (Sushi Grade), and Bigeye Loin. Lock in clean lot definitions, build one sampling record template, and replicate. When in doubt, err on the side of defining smaller, more homogeneous lots.

One final nuance. EU 2073/2005 has different limits for enzymatically matured fishery products like fermented anchovies. That doesn’t apply to standard tuna steaks, loins, saku, cubes or ground meat. Canned tuna must still meet the same m=100/M=200 mg/kg rule under n=9 c=2 with the mean ≤ 100. Histamine is heat‑stable, so canning doesn’t “fix” a high result.

We keep our program simple: define tight lots, pull a smart nine, use an accredited lab, and show our work. That’s what buyers and border posts are looking for in 2025. If you want a quick review of your CoA format or sampling SOP, Contact us on email.