Regulation (EU) 2026/765
Pesticide sampling and 50% MU — supplements from 1.1.2027

Operational question for supplement manufacturers, importers and QA (botanicals, collagen, powders): how does Reg. 2026/765 change official pesticide-residue sampling and the 50% measurement-uncertainty rule — and when is a lot non-compliant under x − U > MRL? Answer from the act: from 1 Jan 2027, packaged food supplements follow Table 3(d) incremental counts, a minimum laboratory sample of 0.1 l / 0.1 kg, and binding interpretation with default expanded MU 50% (copper 20%). CELEX 32026R0765.

1. What does the act do?

Commission Implementing Regulation (EU) 2026/765 of 1 April 2026 (OJ L series 2026/765, 7.4.2026; ELI: eli/reg_impl/2026/765/oj; EUR-Lex: CELEX 32026R0765):

• Article 1 — subject matter: sampling and sample preparation for food; laboratory analysis, MU and interpretation for food and feed — to verify MRLs under 396/2005;
• Article 3 — food sampling/preparation: Parts A and B of the Annex;
• Article 4 — analysis / MU / interpretation (Part C) for food and, by derogation from Articles 2–3 of Regulation 152/2009, for feed (feed sampling still under Annex I / Part A of Annex II to 152/2009);
• Article 5 — repeals Directive 2002/63/EC;
• Article 6 — entry into force on the twentieth day after OJ publication → 27 April 2026; applies from 1 January 2027.

Legal base: Art. 34(6) of Regulation (EU) 2017/625 (OCR). Recital (6) expressly calls for clarity for high-value products, certain processed foods and food supplements. Recital (7): EURL AQC principles on reporting and interpretation become binding.

2. Sampling food supplements — Tables 3(d), 4 and 5

For packaged food supplements, Table 3(d) sets the minimum number of incremental samples by the number of packages in the lot/sublot:

Minimum laboratory-sample size for food supplements:

• Table 4 point 11.2 — Food Supplements (example: Collagen) — packaged units; 0.1 l or 0.1 kg;
• Table 5 point 7.6 — Food Supplements (examples: Ashwagandha, acai, spirulina) — packaged units; 0.1 l or 0.1 kg.

B.4: a smaller laboratory sample than in Tables 4 and 5 may be taken in duly justified cases (such as high product value), provided analysis remains feasible — the reason must be noted in the sampling report.

3. The 50% MU rule: when is a lot non-compliant?

Annex Part C binds reporting and interpretation:

• report the analytical result as x ± U (C.1.2);
• when checking MRL exceedances, official labs and authorities apply a default expanded MU of 50% (coverage factor k=2, 95%); exception: copper — 20% (C.2.2);
• the laboratory must show its own expanded MU for the method/substance/commodity group is ≤ the default; on MRL exceedances it reports the harmonised default MU;
• if IESTI > ARfD, the authority may as a precaution apply a lower MU / lower k;
• on MRL exceedance: confirm identity + duplicate independent analysis (C.1.1);
• the analytical sample must contain the correct product part(s) under Annex I to 396/2005.

4. What this means for supplement operators

• Update sampling SOPs / lab contracts so that from 1 Jan 2027 they apply Table 3(d) and the x − U rule;
• do not assume “x slightly above MRL” is automatically fine — the decision turns on x − U;
• do not confuse this act with Reg. 2019/1793 border-control lists or with new MRLs;
• national supplement notification and FIC / 1924/2006 duties remain separate tracks.

5. Operator checklist

1. Does the QA procedure use application date 1 Jan 2027 (not only EIF 27 Apr 2026)?
2. Do packaged-supplement incremental counts match Table 3(d)?
3. Does the lab receive at least 0.1 l/0.1 kg — or a documented B.4 high-value exception?
4. Does MRL interpretation use x − U ≤ / > MRL with default U=50% (Cu=20%)?
5. On exceedance: identity confirmation + independent duplicate?
6. Is the team clear that 2026/765 ≠ new MRLs, ≠ 2019/1793, ≠ claims, ≠ national notification?

Glossary

MRL

Maximum residue level — Regulation (EC) No 396/2005.

U (expanded MU)

Expanded measurement uncertainty; default 50% (k=2), Cu 20%.

x − U

Result after subtracting expanded MU — basis of the C.2.4 compliance decision.

Table 3(d)

Dedicated incremental-sample scale for packaged food supplements.

OCR 2017/625

Official Controls Regulation — Art. 34(6) legal base for 2026/765.

Conclusion

From 1 January 2027, Regulation (EU) 2026/765 replaces Directive 2002/63/EC and gives supplement operators clear sampling counts (Table 3(d)), a 0.1 kg/l laboratory minimum, and a binding rule: a lot is non-compliant only when x − U > MRL under the default 50% MU (Cu 20%). The act does not change the MRLs themselves or border-control lists — it changes how authority and laboratory reach a lot decision.

Primary sources

1. Commission Implementing Regulation (EU) 2026/765 — CELEX 32026R0765; ELI eli/reg_impl/2026/765/oj; OJ L 7.4.2026; EIF 27.04.2026; applies 1.01.2027.
2. Regulation (EC) No 396/2005 — MRLs (unchanged by this act).
3. Regulation (EU) 2017/625 — OCR; Art. 34(6).
4. Directive 2002/63/EC — repealed (Art. 5 of 2026/765).
5. Regulation (EC) No 152/2009 — feed sampling still Annex I / Part A Annex II; MU/interpretation under 2026/765.