EFSA 2004 - Organotins in foodstuffs

The EFSA CONTAM Panel assessed dietary exposure and health risk for organotin compounds in foodstuffs, focusing on tributyltin (TBT), dibutyltin (DBT), triphenyltin (TPT), and dioctyltin (DOT) because of shared immunotoxicity concerns. The occurrence assessment uses the EU SCOOP Task 3.2.13 database for fish and fishery products, including fish plus seafood other than fish such as molluscs, crustaceans, cephalopods, and echinoderms. These values are species-specific organotin occurrence and exposure data; they must not be collapsed into total tin or inorganic tin.

Key numbers

The Panel established a group TDI of 0.25 µg/kg b.w. for TBT, DBT, TPT, and DOT compounds. The same summary states this is 0.1 µg/kg b.w. when expressed as Sn content, or 0.27 µg/kg b.w. when expressed as TBT chloride. The TDI was derived from a TBT oxide NOAEL for immunotoxicity of 0.025 mg/kg b.w./day and a safety factor of 100.

Table 3 reports selected organotin concentration descriptors in European fish and fishery products as µg/kg, whole weight basis. The table below transcribes the compounds the Panel used for exposure assessment and risk characterization.

Table 4 reports the same descriptors for European “seafood other than fish” as µg/kg, whole weight basis.

Table 5 reports the same descriptors for European fish as µg/kg, whole weight basis.

The summary reports fully aggregated fish and fishery product medians of TBT 7.0 µg/kg, DBT 2.5 µg/kg, and TPT 4.0 µg/kg fresh weight, with corresponding means about 4- to 7-fold higher. It also states that concentrations of organotins in seafood other than fish are generally higher than in fish, and that DOT data in the SCOOP report were very few and always below the limit of determination.

For exposure modeling, EFSA used Norway as the high-consumption European paradigm. Average-consumer seafood intakes used 10 g/day/person for seafood other than fish and 70 g/day/person for fish. High-consumer Q.95 intakes used seafood other than fish 16 g/person/day (0.27 g/kg b.w./day), fish 149 g/person/day (2.5 g/kg b.w./day), and total fish and fishery products 165 g/person/day (2.8 g/kg b.w./day).

Table 1 reports intakes as x 10-3 µg/kg b.w./day for aggregated fish and fishery products.

The text converts these totals to 0.018 µg/kg b.w./day and 0.083 µg/kg b.w./day for average consumers using median- and mean-based concentrations, and to 0.037 µg/kg b.w./day and 0.17 µg/kg b.w./day for high consumers. The Panel also states that combining the TBT Q.95 occurrence figure with total high-consumer fish/fishery intake (2.8 g/kg b.w./day) gives an exposure estimate of approximately 0.30 µg/kg b.w./day.

Methods (brief)

EFSA reviewed organotin exposure and toxicology in response to European Commission mandate EFSA-Q-2003-110. The occurrence assessment used EU SCOOP Task 3.2.13 data submitted by eight European countries for fish and seafood products, with selected analytical data covering 1995-2002. The raw occurrence analysis used the WHO/GEMS medium-bound approach and non-parametric statistics; NWEIGHTED was used because many reported concentration values represented averaged analytical results rather than individual observations. Analytical methods were not harmonized across countries, and EFSA notes that many monitoring plans were not designed specifically for human-intake estimation.

Implications

This source provides the EU regulatory anchor for organotin occurrence and exposure in fish and seafood. It supports seafood, fish, canned-fish, shellfish, mollusc, and bivalve routing for TBT, DBT, TPT, and related organotin species on a µg/kg whole-weight/fresh-weight basis. Downstream use must preserve species identity and should not use these organotin values as total tin or inorganic tin.

Verification notes

• PDF text was extracted with pdftotext -layout; occurrence Tables 3-5 and exposure Table 1 were checked in the extracted text.
• DOI 10.2903/j.efsa.2004.102, raw handle MFK_efsa-journal-2004-opinion-scientific-panel-contam, and cite-key checks found no existing source page before creation.
• TDI values, occurrence descriptors, exposure-intake values, sample counts, participating-country list, and sampling-period notes were checked against the extracted text. Units are preserved as µg/kg, µg/kg b.w., µg/kg b.w./day, mg/kg b.w./day, and g/person/day; no conversion was performed.
• Speciation: the source reports organotin species including TBT, DBT, MBT, TPT, DPT, and MPT, with risk characterization focused on TBT, DBT, TPT, and DOT. Frontmatter uses Sn for element-level routing, but this page must route toxicology and occurrence interpretation to organotins and must not collapse organotin species into inorganic tin.
• Brand firewall: no brand-level food measurements are reported.
• Frontmatter slugs were checked against docs/gpt-collaboration/taxonomy-snapshot.md; missing narrow closed-vocabulary slugs include crustaceans, cephalopods, and echinoderms, so broad seafood/shellfish/mollusc routing is used.

Page history

The five most recent substantive edits to this page. The full version history lives in git; when DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.