Sadhya and Saha 2023 — Regulation of heavy metals in food and food packaging in India

Sadhya and Saha, both law faculty in India, review the Indian regulatory framework governing heavy metals in food items and food packaging, then survey published Indian primary studies that document recurring exceedances of those regulatory limits. The paper reproduces the per-metal, per-food-article concentration limits in Table 1 of the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations 2011 (as amended 7 August 2020), the migration limits in Table 3 of the Food Safety and Standard (Packaging) Regulations 2018 for seven metals (Ba, Co, Cu, Fe, Li, Mn, Zn), and the principal prohibitions of those Regulations (recycled plastic, newspaper wrapping, unlined copper/brass utensils, reuse of tin containers). The authors conclude that despite a layered regulatory architecture, several Indian primary studies report market-site samples that exceed the Indian and FAO maximum permissible limits, and that enforcement gaps, not the limit values themselves, are the operative problem.

Key numbers

All numbers below are reproduced from the article. The review reports no primary measurements; the regulatory-limit values are excerpts from the Indian Regulations themselves and the field-survey values are second-hand from the six cited primary studies.

Food Safety and Standards (Contaminants, Toxins and Residues) Regulations 2011 — Table 1 (excerpted on p. 1334, reproduced in this review’s Table 1)

The review reproduces the named-metal row of the Regulation’s Table 1 verbatim. The 2011 Regulations were amended on 7 August 2020 and the amendment came into force on 1 July 2021 (review p. 1334). Eleven heavy metals are named: lead, copper, arsenic, tin, cadmium, mercury, methyl mercury, chromium, nickel, selenium, antimony.

The review’s body text on p. 1334 names further per-article lead limits from the Regulation that do not appear in the excerpted Table 1 row above: baking powder 10 ppm, canned mushrooms 1.0 ppm, canned fish 5.0 ppm, concentrated soft drinks 0.5 ppm, edible oil and fats 0.5 ppm, fish 0.3 ppm, ready-to-drink fruit juices 0.05 ppm, and “food items not specified” 2.5 ppm.

The review’s body text on p. 1334 names further per-article copper limits from the Regulation: coffee beans 30 ppm, cocoa powder 70 ppm, hard-boiled sugary confectionery 5.0 ppm, tea 150 ppm, soft drinks 7.0 ppm, tomato ketchup 50 ppm, and “unspecified food items” 30 ppm.

The review’s body text on p. 1335 names further per-article arsenic limits from the Regulation: fish and crustaceans 76 ppm, hard-boiled sugar confectionery 1.0 ppm, milk 0.1 ppm, vegetable oil 0.1 ppm. (The 76 ppm value for fish and crustaceans is reproduced verbatim from the review’s body text on p. 1335 and is anomalously high relative to other arsenic-in-fish limits worldwide, which typically fall well below 2 mg/kg total arsenic; this value is flagged in Verification notes as a likely typographic error in the source. Verification against the FSSAI Gazette is required before this value is used downstream.)

The review’s body text on p. 1335 names further per-article cadmium limits from the Regulation: fish 0.3 ppm, “unspecified food articles” 1.5 ppm, leafy vegetables 0.2 ppm, potato 0.1 ppm, wheat 0.2 ppm.

The review’s body text on p. 1335 names further per-article mercury limits from the Regulation: fish 0.5 ppm, salt 0.1 ppm, vegetables 1.0 ppm, packaged drinking water 0.001 ppm, non-predatory fish/crustaceans/cephalopods/molluscs 0.5 ppm.

The review’s body text on p. 1335 names further per-article chromium limits from the Regulation: all fishery products 12 ppm, mineral water 0.05 ppm, refined sugar 0.02 ppm.

Food Safety and Standards (Contaminants, Toxins and Residues) Regulations 2011 — Table 2 (excerpted on p. 1334)

The review reproduces six crop-contaminant limits (mycotoxins) for completeness. Mycotoxins are outside the heavy-metal scope of this wiki and are listed here only for fidelity to the article.

Food Safety and Standard (Packaging) Regulations 2018 — Table 3 (reproduced on p. 1335)

Maximum migration limits (mg/kg) onto food for substances in plastic packaging, listed in Reg 4(4)(c) and Table 3 of the 2018 Regulations. The Regulations came into force on 1 July 2019 (review p. 1335). The review notes that the seven substances below sit alongside other plastic-packaging restrictions: Reg 3(7) prohibits reuse of tin containers; Reg 3(8) bans recycled plastic as a packaging material; Reg 3(9) requires Indian Standards compliance for printing ink on labels; Reg 3(11) bans newspaper for wrapping food items; Reg 4(3)(a)(iii) prohibits unlined copper or brass utensils for food preparation.

Primary studies cited and summarised by the review

Das & Das 2018 (Kolkata, 2014) — across 20 local markets, eight common food items (rice, red lentil, cumin, locally made biscuit, red spinach, fish, chicken, tulsi). Red spinach mean Pb 32.11 mg/kg (32.11 ppm). Mean As highest in fish at 2.52 mg/kg (2.52 ppm), then red spinach 0.47 mg/kg (0.47 ppm). Review citation [11].

Sharma et al. 2009 (Varanasi, September 2004 – March 2005) — Zn, Cd, Cu, and Pb in spinach, cauliflower, and lady’s finger collected paired at production sites and market sites. Concentrations generally lower at the production site and generally exceeding the permissible limits at the market site, with Cd exceeding permissible standards even at production sites. The review draws the methodological point that mode of transport, marketing system, time interval between production and consumption, and other production factors materially affect the concentration found at the consumer-facing market sample. Review citation [16].

Santhi et al. 2008 (Chennai) — 48 samples of frozen and canned pork meat from Chennai retail outlets, tested for Cd, Cr, Cu, Pb, Zn. 95.83% of samples exceeded the maximum permissible Cd limit (0.1 mg/kg, FAO standard cited by the article as footnote 7). 25% of samples exceeded the Pb maximum permissible limit (2.5 ppm, Meat Food Products Order standard, review footnote 8). 20.83% of samples exceeded the Zn permissible limit (50 ppm, Meat Food Products Order standard, review footnote 9). Cr exceedance also reported above limit. The review notes the cited primary study tested against the US FDA standards and the Meat Food Products Order 1973 (an erstwhile Department of Agriculture order, predecessor to the current FSSR framework), not the current Indian Regulations; the review nonetheless concludes the same samples would breach the current FSSR limits. Review citation [12].

Mathaiyan et al. 2021 (four metropolitan cities of Tamil Nadu) — Pb, Cd, As, Hg in edible parts of broiler chicken. Pb concentrations in chicken breast (MRL 0.1 mg/kg) and liver (MRL 0.5 mg/kg) exceeded the MRL in all four cities. As concentrations in chicken breast exceeded an MRL of 0.1 mg/kg in all four cities. Review citation [13].

Swati & Chhaya 2019 (Indian markets) — 10 commercially available food packaging papers and paperboards examined for 14 heavy metals including As, Pb, Ni, Te, Ti, Cr, Ba, V. Sample types covered paper plate, cake box, fruit tray, tissue paper, coffee cup, pastry box, sweet box, pizza box, French fries box, paper bags. Pizza boxes were highest in Al, As, Cu, Fe, Ni, V. Paper plates were highest in Mn, Pb, Te. Fruit trays were also high in Te. Pastry boxes were highest in Ba, Cr, with the same metals also highest in French fries boxes and coffee cups. The review treats this as evidence that paper-based food packaging in India contributes a non-trivial heavy-metal load comparable in significance to the plastic-packaging concerns the 2018 Packaging Regulations address. Review citation [14].

Methods (brief)

This is a legal review article, not an empirical study. The authors are law faculty (NLSIU and the University of Burdwan). The Crimson Publishers journal classifies the article as “Review Article” with submission 30 October 2023 and publication 21 December 2023 (Volume 11, Issue 5). The article carries CC BY 4.0 licensing. The review presents no original measurements, no analytical-method details, no sampling protocol, and no statistical analysis. Its quantitative content is two excerpts from the 2011 Regulations (Tables 1 and 2 of the article), one excerpt from the 2018 Packaging Regulations (Table 3 of the article), and prose summaries of six cited Indian primary studies. References include several non-academic sources (CBS Mornings 2019, Investopedia, Consumer Reports 2010) alongside the academic citations.

The non-academic references in the bibliography and the limited methodological rigor of a Crimson Publishers law-review article support the C-tier evidence rating. The review’s value to this wiki is twofold: as a regulatory-context source for the Indian FSSR 2011 (as amended 2020) and FSSR Packaging 2018 limit values, and as a pointer to the cited primary studies (Das & Das 2018, Sharma et al. 2009, Santhi et al. 2008, Mathaiyan et al. 2021, Swati & Chhaya 2019) which warrant independent ingest as primary occurrence sources for India.

Implications

Certification: Provides the regulatory backdrop for Indian (FSSR 2011 amended 2020; FSSR Packaging 2018) maximum permissible limits across the eleven named metals in food articles and seven named substances in plastic packaging. The actual rule-text values reside in the Indian Government Gazette; this review reproduces the most-cited rows. Threshold work using Indian limits as a comparator should retrieve the Gazette directly rather than relying on this review.

Courses: Useful as a single document that lays out the Indian regulatory architecture (FSSA 2006 enabling act, FSSR 2011 amended 2020 for food contaminants, FSSR Packaging 2018 for packaging-side migration limits) and points to specific primary studies showing recurring market-site exceedance. The Sharma et al. 2009 production-vs-market design is the most pedagogically useful citation here for teaching why field-survey results depend on where in the supply chain the sample is drawn.

App: No occurrence values usable for ingredient contamination_profile. No new contamination data points.

Microbiome: Not applicable. The review does not discuss microbiome endpoints.

Wiki pages this source may touch

• lead
• copper
• arsenic
• tin
• cadmium
• mercury
• mercury-methyl
• chromium
• nickel
• antimony
• barium
• cobalt
• iron
• lithium
• manganese
• zinc
• vegetables
• leafy-vegetables
• fruit
• fish
• chicken
• canned-fish
• canned-vegetables
• canned-fruit
• mineral-water
• soft-drinks-carbonated-beverages
• food-packaging-paperboard-cartons
• food-packaging-cans-lids
• food-packaging-plastic-tubs
• food-packaging-flexible-pouches-films

Verification notes

• 2026-06-03 fresh ingest (Claude Opus 4.7, manual-fetch ingest from raw/Manual Fetch Kimi /June 3 Folder/). DOI 10.31031/EAES.2023.11.000771 verified against the article’s first page. Submission 30 October 2023, Published 21 December 2023, Volume 11 Issue 5, ISSN 2578-0336. Article is Open Access under Creative Commons Attribution 4.0 International (CC BY 4.0; statement on p. 1 of the PDF). Title and byline verified character-for-character against the PDF header.
• The PDF EAES.000771 2.pdf is byte-identical (SHA-256 4e0e51b50b4dc5c655bb27fe47729512913a7166c6b58aabfa91525696420404) to EAES.000771.pdf in the same folder. The ” 2.pdf” suffix is the macOS Finder duplicate-rename pattern. The duplicate path is recorded in near_duplicates so future identity checks resolve here.
• Regulation slugs: this paper discusses three Indian regulations that do not yet exist as wiki/regulations/ pages and are not in the current taxonomy snapshot (last regenerated 2026-05-18, snapshot lists 55 regulation slugs). The proposed slugs and citation anchors are surfaced here for Karen’s review per CLAUDE.md Part 10 — the model does not silently invent regulation pages.
  • Proposed slug: india-fssa-2006 — Food Safety and Standards Act 2006, the enabling statute. India Code citation: Act No. 34 of 2006. The Act establishes FSSAI and the rule-making authority used by the 2011 and 2018 Regulations below.
  • Proposed slug: india-fssr-contaminants-2011-amended-2020 — Food Safety and Standards (Contaminants, Toxins and Residues) Regulations 2011, as amended by the first amendment notified 7 August 2020 and effective 1 July 2021 (review p. 1334; review citation [8] is “(2020) India amends its food safety and standards (contaminants, toxins, and residues) regulations, SGS, Geneva, Switzerland”). Eleven heavy metals; per-food-article limits in mg/kg or mg/L (Table 1 of the Regulation). Companion limit tables for mycotoxins (Regulation Table 2).
  • Proposed slug: india-fssr-packaging-2018 — Food Safety and Standard (Packaging) Regulations 2018, effective 1 July 2019 (review p. 1335). Reg 3(7) tin reuse ban; Reg 3(8) recycled plastic ban; Reg 3(11) newspaper wrapping ban; Reg 4(3)(a)(iii) unlined copper/brass utensil prohibition; Reg 4(4)(c) Table 3 maximum migration limits for seven substances (Ba, Co, Cu, Fe, Li, Mn, Zn). Schedules I, II, III list Indian Standards for paper/board, metal/alloy, and plastic packaging respectively; Schedule IV indicates suggestive packaging material per food article.
• Cited Indian primary studies that warrant independent ingest as primary occurrence sources: Das & Das 2018 (Kolkata, 8 food items, Euro Mediterranean J Environ Integration 3); Sharma et al. 2009 (Varanasi, three vegetables paired production-vs-market, Food Chem Toxicol 47(3):583–591); Santhi et al. 2008 (Chennai, pork meat, Am J Food Technol 3(3):192–199); Mathaiyan et al. 2021 (Tamil Nadu, broiler chicken, Toxicology Reports 8:668–675); Swati & Chhaya 2019 (Indian packaging papers, J Environ Protection 10(3):360–368). None of these were resolvable as existing wiki/sources/ pages on cite-key grep at ingest time and are surfaced here as discovery candidates, not as auto-ingest entries.
• metals: array includes the 11 metals named in the review’s Table 1 (Pb, Cu, tAs, Sn, Cd, tHg, MeHg, Cr, Ni, Se, Sb) plus the 7 substances from the review’s Table 3 (Ba, Co, Cu — already in the 11; Fe, Li, Mn, Zn). Zn is also covered by Santhi et al. 2008 and Sharma et al. 2009 as cited. The review’s reference to arsenic uses “arsenic” generically without speciation; the page records this as tAs per CLAUDE.md Part 14 (when speciation is not specified, default to the total form). The Regulation Table 1 row 7 separately names “Methyl Mercury (Calculated as the element)” at 0.25 mg/kg for all foods alongside row 6 mercury at 1 mg/kg in alumina; both tHg and MeHg are retained. The Regulation lists Cr without hexavalent speciation; Cr (total) is used.
• evidence_tier: C reflects the Crimson Publishers law-review character of this source. The journal Environmental Analysis & Ecology Studies is open-access and DOI-issuing but Crimson Publishers titles are widely treated as low-confidence for quantitative synthesis work. The article’s bibliography mixes academic citations with non-academic citations (CBS Mornings 2019, Investopedia, Consumer Reports 2010). The page therefore functions as a regulatory-context reader rather than a primary occurrence source.
• ingredients: and products: arrays are kept broad and short despite the review’s wide regulatory sweep. The full per-food-article limit list in the FSSR Table 1 covers many additional commodities (baking powder, agar, vanaspati, refined sugar, tomato ketchup, cocoa powder, salt, etc.) that the review only enumerates without contributing primary data on; these are not added to the frontmatter to keep the routing layer’s fan-out faithful to where the review actually contributes evidence (which is regulatory-context only). The packaging-product slugs cover the Reg 4(4)(c) migration-limit scope.
• No brand names appear in the review’s body. Part 12 brand firewall not engaged. (The review names McDonald’s drinking glasses and “kajal/Surma” religious powders parenthetically in Section I as examples of non-food consumer products that can contain heavy metals; these are not in scope for the food-and-packaging focus of the page and are not reproduced.)
• No HMTc threshold proposals or comparisons appear in the review and none are introduced on the page. Part 2 wiki/HMTc firewall not engaged.
• 2026-06-03 fresh-context audit (Claude general-purpose subagent) — verdict REVISE. Two non-blocking findings, both verified and applied:
  • Check 1 ⚠️ (applied): the body-text figure of 76 ppm arsenic in fish and crustaceans is reproduced verbatim from PDF p. 1335 but is anomalously high relative to typical fish-arsenic regulatory limits worldwide (which generally sit below 2 mg/kg total arsenic) and may be a typographic error in the source. An inline caveat plus a Verification-notes flag now warn downstream readers that the value is reproduced as-printed and requires verification against the FSSAI Gazette before any use as a regulatory comparator. The wiki page does not unilaterally correct the value because the source paper is the artifact being recorded.
  • Check 2 ❌ (applied as a documented inconsistency, not removed): the metals: frontmatter array lists Se (the abbreviation vocabulary covers selenium because the Indian Regulation Table 1 explicitly names selenium with a 0.05 mg/L mineral-water limit). However no wiki/metals/selenium.md page exists, and selenium is absent from the metals taxonomy snapshot (snapshot lists 36 slugs: aluminum through zinc; selenium is not among them). The ## Wiki pages this source may touch section accordingly omits a [[metals/selenium]] link to avoid creating an orphan wikilink. Se is retained in the frontmatter array as a true subject-matter tag because the Regulation does name selenium; this is surfaced here as a missing-page proposal for Karen’s Part 10 review (proposed slug: metals/selenium). The same logic applies in principle to barium, cobalt, iron, lithium, manganese, zinc — all listed in metals: (and all present in the metals snapshot/page set as confirmed at ingest), so no inconsistency for those six. Selenium is the only metal in the array whose wiki page does not yet exist.
  • Checks 3 (speciation/methods), 4 (brand firewall), 5 (wiki/HMTc firewall) returned ✅. Check 1 numerical fidelity returned ✅ for all 11 Regulation Table 1 rows, the seven Table 3 migration-limit rows, the six Table 2 mycotoxin rows, and all five cited primary studies (Das & Das 2018; Sharma et al. 2009; Santhi et al. 2008; Mathaiyan et al. 2021; Swati & Chhaya 2019).

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.