evaluations and additional literature. The Panel considered the available toxicological data too limited to

Overview

This source page is a mechanical bulk-ingest record for a PDF in the methylmercury infant-formula research pull. It preserves source-level identity, routeable product/analyte scope, and exact extracted numeric lines for later human or fresh-context audit. It does not derive HMTc thresholds, percentiles, or brand-by-brand comparisons.

Key numbers

The worker extracted the full PDF text with layout preservation twice and compared extraction hashes before commit. The following lines are copied from numeric/table-bearing regions of the PDF and retain the source units and wording where legible:

EFSA Journal 2012;10(4):2592
Scientific Opinion on the re-evaluation of vegetable carbon (E 153) as a
The EFSA ANS Panel provides a scientific opinion re-evaluating the safety of vegetable carbon (E 153).
Vegetable carbon has been evaluated previously by the SCF (1977, 1983) and by JECFA (1970, 1977, 1987).
use levels vegetable carbon (E 153) containing less than 1.0 µg/kg of residual carcinogenic PAHs expressed as
benzo(a)pyrene using a validated analytical method of appropriate sensitivity (e.g. LOD of 0.1 µg/kg). The
estimated dietary exposure of European children to vegetable carbon ranged from 3 to 29.7 mg/kg bw/day at the
mean, and from 15.3 to 79.1 mg/kg bw/day at the 95th/97.5th percentile. The dietary exposure of UK adults was
3.8 mg/kg bw/day at the mean, and 28.1 mg/kg bw/day for high level (97.5th percentile) consumers.
Vegetable carbon, E 153, carbon, CAS Registry Number 7440-44-0, carbon black, CAS Registry
2 Panel members: F. Aguilar, R. Crebelli, B. Dusemund, P. Galtier, J. Gilbert, D.M. Gott, U. Gundert-Remy, J. König, C.
evaluation of vegetable carbon (E 153) as a food additive. EFSA Journal 2012;10(4):2592. (34 pp.)
doi:10.2903/j.efsa.2012.2592. Available online: www.efsa.europa.eu/efsajournal.htm
Re-evaluation of vegetable carbon (E 153) as a food additive
scientific opinion re-evaluating the safety of vegetable carbon (E 153) when used as a food colouring
The EINECS number 215-609-9 in the EC specifications for vegetable carbon (E 153) (Directive
JECFA (JECFA, 2006). The purity is specified as ≥ 95%, calculated on an anhydrous and ash-free
colouring power of 25 and the particle size distribution of the two commercial available preparations
are characteristically 10% < 2 μm, 50% < 5 μm, and 90% < 55 μm or 10% < 1 μm, 50% < 4 μm, and
2011b). The Panel concluded that the presence of nanoparticles in vegetable carbon products currently
receiving 7 mg 7Be-labelled furnace black nanoparticles (27 nm diameter) by oral administration,
vegetable carbon used as a food additive is characteristically 10% < 2 μm, 50% < 5 μm, and 90%
of particles below 275 nm, the Panel considered that vegetable carbon microparticles may also be
EFSA Journal 2012;10(4):2592 2
Re-evaluation of vegetable carbon (E 153) as a food additive
limit of detection of 0.1 µg/kg).
1.0 µg/kg of residual carcinogenic PAHs expressed as benzo(a)pyrene, using a validated analytical
vegetable carbon (E 153). Studies done with carbon blacks without PAHs did not show carcinogenic
9 to 18% in mice and rats (estimated to be equivalent to 4500-9000 mg/kg bw/day for rats and
13 500-27 000 mg/kg bw/day for mice).
give a dietary exposure to vegetable carbon of 3.7 mg/kg bw/day at the mean and of 28.1 mg/kg
bw/day for high level (97.5th percentile) consumers. The main contributors (> 10%) to the total
anticipated mean exposure to vegetable carbon were confectionery (41%) and desserts including
exposure of European children, ranged from 3 to 29.7 mg/kg bw/day at the mean, and from 15.3 to
79.1 mg/kg bw/day at the 95th/97.5th percentile. The main contributors to the total anticipated mean
exposure to vegetable carbon (> 10% in all countries, these contributions differed per country) were
the BMDL10 of 0.07 mg/kg bw/day derived by the EFSA Scientific Panel on Contaminants in Food
of 17 900 and 10 800 using the average and high level dietary exposures of benzo(a)pyrene across
Europe. Using the BMDL10 values derived by the CONTAM Panel for benzo(a)pyrene, the margins of
range from 25 to 189 million if benzo(a)pyrene were at the limit of detection (0.1 μg/kg) and from 2.5
EFSA Journal 2012;10(4):2592 3
Re-evaluation of vegetable carbon (E 153) as a food additive

Methods (brief)

benzo(a)pyrene using a validated analytical method of appropriate sensitivity (e.g. LOD of 0.1 µg/kg). The
matter sample with 20 ml N sodium hydroxide sample with 20 ml N sodium hydroxide
methanol/tetrahydrofuran (1:1) mixture and analysed by HPLC with fluorimetric detector. This
(E 153). The limit of detection (LOD) and the limit of quantification (LOQ) are reported to be 0.1 and
method of appropriate sensitivity (e.g. with a LOD of 0.1 µg/kg). Such a method is proposed for the
HPLC” (OENO 18/2003).
sample can be broken down and dissolved with nitric acid. The resulting solution is filtered and treated
determined gravimetrically with a LOD of 0.0001%. The presence of vegetable carbon in residues
carbon with two concentrations: 0.1 µg/kg which corresponds to the LOD and 1 µg/kg which
When considering the LOD of 0.1 µg/kg, the dietary exposure to PAHs expressed as benzo(a)pyrene
administered either para-dimethylaminoazobenzene (DMAB), methyl cholanthrene, or 3,4-
exception of the group receiving DMAB adsorbed onto carbon blacks, in which an increased incidence
carbon should be below the LOD of 0.1 µg/kg, data reported by NATCOL suggested that the levels
expressed as benzo(a)pyrene, from vegetable carbon at both the LOD value for benzo(a)pyrene and at
When considering the LOD on of PAHs as 0.1 µg/kg, the dietary exposure to PAHs expressed as
carbon at concentrations of 0.1 µg/kg (LOD of PAHs expressed as benzo(a)pyrene) and 1 µg/kg
would range from 25 to 189 million if benzo(a)pyrene were at the LOD (0.1 µg benzo(a)pyrene/kg
benzo(a)pyrene using a validated analytical method of appropriate sensitivity (e.g. with a LOD of 0.1

Implications

This page makes the source discoverable for category-level evidence routing. Values remain source-native and should be used only with the stated matrix, species, basis, geography, and censoring context from the paper. The page does not convert total mercury to methylmercury or use total arsenic as inorganic arsenic.

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Verification notes

Identity check: DOI, raw handle, candidate cite-key, and SHA-256 were compared against existing wiki/sources/ pages before creation.
Full-PDF read: pdftotext -layout was run on the full PDF twice; extracted text hashes matched before the page was written.
Numeric verification: numeric/table-bearing lines were selected mechanically from the verified extraction and preserved without unit conversion or rounding.
Brand firewall: the worker skips PDFs when extracted numeric lines appear brand/manufacturer-sensitive; this page contains category-level or species-level evidence only.
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Update history

The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and 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.

Commit	Date	Change	Description
3171d06	2026-08-02	major	1 section added
bc84bfc	2026-08-02	major	6 sections added; narrative text revised