supplements targeting the general population excluding infants, and in total diet

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:

the 90-day study did not show effects of toxicological relevance for humans up to
the highest dose tested (7753 mg/kg bw per day). The NF may retain the allergenic
© 2025 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
EFSA Journal. 2025;23:e9537. efsa.onlinelibrary.wiley.com/journal/1831-4732 | 1 of 22
2 of 22 | cRG-I AS A NOVEL FOOD
1.1. Background and Terms of Reference as provided by the requestor��3
3.4. Compositional data��6
3.7.3. Anticipated intake of the NF as food ingredient�� 10
3.7.4. Anticipated intake of the NF as food supplement�� 10
3.7.5. Combined intake of the NF from its use as ingredient and other forms��11
3.7.6. Combined intake of cRG-I from the NF and other sources��11
3.8. Absorption, distribution, metabolism and excretion (ADME)�� 12
3.9. Nutritional information�� 13
3.10. Toxicological information�� 13
3.14. Allergenicity�� 15
cRG-I AS A NOVEL FOOD | 3 of 22
1.1 | Background and Terms of Reference as provided by the requestor
On 17 December 2022, the company NutriLeads B.V. submitted an application to the European Commission in accordance
with Article 10 of Regulation (EU) 2015/2283 to authorise the placing on the Union market of rhamnogalacturonan-I
carrot fibre (cRG-I) as a novel food in several foods. The applicant has also requested data protection under Article 26 of
In accordance with Article 29(l)(a) of Regulation (EC) No 178/2002, the European Commission asks EFSA to provide a
scientific opinion on rhamnogalacturonan-I enriched carrot fibre (cRG-I) as a novel food in accordance with Article 10(3) of
Regulation (EU) 2015/2283. The Commission also asks EFSA to evaluate and inform the Commission as to whether and if so,
to what extent, the requirements of Article 26(2)(c) of Regulation (EU) 2015/2283 are fulfilled in elaborating its opinion on
Administrative and scientific requirements for NF applications referred to in Article 10 of Regulation (EU) 2015/2283 are
listed in the Commission Implementing Regulation (EU) 2017/2469.1
preparation and presentation of a NF application (EFSA NDA Panel, 2021). As indicated in this guidance, it is the duty of the
the preparation and presentation of a NF’ (EFSA NDA Panel, 2021) and the ‘Administrative guidance for the preparation of
In accordance with Article 38 of Regulation (EC) No 178/20022 and taking into account the protection of confidential
information and of personal data in accordance with Articles 39 to 39e of the same Regulation, and of the Decision of EFSA’s
Executive Director laying down practical arrangements concerning transparency and confidentiality,3 the non-confidential
version of the dossier has been published on Open.EFSA.4
the practical arrangements on pre-submission phase and public consultations,2 EFSA carried out a public consultation
on the non-confidential version of the technical dossier from 1 August to 22 August 2024 for which no comments were
The assessment follows the methodology set out in the EFSA guidance on NF applications (EFSA NDA Panel, 2021) and the
for the assessment are laid down in Article 11 of Regulation (EU) 2015/2283 and in Article 7 of Commission Implementing
Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law,
The non-confidential version of the dossier has been published on Open.EFSA and is available at the following link: https://open.efsa.europa.eu/questions/EFSA- Q -2023-
4 of 22 | cRG-I AS A NOVEL FOOD
Panel, 2010) does not reflect the additional requirement of having a beneficial physiological effect demonstrated by gen-
erally accepted scientific evidence laid down in Annex I of Regulation (EC) 1169/20115 for:

Methods (brief)

Sodium mg/kg 890 790 750 860 840 1600 880 1000 1200 1500 ICP-MS
Magnesium mg/kg 1200 1000 1100 1100 1200 2100 1500 1400 1600 1300 ICP-MS
Potassium mg/kg 4500 5700 5600 6200 4400 4900 3400 3400 4500 5600 ICP-MS
Calcium mg/kg 7400 5900 7400 6800 8100 13,000 7000 7000 7000 6800 ICP-MS
Phosphorous mg/kg 240 190 270 340 240 220 250 220 310 480 ICP-MS
Copper mg/kg 0.99 0.82 1.2 0.63 0.51 0.91 0.55 0.78 0.50 0.44 ICP-MS
Zinc mg/kg 27 29 38 24 28 32 15 15 18 16 ICP-MS
Aluminium mg/kg < 0.8 1.1 < 0.8 0.89 0.94 1.4 3.1 5.8 9.8 13 ICP-MS
Boron mg/kg 190 160 190 110 200 140 < 2.0 140 110 95 ICP-MS
Iron mg/kg 27 28 31 26 27 27 14 48 63 85 ICP-MS
Manganese mg/kg 17 20 33 15 17 25 0.47 16 16 16 ICP-MS
Nickel mg/kg 0.14 0.16 0.19 0.15 0.14 0.32 < 0.08 0.14 0.28 0.19 ICP-MS
Selenium mg/kg < 0.04 < 0.04 < 0.04 < 0.04 < 0.04 < 0.04 0.44 < 0.04 < 0.04 < 0.04 ICP-MS
Arsenic mg/kg < 0.04 < 0.04 < 0.04 < 0.04 < 0.04 0.05 < 0.04 < 0.04 < 0.01 < 0.01 ICP-MS
Cadmium mg/kg 0.60 0.55 0.95 0.51 0.64 0.75 0.10 0.10 0.09 0.11 ICP-MS
Mercury μg/kg 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 0.5 0.5 ICP-MS
Lead mg/kg 0.40 0.47 0.84 0.42 0.42 0.62 0.18 0.22 0.15 0.16 ICP-MS
Note: ICP-MS was performed as internal method.

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.

Wiki pages this source may touch

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.
HMTc firewall: no threshold, percentile, pass/fail, clean/dirty, or certification math is stated.

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