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India Cosmetic Ingredient Regulations Explained: Cosmetics Rules 2020 and IS 4707

Posted by Cosing Checker

How India regulates cosmetic ingredients under the Cosmetics Rules 2020 and BIS standard IS 4707 Part 2, with worked examples against the EU annexes.

India runs a different legal architecture for cosmetic ingredients than the EU does. There is no single ingredient regulation with numbered annexes. Instead, a central act delegates ingredient safety to a national standard, and two separate authorities split enforcement between imports and domestic manufacturing. This article sets out how the pieces fit together, which BIS standard actually carries the prohibited and restricted lists, and three worked examples of where an ingredient's Indian status and its EU status genuinely differ.

The legal chain: Act, Rules, standard

The base law is the Drugs and Cosmetics Act, 1940, which treats cosmetics as a regulated category alongside drugs. The operative detail sits in the Cosmetics Rules, 2020, notified by the Ministry of Health and Family Welfare (G.S.R. 763(E), 15 December 2020) and administered by the Central Drugs Standard Control Organisation (CDSCO). The Rules do not spell out a prohibited-ingredients list themselves; they point to Bureau of Indian Standards (BIS) specifications for that. Industry trackers summarising the Rules describe a schedule that names the applicable BIS standards for each cosmetic category, which is the mechanism that pulls IS 4707 into binding law rather than leaving it as a voluntary industry standard.

This is the opposite structure from the EU, where Regulation (EC) No 1223/2009 lists ingredients directly in its own Annexes II to VI. In India, the ingredient list lives in a BIS standard that CDSCO's rules make mandatory by reference, and BIS revises that standard on its own publication cycle, independent of any Cosmetics Rules amendment.

CDSCO import registration vs. state manufacturing licences

Enforcement is split by where the product is made. CDSCO handles import registration: a foreign manufacturer or its Indian authorised agent applies through the CDSCO SUGAM portal for an import registration certificate before a cosmetic can be imported and sold in India. Domestic manufacturing runs through State Licensing Authorities (SLAs) instead, which issue manufacturing licences (Form COS-8 for a standalone facility and Form COS-9 for a loan licence, on applications made in Forms COS-5 and COS-6) and carry out premises inspections. A product made in India and a product imported into India are therefore cleared by two different regulators, even though both must comply with the same IS 4707 ingredient limits.

IS 4707: the standard that actually lists the ingredients

IS 4707 is issued in parts, each on its own BIS revision schedule:

  • Part 1 — Colourants: IS 4707 (Part 1):2020, the Fourth Revision, reviewed in 2024 and still current. This is the positive list of dyes, colours and pigments generally recognised as safe for use in cosmetics.
  • Part 2 — GNRAS and restricted ingredients: IS 4707 (Part 2):2025, the Fifth Revision. BIS established this edition on 9 August 2025. The prior 2017 edition stayed in force in parallel until 9 February 2026, six months after establishment, and is now withdrawn.
  • Part 3 — Preservatives allowed with restrictions: a new IS 4707 (Part 3):2025, published alongside the Part 2 revision, covering preservative-specific conditions of use.

Part 2 is organised into two annexes. Annex A lists raw materials that are Generally Not Recognised As Safe (GNRAS) and must not form part of a cosmetic's composition at all. Annex B lists substances permitted only under stated conditions — a field of use, a maximum concentration, or a required label warning, in the same style as the EU's restricted-substance annexes. Together, Annex A and Annex B are the closest Indian equivalent to the EU's Annex II (prohibited) and Annex III (restricted) lists, but they sit inside a single BIS standard rather than inside the Cosmetics Rules text itself.

What the site holds for India, and which part it comes from

cosingchecker.com/regulations/in/ currently carries 1,931 published Indian records. Every one of them is sourced to IS 4707 (Part 2):2025, the fifth revision: 1,614 are Annex A prohibited entries and 317 are Annex B restricted entries. None of the current India records come from IS 4707 Part 1 (the colourants list) or the new Part 3 (preservatives). That is a gap in the site's coverage, not a statement about the colourant list's legal content — Part 1 and Part 3 are separate BIS publications the site has not yet imported, and their absence here should be read as absence from this database, not as evidence about what those standards permit. Anyone checking a colourant's Indian status should go to IS 4707 (Part 1):2020 directly rather than assume silence on cosingchecker means anything.

How the Indian lists relate to the EU annexes

IS 4707 Part 2 was built with visible reference to international precedent, and a large share of its entries carry the same CAS numbers, the same wording, and even the same numeric limits as EU Annex II and Annex III entries. But adoption is not automatic or total: BIS revises the standard on its own timetable, some entries mirror the EU exactly, some carry different numeric limits for the same substance, and some EU entries have no Indian counterpart at all in the current data. A cosmetics-rules-2020-prohibited-ingredients check therefore cannot be done by cross-referencing the EU annexes alone — each substance needs to be checked against the current IS 4707 text itself. cosingchecker.com/market-divergence/ and cosingchecker.com/market-compare/ are built for exactly this side-by-side check across jurisdictions, including India.

Three worked examples of divergence

The following three ingredients are drawn from the site's own India records, cross-checked against the site's EU annex records for the same CAS number.

Ingredient (CAS)EU recordIndia record (IS 4707 (Part 2):2025)
Zinc pyrithione (13463-41-7)Annex II — prohibited (moved there in a 2021 update; GB mirrors this in its own Annex II)Annex B, entry 98 — restricted: permitted up to 0.1% in leave-on hair products, for a purpose other than inhibiting microbial growth
Linalool (78-70-6)Annex III, entry 84 — no concentration cap; must be declared on the label above 0.001% in leave-on products and 0.01% in rinse-off productsAnnex B, entry 81 — same labelling trigger, but the record states 0.001% for both leave-on and rinse-off products
Safrole (94-59-7)Annex II, entry 360 — prohibited, with an explicit carve-out for natural essence content up to 100 ppm in the finished product (50 ppm in oral hygiene products, none in children's toothpaste)Annex A, entry 357 — recorded as an unqualified prohibition, referring only to "the general trace and safety notes published after Annex A" rather than repeating EU-style ppm figures

Zinc pyrithione: prohibited in the EU, restricted in India

Zinc pyrithione is a widely used anti-dandruff and preservative ingredient. The EU record on cosingchecker shows it in Annex II (the prohibited list), where Commission Regulation (EU) 2021/1902 placed it on CMR (reprotoxic 1B) grounds, with the ban applying from 1 March 2022 — a stricter position than the substance's older status as a permitted preservative. India's IS 4707 (Part 2):2025 Annex B, entry 98, still permits it, but only up to 0.1% in leave-on hair products and only when it is not being used to inhibit micro-organisms in the product itself. In practice this narrows the ingredient to a cosmetic (anti-dandruff, conditioning) function rather than a preservative one — a genuine difference in legal status between the two jurisdictions, not just a difference in wording.

Linalool: same labelling logic, different numbers

Linalool is one of the 26 (now expanded) EU fragrance allergens that trigger a labelling requirement rather than a ban. The EU's Annex III, entry 84, sets two different thresholds by product type: 0.001% in leave-on products and a higher 0.01% in rinse-off products, reflecting shorter skin contact time for rinse-off formats. India's Annex B, entry 81, as recorded on the site, applies 0.001% to both leave-on and rinse-off products — it does not carry the higher rinse-off threshold that the EU uses. That is what the site's record captures; it has not been checked against the BIS text for a possible simplification in transcription. A formulator relying on the EU's 0.01% rinse-off figure for an India-bound product would be working to the wrong number; the record is a reminder to read the IS 4707 text directly for each product type rather than transplant an EU threshold across jurisdictions.

Safrole: a flat ban versus a calibrated exemption

Safrole is prohibited in the EU under Annex II, entry 360, but the EU text is not an absolute ban: it explicitly exempts the normal trace content found in natural essential oils, provided the finished product stays under 100 ppm (50 ppm in oral hygiene products, and none at all in toothpaste marketed for children). India's Annex A, entry 357, records safrole as a substance that "must not form part of the composition of cosmetic products," with a general instruction to apply whatever trace and safety notes are published alongside Annex A — the record itself does not restate the EU's specific ppm split. That does not mean India has no equivalent trace tolerance; it means the tolerance, if any, sits in IS 4707's own general notes rather than in a per-substance figure, and needs to be checked in the primary BIS text rather than assumed from the EU number.

Reading these records correctly

A record in any jurisdiction — India's IS 4707 Part 2 included — is evidence of what a named source says about a named substance on a given date. It is not a safety verdict and it is not a substitute for the primary BIS or CDSCO text. An entry's absence from cosingchecker's India data (as with Part 1 colourants and Part 3 preservatives right now) means the site has not yet imported that source, not that the substance is unregulated in India. For any decision with commercial or regulatory consequences, treat the underlying IS 4707 document, the CDSCO guidance on import registration, and the state licensing authority's own requirements as the controlling text.

Sources

  • CDSCO — Acts and Rules: Cosmetics Rules — https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Cosmetics-Rules/
  • CDSCO — Guidance Document on Registration and Import of Cosmetics into India — https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/cosmetics/Guidance-Document-on-Registration-and-Import-of-cosmetics-into-India-converted.pdf
  • ChemLinked — India Updates Cosmetic Ingredient Standards: IS 4707 (Part 2 & 3) Revised — https://cosmetic.chemlinked.com/news/cosmetic-news/india-updates-cosmetic-ingredient-standards-is-4707-part-2-3-revised
  • ChemLinked — India Cosmetic Regulation overview — https://cosmetic.chemlinked.com/cosmepedia/india-cosmetic-regulation
  • Internet Archive / BIS — IS 4707 (Part 1):2020, Classification for Cosmetic Raw Materials and Adjuncts, Part 1 Colourants (Fourth Revision) — https://archive.org/details/gov.in.is.4707.1.2020
  • EUR-Lex — Regulation (EC) No 1223/2009, consolidated text — https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02009R1223-20250901
  • legislation.gov.uk — Regulation (EC) No 1223/2009, Annex II — https://www.legislation.gov.uk/eur/2009/1223/annex/II
  • legislation.gov.uk — Regulation (EC) No 1223/2009, Annex III — https://www.legislation.gov.uk/eur/2009/1223/annex/III
  • cosingchecker.com — India jurisdiction page — https://cosingchecker.com/regulations/in/
  • cosingchecker.com — Market Divergence — https://cosingchecker.com/market-divergence/
  • cosingchecker.com — Market Compare — https://cosingchecker.com/market-compare/

About this article

This article is part of the CosIng Checker blog, where we publish guides, notes and practical explainers about EU cosmetic ingredients, Annex II–VI restrictions, warnings, preservatives, UV filters, colorants and related compliance topics.