
Every cosmetic, ayurvedic beauty and personal care product sold in the EU must be notified on the Cosmetic Products Notification Portal (CPNP) before it is placed on the market. The notification is free and takes under an hour — the work sits in the months of formulation, testing and documentation that must exist first. This guide sets out what Regulation (EC) No 1223/2009 requires, what changed on 01-05-2026, and what changes on 27-09-2026.
What CPNP is, and what it is not
CPNP is a notification database run by the European Commission. The Responsible Person submits product details before first placing the product on the market; the data goes to national competent authorities for market surveillance and to poison centres. There is no fee and no approval step.
This is the point most Indian exporters misread. A CPNP reference number is not a registration, a licence or an approval. Nobody reads your safety report before the number is issued — it records that you have declared the product. Liability rests entirely with the Responsible Person, and enforcement happens afterwards, through border checks, market inspections, retailer audits and Safety Gate recalls. A buyer asking for a "CPNP certificate" means the confirmation screen; treat any consultant selling a "CPNP approval" with suspicion.
The Responsible Person question you must answer first
Under Articles 4 and 5, no cosmetic product may be placed on the EU market unless a person established inside the EU is designated in writing as the Responsible Person (RP). An Indian manufacturer cannot be the RP. Three options, with very different commercial consequences:
| Option | How it works | Commercial consequence |
|---|---|---|
| Your EU importer or buyer acts as RP | Default under Article 4 — the importer is RP unless it designates someone else. The buyer notifies and holds the PIF. | Cheapest and fastest, but the buyer owns the notification and the listing. Switching distributors means re-notifying, and you lose price leverage. |
| Appointed third-party RP service | An EU-established compliance firm is designated RP by written mandate. It holds the PIF, notifies on CPNP and appears on the label. | Typically EUR 400-900 setup plus EUR 40-150 per product per year. You keep the notification and can sell to multiple EU buyers. The usual route for Indian SMEs. |
| Your own EU entity | A subsidiary or branch in a member state is designated RP. | Full control and a real EU address, but incorporation and in-house regulatory capability rarely pay below roughly EUR 500,000 of annual EU turnover. |
Whichever you choose, put the RP mandate in writing, and state who pays for reformulation if an ingredient is later restricted.
The PIF and the CPSR
Article 11 requires a Product Information File (PIF) kept at the RP's EU address, readily accessible to authorities, for ten years after the last batch was placed on the market. It holds the product description, the Cosmetic Product Safety Report, the manufacturing method with a statement of GMP compliance (ISO 22716 is the recognised standard), proof of claimed effect, and animal-testing data.
The Cosmetic Product Safety Report follows Annex I in two parts. Part A is the safety information: composition, physico-chemical characteristics and stability, microbiological quality including preservative efficacy, impurities, traces and packaging material data, foreseeable use, exposure calculations, the toxicological profile of every ingredient, and undesirable effects. Part B is the assessment — conclusion, labelled warnings, reasoning, and the signature of an assessor qualified in pharmacy, toxicology, medicine or an equivalent discipline.
What the assessor will demand from an Indian factory, and what usually delays projects by months: the quantitative formula in percentages, supplier specifications and safety data sheets with CAS and EC numbers, INCI names for every botanical, certificates of analysis, allergen and heavy-metal declarations, a challenge test to ISO 11930, stability data on the actual packaging, and GMP records.
"Ashwagandha extract" or "Kumkumadi oil" is not an acceptable ingredient identity. The assessor needs the INCI name, plant part, solvent and extraction ratio — for example Withania Somnifera Root Extract. Multi-herb decoctions must be broken into individual botanical components, each with its own specification.
Screening against Annexes II to VI
Annex II lists over 1,600 prohibited substances; Annex III restricted substances with limits and conditions; Annexes IV, V and VI are positive lists of permitted colourants, preservatives and UV filters — anything unlisted cannot be used for that function. Check every ingredient in CosIng before committing to a formulation. The traps that repeatedly catch ayurvedic and herbal ranges:
- Heavy metals. Lead, arsenic, mercury, cadmium and antimony are Annex II substances; Article 17 permits only technically unavoidable traces that are safe in normal use. Botanicals, clays, ubtans and mineral powders are the usual sources. Test finished product, not just raw material.
- Prohibited botanicals. Several plant materials familiar in Indian formulation are banned or capped — nux vomica and other Strychnos species, Datura, Aconitum, unrefined tars. Henna is restricted to hair dyeing and not permitted for eyelashes or eyebrows.
- Essential oil allergens. Sandalwood, rose, lemongrass, clove and citrus oils are all high contributors of declarable allergens. You need GC-MS allergen breakdowns from your oil supplier.
- Colourants and preservatives. Natural does not mean permitted. Only Annex IV colourants and Annex V preservatives, within their stated fields of application and limits.
Commission Regulation (EU) 2026/78 added around eighteen newly CMR-classified substances to Annexes II and III. Products containing them could not be sold in the EU from 01-05-2026 and had to be withdrawn. Restricted entries include silver in powder form (0.05% in toothpaste and mouthwash) and hexyl salicylate. Omnibus acts are issued roughly annually and bite on stock already in the channel — a compliant formulation is not permanently compliant.
The notification, step by step
- The RP creates an EU Login account and a CPNP profile.
- Create the product entry: name exactly as on the label, CPNP category, and whether it is for children under three.
- Enter the RP name and EU address, and the country of origin — India.
- Declare the member states of sale and the poison-centre contact person.
- Enter the frame formulation, or the full formulation where the frame formulation is inadequate. Declare CMR 1A, 1B or 2 substances and any nanomaterials.
- Upload legible artwork or photographs of the label and packaging as sold.
- Submit. A reference number is generated immediately; keep the confirmation.
Nanomaterials are the exception to "notify and go". Under Article 16 they must be separately notified six months before the product is placed on the market — nano titanium dioxide and zinc oxide in mineral sunscreens are the usual case.
Labelling
Article 19 requires, on container and outer packaging, in the language of each member state of sale: the RP's name and EU address; nominal content at filling; the date of minimum durability, or the period-after-opening symbol where durability exceeds 30 months; precautions for use; the batch number; the product function unless obvious; the ingredient list in descending order of weight, headed "Ingredients", in INCI, with nanomaterials followed by "[nano]"; and, for imported products, the country of origin. See certificates of origin for how this sits alongside your preferential-origin paperwork.
Commission Regulation (EU) 2023/1545 expanded the labelled fragrance allergen list from 26 to 82 substances. Products placed on the EU market from 31-07-2026 must carry the expanded declaration; stock already on the market before that date may be sold through only until 31-07-2028. Artwork still declaring only the historic 26 is non-compliant for new shipments.
Claims and the Empowering Consumers Directive
Article 20 and Regulation (EU) No 655/2013 require every claim to be legal, truthful, evidenced, honest and fair. Claims implying medicinal action — treating eczema, curing hair fall, healing acne — push the product out of cosmetics and into medicines, where it will be refused entry.
From 27-09-2026 Directive (EU) 2024/825 applies across all member states. It bans generic environmental claims such as "eco-friendly", "green" or "climate neutral" where excellent environmental performance cannot be demonstrated, and bans sustainability labels not based on a third-party certification scheme or set by a public authority. For ayurvedic and herbal ranges this is the most disruptive change: self-declared green-leaf logos, in-house "100% natural" seals and offsetting-based carbon claims must come off the artwork. Claims backed by genuine third-party certification remain usable.
The parallel UK process
Great Britain left the EU system. A product sold in GB needs a separate notification through the Submit Cosmetic Product Notification (SCPN) service run by the Office for Product Safety and Standards, and a UK Responsible Person established in the UK. SCPN is also free, and the PIF must be held at a UK address in English. The UK annexes have begun to diverge, so an EU-compliant formulation is not automatically GB-compliant. Northern Ireland still follows the EU regulation and CPNP. The concession allowing an EU address on GB labels runs to 31-12-2027. Budget for two RPs and often two label versions.
Timelines and realistic costs
| Item | Typical cost | Time |
|---|---|---|
| CPNP notification | Free | Under 1 hour once documents exist |
| UK SCPN notification | Free | Under 1 hour |
| Safety assessment and CPSR | EUR 350-900 per product | 3-6 weeks |
| Lab testing (challenge test, stability, heavy metals, allergen GC-MS) | EUR 500-1,500 per product | Up to 3 months |
| EU RP service | EUR 400-900 setup plus EUR 40-150 per product per year | 1-2 weeks |
| UK RP service | Similar to EU RP | 1-2 weeks |
| ISO 22716 GMP certification of the factory | USD 3,000-6,000 | 3-6 months |
A first range of five SKUs realistically takes six to nine months and EUR 8,000-15,000 to reach a compliant first shipment, plus artwork translation into each destination language.
Mistakes that stop a shipment
- Shipping before the notification exists — customs and the importer's compliance check will hold the consignment.
- Label artwork that does not match what was uploaded to CPNP, or that omits the country of origin.
- Ayurvedic claims translated literally into therapeutic language on pack or on the buyer's webshop.
- A PIF sitting as PDFs in India rather than at the RP's EU address — the legal test is accessibility at the notified address.
- No allergen data for essential oils, so the assessor cannot sign Part B.
- Assuming the EU notification covers Great Britain, or that a GB notification covers Northern Ireland.
- Ignoring the animal-testing ban. Testing finished products or ingredients on animals for cosmetic purposes is prohibited, as is marketing products whose ingredients were so tested after the 2009 and 2013 cut-offs — including tests done outside the EU. Get written declarations from every raw-material supplier.
- Loose tariff classification — see HS code classification. Packaging and some functional ingredients can also trigger separate obligations under REACH.
Where OZIANT and ZJELL fit
OZIANT is a B2B cross-border marketplace connecting overseas buyers to Indian suppliers, including cosmetics and ayurvedic personal care manufacturers. ZJELL Limited is the group's export consulting arm and handles registrations and compliance filings, including EU Responsible Person appointment, PIF and CPSR preparation, and CPNP and SCPN notification. If you are planning a first EU or UK launch, contact the team before you finalise formulation and artwork.
Reviewed 17-09-2026. Rules, fees and deadlines change — confirm anything time-critical with the issuing authority before you ship. For a filing handled end to end, talk to the team or see membership options.
Other guides
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- HS Code Classification: Getting It Right Before You Quote
- Certificate of Origin: Preferential vs Non-Preferential
- Letters of Credit: A Practical Guide for Indian Exporters
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- DGFT Export Promotion Schemes: RoDTEP, Advance Authorisation and EPCG
- US FDA Registration for Food, Cosmetics and Devices
- REACH and UK REACH: What Indian Chemical Exporters Must File
- GOTS and OEKO-TEX Certification for Textile Exporters
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