In This Guide
  1. What Counts as a Cosmetic
  2. From Registration to Notification
  3. CPNP — the EU Anchor
  4. The Product Information File (PIF)
  5. The Israeli Responsible Person
  6. Prohibited & Restricted Substances
  7. Hebrew Labelling Requirements
  8. The Import Process Step by Step
  9. Frequently Asked Questions

1. What Counts as a Cosmetic

Israel aligns with the EU definition: a cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body (skin, hair, nails, lips, external genital organs) or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odours.

Categories include: skin-care, hair-care, colour cosmetics (makeup), perfumes, deodorants, sun-care, oral hygiene (toothpaste, mouthwash), shaving products, intimate hygiene, and baby cosmetics. Products with a therapeutic claim or active pharmaceutical ingredient cross the line into medicinal products and are regulated separately.

2. From Registration to Notification

Historically, each cosmetic product sold in Israel required an individual pre-market registration with the Ministry of Health's Pharmaceutical Division. Registration demanded a full technical dossier, local lab testing, and could take months per SKU — a significant burden, especially for small brands and niche product lines.

Under the 2025 reform, standard cosmetics shift to a notification-based regime. The Israeli Responsible Person files a notification with the Ministry of Health referencing the product's EU CPNP record, uploads the PIF, and — subject to substance compliance and Israeli labelling — can place the product on market. No individual pre-market approval is required in most cases. Post-market surveillance replaces pre-market certification.

3. CPNP — the EU Anchor

The Cosmetic Product Notification Portal (CPNP) is the centralised electronic system to which every cosmetic product placed on the EU market must be notified before placing on market. A CPNP record includes: product category, EU Responsible Person, product formulation by INCI names, frame formulations for poison centres, original packaging, and intended use category.

For Israeli import purposes, a valid CPNP record is the foundational evidence that the product has gone through the EU regulatory framework. The importer in Israel does not file with CPNP — that is done by the manufacturer or the EU Responsible Person — but references the CPNP identifier in the Israeli notification and preserves a copy of the CPNP confirmation in the Israeli PIF.

4. The Product Information File (PIF)

The PIF is the complete technical dossier for a cosmetic product. It is not submitted to the authorities at import; it is held by the Responsible Person and produced on inspection. Its contents are standardised under the EU Regulation:

The PIF must be "at the address" of the Responsible Person

Under EU rules and the Israeli notification regime alike, the PIF must be readily accessible at the address of the Responsible Person — electronically is acceptable. A regulator inspector who turns up unannounced must be able to see the PIF within a reasonable time. Not having the PIF on hand is itself a regulatory breach.

5. The Israeli Responsible Person

Every cosmetic product on the Israeli market must have a designated Responsible Person (RP) — a legal or natural person established in Israel and named on the label as the accountable party. The RP carries the legal responsibility for:

For an imported brand, the importer in Israel typically acts as the RP — but the role can also be contracted to a specialist regulatory-services company. Either way, the RP must be Israeli-established and named on every product sold in Israel.

6. Prohibited & Restricted Substances

EU Regulation 1223/2009 contains six annexes that govern substance use in cosmetics. Israel adopts these same lists substantively:

Annex What it regulates
Annex IIProhibited substances — cannot appear in any cosmetic product (over 1,600 substances: hydroquinone in leave-on, many heavy metals, some preservatives)
Annex IIIRestricted substances — allowed within strict concentration limits and with specified warnings
Annex IVAllowed colourants
Annex VAllowed preservatives
Annex VIAllowed UV filters (for sun-care products)

A product that meets Annexes II–VI and has a valid CPNP record is in compliance substance-wise. The Israeli notification does not re-test the formulation — the EU compliance is accepted. If the EU later updates an annex (e.g., banning a substance that was previously allowed), the change flows through; importers should monitor EU Commission Implementing Regulations for cosmetics.

7. Hebrew Labelling Requirements

Israeli cosmetics labelling mirrors the EU content requirements with a Hebrew language overlay. Required on the product label (primary or secondary packaging):

8. The Import Process Step by Step

  1. Appoint / confirm the Israeli Responsible Person — typically the importer; the RP's details appear on the product label.
  2. Obtain the CPNP reference and PIF from the EU Responsible Person or the manufacturer.
  3. Verify substance compliance — cross-check the INCI list against Annexes II–VI of EU Regulation 1223/2009 for prohibited, restricted, preservative, colourant, and UV-filter compliance.
  4. Prepare Hebrew labelling — pre-print at origin or plan overstickering at an Israeli bonded warehouse.
  5. File the notification with the Ministry of Health Pharmaceutical Division referencing the CPNP record and the Israeli RP.
  6. Ship and clear customs — customs broker files import declaration with the cosmetics notification reference.
  7. Retail & Cosmetovigilance — once on market, the RP monitors undesirable effects, maintains the PIF current, and is subject to Ministry of Health post-market surveillance.

Frequently Asked Questions

Does a CPNP record alone let me import into Israel?
No — it is the foundation but not the full package. You also need: a complete Product Information File, a designated Israeli Responsible Person, substance-compliance verification against Annexes II–VI of EU Regulation 1223/2009, Hebrew labelling, and a filed notification with the Ministry of Health Pharmaceutical Division. The CPNP record is the EU evidence; the Israeli notification is the Israeli filing.
What is a Responsible Person and who can act as one?
A Responsible Person (RP) is a legal or natural person established in Israel, named on the product label, who carries legal responsibility for the product's compliance, PIF maintenance, Ministry of Health notification, cosmetovigilance, and any recall. For an imported brand, the importer in Israel typically acts as the RP; the role can also be contracted to a specialist regulatory-services firm. The RP must be Israeli-established and reachable by regulators.
What goes into a Product Information File?
Under EU Regulation 1223/2009, the PIF must contain: product description and identity, a Cosmetic Product Safety Report (CPSR) from a qualified safety assessor, manufacturing method with ISO 22716 GMP declaration, full INCI ingredient list, evidence supporting any functional or benefit claims, evidence of any claimed effects (SPF, anti-ageing, etc.), data on any serious undesirable effects, and an animal-testing statement where relevant. The PIF is kept by the RP and produced on inspection, not submitted at import.
Which cosmetic ingredients are prohibited in Israel?
Israel applies the substantive lists from EU Regulation 1223/2009. Annex II lists over 1,600 prohibited substances (including certain heavy metals, some preservatives, hydroquinone in leave-on products, and many dyes). Annex III lists restricted substances allowed only within concentration limits and with specific warnings. Annexes IV–VI list permitted colourants, preservatives, and UV filters. A product whose formulation passes these Annexes — as evidenced by its CPNP record and PIF — passes the Israeli substance-compliance test.
Is Hebrew labelling mandatory on cosmetics?
Yes. The product name and function, warnings, usage instructions, and Responsible Person contact information must appear in Hebrew. The INCI ingredients list is permitted in Latin script as per international INCI convention. Labelling may be applied at origin or at an Israeli bonded warehouse through overstickering — smaller brands typically oversticker to preserve inventory flexibility; larger volumes justify pre-printed Hebrew packaging at origin.
What is Cosmetovigilance?
Cosmetovigilance is the structured monitoring of serious undesirable effects (SUE) reported after a cosmetic product is placed on market. The Responsible Person must collect, evaluate, and — when a SUE is confirmed — notify the Ministry of Health. If a pattern emerges, the Ministry can order product withdrawal or recall. It mirrors the EU Cosmetovigilance requirement under Article 23 of Regulation 1223/2009.
Source: Ministry of Health — Pharmaceutical Division, cosmetics notification regime (effective 1 January 2025); EU Regulation (EC) 1223/2009 on cosmetic products and annexes II–VI; ISO 22716 Good Manufacturing Practices for cosmetics; CPNP (Cosmetic Product Notification Portal) — European Commission; Israeli Ministry of Economy import guide (gov.il).
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