Cosmetic regulatory affairs
Cosmetic registration in Sri Lanka
Cosmetic products manufactured in or imported into Sri Lanka are subject to the applicable requirements of the National Medicines Regulatory Authority (NMRA).
RAQ Consultation supports manufacturers, brand owners and importers with regulatory assessment, formulation and label review, manufacturing evidence and product-registration documentation.
Start with the right route
Imported and locally manufactured cosmetics follow different paths
The regulatory steps are not interchangeable. An imported product involves the relevant local-authorisation arrangements and Sample Import Licence, while a local manufacturer must address its manufacturing-site requirements before seeking registration for individual products.
How RAQ supports cosmetic projects
From the first formula review to the final dossier
Regulatory pathway assessment
Identify whether the proposed product fits the cosmetic category and whether the route is imported or locally manufactured.
Formula, label and claims review
Identify potentially restricted ingredients, unsupported claims and documentation gaps.
Manufacturing documentation
Review the applicable ISO 22716, GMP and manufacturing-site evidence.
Registration dossier support
Assist the responsible applicant with dossier preparation, organisation and responses to observations.
Changes and renewals
Support documentation for applicable post-registration matters within the agreed scope.
Services are provided within the scope agreed for each engagement. The NMRA decides applications. RAQ cannot guarantee approval or an approval date.
Imported cosmetics
Bringing an overseas cosmetic brand to Sri Lanka
NMRA's published procedure identifies the Sample Import Licence as the initial step, followed by the product registration application. The local applicant must assemble the authorisation and product information required for the relevant stage.
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Imported · area 1
Authorisation and product identity
Review the brand owner, manufacturer, Sri Lankan authorised party, product name and supporting Letter of Authorization so the information is consistent.
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Imported · area 2
Manufacturing and market evidence
Check the applicable Free Sale Certificate, manufacturing compliance documentation and certificates required under the current process.
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Imported · area 3
Product safety and formula information
Review quantitative composition, ingredient names, applicable restrictions, specifications, finished-product Certificate of Analysis and safety documentation.
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Imported · area 4
Label and sample review
Check product artwork, claims, directions, packaging details and samples against the current NMRA documentation requirements.
Local applicant
The NMRA requires products of foreign manufacturers to be submitted through a Marketing Authorization Holder (MAH) in Sri Lanka. See MAH and local regulatory support.
Certain documents and validations apply at different stages. The final submission list should be taken from the current NMRA application form and guidance rather than treated as a generic universal checklist.
Detailed information for the imported route
Sample Import Licence: detailed document checklist
The application uses form F-CR-001. At this stage the NMRA considers only the percentages of ingredients such as glycolic acid, salicylic acid and urea; the full composition is assessed later, at dossier evaluation.
- Completed application form F-CR-001
- Business registration certificate
- Original Letter of Authorization from the product (brand) owner, issued within a three-year period, naming the brand owner, the product and brand name, the manufacturer and the local authorised agent in Sri Lanka (a sole-agent or a tabulated letter)
- Declaration from the legal manufacturer that no other importers are registered in Sri Lanka
- Signed declaration from the importer, on the NMRA's declaration form
- Composition: each ingredient by INCI name, with CAS number, function and exact quantity (% w/w), as given in the EU CosIng database
- Product label (artwork or a scanned commercial label)
NMRA checklist F-CR-002 (effective 9 February 2026) is the final authority on this list.
Registration dossier: detailed document checklist
- Completed Schedule I Forms A and B
- Copy of the Sample Import Licence
- Original Letter of Authorization from the brand owner (as above) and a copy of the business registration certificate
- Free Sale Certificate (see the points to check below)
- Finished-product certificate of analysis with specifications and results, from testing within one year of submission; lead, arsenic, mercury and cadmium results for leave-on skin care products and hair colours
- Composition in the same INCI, CAS, function and % w/w format
- Manufacturer's declaration that the product is free from steroids (leave-on skin care products) and, for talc powder products, free from asbestos
- Original label artwork
- Cosmetic product safety report for the finished product, signed by a qualified person
- Manufacturing-site evidence: a valid ISO 22716:2007 certificate for the manufacturing facility, or a valid GMP certificate issued by the cosmetic regulatory authority of the country of origin
- Two fully packed samples in the form intended for sale, showing the lot number, manufacturing and expiry dates, and the manufacturer's and importer's details
A separate application is made for each product. Documents are in English, legible, printed on one side of A4, in a hard file cover, with numbered pages and an index. NMRA checklist F-CR-003 (effective 10 December 2025) is the final authority on this list.
Free Sale Certificate: points to check
NMRA checklist F-CR-003 requires a certificate issued by a Chamber of Commerce to be attested by the Sri Lankan embassy in the issuing country, and treats a certificate with no stated validity period as valid for three years from issue. The NMRA's cosmetics page refers to embassy attestation more generally, and the notes to Schedule I refer to an original certificate from the health authority of the manufacturing country. Because these sources are worded differently, RAQ recommends confirming the acceptable issuer and attestation with the NMRA for each certificate.
RAQ's role
RAQ Consultation supports international manufacturers with Sri Lankan regulatory requirements, documentation, NMRA applications and coordination with appropriately authorised local agents; see MAH and local regulatory support. Formal representation arrangements are assessed separately according to applicable regulatory requirements. The MAH's legal responsibilities rest with the appointed MAH.
Locally manufactured cosmetics
Manufacturing-site requirements come before product registration
The NMRA sets out three broad stages for local cosmetic manufacturing: acknowledgement from its Manufacturing Regulatory Division (the name used on the NMRA's cosmetics page and in its ISO 22716 notice); ISO 22716:2007 certification covering the manufacturing site from the Sri Lanka Standards Institution (SLSI) or a body accredited by the Sri Lanka Accreditation Board (SLAB) for that standard; and registration of the individual products.
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Local · site
Manufacturing acknowledgement
New applicants submit a site master file with the information the NMRA requires about the proposed manufacturing site and the products planned. The acknowledgement supports the certification process; it is not product registration.
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Local · site
ISO 22716 certification
The manufacturing site requires a certificate covering the relevant cosmetic manufacturing activities from a body accepted under the applicable NMRA notice. The scope and validity of the certificate matter.
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Local · product
Individual product registration
Each product application must include the required composition, analysis, label, manufacturing and other supporting evidence under the local registration procedure.
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Local · product
Local testing and labels
The NMRA requires test results for lead, mercury, arsenic and cadmium for locally manufactured skin care products. Its published local application instructions address labels in Sinhala, Tamil and English, while its current labelling decisions address multilingual directions for products sold locally. Final artwork should be checked against the latest notices and the intended pack configuration.
Detailed information for the local route
Manufacturing site: what the NMRA announced, and key dates
From 1 May 2024, the NMRA asked cosmetics manufacturers to obtain ISO 22716:2007 certification from SLSI or a body accredited by SLAB for that standard, and stated that it would no longer conduct GMP inspections of cosmetics manufacturing plants. Sites already approved had a grace period until 31 May 2026. For sites that had already applied, the NMRA said it would carry out the GMP inspection and that those sites must obtain ISO 22716 within two years from 1 May 2024.
The NMRA does not accept ISO 22716 certificates whose scope is stated as "Ayurvedic Cosmetics"; the applicant obtains an amended certificate naming a recognised cosmetic category. The NMRA does not issue ISO 22716:2007 certificates.
Product registration dossier: detailed document checklist
- Completed Schedule I application forms (the NMRA's cosmetics page names Forms A and C; checklist F-CR-003 names Forms A and B)
- ISO 22716:2007 certificate for the manufacturing plant (checklist F-CR-003 also still lists an NMRA-issued GMP certificate)
- Copy of the business registration certificate
- Finished-product certificate of analysis with specifications and results, from testing within one year of submission; checklist F-CR-003 asks for lead, arsenic, mercury and cadmium results for leave-on skin care products and hair colours
- Composition: each ingredient by INCI name, with CAS number, function and % w/w, as given in the EU CosIng database
- Manufacturer's declaration that the product is free from steroids (leave-on skin care products) and, for talc powder products, free from asbestos
- Label artwork in Sinhala, Tamil and English
- Safety data: checklist F-CR-003 asks for safety data for the product; the NMRA's cosmetics page asks for material safety data for each raw material
- Two fully packed samples in the form intended for sale, showing the lot number, manufacturing and expiry dates, and the manufacturer's details
- Where the brand owner is not the manufacturer: the file is submitted by the brand owner, with the legal agreement with the contract manufacturer
A separate file is submitted for each product. Documents are in English, legible, printed on one side of A4, in a hard file cover, with numbered pages and an index. NMRA checklist F-CR-003 (effective 10 December 2025) is the final authority on this list. Where the sources differ, as noted above, RAQ recommends confirming the current requirement with the NMRA.
Certificate of analysis for local products
Checklist F-CR-003 asks for a certificate of analysis according to the applicable Sri Lanka Standard (SLS), issued by a SLAB-accredited laboratory. The NMRA's cosmetics page words this as a laboratory accredited by SLAB "or as per the SLSI standards". Where an SLS standard exists, the notes to Schedule I ask for analytical reports to follow it.
Certification is independent of RAQ
ISO 22716:2007 certificates are issued by the certification body, and product registrations by the NMRA. RAQ does not issue either. RAQ can help a manufacturer prepare documentation and systems before certification, where engaged.
Ingredients, safety and claims
Regulatory review begins before the label is printed
The full formula and the finished product's intended claims should be assessed before artwork is finalised. Depending on the product, the NMRA may apply ingredient restrictions, warning statements, product-category limits or additional evidence requirements.
Ingredient review
Check ingredient identity, declared use level, intended function and any NMRA restrictions relevant to the finished product.
Finished-product evidence
Scientific support for claims should relate to the finished product, rather than relying only on claims made for individual raw materials.
Labels and directions
Review the product name, intended use, ingredients, warnings, responsible parties, batch information and required directions in the applicable languages.
Sunscreen and specialist claims
The NMRA names SPF values and "dermatologically tested" among the label claims that need supporting evidence, and states that the evidence must relate to the finished product. RAQ recommends the same finished-product approach for UVA and other performance claims: a raw-material supplier claim, an estimated formula or a comparison with another product should not be relied on as the evidence.
Ingredient restrictions: NMRA decisions in detail
The NMRA asks for every ingredient by its INCI name and CAS number, as given in the EU CosIng database, with its function and exact quantity. A CosIng entry is a naming reference and does not by itself make an ingredient or concentration acceptable in Sri Lanka.
The NMRA's Cosmetic Evaluation Subcommittee publishes decisions on specific ingredients. For example, the NMRA states that products containing more than 4% glycolic acid, or more than 5% urea, will not be registered as cosmetics, and it sets limits for salicylic acid that depend on the product type and purpose, with restrictions for children under three and for uses that may lead to inhalation. Products containing petrolatum need a certificate of analysis, a material safety data sheet and documents on the petrolatum's refining history and manufacturing process.
Products containing herbal ingredients and making therapeutic, medicinal or Ayurvedic claims are referred by the NMRA to the Department of Ayurveda. Herbal ingredients listed in CosIng with recognised cosmetic functions may be considered by the NMRA's Cosmetic Regulatory Division where no such claims are made. Where NMRA guidance on an ingredient differs between its cosmetics and borderline pages, RAQ recommends confirming the product's category with the NMRA.
The NMRA states that these decisions may be revised from time to time. Where engaged, RAQ can review a formulation against the NMRA's current published decisions; the NMRA decides acceptability.
Labelling and claims: NMRA rules in detail
For cosmetics marketed in Sri Lanka, the NMRA requires directions for use in English, Sinhala and Tamil, on the primary or secondary packaging or an insert leaflet. For products intended for export markets, directions for use may be in English only. The NMRA requires a warning for pregnant women on products containing retinol, and "For Hotel Use Only" on products intended for hotel use. Applicants who intend to relabel a product submit two copies of the proposed label artwork.
Examples of claims the NMRA says need scientific or clinical evidence in the dossier include "dermatologically tested", "ophthalmologically tested", "revitalise", "rejuvenate" and SPF values; the list is not exhaustive, and scientific evidence must be in readable English. The notes to Schedule I also ask for documents proving the SPF where it is above 15; in practice, any SPF value on the label is a claim that needs supporting evidence.
There is no single set of tests for every cosmetic. Requirements depend on the product type and what the label says: for example, heavy-metal results for skin care products, SPF evidence for sun protection claims, and, under the notes to Schedule I, stability data for the whole shelf life where it is longer than three years.
Colour cosmetics and variants
When colours share the same product series
The NMRA permits up to ten qualifying shades from the same cosmetic series in one application file, but only where the stated conditions are met, including consistency of formula and other product characteristics apart from colour. Supporting information is required for every shade. This is an administrative filing arrangement, not a discount on the total official registration fee.
The allowance applies to the specified colour-cosmetic categories. A brand should not assume it extends to fragrance variants, different base formulas or products with other changes.
Colour variants: categories and conditions in detail
The NMRA lists these product types: nail polish, hair dye and hair colour, lipstick, lip liner, eye shadow, eye liner, eye pencil, mascara, concealer, colour corrector, contour, foundation and face powder.
The formula, packaging, product features and all other parameters must be identical except for the colour, and the formula, label and test reports are submitted for every variant. The NMRA states that the fee for such a file equals the total fee for ten separate files.
Documents we review
What a cosmetic dossier needs to tell NMRA
- Applicable application forms and registration-stage documents.
- Business registration and authorisation records.
- Free Sale Certificate for imported products, where required.
- Full quantitative composition using the relevant INCI identification and supporting ingredient details.
- Manufacturing-site quality or GMP/ISO documentation appropriate to the product route.
- Finished-product Certificate of Analysis and specifications.
- Finished-product safety documentation and required declarations.
- Original label artwork and applicable consumer information.
- Supporting test reports, ingredient documents and samples where required.
Local and imported applications do not use identical document packages. RAQ works from the relevant current NMRA checklist and the revised cosmetic processing sheet that took effect on 13 July 2026. The detailed checklists for each route are under Imported cosmetics and Locally manufactured cosmetics.
After registration: NMRA rules in detail
Evaluation, validity and renewal
The NMRA may request further information during evaluation, which must be supplied within three months. A first registration is provisional (one or two years); full registration is valid for five years, as stated on the certificate. If a product is rejected, the NMRA allows the Marketing Authorization Holder to appeal within one month.
On renewal, the NMRA states: "Application for renewal should be made before six months from the date of expiry of registration." A hard copy of the import or manufacturing data submission email is attached to the renewal application.
Import and manufacturing data
From 1 April 2026, applicable importers and local manufacturers must submit import or manufacturing data in the format prescribed by the NMRA, including the relevant quarterly reporting periods.
Advertising and promotion
Advertising or promoting a cosmetic requires prior written approval from the NMRA. Cosmetics must not be advertised or promoted to the public for the treatment, prevention or cure of any of the prescribed diseases, disorders or abnormal physical states.
Certificate and licence amendments
An NMRA notice (opens in a new tab) requires the registration certificate and the relevant licence to have at least three months' validity when an amendment is requested; the NMRA states that payments are not refunded if this condition is not met.
FAQs
Frequently asked questions
Is ISO 22716 certification the same as cosmetic product registration?
No. Manufacturing-site compliance and registration of individual products address different requirements. A manufacturer's certification does not automatically register the products made at that site.
Can I register a cosmetic before deciding on the manufacturer?
The legal manufacturer, site and composition influence the documentation and applicable requirements. It is better to establish these details before finalising the regulatory pathway.
Can a product make skin-lightening or therapeutic claims?
Claims must be reviewed in light of the product category, ingredients, evidence and current NMRA decisions. Some claims may be restricted or may affect classification.
Do all colour shades need separate application files?
The NMRA permits a single file for up to ten qualifying variants in the same series under specific conditions. The fee treatment and required supporting material still apply.
Can RAQ confirm an SPF value from the ingredient list?
No. SPF and related protection claims need appropriate finished-product evidence. An ingredient list alone is not sufficient.
Does RAQ issue ISO 22716:2007 certificates?
No. ISO 22716:2007 certification is carried out by SLSI or a body accredited by SLAB for that standard, not by RAQ or the NMRA, and product registration is decided by the NMRA. RAQ is an independent consultancy and can help you prepare, where engaged.
How long does registration take?
The NMRA publishes evaluation targets in working days, which may be extended if a dossier undergoes external evaluation. Timing also depends on the completeness of the file and any further information requests. RAQ does not guarantee approval or an approval date.
The information on this page is general guidance based on publicly available requirements. The applicable procedure and documents should be checked against the current NMRA publications and the individual product circumstances. RAQ is an independent consultancy and does not issue regulatory approvals.
Official NMRA references
- NMRA: Cosmetics (registration, forms, checklists, decisions) (opens in a new tab) ↗
- NMRA: ISO 22716:2007 certification for cosmetics manufacturing sites (opens in a new tab) ↗
- NMRA: Revised cosmetic processing sheet (opens in a new tab) ↗
- NMRA: Manufacturing sites (opens in a new tab) ↗
- NMRA: Requirements for amendments to registration certificates and licences (opens in a new tab) ↗
- NMRA: Announcements (opens in a new tab) ↗
Contact RAQ
Need assistance with cosmetic registration in Sri Lanka?
Tell us the product type, manufacturing country, company roles and the status of the formula, labels and available certificates. We can discuss the applicable documentation review.
Please do not send sensitive formulations or full technical dossiers in your first message.