Regulatory and documents

Prepare your capsule supplement for the markets you plan to enter.

For supplement brands selling across EU markets. Bring the formula, artwork and target countries. Define the review, product documents and notification responsibilities alongside your manufacturing order.

Written offer within 1 to 3 business days.

Build the product file together
Product inputFormula
Product inputLabel artwork
Check country by countryTarget markets
Define in the offerReview and notification responsibilities

FDA registration is a filing, not FDA approval.

In plain words

Turn market requirements into a project brief

The formula, label and document pack need to work for the countries and channels where you sell. Regulatory and documentation support are part of the service around TS LAB’s production of capsule supplements; the offer defines the tasks, deliverables and responsible parties.

Separate the evidence by purpose. A certificate of analysis relates to an identified material or batch. A GMP certificate relates to a manufacturing standard and certified scope. Neither automatically provides a market authorisation.

Notifications

Check the notification route for each target country

There is no single notification that covers every EU market. National requirements differ, and not every country uses the same procedure. Use the authority links below to confirm the current route, documents and fees for your product.

Food supplement notification per country, from primary sources
CountryAuthority or routeWhat the rule saysFee
GermanyBVL notificationNotify when first placing the supplement on the market. Notification is not a product approval.Check current authority guidance
ItalyMinistry of Health, NSISSubmit the product label through the notification system at first commercialisation. Check the current product and applicant requirements.Check current authority guidance
PolandGIS notificationNotify first market placement. GIS states that a compliant product may be marketed on the notification day; waiting for a reply is not required.Check current authority guidance
BelgiumFOODSUPPrepare the product notification file. Check current documentation, fee and procedure requirements with FPS Health.Check current authority guidance

Agree who prepares and who submits

Confirm whether filing is included, who acts as the applicant and what authorisation is required. Scope the preparation and submission work for each target country in your offer.

Label review

Prepare the label and product file together

Food-information rules, supplement-specific requirements and permitted claims all affect the label. Assess the ingredients, wording and language for each intended market before final artwork approval.

Language per market

List every destination country and the language requirements that apply there. A multilingual label may be suitable if it meets each market’s requirements and remains legible.

Ingredients, amounts and allergens

Check the declared ingredients and relevant amounts against the product specification. Allergen presentation, daily portion and required warnings need to be part of the label review.

Name the technical and regulatory checks in your artwork brief. Connect the label review to design and printing.

Marketplace

Scope marketplace evidence separately

Amazon’s US supplement verification programme uses approved third-party Testing, Inspection and Certification providers. The exact action and deadline are shown in the seller account. Check the current policy for the marketplace and product concerned.

Match the certificate to the requested standard

A certificate should be assessed against the precise production standard, site and product scope required. An EU food-supplement GMP certificate is not automatically interchangeable with evidence for a US programme.

Coordinate seller, manufacturer and testing provider

Agree who opens the compliance request, supplies samples and records, pays for testing and follows up. The platform retains control over its listing decision.

For the pack formats and the German market rules, see Amazon and XXL packs.

Responsibilities

Give every deliverable a named owner

Use the offer to distinguish manufacturing evidence, product-specific review, testing and filings. This keeps the responsibilities visible before the order begins.

Agree the scope, document format and issue timing for each deliverable in the offer.
DeliverableInput to the briefOutput to scopeOwner to agree
Manufacturing records The manufacturing activities and production site for your order. Raw-material COAs and relevant certificates, with issuer, scope and validity. Name the TS LAB contact for the agreed documents.
Product and label review Ingredients, proposed claims, artwork and target markets. Review tasks included in the offer and the responsibilities for final artwork. Identify the responsible food business operator and the reviewer for each task.
Product testing Required finished-batch analysis and any external testing. The agreed reports, issuer, document format and issue timing. Confirm the testing provider and who coordinates the work.
National filings Destination countries and the applicable notification or filing route. Any notification or filing work included in the project. Name the applicant and the party responsible for submission.
Marketplace response The current request, required standard and product scope. Evidence, samples, testing and follow-up tasks for that request. Assign the seller, manufacturer and testing-provider tasks.
Packaging obligations The packaging, target markets and supply arrangement. The applicable producer obligations and registration route to check. Identify the responsible party for your business and markets.

Use this matrix to agree the work. Each owner and included deliverable still needs confirmation.

Issuer, scope and limits per certificate

Check any additional certification requirement

If your retailer requires ISO 22000, FSSC 22000, IFS Food or BRCGS, request the exact current certificate before ordering. Supplier ISO certification does not establish certification of the manufacturing site.

Certificates

Review the certificates by issuer and scope

The published evidence includes GMP, HACCP, organic handling, V-CERT and FDA facility registration. Check the current document, named operator, covered activities and validity for the service you need.

FDA registration is a filing, not FDA approval.

See all certificates, with issuer, scope and what each one does not cover.

Questions

Regulatory support and documentation questions

Which certificates does TS LAB hold?

our credentials include GMP, HACCP through Bureau Veritas, organic product handling, V-CERT and FDA facility registration. Request the current documents and check the issuer, scope and validity for your project.

Can I get the GMP certificate with a number and an issuer?

Request the current certificate, including the issuer, identifying number, site, standard, scope and validity. Check that it covers the manufacturing activity your product requires.

Do you file the notification in my country?

Confirm filing in your offer for each country. Regulatory documentation support does not automatically include acting as the applicant or submitting on your behalf; the tasks and any authorisation need to be agreed.

What does an EU notification actually involve?

The procedure depends on the country. Germany uses the BVL route, Italy the Ministry of Health’s NSIS system, Poland the GIS notification system and Belgium FOODSUP. Check the current authority requirements for the product; notification should not be treated as a general EU product approval.

Will a European GMP certificate satisfy Amazon?

Not automatically. The required standard, testing provider and evidence depend on the applicable marketplace programme. Share the current request from your seller account so the manufacturing and testing scope can be reviewed.

Does TS LAB have ISO 22000, FSSC 22000, IFS Food or BRCGS?

Request a current certificate for the exact standard your channel requires. Supplier ISO certification does not transfer to TS LAB. The certificates section identifies our company credentials and their stated scope.

Is FDA registration the same as FDA approval?

No. FDA food-facility registration does not mean the FDA has approved the facility or its products. Dietary supplements are not generally approved by the FDA before marketing.

Do you provide a certificate of analysis for every batch?

Raw-material COAs are part of the sourcing service. A finished-batch COA or additional analysis must have an agreed testing and reporting scope. Confirm the document list, issuer and delivery timing in your order.

Build the document brief for your markets

Send your formula, target countries, channels and any retailer requirements. Receive a written offer within 1 to 3 business days.

Connect the review to the actual product. Explore the document pack.