Every batch of your supplement comes with its documents
Know what you receive with your capsule supplement, what each document covers, and what your retailer or target market may also ask for. We agree the document list for your product before production.
- Match raw-material and batch records to the product you are ordering.
- Review the specification, certificates and supporting statements for your intended market.
- Agree the document list and issue dates with your order.
Which documents come with each supplement batch?
Two levels, and they answer two different questions. The raw material level answers what went in. The batch level answers what came out.
Per raw material
- Certificate of analysis for each raw material lot
- Material specification, with the ingredient name written exactly as it will appear on your label
- Origin statement for the material
- Allergen statement for the material
Confirm each document’s issuer, material or lot reference and format for your project, so the records can be checked against the ingredients and batch you are buying.
Per batch
- Finished-batch certificate of analysis, where included in the agreed testing scope
- Finished product specification, as approved by you
- Batch number and the date of manufacture
- Best before date and the storage conditions it assumes
- Packing specification and the approved artwork proof
- Delivery note and invoice, with the wording your market needs
Agree the fill-weight target, control limits and required batch records in the product specification. Confirm the tests, reporting format and issue dates for the documents you need.
The rule we hold ourselves to
Check each certificate’s issuer, number, scope and validity against the current document. Confirm which records will accompany your order and which additional documents your market requires.
What is a certificate of analysis?
A certificate of analysis, COA, is the laboratory document for one defined lot. It names the material or the product, the lot number, what was tested, the method used, the result and the limit that result is judged against.
of analysisKey
fields
Read the record in three parts
Select a part to highlight its fields.
See what was checked for this batch
A certificate of analysis reports specified test results for an identified lot. Read it alongside the agreed product specification and relevant batch records. The lot reference, methods, results and limits help you understand exactly what was checked.
Check the record against your order
Check that the material or product, lot number and specification match your order. Confirm which tests and limits the document reports, and whether they answer the requirements of your intended retailer or marketplace.
What do the GMP, HACCP, allergen and origin statements actually say?
Each of these answers one question and refuses the next one. Knowing which is which is what stops a document from being sent to the wrong place.
GMP statement
Good Manufacturing Practice for food supplements is a set of written production and quality control requirements covering the whole cycle, from incoming materials to release. There is no single European Union GMP certificate for food supplements: in the European Union a supplement is a food, so the binding frame is Regulation (EC) 852/2004 with mandatory HACCP and Directive 2002/46/EC, and any GMP certificate for a supplement plant is issued by a private certification body against a published guideline.
It covers the site, the processes and the quality system. It is not product approval, and it does not say that one batch met its specification.
HACCP statement
HACCP, Hazard Analysis and Critical Control Points, is the method for identifying food safety hazards and controlling them at defined points. In the European Union it is not optional: Regulation (EC) 852/2004 requires every food business operator to put HACCP based procedures in place. Certification of that system is voluntary, and TS LAB states HACCP certification by Bureau Veritas.
It covers hazard control in the process. It does not cover product legality, label claims, national notification or the composition of your formula.
Allergen statement
An allergen statement lists which of the allergens named in Regulation (EU) 1169/2011 are present in a material or a product, and which are handled on the same site. It is the document your label designer needs before the artwork is set, not after.
It does not decide your label text for you. Allergen labelling on the finished product is a decision the brand owner signs off.
Origin statement
An origin statement says where a raw material comes from. It is asked for by importers, by retailers running documented supply chains, and by any buyer moving production back into Europe who needs to show where the chain actually runs.
It does not make a finished product organic, and it is not a quality verdict on the material.
What does your retailer or marketplace require?
The honest answer is that the two checks are different, and a pack that satisfies one does not automatically satisfy the other.
An Amazon check
Start with the current compliance request in your seller account for the marketplace and product you plan to sell. Check the evidence requested, the submission deadline and whether an approved testing, inspection and certification provider must submit the results.
A manufacturer’s certificate or COA does not automatically satisfy that request. Agree which documents TS LAB can supply and which tests or provider services must be arranged for your product.
A retailer or drugstore check
Retail own brand supply is a different gate. For own brand supply to large retailers, certification of the site to BRCGS Food or IFS Food is the normal condition, and one large drugstore chain states IFS Food among the standards for its own brand products, because it guarantees traceability and controlled production processes.
IFS Food and BRCGS are not listed in the TS LAB materials reviewed for this website. If your buyer requires one, send the current supplier requirements and request confirmation before proceeding.
What is not in the pack?
Written down, so that nothing here is a surprise later.
No approval of any kind
No document here approves a product. The FDA does not approve dietary supplements, and an FDA registration number does not convey approval or endorsement of a facility or its products.
No retailer audit standard
ISO 22000, FSSC 22000, IFS Food and BRCGS are not listed in the materials reviewed. Ingredient-supplier certification does not establish TS LAB’s own certification. Confirm the certificate holder, activities and validity against your buyer’s requirements.
No claim clearance
The document pack does not authorise a health claim. Claims must meet Regulation (EC) 1924/2006 and the conditions applicable to the proposed wording and product. Botanical claims need case-specific review, including whether transitional provisions apply. Agree the claim review before approving artwork.
Notification responsibilities agreed per market
Notification and labelling requirements depend on the intended market and product. Agree who prepares, submits and maintains any required notification, and which regulatory work is included in the project.
No public certificate register for every mark
Organic is the easiest of the five to check, through the public certificate search of the Slovenian Ministry of Agriculture. The GMP scheme has no public register of certificate holders, so that check is the certificate document plus a direct query to the issuing body.
The pack follows the form
This pack is written around capsules, the format we lead with. Softgels, tablets and powders are made here too and carry their own pack. If your project is a gummy or a liquid, it is not part of our published range, and we will say so in the first reply.
Which certificates does TS LAB state?
Five marks, each with the body behind it where the body is known, each on its own page with what it covers and what it does not cover. Request the current certificate to confirm its issuer, holder, scope and validity.
FDA registration is a filing, not FDA approval.
- GMP for food supplements
- Scope: capsule production site, Komenda, Slovenia
- What it covers: the site, its processes and its quality system
- HACCP
- Issuer: Bureau Veritas
- What it covers: hazard analysis and critical control points in the process
- FDA registered facility
- Register: U.S. Food and Drug Administration
- What it is not: FDA registration is a filing, not FDA approval
- V-CERT vegan
- Mark: V-CERT, Certified Vegan Products
- What it covers: certified products inside a defined scope
Questions buyers ask about documents
What is a certificate of analysis?
A certificate of analysis, COA, is the laboratory document for one defined lot. It names the material or the product, the lot number, what was tested, the method, the result and the limit the result is judged against. Read it alongside the approved specification and batch record; each answers a different question about the material or finished batch.
What does a batch certificate of analysis cover that a GMP certificate does not?
A GMP certificate covers the site, its processes and its quality system. It says nothing about whether one specific batch meets its specification. Evidence for an individual batch is the certificate of analysis for that batch, plus the specification it was released against.
Is TS LAB FDA approved?
No, and neither is any supplement manufacturer. The FDA does not approve dietary supplements or the facilities that make them. TS LAB states an FDA registered facility, which is a filing requirement under 21 CFR Part 1 Subpart H, and the FDA states that a registration number does not convey approval or endorsement of a facility or its products.
Will your documents satisfy Amazon?
Amazon decides which evidence it accepts. Share the current request from your seller account and identify the marketplace and product. Some programmes require results directly from an approved testing, inspection and certification provider. Agree the available manufacturing documents, testing scope and submission route before ordering.
Do you hold IFS Food, BRCGS, ISO 22000 or FSSC 22000?
No. TS LAB states GMP, HACCP certified by Bureau Veritas, organic handling, FDA facility registration and V-CERT vegan certification. IFS Food and BRCGS are retailer driven standards normally required for supplying supermarket and drugstore own brands, and for direct to consumer, marketplace, distributor and practitioner channels the tested expectation is GMP, HACCP and documented traceability.
Who is responsible for my product in my market?
Market responsibilities depend on the product and where it is sold. Agree who handles notification, label language, claim review and final artwork approval. TS LAB’s manufacturing documents support that work; they do not themselves establish permission to sell or make a claim.
Can I get an example of the documents before I order?
Ask which sample or redacted documents are available for your project. Tell us what your retailer, importer or marketplace needs to see. Review the available examples, then agree the actual document list, issuer, format and issue dates in your offer.
Ask for the document list for your product
Request an offer within 1 to 3 business days. Ask which sample or redacted documents are available to review for your product.
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