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OEKO-TEX and Textile Safety

What Standard 100 tests and what it does not

Standard 100 is a laboratory screen for substances that are known or suspected to be harmful to human health, run on the finished article or on every component of it. It looks for regulated and non-regulated substances, including those that are not yet restricted by law but are on the candidate list, and it sets limits by how much skin contact and how much mouthing the article is expected to receive.

What it does not do is equally important. It is not an environmental certificate for the process, it does not test emissions from the site, it does not audit labour conditions, and it does not say anything about how the article performs. A bag can hold a Standard 100 certificate and still leak, and a bag can be superbly waterproof and fail the screen. They measure different things.

This is the reason it is frequently misunderstood in marketing. Buyers see a label that reads tested for harmful substances and assume it is an eco label. It is a human-safety label. The environmental and social layers sit in separate schemes, which is why the comparison table later in this article matters more than the logo on the hang tag.

The four product classes and where a dry bag sits

Standard 100 sorts articles into four classes by how intimate the contact is and by how sensitive the user is assumed to be. Class I is for babies and toddlers up to 36 months, Class II is for articles with direct and prolonged skin contact, Class III is for articles with little or no skin contact, and Class IV is for furnishing and decorative material. Limits get looser as the class number rises, because exposure is assumed to fall.

A dry bag is almost always Class II. It is held in the hand, worn against a shoulder or a back, and used for hours at a time, which is direct and prolonged contact even if the outer face is a laminate. A dry bag marketed for children, or one with a teething-age user in mind, should be specified at Class I, and the difference is not a formality: the Class I limit for several substance groups is between a quarter and a tenth of the Class II limit.

The fifth row is the trap. A test report on a roll of fabric, or on a component rather than the finished article, is evidence about an input, not a pass for the bag. A certificate that covers the finished article is a different document with a different number, and the one to ask for is the article certificate with every component listed in its scope.

Where a range includes a children's size, decide early. Testing the whole range at Class I costs more but removes an argument later, and it also future-proofs the line if a retailer asks for it. Our kids' sizing guide covers the size side of that decision, and our eco range is specified at Class II across the board.

The substance groups that actually bite in waterproof construction

Most of the limit list is irrelevant to a welded TPU build, and a handful of groups do nearly all the work. In a polyvinyl chloride construction the plasticiser question dominates: ortho-phthalates such as DEHP, DBP and BBP are restricted in most markets and are the reason so many brands moved away from PVC film entirely. A TPU film has no plasticiser to restrict, which removes the largest single group at a stroke.

Azo dyes that can cleave to release listed aromatic amines are the second group, and they matter because printed and dyed face fabrics are where they live. A sublimated polyester face uses disperse dyes, and disperse dyes are the family most often implicated in dye-fastness and amine failures. This is a print and dye selection question rather than a film question, and it is why the print process belongs in the certificate scope.

The fourth row deserves a note because it is moving fastest. Per- and polyfluoroalkyl substances were used for durable water-repellent finishes across the whole outdoor category, and they are being restricted market by market rather than all at once. A welded bag does not need a DWR at all, because the laminate is the barrier, which means specifying a welded construction sidesteps the group entirely. Our PFAS-free fabric guide covers the detail.

Two groups in the table are hardware problems rather than fabric problems: extractable heavy metals and PAHs. A plated buckle is a heavy-metal risk in exactly the way a printed fabric is a dye risk, and a black rubberised grip or a soft handle is where PAHs turn up. This is the reason hardware must be inside the certificate scope and not treated as a separate purchase.

Certifying a laminate: five materials in one article

A laminated waterproof shell is a composite: a woven face, a polymer film, an adhesive tie layer, a print on the face, and sometimes a coating on the back. Each of those can carry a substance of concern, and a certificate issued on the woven face alone tells you nothing about the film. This is the most common gap in the documentation that arrives with a sample.

The clean way to handle it is component-level evidence feeding an article-level certificate. Each input is tested to the same class, the results are held in a file, and the finished article is then certified on the strength of them. That gives you a document that names the article and a set of documents that back each layer, and it is what an auditor will want to see.

Thread, webbing and print are the three that get missed. Sewing thread is a small mass but it is a dyed textile and it sits close to the closure. Webbing is dyed, finishes against the skin on a harness, and is often bought from a different source than the fabric. Ink sits on the outer face of the panel where it is handled constantly. All three belong in the scope.

Reading the fields on a certificate

A certificate has a number, an issuing institute, a holder, a scope description, a product class, a validity period and a list of what is covered. The number is checkable online against the issuer's register, and that is the first thing to do, because a certificate image in a sales deck is not evidence. Check the number, then check that the dates have not lapsed.

The scope description is where the substance is. It should name the article type and, ideally, the materials covered: face fabric, film, thread, print, webbing, hardware. A scope that reads polyester fabric only, or textile articles without a material list, is a certificate about an input and it should be treated as supporting evidence rather than as an article pass.

The holder field is worth a second look. A certificate held by a trading company rather than by the party making the goods is not worthless, but the accountability sits elsewhere. If the holder is not the party on your order, write the certificate requirement into your own contract so the obligation is yours to enforce.

Why certificates expire and how often they are re-run

A Standard 100 certificate is normally valid for one year, and it has to be, because the limit list is updated annually. New substances are added as evidence accumulates and as jurisdictions restrict them, and a certificate issued against last year's list says nothing about this year's additions. An expired certificate is not a lapsed formality; it is a document tested against a list that no longer applies.

Renewal is not purely administrative either. Where a material or a source has changed, the article is re-tested rather than renewed, because a new dye lot or a new plating bath changes the result. A bag maker who has changed their webbing source mid-year and is still quoting last year's certificate is quoting a document that no longer describes the article.

The practical habit is to ask for the certificate with every order, not once at the start of a relationship, and to diary the expiry date. It takes one line in a purchase order: current certificate, in scope, valid for the full term of the order. That line is the difference between a compliance file that holds up and one that does not.

How the scheme sits next to REACH, Prop 65 and bluesign

Four names come up in every bag compliance conversation and they overlap without being interchangeable. Standard 100 is an article screen for harmful substances. REACH is a European Union regulation on chemical substances, and it applies to articles imported into the EU above threshold concentrations. Prop 65 is a California right-to-know rule with its own list and its own warning mechanics. bluesign is an input and process scheme covering emissions, resource use and occupational health alongside chemical safety.

The clean way to think about it is that Standard 100 answers the question is this article safe to handle, while the others answer different questions about legality, process and place. A line can be fully compliant with REACH and still have no article certificate, and it can carry a certificate and still owe a Prop 65 warning. Our REACH notes and the Prop 65 guide cover those two in detail.

The chemicals themselves are regulated differently in different places, and the underlying substance control frameworks are worth reading directly; the EPA administers chemical review in the United States and WHO publishes the international health assessments that many of the limit values trace back to. Neither issues a Standard 100 certificate, but both shape the list it tests against.

MADE IN GREEN and the traceability layer

MADE IN GREEN is the label that adds a traceability layer on top of an article pass. To use it, the article must meet the Standard 100 limits and the production chain behind it must be registered, so the label can carry a product identifier that resolves to the facilities involved. For a brand that has been asked where a bag was made, not just what it tested for, that is the useful part.

It also changes the documentation burden. Instead of one certificate you hold an article pass plus a chain record, and the two must stay in step: if a facility changes, the label has to be re-registered. That is real administrative cost, worth taking on only where a retail partner asks for it.

For a first range, the sensible sequence is Standard 100 on the article first, then a traceability label once the volumes justify it. Doing it the other way round means paying for chain registration on a product that has not yet been screened, and then redoing it when the material specification changes during development.

Common failures in waterproof constructions

1. Plasticiser content in a PVC film, which fails the phthalate group outright.
2. A disperse dye in a sublimated print that cleaves to a listed aromatic amine.
3. A black pigment carrying PAHs above the Class II limit.
4. A plated buckle that releases extractable nickel or lead in the sweat solution.
5. A water-repellent finish on the face fabric that tests positive for PFAS.
6. A certificate scope that covers the fabric but not the film, the ink or the trim.

The first five are material choices and all five are avoidable at specification stage, which is far cheaper than avoiding them after a failed test. The sixth is not a material problem at all, and it is the most common of the six: a document that exists, looks correct and does not cover what was shipped. Check the scope before you check anything else.

Migration behaviour matters too. A laminated film is a barrier, so a substance locked inside the film is less available than the same substance on a surface the hand touches, but the test extracts in a solvent rather than measuring what a user actually absorbs. This is why the tested result is conservative, and why a pass under the test is a stronger claim than a pass derived by argument.

Cost, lead time and sampling for a certificate

Budget in two dimensions: money and calendar. An article certificate for a single construction typically runs to a low four-figure sum per year in testing fees for a small range, and the laboratory stage takes two to four weeks once samples are submitted. It is not a large cost against an order, but it is a real one against a sampling budget, and it is worth planning rather than discovering.

The calendar is the part that delays launches. Testing cannot start until the specification is frozen, because a material change invalidates the result. If you are still choosing between two films when the sampling clock is running, you will pay for two tests or wait for one. Freeze the material set first, then submit, and treat any subsequent change as a new test rather than an amendment.

Colourways are the hidden multiplier. Each colour is a different pigment set and therefore a different test, so a five-colour range costs materially more than a single-colour one. The usual compromise is to test the darkest and lightest shades plus any colour using a pigment family those two do not represent.

Questions to put to a production partner

• Which product class is the certificate issued at, and does that match how the bag is used?
• Does the scope name the film, the thread, the print, the webbing and the hardware, or only the face fabric?
• What is the certificate number, and does it resolve in the issuing institute register?
• When does it expire, and what happens to the evidence if a material source changes mid-year?
• Is the holder of the certificate the party named on the order?
• Which substance groups have been the difficult ones on this construction historically?
• How many colourways does the certificate cover, and which pigment families sit outside that?

Ask these before sampling rather than after, because the answers change the specification. A partner who can answer all seven crisply has a compliance file already; one who answers with a photograph of a certificate has a sales asset. The distinction is easy to spot once you know which fields to look at, and it is worth finding out early.

Our own line has been produced since 2014 in an SGS-verified 4,950 m2 facility with 137 staff, 7 production lines and 149 machines, 200,000 pieces of monthly output, a 500-piece minimum, sampling in 6 to 10 working days and bulk in 35 to 50 days, FOB Xiamen.Two adjacent notes are worth reading alongside this one: our migration testing guide explains how the extraction works, and the phthalate-free TPU guide covers the film choice that removes the largest substance group.

Building a compliance file that survives an audit

An auditor wants three things: a current article certificate in the right class and scope, component-level test reports behind each material, and a change log showing what was re-tested when a source changed. Those three answer almost every question that follows. Without the third, the first two are a snapshot rather than a record.

Keep the file per article rather than per range, because scope follows the article. A certificate that covers a 20L roll-top does not automatically cover the 40L version if the webbing, the print or the hardware differs, even though the fabric is identical. Where a range shares every material and differs only in cutting dimensions, say so explicitly in the file and have the partner confirm it in writing.

Close the loop with the retail requirement rather than with the certificate. Some partners want Standard 100, some want bluesign on the inputs, some want only REACH declarations, and a few want all three. Build to the strictest partner you have and the file answers the rest. Our bluesign guide covers the input side, and the product line shows which constructions are already covered.