Compliance
Compliance: the documents, and what each one proves
Four questions come up in almost every export enquiry: is it REACH compliant, is it OEKO-TEX certified, is it food contact safe, and does it meet the EN standard for medical use. Each has a different answer and a different owner.
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REACH and food contact: what the paperwork actually proves What REACH SVHC declarations and food contact compliance mean for nonwoven fabric, which documents to request and what each one actually covers. Read more -
OEKO-TEX Standard 100: reading the certificate properly How OEKO-TEX Standard 100 applies to nonwoven fabric: product classes, what is tested, how to read a certificate and what it does not cover. Read more -
EN 13795 and EN 14683: where the fabric stops and the device starts What EN 13795 and EN 14683 require of surgical drapes, gowns and masks, which tests apply, and where the nonwoven supplier's responsibility ends. Read more
At a glance
How the options compare
| Requirement | Applies to | Who proves it | Document |
|---|---|---|---|
| REACH SVHC | Chemicals in articles placed on the EU market | Supplier declaration against the current candidate list | Declaration or test report |
| OEKO-TEX Standard 100 | Textile articles and accessories | Certificate holder for the tested article | Certificate with number and validity |
| Food contact | Materials touching food | Converter or brand owner, with migration testing | Declaration of compliance |
| EN 13795 / EN 14683 | Medical drapes, gowns, masks | Manufacturer of the finished device | Test reports and notified body documents |
| US FDA | Medical devices and food contact in the US | The regulated establishment | Registration and listing |
Why suppliers answer carefully
A responsible supplier distinguishes between what the material is, what it has been tested for, and what the finished article is certified to. Conflating those three is how buyers end up with a document that looks official and covers nothing they need.
Each guide below takes one requirement and explains what the document proves, who has to hold it, and what to ask for at enquiry. The lists are practical rather than legal advice, and the destination regulator has the final word.
Need a document for a tender?
Tell us the market, the standard and the deadline. We will say which documents we can issue and which we cannot.
Questions
Common questions
Can you issue an OEKO-TEX certificate?
The certificate is held by the producer whose article was tested. Ask for the current certificate with its number and validity, and check that the tested article matches the grade you are buying.
Is every nonwoven food contact safe?
No. Food contact depends on the formulation and on migration testing for the intended use. Ask for a declaration of compliance that names the article and the conditions of use.