| Certificate / audit | What it covers | What it does not prove | Issued by |
|---|---|---|---|
| ISO 22716 | Guidelines for production, control, storage and shipment of cosmetic products (GMP) | That a specific product is safe or compliant in a market | Certification bodies auditing against the standard |
| ISO 9001 | Quality management system | Product safety, cosmetic GMP | Accredited certification bodies |
| amfori BSCI | Social compliance audit with A–E rating across performance areas such as wages, working hours, health and safety | Product quality; it is an audit result, not a certificate | Auditing companies under the amfori system |
| Sedex SMETA | Social audit on labour standards, health and safety, environment and business ethics, with a corrective action plan | Sedex says SMETA is not a certification | Approved audit companies; results shared via Sedex |
| FSC Chain of Custody | Tracking of FSC-certified material through the supply chain | That the whole wipe is forest-based, or plastic-free | Accredited certification bodies |
| OEKO-TEX STANDARD 100 | Textile tested for harmful substances, by product class (class 1 for baby articles) | Cosmetic safety of the lotion | OEKO-TEX member institutes |
Short answer
No single certificate makes wet wipes legal. ISO 22716 shows a factory follows cosmetics good manufacturing practice; ISO 9001 shows a quality management system; amfori BSCI and Sedex SMETA are social audits, not product certifications; FSC Chain of Custody tracks certified forest material such as wood pulp; and OEKO-TEX STANDARD 100 shows a textile was tested for harmful substances. Each belongs to a specific company and site, so check the holder, scope and validity, and verify it with the issuer.
What does each wet wipes certification prove?
What is ISO 22716 and why does it matter for wet wipes?
ISO 22716 gives guidelines for the production, control, storage and shipment of cosmetic products (ISO). Most wet wipes for skin are cosmetics, so it is the most relevant factory standard. In the EU, Article 8 of Regulation (EC) No 1223/2009 requires cosmetics to be manufactured under good manufacturing practice, and compliance with the relevant harmonised standard is presumed to meet that requirement (EUR-Lex); EN ISO 22716 is that standard. Great Britain refers to ISO 22716 as its designated standard for cosmetic GMP (GOV.UK).
So GMP itself is a legal duty in those markets; the certificate is one way to demonstrate it. In the US, MoCRA requires the FDA to set cosmetic GMP regulations; check the FDA’s MoCRA page for their current status (FDA).
BSCI vs Sedex: what is the difference?
Both are social compliance audits that many retailers ask for:
- amfori BSCI assesses factories against its code of conduct and gives an A–E rating (amfori). Retailers that are amfori members often request it.
- Sedex SMETA is an audit methodology covering labour standards and health and safety, with environment and business ethics in the four-pillar version. Audits are carried out by approved audit companies, findings lead to a corrective action plan, and Sedex states SMETA is not a certification (Sedex).
Ask which one your retailer requires. Neither is a legal requirement for selling wipes, but either can be a condition of a retail contract.
Which material certifications apply to wet wipes?
FSC Chain of Custody verifies that FSC-certified material is identified or separated from non-certified material along the supply chain, and certificates are issued by accredited certification bodies, not by FSC offices (FSC). For wipes it can apply to wood pulp in the substrate or to cartons. To use FSC labels on your pack, the supply chain up to the label must be certified.
OEKO-TEX STANDARD 100 is a label for textiles tested for harmful substances; product class 1 covers articles for babies, certificates are valid for one year, and labels can be checked online (OEKO-TEX). For wipes, it normally applies to the nonwoven substrate, not to the finished wipe with lotion, so read the scope.
Fibre choices are explained in what wet wipes are made of.
Which certifications are mandatory and which are preferences?
| Item | Status |
|---|---|
| Cosmetic GMP (EU, GB) | Legal requirement; ISO 22716 certification is a common way to show it |
| Responsible person, safety assessment, notification | Legal requirement in EU/GB (EU Responsible Person); MoCRA listing in the US |
| Biocide or pesticide authorisation | Legal requirement only for disinfecting or antibacterial claims |
| ISO 9001, BSCI, SMETA | Buyer or retailer preference |
| FSC, OEKO-TEX | Optional, but required if you put their logo or claim on the pack |
| “FDA certificate” for cosmetics | Does not exist: FDA says it does not provide certificates for cosmetic registration or listing (FDA) |
How do you verify a supplier’s certificates?
- Holder. Company name and address must match the factory that will make your product, not a trading company or a sister site.
- Scope. The scope must cover wet wipes or the relevant process.
- Validity. Check issue and expiry dates; ask for the latest surveillance audit result where relevant.
- Issuer. Verify with the certification body, IAF CertSearch for accredited management system certificates (IAF CertSearch), OEKO-TEX Label Check, the FSC certificate database, or the Sedex platform.
A full supplier vetting checklist is in sourcing wet wipes from China. LX Wipe is a supplier working with partner factories, not a factory owner. Certificates belong to the producing partner factory; depending on the factory and product, options include ISO 9001, ISO 22716, BSCI / Sedex, OEKO-TEX or FSC, and we share copies for the factory assigned to your order.
See how we vet partner factories
Read how LX Wipe selects and audits partner factories, then request the certificate copies that apply to the factory producing your order.
Frequently asked questions
Is ISO 22716 mandatory for wet wipes?
Good manufacturing practice is a legal requirement for cosmetic wipes in the EU and Great Britain, and ISO 22716 is the harmonised or designated standard used to show it. The certificate itself is a common way to demonstrate compliance rather than a separate legal requirement.
Is BSCI a certification?
amfori BSCI is a social compliance audit with an A–E rating rather than a product certificate. Sedex SMETA is also an audit, and Sedex states it is not a certification.
Does OEKO-TEX apply to wet wipes?
Usually to the nonwoven substrate. Check the certificate scope and product class; class 1 covers articles for babies. It does not cover the cosmetic lotion.
Is there an FDA certificate for wet wipes?
No, not for cosmetic wipes. FDA has stated that it does not provide certificates for cosmetic facility registration or product listing.
Which certificates can LX Wipe provide?
Certificates are held by the partner factory producing your order. Depending on the factory and product, options include ISO 9001, ISO 22716, BSCI / Sedex, OEKO-TEX or FSC, and LX Wipe shares copies on request.
Sources
- ISO 22716:2007 Cosmetics — Good Manufacturing Practices (GMP)
- EUR-Lex: Regulation (EC) No 1223/2009 on cosmetic products (Article 8, GMP)
- Sedex: SMETA audit
- amfori: amfori BSCI
- FSC: Chain of Custody certification
- OEKO-TEX: STANDARD 100
- FDA: FDA clarifies it does not provide certificates for cosmetic product facility registration or listing
- IAF CertSearch: verify accredited management system certificates
Regulatory information is a summary for buyers and is not legal advice. Check the official sources and your own compliance adviser before launch. Last reviewed 18 October 2026.