GMP for Small-Batch Cosmetics and Home Manufacture

Does the law require GMP for small-batch cosmetics?

Yes. Article 8 requires cosmetic manufacture to comply with good manufacturing practice, and the text makes no exception for small batches or home production.

The Article adds a presumption. Compliance with good manufacturing practice is presumed where manufacture follows the relevant harmonised standards. Their references are published in the Official Journal of the European Union. The presumption is one way to show compliance, and the Article itself lists no document or certificate that proves it.

Article 8 as adopted has two paragraphs. The first states the duty and the second states the presumption. It describes neither premises nor batch size, and it names no standard or certificate. The duty sits on the manufacture of the product, so it applies to whoever makes it, whether that is a contract manufacturer or the brand itself, at any scale. The duty has a paper trail in the PIF: Article 11(2)(c) lists a statement on compliance with good manufacturing practice among its contents.

Where does ISO 22716 fit?

Eldris asks for an ISO 22716 certificate from the manufacturer, or a GMP statement where the manufacturer has no such certificate.

Article 8 does not name ISO 22716. It refers only to relevant harmonised standards, so whether this standard is the one behind the presumption is not something the Article itself says. The certificate is a document Eldris asks for; it is not named in the Regulation.

Neither document is needed to start an order. Both come from the manufacturer, not from your ingredient suppliers: certificates of analysis come from them and describe the materials, while the GMP statement describes how the product is made. The certificate and the statement answer the same ask from Eldris: evidence from the manufacturer that the product is made under good manufacturing practice. Where a manufacturer holds the certificate, upload it. Where it holds none, upload a GMP statement instead. Either way, after you pay, upload what you have and Eldris tells you what is still missing.

What can a small-batch or home manufacturer document?

A small-batch or home manufacturer can write a GMP statement, describe the method and put a batch number or reference on every pack.

Article 11(2)(c) lists a description of the method of manufacturing among the PIF contents, and a manufacturer can write that for its own product. As a rule, Article 19(1)(e) separately puts the batch number of manufacture, or a reference identifying the product, on the container and packaging. The method says how the product is made, the GMP statement says it follows good manufacturing practice, and the batch number ties each pack to its own batch.

The statement comes from the manufacturer, which for a brand that makes its own product is the brand. If you hold an ISO 22716 certificate, upload it. If you do not, upload your GMP statement. Article 8 does not describe a home workspace, so this page does not say what a home set-up must show or whether a particular set-up meets Article 8.

Is a GMP statement needed to start an order?

No. A GMP statement helps but is not needed to start an order.

The same goes for an ISO 22716 certificate: Eldris asks for one or the other, and neither holds up the start of an order. Stability data and a challenge test are in the same position: they help, but the order can start without them. After you pay, upload what you have in your Eldris portal and Eldris tells you what is still missing, so a statement that arrives later can simply follow.

Article 11 still lists the manufacturing method and a GMP statement among the contents of the PIF. The Responsible Person keeps the PIF for ten years after the last batch is placed on the market. Gather the statement alongside the rest. In Great Britain the Responsible Person also keeps a PIF in English, as GOV.UK guidance explains. If the safety assessor needs more from you, the question appears in your portal, and the 5–10 working days start again from the day you answer.

Who provides GMP evidence when someone else makes the product?

The manufacturer does. If a contract manufacturer makes your product, the ISO 22716 certificate or the GMP statement comes from that manufacturer.

Your ingredient suppliers provide certificates of analysis, and a testing laboratory provides stability and challenge tests. Those are separate documents from the GMP statement. Stability data and a challenge test help without being needed to start an order.

Agree with the manufacturer in writing, when you place the work, that it will supply the certificate or the statement, and keep the document with the formula. The per-formula fee shown on the pricing page covers the CPSR and PIF, and laboratory tests are not in it. The CPSR and PIF service is paid once, and the 5–10 working days run from the day Eldris has your complete documents. For background on production practice, read the general guide to cosmetic good manufacturing practices. The short answer is in the FAQ hub: do I need GMP and how do I prove it.

Frequently asked questions

Is ISO 22716 mandatory?

Article 8 requires good manufacturing practice and does not name ISO 22716. Eldris asks for an ISO 22716 certificate from the manufacturer or, without one, a GMP statement, and neither is needed to start an order. Article 8 itself refers only to relevant harmonised standards.

Can I write my own GMP statement?

A GMP statement comes from the manufacturer, so a business that makes its own product provides its own. This page does not draft one, and it does not say what the safety assessor will accept.

What if my manufacturer has no ISO 22716 certificate?

Eldris asks for a GMP statement instead. It comes from the manufacturer and helps, but it is not needed to start. After you pay, upload what you have in your Eldris portal and Eldris tells you what is still missing.

Do certificates of analysis count as GMP proof?

They are separate documents. Certificates of analysis come from your ingredient suppliers, and the GMP statement comes from your manufacturer. The GMP statement helps but is not needed to start. A testing laboratory supplies stability and challenge tests, which are separate again.

How long must the GMP statement be kept?

The Responsible Person keeps the PIF, which holds the GMP statement, for ten years after the last batch of the product is placed on the market, as Article 11 requires.

Does the GMP statement change the 5–10 working days?

The 5–10 working days run from the day Eldris has your complete documents, and a GMP statement is not needed to start. If the safety assessor needs more, the question appears in your portal, and the 5–10 working days start again from the day you answer.

Does a batch number count as GMP evidence?

A batch number is a labelling item. As a rule, Article 19(1)(e) puts the batch number of manufacture, or a reference identifying the product, on the container and packaging. This page does not treat it as GMP evidence.