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Quality to ISO 22716: good manufacturing practice for cosmetics
In the EU, every cosmetic product must be manufactured in line with good manufacturing practice (GMP) (Art. 8(1) Regulation (EC) No 1223/2009). Manufacturers that work to the harmonized standard EN ISO 22716:2007 are presumed to meet this obligation (Art. 8(2)). The standard covers production, control, storage and shipment – from personnel, premises, equipment and raw materials to complaints and recalls. GMP is mandatory; the certificate is not. A certificate does show, however, that an independent body has taken a look. Switzerland refers to the same standard in Annex 7 of the VKos.
No authority checks your cream before it goes on sale
A new serum does not need approval in the EU. The working group on cosmetic products, chaired by the European Commission and including all Member States, says so explicitly in a guidance document on claims that it endorsed: a cosmetic product is allowed on the Union market without any governmental approval (Technical document on cosmetic claims, 2017). So no agency checks before sale whether the bottle contains what the label says.
Instead, Regulation (EC) No 1223/2009 relies on accountability and on checks in the market. Every product has a responsible person in the EU (Art. 4), a safety assessment with a safety report (Art. 10) – and the obligation to follow good manufacturing practice (Art. 8). Member States monitor products on the market and, explicitly, compliance with the principles of good manufacturing practice (Art. 22).
Think of it as a restaurant kitchen. The safety assessment checks the recipe. Good manufacturing practice makes sure that every plate leaving the kitchen is made exactly to that recipe – clean, consistent and traceable. The best recipe is of little use if the kitchen gets sloppy.
What the law requires: Article 8 and the presumption
Article 8 of the Cosmetics Regulation has just two paragraphs. Paragraph 1: the manufacture of cosmetic products shall comply with good manufacturing practice. Paragraph 2: compliance is presumed where manufacture is in accordance with the relevant harmonized standards whose references have been published in the Official Journal of the EU.
The Commission has published exactly one such standard: EN ISO 22716:2007 “Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices” (OJ C 123, 21.4.2011, p. 3). If a manufacturer works to this standard, it is presumed to comply with Article 8. The regulation does not make the standard compulsory – but it is the recognized way to demonstrate good manufacturing practice.
Two other provisions of the regulation build on this:
- Product information file: it contains a description of the method of manufacturing and a statement on compliance with good manufacturing practice (Art. 11(2)(c)).
- Traces of prohibited substances: small, unintended amounts are only allowed if they are technically unavoidable under good manufacturing practice and the product remains safe (Art. 17).
Important for your planning: the regulation requires good manufacturing practice, not a certificate. Certification is voluntary, and ISO itself does not certify – independent certification bodies do. A certificate is therefore only as meaningful as its details: Is it valid? Does it cover the site where your product is made? Does the scope include cosmetics? And who carried out the audit?
What ISO 22716 covers – and what it does not
ISO 22716 gives guidelines for the production, control, storage and shipment of cosmetic products. It covers the quality aspects of the product. It does not cover research and development, the distribution of finished products, occupational safety or environmental protection (ISO 22716:2007).
The standard is organized by topic. The overview shows the areas and one question you can ask your manufacturer about each:
| Area | What it is about | Your question for the manufacturer |
|---|---|---|
| Personnel | Responsibilities, training, hygiene | Who is in charge of production and of quality control? |
| Premises and equipment | Layout, cleaning, maintenance, calibration | How is equipment cleaned between two products? |
| Raw materials and packaging materials | Purchasing, receipt, testing, release, storage | How are raw materials tested before use? |
| Production and finished products | Manufacturing, filling, batch coding, release, shipment | How is each batch documented? |
| Quality control laboratory | Test methods, samples, results | Which tests are run before release? |
| Deviations and out-of-specification products | What happens when something does not fit | Who decides about quarantined goods? |
| Complaints and recalls | Investigation, measures, recall | How quickly can affected batches be narrowed down? |
| Subcontracting, change control, internal audits, documentation | Contracts, managing changes, self-inspection, records | Who checks that the system works day to day? |
Where GMP and the safety report work together
The safety assessment under Article 10 relies on data that only clean manufacturing can deliver. Among other things, Annex I Part A requires the safety report to include:
- Stability: the physical and chemical characteristics of the product and its stability under reasonably foreseeable storage conditions.
- Microbiological quality: the microbiological specifications of the raw materials and the product, plus the results of the preservation challenge test.
- Purity and packaging: the purity of the substances, where relevant evidence that traces of prohibited substances are technically unavoidable, and the relevant characteristics of the packaging material.
These data only hold if every batch is made like the one that was tested. That is exactly what good manufacturing practice ensures. Two obligations make the link visible in everyday business:
- Batch number: the container and packaging bear the batch number or a reference that identifies the product (Art. 19(1)(e)). That way, every bottle can be traced back to its production.
- Supply chain: at the request of the authorities, the responsible person identifies the distributors it supplies. Distributors identify from whom they obtained a product and to whom they supplied it – for three years after the batch was made available (Art. 7).
If something still goes wrong, the obligations of the responsible person apply: corrective measures, withdrawal or recall (Art. 5(2)) and the notification of serious undesirable effects (Art. 23). More in Responsible person, safety assessment, notification.
Good manufacturing practice for personalized cosmetics
With a standard cream, one batch yields thousands of identical jars. With personalized cosmetics, the genetic result changes the selection and the dosage of the active ingredients. The kitchen with one recipe becomes a kitchen with many variants – and every variant must be documented just as carefully.
From this, you can derive what to look for in a manufacturer of personalized cosmetics:
- Matching: How does the manufacturer make sure that sample, formula and finished product clearly belong together?
- Safety report: Does the safety assessment cover the formulas that are actually mixed?
- Label: Does the ingredient list match the individual formula? More in Labeling cosmetics.
- Interfaces: Every handover between companies is a point where something can get lost. The more steps run under one roof, the shorter the chain.
How the genetic result feeds into the formula is explained in Personalized cosmetics: how genes shape the formula.
Checklist: how to vet your cosmetics manufacturer
- An ISO 22716 certificate is available – valid, for the site where your product is made, with a suitable scope and a named certification body.
- Raw materials are tested and released before use.
- Every batch is documented and traceable via its batch number back to the raw materials.
- Stability and microbiology data and the preservation challenge test are available for the safety report.
- There is a defined procedure for deviations, complaints and recalls.
- Changes to formula, raw material supplier or packaging go through change control.
- Agreed in writing: Who is the responsible person, and who prepares the safety report, product information file and notification?
- For personalized products, the matching of sample, formula and product is described.
- For deliveries to Switzerland, it is clear who carries the self-supervision obligation there.
Switzerland: the same standard, a different framework
In Switzerland, cosmetics are consumer products under the Foodstuffs Act (LMG) (Art. 5(b) LMG). Good manufacturing practice must be observed when they are manufactured (Art. 55 of the Foodstuffs and Consumer Products Ordinance, LGV). The FDHA Ordinance on Cosmetic Products (VKos) links the presumption to the same standard as the EU: Annex 7 lists SN EN ISO 22716:2008-02 (Art. 12(2) and (3) VKos).
The differences lie in the framework around it:
- Self-supervision: anyone who manufactures, imports or places consumer products on the market is obliged to carry out self-supervision (Art. 26 LMG). For businesses handling cosmetics, this includes in particular checking product safety, good manufacturing practice, sampling and analysis, traceability, withdrawal and recall, and documentation (Art. 75(b) LGV).
- Responsible person in the business: every consumer products business designates a responsible person with a business address in Switzerland (Art. 73 LGV). This means a natural person who is responsible to the enforcement authorities for product safety (Art. 2(1)(7) LGV) – not the same as the responsible person under EU law.
- Evidence: the Swiss product information file also contains a statement on compliance with good manufacturing practice (Art. 5(1)(c) VKos).
- Record keeping: the manufacturer must be able to present the information to the cantonal enforcement authorities for three years from placing on the market; importers and distributors for three years from delivery of the lot (Art. 13 VKos).
What this means for you: a manufacturer in the EU that works to ISO 22716 meets the standard that Switzerland also refers to. Self-supervision for the Swiss market, however, remains with the Swiss manufacturer or importer – details in the Switzerland section of Responsible person, safety assessment, notification.
What comes next
How a cosmetics project runs from briefing to first delivery is shown in How to get cosmetics manufactured: the process. Which partner models are available is explained in White label, private label or your own formula?.
Frequently asked questions
Is ISO 22716 mandatory for cosmetics manufacturers?
May I advertise “made under GMP”?
Does ISO 22716 also apply to storage and shipping in my studio or shop?
How does ISO 22716 differ from ISO 9001?
Is an ISO 22716 certificate also recognized in Switzerland?
Related: Quality assurance and certifications at Novogenia · Responsible person, safety assessment, notification · Supplement quality assurance
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Request a project →Discover BeautyMeNote: This guide is general information for businesses and professionals and does not replace legal advice. BeautyMe products are cosmetic products; statements in this guide are not promises of cure. The genetic traits determined in a genetic analysis are well documented (each gene included is backed by at least three independent studies); recommendations for skincare and formulation derived from them are logical conclusions, not scientifically proven. Regulations can change; errors and changes excepted.