The topic is short and compact
Article 8 of Regulation (EC) No 1223/2009 makes good manufacturing practice mandatory for every cosmetic product sold in the EU.
ISO 22716 structures quality and safety controls into 17 sections and establishes the presumption of conformity.
COSMOS ORGANIC requires at least 20 percent organic ingredients in the total product for leave-on products.
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Good manufacturing practice is the foundation for safety, consistent quality and batch reproducibility. In the EU, it is not a voluntary seal of quality, but a legal requirement.
According to Article 8 of Regulation (EC) No. 1223/2009, the manufacture of cosmetic products must comply with good manufacturing practice. Compliance is presumed if manufacturing is carried out in accordance with the relevant harmonized standards. Proof of this is part of the product information file and thus a prerequisite for placing on the market.
Good manufacturing practice is a duty, not an option.
Manufacturing according to a harmonized standard establishes the presumption of conformity.
The proof belongs in the product information file.
Good manufacturing practice is not an award, but a duty
Good manufacturing practice is the foundation for safety, consistent quality and batch reproducibility. In the EU, it is not a voluntary seal of quality, but a legal requirement.
According to Article 8 of Regulation (EC) No. 1223/2009, the manufacture of cosmetic products must comply with good manufacturing practice. Compliance is presumed if manufacturing is carried out in accordance with the relevant harmonized standards. Proof of this is part of the product information file and thus a prerequisite for placing on the market.
Good manufacturing practice is a duty, not an option.
Manufacturing according to a harmonized standard establishes the presumption of conformity.
The proof belongs in the product information file.
ISO 22716: the practical way to proof
European regulations require good manufacturing practices but refer to harmonized standards for practical implementation. For cosmetics, this is ISO 22716.
The standard covers manufacturing, quality control, storage, internal transport, and shipping, and is structured into 17 sections. It thus addresses physical, chemical, and microbiological risks throughout the entire production cycle, from raw material receipt to the release of the batch.
17 sections from raw material receipt to shipping.
Hygiene, traceability, cleaning validation, and deviation management.
Manufacturing according to this standard demonstrably fulfills Article 8.
Distinguishing between COSMOS NATURAL and COSMOS ORGANIC
Beyond legal requirements, voluntary certifications serve for positioning. For natural and organic cosmetics, COSMOS is the authoritative standard, awarded by Ecocert, among others.
COSMOS distinguishes between two levels. COSMOS NATURAL requires the formulation to fully comply with the standard and to be composed of ingredients of natural origin, but does not require a minimum percentage of organic ingredients. COSMOS ORGANIC additionally requires that the vast majority of the processed agricultural ingredients come from organic farming, and defines a minimum percentage of the total product.
COSMOS NATURAL: natural origin, no minimum organic content.
COSMOS ORGANIC: additionally defined minimum organic content of the total product.
The level belongs in the briefing because it determines the selection of raw materials.
Why COSMOS ORGANIC restricts the formulation
The minimum proportion of organic ingredients is mathematically challenging because water and added minerals are not considered organic. They do not come from agricultural cultivation and therefore do not count towards the organic share.
For leave-on products such as day cream, facial serum or foundation, at least 20 percent of the total product must be organic. For rinse-off products, non-emulsified aqueous products and formulations with a high mineral content, the requirement drops to at least 10 percent. In water-rich emulsions, this means partially replacing the pure water with certified plant waters or extracts.
Leave-on: at least 20 percent organic ingredients in the total product.
Rinse-off and mineral-rich products: at least 10 percent.
Water and minerals do not count towards the organic share.
Vegan: formulation alone is not enough
Vegan positioning has evolved from a niche topic to a shelf expectation. However, resilient certification requires more than just replacing raw materials of animal origin.
Recognized standards demand that neither the product nor its components have been manufactured or developed using animal products, by-products, or derivatives. Classic raw materials such as beeswax, lanolin, carmine, marine collagen, keratin, or animal squalane must be replaced by plant-based, mineral, or synthetic alternatives. In addition, there are raw material audits and validated cleaning procedures to rule out carryover from previous batches.
Replacement of all animal raw materials, including processing aids.
Supplier audits with proof across the entire chain.
Validated line cleaning to prevent cross-contamination.
Vegan is not the same as cruelty-free
Vegan claims and cruelty-free status are frequently conflated. Vegan refers to the absence of animal-derived ingredients. Animal testing, on the other hand, is legally prohibited in the EU regardless of this.
The ban has applied to finished cosmetic products since September 2004, and to ingredients since March 2009. The marketing ban on products tested on animals elsewhere has been fully in force since March 2013. It follows that every cosmetic product legally marketed in the EU is already cruelty-free, which is why making such a claim as a unique selling proposition is generally inadmissible.
Ban on finished products since 2004, on ingredients since 2009.
Full marketing ban since 2013.
Cruelty-free is not a permissible unique selling proposition in the EU.
Why legal obligations may not be claimed is explained in EU advertising claims.
Applying a certification retrospectively to a finished formulation regularly leads to unstable emulsions, phase separation, or incompatibilities with the packaging. The reason is simple: the requirements interfere with the raw material selection, and that determines stability.
Therefore, the target profile belongs in the technical briefing before the first formulation is created. This includes the desired standards, the pre-qualification of raw material suppliers, and the question of whether the production line can provide the necessary cleaning proofs.
Define target standards in the briefing before formulation development.
Check raw material suppliers for proof in advance.
Clarify cleaning and separation proofs of the line early on.
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FAQ
What does Article 8 of the Cosmetics Regulation require?
It stipulates that cosmetic products must be manufactured in accordance with good manufacturing practice. Compliance is presumed if manufacturing is carried out in accordance with the relevant harmonised standards. Proof of this is part of the product information file.
What does ISO 22716 cover?
The standard describes good manufacturing practice for cosmetics across manufacturing, quality control, storage, internal transport, and shipping. It is structured into 17 sections and addresses physical, chemical, and microbiological risks.
What is the difference between COSMOS NATURAL and COSMOS ORGANIC?
COSMOS NATURAL requires a consistently standard-compliant formulation made of ingredients of natural origin, with no minimum percentage of organic ingredients. COSMOS ORGANIC additionally requires that the majority of the processed agricultural ingredients are organic, plus a minimum percentage of the total product.
What is the minimum organic content for COSMOS ORGANIC?
For leave-on products such as creams and serums, at least 20 percent of the total product. For rinse-off products, non-emulsified aqueous products, and mineral-rich formulations, the requirement drops to at least 10 percent because their water and mineral content cannot be certified organic.
What does a vegan certification require beyond the formulation?
Raw material audits across the entire supply chain and validated cleaning procedures of the production line to rule out carryover from previous batches. The replacement of animal raw materials alone is not sufficient for a recognized certification.
Is vegan cosmetics automatically cruelty-free?
In the EU, every legally marketed cosmetic product is cruelty-free: the ban has applied to finished products since 2004, to ingredients since 2009, and the marketing ban has been fully in force since 2013. Vegan, on the other hand, refers to the absence of animal-derived ingredients.
