Cosmetics and microalgae: what the regulations require to register yours

Introduction

Cosmetics with microalgae have moved from being a trend to a solid bet in formulation, thanks to compounds such as phycocyanin from Spirulina, astaxanthin from Haematococcus or polysaccharides from Chlorella. However, bringing a microalgae ingredient to the cosmetic market is not just a matter of efficacy: it requires compliance with strict regulations and proof of safety. This article summarises what technical and purchasing managers need to know to register a cosmetic product with microalgae, focusing on the European Union and with a practical outlook for Latin America.

The starting point is clear: in the EU, Regulation (EC) 1223/2009 establishes the mandatory requirements for any cosmetic product, including those containing microalgae or their extracts. In addition, in 2026 relevant updates have come into force affecting the list of restricted and prohibited substances. Below, we break down what you need to know.

Regulation (EC) 1223/2009: regulatory basis in the EU

Regulation (EC) 1223/2009 is the legal framework governing all cosmetic products in the European Union. It applies to any product placed on the EU market, regardless of its origin. Its key requirements are:

• Responsible Person: any company marketing a cosmetic product must designate a responsible person established in the EU, who assumes legal responsibility for compliance.
• Product Information File (PIF): includes product description, specifications, manufacturing method, safety assessment, stability and microbiology data, among others.
• Safety assessment: carried out by a qualified assessor, who must justify the safety of the product for its intended use.
• Prior notification: the product must be registered in the European cosmetic notification portal (CPNP) before being placed on the market.
• Complete labelling: with mandatory information such as ingredient list (INCI), usage precautions, batch number and responsible person details.

This regulation is the mandatory reference for any company wishing to operate in the European market. As the European Commission states, cosmetics legislation in the EU is one of the most harmonised in the world, and compliance is essential to avoid penalties and ensure consumer trust.

2026 Update: Omnibus Act VIII

On 1 May 2026, the Omnibus Act VIII came into force, amending the annexes of Regulation (EC) 1223/2009. This update adds 18 new substances to the list of restricted or prohibited ingredients, most of them classified as CMR (carcinogenic, mutagenic or toxic for reproduction). For microalgae, this means that any derived ingredient must be checked against the updated lists, as substances such as certain pigments or extracts could be affected.

The Irish Health Products Regulatory Authority (HPRA) has published a summary of the Omnibus Act VIII, highlighting the incorporation of these substances. It is crucial for formulators and suppliers to periodically review these lists, as the regulation evolves to protect consumer health.

What to check in your microalgae ingredient

Before registering a cosmetic product containing microalgae, you must verify several specific aspects of the ingredient:

• Presence in CosIng: the European Commission's cosmetic ingredients database lists authorised or referenced substances. If your microalgae or extract appears in CosIng, it facilitates the validation of the INCI name and the permitted use.
• Ingredient function: if it acts as a colourant, preservative or UV filter, it must be expressly authorised in the annexes of the Regulation. For example, phycocyanin from spirulina may be used as a colourant, but only if it meets the specifications of Annex IV.
• Nanomaterials: if the extract contains nanoparticles, additional authorisation and labelling requirements apply, in accordance with Article 16 of the Regulation.
• Prohibited or restricted substances: the final product must not contain substances from Annexes II to VI that are prohibited or restricted. The 2026 update has expanded this list, so a thorough review is essential.

In the case of microalgae such as Chlorella vulgaris or Arthrospira platensis (spirulina), their cosmetic use is well documented, but each batch must meet purity specifications and be free from contaminants.

CPNP notification and labelling

Notification in the CPNP (Cosmetic Products Notification Portal) is mandatory before placing any cosmetic product on the EU market. This portal, managed by the European Commission, centralises information on all cosmetic products and allows health authorities to access the data. The notification includes the product information file, the label and the packaging, and must be completed before the product is placed on the market.

Labeling must comply with the requirements of Article 19 of the Regulation: name and address of the responsible party, nominal content, minimum durability date, usage precautions, batch number, and list of ingredients in descending order of concentration, using INCI nomenclature.

For microalgae, it is important that the INCI correctly reflects the species and the part used, for example, Chlorella vulgaris extract or Spirulina platensis powder. An incorrect INCI can lead to rejection during notification.

Registration in Latin America

Unlike the EU, Latin America does not have a single regulation. Each country has its own health registration system, although there are harmonization efforts within Mercosur. In general, requirements usually include:

• Notification or health registration with the competent authority (e.g., ANVISA in Brazil, COFEPRIS in Mexico, INVIMA in Colombia).
• Technical information: qualitative and quantitative formula, ingredient specifications, INCI, and certificates of analysis.
• Safety and stability testing: accelerated stability and shelf-life studies, as well as microbiological and safety tests.
• Labeling in Spanish or Portuguese, depending on the country, in compliance with local regulations.
• Supplier documentation: evidence that the ingredient is not restricted and meets specifications.

For microalgae, it is essential to provide solid documentation on taxonomic identification and the absence of contaminants, as local authorities are often strict with novel ingredients.

Recommended technical dossier

To expedite registration both in the EU and Latin America, it is recommended to prepare a complete technical dossier including:

• Taxonomic identification: full scientific name, strain, and genetic identification methods.
• Method of production: description of cultivation, harvesting, and extraction, as well as extract purity.
• Certificates of analysis: content of active ingredients, heavy metals, microorganisms, and mycotoxins.
• Toxicological assessment: safety studies, including ocular and dermal irritation, and sensitization.
• Justification for use: function of the ingredient in the cosmetic and usage concentration.

This dossier not only facilitates registration but also demonstrates professionalism and transparency to customers.

If your company is looking for microalgae ingredients with reliable technical documentation, at ALGACEL we offer high-quality biomass, ingredients, and pigments. Check our range of microalgae and request the technical data sheet for detailed specifications.

Frequently Asked Questions (FAQ)

What is the CPNP and why is it mandatory?

The CPNP is the European portal for notifying cosmetic products. It is mandatory to notify each cosmetic before placing it on the market in the EU, as it allows health authorities to access product information and take action in the event of an alert. Notification is free of charge and carried out online.

What is CosIng and how does it help me with microalgae?

CosIng is the European Commission's database of cosmetic ingredients. It contains substances authorised or referenced for cosmetic use. If your microalga appears in CosIng, it is easier to validate its INCI and its use, but it does not exempt you from the safety assessment of the final product.

Can microalgae be used as colorants in cosmetics?

Yes, some microalgae such as spirulina (phycocyanin) can be used as colorants, but they must meet the requirements of Annex IV of Regulation (EC) 1223/2009. That is, they must be expressly authorised and comply with purity specifications. If they are not listed in the annex, they cannot be used as colorants.

What impact does the Omnibus Act VIII have on cosmetics with microalgae?

The Omnibus Act VIII, in force since May 2026, adds 18 substances to the restricted or prohibited list. If any of these substances is present in your microalgae ingredient, you will need to reformulate or seek alternatives. It is essential to review the updated lists before launching a product.

Is it mandatory to notify the cosmetic in each EU country?

No, notification in the CPNP is unique and valid for the entire EU. The CPNP centralises the information and authorities from all member states can access it. There is no need to notify country by country.

How does organic certification affect cosmetics with microalgae?

In the EU, cosmetics cannot be certified as organic under European organic regulations nor use the EU organic logo. However, they may use the term "organic" on the labelling if the agricultural ingredient comes from organic production, but the product itself cannot carry the EU organic logo. This is relevant if your microalga is cultivated organically.

References

• National Statistics Institute
• Official State Gazette