In imported cosmetic products it is necessary to indicate the country of origin?
The container and packaging of cosmetic products should bear the following information in indelible, easily legible and visible lettering:
The name or registered name and the address of the Responsible Person. Such information may be abbreviated in so far as the abbreviation makes it possible to identify that person and his address. If several addresses are indicated, the one where the responsible person makes readily available the product information file shall be highlighted.
The country of origin shall be specified for imported cosmetic products.
Why should we conduct a Challenge test?
The Challenge test is mandatory for all cosmetic products, according to Regulation EC 1223/2009. Challenge test is essential to justify the effectiveness of the preservation system and justify the shelf life and period after opening of cosmetics in terms of safety.
Water-based cosmetic products provide a perfect environment for microbial growth, and the products’ additional components can serve as nutrients for these microorganisms. It should be kept in mind that a contaminated product (which may show no visible signs of contamination) is much more dangerous for users than preservatives.
The reasons for microbial preservation of cosmetics are:
- to ensure the microbial safety for the consumers
- to maintain the intended quality and specifications
- to preserve the image and the reputation of your company
When should the Durability be indicated and when the PAO (Period After Opening)?
The indication of the Durability Date is obligatory for all cosmetic products which the minimum durability date does not exceed the 30 months.
For cosmetic products which the minimum durability date exceed the 30 months an indication of the time after opening the package in which the product can be used without endangering the health of consumers, is called PAO.
For single use products the indication of PAO is not obligatory.
What is withdrawal and recall of a cosmetic product?
Withdrawal means any measure aimed at preventing the making available on the market of a cosmetic product in the supply chain.
Recall means any measure aimed at achieving the return of a cosmetic product that has already been made available to the end user.
What are the obligations of the distributor?
‘Distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market. This includes wholesalers, retailers, shops, beauty or hair salons, telesales, outlets and internet selling.
Before making a cosmetic product available on the market distributors shall verify that:
- The mandatory labeling information is present.
- The language requirements are fulfilled.
- The date of minimum durability specified, where applicable, has not passed.
- Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardize its compliance with the requirements set out in the Cosmetics Regulation.
Where distributors consider or have reason to believe that:
A cosmetic product is not in conformity with the requirements laid down in the Cosmetics Regulation, they shall not make the product available on the market until it has been brought into conformity with the applicable requirements.
Do products containing only natural ingredients need a Safety Assessment?
A safety assessment is required for all cosmetic products, regardless of the origin of the materials they contain. It does not matter whether a cosmetic product is made up of all natural or all synthetic ingredients – the legislation does not distinguish between the origins of an ingredient.
Whether an ingredient is synthetic or natural has no bearing on whether an ingredient is safe to use. The Annexes of the EU Cosmetics Regulations include many natural materials, as well as many man-made materials, that are prohibited from use in cosmetics for reasons of safety.
Is my product vegan?
There is no legal definition of a vegan cosmetic product. Responsible persons may include claims that the product does not contain any animal-derived ingredients or is ‘suitable for vegans’. Such claims are acceptable, but it is a legal requirement that all claims can be substantiated and are not misleading to the consumer. It should therefore be clear to the consumer what criteria are being applied.
It must be remembered that certification by a commercial organization of either ingredients and/or a final cosmetic product is optional, while compliance with the EU Cosmetics Regulations is mandatory.
Does my product labeling have to be reviewed or approved?
There is no legal requirement for labeling to be reviewed or approved by a third party.
However, as mistakes can be costly to rectify and can have a reputational impact, it is recommended that the artwork is checked by a specialist experienced with the EU Cosmetics Regulation.
What information needs to be printed on the label of a cosmetic product?
The labeling requirements for cosmetic products are detailed under Article 19 of the EU Cosmetics Regulation.
The container and packaging of cosmetic products should bear the following information in indelible, easily legible and visible lettering
- Name and address of the EU Responsible Person.
- The nominal content at the time of packaging, given by weight or by volume
- Period after Opening or date of minimum durability where relevant
- Warning statements and precautionary information;
- The batch number of manufacture
- The function of the cosmetic product, unless it is clear from its presentation
- Declaration of ingredients. The list shall be preceded by the term ‘ingredients’
- Country of origin for imported products.
Do I need a Responsible Person in the EU?
Yes.
Every cosmetic product placed on the EU market must have a designated Responsible Person (RP) established in the European Union.
Who can be the Responsible Person?
The RP can be:
-
The EU manufacturer, or
-
The importer (for products manufactured outside the EU), or
-
A third party established in the EU, formally appointed in writing by the brand owner.
What are the obligations of the Responsible Person?
The Responsible Person is legally responsible for ensuring that the cosmetic product:
-
Complies with EU Regulation (EC) No 1223/2009
-
Has a Cosmetic Product Safety Report (CPSR) in place
-
Has a complete and up-to-date Product Information File (PIF)
-
Is notified in the CPNP before being placed on the market
-
Is properly labelled and compliant with claims legislation
-
Is subject to correct market surveillance, including cooperation with authorities in case of inspections, recalls, or adverse effects
What about non-EU brands?
Non-EU manufacturers cannot act as Responsible Persons themselves.
They must appoint an EU-based Responsible Person before importing or selling cosmetics in the EU.
When is CPNP notification mandatory and who is responsible for it?
CPNP notification is mandatory before a cosmetic product is placed on the EU market.
This means before the product is sold, distributed, or supplied, whether free of charge or not.
Who is responsible for the CPNP notification?
The Responsible Person is legally responsible for submitting the notification in the Cosmetic Products Notification Portal (CPNP).
What information is submitted to the CPNP?
The notification includes, among others:
-
Product name and category
-
Responsible Person details
-
Country of manufacture
-
Presence of nanomaterials (if applicable)
-
Label artwork
-
Formula framework information (for poison centres)
Important:
CPNP notification is not an approval process. Authorities do not “approve” products in advance, but incorrect or missing notification can lead to enforcement actions.
How often does a CPSR need to be updated?
A Cosmetic Product Safety Report (CPSR) is not a one-time document.
It must be reviewed and updated whenever relevant changes occur.
A CPSR update is required when:
-
The formula changes
(new ingredient, concentration change, replacement of a raw material) -
A supplier or raw-material specification changes
(new impurity profile, new manufacturing process) -
Regulatory requirements change
(new ingredient restrictions, bans, or labelling obligations) -
New safety or toxicological data becomes available
-
The product use changes
(e.g. from rinse-off to leave-on, children’s use, professional use)
Is there a fixed validity period?
No fixed expiry date exists.
However, the CPSR must always reflect the current formula and the current regulatory framework.
Best practice:
A CPSR should be periodically reviewed, especially in times of major regulatory updates (e.g. fragrance allergens, microplastics, ingredient reclassifications).
Are “natural” or “organic” cosmetics exempt from EU legislation?
No.
Cosmetic products marketed as “natural” or “organic” are not exempt from EU cosmetics legislation.
All cosmetic products placed on the EU market — regardless of their origin, positioning, or marketing claims — must fully comply with EU Regulation (EC) No 1223/2009.
What does this mean in practice?
“Natural” or “organic” cosmetics must:
-
Have a Cosmetic Product Safety Report (CPSR)
-
Be assessed for toxicological safety, including impurities and allergens
-
Comply with ingredient restrictions and bans
-
Meet labeling and claims requirements
-
Be notified in the CPNP
-
Have a designated EU Responsible Person
Do natural ingredients mean automatic safety?
No.
Natural and organic ingredients may still:
-
Cause skin irritation or sensitisation
-
Contain natural allergens
-
Have usage restrictions or concentration limits
For example, essential oils and plant extracts are subject to the same safety evaluation and regulatory controls as synthetic ingredients.
What about “organic” certification?
Terms such as “organic” or “natural” refer to private certification schemes (e.g. COSMOS, ECOCERT) and do not replace or override EU legal requirements.
Compliance with EU cosmetics legislation is mandatory, regardless of any voluntary certification.
Who is legally responsible for marketing claims on a cosmetic product?
The Responsible Person (RP) is legally responsible for all marketing and advertising claims made for a cosmetic product placed on the EU market.
This includes claims appearing on:
-
Product labels
-
Packaging
-
Websites and e-shops
-
Social media
-
Advertising, brochures, and promotional materials
What does legal responsibility mean?
The Responsible Person must ensure that all claims:
-
Comply with EU Regulation (EC) No 1223/2009
-
Meet the requirements of EU Regulation (EU) No 655/2013 on cosmetic claims
-
Are truthful, substantiated, and not misleading
-
Can be supported by appropriate evidence upon request by authorities
Can responsibility be transferred to marketing or distributors?
No.
Even if claims are created by:
-
A marketing agency
-
A distributor or retailer
-
Influencers or third-party platforms
Legal responsibility remains with the Responsible Person.
What happens if claims are non-compliant?
Non-compliant or misleading claims may result in:
-
Requests for substantiation by authorities
-
Corrective actions, including label or website changes
-
Product withdrawal or recall
-
Administrative penalties
Best practice:
All claims should be reviewed for compliance before use, including digital marketing and social-media content.