[Reading time ~ 15 min]
For most actors of the cosmetics & personal care products industry, the European Cosmetic Regulation no 1223/2009 enforces new measures that have to be fulfilled before placing a cosmetic product on the European market: appointment of a Responsible Person, creation of the Product Information File, labeling compliance, CPNP notification, etc.
Discover the 5 key steps, recommended by EcoMundo’s experts, to place your products on the European market.
- Step 1: appointment of a Responsible Person
- Step 2: control of the product’s composition
- Step 3: creation of the Product Information File (PIF)
- Step 4: creation of compliant labels
- Step 5: CPNP notification before placing the product on the market
Step 1: the appointment of a Responsible Person
First major novelty of Regulation 1223/2009: every cosmetic brand must appoint a Responsible Person (RP), natural or legal, within the European Union, for each and every cosmetic product placed on the European market.
What is a Responsible Person?
Definition: Natural or legal person established in the European Community acting for all the European countries at once. The RP can be a consulting firm (like EcoMundo), a manufacturer, an importer, or a distributor.
Who can be a Responsible Person?
- The manufacturer established in the Community
- The importer: each importer can take the role of RP if the cosmetic product is manufactured outside the European Union.
- The distributor: the distributor becomes RP if the product is placed on the market under its name or brand, or if he modifies the product already on the market with the risk to affect the product’s compliance with the Regulation.
- A person established in the Community: the manufacturer or importer can appoint a third person established in the community, e.g. a consulting firm specialized in cosmetic compliance.
NB: In the case where the manufacturer, the importer or the distributor, appoint a Responsible Person, the only formalism imposed by the Cosmetic Regulation 1223/2009 is that there has to be a written agreement between the parties.
What are your Responsible Person’s responsibilities?
The Responsible Person is:
- The preferential point of contact with the authorities; the authorities will prior turn to the RP to ask for information.
- The product’s compliance guarantor; the Responsible Person is in charge of keeping the Product Information File for 10 years after the last batch of the product is placed on the market.
- The product’s safety guarantor; the Responsible Person ensures that the product is safe for human health.
- Lastly, the Responsible Person is in charge of the respect of several obligations, such as:
- To proceed to cosmetovigilance [FR],
- To check claims substantiation
And many other obligations, as important as these ones, which shall be further detailed in another article.
How to choose a trustworthy Responsible Person?
The Responsible Person can be a legal or natural person: because of the multiplicity of his/her responsibilities, it is often simpler to call on the services of consulting firms specialized in this field, i.e. cosmetology, toxicology, Pharmacy,etc.
Some service providers such as EcoMundo can facilitate all steps to reach full compliance: formula review, artwork & claim review, product information file including safety assessment and CPNP notification.
Step 2: the review of the product’s composition
The second crucial step to validate before placing your cosmetic products on the market, is to review the composition or formula of your cosmetic product on a regulatory perspective, i.e against the Annexes of the Regulation.
To get a good grasp, let's have a look at some key definition, that you can also acess here => the Cosmetic Regulation
- Cosmetic product: any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.
- Cosmetic raw material: mixture of ingredients.
- Cosmetic ingredient: a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
- Allergen: Ingredient susceptible to provoke an allergic reaction to certain subjects. Currentely there are 26 recognized allergens and those must be labelled if their concentration exceeds the 0.01% threshold in rinse-off cosmetic products, and 0.0001% in leave-on products.
All ingredients don’t have the same regulatory status!
Some ingredients are prohibited, restricted or allowed by the Cosmetic Regulation. You should make sure that the product that you want to place on the market is fully compliant with the Annexes of the Regulation outiling these restrictions.
What are the critical regulatory statuses?
Regulation 1223/2009 features several annexes that list some of the regulated substances susceptible to be harmful to human health. There are three categories of ingredients:
a. Prohibited ingredients
These prohibited substances are classified in Annex II of the Regulation 1223/2009.
The CMR substances (Carcinogenic, Mutagen, Reprotoxic) are listed in Annex VI of the CLP Regulation (EC No 1272/2008), and when they are of 2, 1A, 1B categories, they are prohibited.
They can be authorized in fnished cosmetics products under the following conditions:
- If they are compliant with the provisions related to the safety of food products, as defined by Regulation (EU) No 178/2002.
- In case there is no substance for substitution that is appropriate after the analysis of alternative solutions.
- If a request has been made for a particular use of the products’ category, with a determined exposition.
- When the substances have been assessed and judged safe by the SCCS for a use in cosmetic products (sole condition for category CMR 2).
b. Restricted Ingredients
These substances are listed in Annex III of the Cosmetic Regulation, which counts about 300 substances. These ingredients can be used in cosmetic products only under the conditions described in the annex (product type, purity criteria, percentage of maximal use,etc.).
c. Allowed Ingredients
Three functions of ingredients are listed by the Regulation: colorants, conservative agents and UV filters.
- Allowed colorants: they are listed in the Annex IV of Cosmetic Regulation (153 of them)
- Allowed conservative agents: they are listed in the Annex V (59 of them)
- Allowed UV filters: they are listed in the Annex VI (29 of them )
These ingredients are authorized if they respect the Regulation's restrictions and depending type of products in which they are contained, the part of the body that is concerned, as well as the concentration of the ingredient in the product.
Is there a simple way to verify my cosmetic product’s composition?
To check the compliance of the formula of your cosmetic product, you must compare the ingredients to the Annexes of the Regulation. It is important to note that this work must be done on a regular basis, insofar as these annexes are updated several times a year (on an average of three months). It is crucial to conduct a continuous regulatory watch.
According to the complexity of your formulas, you may want to use a software that will make the process quicker and more reliable.
For example, COSMETIC Factory a software designed by EcoMundo includes a functionality to review cosmetic formulas. The software can also assist with the drafiting of the so-called Product Information File, and the review of the labels, both key-steps to ensure complaince of cosmetics.
Step 3: creation of the Product Information File (PIF)
Another prerequisite to place your cosmetic product on the EU market is the constitution of the Product Information File (PIF). The PIF has to be made available for the authorities, which can consult it at any time (electronic or paper). The drafting and the keeping of the PIF is mandatory even for cosmetic placed on the market before the entry into force of the Regulation (2013).
What is the PIF?
The PIF (Product Information File) is a regulatory file which must be:
- Kept for 10 years (from the date when the last batch of the cosmetic product is placed on the market) by the Responsible Person.
- Kept under electronic or paper format.
- Written in an easily understandable language for the authorities of the member states where it is archived.
What does the PIF must contain?
- A description of the product: the Regulation does not impose a standardized form, but imposes “a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product”.
- The Product Safety Report.
- A description of the method of manufacturing and a statement of compliance with the Good Manufacturing Practices.
- The proof of the effect claimed for the cosmetic product.
- Data on any animal testing performed by the manufacturer, its agents or suppliers, related to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.
a. The product’s description
This description has to enable the reader to identify the product, without ambiguity, and to establish a clear relation between the cosmetic product and its PIF.
b. The Product Safety Report
This report aims to establish a safety assessment of the cosmetic product on the basis of relevant information.
The product safety report must be filled in accordance with Annex I of the Cosmetic Regulation.
Two distinct parts:
- Part A: Information about the safety of the cosmetic product
- Part B: Safety assessment of the cosmetic product
Part A: Information about the safety of the cosmetic product
This part aims at gathering the necessary data to identify and clearly quantify, from the identified risks, the risks that your product may present for human health.
The data will regard the raw materials, the manufacturing process, the packaging, the conditions of use of the product, microbiology, the quantity used, the toxicological profile of the substances, etc.
You must, therefore, gather the following data:
- Quantitative and qualitative composition of the cosmetic product
- Chemical / physical characteristics and stability data of the cosmetic product
- Microbiological quality
- Impurity, traces, and information regarding the packaging material
- Normal and reasonably predictable use
- Exposures to chemicals
- Exposures to substances
- The toxicological profile of the substances
- Adverse effects and serious adverse effects
- Information on the cosmetic product
Part B: Safety assessment of the cosmetic product
What must include the safety assessment of a cosmetic product?
- The conclusion of the evaluation: an indication regarding the safety of the cosmetic product.
- The warnings and instructions of use on the label.
- The scientific rationale: made on a case-by-case basis for each cosmetic product, verification of the presence of all required data, assessment of these data by an expert who analyses the relevance of the data.
- The references of the person in charge of the assessment and approval: name and address of the person in charge of the safety assessment, date and signature, etc.
c. Good Manufacturing Practices (GMP)
What are the Good Manufacturing Practices?
They come from the ISO standard 22716 published in 2007, providing the guidelines for the production, the storage, and the shipping of cosmetic products.
What should be mentioned in the PIF?
The PIF must contain a description of the manufacturing conditions and the declaration of compliance with the ISO 22716 Good Manufacturing Practices.
Who takes care of the compliance with the Good Manufacturing Practices?
There is no licensed organism that can deliver a certification for the Good Manufacturing Practices, and the declaration of compliance with the GMPs can be done internally or by a third company.
d. Claim substantation
The Claims must comply with Regulation No 655/2013 specifically drafted for the making of claims.
What is a "claim"?
Claims are text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have’.
The proofs of the claims may be: consumer perception test, clinical tests, bibliographic search, properties of ingredients that compose the product.
Examples of claims:
e. Animal testing
Animal experimentation is now prohibtied!
The testing ban on finished products applies since September 2004. Since this date you can no longer test your finished product on animal on the EU market.
The testing ban on ingredients or raw materials applies since March 2009. Since this date, you can no longer test your ingredients and raw materials on animals on the EU market.
Also, the marketing ban that applies since Marche 2009 for all human health effects with the exception of repeated-dose toxicity, reproductive toxicity and toxicokinetics for the EU market.
However, all historical animal data can still be used and be relied on for the drafting of cosmetic safety assessment or to fill a data gap for toxicological endpoint such as skin irritation. Note that the majority of ingredients used in cosmetic products are ingredients that are also used in many other consumer and industrial products, such as pharmaceuticals, detergents, food, etc. and animal testing may be necessary to ensure compliance with the legal frameworks applicable to these products. In those situations, the Commission considers that animal testing that has cleary been motivated by compliance with non-cosmetics related legislative frameworks should be tolerated for use in the cosmetics safety assessment.
What information must the PIF hold?
Regarding animal experimentation, the PIF must include data related to tests on animals that were carried out by the manufacturer, its staff or its providers.
Step 4: Creating compliant labels
Mandatory requirements on the label:
- Name and address of the Responsible Person
- Country of origin
- Nominal content
- Date of minimum durability or period-after-opening
- Precautions & warnings*
- Batch number
- Product function*
- Ingredients list
*Translation in the language of the export country is mandatory. Note that Austria, Bulgaria, France, Poland, Portugal and Slovakia, request full translation of the label, i.e. even the marketing content and claims.
Statements must appear visibly, legibly and indelibly on the label.
Which symbols should I use?
The hour-glass symbol to illustrate the Date of Minimum Durability (DOMD) when equal or below 30 months. The DOMD is defined by the stability test. You must add date near the symbol
If the DOMD exceeds 30 months, the open-jar symbol will indicate the period after opening "PAO” defined by the combination of the stability test and challenge test.
The hand-in-book symbol will indicate to the consumer that a card, tag or leaflet is enclosed with the product with more regulatory information.
To save time: use a software!
When it comes to ensuring labeling compliance , and considering that they must include some of the information contained in the Product Information File (ingredients list, claims, etc.), it can be very helpful to have all this data automatically compiled by a tool.
The COSMETIC Factory software offers you such features: for example, it can automatically generate a work document containing all the regulatory information that your label must include, making a much needed bridge between the regulatory and marketing teams.
Step 5: Notify using the CPNP portal
Last but not least, the Responsible Person must notify the European Commission via the CPNP portal.
What is the CPNP portal?
Cosmetics Products Notification Portal (CPNP): CPNP is the online notification portal created for the enforcement of Regulation (CE) No 1223/2009 by the European Parliament and the Council of Cosmetic Products. It is a website that Responsible Persons and Authorities can use to access products’ information
What are the regulatory requirements?
Regulation No 1223/2009 requires that any company willing to place a cosmetic product on the market notify online BEFORE doing so.
What must be transmitted at the time of notification?
- Name and category of the product.
- The name and address of the Responsible Person, plus contact details.
- In case of import, the country of origin.
- The first country where the product will be placed on the market.
- The presence of nanomaterials and CMR substances.
- The cosmetic product’s formulation.
- A compliant label with photo of the external packaging (if legible).
Only one notification is needed for all 31 countries of the European Economic Area (EEA).
The five steps we described in this article are all mandatory to ensure compliance of your cosmetic products with the European regulation and enable you to place them on the market.
Discover our cosmetic software
To make it easier to ensure your products’ compliance with the regulation, EcoMundo has developed a software called COSMETIC Factory.
This software assists you during all the key steps of placing your cosmetic product on the market. Its features handle the regulatory watch, the validation of your formulas, the review of labels and directly creates the Product Information File from your data.
Discover our European Cosmetics Regulation services
- Regulation 1223/2009 services
- EU cosmetic compliance
- Responsible Person for Europe
- Formula review
- Claim review
- Cosmetic labeling services
- PIF creation
- Safety Assessment
- CPNP notification services
- Cosmetic certification for Europe
Do not hesitate to contact our expert Sylvain De Backer by phone on +33 (0)1 83 64 20 54 for Europe and for North America please dial + 1 (778) 231-1607 or send an email at [email protected].
Do you import cosmetic products into Europe? Did you know that you must meet a number of...
EC 1223/2009 requires that all cosmetics placed on the EU market comply with GMP...