This article provides some insight on the role of Responsible Person (RP) of a Cosmetic Product, and everything that needs to be considered before selling your cosmetics product in Europe. This is why usually importers delegate that complex role to a third party.
Taobé Consulting, in partnership with ecosistant, assumes this important role of the Responsible Person for Cosmetics and takes care of all regulatory aspects, allowing you to focus on the sale of your products!
- Regulatory watch services
- Extensive global brand network
- Customisable partnerships
- Fast market access registration
Who is the Responsible Person?
Article 4 of Regulation (EC) no. 1223/2009 (click here for the last consolidated version) is dedicated to the central figure in the field of the cosmetic products, i.e. the Responsible Person:
“a natural or legal person designated as such within the Community”
Article 4 of the Regulation defines that:
“Only cosmetic products for which a natural or legal person has been designated as a ‘responsible person’ within the Community ” shall be placed on the market.”
For each cosmetic product placed on the market, the Responsible Person must ensure compliance with the obligations established by the Regulation. The appointment of the Responsible Person within the European Union is an essential requirement for the placing on the market of a cosmetic product within the Community.
The Responsible Person for Cosmetics is the warrant of the obligations imposed by the Regulation. Their name (or company name) and complete address must be indicated on the label of each cosmetic. If several addresses correspond to the Responsible Person, the label must highlight the address where the P.I.F. (Product Information File) is kept available to the authorities.
Obligations of the Responsible Person
The obligations of the Responsible Person are numerous and complex.
It is therefore easy to understand how the Responsible Person is a central figure and plays a key role in the marketing of cosmetics.
The CPNP
Article 13 of Regulation (EC) 1223/2009 indicates that, before placing a cosmetic on the market, the Responsible Person is obliged to notify the product on the European CPNP portal by transmitting the following information:
a) category of the cosmetic product on the market and the name or names that allow its specific identification;
b) name and address of the Responsible Person from whom the product information file is kept immediately available;
c) the country of origin in the case of imports;
d) the Member State in which the cosmetic product is to be placed on the market;
e) information enabling a natural person to be contacted in case of need;
f) the presence of substances in the form of nanomaterials;
g) the name and Chemical Abstracts Service (CAS) number or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008;
h) the framework formulation enabling prompt and appropriate medical treatment to be provided in the event of impairment of health.
The P.I.F.
The Responsible Person, as indicated in the guidelines of Cosmetics Europe, the association of European cosmetic actors, regarding P.I.F., has specific obligations:
- ensure that a cosmetic product placed on the EU market is harmless to human health under normal or reasonably foreseeable conditions of use;
- maintain specific information on the product it places on the market as established by Article 11 of Regulation 1223/2009;
- demonstrate following a request from the competent authorities of the Member State that the product placed on the market meets the requirements of the Regulation;
- ensure that the Safety Assessment of the cosmetic has been carried out by a Safety Assessor, or by an appropriately qualified and experienced person;
- keep the Product Safety Assessment and the data on which it is based as part of a “Cosmetic Product Safety Report” in the P.I.F. and update it in anticipation of further related information produced after the placing of the product on the market;
- make sure you have the P.I.F. available in order to respond to requests from the competent authority in the place where the P.I.F. is stored and to prove the conformity of the product with the Regulation;
The cosmetovigilance
Article 23 of Regulation (EC) 1223/2009 states that:
“In the event of serious undesirable effects, the responsible person and the distributors shall notify the competent authorities of the Member State in which serious undesirable effects have been detected as soon as possible”
The Responsible Person must therefore notify the Competent Authorities:
- all serious undesirable effects known to you or which can reasonably be expected to be known to you;
- the name of the cosmetic product concerned, allowing specific identification of the cosmetic product;
- any corrective measures you have taken.
The Responsible Person, if the cosmetic product does not comply with the prescriptions, must take corrective measures in order to make the product compliant, in some cases the Responsible Person must withdraw the cosmetic product from the market when, for example, non-compliance may represent a risk to the health of the final consumer.
Who can hold the role of Responsible Person for Cosmetics Products?
Based on the above obligations, let’s see in more detail how the Article 4 establishes who can cover this role:
– the Manufacturer:
“for cosmetic products manufactured within the Community and subsequently not exported and reimported into the Community, the manufacturer established within the Community is the responsible person. The manufacturer may, by written mandate, designate a person established within the Community as the responsible person, who shall accept in writing.” or, where the manufacturer is established outside the European Community: “he shall designate by written mandate a person established within the Community as the responsible person, who shall accept in writing.”
Therefore, the essential requirement is that a Responsible Person be appointed within the territory of the European Union.
– the Importer
“the respective importer is the person responsible for the specific cosmetic product that he places on the market. The importer may designate by written mandate a person established within the Community as the responsible person, who shall accept in writing.”.
Therefore, in case of importation of a non-EU product on the European territory, if a Responsible Person is not appointed, it is the Importer himself who automatically becomes the Responsible Person.
– the Distributor
“The distributor is the person responsible when placing a cosmetic product on the market under his name or trademark or modifying a product already placed on the market in such a way that compliance with the applicable requirements may be compromised.”
Therefore, the distributor is considered a Responsible Person only if he places a cosmetic product on the market under his name or trademark or making substantial changes; the translation of information is not considered a substantial change such as to compromise compliance with the requirements of the Regulation.
Therefore, the Responsible Person can be:
- The Manufacturer
- The Importer
- The Distributor
- An external natural or legal person appointed by written mandate who accepts in writing. Such designation shall be mandatory if the manufacturer of a cosmetic is established outside the Community.
So, how can we help you?
Distributors already have a lot of obligations to meet, such as:
- Check of transport and storage conditions, in order to comply with the Cosmetic Regulation
- Check of the labelling, language and date of minimum durability, in order to ensure the full aderence to the regulation, including the enviromental information according to the specific laws of the member State where the product will be put on market
- Refraining from selling a product that is not-compliant with cosmetic regulations, so he must to check and control if the product is compliant or not
- Take care of the obligations in case of non-compliance, by taking the necessary corrective actions even if this means withdraw the product off the market and informing the competent authorities
- Take care of informing the authorities in the event of a Serious Adverse Event, even informing by their corrective actions
- Cooperation with Member States when requested, knowing the necessary measures in place to eliminate the risks associated with a given product placed on market. This is done by providing documents that demonstrate the compliance to the law of the product.
- Notification before a cosmetic product is offered for sale in another EU country, by providing the translated label on the notification portal
- Notification if a product is taken off the market and subsequently reintroduced
This is why Taobé offers to take over the additional obligations that a Responsible Person in the EU and the UK must cover, by:
- Checking the formula compliance per the most recent applicable restrictions
- Performing the Cosmetic Product Safety Report (CPSR)
- Checking the labelling compliance – including regulated data and claims
- Performing the CPNP (for European market) and SCPN (for UK market) notifications
- Performing the Product Information File (PIF)
- Doing the regulatory surveillance and PIF update
And with ecosistant support, you can also be covered with:
- Packaging waste obligations in order to comply with the related regulation for every EU country
- Extended Producer Responsibility (EPR)
- Signing up and registration at dual system and official organizations
- Reoccuring volume reporting
In addition, bear in mind that, most importantly, you might need assistance with the Customs in the EU entry port. Customs clearance can sometimes be very slow and tricky. With our support, we can speed up the process and easily supply the documentations or declarations requested by the authorities.
Should this partnership interest you, please get in touch and learn how to make Taobé as your mandated RP, with the precious support of ecosistant. Contact Taobe Consulting today to discuss your regulatory needs and gain peace of mind with a warrant of compliance during the life of your product on the market!
We bring Europe to your doorstep!
About the Author
Andrea Garulli
Andrea Garulli, Senior Safety Assessor @taobe.consulting wrote this article on the role of the Responsible Person under the Cosmetics Regulation 1223/2009.
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