The Formula Verification service aims at verifying a Formulation in all its characteristics, giving also some indications about the Safety of it even before starting any EU compliance process. In some cases, can also clarify under which regulatory scope innovative products should fall.
The improvement of technologies and the complex EU regulatory framework may arise borderline classifications between:
- Cosmetic products;
- Medical devices;
- Medicinal products;
The analysis of the formula will be focused, but not limited to:
- The compliance of each ingredient;
- The presence of active substances;
- The study of the formulation and delivery system (if any);
- The mechanism of action and related literature of new ingredients.
- Any possible expected result regarding Laboratory Testing to be run (e.g. Challenge, Stability etc.)
Our pool of experts will guide you on the correct classification and on the regulatory strategy to place your product on the EU market. Please do not hesitate to contact us!
The Cosmetic Products Notification Portal (CPNP) is an online notification system created for the implementation of the EU Cosmetics Regulation 1223/2009/EC. Cosmetic products that will be placed on the market in the European Union need to be notified in the CPNP, and there is no need for any further notification or registration at a national level in the European Union.
The Regulation states that the designated Responsible Person, and distributors of cosmetic products under some circumstances, are required to submit certain information about cosmetic products and their specifications to the CPNP.
The information uploaded to this portal is not available to the public, as its access is restricted to the Competent Authorities and to European Poison Centers and similar bodies. However, although the CPNP is publicly accessible for notification purposes, the notification will only be valid when completed by the EU Responsible Person and accompanied by a valid Product Information File.
Obelis, as a Responsible Person, provides the CPNP Notification service and takes care of the whole process of registering the products in the CPNP.
With 30 years of experience, Obelis also provides support to both manufacturers and distributors, that are sometimes required to access the CPNP for updating the information on a cosmetic product, such as updating labels on the portal, uploading translated or additional ones, etc. We can assist you with our CPNP update/upload dedicated service to keep all the information updated on the portal. Do not hesitate to contact our CPNP experts!
Today, in Cosmetics Industry, the Claims became one of the most important sector, especially commercially speaking. Due to the particular impact that Claims can have for the final Customers, those have been strictly regulated firstly by the Cosmetics Regulation (EC) No 1223/2009, but also with several additional interventions of the EU legislator, like the Commission Regulation (EC) 655/2013 or the introduction of Guidance and Technical Documents.
That makes todays Claims Regulatory scenario quite interesting and intricated. The manufacturers have to pay particular attention and try to balance their Commercial inspirations with the EU dictates.
Obelis has of course the necessary experience to easily understand what can be accepted or not. As part of the CPNP notification service, our consultants have to daily deal with Claims, during the Labelling review prior the CPNP notification on the Portal. This is helping manufacturers to clean any possible issue regarding the Claims, substantiating those sometimes with the Assessors and the RP’s comments/approvals, or sometimes with specific Lab tests (when required by the Law).
Apart from this, Obelis also provides a service dedicated to the Research and the eventual possible Validation of a specific Claim. This can be the case of a Claim to be assessed even before starting any CPNP notification process, or the case of a specific innovative or borderline claim. In those particular cases, Obelis will be more than pleased to provide you with the best EU Cosmetics experts in Labelling and Claims, and help you to improve your Claims Marketing Effect, fully complying with the Law. Do not hesitate to contact us!
Since the Cosmetics Regulation (EC) No 1223/2009 entered in force, applying for a CPNP Notification is the only requirement for freely market Cosmetic Products in all EU member States (with the sole exception of language requirements). As a Regulation, the Law is fully applicable in the entire Union and does not leave space to National Executive Acts.
A different situation emerges when importing products directly in Italy, Spain and Portugal. Also in those countries, the Cosmetic safety is guaranteed by the CPNP, but he National Laws introduced a requirement related to the sanity of the goods shipped. Briefly, whenever Cosmetics product are in imported in Europe by using one of those three members states as first international point of arrival, a particular customs clearance tool has to be requested: the Sanitary Certificate.
- Italy: the certificate is called Nulla Osta Sanitario, and has to be requested by the importer or the European Representative, by applying on the Ministry of Health electronical database. The application concerns commodity shipments and implies the payment of an Official TAX, calculated on the shipments weight.
- Portugal: the Documento de Conformidade can be requested by the importer or the European Representative, by submitting an Official Form, containing several info about the products, to the Portuguese Ministry of Health.
- Spain: the Declaración responsable de actividades de importación de productos cosméticos can be requested only by the Spanish Importer, has having a registered address in Spain is a mandatory requirement for this process applicants.
Also in this case, the applicant will have to fill in official forms and a declaration, to be submitted to the Spanish Ministry of Health. A TAX can be imposed depending on the products type.
Would you like to have more information about those processes, feel free to contact Obelis Experts, that will gladly share their expertise in EU National Sanitary requirements. Additionally, for Portugal and Italy, Obelis can apply directly for you and your importer. Should you need it, do not hesitate to contact us!
Setting high standards for the labelling of cosmetic products (including their container, outer packaging and inserts) is a focal point of Regulation (EC) No. 1223/2009 (Cosmetics’ Regulation), with an entire Article (Art.19) dedicated to the requirements for accurate and appropriate labelling.
Ensuring compliance with these labelling requirements is therefore an essential step that must be taken by every manufacturer on their path to notifying and commercialising their product in the European Union (EU) market. For a more detailed list of the EU Regulation’s labelling requirements, please click here.
While Art. 19 sets the regulatory requirements for a compliant label, the substantive content of the label must reflect the Product’s Information File (PIF). Consequently, the label review is performed following the compilation and assessment of the PIF and is thus the last step of the service leading to the notification of your products. Moreover, a product is formally notified only after the required mandatory information has been uploaded to the Cosmetic Product Notification Portal (CPNP). Uploading a compliant label to the CPNP is part of this mandatory information and therefore a pre-requisite for a valid notification.
To ensure that your labels are fully compliant in these respects, Obelis, offers a multifaceted and adaptable label review service that can be tailored to your commercial needs. As part of the label review service, Obelis consultants will ensure:
- that your product’s labels include all the essential elements foreseen by Article 19 of the Cosmetics Regulation
- that the information on the label is in accordance with your product’s PIF and its resultant Safety Assessment
- that you get commercial-minded and solution-oriented input that can minimise the costs of designing and printing product packaging
Apart from being packaged into our Cosmetic Notification Service, you can also make use of our stand-alone labelling review service. As part of this service, our labelling experts can review your updated labels for previously notified products, upload new labels to the CPNP, perform retrospective checks of your old labels or perform any other label-related review that you may request independently of a full notification service.
Like with all services offered by Obelis, you can choose amongst different service packages based on your commercial needs and the urgency of your request. For more information on our service packages, their specific features and applicable time-frames, please contact our Customer Relations department here.
Your score is between 5 and 7: Good Progress!
You made good progress and you are almost ready to enter the EU Market!
Remember that EU Compliance involves many challenges such as Product Information File Creation, Safety Assessor Selection and more.
Obelis European Responsible Person Center (O.E.R.P.C.) is excited to announce its participation in one of the largest worldwide Cosmetic exhibitions – Cosmoprof Asia. The Exhibition shall take place in the Hong Kong Convention & Exhibition center between the 12th -14th of November 2014.
Obelis will be located in Hall 1E, Booth # T7C.
“CTMR 88 (1), (2) The Community Trade Mark Regulation obliges natural and legal persons not having their domicile or their principal place of business or a real and effective industrial or commercial establishment in the Community to be represented, in all proceedings before the Office other than the filing of a CTM application, by a professional representative, namely either a legal practitioner or a person whose name is entered on the list of professional representatives maintained by the Office”.
Through its extended network of collaborators, OEARC can now provide you with cost effective and simplified trade mark and design registration for the entire EU.
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Obelis is pleased to announce a new service offering dedicated training sessions by our regulatory team on site at our clients’ premises. Such on-site training can be dedicated to the general framework and requirements of the Directive as well as specific training aimed at our clients’ specific situation or requests.
- Obelis Senior Regulatory Expert, Dr. Peter Ruys – MDD, AIMDD & IVD On-Site Training
- Obelis Regulatory Expert, John L. Webster – MDD, AIMDD & IVD On-Site Training
- Obelis C.C.O. Ms. Sandra Ferretti – Cosmetic On-Site Training
The on-site training usually consists of a 2 day workshop, held in our clients’ office with the appropriate set-up, such as a meeting room with screen and projector. Each participant will receive copies of slides and other relevant material as well as a certificate of attendance. The training will be performed in English and the maximum quantity of participants is 12. The price depends on the number of participants, subjects treated and the travelling required between Obelis head office and the client’s office.
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