Why do you need a Responsible Person in Europe?

02/03/2018

Why do you need a Responsible Person in Europe?

What is a Responsible Person?

Since Regulation (EC) No. 1223/2009 for cosmetic products came into effect, it has been necessary to designate a Responsible Person for cosmetic products sold in the European Union. The Responsible person, who must have a presence in the EU, guarantees compliance with the Regulation to European authorities, and ensures that the product is safe for human health under normal and reasonably foreseeable conditions of use.

Who can be a Responsible Person?
The Responsible Person can be a manufacturer, importer, or distributor, and can also be a consultant. It will be someone who is capable of taking on the responsibilities of the role and complying with the safety and regulation requirements that the position requires, someone like the experts at Cosmeservice.

Is it obligatory to have a Responsible Person?
Article 4 of the Regulation on cosmetic products states that cosmetics can only be sold in Europe if there is a designated Responsible Person. In other words, a Responsible Person is essential in order to sell cosmetics.

What obligations does the Responsible Person have?
The Responsible Person is responsible for ensuring that the cosmetic product complies with Regulation 1223/2009 and its amendments. Cosmeservice can be your Responsible Person and take care of all of the following requirements:

1. GUARANTEE THE SAFETY OF THE COSMETIC PRODUCT

The Responsible Person will assess the safety of the cosmetic product and is responsible for preparing the product information file (PIF), keeping it and maintaining it for 10 years after the last batch is placed on the market. Ask our experts if you would like more information about the product information file.

2. GUARANTEE THE QUALITY OF THE MANUFACTURING PROCESS
Good Manufacturing Practices are are certified by the ISO 1223/2009 standard, and provide guidelines for the manufacture, control, storage and shipping of cosmetic products. The Responsible Person guarantees compliance with GMP.

3. GUARANTEE THE COMPLIANCE OF THE COSMETIC FORMULA
The Responsible Person must verify that the formula complies with the Regulation. Many cosmetic ingredients are permitted, but some are restricted or prohibited by the Annexes of the Regulation. To check the legal compliance of cosmetic formulas the annexes need to be reviewed regularly, as they are updated periodically.

4. MONITOR THE PROHIBITION ON ANIMAL TESTING
Testing cosmetic products on animals is prohibited by Article 18 of Regulation (CE) 1223/2009. The cosmetics industry has now developed alternative tools to avoid tests involving animals.

5. GUARANTEE CORRECT PACKAGING AND LABELLING
There are compulsory requirements for labelling and packaging for all cosmetics products, as well as symbols that must appear in a particular way and size. This information must also be translated into the relevant language. What symbols should I use? What are the official languages of each country? Do not hesitate to ask us, we will be happy to help.

6. NOTIFICATION IN THE CPNP
Article 13 of Regulation 1223/2009 requires the Responsible Person to submit information about cosmetic products to the European Commission by a notification in the Cosmetic Product Notification Portal. This portal, a single service for the whole European Union, allows information to be collected and used by competent authorities when necessary.

Cosmeservice can be your Responsible Person
If you are overwhelmed by all these requirements, it is a good idea to ask a qualified expert to ensure your product is safe and can be sold in the EU. Cosmeservice can be your Responsible Person, and your guide through the process. Our work is in the safety of cosmetic products, and our mission is to study the European regulation and legislation in the various annexes and amendments, and handle the corresponding databases and records, in order to free manufacturers and distributors from this task. Cosmeservice’s objective is to actively contribute to consolidating the position of manufacturers and distributors in the European cosmetics market. We operate with the maximum quality, reliability and safety for consumers.

Do you have any questions about the role of the Responsible Person?
If you have any questions about complying with the Regulation, or if you are looking for specific services, COSMESERVICE can act as your Responsible Person in Europe and provide you with the following services:

• Cosmetic Safety services. Safety Assessment.

• Compliance with the Regulation. Creating the PIF.

• Responsible Person in Europe.

• Formula review.

• Labelling review.

• Review and justification of claims.

• Notification in the CPNP.

Do not hesitate to contact us, we will be happy to help. Write to us at info@cosmeservice.com or call us on (+34) 956 14 33 02.

Just get in touch, and we will make it happen!

COSMESERVICE,

Safety and Regulation team.

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