Obelis “Success Story” in the Belgian Cosmetics Catalogue!
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Obelis has been listed in the official Belgian Cosmetics Catalogue 2016! The catalogue, published in September 2016 by the Belgian Federal Agency for Exportations, presents the most up-to-date insig [...]

3 Leading Factors That Can Expedite Sales to Europe
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The EU Cosmetic Regulation EC 1223/2009, published in the official journal of the European Union on November 30th  2009 and introduced on July 11th 2013, requires all cosmetic products to apply a sp [...]

Obelis to organize the First International Congress on Cosmetics Regulations!
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Obelis, together with BioEvents, is organizing the first edition of International Congress on European Regulations and Compliance for Cosmetic (CRCC 2016). The congress will take place between 7th a [...]

Revision of SCCS Guidance on the Safety of Cosmetics – What has Changed?
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Notes of guidance: The latest edition of the “Notes of guidance for testing of Cosmetic Ingredients and their Safety Assessment” has been issued and closed for comments following the deadline o [...]

Responsible Person

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in Responsible Person
| What is a Responsible Person? | Non-EU Manufacturer | EU Manufacturer | EU Importer | EU Distributor | EU Laboratory |

What is a Responsible Person?

in Responsible Person

“Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market” (Art.4, p.1).

As clearly indicated by the EC 1223/2009, designating a Responsible Person is a mandatory requirement.

“Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24” (Art.5, p.1).

The RP is responsible to ensure that all the obligations related to product conformity have been carried out prior to placing the product onto the European Market and then to act as the Cosmeto-Vigilance contact point in Europe towards the cosmetic product he is responsible for.

In daily practice, the Responsible Person is engaged in:

    • Ensure compliance with requirements of the regulation (requirements such as: safety, GMP, PIF, notification, composition, labeling, claims, and communication of serious undesirable effects…).
    • Immediate corrective measures, withdrawal/recall if appropriate in case of non-conformities.
    • Immediate information to competent authorities (CA) and other economic operators in case of risk to protection of human health.
    • Provide information and documentation to demonstrate conformity as per requests by competent & national authorities. Keep the PIF readily accessible to the Competent Authorities for a period of 10 years after the last batch was placed on the market.

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Non-EU Manufacturer

in Responsible Person

Under the EC 1223/2009 the Non-European Manufacturer is, by definition, responsible to fulfill the obligations under the regulation, only for products manufactured within the European community and placed, under his name, onto the European Market. The Non-EU manufacturer can fulfill those obligations only by designating a Responsible Person established within the European Community to do so on his behalf (Mandatory!).

EC 1223/2009 article 4.4
“Where, for a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer is established outside the Community, he shall designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.”

What obligations is he responsible for? The one designated by the Non-European manufacturer as Responsible Person is responsible for all obligations under the EC 1223/2009 for a Cosmetic product:

EC 1223/2009 article 5.1
“Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24.”

In case of products placed on the market under the name of a Non-EU manufacturer and not actually manufactured within the European Community, the EU importer will be responsible to fulfill all obligations under the EC 1223/2009this creates two problems:

  1. The EU importer is unable or unwilling to assume the responsibilities.
  2. The Non-EU manufacturer is unwilling to disclose all information (composition, product specifications, trade names and more) on his Cosmetics.

How to address these two problems?

  1. EU Importer designates “EU Responsible Person”;
  2. The solution is to delegate the responsibilities to a professional EU based “Responsible Person”, able to release the EU importers of their obligations under the law (under individuals signed legal mandates) while still protecting your product specifications and brand. The designation will cover all products manufactured by you and imported by your clients into the European Market.

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EU Manufacturer

in Responsible Person

Under the EC 1223/2009 the European Manufacturer is, by definition, responsible to fulfill the obligations under the regulation for the products placed, under his name, onto the European Market.

EC 1223/2009 article 4.3
“For a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person.”

What obligations is he responsible for? The European manufacturer as Responsible Person is responsible for all obligations under the EC 1223/2009 for a Cosmetic product:

EC 1223/2009 article 5.1
“Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24.”

In case the European manufacturer is having difficulties to understand the regulatory maze to compliance and as such unable to fulfill the obligations under the law for his Cosmetics? The solution resides in the EC 1223/2009:

EC 1223/2009 article 4.5
“The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.”

The solution provided by the EC 1223/2009 is to delegate your responsibilities to a professional EU based company, able to fulfill all the obligations under the law under a mutually signed legal mandate. The designation will cover all products manufactured by you.


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EU Importer

in Responsible Person

Under the EC 1223/2009 the Importer is, by definition, responsible to fulfill the obligations under the regulation for the products imported by him into the European community.

EC 1223/2009 article 4.5
“For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market.”

What obligations is he responsible for? The importer as Responsible Person is responsible for all obligations under the EC 1223/2009 for a Cosmetic product:

EC 1223/2009 article 5.1
“Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24.”

In case the Importer is unable or unwilling to fulfill the obligations under the law for the Cosmetics imported from his different suppliers (Non-EU manufacturers)? The solution resides in the EC 1223/2009:

EC 1223/2009 article 4.5
“The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing.”

The solution provided by the EC 1223/2009 is to delegate his responsibilities to a professional EU based company, able to fulfill all the obligations under the law under a mutually signed legal mandate. The designation will cover all products imported by onto the European Market him according to his list of suppliers.


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EU Distributor

in Responsible Person

Under the EC 1223/2009 the European Distributor will be, by definition, responsible to fulfill the obligations under the regulation for any Cosmetic product which he will place on the market under his name or of any product which he modified in a significant way – under such cases, the distributor may not delegate his responsibilities (!).

EC 1223/2009 article 4.6
“The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.”

What obligations is he responsible for? The European distributor assuming the role of the manufacturer, as Responsible Person is responsible for all obligations under the EC 1223/2009 for a Cosmetic product:

EC 1223/2009 article 5.1
“Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24.”

In case the distributor is having difficulties to understand the regulatory maze and as such unable to fulfill the obligations under the law for his Cosmetics? The solution does not reside in the EC 1223/2009 as the distributor cannot delegate his responsibilities if he places a product on the market under his name or makes a significant change to the product which will affect the compliance of the product;

As such, the only solution in such a case is for the distributor to locate a consultant to assist him in fulfilling its obligations under the EC 1223/2009.


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EU Laboratory

in Responsible Person

In need of a solution or a partner, to assist you and your clients to place their Cosmetic products onto the European Market?

Whether they are EU manufacturers, Non-EU manufacturers, importers or distributors, or in case you need regulatory consultancy, Obelis will assist you with a tailored solution to your needs and theirs to achieve compliance and entrance to the European Market.


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