{"id":4291,"date":"2025-10-31T10:25:40","date_gmt":"2025-10-31T09:25:40","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?p=4291"},"modified":"2025-10-31T11:18:10","modified_gmt":"2025-10-31T10:18:10","slug":"wat-are-the-obligations-under-cosmetics-regulation-ec-no-1223-2009","status":"publish","type":"post","link":"https:\/\/www.pharmanager-development.com\/en\/wat-are-the-obligations-under-cosmetics-regulation-ec-no-1223-2009\/","title":{"rendered":"Wat Are the Obligations Under Cosmetics Regulation (EC) No 1223\/2009?\u00a0"},"content":{"rendered":"\n
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Cosmetics <\/a>Regulation (EC) No 1223\/2009<\/a>\u202fis the European reference framework for product safety and regulatory compliance.\u00a0
It governs every stage of a cosmetic product\u2019s life cycle:\u202fformulation, manufacturing, regulation, quality, labelling, and market placement.\u00a0
His objective is clear: to ensure safety for human health and the traceability of every cosmetic product made available in the European Union. For any company in the sector – manufacturers, brands, importers, or distributors – it is essential to understand and apply this regulation in order to avoid non-compliance.\u00a0<\/p>\n\n\n\n

1. Designating a Responsible Person: A Key Requirement in article 4 of Regulation (EC) No 1223\/2009<\/strong> <\/h2>\n\n\n\n

The regulation requires a\u202fResponsible Person\u202fto be appointed for every cosmetic product. 
This person acts as the\u202fregulatory compliance guarantor\u202fand serves as the\u202fmain contact point for authorities. <\/p>\n\n\n\n

Their role includes:\u00a0
\u2022 verifying product compliance with\u202fRegulation (EC) No 1223\/2009,\u00a0<\/a>
\u2022 keeping the technical documentation available for authorities,\u00a0
\u2022 ensuring traceability and communication in case of issues,\u00a0
\u2022 and managing\u202fcosmetovigilance\u202fafter market placement.\u00a0<\/p>\n\n\n\n

The Responsible Person can be the\u202fmanufacturer, the\u202fimporter, or a\u202fmandated representative\u202fappointed in writing. <\/p>\n\n\n\n

2. The Product Information File (PIF): A Pillar of Regulatory Compliance<\/strong> <\/h2>\n\n\n\n

The\u202fPIF\u202fis a central requirement of\u202fRegulation (EC) No 1223\/2009, located in article 11. 
It compiles all the information necessary to demonstrate product compliance. <\/p>\n\n\n\n

It must include: 
\u2022 the description of the cosmetic product, 
\u2022 the\u202fCosmetic Product Safety Report (CPSR), 
\u2022 A description of the manufacturing method in accordance with ISO 22716 (GMP), 
\u2022\u202fevidence supporting claimed effects by the product, 
\u2022 And the data related to tests on animals. <\/p>\n\n\n\n

The PIF must be\u202fkept up to date\u202fand retained for\u202fat least 10 years\u202fafter the last product has been placed on the market of the product, by the responsible person.  <\/p>\n\n\n\n

Without a complete PIF, a cosmetic product is considered\u202fnon-compliant, under the European regulation.\u00a0<\/p>\n\n\n\n

3. Safety Assessment: A Mandatory Step Before Market Placement of article 10 of the European regulation<\/strong> <\/h2>\n\n\n\n

Each cosmetic product must undergo a\u202fsafety assessment\u202fcarried out by a\u202fqualified expert\u202f(toxicologist, pharmacist, or chemist). 
This assessment determines whether the product is\u202fsafe for human health\u202funder normal or reasonably foreseeable conditions of use. <\/p>\n\n\n\n

It considers: 
\u2022 the full formulation, 
\u2022 the potential toxicity of ingredients, 
\u2022 the route of exposure (cutaneous, ocular, oral), 
\u2022 and the target population (adults, children, professionals). <\/p>\n\n\n\n

The\u202fCosmetic Product Safety Report (CPSR)\u202fis a key component of the PIF. <\/p>\n\n\n\n

4. CPNP Notification: A Mandatory Administrative Step located in article 13 of regulation (CE) n\u00b01223\/2009<\/strong> <\/h2>\n\n\n\n

Before being placed on the market, every cosmetic product must be\u202fnotified through the European CPNP portal(Cosmetic Products Notification Portal<\/em>). 
This notification enables authorities and poison control centres to access essential information about the product. <\/p>\n\n\n\n

A product\u202fnot notified on the CPNP\u202fcannot be\u202flegally marketed within the European Union. <\/p>\n\n\n\n

5. Cosmetic Labelling: Transparency and Traceability<\/strong> <\/h2>\n\n\n\n

Labelling is strictly regulated by\u202fRegulation (EC) No 1223\/2009, article 19. \u00a0It must include:\u00a0<\/p>\n\n\n\n