Regulation (EC) No 1223/2009
Regulation (EC) No 1223/2009 is the main European regulatory framework for cosmetic products. It establishes the rules that must be followed in order to place and make cosmetic products available on the European Union market.
The purpose of the Regulation is to ensure a high level of protection of human health, making sure that cosmetic products are safe under normal or reasonably foreseeable conditions of use.
The Regulation applies to the entire cosmetic supply chain and involves several operators, including manufacturers, importers, distributors, brand owners and Responsible Persons. Each operator has specific obligations depending on their role in the supply chain.
What the Cosmetics Regulation Covers
Regulation (EC) No 1223/2009 covers many aspects related to the compliance of cosmetic products, from product development to market placement.
In particular, it sets requirements concerning:
- cosmetic product safety;
- safety assessment;
- Responsible Person;
- Product Information File;
- CPNP notification;
- labelling;
- prohibited and restricted ingredients;
- use of colorants, preservatives and UV filters;
- nanomaterials;
- cosmetic claims;
- serious undesirable effects;
- Good Manufacturing Practices;
- animal testing.
Proper management of these aspects is essential to avoid non-compliance, objections from competent authorities, market access issues or distribution problems.
Definition of Cosmetic Product
One of the key elements of the Regulation is the definition of a cosmetic product.
A cosmetic product is a substance or mixture intended to be placed in contact with the external parts of the human body, with the teeth or with the mucous membranes of the oral cavity, exclusively or mainly for cosmetic purposes.
These purposes include, for example:
- cleaning;
- perfuming;
- changing appearance;
- protecting;
- keeping in good condition;
- correcting body odours.
This definition is important because it helps distinguish cosmetic products from other product categories, such as medicinal products, medical devices, biocides or detergents.
Correct product classification is the first step in identifying the applicable regulatory framework.
Responsible Person
The Regulation introduces the figure of the Responsible Person, which is essential for placing a cosmetic product on the EU market.
For each cosmetic product placed on the EU market, a Responsible Person established within the European Union must be identified. This person or entity ensures that the product complies with the obligations laid down by Regulation (EC) No 1223/2009.
Depending on the case, the Responsible Person may be:
- the manufacturer established within the European Union;
- the importer;
- a person designated by written mandate;
- the distributor, if the product is marketed under their own name or trademark, or if they modify a product already placed on the market in a way that may affect compliance.
The Responsible Person plays a central role in the regulatory compliance of the cosmetic product.
Safety Assessment
Before being placed on the market, each cosmetic product must undergo a safety assessment.
The assessment takes into account several elements, including:
- qualitative and quantitative composition;
- physical and chemical characteristics;
- microbiological quality;
- impurities and traces;
- packaging material;
- area and method of application;
- exposure to the product;
- toxicological profile of the ingredients;
- possible undesirable effects;
- characteristics of the target population.
The outcome of the safety assessment is included in the Cosmetic Product Safety Report, an essential document to demonstrate the safety of the cosmetic product.
PIF – Product Information File
The PIF, or Product Information File, is the technical information file of the cosmetic product.
It must be prepared before the product is placed on the market and must be kept available to the competent authorities at the address indicated by the Responsible Person.
The PIF includes, among other information:
- description of the cosmetic product;
- Cosmetic Product Safety Report;
- manufacturing method;
- statement of compliance with Good Manufacturing Practices;
- proof of the effects claimed for the product;
- data relating to animal testing, where applicable.
Incomplete, outdated or inconsistent documentation may represent a significant regulatory issue, especially where there are discrepancies between formulation, labelling and CPNP notification.
CPNP Notification
Before being placed on the market, a cosmetic product must be notified through the CPNP – Cosmetic Products Notification Portal.
The CPNP is the European portal for the notification of cosmetic products. Once the CPNP notification has been submitted, no additional national notification is generally required within the European Union.
The notification makes certain product information available to competent authorities and, where applicable, poison centres.
The CPNP notification must be consistent with:
- formulation;
- labelling;
- product category;
- Responsible Person;
- country of origin;
- product data;
- documentation included in the PIF.
Cosmetic Labelling
Regulation (EC) No 1223/2009 establishes the mandatory information that must appear on the label of a cosmetic product.
The main required information includes:
- name or company name and address of the Responsible Person;
- nominal content;
- date of minimum durability or PAO, where applicable;
- particular precautions for use;
- batch number;
- product function, unless clear from its presentation;
- list of ingredients according to INCI nomenclature;
- country of origin for products imported from non-EU countries.
The information must be easy to read, visible and indelible.
Labelling must also be consistent with the formulation, PIF, safety assessment, CPNP notification and claims used for the product.
Prohibited Ingredients and Restricted Substances
The Regulation includes specific annexes governing the use of cosmetic ingredients.
In particular, it provides for:
- prohibited substances;
- restricted substances;
- authorised colorants;
- authorised preservatives;
- authorised UV filters.
Formula review is therefore an essential step to verify that the ingredients used are permitted, used within the allowed limits and compliant with the applicable conditions of use.
This activity is particularly important because the annexes to the Regulation are subject to amendments and updates over time.
Nanomaterials
Regulation (EC) No 1223/2009 includes specific provisions for nanomaterials.
Products containing nanomaterials may be subject to additional obligations, including specific labelling requirements and dedicated notification procedures.
The presence of nanomaterials should therefore be assessed carefully during product development and when collecting technical documentation for raw materials.
Cosmetic Claims
Cosmetic claims are statements used to describe the characteristics, functions or effects of a product.
They may appear on:
- labels;
- packaging;
- websites;
- product sheets;
- advertising materials;
- social media;
- catalogues;
- commercial communications.
Claims must be truthful, clear, correct and supported by adequate evidence.
They must not attribute characteristics to the cosmetic product that it does not have, nor create confusion with other product categories, such as medicinal products or medical devices.
Serious Undesirable Effects
The Regulation also governs the management of serious undesirable effects.
The Responsible Person and distributors have specific obligations to notify competent authorities when they become aware of serious undesirable effects associated with the use of a cosmetic product.
The collection and management of this information is part of the post-market surveillance system for cosmetic products.
GMP – Good Manufacturing Practices
Cosmetic products must be manufactured in compliance with GMP, meaning Good Manufacturing Practices.
GMP help ensure that products are manufactured, controlled, stored and shipped according to appropriate procedures.
The main technical reference for the cosmetic sector is UNI EN ISO 22716, which provides guidelines for the production, control, storage and shipment of cosmetic products.
Compliance with GMP is also important within the PIF, where information on the manufacturing method and compliance with Good Manufacturing Practices must be available.
Animal Testing
The Cosmetics Regulation includes specific prohibitions concerning animal testing in the cosmetic sector.
European legislation introduced significant restrictions both on animal testing for finished cosmetic products and on the marketing of cosmetic products tested on animals, according to the applicable regulatory conditions.
This is one of the most important principles of the European cosmetic regulatory framework.
Why Compliance with Regulation (EC) No 1223/2009 Is Important
Compliance with Regulation (EC) No 1223/2009 is not a merely formal requirement. It is essential for placing and keeping cosmetic products on the European Union market.
Proper regulatory management allows companies to:
- verify product safety;
- prepare complete technical documentation;
- reduce the risk of non-compliance;
- ensure correct labelling;
- support adequately documented claims;
- properly manage notifications and updates;
- prevent objections, withdrawals or sales blocks.
Regulatory Support for Cosmetic Compliance
Cosmetic compliance requires technical, regulatory and documentary expertise.
Support can be provided for:
- cosmetic formula review;
- verification of prohibited or restricted ingredients;
- preparation and update of the PIF;
- cosmetic safety assessment;
- CPNP notification;
- labelling review;
- claims assessment;
- import and export support;
- documentation updates following regulatory changes.
A correct regulatory approach allows the product to be managed throughout its entire life cycle: from development and production to market placement and continued compliance.