Jan 2021
EU Regulation 1223/2009

Regulation No (EC) 1223/2009 are a necessary set of regulations companies must comply with in order to sell their cosmetic products within the European Union (EU) market. The EU Regulation No 1223/2009 describes cosmetics as substances that have been prepared to be used for personal care, to topically clean, protect, improve or change the appearance of and make cosmetic corrections to the skin, hair, nails or teeth (oral cavity). Cosmetics products include skincare creams, emulsions, sunscreens, makeup, perfume, shampoo, teeth whitening products and odor reducing deodorants.

All of the cosmetic products placed on the EU market need to comply with the EU Cosmetics Regulation No 1223/2009. These cosmetic regulations are put in place to protect the consumer and the company itself. This includes cosmetic products sold online, in shops, distributed to consumers from a warehouse, used on consumers by clinic or spa professionals or made available in hotels. These cosmetic regulations govern all 27 EU member states, with compliance required all products sold within the EU. Even if cosmetic product owner is not based within the EU they are still required to comply and adhere to these provisions set by EU regulations.

To ensure the cosmetic products are safe for use it is fundamental that the products are tested properly, this includes stability tests and preservative efficacy testing on ready to sell products to support shelf life claims and expiration dating. Stability tests must be provided as part of the Product Information File (PIF) to support expiry or Period After Opening (PAO) statements. If a cosmetic product contains or comes into contact with water it has to be challenged through microbial testing. The microbial challenge tests consist of several trials performed to speed up the growth of microorganisms that could be present within the product and to ensure the cosmetic product can withstand certain temperatures and environments. Testing is also important to determine whether the cosmetic product is safe in its final packaged state and to confirm that the product is suitably preserved over its declared shelf life and will not pose a risk to consumer safety.

A safety assessment referred to in regulation 1223/2209 as the represents the most valuable part of the required Product Information File (PIF). A CPSR is required for each product intended for sale within the EU and must be provided by a qualified Safety Assessor professionally trained in pharmacy, toxicology, or chemistry. The safety assessors use the data provided from the stability and challenge tests and compile all the information about the cosmetic product, including Safety Data Sheets (SDS), cosmetic claims, labeling, the ingredients that go into it, safety calculations, whether the right percentages of ingredients are listed correctly which will be presented in the CPSR. The safety assessor provides a conclusion of the evaluation regarding the safety of the cosmetic product.

The PIF contains all the most important information about the finished product, including the safety assessment, which is provided in two parts (A and B). The information in the PIF serves to identify the product, its purpose of use, and whom the regulatory authorities should contact regarding product safety and distribution if and when required. The PIF also contains information about the finished product, its ingredients, the packaging, manufacturing process and product labeling.

Accompanying the PIF must be several declarations which confirm that the cosmetic product's is compliant with EU regulations. The compliance statements include presence and purity of certain materials such as the presence of nanomaterial's, GMP ISO 22716 compliance, method of manufacturing and storage requirements and any declarations of prohibited animal testing or banned and restricted substances (substances with endocrine-disrupting properties within the cosmetic product are banned by the EU).

Mandatory product labeling requirements set out by EC Regulation 1223/2009 include the name and address of the Responsible Person, country of origin, nominal content and weight in metric measurements, any cosmetic claims, and the list of ingredients, in the correctly stipulated order. The date of minimum durability or period after opening (PAO), precautions and warnings and batch or lot number are also required to be included on the label.

Checklist of key points of EC Regulation 1223/2009:

  • Review any restrictions and maximum threshold in %w/w for the cosmetic ingredients in the formula using CosIng ingredients database and only use compliant cosmetic ingredients, identified by CAS number and International Nomenclature of Cosmetic Ingredients (INCI) name.
  • Identify ingredients susceptible to provoke allergic reactions such as essential oils, which have a legal dermal limit when used in cosmetic products. Currently there are 26 recognized perfume allergens, and each must be labeled correctly if exceeding 0.01% threshold in rinse-off cosmetic products, and 0.0001% in leave-on products.
  • Obtain Safety Data Sheets (SDS) from the supplier of each raw material batch used in manufacture and have a system for storing and retrieving each of these.
  • Compile a Product Data Sheets (PDS), showing full composition information, CAS numbers, and INCI names.
  • Adhere to the regulations for cosmetic claims, providing proof of the effects of these claims for the cosmetic product (in-vivo or in-vitro test results, bibliographic search and properties of ingredients that compose the product).
  • Carry out product safety assessment (CPSR) of the cosmetic product.
  • Comply with animal test bans.
  • Prepare a compliant product label with correct identification of each batch or lot. A batch recording system must be set up, with its own code logic enabling tracing of each unit sold.
  • Ensure that the manufacturer of your product is compliant with cosmetics ISO 22716 for Good Manufacturing Practices (GMP).
  • Appoint a Responsible Person (RP) that will be registered for the product in the EU and ensure that they are aware of their legal responsibilities.
A Responsible Person is the person who is registered to represent the cosmetic product that will be sold within the EU market and has to be located in one of the 27 EU member states making sure it is compliant with EU Cosmetics Regulations 1223/2009. If the cosmetic company is from outside the EU, someone from within the EU community must be appointed as Responsible Person this can be a manufacturer of cosmetic production, a consulting firm, an agent or a distributor of the cosmetic product within the EU but there has to be in a written agreement between the parties. Lastly, the Responsible Person is also accountable to keep the PIF for up to ten years following the product launch and must notify the European Commission by uploading the product information to the Cosmetics Products Notification Portal (CPNP), demonstrating that the products are fully compliant.

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