EU Cosmetics Regulations and Registration

Cosmetics suppliers (manufacturers/importers/exporters) who would like to place cosmetic products on the EU market have to comply with the following regulations:

  • EU Cosmetics Directive 76/768/EEC;
  • New EU Cosmetic Products Regulation (EC) No 1223/2009;
  • REACH Regulation (EC) No 1907/2006;


A cosmetic product is any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, and/or correcting body odours, and/or protecting them or keeping them in good condition.

Current EU Cosmetics Directive (76/768/EEC)

The EU Cosmetics Directive (76/768/EEC)[Fulltext,pdf] was revised in January 2003 to ban over 1,100 chemicals in cosmetics. Ingredients were reviewed for safety by SCCS (EU Scientific Committee on Consumer Products). The main requirements are listed as below:

  • A safety assessment of the finished cosmetic product must be performed before the product can be placed on the EU market;
  • A full technical file or product information file (PIF) for a cosmetic product must be kept available for inspection by authorities at a specified EU address("Responsible Person"). PIF shall include the following information:
    • qualitative and quantitative composition of the product;
    • the physico-chemical and microbiological specifications of the raw materials and the finished product;
    • the method of manufacture complying with GMP;
    • assessment of the safety for human health of the finished product etc.;
  • Notification to competent authorities must be done to inform the competent authorities that a cosmetic product will be placed on the EU market (pre-market notification);
  • The requirements of labelling and languages must be met.


Note: Non-EU companies who place EU cosmetic products on EU market shall appoint a "Responsible Person" in EU to keep safety assessment report and PIF available and submit pre-market notification to EU toxic centers and competent authorities.

New EU Cosmetic Products Regulation (EC) No 1223/2009

The new EU Cosmetic Products Regulation, EU Regulation (EC) No 1223/2009[Fulltext, pdf] was adopted on November 30, 2009. Most of the provisions of this new regulation will be applicable as from 11 July 2013 and replace the Cosmetics Directive (76/768/EEC) thereafter.

The new regulation has included harmonized notifications, clearer provisions for the content and format of product safety assessments and product information files (PIF) and strengthened coordinated efforts of market surveillance activities among competent authorities of member states.

The new Cosmetics Regulation Europe has also taken into consideration some of the latest technological developments, including the possible use of nanomaterials. For example, nanomaterials in the cosmetic products must be mentioned on the list of ingredients on the packaging, with the names of such ingredients followed by the word “nano” in brackets.

REACH Regulation (EC) No 1907/2006 and Cosmetics

REACH is the EU regulation (EC) No 1907/2006 concerning the Registration, Evaluation and Authorization of Chemicals. It came into force on 1 June 2007. Both chemical raw materials and finished cosmetics products are impacted by REACH.

Most of cosmetic products belong to chemical preparations (mixtures) under REACH regulation and each chemical substance or ingredient shall be (pre)registered with the European Chemical Agency (ECHA) if the annual tonnage of the substance exceeds 1 ton (called "REACH registration").

To avoid REACH registrations, suppliers of cosmetics products have to ensure that all ingredients (either in cosmetics formulations or finished products) have been properly registered if the tonnage of the ingredient is above 1 ton per year. Non-EU companies may appoint an REACH only representative to submit pre-registration/registrations.

EU manufacturers and importers of cosmetic products may be required to apply for prior authorization for the use of substances of very high concern in their products.

Placing Cosmetic Products on EU Market Step By Step

  • Step 1: Prepare Product Information File("PIF") and safety assessment report;
  • Step 2: Appoint a Responsible Person in EU to keep and update PIF and safety assessment report available;
  • Step 3: Submit pre-market notification to EU toxic centers and national competent authorities;
  • Step 4: Make sure that labelling meets the requirements of destination countries;
  • Step 5: Check if the ingredient requires REACH registration or not. If yes, submit REACH registrations to ECHA. Non-EU companies need to appoint REACH only representative to submit registrations.

Our Services

We offer integrated and cost-effective compliance solutions for the entry of cosmetic products into the EU. Our services are listed as below:

  • Preparation of product information file("PIF");
  • Safety assessment report;
  • Act as responsible person(for non-EU companies);
  • Pre-market notification;
  • Advice on labelling and languages;
  • REACH registration;
  • REACH only representative (for non-EU companies);