Reading the EU Cosmetics Regulation | Labeling and Prohibited Substances Set Out in 1223/2009

Cosmetics sold in the EU are governed by Regulation (EC) No 1223/2009, adopted on November 30, 2009, commonly known as the EU Cosmetics Regulation. It replaced the Cosmetics Directive, which had been in place since 1976, and has been fully applicable since July 11, 2013. A key feature is that it applies directly across the EU, without going through each member state’s national law.

The “responsible person” and “safety report” required before placing a product on the market

Under this regulation, only products for which a legal or natural person has been designated within the EU as the “responsible person” may be placed on the market. The responsible person maintains a product information file for each product, including a safety report, and notifies the European Commission through the Cosmetic Products Notification Portal (CPNP). The European Commission explains that notification to the CPNP is required only once and covers the entire EU.

“Ingredients that cannot be used” and “ingredients with conditions” defined in the annexes

The handling of ingredients is organized in the annexes. Annex II lists prohibited substances; Annex III lists restricted substances subject to conditions on concentration or use; and Annexes IV, V, and VI list permitted colorants, preservatives, and UV filters, respectively. In the text as enacted in 2009 and published in the Official Journal of the European Union, the reference numbers in Annex II ran up to 1,328, and entries have continued to be added with subsequent amendments. In addition, under Article 15, substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) are prohibited except in cases that meet strict conditions.

The framework of the EU regulation is that a product is placed on the market by a responsible person within the region who is able to explain its safety. The lists of prohibited, restricted, and permitted substances are the rules that support this premise, and ingredient names are displayed using common ingredient names that take into account the international nomenclature INCI.

Labeling rules also differ from Japan’s

Article 19, which sets out labeling items, differs from Japan in its approach to expiration dates. As a general rule, the “date of minimum durability” must be displayed, meaning the date until which the product is considered to retain its initial function if properly stored. For products that remain stable for more than 30 months, this display may be omitted, but instead the period after opening during which the product can be used must be indicated with an open-jar symbol and the number of months. Display of the lot number, or manufacturing number, is also mandatory. In addition, ingredients formulated as nanomaterials must be marked with “(nano)” after the ingredient name.

For the basis of statements made in labeling and advertising, known as claims, a separate regulation, Regulation (EU) No 655/2013, sets common criteria. Japan’s approach to expiration dates is Cosmetic Expiration Dates and the 3-Year Rule introduced here.

References: European Commission; Official Journal of the European Union (Regulation (EC) No 1223/2009)

—The Value Village Editorial Team