EU Cosmetics Regulation on animal testing Under EU 1223/2009 Regulation

This article explains how to comply with the EU Cosmetics Regulation on animal testing according to the regulation 1223/2009.

Regulation 1223/2009 is the legislation that covers cosmetic products in the EU. This also applies to the EFTA nations. This article explains how to comply with the EU Cosmetics Regulation on animal testing. 

The EU has prohibited animal testing of cosmetic products since March 11, 2013.

Meanwhile, the 7th Amendment of the Cosmetic Directive developed a regulatory framework for phasing out animal testing.

The prohibition applies to all cosmetic products placed on the EU market. This also covers those produced in the EU and those imported from third countries.

Animal Testing Phasing-Out Timeline

11 September 2004 – Ban of the testing of finished products on animals.

11 March 2009 – Ban of the testing of ingredients or combination of ingredients on animals.

11 March 2009 – Marketing ban of cosmetic products and their ingredients which have been tested on animals. This was done to meet the requirements of the EU Cosmetics Directive.

Likewise, this is regardless of whether or not there are available alternative methods. Applied to all, but the most complex human health effects to be tested to show the safety of cosmetic products. The deadline was extended to 11 March 2013.

• repeated-dose systemic toxicity
• reproductive toxicity
• skin sensitization
• toxicokinetics
• carcinogenicity

Compliance with EU Cosmetics Regulation on animal testing Products

The safety assessment of cosmetic products can still rely on the animal testing data before the marketing ban’s implementation dates (11 March 2009/11 March 2013).

Note that the Product Information File must include any data about animal testing.

• Any animal testing performed by the manufacturer, supplier, or agent.
• Any animal testing relating to the development or safety assessment of the product or its ingredients.
• Any animal testing is done to meet the regulatory or legislative requirements of third countries.

The Cosmetics Regulation using the phrase ‘in order to meet the requirements of this Regulation’ to qualify the scope of the 2013 marketing ban.

Hence, animal testing that aims to comply with non-cosmetics related legislative frameworks should not be considered to have been carried out ‘in order to meet the requirements of this Regulation’.

Consequently, it should not trigger the marketing ban and be relied on in the safety cosmetic assessment.      

Reliance on such data is subject to its compliances with the data quality requirements. It would also depend on its relevance for the safety cosmetic assessment.

There are testing carried out on ingredients that have been explicitly developed for cosmetic purposes and are exclusively used in cosmetic products.

In this case, it would be assumed to be carried out ‘in order to meet the requirements of this Regulation’.

Animal testing for compliance with cosmetics requirements in third countries also has data. The EU does not rely on this data for the safety assessment of cosmetics.

Compliance with the EU Regulation 1223/2009 is a key aspect of successfully selling your cosmetic products in the EU market.

Contact QSE Academy for more information on how to follow the regulation. You may also read our blog posts for more tips, explanations, and data.

QSE Academy has developed toolkits and packages to help your cosmetics company begin this process and comply with the ISO 22716 standard.