The science of cosmetic testing without the use of animals

Martina Klaric, Project Manager at Cosmetics Europe, tells the NC3Rs how the industry is moving forwards following the changes to EU cosmetic testing regulations.

 

 

Timeline of changes to EU regulations

2003  On 15 January 2003, the EU passed a law banning the testing of cosmetics and their ingredients on animals. Known as the 7th Amendment to the Cosmetics Directive it imposed a timeline for phasing out animal testing.
2004 Animal testing of finished cosmetic products in the European Union (EU) has been prohibited since 2004.
2009 Animal testing of cosmetic ingredients in the EU has been prohibited since 2009.

Marketing of cosmetic products and their ingredients that have been tested on animals has been prohibited in the EU since 11 March 2009.
2013 To ensure the continued safety of cosmetic products, the marketing ban allowed animal testing for only the most complex human health effects (i.e., testing was permitted for repeated dose systemic toxicity, skin sensitisation, carcinogenicity, reproductive toxicity and toxicokinetics) until 11 March 2013.

As a result, 11 March 2013 marked the completion of the implementation of the legislation and the instigation of the full EU marketing ban on products with ingredients tested on animals after March 2013 [1]. 


The European Cosmetics regulation and implications of the testing ban

The Europe-wide ban on cosmetic testing in animals has now been in place for over a year; however, it is difficult to judge the impact that the ban has had at this point in time, given that the consumer market is influenced by many factors including new legislation. Any new regulation presents a challenge but the testing/marketing ban means that the cosmetics industry in Europe has to remain particularly innovative.

Prior to the implementation of the 2013 marketing ban the EU Commission had to establish the availability of alternative methods for testing cosmetic products and their ingredients.

The cosmetics industry has been strongly supporting the development of alternative methods through the co-funding of the SEURAT-1 research programme (2011-2015) together with the Commission and by driving its own research programme in areas of genotoxicity, eye irritation, skin sensitisation, skin bioavailability and systemic toxicity, where we have achieved considerable progress with new methods and regulatory acceptance of alternative approaches.

However, alternative replacement test methods still have to be developed or accepted for regulatory safety assessment for acute toxicity, reproductive toxicity, carcinogenicity/mutagenicity, skin sensitisation/photosensitisation or repeat dose toxicity [2]. These complex endpoints still do not have alternative test methods and testing approaches accepted by the international regulatory community [3]. The expectancy for when these endpoints can be covered by replacement alternatives is probably beyond a time period of ten years; with the exemption of skin sensitisation where replacement approaches can be anticipated to come into regulatory use within the coming two to four years [2] (see Figure 1).

Figure 1.

Global considerations – promoting the use of alternative methods internationally

The regulatory framework for alternative methods including their use and acceptance differs considerably across the globe. This creates a challenging situation for the global cosmetics industry, which strives to maintain and enable the highest level of global consumer protection while minimising barriers to international trade.

Cosmetics Europe therefore also invests in the promotion of the development, use and regulatory acceptance of alternative methods globally. Different international regulatory collaboration fora and networks are used as a vehicle, including the International Cooperation on Cosmetic Regulations (ICCR).

The ICCR regulatory authorities are committed to increasing collaboration in the area of validation of alternative methods, which has lead to the creation of the International Collaboration on Alternative Test Methods (ICATM). A number of ICCR reports related to alternative methods are available including a report on the Applicability of Animal Testing Alternatives in Regulatory Frameworks within ICCR Regions and an Inventory of Applicable Alternative Test Methods which have been worked upon by ICATM [4].

Regulators around the world are increasingly interested in moving away from animal testing for cosmetics.

We have participated with the European Partnership for Alternative Approaches to Animal Testing (EPAA) and with the coordination of the Institute for In Vitro Sciences (IIVS) in their efforts to promote the international use alternatives to animal testing. The project focused on the information and education about these methods, and to provide science-based advocacy to key stakeholders. IIVS has run several activities in China which provided contact with scientists and key decision-makers on the implementation of alternative methods.

To broaden general awareness of alternatives in China, EPAA helped support the Chinese translation and publication of The Three Rs and the Humanity Criterion by Professor Michael Balls, which will be distributed free of charge to many libraries and all major universities within China. To further encourage the use of alternatives they held hands-on trainings on OECD Test Guideline methods (e.g. bovine corneal opacity and permeability assay for eye irritation) in China and Brazil for scientists coming from over a dozen countries.

Korea, with the formation of the Korean Center for the Validation of Alternative Methods (KoCVAM) and the commitment of substantial funds for its work, has made a good progress for the adoption of OECD Test Guideline methods and participation in international validation efforts.

Vietnam has recently announced that they plan to phase out the Draize rabbit eye test for cosmetics once its laboratory is fully validated to handle the alternative test methods required to establish the safety of cosmetic products.

Recently the USA, New Zealand and Australia also introduced regulatory proposals to the respective parliaments that foresee moving towards alternative testing for cosmetics.

Clarifying the status of alternatives

However, there are currently misunderstandings about the state-of-the-art of the science of alternative methods, which is leading to related regulatory measures that do not take into account the alternative toolbox available today.  Together with the European Commission, Cosmetics Europe is therefore also committed to clarifying the status of availability of the so-called full replacement alternative methods to regulators and industry worldwide.

Cosmetics Europe, The Personal Care Association, has been the voice of Europe’s cosmetic, toiletry and perfumery industry since 1962 and represents the interests of more than 4000 companies.

References

[1] European Commission (2013a). Communication from the Commission to the European Parliament and the Council. COM (2013) 135 final.

[2] Adler S, Basketter D, Creton S, et al. (2011). Alternative (non-animal) methods for cosmetic testing: current status and future prospects – 2010. Arch. Toxicolog. 85, 367-485.

[3] European Commission (2013b) EURL ECVAM progress report on the development, validation and regulatory acceptance of alternative methods (2010-2013). Available: http://ihcp.jrc.ec.europa.eu/our_labs/eurl-ecvam/eurl-ecvam-releases-2013-progress-report-development-validation-regulatory-acceptance-alternative-methods

[4] International Cooperation on Cosmetics Regulation www.iccrnet.org

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