EU prohibition on animal testing – potential concerns

This prohibition was set forth in the 7th Amendment (2003/15/EC)3 to the Cosmetics Directive, and is included in the Cosmetic Regulation as well. A proviso was included in the 7th Amendment that this deadline could be pushed back should suitable replacements for animal testing have not been found. At this point alternatives for many of the endpoints of concern have not been identified, but the EU has pressed ahead with the prohibition. Such a prohibition is somewhat at odds with the currently proscribed legal requirements for data to be considered when compiling a safety report and conducting a safety assessment. The conflict is even more evident when one considers the guidance notes outlined by the SCCS on the safety assessment process.4 The prohibition further raises potential concerns in relation to the availability of suitable data on which a safety assessment could be based. In this article we shall first consider the history of the safety assessment as applicable to cosmetics and the task faced by individuals undertaking such a responsibility. We shall then move to look at the prohibition of animal testing and the alternative test methods currently validated for use (as well as discuss the numerous endpoints for which full alternative replacement tests are not yet available). Lastly we consider the conflicts between the legal requirements for safety assessment compared to the prohibition on animal testing and discuss the potential concerns these raise for a safety assessor.

The EU Cosmetics Directive was initially published in 1974 and has been revised multiple times, including 14 updates since the beginning of 2009 alone. Among the most significant changes since inception was the introduction of a legally required “…assessment of the safety for human health of the finished product” conducted by a ‘qualified person’. This was introduced by Directive 93/35/EC5 and commonly referred to as the 6th Amendment. The requirements of this assessment, and the depth of data it needs to be based upon, is now being expanded and proscribed in much greater detail as part of the move to the EU Cosmetics Regulation which will be enforced from the 11th July 2013. One of the biggest changes is in relation to the level of information that has to be provided for the ‘Toxicological Profile of the Substances’ under Point 8, Part A of the Cosmetic Product Safety Report (CPSR). This requires that: “…the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints. A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisation, and in the case of UV absorption photo-induced toxicity shall be made”. In particular it also requires that: “…systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL) shall be calculated. The absence of these considerations shall be duly justified.” The SCCS guidance notes on safety assessment expand on this further by noting: “The No Observed (Adverse) Effect Level is defined as the highest dose or exposure level where no (adverse) treatment-related findings are observed. It is mainly derived from repeated dose animal studies (90 day, developmental toxicity studies, etc).” This legal requirement for the provision and consideration of animal test data as part of the safety report/safety assessment is now a sharp contrast with the major change to prohibit the use of animal testing to prove safety that has now been enforced. Indeed the requirement for calculations of MoS based on animalderived NOAELs itself presents a problem to safety assessors simply because of the lack of such data for most ingredients. The prohibition on animal testing now means that no new data of this type, either for existing or novel ingredients, can be generated for the purposes of showing compliance with the cosmetics legislation. Moreover as the prohibition has been enforced without alternative methods being available for many endpoints, not just repeated dose toxicity, there are concerns over the wider ability to generate data that may be used as part of a safety assessment. Some of these endpoints for which suitable alternatives are not available include ones identified as of ‘critical concern’ for cosmetic products, such as skin sensitisation. One problem facing safety assessors, therefore, is whether these two legal requirements combine in such a way as to make protection of consumer safety unduly difficult.

Discussion