In a draft report published on November 19 [1], three EU scientific committees [2] assess the applicability of the so-called Threshold of Toxicological Concern (TTC) approach to the human health-related risk assessment of chemical substances. Based on the concept of “safe levels of exposure”, TTC is an approach that aims to establish a human exposure threshold value below which there is a very low probability of an appreciable risk to human health.

Applicability to cosmetics?

The European Commission asked the three scientific committees to review the available scientific literature as well as a Colipa [3] report which stated that while being a useful additional tool in the absence of chemical-specific toxicology data, the TTC concept did not provide a full safety assessment of cosmetic ingredients and impurities, in particular regarding local effects at the site of application.

In their conclusion, the three scientific bodies say that: “The principle of the TTC approach in itself is scientifically acceptable. However, the application of this principle in terms of risk assessment for safety evaluation of a chemical is dependent on the quality, quantity, and relevance of the underlying toxicity database, and a reliable estimation of the exposure to the chemical in the respective field of application.

Lack of knowledge

So far, only limited information and knowledge exist on the levels of exposure linked to a wide variety of consumer products, such as cosmetics, where "complex exposure scenarios" and "multiple exposure routes" have to be considered.

This preliminary report comes just days before a 30 December deadline to pre-register substances for safety screening and registration under the EU’s chemical regulation REACH. Conclusions can be commented upon until 2 January 2009.

French authorities’ concerns

In parallel, on the occasion of a scientific conference on the links between human fertility, children development and chemical exposure, which was held in Paris on November 25, French Minister of Health, Roselyne Bachelot, and her colleague Nathalie Kosciusko-Morizet, Minister of Ecology, announced they would call upon the French Agency for the Medical Safety of Health Products (AFSSAPS) to assess the risks posed by cosmetics during pregnancy and for young children.

Roselyne Bachelot, French Minister of Health

Roselyne Bachelot, French Minister of Health

Two months ago, after polemics regarding the distribution of cosmetics in maternities, the Agency already announced its intention to tighten controls over cosmetics intended for children of less than 3 years old. At the same time, the Agency also announced the creation of an ad hoc working group that would evaluate the safety assessment methods specifically developed by manufacturers of baby care goods.

Pregnant women

French Health Minister also said she will launch a campaign to inform pregnant women about the possible risks linked to the exposure with certain chemical substances in a variety of products, including paints, pesticides, etc. (not specifically in cosmetics!) and would consider the possibility of a logo identifying products containing substances that are toxic to reproduction.

However, such a labelling system should be dealt with at the European level where the rules governing cosmetic products are currently under revision. “[We do] not think this is something which is suitable for individual countries to take forward unilaterally and hope that the French raise this during the current negotiations on the revision of the cosmetics directive, where a discussion can take place among experts on cosmetic products,” a spokesperson for the British Department for Business, Enterprise & Regulatory Reform (BERR) told The Independent last week.

French authorities have also announced a review of carcinogenic, mutagenic and reprotoxic substances (CMR) classified in the third category of the group. Indeed, CMR substances are classified according to three levels of toxicity: CMR1 are substances that are known to be toxic, CMR2 are substances that are likely to be toxic, and CMR3 are possibly toxic but need further assessment.

Misleading information

While CMR1 and CMR2 are forbidden for use in cosmetics, the use of CMR3 remains possible. However, the French cosmetics trade body (FEBEA) denied any use of endocrine disruptor [4] in cosmetics products. According to the trade body, there is a lot of incorrect and misleading information regarding this matter.

For instance, FEBEA said the cosmetics industry does not use bisphenol A and only uses one phthalate (diethylphthalate or DEP). According to the SCCP [5], DEP is not an endocrine disruptor, FEBEA said. Similarly, the parabens that are authorised for use in cosmetics (methyl-, ethyl-, propyl-, iso propyl-, butyl-, and iso butyl-parabens) are considered as safe for use by the SCCP.

It is important to stress again that any ingredient used in a cosmetic product, whether natural or man-made, must be safe,” added CTPA, the UK’s cosmetics trade body. Actually, what would be the meaning of a logo warning women of a potential risk, while French and European legislations stress that cosmetics must be safe? Whether the legislations are inefficient and must be changed, or the logo story is a scaring nonsense.