Ingredients of Concern
The fragrances contained in consumer products (fine fragrances, cosmetic products, household products, air fresheners) typically contain 50 to 100 ingredients that are selected from an overall palette of more than 2000 fragrance substances commonly in use. A minor part of these ingredients show hazardous properties to human health and/or the environment when exposure occurs at high concentrations. However, the risk emanating from these substances can be controlled by appropriate measures (e.g. use restrictions). The fragrance industry relies on ingredients that are safe for human health and the environment as assessed by IFRA (www.ifraorg.org), taking into account normal use in finished consumer products. Nevertheless, some ingredients are discredited in the media, a fact that is mostly based on hazard classification and not considering risk. The most important substances currently of concern in Europe are as follows:
These have been discovered even before 1900 and where in use in perfumery for many decades. Musk Ambrette was then shown to cause photodermatitis and persistent light reactions which led to its withdrawal from the market. The same fate suffered recently Musk Xylene due to its environmental behaviour. As a result, only one NM can still be used, namely Musk Ketone. Its safety has been thoroughly assessed by the European regulators and application in consumer products has been authorized, although quantitative restrictions have been imposed in cosmetic products sold in Europe and Switzerland.
Polycyclic musks (PCM)
This is a more modern category of musk compounds that are essential for many classical perfumes. PCM have the tendency to accumulate in the environment (poor biodegradability) and to be toxic against aquatic organisms (Algae, Daphnia, Fish). The safety for human health and the environment of the PCM that are used by LUZI AG has been positively assessed by the European legislative authorities.
Regarded as ingredient of concern by ÖKO-Test (German consumer magazine) and environmental scientists due to its structural similarity to the polycyclic musks. Detection in the aquatic environment is being monitored.
According to European legislation, 26 specific fragrance substances have to be declared in cosmetic products (Directive 2003/15/EC) and detergents (Regulation EC No 648/2004) when their concentrations exceed 0.01% (rinse-off cosmetics, detergents) and 0.001% (leave-on cosmetics). This labelling serves as information for people suffering sensitivity against fragrances. Adequate use of these “26” is secured by the IFRA Standards that ask for different limits depending on the exposure given by the various consumer products.
Among the “26” (see above), 7 show a higher sensitization rate in the European population according to clinical datas. Consumer products containing these 7 allergens are devalued by the German consumer magazine ÖKO-TEST.
Under European chemical law, substances and mixtures (e.g. perfume oils) having the potential to evoke skin sensitization must be labelled with the risk phrase R43 (“May cause sensitization by skin contact”). As with the “26” (see above), safe use levels of R43-substances in finished consumer products can be defined through IFRA Standards in place.
2,2-Dimethyl-3-(3-tolyl)propan-1-ol (trade name Majantol®) was reported in 2007 by dermatologists to be a new allergen of clinical relevance. Subsequently, an organochlorine impurity was identified as the probable cause of the problem. IFRA Standards were issued in 2008 and 2010, addressing use restrictions and purity requirements (specification), allowing safe use of this fragrance substance that has an important function as a muguet note. Consumer products containing Majantol® are not devalued by ÖKO-Test.
A few fragrance materials (e.g. Citrus oils, 2-Acetonaphthone, N-Methyl methylanthranilate) show the tendency to evoke skin reactions on sun exposure. This is mostly of concern in cosmetic products that stay on the skin, but the negative effects are clearly related to concentration (dose response). At low levels, phototoxic fragrance ingredients can be safely used in suncare products when adherence to the IFRA Standards is followed.
Ingredients that are classified as carcinogenic, mutagenic and toxic to reproduction are of special concern all over the world. Depending on the evidence, CMRs are grouped into 3 categories. CMR 1a are known to be effective in humans (e.g. Asbestos, Benzene), CMR 1b have shown effects in animals (e.g. Safrole, a constituent of Nutmeg oil). CMR 2 are suspected, but their effect has not been proven in humans. A few fragrance ingredients are classified as CMR 2 (self-classification by the industry). Butylphenyl methylpropional (Lilial®, CAS 80-54-6) is such an example. The safe use of Safrole and the CMR-2-materials has been assessed by the European authorities and IFRA, respectively.
Diethyl phthalate (DEP)
Some phthalates (e.g. dibutyl-, diethylhexyl-) are considered as endocrine disruptors (hormone active substances) and their inclusion in consumer products has been forbidden by the European authorities as a precautionary action. In contrast, DEP shows a different (and more positive) toxicological profile and no restrictions are in place in Europe. DEP is used as a solvent in fragrances and functions also as a denaturant in ethyl alcohol (for tax reasons). Nevertheless, ÖKO-Test devalues cosmetic products containing DEP.
Their bad reputation comes from environmental pollutants like chlorine and fluorine containing hydrocarbons (CFCs, responsible for Ozon depletion) and pesticides (e.g. DDT). There is only one HO compound of major importance to the fragrance industry. Trichlor-methyl phenyl carbinyl acetate (CAS 90-17-5) which is used for its powdery, long lasting rosy note. This trichloromethyl substance is apparently biodegradable and not of concern like CFCs and DDT. Indifferently, ÖKO-Test devaluates cosmetic products containing any HO.
Substances that are toxic against aquatic organisms (Algae, Daphnia, Fish) and have the potential for bioaccumulation are classified as environmentally hazardous (risk phrases R50/53 and R51/53). Mostly, these substances are released from consumer products into the environment in rather diluted form and are eliminated by wastewater treatment plants to a large extent.
Substances of animal origin
Due to hygienic and ethical reasons, as well as legal restrictions, odorants of animal origin (Ambergris, Musk, Civet and Castoreum) are no longer used in perfumery. Their synthetic counterparts are, however, more popular than ever, also because they became available at affordable cost.