The European Chemicals Agency (ECHA) has published the proposal of the Netherlands for the harmonised classification and labelling (CLH) of Hydroxycitronellal (CAS 107-75-5), a key ingredient in the cosmetics industry, known for its use as a fragrance in various products.
This proposal, if approved, could bring with it significant implications for its use in cosmetic products within the European Union.
What is Hydroxycitronellal?
Hydroxycitronellal is a chemical compound that is widely used in the cosmetics industry due to its pleasant floral fragrance. This ingredient is found in products such as perfumes, creams, and lotions. However, due to recent concerns about its potential adverse health effects, its classification is being reviewed to ensure that it is safe for consumers to use.
Proposed Classification of Hydroxycitronellal
The Netherlands has proposed the following classification for Hydroxycitronellal, which implies a more rigorous assessment of the risks associated with this ingredient:
Skin Sens. 1B, H317 : May cause an allergic skin reaction. This indicates that Hydroxycitronellal has the potential to cause skin sensitization, meaning that some people may develop an allergy after continuous or repeated exposure to the ingredient.
Repr. 1B, H360D : May cause harm to the unborn child. This category indicates that Hydroxycitronellal may pose a risk to reproductive health, particularly with regard to fetal development.
Current Regulation of Hydroxycitronellal in Europe
Hydroxycitronellal is currently included in entry 72 of Annex III of Regulation (EC) No 1223/2009 on cosmetic products , which regulates maximum concentrations of certain substances in cosmetic products to ensure consumer safety. For Hydroxycitronellal, the regulations state that:
The maximum concentration allowed in cosmetic products (excluding oral products) is 1.0% .
In addition, it must be declared in the list of ingredients of cosmetic products when its concentration exceeds 0.001% in leave-on products (such as lotions or creams) and 0.01% in rinse-off products (such as shampoos or shower gels).
To date, Hydroxycitronellal is not included in Annex VI of Regulation 1272/2008 (CLP) , which regulates the classification, labelling and packaging of hazardous substances and mixtures. However, if the Dutch proposal is adopted and Hydroxycitronellal is classified as a CMR Reprotoxic Category 1B substance, this could have serious implications for its future use in cosmetics.
Possible Consequences of CMR Classification
If the proposed classification of Hydroxycitronellal as CMR Reprotoxic 1B is approved, its use in cosmetic products would be banned throughout the European Union , unless a specific exemption is granted for its controlled use. This ban would affect a wide range of products currently containing Hydroxycitronellal, forcing manufacturers to reformulate such products or, in some cases, withdraw them from the market.
It is important to note that while Hydroxycitronellal is already subject to concentration restrictions, classification as CMR would entail much stricter regulation, with the aim of protecting the health of consumers, especially with regard to reproductive risks and skin sensitization.
Implications for the Cosmetics Industry
For the cosmetics industry, the potential classification of Hydroxycitronellal as a CMR represents a significant challenge. Manufacturers that rely on this ingredient will need to evaluate safe alternatives to replace it or modify their formulations to comply with regulations. They will also need to closely monitor the development of this regulatory proposal and prepare for a potential ban if an exemption is not granted.
Since Hydroxycitronellal is a widely used ingredient in perfumery and personal care products, its removal or restriction would have a considerable impact on product formulations. In addition, manufacturers will be required to ensure that their labels are clear and comply with ingredient declaration requirements, especially if the compound is present at levels above established thresholds.
Conclusion
The proposed classification of Hydroxycitronellal as a CMR Reprotoxic Category 1B substance and skin sensitiser is an important step towards protecting consumer health in Europe. Although it is still in the consultation process, the potential implications for the cosmetics industry are clear: stricter regulation and a ban on its use in cosmetics could substantially change the formulations of many products.
The industry must remain vigilant to regulatory developments and prepare for possible changes in the regulations governing this ingredient, which underlines the need for constant adaptation to new research and safety standards in cosmetic formulation.
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