What you should know about fragrances and updates in cosmetic regulations of the European Union

Fragrances are chemical mixtures of organic compounds that have a smell or aroma, generally pleasant, widely used in perfumes and other scented products.Let's remember that cosmetic products are applied to the superficial parts of the human body, teeth and oral mucous membranes, and have the exclusive purpose of cleaning them, perfuming them, modifying their appearance, protecting them, keeping them in good condition and correcting body odors.Fragrances are also in many other household products such as detergents, softeners, air fresheners, candles, toys, etc. They have a significant impact on sensory experiences and on how we perceive our environment, for example, they evoke memories, generate feelings of confidence and well-being, reduce stress, or reinforce personal identity. In addition, fragrances have great cultural, historical, social, economic and emotional value. Aromatic substances can derive from chemical synthesis or from natural sources, obtained from plants, by distillation, expression (pressing) and extraction. Botanical extracts may contain aromatic substances.IFRAThe International Fragrance Association, founded in 1973, establishes standards, limitations or even prohibitions of certain ingredients in order to guarantee a high degree of protection and safety to the majority of the population. The 51st Amendment to the IFRA Standards is under review and is mandatory for all its members.IFRA Standards are recognized by Cosmetics Europe, the cosmetics industry association of Europe, by the legislative authorities of Brazil, and the Association of Southeast Asian Nations (ASEAN), among others. However, despite strict safety controls, it is estimated that between 1 and 9% of the European population is allergic to fragrance allergens in cosmetic products. To protect the population there are two options: I) restrict fragrance allergens II) provide information on the presence of individual fragrance allergens in cosmetic products, so that sensitized people can avoid contact with them.Europe was the first continent to legislate on fragrance allergens in cosmetic products, and has influenced other countries and regions to implement similar measures.In 2023, Regulation (EU) 2023/1545 was approved, which stipulates that any fragrance allergen that exceeds the limits specified by the EU must be included on the product label. 5In the period from 2024 to the first half of 2025, data were collected to assess the safety of acetylated vetiver oil (AVO), citral (skin sensitizer) and other fragrance allergens:AVOIt is safe when used at the intended maximum concentrations (IMC) of 0.9% (w/w) in fragrance pump sprays, 0.05% (w/w) in deodorant sprays and 0.1% (w/w) in hair sprays and body lotions. CitralThe SCCS issued a preliminary opinion and concluded that, based on the QRA2 methodology, Citral is considered safe at the proposed concentrations in cosmetic products. However, the SCCS will evaluate other fragrances and cosmetic ingredients individually in the future. 7Tea tree oil (TTO)Recently, the SCCS (Scientific Committee on Consumer Safety) has evaluated the safety of tea tree oil (antiseborrheic and antimicrobial agent), dermally. It is safe up to a maximum concentration of 2.0% in shampoo, 1.0% in shower gel, 1.0% in facial lotion and 0.1% in face cream. According to the data provided, TTO is a moderate skin sensitizer, and its use in aerosols or sprayable products that may result in consumer exposure by inhalation is not intended.8FurocoumarinsThey are a group of photosensitizing chemical compounds, found in various plants and may be present in fragrances and cosmetics. They are substances prohibited in cosmetics (Annex II) due to their phototoxic, photomutagenic and photocarcinogenic potential.Currently the policy limits bergapten (5-methoxy-psoralen) to 15 ppm (0.0015%) in products applied to areas of the skin exposed to UV radiation. Bergamottin was removed due to its lack of significant phototoxic effects.In the EU for sunscreen and tanning products, the concentration of furocoumarins will be a maximum of 1 ppm, or what is the same, less than 1mg/kg.There is a forecast that IFRA will publish new limits in mid-2026. The policy will establish limits of 1ppm or 5 ppm for leave-on products and 50 ppm for rinse-off products.In Switzerland the legislation is stricter, the limit of 1 ppm applies to all leave-on products that may be directly exposed to sunlight under normal conditions of use. Switzerland is part of the European Free Trade Association (EFTA), without legal obligation to follow EU product legislation, and trade with Switzerland is established through multiple mutual recognition agreements.9p-Cymene:Natural Complex Substance or NCS (Natural Complex Substance) present in many essential oils, 60% of fragrances and up to 40% of cosmetic products are expected to contain p-cymene.Classified as CMR according to CLP, so it could not be used in cosmetics. P-cymene is the first substance under evaluation, but others will follow. The reformulation of these NCS products would have an impact on the industry of billions of euros. Cosmetics Europe and IFRA have created a defense consortium, where EFfCI is as an observer.In conclusion, we are in a strictly regulated, competitive and environmentally demanding environment. The constantly expanding European cosmetics industry is committed to complying with the rules to ensure that all cosmetics and personal care products in Europe meet strict safety standards before being made available to consumers and environmental protection. The ultimate goal of the EU is to strengthen competitiveness, boost innovation and move consistently towards the sustainability required by the European framework between now and 2030.In order for small and medium-sized companies to easily adapt to regulatory compliance, it is essential to have collaborative spaces that allow them to access strategic information and anticipate regulatory changes, share good practices and strengthen the capacity to adapt to minimize risks and take advantage of the advantages.

What you should know about fragrances and updates in cosmetic regulations of the European Union

Fragrance regulation in cosmetics: IFRA standards, allergens and the future of European sustainability

Meltem Kuzu Díaz

Scientific Officer at AEIC