Compliance of Fragrance and Aroma in Cosmetics

Compliance with regulations regarding fragrance and aroma is vital for manufacturers aiming to ensure the safety. Two critical frameworks in this context are the International Fragrance Association (IFRA) standards, particularly IFRA 51, and the recent allergen regulations that have been established to protect consumers from potential allergic reactions.

International Fragrance Association (IFRA) Standards

IFRA is a crucial guideline that sets safety standards for fragrance ingredients used in cosmetic products. This set of regulations aims to promote the safe usage of fragrances, minimizing health risks while maximizing fragrance integrity. The standard encompasses various aspects, including the concentration levels of fragrance materials permitted in different product categories, ensuring that cosmetic formulations do not exceed established safety thresholds.

The table below shows the IFRA categories and product types. To comply with IFRA 51, manufacturers must consider the concentration limits appropriate to the product category for fragrance and flavour products used in cosmetics.

IFRA Category Product Type
IFRA Category 1 Leave on products generally applied to lips: Lip Products of all types (solid and liquid lipsticks, balms, clear or colored, etc.); Children’s toys
IFRA Category 2 Leave on products generally applied to axillae: Deodorant and antiperspirant products of all types including any product with intended or reasonably foreseeable use on the axillae or labelled as such (spray, stick, roll-on, under-arm, deo-cologne, etc.); Body sprays (including body mist)
IFRA Category 3 Products generally applied to the face using fingertips: Eye products of all types (eye shadow, mascara, eyeliner, eye make-up, eye masks, eye pillows, etc.) including eye care and moisturizer; Facial make up and foundation; Make-up remover for face and eyes; Nose pore strips; Wipes or refreshing tissues for face, neck, hands, body; Body and face paint (for children and adults); Facial masks for face and around the eyes
IFRA Category 4 Fragrancing products generally applied to neck, face and wrists: Hydroalcoholic and non-hydroalcoholic fine fragrance of all types (Eau de Toilette, Parfum, Cologne, solid perfume, fragrancing cream, etc.), aftershaves of all types (except creams and balms); Fragranced bracelets; Ingredients of perfume kits and fragrance mixtures for cosmetic kits; Scent pads, foil packs; Scent strips for hydroalcoholic products
IFRA Category 5A Leave on products applied to the body using the hands (palms): Body creams, oils, lotions of all types; Foot care products (creams and powders); Insect repellent (intended to be applied to the skin); All powders and talc (excluding baby powders and talc)
IFRA Category 5B Leave on products applied to the face using the hands (palms): Facial toner; Facial moisturizers and creams (including care products for beard and moustache)
IFRA Category 5C Leave on products applied to the hands using the hands (palms): Hand cream; Nail care products including cuticle creams, nail lacquer remover, etc.; Hand sanitizers
IFRA Category 5D Leave on products applied to babies using the hands (palms); Baby cream/lotion, baby oil, baby powders and talc
IFRA Category 6 Products with oral and lip exposure: Toothpaste; Mouthwash, including breath sprays; Toothpowder, strips, mouthwash tablets
IFRA Category 7A Rinse-off products applied to hair with hand contact: Hair permanent or other hair chemical treatments (rinse-off) (e.g., relaxers), including rinse-off hair dyes
IFRA Category 7B Leave-on products applied to hair with hand contact: Hair sprays of all types (pumps, aerosol sprays, etc.); Hair styling aids non sprays (mousse, gels, leave-on conditioners); Hair permanent or other hair chemical treatments (leave-on) (e.g., relaxers), including leave-on hair dyes; Shampoo – Dry (waterless shampoo); Hair deodorizer, hair perfume
IFRA Category 8 Products with significant anogenital exposure: Intimate wipes; Intimate deodorant spray; Tampons; Baby wipes; Toilet paper (wet)
IFRA Category 9 Rinse off products with body and hand exposure: Bar soap; Shampoo of all type; Cleanser for face (rinseoff); Conditioner (rinse-off); Liquid soap; Body washes and shower gels of all types; Baby wash, bath, shampoo; Bath gels, foams, mousses, salts, oils and other products added to bathwater (e.g., bath bombs); Foot care products (feet are placed in a bath for soaking); Shaving creams of all types (stick, gels, foams, etc.); All depilatories (including facial) and waxes for mechanical hair removal; Shampoos for pets (safety assessments only relate to the human exposure during the application of such products, not to the exposure of the product on the pet).
IFRA Category 10A Household care products with mostly hand contact, excluding aerosol/spray products: Hand wash laundry detergent (including concentrates); Laundry pre-treatment of all types (e.g. paste, sprays, sticks); Hand dishwashing detergent (including concentrates); Hard surface cleaners of all types (bathroom and kitchen cleansers, furniture polish, etc.); Machine laundry detergents with skin contact (e.g., liquids, powders) including concentrates; Toilet seat wipes; Fabric softeners of all types excluding fabric softener sheets; Household cleaning products, other types including fabric cleaners, soft surface cleaners, carpet cleaners, furniture polishes sprays and wipes, leather cleaning wipes, stain removers, fabric enhancing sprays, treatment products for textiles (e.g., starch sprays, fabric treated with fragrances after wash, deodorizers for textiles or fabrics); Floor wax; Fragranced oil for lamp ring, reed diffusers, pot-pourri, liquid refills for air fresheners (non-cartridge systems), etc.; Ironing water (Odorized distilled water); Dry cleaning kits (involving manual application on the textile)
IFRA Category 10B Household care products with mostly hand contact, aerosol/spray products: Animal sprays applied to animals of all types (safety assessments only relate to the human exposure during the application of such products, not to the exposure of the product on the pet); Air freshener sprays, manual, including aerosol and pump; Aerosol/spray insecticides
IFRA Category 11A Products with intended skin contact but minimal transfer of fragrance to skin from inert substrate, without UV exposure: Feminine hygiene conventional pads, liners, interlabial pads; Baby diapers; Incontinence pant, pad; Toilet paper (dry)
IFRA Category 11B Products with intended skin contact but minimal transfer of fragrance to skin from inert substrate, with potential UV exposure: Tights with moisturizers; Scented socks, gloves; Facial tissues (dry tissues); Napkins; Pillow spray; Paper towels; Wheat bags; Facial masks (paper/protective) e.g. surgical masks not used as medical device; Fertilizers, solid (pellet or powder)
IFRA Category 12 Products not intended for direct skin contact, minimal or insignificant transfer to skin: Candles of all types (including encased); Laundry detergents for machine wash with minimal skin contact (e.g. Liquid tabs, pods); Automated air fresheners and fragrancing of all types (concentrated aerosol with metered doses (range 0.05-0.5mL/spray), plug-ins, closed systems, solid substrate, membrane delivery, electrical, powders, fragrancing sachets, incense, liquid refills (cartridge), air freshening crystals, solid non aerosol car diffuser); Air delivery systems; Cat litter (safety assessments only relate to the human exposure during the application of such products, not to the exposure of the product on the pet); Cell phone cases; Deodorizers/maskers not intended for skin contact (e.g. fabric drying machine deodorizers, carpet powders); Dry cleaning kits (placed in the dryer); Dryer sheets and fabric softener sheets; Fuels; Insecticides (e.g. mosquito coil, paper, electrical, for clothing) excluding aerosols/sprays; Joss sticks or incense sticks; Dishwash detergent and deodorizers – for machine wash; Olfactive board games; Paints; Plastic articles (excluding toys); Scratch and sniff; Scent pack; Scent delivery system (using dry air technology); Shoe polishes; Rim blocks (Toilet); Toilet gel; Scent beads

New Allergen Regulation

In addition to IFRA standards, manufacturers must also be aware of the new allergen regulations established by various regulatory bodies, including the European Union’s Cosmetics Regulation (EC) No. 1223/2009. This regulation focuses on labelling specific allergens present in cosmetic products, aiming to provide more transparent information to consumers and allowing them to make informed choices.

The allergen regulations require manufacturers to list certain fragrance allergens on product labels if they are present above specified thresholds. These allergens, including linalool, limonene, and citral, can provoke allergic reactions in specific individuals. To comply with these new regulations, manufacturers should:

Identify Allergens: Supply technical documentation from the fragrance/aroma supplier or conduct a thorough analysis of fragrance formulations to identify any allergens that may be present and assess their concentrations.

Labeling Compliance: Customize labels to include disclaimers or notes regarding the presence of any allergens that fall under regulatory scrutiny, ensuring compliance with the specified format and font. To learn how to label in accordance with the new allergen regulation, check out our article: New Allergen Labelling.

The landscape of cosmetic fragrances is heavily regulated to protect consumers from adverse effects while allowing manufacturers to offer appealing products. By adhering to IFRA 51 and the new allergen regulations, cosmetic manufacturers can navigate the complexities of compliance, ensuring their products not only meet legal requirements but also foster consumer safety and satisfaction. As the market continues to evolve, staying informed and proactive about regulatory changes will be key to thriving in the cosmetics industry.

If you need support regarding the compliand of the fragrance and/or aroma in your formulation and the compliance of your cosmetic product label, take a look at our services!

Cosmetic Label Review

Cosmetic Product Safety Report – CPSR