Cosmetic formulations that have needed changing
We are able to approve the vast majority of recipes we receive without modification. Sometimes, however, one particular ingredient is present at too high a level or is not considered safe at all, and in these instances we work with our customers to decrease the concentration or change the ingredient. We've included here a few of the most common reasons for not initally being able to certify products as safe. Admittedly, they were generally developed by less experienced companies, but in some cases they were advised by people who specialise in cosmetic formulation.
Essential oils
The most common issue we see is the use of essential oils at too high a level. We ensure that all recipes we see comply with the extensive regulations from IFRA, the International Fragrance Association. In many "natural" products essential oils are the most toxic components. The main concern is skin sensitisation, but phototoxicity and more serious systemic toxic effects are sometimes an issue. In addition to any specific restrictions, we operate a limit of 1% total essential oil in every-day leave-on products and 3-4% in wash-off products.
Rose oil and methyl eugenol
Products containing rose oil are the single greatest reason for initial rejection. Rose oil contains methyl eugenol, which contributes to the floral scent, but it is a suspect carcinogen and is restricted to 0.0004% under IFRA rules in leave-on and 0.001% in rinse-off products. Typically it contains 1-1.5% methyl eugenol which means the maximum allowed in a leave-on skincare product is around 0.025%. Specially purified grades containing low levels of methyl eugenol are available. Charabot in France have a rose absolute (reference 253433) containing 0.02% methyl eugenol, but minimum order size may be too great for small customers. Other oils that are high in methyl eugenol and so very restricted include Sweet and Holy Basil, Bay (Laurus Nobilis), Hyacinth Absolute, Nutmeg and Elemi oil.
Phototoxic citrus oils
Bergamot and lime essential oils are the most commonly used phototoxic oils and they are restricted to 0.4% and 0.7% respectively, in leave-on products. If they are combined with other phototoxic oils such as grapefruit and lemon the allowable levels are reduced even further. Formulators can get round the restriction by using FCF (Furo-coumarin free) bergamot oil and by using distilled rather than cold expressed lime oil, though the scent is not quite the same. Mandarin and sweet orange essential oils have very low phototoxicity and are not restricted in practice.
High citral essential oils
Citral is one of the 26 declarable EU allergens, is a powerful skin sensitiser and can be quite restrictive for certain oils in leave-on products. Lemongrass and May Chang (Litsea Cubeba) oils are the most common examples and are limited to 0.3% in women's face and hand creams, with even tighter restrictions in lip and dedorant products. Others that are high in citral include lemon-scented tea tree (Leptospermum Petersonii), lemon myrtle and lemon balm oils.
Novel actives
There is a big demand for new actives such as for anti-ageing and anti-wrinkle properties and new ones are appearing in the market each year. However, because of their novelty, they often have insufficient toxicity testing to dispel lingering doubts as to their safety. Recent ones that we have rejected include:
- So-called snake peptide (INCI name: Dipeptide Diaminobutyroyl Benzylamide Diacetate) since its mode of action implies neurotoxicity
- Peumus Boldus extract - a herbal slimming remedy but which contains the alkaloid boldine which is a reproductive toxin
- Palmitoyl Hexapeptide-19
- Various Chinese bioactive herbs that have no systemic toxicity data
- Pueraria Lobata Root Extract and Pueraria Mirifica Root Extract (the latter is formally banned in Canada)
Alpha-hydroxy acids (AHA's)
The EU consumer safety body in SCCNFP/0370/00 have recommended a maximum level of 4.0% glycolic acid and 2.5% lactic acid, and we stick to these guidelines
Vitamin A
Vitamin A (usually added in cosmetics as retinyl palmitate) is commonly used in face creams at 1% or greater but it is a well-established reproductive toxin (teratogen) and is associated with increased bone fracture risk. Its toxicity has been heavily studied and our calculations are that the maximum safe level in a once per day face cream is 0.6%.
Purity of ingredients sourced outside the EU
Petrolatum (petroleum jelly) is prohibited unless documentation is available proving that it is free from carcinogenic material. In practice, this means using just US or European Pharmacopia-standard white petroleum jelly. Many pigments have purity restrictions and there is no guaruntee that ones sourced from outside the EU or the US will comply. Unless adequate doucmentation is available showing that they conform to EU or FDA cosmetic or food grade standards then they will not be acceptable. Other common ingredients with EU purity requirments that must be adhered to due to nitrosamine carcinogenicity concerns include Triethanolamine (TEA), and DEA and MIPA containing surfactants such as Cocamide DEA.
Please call us on 01244-351644 (UK) or email edmund@efchemicalconsulting.co.uk to find out more about cosmetic safety assessments or to discuss pricing.