EF Cosmetics Safety

Problem and unsafe ingredients

Formulations that have needed changing

We are able to approve most recipes we receive without modification, especially those developed by experienced EU-based formulators. Sometimes, however, one particular ingredient is present at too high a level, is not considered safe at all, or has insufficient toxicity information to make a judgement. The problem is more common for imported ingredients and imported products. In these instances we work with our customers for no extra charge to modify the recipe to make it acceptable. We've included here a few of the most common reasons for not initally being able to assess products as safe.

Natural extracts

Natural extracts can cause difficulty for safety assessors because the chemical composition is often variable or unknown. Extracts of common culinary spices and herbs are not usually a problem, depending on concentration, because we can cross-reference their safety to their use in the highly regulated food industry. Medical herbs from both Western and Eastern cultures are much more of a problem because toxicity data is lacking and there is a nagging doubt that they are pharmacologically active (and so potentially toxic). Each one has to be considered individually. The fact that a particular ingredient is used in ethnic medicine or is being sold in dietary supplements in the EU or US is no reassurance to the safety assessor because this industry is much less regulated than cosmetics.

Changing regulations on preservatives

There is a lot happening at present in the EU with preservatives which formulators (especially non-EU formulators) must keep a close eye on. The limit for propylparaben and butylparaben has been reduced along with a ban on using these ingredients in baby nappy area products. Isopropylparaben and isobutylparaben are now banned. The mixture MIT/CMIT (currently allowed up to 0.0015%) is now banned in leave-on products, due to skin sensitisation concerns, though there is no threat to wash-off products. MIT itself will soon be banned in leave-on products, and Cosmetics Europe in 2013 have advised everyone to stop using it in leave-on products immediately. And phenoxyethanol has also been referred to the SCCS for an opinion due to systemic toxicity concerns, particularly in baby products. We don't believe adult products are under threat.

Natural preservatives

Some customers try to use naturally-derived "anti-microbial" ingredients to preserve their cosmetic products. However, unlike most of the official preservatives listed in the EU annex, they often do not have good quality chemical characterisation data and they have insufficient toxicity data to be able to declare them safe. Any ingredient that can kill or prevent microbial growth has a greater than average degree of toxicity and the safety assessor needs sufficient data from the supplier to quantify the systemic toxicity. Examples of natural preservatives we have rejected include Lonicera Japonica (Honeysuckle) Extract, Naticide, and Glucose Peroxidase with Lactoperoxidase. We have, however, been able to approve Leuconostoc-Radish Root Ferment Filtrate (Leucidal Liquid from Active Chemicals). It is unneccessary to use such anti-microbials to obtain organic approval. Ecocert have a list of nature-identical preservatives off the EU Annex list that they approve, which are all acceptable to us. Customers looking for such Ecocert/organic preservatives that are reasonably effective could try Lonza Geogard 221, Geogard Ultra or Arch Microkill ECT.

Essential oils containing methyl eugenol

Methyl eugenol is a suspect carcinogen and is restricted by the EU to 0.0002% in leave-on and 0.001% in rinse-off products (higher amounts allowed in perfumes). Rose oil or absolute is the most common culprit and contains 1-1.5% methyl eugenol which means the maximum allowed in a leave-on skincare product is around 0.02%. Other oils that are high in methyl eugenol and so very restricted include Sweet and Holy Basil, Bay (Laurus Nobilis), Hyacinth Absolute, Nutmeg, Bay Rum, Ravensara Aromatica and Elemi oil. The allowed amounts of all these essential oils are much less than 0.05% in the final product. Products containing mostly rose water can also fall foul of the regulations. The IFRA Annex 1 Excel file on the IFRA website give the typical concentrations of restricted components in common essential oils.

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 under the IFRA guidelines, with even tighter restrictions in lip and deodorant products. Others that are high in citral include lemon-scented tea tree (Leptospermum Petersonii), lemon myrtle and lemon balm oils.

Other perfuming ingredients

The common perfuming ingredients Butylphenyl methylpropional (Lilial) and Hydroxyisohexyl 3-cyclohexene carboxaldehyde (Lyral) are both under threat of being banned or restricted. Customers using synthetic perfumes are recommended to check if they contain these components. The timescale for a potential ban is not yet known.

Peptides

Peptides generally have insufficient systemic toxicity data to be acceptable under the new regulation 1223/2009. Many of them have originally been isolated from venom e.g.from poisonous spiders and snakes, which indicates they are potent neurotoxins, and additionally they have the palmitoyl group attached to increase absorption through the skin. Ones that we have rejected include Palmitoyl Hexapeptide-19, Syn-Coll, and the so-called snake peptide (INCI name: Dipeptide Diaminobutyroyl Benzylamide Diacetate). Some others such as the Matrixyl actives are OK as long as the concentration is very low (<0.025% in a face cream). In general, the only way to allow peptides in a cosmetic product is to use very low concentrations (below the threshold of toxicological concern).

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. The SCCS are currently considering imposing a maximum limit of 0.089% in body creams and 0.53% in face cream, calculated as retinyl palmitate.

Purity of ingredients sourced outside the EU

Many pigments have purity restrictions and there is no guarantee that ones sourced from outside the EU will comply. Unless adequate doucmentation is available showing that they conform to EU 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. 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. Other problem ingredients in terms of purity can be talc, paraffin, and paraffinum liquidum (mineral oil).