Friday, 25 November 2011

Regulatory Matters - encourage, educate, enforce!!!

Where aromatherapists manufacture creams for client use they assume the role of manufacturer and need to be aware of their duties as regards records, labelling and safety assessment under EU and national law.

If you are thinking to use SP essential oils for skincare products we ask you review the following article.  We ensure that all recipes we use 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.  Lavender Oil example safety calculation.

What is a Product Information File?

Rose oil and methyl eugenol

Products containing rose oil are the single greatest reason for initial rejection for safety assessment. Rose oil contains methyl eugenol, which contributes to the floral scent, but it is a suspect carcinogen and is restricted to 0.0004% 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 is large.  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.

UK Cosmetics regulation 
the UK Cosmetics safety regulations are very clearly worded and worth a look for anyone making or marketing cosmetics. Like all regulations certain myths arise. The emphasis is on health assessment and safety. Toxicity is a measure which must be looked at arithmetically and a safety margin can be simply calculated based on known toxicity levels per kg and an adult of say 60kg. IFRA guidelines show the common essential oils in use as very safe and unhazardous. Stability of cosmetics is very important particularly in 'organic' formulations which no longer rely on the parabens system. Essential oils with their preservative properties help with that in practice. 

A standard laboratory microbiological test will ensure each batch has bacteria counts of no more than 100 parts per gram.  Sample counts of batches are a sensible precaution.

Microbiological challenge to support shelf life and discard on opening dates

The other issue you need to reflect on as part of the Health Assessemnt is microbiological challenge assessment. With a new product there is no history record of stability at the indicated shelf life and discard on opening dates so a lab microbiological challenge will usually be necessary. This will be necessary even if the product is irradiated for sterility if it is not in a closed retort like a tin and necessary preservatives considered. Of course if it is irradiated it cant be called 'organic'.

Stay on the side of the angels!


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