A guide to Cosmetic Regulations in the EU for those using Shirley Price Organic Essential Oils
Background information
Cosmetic, Toiletry and Perfume Association
Cosmetic Products (Safety) Regulations
Guidance
Notification Once the safety assessment has been carried out and before you place the product on
the UK market, if the UK is the first market in the EU, please notify by email
cosmeticnotification@bis.gsi.gov.uk of the type of product you are supplying, together
with your name, company and address details, or if importing from outside of the EU, the
details of the importing company in the UK. You are also advised to contact your local
Trading Standards Office http://www.tradingstandards.gov.uk
You will receive a receipt such as this below.
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TO:
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Thursday, December 1, 2011 11:10 AM
Message body
Receipt notified
Tony Eden-Brown | BIS | Electronics, Materials, Chemicals and Product Regulations | 020 7215 0360
Dear Sirs
COSMETICS DIRECTIVE
Notification to the Competant Authority
“A notification is a pre-market administrative document to inform the competent authorities that a cosmetic product will be placed on the EU Market. The manufacturer or his agent or the person to whose order a cosmetic product is manufactured or of the initial importation of the address of the place of manufacture or of initial importation into the Community of the cosmetic products before the latter are placed on the Community market” (Article 7a (4) of the EU Cosmetics Directive 76/768/EEC)
A notification does not imply any official approval in the EU. Cosmetic products do not need to be approved to be placed on the EU market.
In its capacity of person responsible for placing manufactured cosmetic products on the EU Shirley Price Aromatherapy Ltd can notify the competent authority that a cosmetic product will be placed on the EU market.
In accordance with the transposition of the EU Cosmetics Directive 76/768/EEC into national laws and given that its headquarters is located in Hinckley England Shirley Price Aromatherapy Ltd the UK transposition of the EU Cosmetics Directive set by The Cosmetic Products (Safety) Regulations 2008. Shirley Price Aromatherapy Ltd therefore notifies to the UK Competant Authority BIS department for Business, Innovation and Skills that a cosmetic product will be placed on the EU market. Shirley Price Aromatherapy Ltd is in contact with and is inspected by Leicestershire City Council Trading Standards.
Pre-existing cosmetic products notified
A catalog of pre existing Cosmetic Products available for distributors to order is set out below. Formulated in the 1970s and 1980s by Shirley Price Aromatherapy Ltd these products have been manufactured to a first class record of safety and effectiveness since 1974 and sold in 40 countries worldwide..
Product data sheets are available online at www.ShirleyPriceEssentia.com.
Yours sincerely
P.I Brealey BSC FCA
Shirley Price Aromatherapy Ltd
8 Hawley Road, Hinckley, Leicestershire LE100PR T: 01455 615466 F: 01455615054
Aromatherapy products supplied to consumers fall within the scope of the General Product Safety Regulations 20057 unless they are intended to perform a medical or cosmetic function or are presented as performing such a function. The latter are only cosmetic products if they are intended to be placed in contact with the external surfaces of the human body, as in paragraph 7, and are intended for any of the purposes listed in paragraph 6. Both Local Authorities and The Aromatherapy Trade Council will offer advice.
The field of application of cosmetics is to one or more of the following:
• the epidermis;
• the hair system;
• the nails;
• the lips;
• the external genital organs;
• the teeth; or
• the mucous membranes of the oral cavity.
Regulatory Matters - encourage, educate, enforce!!!
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.
http://www.legislation.gov.uk/uksi/2008/1284/contents/made
the UK Cosmetics safety regulations are very clearly worded and worth a look for anyone making or marketing cosmetics using Shirley Price Essential Oils. 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.
www.organicbeautyonline.info
NORMAL ANTI AGING DRY SKIN OILY SKIN
