Helen Ellis BSc MTTS Past President – The Trichological Society
A surfactants chemist and Past President of The Trichological Society addressing scientific and practical issues associated with surfactants:
Shampoo production and The Cosmetic Products (Safety) Regulations 1996
This is a brief introduction to the responsibility you face when making your own shampoo and hair care products for sale.
The aim of The Cosmetic Products (Safety) Regulations 1996 was to inform and protect customers who buy and use cosmetics. Prior to the implementation of the European directives, that led to the regulation, there was considerable inconsistency in the levels of product information provided and the range of ingredients in cosmetic formulae. It is of some concern that generally there is a poor understanding by many people involved in the fringes of cosmetic products of The Cosmetic Products (Safety) Regulations 1996. This leads to many people being in breach of the law due to ignorance.
Under the Cosmetics regulations the ingredients that are allowed to go into shampoo are controlled by the International Nomenclature of Cosmetic Ingredients list, INCI list. This defines the ingredients that are permitted for use and the names that must be used on the ingredient labels.
The Cosmetic regulations define a cosmetic preparation and give appendices of ingredients that are banned and restricted for use in cosmetic preparation. This includes ingredients such as dyes, preservatives and plant additives.
The main definition of a cosmetic substance is so wide that shampoos of any description easily fall within it unless being used for purely medical purposes. The definition is as follows: –
“cosmetic product” means any substance or preparation intended to be placed in contact with any part of the external surfaces of the human body (that is to say, the epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odour’s except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease.
This being the case the regulation requires that every formulation put up for sale must have a Product Information Package put together by the “Responsible Person”. The Responsible Person is the manufacturer of the product or agent for the product.
The PIP must contain the EC address to be put on the label, the formula of the product (unless protected by a specific confidentiality exemption), specifications and safety data on each ingredient of the formula, method of manufacture, any data relevant to safety of the product or known undesirable effects on human health and proof of effect where specific claims are being made.
The PIP can then be presented to a Safety Assessor to be reviewed and, hopefully, signed off as safe for cosmetic use. This is a qualified toxicologist, pharmacist or chartered chemist. Obviously for the assessment to have any value the Safety Assessor should have sufficient knowledge of surfactant chemistry and safety to understand the information put before them. Oddly the regulations make no such judgement on the suitability of the assessor and just specify the level of qualification required to act as assessor.
The completed PIP must be freely accessible to the Competent Authority, which is the Department of Trade and Industry. But the Trading Standards Department of your Local Authority enforces the regulation, in England. This is due to the fact that the regulations are under the umbrella of the Consumer Protection act. However, it does seem a strange situation given the chemical nature of the products that it is not the Health and Safety Executive that oversee the enforcement. How many Trading Standards Officers would actually understand what was in front of them if presented with a Product Information Package?
Before you start selling your cosmetic product the regulation requires that you notify the Consumer Safety Unit of the Department of Trade and Industry of your intention. Also they need to know the type of products that you will be making; not the details of every product but the general class.
Once you have your product signed off by the Assessor it can go on the market. For this the product needs to be labeled. The label must have a full list of ingredients on the label using the INCI names, in order of their w/w inclusion in the formula, except for those below 1%, which may be in any order.
In addition to this the ingredients used to make the product must be of “cosmetic grade”. This is to ensure that dangerous levels of reaction byproducts are not present in the surfactant or that harmful ingredients are not added to, for instance, improve the pour temperature of the surfactant or to preserve it. In a floor cleaner such impurities and additives are not a problem. This information is available from your raw materials supplier who will be glad to advise you if you tell them what you are doing. Ensure also that you get the Safety Data Sheets for all your raw materials from the manufacturers so that you, or another expert, can assess the hazard presented by the product. Include these all in your PIP. Remember that they are the experts in the production of cosmetics materials so use them.
If you include a perfume in your product ask the perfume company for a declaration of the limit of safe inclusion of the perfume in your formulation. For this they will need to know the type of product that you are creating and the level at which you are considering including the perfume. They can be most helpful in these matters. The declaration must then be included in your PIP to help the Assessor.
If specific claims are made about the properties of the product they have to have been proven by experiment. If the product is just a shampoo for the washing of hair then this will be apparent from the formula and not require performance data. Only if it were claimed that, for instance, the product improved hair shine would qualitative or quantitative test results be required.
As an aside to the Cosmetics Regulations you must ensure that your product is not classified as hazardous. Many raw materials used in the production of shampoos, in their neat state, are classified as hazardous to health e.g. Irritant, corrosive, harmful.
Under the Chemicals (Hazard Information and Packaging) Regulations 1994, or CHIP regulations, if a product contains a hazardous chemical a risk assessment of the formulation needs to be carried out to prove mathematically and/or experimentally that the product is not a hazard to human health. This is not something that can be done too easily without the help of an expert or a lot of patience to learn to interpret the methods of the regulations. These analyses then have to be kept for 5 years after the last date of manufacture of the product for inspection by the Health and Safety Executive, if they should so request. The HSE are the enforcing authority for this regulation.
This is only an introduction to some of the major points of the regulations. If you need to find more out about your responsibilities then contact the DTI Consumer Affairs section. They will send you a free copy of “A Guide to the Cosmetic Products (Safety) Regulations”. Alternatively you may view regulations on the HMSO website. This guidance document is a very clear and detailed introduction to the working of the regulation but does not replace the regulation itself.
A great deal of meticulous observation of the law is required if you are not to fall foul of it. I hope this serves to illustrate the great legal responsibility to be carried with the manufacture of shampoos and other hair care products.
1) A Guide to the Cosmetic Products (Safety) Regulations, by DTI Consumer Affairs Section. Tel 0207 215 5000
2) The Cosmetic Products (Safety) Regulations 1996. Statutory Instrument 1996 No 2925. ISBN 0110633229
3) The Chemicals (Hazard Information and Packaging for Supply) Regulations 1994. Statutory Instrument 1994 No 3247. ISBN 0110545702
© Helen Ellis BSc, MTTS, Dip Phyt, MNIMH: -2001