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Safety Assessments - Facts & Myths by David Munden
With thanks to David Munden of Advantis Laboratories Ltd
Advantis Laboratories Ltd.
Celan House,
Unit 13 Lawson Hunt Industrial Park Guildford Road,
Broadbridge Heath,
Horsham West Sussex,  RH12 3JR
Tel: 01403 263100 - Fax: 01403 254493
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EU Regulations and Safety Assessments - Facts & Myths

Cosmetics, including soaps and bath products are governed by the EU Cosmetics Directive and its many amendments.

The main areas that these cover include:

· What materials can or cannot be used and at what levels.

· The requirements for shelf life and safe use life after opening

· What must go on labels and where

· How to list the ingredients 

· Animal testing issues and what you can claim about not testing on animals

· An assessment of the safety of the product

· The requirement to hold a Product Information File (PIF) and what is in it

A PIF is required by EU law for all cosmetic/toiletry products that are on sale to the public. It must be held by the so called ‘responsible person’. This is usually someone in the company that supplies the product to the retail outlet. This may be the distributor, the manufacture, the retailer themselves or the importer

The PIF is an active legal document. It must record any changes to the product, keep a record of each batch, any customer complaints and other relevant information. It must be made available to Trading Standards Officers (TSO’s) within a reasonable time with heavy fines for non-compliance. However, it is not uncommon for TSO’s to expect them to be available when they call even though they should not expect this so it is advisable to have them available to create a good impression.

The most important part of a PIF is the Safety Assessment. There are many myths and misunderstanding about these. For example some people think they can sign them off simply because they are a Pharmacist, a Dermatologist or a Doctor. As a result many assessments are illegal.

An assessment must be carried out by a person who is both suitably qualified and experienced within the EU. A Chartered Chemist is the most common qualification. Other suitably qualified people include Medical Practitioners, Pharmacists or a Chartered Biologists. What ever the qualification, they must have the relevant experience. This is more difficult to define but must be gained within the EU. An experienced cosmetic chemist can save time, and hence money, by spotting less obvious safety issues that others may miss.

Probably the most common misconception is about what is being assessed. The assessment is on the product itself as sold and not just the formulation. It must take intro account the presentation of the product including any instructions and warnings. It cannot be just on a base or part of the formulation that is used to make the product. Thus selling a material or base and describing it as being supplied with a safety assessment, or pre-certified, can be misleading and of little or no use to the assessor of the product.

There is a lot of discussion, and hence myths, about these so called pre-certified products. As stated, an assessment is on the product as sold. It follows that if a pre-certified product is simply resold without any change that would affect its safety, then the assessment supplied with it is valid. If changes have been made to the product in anyway it must be established whether or not these affect the safety. A note to this effect should be added to the assessment to make it clear that this has been taken into account.

Reworking or modifying a product in any manner, such as melting it and casting it into a mould, stamping it or adding anything to it whatsoever could invalidate any so called pre-certificate. Even repacking a product can affect safety if the repacking is carried out in unhygienic conditions. Adding labels can affect safety if any instructions or warnings on these are incorrect, inadequate or not appropriate.

The packaging itself may not be safe. For example, if the packaging has something sharp on it or if it makes the product look like an edible product, i.e. a food that could encourage children to eat it.

The above are real examples that have lead to pre-certified products being rejected. In general, although a pre-assessment can be acceptable it is recommended that the validity of it is checked.

The assessment is a legal document and, in the event of a consumer being injured by the product, an assessor may have to stand up in a court of law to defend their assessment. The court will decide if their experience was sufficient for them to make the assessment. There will be other experts arguing against them so they must be able to defend their assessment otherwise the client could loose the case. In such an event, the retailer could be fined large sums and so it is important that assessors have professional indemnity insurance in case the retailer claims against them. The holder of the PIF has a duty of care to ensure that the assessor is suitably qualified and experienced. Do not be afraid to ask the assessor what their experience is, proof of their qualification and if they are insured for a sufficient sum.

Another myth is that assessments have to be renewed every year. This is not true, provided that the product is not altered in anyway an assessment will remain valid so long as the details available to the assessor at the time, including the prevailing legislation, data available on the raw materials, etc, do not change in a manner that affects the assessment. It is up to the holder of the PIF to ensure that they keep their assessment up to date.

Another myth is that assessments cannot be passed on. The document refers to the product and provided this does not change in other than something that has no effect on the safety of the product, such as a change of product or company name, then the assessment will still be valid if a business is sold. It is an asset of the company and has a market value that can be included in the company’s valuation should the company be sold

An important part of an assessment is to check that any perfume, essential oil or mixtures of these comply with the guidelines stated by The International Fragrance Association (IFRA). These state what materials or essential oils can or cannot be used in perfumes and their use levels. The guidelines are updated regularly. Although not enforceable in law, the assessor is ethically bound to abide by them. Some eventually do become law, for example, the restrictions on the use level of rose oil because it contains methyl eugenol.

Labeling requirements, such as the Ingredient listing requirements, can be confusing. Even large companies make errors. One problem is the legislation is constantly changing. For example, the introduction of the requirement to label any one or more of the EU designated allergens that are found in perfumes and essential oils if their level in the product exceeds that stated in the Directive. There is also a requirement to label the time a product remains safe to use after opening. This is known as the ‘Period After Opening’ or PAO.

Many people are confused by the PAO and Best Before requirements and when to use them. Some products do not go off when in use and so do not require a PAO. Sealed containers, such as crimped airless pumps, that cannot be opened do not need a PAO. If a products is labeled with a ‘Best Before End of XX’ date then a PAO is not required as the BBE of defines the total life of the product initially unopened and then when in use. A ‘Best Before E! nd of XX. date is required if the life of the product is less than 30 months. Single use products do not require a PA Out may require a Best Before date.

Advantis Laboratories Limited employs qualified and experienced assessors and regulatory affairs experts. Thus we can offer safety assessments and any other advice that may be required covering all aspects of cosmetic regulations and legislation including what you can and cannot say on labels and in claims. We can help if you have problems with regulatory enforcement officers

The service is fast and efficient due to our extensive databases. This ensures that our charges are kept as low as possible. We have professional liability insurance cover and are a Full Member of the Cosmetics, Toiletries and Perfumery Association.

D.R.Munden B.Sc.,C.Chem.,M.R.S.C. 27th
September 2007

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