Advice To Help You Comply With Legislation

Complying With Laws Surrounding Cosmetics

New EU legislation has come into force, tightening and clarifying the rules around the making, packaging and marketing of cosmetics. These rules are designed to ensure that proper systems are in place to regulate the safe manufacture and selling of cosmetics, by harmonising the somewhat disparate previous legislation, as well as making some changes.

There are new rules on ensuring records are kept of the complete supply chain, as well as alterations to things such as Good Manufacturing Practice, the organisation of the Product Information File and the Safety Assessment. There is also a requirement that notification of cosmetic products must be made on the European Commission central notification system (CPNP). This covers both new products and those already on the market. If you intend to use a new nanomaterial that is not already listed in the Annexes to Regulation No. 1223/2009, a further notification is required six months before the product is put on the market.

There have been numerous changes to what needs to be done in order to comply with EU regulations, so it is vital you fully understand the new legislation and alter your processes accordingly. The text of the legislation and information on the CPNP is included below.

If you make or market cosmetics, it is vital that you are aware of all these regulations and follow them, as non-compliance can lead to prosecution. If you are uncertain about anything or need more advice, do not hesitate to contact us.

Claims Made About Cosmetics

There is also separate new legislation (EU Regulation No. 655/2013) on the claims made by cosmetics manufacturers to ensure these are fair and truthful, as well as being useful and relevant to the consumers.

This should ensure that users are not misled, and that all manufacturers and retailers are on a level playing field. This should help prevent honest businesses from having to compete against those trying to take market share through deception and obfuscation.

Key points of the legislation regarding claims made about cosmetics:

  • All claims made for a product must be substantiated – If you are making a claim for your product, it must be backed by robust, scientifically relevant evidence and/or studies. Equally, interpretation of those results must be fair, scientifically defensible and should come from studies conducted using proper scientific practices and ethics (e.g. a study should not be designed to force a particular result or lack generally accepted controls). For example, you cannot claim your antiperspirant keeps you dryer if you only tested it against deodorants, as these are similar but different products. Similarly you cannot make a claim based on users’ perception of the effectiveness of a product if your survey only includes a too small or non-representative sample (e.g. if your product is marketed as being for ‘mature’ skin, a survey of women in the twenties would not be acceptable). You also need to ensure any questions asked are clear and not designed to push participants in a particular direction. More guidance on what is considered acceptable, scientifically relevant evidence is contained in the documents linked to below.
  • All claims made for a product must be relevant – Anything you say about your product doesn’t just need to be true, it should actually be relevant to what your product is or says it can do. For example, you cannot claim your product ‘does not contain hydroquinone’, as this is irrelevant due to the fact it is banned in the EU and therefore no other cosmetic should have it either. Similarly, if the product suggests it contains a certain ingredient, it must contain that ingredient, not just a flavouring or smell of it. You should also be careful not to make claims about specific ingredients if that claim is irrelevant to the finished product. For example, aloe vera may be moisturising, but mentioning its moisturising properties is not allowed if the product itself does not moisturise.
  • Comparative claims should be fair, not too general and should not denigrate competitors – Claims made comparing your product to others, or which suggest a comparison, should be fair and not make potentially misleading claims. It is also not permitted to make a claim that denigrates competitors, or which denigrates ingredients others may legally use.  For example, you cannot say, ‘contrary to product X, this product does not contain ingredient Y, which is known to be irritating’. You also cannot say something like, ‘Low in allergens because without preservatives’, as this both suggests the presence of preservatives is the key to how allergenic something is, and also suggests that all different types of preservatives (and therefore products containing them) are allergenic.
  • Claims should be understandable to the average end user – The key here is that anything you say about your product should actually help the average buyer to make an informed choice, and not seek to confuse, mislead or suggest anything that cannot be backed up. For example, with an anti-wrinkle treatment mentioning lots of complicated sounding chemicals and what they do may sound impressive to consumers, even if they may not actually understand the scientific language or if what the chemical is doing is actually helpful for wrinkles. As a result, these sorts of claims should not be made if they are unclear, if they are actually irrelevant to what the product is designed to so, or if effectiveness is not backed by evidence. Another example might be saying ‘dihydrogen monoxide binds with facial pollutants and dead epidermal particles to help cleanse the skin’. This sounds more impressive than ‘putting water on your face helps to clean it’. Saying the former would probably not be permitted as it deliberately uses unclear language to confuse the consumer as to what benefit you are claiming.
  • No claims should be made that suggest authorisation or approval by a competent legal authority – This regulation mainly ensures that no claim is made that is mere legal compliance, and that it therefore does not suggest to the consumer they are being offered a benefit or that a specific authority has approved the product, when all the makers are doing is following the law. For example, you cannot say, ‘this product complies with provisions of the EU cosmetics legislation’, as every product should do that. Similarly, you cannot include a CE mark on your product.

These are only some of the key points the new legislation covers. If you make or market cosmetics you need to be completely clear and compliant on all aspects of the new laws. You can find out more in the PDFs below.