In this article Martin Mackenzie-Smith and Daniela Del Ciotto, owners of The Cosmetic Experts, remind us of related regulations and the implications.
A bulk shipment to the EU
There is a new cosmetic ready to go. All tested in the UK and approved under cosmetic regulations for the EU. Next step is to get some into small packs for free samples. Once the small manufacturing batch is arranged, it can go off for filling in sunny Spain.
Or can it? The product safety data sheet reveals it has some hazards. Cosmetic bulk is not exempt from CLP unlike finished cosmetic in the pack.
Various issues now need to be resolved:
1) Poison Centre notification. This counts as an EU import so needs to be notified.
- How long does it take? Does the company have an EU branch that can do this, or will the filler take on the responsibility? Only an EU entity can do this.
- Is there someone with the time and experience to create the notification? An agent can help on behalf of the EU entity.
- Notification is via the ECHA system but do Spain charge? Some EU states do.
- Is the SDS suitable for Spain and the notification? It needs to be in Spanish for the notification and extra attention to some sections.
- Does it need a UFI number? Not yet... 1 January 2024 for products/mixtures intended for INDUSTRIAL use only.
2) Bulk labelling needs to meet both transport and CLP requirements. This should be on the SDS but needs to be transferred to the correct label format. Is the company set up for this? Does the Dangerous Goods Advisor need to review?
3) The packaging needs to be of the correct UN standard for the mixture hazard being shipped. Are these in stock or does it need ordering?
4) Has the Spanish SDS been sent to the filler? They may need it for health and safety.
5) Are there any REACH implications? Likely not for the batch as this applies to the ingredients but if a lot of other products are going into the EU, someone, somewhere should be keep an eye on the total tonnage of ingredients entering...
6) Check the transport company is happy to ship the hazardous bulk and that you have all the correct documents. Did the original cost estimate of shipping change? What else is required in these post Brexit times?
This is not a cosmetic
The definition of a cosmetic - A "cosmetic product" shall mean any substance or mixture intended to be placed in contact with the various external parts of the human body (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 and/or correcting body odours and/or protecting them or keeping them in good condition.
BUT… there are products sold alongside cosmetics which do not meet the definition as they are not placed on the skin.
These are general products requiring CLP labelling when hazardous plus poison centre notification (NB UFI codes now apply for consumer products in the EU), inc:
2) Room sprays
3) Reed diffusers
4) Aromatherapy products (Where not applied to the skin)
Here are some products often sold as cosmetics but also do not meet the definition:
1) Animal cosmetics - These are general products as they are not for human use. CLP and potentially the detergent regulations may apply. They must use different preservatives from standard cosmetics. NB They must be safe to use, and a safety assessment is highly recommended.
2) Products aimed as sexual aides (As the function may go beyond the cosmetic ones) are likely medical. It is possible (but difficult) with careful claims for cosmetics (Which have external application) to be sold in this area.
3) Teeth whiteners (Where they exceed the legal content of Hydrogen Peroxide for cosmetics). This would be pharmaceutical/medicinal if allowed at all.
4) Insect repellents (Including cosmetics where the biocidal function exceeds the cosmetic one) are biocides. It is possible for cosmetics to have this as a secondary function but quite difficult to claim. Some markets do not allow this at all or only with extra regulations applied.
5) Products claiming healing or similar treatment claims. These again exceed the cosmetic definition and would be pharmaceutical/medicinal. Claims made in a non-obtrusive way such as “Suitable for use on skin that may be prone to” can be used in cosmetics.
6) Hand sanitisers – these are biocides in general. It is possible for cosmetics to claim anti-bacterial as a secondary function.
7) Hair growth products are likely to be pharmaceutical/medicinal. Cosmetic products can claim prevention of hair fall or reducing hair loss.
8) Lip Plumpers can be medicinal where actives cause irritation/inflammation. It is possible to design products without irritation that are suitable as cosmetics.
9) Spot products. These could be medical in nature as spots are broken skin. With care to avoid treatment and healing claims, these could however be anti-blemish products.
It should be noted that cosmetics which are borderline must be carefully evaluated by checking the presentation, claims and composition – all must be suitable. All claims must be substantiated. Different markets may have different rules on these product types which complicates matters!
The Cosmetic experts have met these issues and more. Please contact us if you need help with such issues – let The Cosmetic Experts be your resource.
- The Cosmetic Experts LLP