Future rules on labelling of cosmetic products / Allergens...
For your interest and information – don’t shoot the messenger!!
European Commission regulates the labelling of fragrance allergens in cosmetic products
Regulation 2023/1545 introduces new obligations to individually label the 56 additional fragrance allergens listed by the SCCS. These allergens must be labelled individually if their concentration surpasses 0.001% in leave-on products and 0.01% in rinse-off products.https://coslaw.eu/more-allergens-to-be-individually.../
This could be a heavy subject, so here’s an overview!
1) In essence, a further 56 fragrance raw materials have been determined to be potential allergens, taking the total from 25 to 81.
2) If these materials are present within a cosmetic product at levels of over 0.001% in leave on products (skin cream, EDT etc) and 0.01% in rinse-off products (Soap, shampoo etc) then these materials will be required to be labelled individually in the same way that the previously existing 25 allergens have been labelled for a number of years.
3) IMPORTANT:
These labelling requirement changes will NOT relate to makers/sellers of Home fragrance products such as Candles, Wax Melts, Diffusers, Room Sprays etc (…and breathe!).
These changes WILL apply to makers/sellers of cosmetic products such as bath bombs, soaps, skincare products, eau de toilettes etc.
4) WHEN IS THIS HAPPENING?:
a) These changes entered into force and legislation fully passed on the 16th August 2023. Also known as.. rubber-stamped.
b) Any cosmetic products that you have not launched yet (New Products) must comply with the new labelling requirements by 31st July 2026.
c) Any cosmetic products that you already sell/offer/have on the market (Existing products) must comply with the new labelling requirements by 31st July 2028.
Fragrance Liaison view – don’t panic, there’s no going back, but don’t panic. The rationale for these lengthy time frames within points b and c is there to allow you to consider your long term plans for your Existing Products…. “Will I still be making product x, y or z available as of 31st July 2028?” If the answer is yes then you have until that date to plan new labelling for your products or indeed to perhaps look toward alternative fragrance oils IF you don’t want extended labelling for any reason.
Similarly, for your future product development plans you need to be aware that as of 31st July 2026 your labelling will need to reflect the inclusion of allergens from a list of 81 and not 25 allergens.
Obviously for both new and existing products you won’t be waiting until the last possible moment to address these changes. That said, all reputable fragrance houses will be making decisions right now as to when in the future they will be providing documentation for cosmetic assessments, future labelling requirements.
So it is important that you check through your own fragrance oil / cosmetic assessment suppliers as to when fragrance houses will be in a position to provide the documentation you need in order to understand new labelling requirement to your existing and new products in the future.
5) WHERE WILL THESE NEW LABELLING REQUIREMENTS BE NEEDED?:
The new labelling will be required for products that you are selling/offering/marketing within the EU & Northern Ireland. The UK have not elected to take up these new labelling requirements and their timeframes and there are no plans to do so as of now, 25th September 2023.
Cutting to the chase, this actually means that if you are in the UK and you are selling into both the UK (not incl N.I.) and the EU (incl N.I.) you could conceivably need 2 different packaging formats with an allergen listing on pack compliant for the UK and yet another allergen listing on pack compliant for the EU and N.I.
This is obviously going to be time consuming, complicated and costly, so the smart money at this time is that makers/sellers will work towards the new labelling requirements regardless of where you are and where you customers are.
6) CONSIDERING THE ABOVE…
Your own brand/product requirements will have an impact on fragrances you can use going forward.
No Labelled Allergen fragrance oils will be possible. *
Allergen free fragrance oils will be challenging under the future labelling requirements because quite simply in the future there will be 81 allergens rather than 25. *
Hypoallergenic fragrance oils will be challenging under the future labelling requirements because quite simply in the future there will be 81 allergens rather than 25. *
(*) As has always been the case, the more restrictive your own fragrance oil requirements it is inevitable that potential fragrance performance/character could be affected in product.
Raw Material suppliers and Fragrance Houses will do as they have always done, they will adapt and in the future there will be alternative materials to use to minimise labelling, but this is a long process.
Think carefully about :- Where your customers are, the space you have on pack for future INCI listings, which of your existing products will still be on the market in July 2028, your future product developments and when your assessments can take into account the future labelling requirements.
IF you sell into the UK and the EU (incl Northern Ireland) you could conceivably use 2 different labelling lists – in reality it could be more sensible all round if you adhere to the EU requirements discussed here.
I repeat, these changes do not apply to Non-Cosmetic products such as candles, melts, diffusers, room sprays etc.!
For Cosmetic makers - Don’t panic, there is time to adapt!
Sorry!