Some peripheral areas need looking at closely

Published: 21-May-2024

Martin Mackenzie-Smith and Daniela Del Ciotto, owners of The Cosmetic Experts, explore further on cosmetic regulations implications

Safety Data Sheets

Safety Data Sheets (SDS) are in theory not really needed for finished cosmetics – safety is covered by the Cosmetic Product Safety Report (CPSR or safety assessment). Safety data sheets deal with bulk quantities and some of the hazards that are on a SDS for a cosmetic are not applicable to the products when used in a cosmetic way.

However as soon as transport is arranged you will almost certainly be asked for a SDS, so it best to be ready.

There are various types of SDS depending on the region - GB, EU, USA, Australia, etc. All use the same basis – Globally Harmonized System of Classification and Labelling of Chemicals (GHS), a framework that standardizes the classification and labelling of chemicals worldwide. However…

  1. Classification of individual chemicals may differ – in general for instance the EU is quicker to change classifications than the UK – and sometimes the classification may differ.
  2. The classification of mixtures may differ when different rules are applied – for instance lower levels of category 2 reproductive chemicals will cause category 2 reproductive classification of the mixture in the USA but not in the EU & GB.
  3. Different areas apply different “building blocks” such as when environmental hazards are significant enough cause the labelling instructions to include “toxic to the aquatic environment”.
  4. Extra requirements may be needed for different areas re what addresses have to appear or specific references may be needed (UFI numbers may apply to cosmetic bulk for instance).
  5. Although when shipping from the GB region the SDS should be in English, it may well be that forwarding agents or handlers abroad will not accept the English version and a translation will be needed.

IFRA

The International Fragrance Association (IFRA) primary objectives are to represent the collective interests of the fragrance industry and promote the safe use of fragrances.

IFRA produce standards which ban, limit or set criteria for the use of certain ingredients, based on scientific evidence and consumer insights. This hazard data for ingredients is likely the most up to date you will find. Countries and other authorities (Like ECHA) tend to follow with legislation from the data supplied.

If there is a mixture of fragrance ingredients (like essential oils for instance) then it must be known what uses are allowed and at what level. This is because many fragrances ingredients (Particularly essential oils) have potential hazards and such risks must be managed/avoided with care.

An IFRA assessment will provide the level the fragrance can be used in for various product types. Any use must normally fall within the advised level as any safety assessor will be checking for this. The assessment will also advise the allergens that need to be listed.

As the EU 2023 new allergen legislation is starting to be planned the advised (IFRA 51) allergen lists will contain the new ones. Many of the new allergens are grouped together to reduce the impact of the increased numbers required.

It should be noted that the allergen requirements do not match those of CLP. For instance:

“Citral” is the allergen listing combined name for 3 CAS numbers (They are isomers of each other) including itself: 141-27-5 (Geranial), 106-26-3 (Neral), 5392-40-5 (Citral). So, if the combined level is reached then it will be listed on the label. However, a supplied CLP data sheet for the mixture might not show any of them if their individual content is below 0.1%.

And the IFRA regulations take into account allergens which are not in the 2023 legislation. For instance:

Farnesol has the CAS numbers 4602-84-0, 106-28-5, 3790-71-4, 16106-95-9, 3879-60-5 which are in scope of IFRA, however only the CAS 4602-84-0 is in scope of Allergens legislation. Thus, if details about the materials are included in the IFRA assessment, it could show Farnesol but not show in the allergen listing.

The Cosmetic Experts can help with both SDS & IFRA. See the link here for these services and more.

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