The ECHA’s new PCN
what do they mean for the cosmetics industry?

The European Chemicals Agency (ECHA) is an agency of the EU which implements the EU’s chemicals regulations for the protection of health and the environment.

As of 1 January 2021, there has been a requirement that chemical mixtures classified as hazardous must be reported not to national authorities as was previously the case, but to the ECHA as the sole reporting point. These so-called Poison Center Notifications (PCN) unify and simplify the reporting process and the flow of information within the EU. They include, besides data on physical and chemical properties, information on composition, hazard classes, toxicological information etc. Upon the PCN notification, the mixtures are also assigned a UFI code (Unique Formula Identifier), a 16-digit mixture-specific code that enables rapid identification of the product in the event of an emergency. Cosphatec products also fall within this definition.

Depending on the recipient of a mixture, there are various obligatory reporting dates from which manufacturers must prepare a PCN:

RecipientCompulsory notification from
Commercial use (no industrial installations)01.01.2021
Exclusive use in industrial installations01.01.2024
Mixture has already been reported through national authorities (e.g. in Germany: the German Federal Institute for Risk Assessment – BfR)01.01.2025
*Postponed to 01.01.2021

Ambiguities in the definition

For this classification, it is therefore important who the final recipient of the mixture is. For example, if a producer manufactures a shampoo product for use at home or in a hairdresser’s salon, the users of the final product are deemed to be consumers. The reporting requirement would therefore be effective from 1.1.2021. Nevertheless, this definition left plenty of room for interpretation and many questions unanswered – and led to uncertainty among manufacturers. With “Guidance on Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, version 4.0, March 2021” (currently only in English), the ECHA has now provided a clear definition.

If the final application for which a mixture is used is a cosmetic end product or an end product which is not classified as hazardous, it is exempt from the reporting period for consumer and commercial use. This includes, for example, hair dyes.

According to the current guideline, manufacturers of mixtures for cosmetics production must comply with the reporting periods for use in industrial installations. Thus a little more time is being allowed and the time limit for PCN notification has been extended to 1.1.2024 – this of course includes all Cosphatec products that are subject to a reporting requirement.

Here you can read the exact wording of “Guidance on harmonised information relating to emergency health response – Annex VIII to the CLP Regulation”

Please note that the notification must specify the type of use of the original mixture which has been marketed by the party with a reporting obligation, as well as the final mixtures in which it may have been integrated (see section 5.2.3). However, if original mixtures are integrated into final mixtures for which no notification obligations apply (for example if the final mixture is a cosmetic product or the final mixture is not classified on the basis of its health or physical hazards), the uses of those final mixtures need not be taken into account with regard to reporting obligations relating to the original mixture. If, for example, a mixture supplied to a consumer is integrated, for industrial use, into a final mixture which has only been classified in terms of environmental hazard, a notification for mixtures for industrial use is sufficient (relevant fulfilment period and option for an abridged notification).