Q&A info

Where exposure to workers in the EEA is established, the REACH requirements apply. Note that the REACH provisions under Annexes VII to XI encourage the use of adaptations; animal testing should be performed as a last resort only (Article 25 of REACH).

Consequently, testing on vertebrate animals will be required only if there is no available information which meets the information requirements, and where no adaptation possibility under column 2 of REACH Annexes VII to X, or under Annex XI can be applied.

This will represent the only means to assess the potential human health risks arising from exposure to workers. 

As for every adaptation of an information requirement in a registration dossier, you need to insert a justification in each of the relevant endpoints of the IUCLID dossier.

Two main types of scenarios have been identified:

1. Where the substance is imported into the EEA in a cosmetic product that is not further processed in the EEA: in addition to following the instructions provided by ECHA (see below), you shall add, to the respective endpoint(s) in IUCLID, an explanatory note stating that the substance is solely used in cosmetics, imported in the finished state and not further processed nor repackaged inside the EEA;
2. Where the substance/cosmetic product is further processed in the EEA, but where absence of worker exposure can be demonstrated: you may avail yourself of the regular adaptation possibilities, pursuant to Annex XI, section 3.1 of REACH, to waive the testing requirements addressed by sections 8.6 and 8.7 (repeated dose toxicity and reproductive toxicity respectively) of Annex VIII to REACH and the test in Annex IX and X.

• Illustration of cosmetics-based waiving scenarios [PDF]

When applying these adaptations, for the purpose of the justification required according to Annex XI, section 3.2, you do not need to consider the life-cycle stages related to the use of the finished cosmetic product, as these are regulated separately under the Cosmetics Regulation.

While testing for acute toxicity cannot normally be waived under Annex XI, section 3.2, for the purpose of registrations dossiers that cover only cosmetic uses, a similar waiver containing the elements of Annex XI, section 3.2 may be used for this endpoint.

See section 5.1 of the Guidance on information requirements and chemical safety assessment, Chapter R.5: Adaptation of information requirements for further details on how to make use of this adaptation possibility.

Furthermore, ECHA provides further specific recommendations to follow below when you create or update your registration dossier.

In IUCLID 6, a request for ‘waiving' a standard information requirement under REACH must be recorded in the fields ‘Data waiving' and a ‘Justification for data waiving' must be recorded for each endpoint where waiving is proposed. Please follow the instructions below when you create or update your registration dossier.

The description of the information to be provided has been organised by ‘IUCLID Section' and ‘Field'. In addition, a distinction has been made between the information to be entered in the substance dataset, and information that can only be entered when you create the dossier.

Please use from the column "Selection/ entry" the appropriate pick-list selection and the recommended standard text to be entered in the corresponding ‘Field'.

If the substance is only imported in the EEA in a cosmetic product in its final state (neither further processed nor repackaged inside the EEA), the waiving possibility is only relevant for human health endpoints and is only based on the fact that there are no uses in any stage of the life-cycle which may be relevant to REACH (no exposure to workers; exposure to professionals and consumers is covered by the Cosmetics Regulation).

The following specific data waivers can be used only for human health information requirements (Sections 8 of REACH Annexes VII-X).

* Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier.
** The information to be provided for each use, entered in IUCLID section 3.5.5: Consumer uses, is described in the manual How to prepare registration and PPORD dossiers (Chapter 9.6.4.3 and Annex 2). The manual is available on the ECHA website (under Support > Manuals), as well as inside the IUCLID 6 Help system.
***All uses outside the cosmetic use have to be documented in Section 3.5

**** A separate justification should be entered for each reason for the update.

In IUCLID 6, a request for ‘waiving' a standard information requirement under REACH must be recorded in the fields ‘Data waiving' and a ‘Justification for data waiving' must be recorded for each endpoint where waiving is proposed. Please follow the instructions below when you create or update your registration dossier.

The description of the information to be provided has been organised by ‘IUCLID Section' and ‘Field'. In addition, a distinction has been made between the information to be entered in the substance dataset, and information that can only be entered when you create the dossier. Please use from the column "Selection/ entry" the appropriate pick-list selection and the recommended standard text to be entered in the corresponding ‘Field'.

If the substance is further processed inside the EEA, i.e. it is imported or manufactured in the EEA, and still further formulated or re-packaged, before or after inclusion in the final cosmetic product, you need to demonstrate the absence of exposure to workers to benefit from the adaptation possibility.

This case also covers situations where you do not need to provide an exposure assessment: either no CSR is required due to the low tonnage of the substance manufactured or imported, or no exposure assessment is required because the substance does not require classification.

Consequently, you should document the absence of exposure as appropriate, using exposure scenarios and/or other approaches. You can apply for the following specific data waivers, specifically for the human health information requirements (Sections 8 of REACH Annexes VII-X).

*Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier.
**The information to be provided for each use, entered in IUCLID section 3.5.5: Consumer uses, is described in the manual How to prepare registration and PPORD dossiers (Chapter 9.6.4.3 and Annex 2). The manual is available on the ECHA website (under Support > Manuals), as well as inside the IUCLID 6 Help system.
***All uses outside the cosmetic use have to be documented in Section 3.5.

**** A separate justification should be entered for each reason for the update.

See also: https://echa.europa.eu/documents/10162/13628/reach_cosmetics_factsheet_en.pdf

Yes, the ECHA decision is legally valid and binding, so you have to comply with it.

However, if the substance is used exclusively in a cosmetic product and falls under one of the scenarios described, i.e. animal testing would only serve the purpose to address human health risks resulting from the exposure to the finished cosmetic product, you should be able to comply with the decision you received by requesting use of waiving possibilities, as per the REACH Annexes.

Illustration of cosmetics-based waiving scenarios.

It is only where the required testing relates to potential human health effects for workers that animal tests may be required. In such circumstances, the tests are performed to meet the requirements of REACH.

No, the entry into force of the total marketing ban under the Cosmetics Regulation (EC) No 1223/2009 does not influence the REACH requirements.

However, if your registered substance is exclusively used in cosmetics, ECHA recommends that you spontaneously update your registration dossier to clearly indicate the uses, should you wish ECHA to take this into account in any subsequent examination. Please follow the instructions provided according to the scenarios described in Q&A 991.

If you have not registered your substance already, ECHA recommends that you follow the instructions provided according to the scenarios described in Q&A 991.

• For more information regarding the Cosmetics Regulation and the requirements therein, please visit the European Commission website
• For more information on the interface of REACH and the Cosmetics Regulation, you may consult the factsheet ECHA has published in consultation with the European Commission.
• You may also contact the ECHA Helpdesk.