Questions and Answers

REACH

Cosmetics

[991] When can an adaptation of the information requirements under REACH be exercised by a Registrant, in case the substance is used in cosmetic products in the EEA?
REACH
Cosmetics
Version: 1.0
Latest update: 04/06/2015

In general, testing for human health endpoints can be adapted (‘waived’), if the substance is used in the EEA exclusively in cosmetic products falling within the scope of the Cosmetics Regulation, and if the testing would not be necessary to fulfil the REACH requirements for the assessment of worker exposure.

Two main scenarios are foreseen where cosmetics-based waiving could be applied. 

  • In cases where imported products fall within the scope of the Cosmetics Regulation (EC No 1223/2009) and which, from the time of import, are neither further processed nor repackaged inside the EEA, an adaptation of animal testing requirements for human health endpoints can be sought, based on the absence of relevant worker exposure;  
  • In other cases, you may be able to seek an adaptation of an information requirement by demonstrating that the substance is handled under strictly controlled conditions during all stages of the life-cycle, other than the use as a cosmetic product (i.e. manufacture, formulation and/or packaging stage).  

In all circumstances, you shall provide a reasoned justification for requesting the waiver.

[992] If a chemical is only used in a cosmetic product, and if there is a potential for worker exposure during the manufacturing process, will testing on animals be required under REACH?
REACH
Cosmetics
Version: 1.0
Latest update: 04/06/2015

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. 

[993] In practice, how can an adaptation of an information requirement be exercised by a Registrant where the substance is solely used in cosmetics?
REACH
Cosmetics
Version: 1.0
Latest update: 04/06/2015

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.

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.

[994] How can a Registrant indicate the request for adaptation of information requirements for human health endpoints in the IUCLID dossier if the substance is imported and not further processed in the EEA?
REACH
Cosmetics
Version: 1.0
Latest update: 04/06/2015

In IUCLID 5, 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).

 

  IUCLID section Field Selection / entry
Substance dataset Any Endpoint Study Record– Annexes VII to X* ‘Data waiving' other justification
‘Justification for data waiving' The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation.The substance is imported in a cosmetic product in its final state (i.e. the product is from the time of import neither further processed nor repackaged inside the EEA). Waiving of animal testing requirements for human health endpoints is proposed based on the absence of use other than in finished cosmetic products.
Section 3.5 – Consumer uses ** Product category *** PC39
Dossier Dossier header Dossier submission remark This dossier covers a substance that is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is imported in a cosmetic product in its final state. The product is from the time of import neither further processed nor repackaged inside the EEA. 
Updates only Dossier header Spontaneous update, ‘Justification' ‘other' +  ‘Cosmetics Regulation / 2013'

*Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier.
**The minimum information required for each use entered in the table “Consumer uses” is described in Data Submission Manual 5, Chapter 4.3.5.1. In addition to this, it is highly recommended to indicate the cosmetics use in the ‘Product category’ field.
***All uses outside the cosmetic use have to be documented in Section 3.5

[995] How can a Registrant indicate an adaptation of information requirements for human health endpoints in the IUCLID dossier if the substance is imported and further processed in the EEA, without exposure to workers?
REACH
Cosmetics
Version: 1.0
Latest update: 04/06/2015

In IUCLID 5, 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 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).

 

  IUCLID section Field Selection / entry
Substance dataset

Endpoint Study Record corresponding to:*
-Annex VII

-Annex VIII (except sections 8.6 and 8.7)
‘Data waiving’ ‘other justification’
‘Justification for data waiving’ The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and/or further processed inside the EEA before/after inclusion in the final cosmetic product. Waiving of animal testing requirements for human health endpoints is proposed since, with the exception of the life cycle stage that covers the use as a cosmetic product (for which the safety assessment is done under the Cosmetics Regulation), the substance is otherwise handled only under strictly controlled conditions. Where it is demonstrated that the substance is handled according to strictly controlled conditions (see, as an example, REACH Annex XI, Section 3(2)(b)) during all life cycle stages, with the exception of the use as a cosmetic product, the absence of exposure to workers is documented in IUCLID section 13:
<registrant to choose the appropriate option(s)>
  • in the exposure scenario of the CSR.
  • in an assessment report (if no exposure scenario is required).
Endpoint Study Record corresponding to:*

 

-Section 8.6 and 8.7 of

Annex VIII
-Annex IX
-Annex X

‘Data waiving’ ‘Exposure considerations’
‘Justification for data waiving’ The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and/or further processed inside the EEA before/after inclusion in the final cosmetic product. Waiving of animal testing requirements for human health endpoints is proposed since, with the exception of the life cycle stage that covers the use as a cosmetic product (for which the safety assessment is done under the Cosmetics Regulation), the substance is otherwise handled only under strictly controlled conditions. Where it is demonstrated that the substance is handled according to strictly controlled conditions (see, as an example, REACH Annex XI, Section 3(2)(b)) during all life cycle stages, with the exception of the use as a cosmetic product, the absence of exposure to workers is documented in IUCLID section 13:
<registrant to choose the appropriate option(s)>
  • in the exposure scenario of the CSR.
  • in an assessment report (if no exposure scenario is required).
Section 3.5 – Consumer uses ** Product category *** PC39
Dossier Dossier header Dossier submission remark This dossier covers a substance that is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and/or further processed inside the EEA before/after inclusion in the final cosmetic product. All manipulation of the substance outside the cosmetics use takes place under strictly controlled conditions
Updates only Dossier header Spontaneous update, ‘Justification’ ‘other:’ + ‘Cosmetics Regulation / 2013’

*Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier.
**The minimum information required for each use entered in the table “Consumer uses” is described in Data Submission Manual 5, Chapter 4.3.5.1. In addition to this, it is highly recommended to indicate the cosmetics use in the ‘Product category’ field.
***All uses outside the cosmetic use have to be documented in Section 3.5.

[996] I received a decision under REACH imposing the requirement to provide information performing an animal test. The decision was adopted before March 2013 and I have not yet started the test. Am I still required to comply with the decision?
REACH
Cosmetics
Version: 1.0
Latest update: 04/06/2015

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 or as described in this Q&A section. 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.

[997] Does the entry into force of the total marketing ban for animal tested cosmetic products/ingredients affect the compliance of the registration dossiers I already submitted?
REACH
Cosmetics
Version: 1.0
Latest update: 04/06/2015

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.

[998] Where do I find more information on the Cosmetics Regulation and the animal testing/marketing ban?
REACH
Cosmetics
Version: 1.0
Latest update: 04/06/2015

  • 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.