- Controle op technische volledigheid
- Manual verification
- Data-waiving justifications
- Specific advice
The representatives of the Member States are appointed by the Council. The members from European Commission and European Parliament are directly appointed by the institution concerned. The Commission appoints the three observers representing interested parties.
The EU’s Cosmetics Regulation is targeted towards consumer protection and aims to ensure the safety of cosmetic products when used under normal or reasonably foreseeable conditions of use. The Cosmetics Regulation forbids testing of finished cosmetic products and cosmetic ingredients on animals for the purpose of fulfilling the requirements of that Regulation.
The REACH Regulation aims to ensure the safe use of all chemicals manufactured or imported in the EEA above 1 tonne/year and covers all life cycle stages of the substance from its manufacture to its use by consumers as such or in articles. REACH requires companies to provide safety data on the properties of chemicals handled at industrial sites to make sure that also workers are protected.
To generate safety data under the REACH Regulation, registrants may need to perform animal testing, as a last resort. This also applies to substances used as ingredients in cosmetic products, in order to:
- assess risks to workers that are exposed to these substances; and
- fulfil the environmental requirements of the REACH registration.
The human health information requirements in REACH Annexes VII-X can only be waived/omitted on the grounds that the substance is used as an ingredient in cosmetics products when:
- the substance is used exclusively in cosmetic products; and
- there is no worker exposure to the substance in the EEA during manufacture or formulation/re-packing; either because these activities take place outside of the EEA, or because they take place under strictly controlled operating conditions.
If exposure to workers in the EEA can be excluded due to that the substance is imported in a cosmetic product in its final state, or it is handled in the EEA under strictly controlled operating conditions, it is possible to waive an information requirement for human health endpoints. Instructions on how to report such a data waiving in IUCLID are given in the Q&A on cosmetics (link below). Furthermore, it is important that the use description provided in the registration dossier supports the conditions for waiving the information requirement:
- If absence of exposure to workers is argued because the substance is imported in the EEA in a cosmetic product in its final state, there must be no uses reported outside of the use of the substance in a cosmetic product;
- If absence of exposure to workers is argued because the substance is handled under strictly controlled operating conditions during manufacture/formulation/re-packing within the EEA, there must be no uses reported outside of the manufacture of the substance, the formulation and re-packing of the cosmetic product, and the use of the substance in a cosmetic product. The use description of the manufacture/formulation/re-packing of the substance must unambiguously demonstrate that strictly controlled conditions are applied (see link to Practical Guide 16 below).
If the registration covers other uses than those describing the manufacture of the substance, the formulation/re-packing of the cosmetic product, and the use of the substance in the final cosmetic product; or if the use description of the manufacture and formulation stages is not compatible with strictly controlled conditions, then the only valid reasons for omitting/waiving the required information under REACH are given in columns 1 or 2 of Annexes VII-X, or sections 2 and 3 of Annex XI of the REACH Regulation.
In autumn 2020, ECHA’s Board of Appeal adopted two decisions which examine the links between REACH and the Cosmetics Regulation with regard to the requirements for testing on animals. In its decisions the Board of Appeal confirmed that the REACH Regulation does not contain an automatic exemption from the information requirements for registration if a substance is used as an ingredient in cosmetic products. Further to this, the Board of Appeal also concluded that a registrant can benefit from an exemption only if it shows that the conditions for an adaptation (for example, a waiver for the studies) are fulfilled.
Active substances that are used in plant protection products (PPPs) only, and that meet the criteria of REACH Article 15(1), are regarded as registered under REACH. This applies for the quantity that the substance is manufactured or imported for the use as a plant protection product.
If a substance is not only used as an active ingredient in plant protection products, but has other uses in addition to this, it needs to be registered under REACH for the quantity that corresponds to the other uses. When registering the substance for other uses than as an active substance in PPP, the only valid reasons for omitting/waiving the required information under REACH are given in columns 1 or 2 of Annexes VII-X, or sections 2 and 3 of Annex XI to the REACH Regulation. Referring to that the substance is also used as an active substance in plant protection products is not a valid justification for waiving the information requirements.
Note that even if co-formulants of plant protection products are mentioned in Article 15(1) of the REACH Regulation, they do not meet the conditions that this Article sets for being regarded as registered and, therefore, do not qualify for the exemption that applies to active substances. Therefore, it is not possible to waive an information requirement in REACH Annexes VII-X based on that the substance is a co-formulant in a PPP.
If you have questions related to technical completeness check, use ECHA’s contact form:
- ECHA’s contact form
- In the contact form, select ‘Registration’ under Topic.
Provide the following details related to your question in the ‘Question’ field:
- Indicate clearly that your question concerns the technical completeness check.
- If you are still preparing your dossier and need help to understand how to fill in a particular IUCLID section, provide as many details as possible on your situation and approach to fulfil the information requirement.
- If you have already submitted your dossier and need help to understand the completeness check outcome, include the submission number assigned to your submission by ECHA.
- In the contact form, select ‘Registration’ under Topic.
For questions related to the Validation assistant, there is a separate instruction available: