EU - SCCS Issues Final Opinion on Citral Sensitisation Endpoint
On 26th August 2024, the SCCS published its final Opinion on Citral’s Sensitisation Endpoint.
Citral is listed in Annex III of the EU Cosmetics Regulation (EC) 1223/2009. Under this Annex, the presence of Citral, “shall be indicated in the list of Ingredients appearing on the labelling, when the concentration exceeds:
- 0.001% in leave-on products;
- 0.01% in rinse-off products.”
A model for dermal sensitisation quantitative risk assessment (QRA) was developed and implemented by IFRA to derive ‘acceptable exposure levels’ of Citral. The SCCS agreed that the ‘QRA2’ methodology indicated that Citral can be considered safe in relation to the induction of sensitisation at the concentrations proposed for use in cosmetic products. However, they have identified some aspects of the methodology that need clarification and therefore, some refinement is needed before a firm conclusion on the safety of Citral can be drawn.
The SCCS will consider the suitability of the QRA2 methodology for fragrances and other cosmetic ingredients on a case-by-case basis until the applicability of this approach to fragrances and cosmetic ingredients is established.
The Opinion can be found here.
EU - ECHA’s RAC Classifies Talc as CMR 1B
The RAC assessed a vast database of information on Talc and concluded that there is sufficient evidence that exposure to Talc may cause cancer. Currently there is no entry in Annex VI to CLP for Talc.
RAC’s new classification assigns Talc the following hazard categories:
- Carcinogen 1B; H350: Suspected of causing cancer, particularly through inhalation.
- Specific Target Organ Toxicity, Repeated Exposure (STOT RE 1); H372: Causes damage to the lungs via prolonged inhalation exposure.
The RAC discussed assigning this classification to a specific route of exposure. However, CLP criteria (Annex I, Table 3.6.3) stipulates, "state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard". RAC concluded that no specific route of exposure can be designated due to a lack of data.
Minutes of the RAC meeting can be found here.
GB - UK Bans 13 Additional CMR Ingredients in Cosmetics, Revises Kojic Acid Transition Period
On 3rd October 2024, the United Kingdom notified the WTO of a draft amendment to the GB Cosmetics Regulation, adding to the list of banned substances. The regulation now includes 13 additional substances classified as carcinogenic, mutagenic, or reprotoxic (CMR). Note: these substances are already listed in Regulation (EC) No 1223/2009 (EU) Annex II.
This follows an initial wave of CMR bans by the UK on 10th April 2024, when 52 chemicals were prohibited through the same legislative instrument. Revised deadlines for compliance are:
- April 20th 2025: deadline for placing on the market products containing these ingredients.
- October 20th 2025: deadline for making such products available on the market.
However, 13 substances banned in the EU (added to Regulation (EC) No 1223/2009 Annex II through Omnibus Acts V, VI, and VII) remain unrestricted in the UK.
In addition to the modification of compliance deadlines for cosmetics containing these restricted CMR ingredients, the GB Cosmetics Regulation amendment also includes revised transition periods for Kojic Acid (added to Schedule III in April 2024):
- June 20th 2025: deadline for placing products containing Kojic Acid on the market
- November 1st 2025: deadline for making such products available on the market.
The WTO notification can be found here.
Thailand - Eight Voluntary Industrial Standards for Cosmetics Approved
On 1st October 2024, eight new TISI voluntary standards relating to cosmetics were published in the Royal Gazette, which were brought into force on 2nd October 2024. These cover testing methods, microbiology and natural/organic ingredients.
The Gazette publications can be found here.
We have highlighted above the most important updates, however a full list of updates is available in the Worldover platform.
SCCS - Scientific Committee on Consumer Safety
ECHA - European Chemicals Agency
IFRA - International Fragrance Association
RAC - Committee for Risk Assessment
CLH - Harmonised Classification and Labelling
CLP - The Classification, Labelling and Packaging Regulation ((EC) No 1272/2008)
WTO - World Trade Organisation
TISI - Thai Industrial Standards Institute
