The European Commission has notified the World Trade Organization (WTO) of Omnibus Act IX, a draft amendment introducing new ingredient bans and restrictions under the EU Cosmetics Regulation. The proposal incorporates substances classified as CMRs (carcinogenic, mutagenic, or toxic for reproduction) as well as recent safety assessments issued by the Scientific Committee on Consumer Safety (SCCS).
As part of the amendment, 16 additional substances are proposed for inclusion in Annex II of Regulation (EC) No 1223/2009, effectively prohibiting their use in cosmetic products within the European Union. The list includes various industrial chemicals, solvents, colourants, Benzophenone-1, Benzophenone-2, as well as prostaglandins and their analogues.
Beyond the new bans, Omnibus Act IX also introduces updates to existing ingredient restrictions. The proposal revises the conditions applicable to nano Hydroxyapatite, including higher permitted concentrations in certain oral care products, while maintaining the prohibition of its use in other cosmetic categories. In addition, new regulatory requirements are proposed for Cannabidiol (CBD) and Butylated Hydroxyanisole (BHA).
Under the draft regulation, CBD would be permitted in leave-on, rinse-off, and oral care products subject to concentration limits and strict impurity specifications for THC. Meanwhile, BHA would remain allowed in selected leave-on and rinse-off products but would no longer be permitted in oral care products or products that may result in lung exposure through inhalation.
The proposal also includes significant changes to preservative regulations. Butylparaben and its salts would be subject to revised restrictions, while the remaining exemptions for mercury-based preservatives would be removed. If adopted, this would complete the phase-out of preservatives such as Thiomersal (Thimerosal) and phenylmercuric salts from cosmetic products in the EU.
The measures linked to the CMR classifications are expected to apply from 1 February 2027, while the remaining restrictions and requirements will be subject to transitional periods following the entry into force of the regulation. Companies are encouraged to evaluate their formulations early to assess potential compliance impacts and necessary reformulation activities.