The European Union has adopted the ninth omnibus act and the third omnibus act affecting the Cosmetic Regulation (EC) No 1223/2009, and both texts introduce new entries to Annex II — the list of substances prohibited in cosmetic products placed on the EU market.

For anyone holding a Product Information File today, the practical consequence is immediate: every new Annex II entry must be screened against current formulations. If a banned substance appears in a product, the file cannot stay as it is. The responsible person has to reformulate, withdraw the product, or stop the notification in the CPNP. There is no grey zone around Annex II entries — unlike restrictions under Annex III, a prohibition leaves no concentration threshold to work with.

Omnibus acts are the Commission's housekeeping instrument for cosmetic law. Rather than publishing a separate regulation for each individual change, the Commission bundles technical updates — new bans, revised restrictions, updated annex entries — into a single amending act. The numbering tells you this is a mature process: the ninth act in the omnibus series, alongside a third act, signals that the EU is consolidating these amendments at a steady cadence.

Each ban in these acts traces back to the Scientific Committee on Consumer Safety (SCCS). Under the regulatory machinery of Regulation 1223/2009, a substance reaches Annex II only after the SCCS has assessed it and concluded it is not safe for use in cosmetic products, or after it is classified as a substance of concern under other EU chemical legislation such as REACH. The ban then flows through the Standing Committee procedure before publication in the Official Journal.

What does this mean in workload terms? The compliance task falls into three buckets.

First, ingredient screening. Raw material suppliers and formulators need to run the new Annex II entries against their ingredient inventories and finished-product dossiers. This includes checking INCI names, CAS and EC numbers against the annex entries — a mismatch at the CAS-number level is where banned substances hide in practice.

Second, supplier verification. Contract manufacturers and brands buying finished formulas should request confirmation from their suppliers that no newly banned substance is present, including as an impurity or by-product. The responsible person bears the legal risk either way.

Third, timeline management. Omnibus acts typically set a transition period — usually a deadline from entry into force after which products containing the banned substances may no longer be placed on the market, with a later cut-off for making them available. Brands with slow-moving stock or long lead times need those two dates mapped against their production and distribution calendar now, not when the deadline lands.

For distributors and retailers, the exposure is narrower but real: products already on shelves containing a banned substance must be cleared by the applicable deadline, which means inventory checks and coordination with suppliers on withdrawal or replacement stock.

The next data point to watch is the full text of both omnibus acts in the Official Journal of the European Union — the specific substance names, CAS/EC identifiers and the exact transitional deadlines are what formulators and responsible persons need to extract and load into their compliance screening systems.