Omnibus III: new restrictions for Salicylic Acid and Titanium Dioxide in Cosmetics

On May 26, 2021, the EU Commission published the Regulation EU 2021/850 (Also known as Omnibus III) amending the Annexes to the EU Cosmetics Regulation in order to include the substances classified as CMR in the Commission Delegated Regulation (EU) 2020/217 

The new Regulation will apply as of October 1, 2021, the same date the amendments to the CLP Regulation enter into force.  

The complete list of modifications introduced in the Annexes to the EU Cosmetics Regulation are available here, but let’s focus today on two substances in particular – Titanium Dioxide and Salicylic Acid – that are commonly used in cosmetic formulations. 

 

Salicylic Acid  

Salicylic Acid has been classified as CMR substance of category 2, but since the 2019 SCCS’s opinion confirmed the safety of this ingredient when used under certain conditions, it has been included in the Annex III to the EU Cosmetics Regulation – list of substances which cosmetic products must not contain except subject to the restrictions laid down. 

The amendments introduced by Omnibus III are highlighted in yellow in the table below: 

Substance 

Restrictions 

Wording of conditions of use and warnings 
Product type, Body Parts  Maximum concentration allowed in ready for use preparation 

Other 

Salicylic acid 

(a) Rinse-off hair products 

 

(b) Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant 

 

(c) Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant 

(a) 3,0 % 

(b) 2,0 % 

(c) 0,5 % 

(a) (b) (c) 

Not to be used in preparations for children under 3 years of age. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Not to be used in oral products. For purposes other than inhibiting the development of micro- organisms in the product. This purpose has to be apparent from the presentation of the product. 

These levels are inclusive of any use of salicylic acid. 

(a) (b) (c) 

Not to be used for children under 3 years of age 

 

Titanium Dioxide  

Titanium Dioxide – in a powder form containing 1% or more of particles with diameter smaller than 10 μm – has been classified as CMR substance of category 2 being considered carcinogen by inhalation. In light of this, the EU Commission asked the SCCS to conduct a safety assessment in order to establish whether Titanium Dioxide can be used in cosmetic products by way of exception:  

‘’According to article 15 of the EU Cosmetics Regulation, the use of CMR substances in cosmetic products shall be prohibited – with some exceptions, such as a risk assessment of the SCCS in which the substance is declared safe for use in cosmetics.’’ 

The final opinion was delivered on October 6, 2020, and the conclusions were used as the basis for the restrictions introduced by Omnibus III act 

In fact, according to Omnibus III, Titanium Dioxide is now added to Annex III to the EU Cosmetics Regulation and the following restrictions must be met.  

Substance 

Restrictions  Wording of conditions of use and warnings 
Product type, Body Parts  Maximum concentration allowed in ready for use preparation 

Other 

Titanium Dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm 

(a) Face products in loose powder form 

 

(b) Hair aerosol spray products 

 

 

 

(c) Other products 

 

(a) 25 % 

 

 

 

(b) 1,4 % for general consumers and 1,1% for professional use 

 

 

 

(a) (b) 

Only in pigmentary form   

 

(c)  

Not to be used in 

applications that may lead to 

exposure of the end-user’s lungs by inhalation’. 

 

 

Titanium Dioxide is also used as a colorant (white) and a UV filter according to the restrictions set out in Annexes IV and VI to the EU Cosmetics Regulation: its use under these conditions is not impacted by the new entry in Annex III.  

If you are a cosmetics manufacturer, contact us at your earliest convenience so to arrive well-prepared at the deadline of October 1, 2021. Follow Obelis News and Blog to always be updated on regulatory changes and do not miss our CosLaw! 

 

References 

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