June 23, 2021 – 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 written in red 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:
- European Commission. (2021). Commission Regulation (EU) 2021/850 of 26 May 2021 amending and correcting Annex II and amending Annexes III, IV and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. Retrieved on 02/06/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R0850&from=EN
- SCCS. (2020). Opinion on Titanium dioxide (TiO2) used in cosmetic products that lead to exposure by inhalation. Retrieved on 02/06/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_238.pdf
- European Commission. (2019). Commission Delegated Regulation (EU) 2020/217 of 4 October 2019 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures and correcting that Regulation. Retrieved on 02/06/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0217&from=EN
- SCCS. (2019). Opinion on salicylic acid (CAS 69-72-7) – Submission I – Corrigendum of 20-21 June 2019. Retrieved on 02/06/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_223.pdf
- European Commission. (2009). Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Retrieved on 02/06/2021 from https://ec.europa.eu/health/sites/default/files/endocrine_disruptors/docs/cosmetic_1223_2009_regulation_en.pdf
Leave a Reply