From November 27th, 2019, the changes introduced in Annex VI and V of the Regulation 1223/2009 have obliged us. What substances do they concern? You already know from the title 😉 And what exactly are these changes? I invite you to read below article.
- Titanium Dioxide (nano)
We’ll start with Titanium Dioxide. It is a well-known UV filter used in cosmetics, belonging to the group of physical (mineral) filters. This substance is included in the Annex VI of the Regulation 1223/2009, in the list of UV filters allowed for use in cosmetic products – position 27: Titanium Dioxide and 27a: Titanium Dioxide (nano). The nano form is allowed to be used in cosmetics at a maximum concentration up to 25 % and is subjected to many other restrictions, including its purity, particle size, photostability, moreover, it cannot be used in products that create inhalation exposure. The Regulation also indicates which substances can be used for coating of nano-Titanium Dioxide, including such as: silica, alumina, stearic acid, glycerin and dimethicone. The Scientific Committee on Consumer Safety (SCCS) in the opinion no. SCCS/1580/16 confirmed the safety of subsequent substances coating titanium dioxide nanoparticles, or actually their combinations. Hence, Commission Regulation (EU) No 2019/1857/ EU of November 6th, 2019 introduced a provision in the conditions of use of nano-Titanium Dioxide by adding the following combinations of coating substances:
- Silica at a maximum concentration of 16 % and Cetyl Phosphate at a maximum concentration of 6 %,
- Alumina at a maximum concentration of 7 % and Manganese Dioxide at a maximum concentration of 0,7 % (not to be used in lip products),
- Alumina at a maximum concentration of 3 % and Triethoxycaprylylsilane at a maximum concentration of 9 %.
The significant oral toxicity of manganese dioxide and the potential risk of its harmful effects after ingestion were also taken into account in the SCCS opinion mentioned above. Therefore, sunscreen face products containing nano-Titanium Dioxide together with a combination of alumina and manganese dioxide coatings should contain a warning: Not to be used on the lips.
The above-described changes to the Regulation 1223/2009 regarding nano-Titanium Dioxide have been in force from November 27th, 2019.
Link to the website with the Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R1857&from=EN
Link to the website with the SCCS opinion: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_202.pdf
Another change concerns the preservative Climbazole – 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one. This substance is on the list of allowed preservatives (Annex V) of the Regulation 1223/2009 and takes the position 32. The only condition for using this preservative until now was its maximum concentration in the ready for use preparation of 0.5 %. The change introduced on the basis of SCCS/1506/13, SCCS/1590/17, SCCS/1600/18 opinions and the Commission Regulation (EU) No 2019/698/EU of 30th April 2019 specifies more precisely the conditions for using Climbazole as a preservative, divided into individual product categories. Thus, this preservative can be used in the following cosmetic preparations:
- hair lotions – maximum concentration: 0.2 %,
- face creams – maximum concentration: 0.2 %,
- foot care products – maximum concentration: 0.2 %,
- rinse-off shampoos – maximum concentration: 0.5 %.
Apart from the preservative effect, Climbazole is also used as the active ingredient in anti-dandruff shampoos. Hence the presence of this substance in the Annex III of Regulation 1223/2009 – the list of substances which cosmetic products must not contain except subject to the restrictions laid down (position 310). In accordance with an earlier amendment imposed by the Regulation 2019/698/EU, the restrictions on the use of Climbazole described in the Annex III apply to its use in rinse-off anti-dandruff shampoos up to a maximum concentration of 2 %.
From November 27th, 2019, cosmetic products containing Climbazole that do not meet the above requirements shall not be placed on the market in the European Union. However, from February 27th, 2020, these cosmetics cannot be made available on the EU market at all, in other words – they must be withdrawn from the market.
Link to the website with the Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R0698&from=EN
Link to the website with SCCS opinions: https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_120.pdf https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_212.pdf https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_220.pdf
- A new preservative
Last but not least, a curiosity – the family of preservatives has increased 😉 From now, Annex V will include a new preservative – 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one, INCI name: Hydroxyethoxyphenyl Butanone (HEPB). This substance will take the next – 60th position in the list of allowed preservatives. In addition to the preservative effect, HEPB also has skin conditioning properties. The SCCS Committee in its opinion No. SCCS/1582/16 confirmed the safety of this preservative using in cosmetics at the maximum concentration of 0.7 %. And this concentration will now appear in the Annex V, under position 60th. However, further research is needed regarding eye irritation potential of this substance.
The described change has been introduced by the Commission Regulation (EU) No 2019/1858 of November 6th, 2019, effectively from November 27th, 2019.
Link to the website with the Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R1858&from=EN
Link to the website with the SCCS opinion: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_203.pdf
Finally, I have to admit that I am happy with the last one change. In the times of “free froms”, when preservatives have poor reputation, a run of misfortune of parabens and phenoxyethanol, the list of allowed preservatives likely will be drastically shortened, which will certainly have a negative impact on the cosmetics sector. That is even better that the new preservative appears in Annex V 🙂 I am very curious how HEPB will get on the market, and you?