Amendments to Annexes III and VI to the EU Cosmetics Regulation

May 18, 2022 – By the end of this year, there will be new amendments to Annexes III and VI to the EU Cosmetics Regulation. Annex III is the list of substances that can be used in cosmetics only according to certain restrictions specified therein. Conversely, Annex VI includes the UV filters allowed for use in cosmetics.

With this in mind, on April 12, 2022, the European Commission notified the World Trade Organization (WTO) of a draft Regulation featuring the following modifications.

 

New restrictions for BHT and Acid Yellow 3

According to the draft, Butylated Hydroxytoluene (BHT) and Acid Yellow 3 will be subjected to specific limits and added to Annex III. Hence, BHT will be allowed:

  • In mouthwash products, up to 0.001%;
  • In toothpastes, up to 0.1%;
  • In other leave-on and rinse-off products, up to 0.8%.

In 2019, the European Commission included BHT in the list of substances that the Scientific Committee on Consumer Safety (SCCS) must assess with priority due to their potential endocrine-disrupting properties. Considering this, in December 2021, the SCCS issued its Final Opinion 1636/21 on BHT. The European Commission has transposed the Committee’s conclusions into this draft Regulation.

Moreover, the draft Regulation limits the use of Acid Yellow to non-oxidative hair dye products at a maximum concentration of 0.5%. Any other use not explicitly regulated will not be allowed. The SCCS confirmed this use is safe in its Final Opinion 1631/21 from July 2021.

 

Application dates

The European Commission will likely publish the Regulation mentioned above in the last quarter of 2022. Then, the new restrictions on BHT and Acid Yellow 3 will start applying six months after the Regulation enters into force. Furthermore, products placed on the EU market before that date can be made available for six more months (12 months following the Law’s entry into force).

 

Lowered allowed level of Homosalate

The UV filter Homosalate was also included in the list of potential endocrine disruptors to be evaluated with priority. Therefore, in June 2021, the SCCS released the Final Opinion 1622/20, in which it stated that the present limit for Homosalate as a UV filter (10% in the finished product) is not safe. Following the SCCS Scientific Advice 1638/21 of December 2021, the European Commission has further restricted the use of Homosalate in Annex VI.  According to the draft Regulation, it can only be used in face products except propellent sprays up to a maximum concentration of 7.34%.

The application deadlines are as follows:

  • 24 months after the entry into force of the draft Regulation for placing on the market;
  • 30 months after the entry into force for making available.

The European Commission provided a longer transition period because beauty brands should reformulate their sunscreen products with Homosalate and test their SPF efficacy.

 

New UV filter: Piperazine

The draft Regulation permits using a new UV filter, Piperazine (HAA299), that will be added to Annex VI. According to the SCCS findings, HAA299, both in bulk and nano form, is safe as a UV filter up to a maximum concentration of 10%. The European Commission has implemented these limits in the draft Regulation. In the case of the combined use of Piperazine and Piperazine (nano), the sum shall not exceed 10%.

Moreover, HAA299 in nano form must meet some additional requirements:

  • Purity ≥ 97%;
  • Median particle size D50 ≥ 50 nm of number size distribution.

And “it cannot be used in applications that may lead to exposure of the end user’s lungs by inhalation” (EC, 2022) due to Piperazine (nano) possible inflammatory effects on these organs.

 

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