Warning label requirements for certain Hair and Eyelash Dyes / Lyrial, Atranol and Chloroatranol totally prohibited in the EU

January 24, 2022 – Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers concluded that the potential health risks of the use of hair dyes were of concern. Considering this, the European Commission published Regulation (EU) 2020/1683 on November 13, 2020.

This December 3, 2021, marked the entry into force of the Regulation’s obligations, which aims to surge consumers and professionals’ awareness of possible adverse effects stemming from hair dyes and products intended for coloring eyelashes. As a result, new requirements for label warnings are in place.

The obligations involve three hair dye ingredients, Dimethylpiperazinium Aminopyrazolopyridine HCl, Methylimidazoliumpropyl p-Phenylenediamine HCl and Tetrabromophenol Blue.

Labels of products containing the substances mentioned above must include the following warnings:

  1. Mixing ratio;
  2. Triangle with exclamation mark symbol;
  3. Hair dyes can cause severe allergic reactions;
  4. Read the instructions for use and follow them;
  5. This product is not intended for persons under 16 years of age;
  6. Temporary black henna tattoos may increase your risk of allergy;
  7. Do not color your hair if:
    • you have a rash on your face or sensitive, irritated or damaged scalp;
    • you have ever experienced any reaction after coloring your hair;
    • you have experienced a reaction to a temporary “black henna” tattoo in the past.

Likewise, If the hair dye is only intended for professional use the package labelling must also include a warning stating that the product is only intended for professional use.

Pursuant to the assessment, the Safety Assessor will indicate the mandatory precautions for use to be added on labels. Nevertheless, the manufacturer is always allowed to embed additional details, and share further information with the Safety Assessor and the Responsible Person in order to receive their assessment according to the manufacturer’s experience with the products.

 

Furthermore, in 2017, the European Commission published Regulation EU No 2017/1410, which prohibits the use of Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (HICC, trade name: Lyral), 2,6-Dihydroxy-4-methyl benzaldehyde (Atranol) and 3-Chloro-2,6-Dihydroxy-4-methylbenzaldehyde (Chloroatranol).

According to the assessment of the Scientific Committee on Consumer Safety, these three fragrance allergens caused the highest number of contact allergies cases in past years. Consequently, no more products containing these substances can be marketed as of August 23, 2021

 

In this respect, should you desire more insights on other label warning requirements for your products or on upcoming prohibitions as well, contact us today!

Obelis’ mission is to make the European Union a safer market through compliance. This vision is in line with the European Commission’s new legal requirements in the field of label requirements and substance prohibition.

Should you desire to stay up to date with the European Commission’s initiatives concerning these topics, COSlaw is glad to share with you the latest news on EU regulatory compliance through its News Section. We strive to keep you up to date on all relevant information!

Or, should you be interested in placing cosmetic products in the European market, Obelis, with over 30 years of experience, will be your European Authorized Representative of choice, assisting you through your journey into EU regulatory compliance.

 

 

References:

Leave a Reply

Your email address will not be published.

Share This

Copy Link to Clipboard

Copy