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IMPORTANT CHANGES IN REGULATION IN 2021

                                           ENDOCRINE DISRUPTORS

Endocrine disruptors are chemical substances that alter the functioning of the endocrine system and negatively affect the health of humans and animals. They may either be of synthetic or natural origin. Exposure to endocrine disruptors can occur from different sources, such as residues of pesticides or consumer products used or present in our daily life.
The Commission launched a first public call for data from 16 May -15 October on 14 substances that merit a higher priority for assessment. These substances include Benzophenone-3, kojic acid, 4-methylbenzylidene camphor, propylparaben, triclosan, resorcinol, octocrylene, triclocarban, butylated hydroxytoluene (BHT), benzophenone, homosalate, benzyl salicylate, genistein and daidzein. 
A second call for data related to the remaining 14 substances could take place in 2021, taking into consideration any relevant developments. These substances are Butylparaben, tert-butylhydroxyanisole/Butylated hydroxyanisole/BHA, ethylhexyl methoxycinnamate (EHMC)/octylmethoxycinnamate (OMC)/ octinoxate, benzophenone-1/BP-1, benzophenone-2/BP-2, benzophenone-4/BP-4, benzophenone-5/BP-5, methylparaben, cyclopentasiloxane/decamethylcyclopentasiloxane/D5, Cyclomethicone, salicylic acid, butylphenyl methyl propanol/BMHCA, triphenyl phosphate and deltamethrin.


                                 Butylphenyl Methylpropional (BMHCA, Lilial)


On August 11, 2020, the European Commission published in the Official Journal of the EU a Delegated Regulation amending the Classification, Labelling and Packaging Regulation (CLP Regulation). The change concerns several ingredients, which were classified as CMR substances, and notably the allergen Buthylphenyl Methylpropional, also known as BMHCA or Lilial. Lilial is a well-known fragrance ingredient, commonly found in cosmetic products.
Cosmetic products are normally excluded from the application of the CLP Regulation, except for aerosols. Nevertheless, the Cosmetics Regulation (EC) 1223/2009 prohibits the use of substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) under the CLP Regulation in cosmetic products, and allows it only whenever there is an exemption under art.15.
The amendment to the CLP Regulation classifies Butylphenyl Methylpropional as a CMR 1B and applies from March 1, 2022. The exact timing for the prohibition of placing or making available of cosmetic products containing the allergen on the EU market is not known with certainty. The Commission will have to add the ingredient to Annex II of the Cosmetics Regulation, which  will most probably happen through Omnibus Act IV which is to be published beginning of 2021.
The implementation time after the publication of an Omnibus Act is very short, practically they apply immediately after the publication. As such, it is highly advisable for cosmetic manufacturers to immediately start the process of replacing fragrances with Lilial-free ones and to refrain from placing new products containing Lilial on the EU market.

HEMA & DI-HEMA TRIMETHYLHEXYL DICARBAMATE

Hydroxyethylmethacrylate (HEMA) and Di-HEMA Trimethylhexyl Dicarbamate (Di-HEMA TMHDC) are two colorless viscous liquids that readily polymerize when exposed to UV-light. Because of their physical properties, these monomers are typically used in nail enhancement products. EU Commission has decided to add Di-HEMA TMHDC and HEMA to the Cosmetic Regulation Annex 3 (III/313 & II/314) and to add warnings to be present on the label.
“Can cause an allergic reaction. Professional use only.”
From 3 June 2021 products containing that substance and not complying with those conditions shall not be placed on the Union market. From 3 September 2021 products containing that substance and not complying with those conditions shall not be made available on the Union market.




 
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