Regulatory changes regarding the classification and labeling of hazardous substances in cosmetics
The classification, labeling, and packaging of hazardous substances and mixtures in cosmetics have undergone recent regulatory changes.
With the publication of Delegated Regulation (EU) 2022/692, amendments were introduced to Regulation (EC) No. 1272/2008 in order to adapt it to technical and scientific advances in the field.
This regulation provides for an update and amendment of Table 3 of Part 3 of Annex VI of Regulation (EC) No. 1272/2008, which contains the list of hazardous substances subject to harmonized classification and labeling according to the criteria established by the same regulation.
Among the 30 substances covered by this regulation, many are already banned according to Annex II of Regulation (EC) No. 1223/2009 on cosmetic products, while 7 of these substances are currently used in cosmetics without restrictions or limitations.
In November last year, the European Commission forwarded a draft regulation to the World Trade Organization (WTO) that provides for the inclusion in the Cosmetics Regulation of substances classified as CMRs (Carcinogenic, Mutagenic, or Toxic for Reproduction) according to Regulation (EU) 2022/692. This measure was taken because no applications for exceptional use in cosmetic products were submitted for these substances, as required by Article 15 of the Cosmetics Regulation.
Among the substances that are subject to this amendment and will be included in Annex II of the Cosmetics Regulation are the following 7 substances, which are already listed in the Cosing with an INCI name and are currently not restricted:
In addition, entry 1024 in Annex II of the Cosmetics Regulation will be amended as follows:
This change is necessary. Entry 1024 in Annex II of Regulation (EC) No. 1223/2009 does not include salts of this substance. These salts have been classified as CMR [category 1B] according to Delegated Regulation (EU) 2022/692.
Regarding the substance Margosa-from the seeds of Azadirachta indica by means of water and a subsequent treatment with organic solvents-INCI Azadirachta Indica Seed Extract, it is emphasized that this measure covers only derivatives of the plant obtained by extraction processes with water and solvents, as indicated in the entry itself.
Once the measure is published, presumably in the third quarter of 2023, the proposed measures will apply from the same date that the ATP (Adaptation to Technical Progress) transposing the amendments comes into effect, i.e., December 1, 2023, without any transitional phase.
This means that, as of that date, products that do not comply with the new provisions can no longer be placed on the market or sold to end consumers.
Update your cosmetics by following the new regulations for hazardous substances. Contact us and our regulatory department will best support you!