Amendment to CLP Regulation – New and Updated Harmonized Classification of Cosmetic Ingredients
The Commission Delegated Regulation (EU) 2022/692, amending the CLP Regulation, was published on May 3rd. It introduces new and updated classification of a list of chemicals, including classifications for 12 ingredients that are used in cosmetic products.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

REGULATION (EC) NO 1223/2009 AND CMR SUBSTANCES

Regulation (EC) No 1272/2008, commonly called CLP Regulation, provides for a harmonized classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR) based on an opinion prepared by the Committee for Risk Assessment of the European Chemicals Agency (ECHA). Depending on the level of evidence of their CMR properties, substances are classified as CMR substances of category 1A, 1B or category 2.

By default, the use of substances classified as CMR (under the CLP Regulation) is banned according to Article 15 of the European Cosmetics Regulation (Regulation (EC) No 1223/2009). Nevertheless, a CMR substance may be used in cosmetic products, by way of exception, if specific conditions are fulfilled.

With the aim of implementing the prohibition of CMR substances, ensure legal compliance (particularly for economic operators and national competent authorities) and to ensure a high level of protection of human health, these compounds are included in Annex II (list of substances prohibited in cosmetics products) or Annex III (list of substances which cosmetic products must not contain except subject to the restrictions laid down) of the EU Cosmetics Regulation. A CMR substance may also be deleted from Annexes III to VI of the Regulation for these purposes.

COMMISSION DELEGATED REGULATION (EU) 2022/692

On May 3rd 2022, the Commission Delegated Regulation (EU) 2022/692 was published in the Official Journal of the European Union. It amends the CLP Regulation for the purposes of its adaptation to technical and scientific progress.

ECHA has received proposals to introduce harmonized classification and labelling of certain substances and to update or delete harmonized classification and labelling of other substances. Taking into those proposals and comments received from the parties concerned, RAC adopted several opinions on those proposals.

The Commission Delegated Regulation (EU) 2022/692 includes new or updated classification for 12 chemicals that may be used as cosmetic ingredients. Seven out of these 12 are now classified as carcinogenic, mutagenic or toxic to reproduction (CMR). This means that these 7 ingredients may be prohibited or restricted in cosmetic products marketed in the EU in the future.

The ingredients used in cosmetics which are now classified as CMR are the following:

  • Benzophenone (CAS number: 119-61-9)
  • Teophylline (CAS number: 58-55-9)
  • Melamine (CAS number: 108-78-1)
  • Azadirachta Extracts (CAS number: 84696-25-3)
  • Trimethylolpropane Triacrylate (CAS number: 15625-89-5)
  • Pentetic Acid (CAS number: 67-43-6)
  • Pentasodium pentetate (CAS number: 140-01-2)

The Commission Delegated Regulation shall enter into force on the twentieth day following that of its publication and shall apply from 1 December 2023.

If you wish to get more information on the safety of cosmetic ingredients, feel free to contact us at info@criticalcatalyst.com.

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. Commission Delegated Regulation (EU) 2022/692 of 16 February 2022 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

further
reading

drug_device_combination_1
medical devices

Regulatory Framework of Drug-Device Combination

The advances in technology continue to merge different types of products and the historical lines of separation between medical devices and medicinal products are getting thinner. Products combining medicinal products and medical devices are regulated either by Regulation (EU) 2017/745 (MDR) or by Directive 2001/83/EC.

Read More »
cosmetic products

SCCS Preliminary Opinion on Alpha-Arbutin and Beta-Arbutin

Alpha-arbutin and Beta-arbutin are used in cosmetic with antioxidant, bleaching and skin conditioning functions. Following concerns raised during discussion within the Working Group on Cosmetic Products and consequent call for data on these ingredients, the SCCS assessed the safety of Alpha-arbutin and Beta-arbutin in cosmetic products.

Read More »
cosmetic products

Request for SCCS Scientific Opinion on Citral

The European Commission requested the SCCS to assess whether the derived safe use levels for Citral by the application of the QRA2 based on the induction of skin sensitization is adequate to protect consumers. A period of 9 months was set for issuing the scientific opinion.

Read More »
cosmetic products

SCCS Scientific Advice on the Safety of Triclocarban and Triclosan

The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary version of the scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products. The deadline for comments was set at 27 May 2022.

Read More »
cosmetic products

Cosmetic Regulation in the Andean Community

In the Andean Community (Bolivia, Colombia, Ecuador and Peru), cosmetic products are mainly regulated by Decision 833. All cosmetic products made available in these countries must undergo a Mandatory Sanitary Notification (NSO) and need to be manufactured according to Good Manufacturing Practices (GMP).

Read More »
cosmetic products

Cosmetic Product Labelling in the European Union

The Regulation (EC) No 1223/2009 lays down the mandatory information that needs to be included in the packaging and container of a cosmetic products. In addition to this information, most cosmetic products include certain claims, which must be supported and properly substantiated.

Read More »
cosmetic products

Environmental Claims in the UK

Green claims are a trend among consumer goods and services. We often see claims like ‘clean beauty’, ‘environmental friendly’ and so many others. But how can companies ensure that these claims are not misleading? The UK’s Competition and Markets Authority (CMA) has published its Green Claims Code, in order to help companies comply with legal obligations when making environmental claims.

Read More »
cosmetic products

Parabens in Cosmetic Products

Parabens are widely used as preservatives in cosmetic and personal care products. Over the years, there have been some concerns related to the safety of parabens. The SCCS has published several opinions regarding the use of these ingredients in cosmetics, indicating the concentration levels they considered safe for human health. In the EU, some parabens can be safely used as preservatives, while others are prohibited in cosmetic products.

Read More »
cosmetic products

The Product Information File (PIF)

A Product Information File (PIF) is mandatory for all cosmetic products placed in the European Union market. It is a document that compiles the technical information of the cosmetic product and it must be kept for a period of 10 years by the Responsible Person.

Read More »