José María Ferrer / 26 November 2024

The safety of cosmetic products in the European Union

When we think about food and food safety in the EU, we associate this topic with the work of EFSA as the body providing the technical and scientific advice necessary to ensure food safety. When it comes to cosmetics, our attention should be directed to the Scientific Committee on Consumer Safety (SCCS).

The SCCS’s activities are integrated into the process established by Regulation (EC) No 1223/2009, particularly in relation to various situations outlined in Article 31:

  • In the event of a potential risk to human health arising from the use of substances in cosmetic products that needs to be addressed at the EU level, the Commission, after consulting the SCCS, may amend Annexes II to VI accordingly.
  • Following consultation with the SCCS, the Commission may amend Annexes III to VI and VIII to adapt them to scientific and technical progress.
  • Where necessary to ensure the safety of cosmetic products placed on the market, the Commission, after consulting the SCCS, may amend Annex I.

What does the SCCS do?

The Scientific Committee on Consumer Safety is responsible for issuing opinions on health and safety risks (chemical, biological, mechanical, and other physical risks) associated with non-food consumer products (e.g., cosmetic products and their ingredients, toys, textiles, clothing, personal and household care products) and services (e.g., tattoos and artificial tanning). This work enables the European Commission to amend and update legislation on cosmetics whenever necessary to ensure consumer health and safety.

What is the SCCS currently working on?

The SCCS remains actively engaged in responding to the various requests it receives. At present, it is finalising its opinion on a new coating for titanium dioxide (in nano form).

In this case, the issues addressed in the draft opinion relate to the safety of using titanium dioxide (nano) in the proposed applications and formulations.

The SCCS’s preliminary considerations highlight the need for further information to resolve uncertainties and doubts arising during the evaluation of potential uses of titanium dioxide (nano). As such, the SCCS will continue its work, awaiting additional data to enable the issuance of a well-founded scientific opinion with the highest level of assurance.

The Committee’s activities, through reports and opinions, support legislative measures that update and develop cosmetics regulations. One of the most recent examples is the upcoming amendment to the cosmetics legislation (Regulation (EC) No 1223/2009), which will incorporate a significant number of substances into Annex II, thereby expanding the list of substances prohibited in cosmetic products.

In this specific case, based on the SCCS’s evaluation, the substances to be added to Annex II of Regulation 1223/2009 are:

  • óxido de fosfina difenil(2,4,6-trimetilbenzolil)
  • 2,2′,6,6′-tetrabromo-4,4′-isopropilidenodifenol; tetrabromobisfenol-A
  • transflutrina (ISO); 2,3,5,6-tetrafluorobenzil (1R,3S)-3-(2,2-dicloroetil)-2,2-dimetilciclopropanocarboxilato
  • clotianidina (ISO); (E)-1-(2-cloro-1,3-tiazol-5-ilmetil)-3-metil-2-nitroguanidina
  • benzil(dietilamino)difosfonio difenil 4[1,1,1,3,3,3-hexafluoro-2-(4-hidroxifenil)propan-2-il]fenolato
  • benziltrifenilfosfonio, sal com 4,4′[2,2,2-trifluoro-1(trifluorometil)etilideno]bis[fenol] (1:1)
  • mistura de reação de 4,4′-[2,2,2-trifluoro-1(trifluorometil)etilideno]difenol e benzil(dietilamino)difenilfosfonio 4[1,1,1,3,3,3-hexafluoro-2-(4-hidroxifenil)propan-2-il]fenolato (1:1)
  • mistura de reação de 4,4′-[2,2,2-trifluoro-1(trifluorometil)etilideno]difenol e benziltrifenilfosfonio, sal com 4,4′[2,2,2-trifluoro-1(trifluorometil)etilideno]bis[fenol] (1:1)
  • propilfosfonato de dimetilo
  • maleato de dibutilestanho
  • óxido de dibutilestanho
  • mistura de reação de 1-(2,3-epoxipropoxi)-2,2-bis((2,3-epoxipropoxi)metil)butano e 1-(2,3-epoxipropoxi)-2-((2,3-epoxipropoxi)metil)-2-hidroximetilbutano
  • 4,4′-[2,2,2-trifluoro-1(trifluorometil)etilideno]difenol; bisfenol AF
  • benfluralina (ISO); N-butil-N-etil-α,α,α-trifluoro-2,6-dinitro-p-toluidina
  • N,N-dimetil-p-toluidina
  • 1,4-benzenodiamina, N,N’-derivados mistos de fenil e tolueno
  • 4-nitrosomorfolina
  • difenoconazol (ISO); 1-({2-[2-cloro-4-(4-clorofenoxi)fenil]-4-metil-1,3-dioxolan-2-il}metil)-1H-1,2,4-triazol; 3-cloro-4-[(2RS,4RS;2RS,4SR)-4-metil-2-(1H-1,2,4-triazol-1-ilmetil)-1,3-dioxolan-2-il]fenil 4-clorofenil éter
  • 4-metilimidazol
  • 3,3’-dimetilbifenil-4,4’-diisocianato
  • foramsulfurão (ISO); 2-{[4,6-dimetoxipirimidin-2-il)carbamoil]}–4-formamido-N,N-dimetilbenzamida; 1-(4,6-dimetoxipirimidin-2-il)-3-(2-dimetilcarbamoil-5-formamidofenilsulfonil)ureia.

Are cosmetics marketed in the EU safe?

Considering the current regulatory framework and the work carried out by the SCCS to ensure consumer health and safety, we can confidently state that the EU has the safest system in the world. Among the various elements addressed in the regulatory and technical field for cosmetics, the following points stand out:

  • All cosmetic products marketed in the EU must comply with strict safety requirements to protect human health.
  • Technical work, combined with legislative measures, ensures that the latest technological and scientific advances are taken into account.
  • All cosmetics must have a safety report before being placed on the market.
  • Economic operators marketing these products must ensure they meet all safety requirements in accordance with Regulation (EC) No 1223/2009.

Economic operators placing cosmetic products on the market, in addition to considering the work of the SCCS, also rely on the supporting document published in the Commission Implementing Decision of 25 November 2013 on the guidelines relating to Annex I of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. This document aids in the preparation of safety dossiers and their submission to the Scientific Committee on Consumer Safety (SCCS).

From the perspective of the cosmetics sector, it is important to pay attention to the opinions and reports of the SCCS, as they may impact the regulatory framework applicable to cosmetic products. At AINIA, we will continue to provide updates on the evolution of legislation applicable to cosmetic products.

José María Ferrer (407 articles)

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