Omnibus V draft notified to the WTO: upcoming restrictions

March 28, 2022 – On February 3, 2022, the European Commission notified the World Trade Organization (WTO) of the Omnibus Act V draft. The law aims at transposing into the EU Cosmetics Regulation the ingredients classified as CMR substances in the 17th Adaptation to Technical Progress (ATP), published in March 2021. In fact, as a general principle, CMR substances are prohibited for use in cosmetics (Article 15 of the EU Cosmetics Regulation).

 

According to the Agreement on Technical Barriers to Trade (TBT), all signers (including the European Union) must notify the WTO of their law drafts to avoid unnecessary and unjustified technical barriers to international trade. After the notification, the legislative process is frozen: stakeholders have 60 days to send their comments to the WTO.

 

What is going to happen?

Firstly, the draft foresees the prohibition of 14 new ingredients. Hence, the following substances will be added to Annex II to the EU Cosmetics Regulation:

  • Tetrafluoroethylene;
  • 6,6′-di-tert-butyl-2,2′-methylenedi-p-cresol; [DBMC];
  • (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone; pyriofenone;
  • (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate;
  • Azamethiphos (ISO); S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate;
  • 3-methylpyrazole;
  • N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide; pydiflumetofen;
  • N-{2-[[1,1′-bi(cyclopropyl)]-2-yl]phenyl}-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide; sedaxane;
  • 4-methylpentan-2-one; isobutyl methyl ketone (MIBK);
  • Dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine;
  • Imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid;
  • Thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine;
  • Triticonazole (ISO); (RS)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-methyl)cyclopentanol;
  • Desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate.

 

Moreover, Methyl Salicylate will be added to Annex III to the EU Cosmetics Regulation.

 

Methyl Salicylate

Methyl Salicylate (CAS no. 119-36-8) is a substance with several functions in cosmetics formulas: fragrance/flavoring ingredient and soothing agent

In 2021, ECHA classified Methyl Salicylate as a CMR substance of category 2: it means that it is suspected to be toxic for reproduction. Thus, the cosmetic industry asked the European Commission to apply the exemption procedure set by Article 15(1) of the EU Cosmetics Regulation. According to it, the use of a substance classified as CMR 2 can be permitted by way of exemption if the Scientific Committee on Consumer Safety (SCCS) has evaluated it and found it safe.

As a result, on October 26-27, 2021, the SCCS issued its final opinion on Methyl Salicylate (SCCS/1633/21), stating the maximum safe concentration of methyl 2-hydroxybenzoate for several categories of cosmetics. Therefore, the use of Methyl Salicylate will be restricted as follows:

  • Up to 0.06% in leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant, and hydroalcoholic-based fragrances) and leave-on hair products (except spray/aerosol products);
  • Up to 0.05% in face makeup (except lip products, eye makeup, and makeup remover);
  • Up to 0.002% in eye makeup and makeup remover;
  • Up to 0.009% in leave-on hair products spray/aerosol;
  • Up to 0.003% in deodorant spray/aerosol;
  • Up to 0.4% in body lotion spray/aerosol;
  • Up to 0.06% in rinse-off skin products (except hand wash) and rinse-off hair products;
  • Up to 0.6% in hand wash, hydroalcoholic-based fragrances, and mouthwash intended for children above 10 years of age and adults;
  • Up to 0.03% in lip products;
  • Up to 2.52% in toothpaste;
  • Up to 0.1% in mouthwash intended for children aged 6-10 years;
  • Up to 0.65% in mouth spray.

Furthermore, cosmetic products for children under six years cannot contain Methyl Salicylate. The only exception is toothpaste.

 

Deadline

The European Commission will likely publish the Omnibus Act V in September 2022. The new restrictions will apply as of December 17, 2022 — the exact date from which the 17th ATP will be applicable.

Do not forget that Omnibus Acts do not differentiate between placing on the market and making available on the market. Hence, as of December 17, 2022, beauty brands cannot place cosmetics not compliant with Omnibus Act V on the EU market anymore, and they must recall products already on shelves.

 

Reformulation may take months. Now it is time to act so that you are not caught unprepared.

Follow COSlaw.eu, and you will not miss any cosmetic news!

 

 

References:

  • European Commission. (2022). Commission Regulation (EU) of XXX amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction and correcting that Regulation. Retrieved on 28/02/2022 from https://members.wto.org/crnattachments/2022/TBT/EEC/22_1326_00_e.pdf
  • European Commission. (2022). Annexes to the Commission Regulation …/… amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction and correcting that Regulation. Retrieved on 28/02/2022 from https://members.wto.org/crnattachments/2022/TBT/EEC/22_1326_01_e.pdf
  • European Commission. (2021). Commission Delegated Regulation (EU) 2021/849 of 11 March 2021 amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures. Retrieved on 28/02/2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R0849&from=EN
  • SCCS. (2021). Opinion on Methyl salicylate (methyl 2-hydroxybenzoate). Retrieved on 28/02/2022 from https://ec.europa.eu/health/system/files/2021-11/sccs_o_255_0.pdf

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