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Another revolutionary change in cosmetic law is ahead of us, which we have been waiting for for a long time. This is about the famous topic of microplastics and the ban on their use in cosmetics. This change is introduced by Commission Regulation (EU) 2023/2055 of 25 September 2023 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards synthetic polymer microparticles.

Problematic microplastics

Let’s start with what microplastics actually are. As defined by ECHA (European Chemicals Agency) „synthetic polymer microparticles are polymers that are solid and which fulfil both of the following conditions:

(a) are contained in particles and constitute at least 1% by weight of those particles; or build a continuous surface coating on particles;

(b) at least 1% by weight of the par­ ticles referred to in point (a) fulfil either of the following conditions:

  • all dimensions of the particles are equal to or less than 5 mm;
  • the length of the particles is equal to or less than 15 mm and their length to diameter ratio is greater than 3.”

Where does the problem with microplastics come from? First of all, these are issues related to their impact on the environment and human health. For years, much has been said about the enormous pollution of the oceans with microplastics. The problem is that microplastics decompose very slowly and can easily enter the digestive system of living organisms. Due to their ubiquitous use, these polymers are common in the environment and have also been detected in drinking water and food. Therefore, appropriate steps have been taken to limit the use of these substances in industry, including the cosmetics industry.

Exclusions

It is worth adding that some polymers have been excluded from the above definition of microplastics. These are:

  • natural polymers – i.e. that are the result of a natural polymerisation process, independently of the process through which they have been extracted, which are not chemically modified substances;
  • polymers that are degradable;
  • polymers that have a solubility greater than 2 g/L;
  • polymers that do not contain carbon atoms in their chemical structure.

What will change?

Under the new law, microplastics cannot be placed on the market as substances on their own or in mixtures in concentrations ≥0.01% by weight. In practice, for the cosmetics industry, this means a ban on the use of synthetic polymer microparticles:

• intended for use as an abrasive material, i.e. for exfoliation (peelings) – on the date of entry into force of the regulation, i.e. 17th of October 2023,

• in rinse-off products – from 17.10.2027,

• for encapsulating fragrances – from 17.10.2029,

• in leave-on products except makeup, lip and nail products – from 17.10.2029,

• in makeup, lip and nail products – from 17.10.2035.

Additionally, in the case of make-up, lip and nail cosmetics, it will be necessary to use the following marking on the labels: “this product contains microplastics“. This marking will be used from 17.10.2031 to 16.10.2035.

From October 17, 2025, products containing, among others: film-forming ingredients will have to be provided with instructions of use and how to dispose the product (in the form of text or pictogram).

Summary

We are undoubtedly facing a total turnaround in the cosmetics industry. The ban on the use of microplastics will pose a major challenge for both raw material and cosmetics producers. A huge part of cosmetic ingredients, including emulsifiers and film-forming substances, fall under the new definition of microplastics. The color cosmetics industry faces a particularly difficult test. It will be difficult to develop new replacements for polymers that have been used in this segment for years and then completely reformulate all makeup products, lipsticks and nail polishes.

It is also worth emphasizing that the cosmetics industry will probably not have a complete list of banned microplastics with INCI names. Such a list would certainly make the work of everyone easier: raw material suppliers, people from R&D departments and safety assessors. Therefore, there will be no other option but to rely on reliable documentation from suppliers of cosmetic raw materials in order to classify a given substance into the – quite complicated – definition of microplastics.

The full text of the new regulation can be found here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R2055

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For a long time, the cosmetic law has not changed at such a dizzying pace. On July 26th, the long-awaited regulation introducing the need to label 56 new fragrance allergens appeared. This is a real revolution that the industry has been waiting for for a long time and about which we have already written on the blog: https://www.cosmeticscare.eu/en/from-26-to-82-longer-list-of-allergens/

What will change?

The aforementioned changes are introduced by the EU Commission Regulation 2023/1545 of 26 July 2023 amending Regulation (EC) No. 1223/2009 of the European Parliament and of the Council as regards the labeling of fragrance allergens in cosmetic products. So far, it was necessary to mark in the INCI composition on the cosmetic label 24 allergens listed in items 45 and 67-92 of Annex III to Regulation No. 1223/2009, i.e.:

  • Alpha-Isomethyl Ionone,
  • Amyl Cinnamal,
  • Amyl Cinnamyl Alcohol,
  • Anise Alcohol,
  • Benzyl Alcohol,
  • Benzyl Benzoate,
  • Benzyl Cinnamate,
  • Benzyl Salicylate,
  • Cinnamal,
  • Cinnamyl Alcohol,
  • Citral,
  • Citronellol,
  • Coumarin,
  • Eugenol,
  • Evernia Prunastri Extract,
  • Evernia Furfuracea Extract,
  • Farnesol,
  • Geraniol,
  • Hexyl Cinnamal,
  • Hydroxycitronellal,
  • Isoeugenol,
  • Limonene,
  • Linalool,
  • Methyl 2-Octynoate,

if they exceeded the concentration:

  • 0.01% in rinse-off products (e.g. soaps, shampoos),
  • 0.001% in leave-on products (e.g. creams).

The new regulation introduces the obligation to label additional – 56 new fragrance allergens, in addition to those listed above. Annex III will therefore be extended to these allergens, including:

  1. Pinus Mugo,
  2. Pinus Pumila,
  3. Cedrus Atlantica Oil/Extract,
  4. Turpentine,
  5. Alpha-Terpinene,
  6. Terpinolene, 
  7. Myroxylon Pereirae Oil/Extract,
  8. Rose Ketones, 
  9.  3-Propylidenephthalide,
  10. Lippia Citriodora Absolute, 
  11. Methyl Salicylate, 
  12. Acetyl Cedrene,
  13. Amyl Salicylate,
  14. Anethole,
  15. Benzaldehyde,
  16. Camphor,
  17. Beta-Caryophyllene,
  18. Carvone,
  19. Dimethyl Phenethyl Acetate,
  20. Hexadecanolactone,
  21. Hexamethylindanopyran,
  22. Linalyl Acetate,
  23. Menthol,
  24. Trimethylcyclopentenyl Methylisopentenol,
  25. Salicylaldehyde,
  26. Santalol,
  27. Sclareol,
  28. Terpineol,
  29. Tetramethyl acetyloctahydronaphthalenes,
  30. Trimethylbenzenepropanol,
  31. Vanillin,
  32. Cananga Odorata Oil/Extract,
  33. Cinnamomum Cassia Leaf Oil,
  34. Cinnamomum Zeylanicum Bark Oil,
  35. Citrus Aurantium Flower Oil,
  36. Citrus Aurantium Peel Oil,
  37. Citrus Aurantium Bergamia Peel Oil,
  38. Citrus Limon Peel Oil,
  39. Lemongrass Oil,
  40. Eucalyptus Globulus Oil,
  41. Eugenia Caryophyllus Oil,
  42. Jasmine Oil/Extract,
  43. Juniperus Virginiana Oil,
  44. Laurus Nobilis Leaf Oil,
  45. Lavandula Oil/Extract,
  46. Mentha Piperita Oil,
  47. Mentha Viridis Leaf Oil,
  48. Narcissus Extract,
  49. Pelargonium Graveolens Flower Oil,
  50. Pogostemon Cablin Oil,
  51. Rose Flower Oil/Extract,
  52. Santalum Album Oil,
  53. Eugenyl Acetate,
  54. Geranyl Acetate,
  55. Isoeugenyl Acetate,
  56. Pinene.

After these changes, there will be 371 entries in Annex III.

And one more important information – allergens will be marked in two ways: individually or by grouping. Individual labeling is already known to us and it is simply about one name for one specific substance, e.g. Limonene will be labeled as Limonene. What is new will be group tagging, where several similar allergens will be grouped into one item. An example would be position 70 where Citral, Geranial and Neral will be labeled as Citral. So if in a given fragrance composition there will be e.g. Geranial and Citral in the proper concentration, then in the INCI we have to enter only Citral.

Link to the full text of the new regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1545

Change dates

Fortunately, the transitional periods proposed by the European Commission are quite long. We have time to adapt to the new changes until:

  • July 31, 2026 – for placing cosmetics that do not meet the new requirements on the market,
  • July 31, 2028 – to be made available on the market.

After these dates, it will be necessary to update the labels and documentation (including safety assessment) of cosmetics with new allergens.

Undoubtedly, there is a lot of work ahead of the manufacturers of fragrances and cosmetics. The former will have to update e.g. lists of allergens, the latter – INCI compositions on labels. Fingers crossed that the proposed transitional periods will be sufficient to introduce such major changes.

New allergens Read More »

Today a short post about new banned substances. Once again, there have been changes in the cosmetics law introducing a ban on the use of certain substances in cosmetics. All this thanks to the new Commission Regulation (EU) 2023/1490 of 19 July, 2023. So what substances will be banned? You can read about it below.

What substances?

First, a few words of introduction as a reminder. The list of substances prohibited in cosmetic products is included in the Annex II of the Regulation 1223/2009. And this is the annex that is most often updated by the new law. In the vast majority of cases, new CMR substances – classified as carcinogenic, mutagenic or toxic to reproduction – are added to the list of banned substances. If such substances are classified as CMR under Delegated Regulation (EU) 2022/692, the so-called 18 ATP to CLP and at the same time the cosmetics industry does not take defensive measures for them, then they are automatically banned.

Currently, as many as 30 new substances will be included in Annex II, including:

• Ammonium Bromide,

• Tellurium Dioxide,

• Cumene,

• Benzophenone,

• Theophylline,

• Melamine,

• Margosa, ext. (from the kernels of Azadirachta indica extracted with water and further processed with organic solvents),

• Trimethylolpropane Triacrylate,

• Pentetic Acid,

• Pentasodium Pentetate.

An interesting example here is theophylline, which is an alkaloid naturally found in cocoa beans and tea leaves. It has been classified as toxic to reproduction (Repr. 1B), and thus – it will be banned in cosmetics. It is worth realizing that we will still be able to consume theophylline, e.g. by drinking tea, but it will not be used in cosmetics. This is an interesting “legislative paradox” 😉

After the update of the law, Annex II will already contain 1724 substances. In addition, entry 1024: “2-ethylhexanoic acid and its salts with the exception of those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008 ” will be amended. Until now, this entry covered only 2-ethylhexanoic acid without its salts.

Change dates

The new regulation enters into force on the twentieth day after its publication, i.e. August 9, 2023, and will apply from December 1, 2023.

I encourage you to read the full text of the regulation and the full list of new banned substances at the link:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1490

New banned substances Read More »

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