The ‘Omnibus Regulation’

‘Omnibus Regulation 2019’ : Update

December 13th, 2019

As estimated below, the Omnibus Regulation 2019 has been published and we invite you to consult the legal text EU No 2019/1966. The main (if not unique) impact of this new Regulation on the cosmetic industry concerns the use of Salicylic Acid and its salts.

Furthermore, the transition period indicated in the draft version of this Regulation has been confirmed. The new legal requirements related to Salicylic Acid and its salts will start to apply on May 1st, 2020.

Any questions?

Caution: Salicylic Acid

July 11th, 2019

Soon after the publication of the ‘Omnibus Regulation 2018’ (see IL-061), the European Commission started a public consultation with regard to the next version ‘Omnibus Regulation 2019’. From now on, such an amendment to the European Cosmetics Regulation, prohibiting batches of substances classified CMR, will be published every year.

As you may know, Article 15 of the European Cosmetics Regulation regulates the use of CMR substances in cosmetic products. In principle, the use of CMR substances is prohibited in the EU although exemptions remain possible under specific conditions. The regulatory procedure implies the publication of an amendment to Annex II (prohibited substances) before a ban takes effect. Annex III (restricted substances) and Annex V (preservatives) may also have to be adapted if an exemption is granted.

The draft ‘Omnibus Regulation 2019’ is now under consultation at the World Trade Organization level and until August 11th, 2019. The new regulation is expected to be published by the end of the year and without further modifications. The content of this regulation is reported below. Despite a long list of ingredients, only a few ones are relevant to the cosmetic industry:

Cosmetic ingredients prohibited (addition to Annex II):

NamePrevious entry
Acetaldehyde; Ethanal/
Quinolin-8-ol (INCI: Oxyquinoline, CAS 148-24-3)III.51
4-Methyl-o-phenylenediamine; 3,4-Diaminotoluene (INCI: Diaminotoluene)III.9

Cosmetic ingredients further restricted (modification of Annex III and Annex V):

NameEntry
Salicylic acid used for other purposes than preservationIII.98
Salicylic acid and its salts used as a preservativeV.3

While the ban of the three first ingredients is expected to have a very little impact (if any), we ask you to pay the greatest attention to the new restrictions affecting Salicylic acid and its salts.

Salicylic acid and its salts* have been recently classified as substances toxic for reproduction. However, the Scientific Committee on Consumer Safety released a positive Scientific Opinion on December 21st , 2018 (with corrigendum on June 21st , 2019), which supports the safe use of Salicylic acid under specific conditions. The SCCS conclusions have been transposed in the current draft legislation:

Product categoryCurrent situationFuture situation
Products for children under 3 years of ageNon-preservative use: Prohibited except for shampoos(max. 3 %)
To label: the function of the ingredient – e.g. Salicylic Acid (antidandruff)
Non-preservative use: Prohibited
 Preservative use: Prohibited except for shampoos(max. 0.5 %)Preservative use: Prohibited but salts of Salicylic Acid allowed at up to 0.5 % (as acid) only in shampoos.
Rinse-off hair productsNon-preservative use: Maximum 3.0 %
To label: the function of the ingredient – e.g. Salicylic Acid (antidandruff)
Non-preservative use: Maximum 3.0 %
To label: the function of the ingredient – e.g. Salicylic Acid (antidandruff)

Products that may lead to exposure of the end-user’s lungs by inhalation: Prohibited
 Preservative use: Maximum 0.5 % (as acid) of Salicylic Acid or its saltsPreservative use: Maximum 0.5 % (as acid) of Salicylic Acid or its salts

Products that may lead to exposure of the end-user’s lungs by inhalation: Prohibited
 To label (any types of use):
· “Not to be used for children under 3 years of age” if:
– The product may be used for children under 3 years of age.
– The product remains in prolonged contact with the skin
To label (any types of use):
· “Not to be used for children under 3 years of age” if:
 – The product may be used for children under 3 years of age.
 – The product remains in prolonged contact with the skin
Other productsNon-preservative use: Maximum 2.0 %
To label: the function of the ingredient – e.g. Salicylic Acid (antidandruff)
Non-preservative use: Maximum 2.0 %
To label: the function of the ingredient – e.g. Salicylic Acid (antidandruff)

Oral products, body lotion, eye shadow, mascara, eyeliner, lipstick, roll on deodorants and products that may lead to exposure of the enduser’s lungs by inhalation: Prohibited
 Preservative use: Maximum 0.5 % (as acid) of Salicylic Acid or its saltsPreservative use: Maximum 0.5 % (as acid) of Salicylic Acid or its salts

Oral products and products that may lead to exposure of the end-user’s lungs by inhalation: Prohibited (except lipsticks)
 To label (any types of use):
· “Not to be used for children under 3 years of age” if: –
 The product may be used for children under 3 years of age.
– The product remains in prolonged contact with the skin
To label (any types of use):
· “Not to be used for children under 3 years of age” if:
– The product may be used for children under 3 years of age.
– The product remains in prolonged contact with the skin

Products that may lead to exposure of the end-user’s lungs by inhalation: These terms typically translate to specific product categories, including aerosols, some types of spray and loose powders (if size of particles/droplets exceed 10 micrometers).

According to the plan of the European Commission, this regulation should be enforced by the end of this year. A short transition period will be granted and the legal changes reported above will start to apply on May 1 st , 2020.

* Salicylic acid and its salts

INCICASEINECS
Salicylic acid69-72-7200-712-3
Calcium salicylate824-35-1212-525-4
Magnesium salicylate18917-89-0242-669-3
MEA- salicylate59866- 70-5261-963-2
Sodium salicylate54-21-7200-198-0
Potassium salicylate578-36-9209-421-6
TEA- salicylate2174-16-5218-531-3

Publication of the ‘Omnibus Regulation’ 

May 27th, 2019

Article 15 of the European Cosmetics Regulation regulates the use of CMR substances in cosmetic products. In principle, the use of CMR substances is prohibited in the EU although exemptions remain possible under specific conditions. The regulatory procedure implies the publication of an amendment to Annex II (prohibited substances) before a ban takes effect. Annex III (restricted substances) and Annex V (preservatives) may also have to be adapted if an exemption is granted.

The long-awaited Regulation EU No 2019/831 (so-called ‘Omnibus Regulation’) has been adopted on May 22nd and explicitly prohibits the use of 227 substances. Furthermore, it further restricts the use of four others. Most of the banned substances were not used in cosmetic products anyway and are reported in this regulation to adapt the European Cosmetics Regulation to the new classifications of the CLP Regulation (EC No 1272/2008). Only the substances reported below have a documented usage in cosmetic products:

Cosmetic ingredients prohibited (addition to Annex II):

NamePrevious entry
Methenamine 3-Chloroallylochloride (INCI: Quaternium 15)V, 31
2-Chloracetamide (INCI: Chloroacetamide)V, 41
DichloromethaneIII, 7
Formaldehyde, Paraformaldehyde and Methylene Glycol (no exemption granted)III, 13 and V, 5
Perboric Acid and Sodium PerborateIII, 1a and III, 12
Borates, Tetraborates and Octaborates and other Boric Acid Salts or EstersIII, 1a and III, 1b
Cyclotetrasiloxane (D4)/
Methyl Pyrrolidone/

The non-intentional presence of Cyclotetrasiloxane will be tolerated. Indeed Cyclotetrasiloxane is a common impurity stemming from the manufacturing process of other silicones such as Cyclopentasiloxane or Dimethicone. The trace level not to exceed can be determined as follows:

  • Maximum 0.1% in rinse-off products because of the REACH Restriction (see IL-051) limiting the presence of D4, D5 and D6 in wash-off products at 0.1%, whatever their source and function, from January 31st, 2020.
  • Maximum 0.3% in leave-on products because exceeding this concentration can hardly be considered as unavoidable in Good Manufacturing Practices.

Cosmetic ingredients further restricted (addition to Annex III):

NameConditions
2-Furaldehyde (Furfural)Maximum 10 ppm (0.001 %)
Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (INCI: Trimethylbenzoyl diphenylphosphine oxide)Maximum 5.0 % in nail modelling products for professionals (no other permitted use)

The use of Trimethylbenzoyl diphenylphosphine oxide will only be permitted for the application of artificial nail systems. Beyond the concentration limit, the following warnings will have to be listed on the product labels:

  • For professional use only
  • Avoid skin contact
  • Read directions for use carefully

Cosmetic ingredients further restricted (addition to Annex V):

NameConditions
Polyhexamethylene biguanide hydrochloride (INCI: Polyaminopropyl Biguanide), PHMBMaximum 0.1%

However, the use of Polyaminopropyl Biguanide is prohibited in applications that may lead to exposure of the end-user’s lungs by inhalation (aerosols, sprays if the size of droplets are below 10 µM, loose powders, etc.).

This regulation will be enforced on June 11th , 2019. As previously communicated, no transition period will be granted and the legal requirements will therefore start to apply at the enforcement date of the regulation.