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Table 1 Synopsis of the various passages of the CLP regulation and the relevance for cosmetic products

From: Dangerous cosmetics - criteria for classification, labelling and packaging (EC 1272/2008) applied to personal care products

 

Consequences for cosmetics

What would happen without the general exception for cosmetics?

General exception for cosmetics (A)

No labelling of any cosmetic products.

Many cosmetics fulfill the criteria for classification and labelling and would need to be classified and labelled.

Special regulations for containers smaller than 125 ml (B)

Many cosmetic containers are smaller than 125 ml.

Most cosmetic products that fulfill the criteria for classification and labelling are sold in small containers. Only a small number of H-statements would be applied to cosmetic products in small packages.

Labelling of mixtures which are not classified as sensitizing (C)

Most cosmetic products contain sensitizing fragrances.

Most cosmetic products would have to be labelled.

Stricter classification due to data gaps (D)

There is insufficient published data for many cosmetic ingredients.

The final classification of many cosmetic ingredients would be more severe than in the examples listed here, as I did not consider data gaps as criteria to classify cosmetics more strictly.

Classification of aerosol dispensers (E)

Hair spray is labelled, irrespective of the general exception for cosmetics.

This regulation is not affected by the general exception for cosmetics.

  1. Respective paragraphs in the CLP regulation[1].
  2. (A) Art. 1 (5) “This Regulation shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user: …(c) cosmetic products as defined in Directive 76/768/EEC”.
  3. (B) Annex I Part 1 “1.5.2. Exemptions from Article 17 [(Article 29(2)] 1.5.2.1. Labelling of packages where the contents do not exceed 125 ml 1.5.2.1.1. The H-statements and the P-statements linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where: (a) the contents of the package do not exceed 125 ml; and (b) the substance or mixture is classified in one or more of the following hazard categories: 1) Oxidising gases of category 1; 2) Gases under pressure; 3) Flammable liquids of category 2 or 3; 4) Flammable solids of category 1 or 2; 5) Self-reactive substances or mixtures Types C to F; 6) Self-heating substances or mixtures of category 2; 7) Substances and mixtures which, in contact with water, emit flammable gases of categories 1, 2 or 3; 8) Oxidising liquids of category 2 or 3; 9) Oxidising solids of category 2 or 3; 10) Organic peroxides Types C to F; 11) Acute toxicity of category 4, if the substances or mixtures are not supplied to the general public; 12) Skin irritation of category 2; 13) Eye irritation of category 2; 14) Specific target organ toxicity — single exposure of category 2 or 3, if the substance or mixture is not supplied to the general public; 15) Specific target organ toxicity — repeated exposure of category 2, if the substance or mixture is not supplied to the general public; 16) Hazardous to the aquatic environment — Acute of category 1; 17) Hazardous to the aquatic environment — Chronic of category 1 or 2”.
  4. (C) Annex II Part 2 “2.8: Mixtures not classified as sensitizing but containing at least one sensitizing substance must be labelled according to the special rules for supplemental label elements for mixtures…. The label on the packaging of mixtures containing at least one sensitizing substance in a concentration equal or greater than 0.1% …shall bear the statement: EUH208 ‘Contains (name of sensitizing substance). May produce an allergic reaction’”.
  5. (D) Annex I Part 3 “3.1.3.6.2.2. In the event that an ingredient without any useable information at all is used in a mixture at a concentration of 1% or greater, it is concluded that the mixture cannot be attributed a definitive acute toxicity estimate. In this situation the mixture shall be classified based on the known ingredients only, with the additional statement that x percent of the mixture consists of ingredient(s) of unknown toxicity. 3.1.3.6.2.3. If the total concentration of the ingredient(s) with unknown acute toxicity is ≤ 10% then the formula presented in section 3.1.3.6.1 shall be used. If the total concentration of the ingredient(s) with unknown toxicity is > 10%, the formula presented in section 3.1.3.6.1 shall be corrected to adjust for the total percentage of the unknown ingredient(s) as follows:….”.
  6. (E) Art. 14 (2) c) “The exemptions for labelling of small packages of aerosols as flammable laid down in Directive 75/324/ EEC shall apply to aerosol dispensers”
  7. Directive 75/324/ EEC [5] Annex 2.2 “Labelling: Without prejudice to the Directives relating to the classification, packaging and labelling of dangerous substances and preparations, particularly as regards danger to health and/or the environment, any aerosol dispenser must visibly bear the following legible and indelible marking: …. (b) Where the aerosol is classified as ‘flammable’ or ‘extremely flammable’ according to the criteria of point 1.9: — the flame symbol, in accordance with the model in Annex II to Directive 67/548/EEC; — the indication ‘flammable’ or ‘extremely flammable’, depending on the classification of the aerosol as ‘flammable’ or ‘extremely flammable’“.
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