1. How to Assess the Safety of a Cosmetic Ingredient
The regulation and safety assessment of cosmetic ingredients are primarily influenced by the REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) and CLP (Classification, Labeling, and Packaging) regulations, as well as the SCCS (Scientific Committee on Consumer Safety).
- The SCCS provides independent scientific assessments of cosmetic ingredient safety, and its opinions often lead to regulatory updates, especially when new scientific evidence emerges.
- REACH assesses the safety of chemicals and may restrict or prohibit their use in cosmetics (e.g. D4, D5, D6).
- CLP sets out criteria for classifying chemical hazards and labeling them clearly that can also directly impact their use in cosmetics (e.g. CMR substances).
Within this regulatory framework, certain substances, such as microplastics, nanomaterial, PFAS (Per- and Polyfluoroalkyl Substances), endocrine disruptors and more, are under increased scrutiny. These substances are subject to more frequent regulatory updates, which are crucial for the safe formulation of cosmetics.
2. Overview of Cosmetic Ingredient Regulations
Once the safety assessment of an ingredient is completed and it is deemed of concern, it is regulated through the Annexes of the Cosmetic Product Regulation as follows:
- Annex II: Prohibited Substances
- Annex III: Restricted Substances
- Annex IV: Authorized Colorants
- Annex V: Authorized Preservatives
- Annex VI: Authorized UV Filters
It's important to note that Annex I details the mandatory safety information required for all cosmetic products, ensuring consumer protection from potential hazards.
Additionally, all cosmetic ingredients must be registered with the Personal Care Products Council (PCPC) via the INCI (International Nomenclature of Cosmetic Ingredients) application. Once registered, these ingredients are included in the Cosing database, making them eligible for use in products within the EU market.
1 cosmetic ingredient = 1 INCI name = registered in Cosing
3. Prohibited Substances: Annex II
Annex II of the Cosmetic Regulation lists about 1,730 substances strictly prohibited from cosmetic products. This "negative list" was initially based on pharmaceutical and poison control references, and it continues to expand, albeit gradually.
Substances may be added to this list due to a reclassification of their hazard status or through direct input from the REACH and CLP regulations.
Case of CMR Substances (Article 15)
When a substance is classified as CMR, it is automatically prohibited from use in cosmetics. However, rare exceptions exist for Class 2 CMRs (those with insufficient evidence to classify as Class 1), provided they are deemed safe by the Scientific Committee on Consumer Safety (SCCS).
e.g.: Salicylic Acid and Methyl Salicylate, both Class 2 CMRs, are allowed under strict conditions and are listed in Annex III.
4. Restricted Substances: Annex III
Annex III contains a list of around 380 restricted substances that may only be used in cosmetics under specific conditions. These conditions might include:
- Type of Product: Restrictions may apply only to certain types of cosmetics.
- Concentration Limits: Substances may only be used below specific concentration thresholds.
- User Category: Some substances may be restricted for particular user groups, such as children under three years old.
- Targeted Skin Areas: Ingredients might be restricted based on the area of the body where they can be applied.
- Usage Restrictions: Certain substances are limited to professional use only.
- Other: e.g. Allergen Labeling (more below)
Most of the time restricted ingredients come from the result of the SCCS safety evaluation opinion which are translated in the CPR in the following months.
5. Authorized Substances: Annexes IV, V, and VI
The EU maintains positive lists of substances that are authorized for use under specific conditions:
- Annex IV: 155 colorants
- Annex V: 60 preservatives
- Annex VI: 35 UV filters
As positive lists, the included ingredients can already be present in Annexes II and III, and still be authorized through those 3 annexes for a special use in a product.
Rules for the use of these substances are:
- Maximum concentrations in ready-to-use preparations;
- The type of product and/or targeted skin area (e.g.: Do not use in products intended for mucous membranes);
- User category;
- Specific information on the packaging of cosmetic products when needed.
Special Case: Nanomaterials (Article 16)
Nanomaterials are only permitted for use as colorants, preservatives, or UV filters without additional authorization if specified in the regulation. If not, nanomaterials may undergo a separate authorization process to be included in cosmetic products.
Specific Considerations: Fragrances
Fragrances in cosmetics are regulated by the International Fragrance Association (IFRA), which sets concentration limits based on safety assessments by the Research Institute for Fragrance Materials (RIFM). While IFRA Standards are recommended for safety, discrepancies can occur between IFRA and the EU Cosmetic Regulation, particularly with allergenic substances. For example, Lilial is banned in the EU as a CMR 1B substance but only restricted by IFRA.
Allergen Labeling
Allergens are a special case under Annex III of the EU Cosmetic Regulation. Although not always restricted in use, specific allergens must be listed on product labels if their concentration exceeds 0.01% in rinse-off products or 0.001% in leave-on products. This requirement ensures transparency and helps protect consumers from potential allergic reactions.
Final Thoughts: Staying Compliant with Evolving Regulations
The regulation of cosmetic ingredients in Europe is continually evolving, driven largely by the influence of REACH, CLP regulations, and the scientific evaluations of SCCS. As the EU revises its Cosmetic Regulation, manufacturers and stakeholders must stay vigilant, particularly regarding substances like endocrine disruptors, CMRs, and nanomaterials. Keeping abreast of regulatory updates, maintaining clear communication with regulatory professionals, and ensuring ingredient traceability with manufacturers are essential steps to ensure compliance and consumer safety.
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For more information, contact EcoMundo's experts.
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1. How to Assess the Safety of a Cosmetic Ingredient
The regulation and safety assessment of cosmetic ingredients are primarily influenced by the REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) and CLP (Classification, Labeling, and Packaging) regulations, as well as the SCCS (Scientific Committee on Consumer Safety).
- The SCCS provides independent scientific assessments of cosmetic ingredient safety, and its opinions often lead to regulatory updates, especially when new scientific evidence emerges.
- REACH assesses the safety of chemicals and may restrict or prohibit their use in cosmetics (e.g. D4, D5, D6).
- CLP sets out criteria for classifying chemical hazards and labeling them clearly that can also directly impact their use in cosmetics (e.g. CMR substances).
Within this regulatory framework, certain substances, such as microplastics, nanomaterial, PFAS (Per- and Polyfluoroalkyl Substances), endocrine disruptors and more, are under increased scrutiny. These substances are subject to more frequent regulatory updates, which are crucial for the safe formulation of cosmetics.
2. Overview of Cosmetic Ingredient Regulations
Once the safety assessment of an ingredient is completed and it is deemed of concern, it is regulated through the Annexes of the Cosmetic Product Regulation as follows:
- Annex II: Prohibited Substances
- Annex III: Restricted Substances
- Annex IV: Authorized Colorants
- Annex V: Authorized Preservatives
- Annex VI: Authorized UV Filters
It's important to note that Annex I details the mandatory safety information required for all cosmetic products, ensuring consumer protection from potential hazards.
Additionally, all cosmetic ingredients must be registered with the Personal Care Products Council (PCPC) via the INCI (International Nomenclature of Cosmetic Ingredients) application. Once registered, these ingredients are included in the Cosing database, making them eligible for use in products within the EU market.
1 cosmetic ingredient = 1 INCI name = registered in Cosing
3. Prohibited Substances: Annex II
Annex II of the Cosmetic Regulation lists about 1,730 substances strictly prohibited from cosmetic products. This "negative list" was initially based on pharmaceutical and poison control references, and it continues to expand, albeit gradually.
Substances may be added to this list due to a reclassification of their hazard status or through direct input from the REACH and CLP regulations.
Case of CMR Substances (Article 15)
When a substance is classified as CMR, it is automatically prohibited from use in cosmetics. However, rare exceptions exist for Class 2 CMRs (those with insufficient evidence to classify as Class 1), provided they are deemed safe by the Scientific Committee on Consumer Safety (SCCS).
e.g.: Salicylic Acid and Methyl Salicylate, both Class 2 CMRs, are allowed under strict conditions and are listed in Annex III.
4. Restricted Substances: Annex III
Annex III contains a list of around 380 restricted substances that may only be used in cosmetics under specific conditions. These conditions might include:
- Type of Product: Restrictions may apply only to certain types of cosmetics.
- Concentration Limits: Substances may only be used below specific concentration thresholds.
- User Category: Some substances may be restricted for particular user groups, such as children under three years old.
- Targeted Skin Areas: Ingredients might be restricted based on the area of the body where they can be applied.
- Usage Restrictions: Certain substances are limited to professional use only.
- Other: e.g. Allergen Labeling (more below)
Most of the time restricted ingredients come from the result of the SCCS safety evaluation opinion which are translated in the CPR in the following months.
5. Authorized Substances: Annexes IV, V, and VI
The EU maintains positive lists of substances that are authorized for use under specific conditions:
- Annex IV: 155 colorants
- Annex V: 60 preservatives
- Annex VI: 35 UV filters
As positive lists, the included ingredients can already be present in Annexes II and III, and still be authorized through those 3 annexes for a special use in a product.
Rules for the use of these substances are:
- Maximum concentrations in ready-to-use preparations;
- The type of product and/or targeted skin area (e.g.: Do not use in products intended for mucous membranes);
- User category;
- Specific information on the packaging of cosmetic products when needed.
Special Case: Nanomaterials (Article 16)
Nanomaterials are only permitted for use as colorants, preservatives, or UV filters without additional authorization if specified in the regulation. If not, nanomaterials may undergo a separate authorization process to be included in cosmetic products.
Specific Considerations: Fragrances
Fragrances in cosmetics are regulated by the International Fragrance Association (IFRA), which sets concentration limits based on safety assessments by the Research Institute for Fragrance Materials (RIFM). While IFRA Standards are recommended for safety, discrepancies can occur between IFRA and the EU Cosmetic Regulation, particularly with allergenic substances. For example, Lilial is banned in the EU as a CMR 1B substance but only restricted by IFRA.
Allergen Labeling
Allergens are a special case under Annex III of the EU Cosmetic Regulation. Although not always restricted in use, specific allergens must be listed on product labels if their concentration exceeds 0.01% in rinse-off products or 0.001% in leave-on products. This requirement ensures transparency and helps protect consumers from potential allergic reactions.
Final Thoughts: Staying Compliant with Evolving Regulations
The regulation of cosmetic ingredients in Europe is continually evolving, driven largely by the influence of REACH, CLP regulations, and the scientific evaluations of SCCS. As the EU revises its Cosmetic Regulation, manufacturers and stakeholders must stay vigilant, particularly regarding substances like endocrine disruptors, CMRs, and nanomaterials. Keeping abreast of regulatory updates, maintaining clear communication with regulatory professionals, and ensuring ingredient traceability with manufacturers are essential steps to ensure compliance and consumer safety.
_
For more information, contact EcoMundo's experts.
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