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EU Cosmetic Regulation (EC) No. 1223/2009: 2026 Evolution and the Impact on African Markets

Regulation (EC) No. 1223/2009 is the central legal framework governing cosmetic products within the European Union. Replacing the older Directive 76/768/EEC, this EU regulation ensures a high level of protection for human health and establishes the standards for any cosmetic product on the market. Since its implementation, this regulation establishes a harmonized system where cosmetic products are safe for consumers and can move freely across borders.

As of 2026, Regulation (EC) No. 1223/2009 has continued to evolve through successive amendments to its annexes, reflecting developments in scientific knowledge and consumer safety. These amendments concern, among other areas, fragrance allergens, nanomaterials, substances with potential endocrine-disrupting properties, and substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR). Although the Regulation is directly applicable to cosmetic products placed on the EU market, including products manufactured outside the EU, its requirements also have implications for international manufacturers and exporters, including those in Africa.

1. The Regulatory Framework and Core Obligations

The regulation ensures that cosmetic products in the European Union meet rigorous safety standards. It dictates that every product complies with safety rules before it can be placed on the market. Under this framework, a cosmetic product intended to be placed in contact with the external parts of the human body must fulfill specific functions such as cleaning, perfuming, or protecting.

Structural Requirements and Market Placement

  • The Responsible Person (RP): A designated entity within the EU that ensures the safety of the cosmetic product. The RP is the primary contact for authorities and ensures the cosmetic product is placed on the market only if it follows the rules laid down in this regulation.
  • The Product Information File (PIF): This dossier includes a detailed description of the cosmetic product and the composition of the cosmetic product, including the quantitative composition of the cosmetic ingredients. It must be kept for ten years after the last batch of the cosmetic product is sold.
  • Safety Assessment: Article 3 requires that cosmetic products in the EU must be safe under normal or reasonably foreseeable conditions of use. A qualified safety assessor must evaluate the safety of a cosmetic product, documenting it in a Cosmetic Product Safety Report (CPSR).
  • Notification: The RP must ensure the cosmetic product is made available only after it has been notified via the Cosmetic Products Notification Portal (CPNP). This applies to all products that have been notified before they reach the consumer.

2. 2026 Technical Updates and Ingredient Restrictions

Between 2023 and 2026, the European Commission addressed the non-essential elements of this regulation by adapting the annexes to scientific progress. These updates are mandatory for cosmetic products and influence the safety of finished cosmetic products.

Recent Key Amendments:

  • Fragrance Allergens – Regulation (EU) 2023/1545: This amendment significantly expanded the list of fragrance allergens subject to individual labelling requirements. It introduced additional substances that must be declared in the list of ingredients when present above the specified concentration thresholds. Transitional periods were provided to allow manufacturers to adapt their formulations and packaging (European Commission, 2023).
  • Nanomaterials – Regulation (EU) 2024/858: This amendment introduced restrictions on the use of certain nanomaterials in cosmetic products following scientific safety assessments. It amended the relevant annexes of Regulation (EC) No. 1223/2009 for a number of specific substances (European Commission, 2024a).
  • Vitamin A, Alpha-Arbutin and Arbutin – Regulation (EU) 2024/996: This amendment introduced specific concentration limits and conditions of use for Vitamin A derivatives, Alpha-Arbutin and Arbutin, together with restrictions concerning certain substances with potential endocrine-disrupting properties (European Commission, 2024b).
  • CMR Substances – Regulation (EU) 2026/78: The EU continues to update the cosmetics framework in response to the classification of substances as carcinogenic, mutagenic, or toxic for reproduction. Regulation (EU) 2026/78 amended several annexes of Regulation 1223/2009 concerning the use of such substances in cosmetic products (European Commission, 2026a).
  • Further Ingredient-Specific Controls – Regulation (EU) 2026/909: Adopted in April 2026, this amendment introduced or modified restrictions and conditions of use for several substances, including Benzyl Salicylate, Triphenyl Phosphate, Aluminium, Citral, and several hair-dye substances (European Commission, 2026b).

3. Impact on African Markets and Manufacturers

Regulation (EC) No. 1223/2009 is not directly applicable to African countries. However, it becomes legally relevant for African manufacturers when their cosmetic products are intended to be placed on the EU market. In this case, products manufactured outside the EU must comply with the requirements of the Regulation, including safety assessment, responsible person requirements, product information, labelling, ingredient restrictions, and notification requirements (European Parliament and Council of the European Union, 2009).

Market Access and Export Requirements

African manufacturers seeking to place cosmetic products on the EU market must comply with Regulation (EC) No. 1223/2009. For imported cosmetic products, an EU-based Responsible Person must be designated, and the product must comply with the Regulation’s requirements concerning safety, documentation, labelling, ingredients and notification.

The Regulation also establishes specific requirements concerning product durability and labelling. Where the minimum durability is 30 months or less, the date of minimum durability must be indicated. Where the minimum durability exceeds 30 months, the Period After Opening (PAO) indication is required when relevant, in accordance with Article 19 of the Regulation (European Parliament and Council of the European Union, 2009).

Regulatory Influence and Benchmarking

Although African countries are not legally required to adopt Regulation 1223/2009 for products sold in their domestic markets, the EU framework can serve as an important international reference point for cosmetic safety and regulatory practices. This influence is particularly relevant for African companies operating internationally or seeking access to the European market.

African countries nevertheless maintain their own national and regional regulatory frameworks. For example, Algeria regulates cosmetic and personal-hygiene products through its national legislation, including provisions concerning prohibited and restricted substances and substances permitted for use in cosmetics. South Africa regulates cosmetics under the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 (Republic of Algeria, 2010; Republic of South Africa, 1972).

The comparison with the EU should therefore be understood as a matter of regulatory benchmarking rather than direct legal harmonisation.

Regional Harmonization and Intra-African Trade

Regulatory fragmentation remains an important challenge for the African cosmetics industry. Unlike the EU, Africa does not currently have a single continental cosmetics regulation equivalent to Regulation (EC) No. 1223/2009. Differences between national and regional regulatory frameworks can increase compliance costs and create barriers to intra-African trade.

The African Organisation for Standardisation (ARSO), with support from the Standards Alliance, has been working towards greater harmonisation of standards for cosmetics and personal-care products in Africa. These initiatives aim to reduce regulatory barriers and facilitate trade while strengthening consumer protection (Standards Alliance/ARSO, n.d.).

The EU experience therefore provides a useful comparative example of regulatory harmonisation, while African initiatives seek to develop approaches adapted to the continent’s own regulatory and economic context.

4. Science, Safety, and Animal Testing

The EU cosmetics framework has progressively established restrictions on animal testing for cosmetic products and their ingredients. Under Article 18 of Regulation (EC) No. 1223/2009, animal testing for cosmetic products and cosmetic ingredients is subject to specific prohibitions and restrictions, including a marketing ban for products tested on animals to meet the requirements of the Regulation.

Consequently, cosmetic safety assessment increasingly relies on alternative approaches, including in vitro, in silico, and other New Approach Methodologies (NAMs). The development of these approaches is closely linked to the EU’s objective of ensuring consumer safety while reducing reliance on animal testing (Rogiers et al., 2020; Safety Testing of Cosmetic Products, 2021).

The safety assessment must consider the toxicological profile of the ingredients, the level and type of exposure, the intended use of the cosmetic product, and other relevant safety information. The safety assessor must evaluate the product in accordance with the requirements of Annex I, which establishes the content of the Cosmetic Product Safety Report (CPSR). Scientific evidence must also support cosmetic claims where required under the EU framework (European Parliament and Council of the European Union, 2009; Nohynek et al., 2010; Arnesdotter et al., 2021).

Conclusion

Regulation (EC) No. 1223/2009 remains the cornerstone of the European regulatory framework for cosmetic products and continues to evolve in response to scientific evidence, technological developments, and emerging consumer safety concerns. Recent amendments concerning fragrance allergens, nanomaterials, Vitamin A and arbutins, CMR substances and other cosmetic ingredients demonstrate the dynamic nature of the EU regulatory system.

For African manufacturers, the Regulation is particularly relevant when cosmetic products are intended for the EU market, where compliance with European safety, documentation, ingredient, labelling and notification requirements is mandatory. However, Regulation 1223/2009 does not constitute a general regulatory framework for African countries, which maintain their own national and regional systems.

At the same time, the EU framework provides an important international reference point for cosmetic safety and regulatory practices. In Africa, ongoing efforts towards greater harmonisation of cosmetics standards, particularly through ARSO initiatives, highlight the importance of developing regulatory systems that can facilitate intra-African trade while ensuring consumer protection. The evolution of Regulation 1223/2009 therefore illustrates a broader transformation in cosmetic regulation: from a relatively static system of ingredient control towards a dynamic, science-based framework combining product safety, regulatory responsibility, scientific assessment, transparency and continuous adaptation. For the African cosmetics industry, understanding these developments is increasingly important both for accessing international markets and for contributing to the development of stronger and more harmonised regulatory frameworks across the continent.

Regulatory and Official Sources

  1. European Parliament and Council of the European Union. (2009). Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Official Journal of the European Union, L 342, 59–209.
  2. European Commission. (2023). Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in cosmetic products. Official Journal of the European Union, L 188, 1–23.
  3. European Commission. (2024). Commission Regulation (EU) 2024/858 of 14 March 2024 amending Regulation (EC) No 1223/2009 as regards the use of certain nanomaterials in cosmetic products. Official Journal of the European Union.
  4. European Commission. (2024). Commission Regulation (EU) 2024/996 of 3 April 2024 amending Regulation (EC) No 1223/2009 as regards the use of Vitamin A, Alpha-Arbutin and Arbutin and certain substances with potential endocrine disrupting properties in cosmetic products. Official Journal of the European Union.
  5. European Commission. (2026). Commission Regulation (EU) 2026/78 of 12 January 2026 amending Regulation (EC) No 1223/2009 as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction. Official Journal of the European Union.
  6. European Commission. (2026). Commission Regulation (EU) 2026/909 of 27 April 2026 amending Regulation (EC) No 1223/2009 as regards the use of Benzyl Salicylate, Triphenyl Phosphate, Ammonium Silver Zinc Aluminium Silicate, Aluminium, water-soluble zinc salts, Acetylated Vetiver Oil, Citral, HC Blue No. 18, HC Red No. 18, HC Yellow No. 16, Hydroxypropyl-p-phenylenediamine and its dihydrochloride salt, and DHHB in cosmetic products. Official Journal of the European Union.
  7. European Commission. (n.d.). Cosmetics – Legislation and regulatory framework. Directorate-General for Health and Food Safety.
  8. European Commission. (n.d.). Cosmetic Product Notification Portal (CPNP).
  9. Council of the European Communities. (1976). Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. Official Journal of the European Communities, L 262, 169–200.

African Regulatory and Harmonisation Sources

  1. African Organisation for Standardisation (ARSO) / Standards Alliance. (n.d.). Support for the African Organisation for Standardisation (ARSO): Harmonisation of cosmetics and personal-care-product standards in Africa.
  2. Republic of Algeria. (2010). Décret exécutif n° 10-114 du 18 avril 2010 modifiant et complétant le décret exécutif n° 97-37 du 14 janvier 1997 définissant les conditions et modalités de fabrication, de conditionnement, d’importation et de commercialisation sur le marché national des produits cosmétiques et d’hygiène corporelle. Journal officiel de la République algérienne démocratique et populaire.
  3. Republic of South Africa. (1972). Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972.

Academic Sources

  1. Nohynek, G. J., Antignac, E., Re, T., & Toutain, H. (2010). Safety assessment of personal care products/cosmetics and their ingredients. Toxicology and Applied Pharmacology, 243(2), 239–259. https://doi.org/10.1016/j.taap.2009.12.001
  2. Pauwels, M., & Rogiers, V. (2010). Human health safety evaluation of cosmetics in the EU: A legally imposed challenge to science. Toxicology and Applied Pharmacology, 243(2), 260–274. https://doi.org/10.1016/j.taap.2009.12.007
  3. Rogiers, V., Dréno, B., Picceri, G. G., Almeida, L. M., Fink, D., Garcia-Bilbao, A., Mavon, A., et al. (2020). The way forward for assessing the human health safety of cosmetics in the EU – Workshop proceedings. Toxicology, 436, 152421. https://doi.org/10.1016/j.tox.2020.152421
  4. Arnesdotter, E., Rogiers, V., Vanhaecke, T., & Vinken, M. (2021). An overview of current practices for regulatory risk assessment with lessons learnt from cosmetics in the European Union. Critical Reviews in Toxicology, 51(5), 395–417. https://doi.org/10.1080/10408444.2021.1931027
  5. Daly, P., & Moran, G. (2015). Safety assessment of a novel active ingredient, acetyl aspartic acid, according to the EU Cosmetics Regulation and the Scientific Committee on Consumer Safety guidelines. International Journal of Cosmetic Science, 37(Suppl. 1), 21–27. https://doi.org/10.1111/ics.12257
  6. Lores, M., Llompart, M., Alvarez-Rivera, G., Guerra, E., Vila, M., Celeiro, M., Lamas, J. P., & Garcia-Jares, C. (2016). Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls – A review. Analytica Chimica Acta, 915, 1–26. https://doi.org/10.1016/j.aca.2016.02.033
  7. Bialas, I., Zelent-Kraciuk, S., & Jurowski, K. (2023). The Skin Sensitisation of Cosmetic Ingredients: Review of Actual Regulatory Status. Toxics, 11(4), 392. https://doi.org/10.3390/toxics11040392
  8. Safety Testing of Cosmetic Products: Overview of Established Methods and New Approach Methodologies (NAMs). (2021). Cosmetics, 8(2), 50. https://doi.org/10.3390/cosmetics8020050

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