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Cosmetics

The objective of EU cosmetics legislation is to protect consumers from potential harm while allowing them to enjoy a wide range of cosmetic and personal care products. By imposing safety requirements and promoting responsible manufacturing practices, the legislation aims to ensure that cosmetic products available on the market are safe for use.
Consumers of cosmetic and personal care products are safeguarded by safety requirements outlined in cosmetics legislation.

Manufacturers have the responsibility to ensure the safety of their products before they are made available to the market, using scientific evidence and the latest research data. Certain cosmetic products that are scientifically complex or pose a higher potential risk to consumer health receive special attention from regulators.

The cosmetics legislation establishes a framework for assessing and controlling the safety of cosmetic products. It includes guidelines for ingredient safety, product labeling, and good manufacturing practices. Manufacturers must conduct safety assessments, including evaluating potential risks and ensuring product quality.

Regulators closely monitor the safety and compliance of cosmetic products, conducting inspections and market surveillance activities. They collaborate with industry stakeholders, scientific experts, and consumer organizations to stay informed about emerging risks and scientific developments.

The current EU legislation

Cosmetic legislation encompasses various types of products and addresses specific concerns related to their safety and efficacy. Here are some examples:

1. Hair dye products: The European Commission has implemented a safety assessment strategy for hair dye substances due to safety concerns associated with their use.

2. Sunscreen products: The efficacy and claims of sunscreen products are important for public health. All UV filters used in cosmetic products must undergo assessment by the scientific committee for consumer safety and receive authorization from the Commission.

3. Nanomaterials in cosmetics: The use of insoluble nanoparticles in cosmetic products is referred to as nanotechnology. EU legislation provides stringent protection for human health when nanomaterials are used in cosmetics.

4. Toxic, Carcinogenic, mutagenic, or toxic for reproduction substances (CMR substances): The use of CMR substances in cosmetic products is generally prohibited, except in exceptional cases where strict conditions and restrictions apply.

5. Borderline products: These are products that are challenging to classify into a specific product category, either within a country or across different countries, leading to differences in regulatory frameworks.

6. Preservatives: Preservatives play a crucial role in preventing microbial growth and extending the shelf-life of cosmetic products. They undergo thorough evaluation, including safety assessments and quality testing, to ensure their safety and efficacy.

7. Endocrine disruptors (ED) are chemicals that may interfere with the hormonal system and, as a result of that, produce harmful effects in both humans and wildlife. A wide range of chemicals, both natural and man-made, may cause endocrine disruption.


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Cosmetic ingredient database (from EC website)

CosIng – Glossary of ingredients

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Common cosmetic ingredient names for labelling which have been compiled and updated by the Commission.
CosIng is the European Commission database for information on cosmetic substances and ingredients contained in the
  • Cosmetics Regulation (EC) No 1223/2009EN••• of the European Parliament and of the Council
  • Cosmetics Directive 76/768/EECEN••• (cosmetics directive), as amended
  • Glossary of common ingredient namesEN••• for the purpose of labelling cosmetic products placed on the market (as established by Decision (EU) 2019/701EN••• of 5 April 2019)
  • Opinions on cosmetic ingredients of the Scientific Committee for Consumer Safety (list of SCCS opinions)

CAS, ELINCS or EINECS numbers can be searched for in CosIng.

The database includes all data since the adoption of the Cosmetics Directive in 1976. Current data is listed as 'active', while historical data is listed as 'not active'.

References to scientific opinions of the scientific committee on consumer safety are restricted to those published on the internet.

You can find more information about INCI-names in the Personal Care Products Council website.

Please note that CosIng database has informative purpose and no legal value.

Search in the CosIng database

Important notice
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Please note that ingredient assigned with an INCI name that appears in the inventory section of CosIng does not mean it is to be used in cosmetic products nor approved for such use.
Concerning ingredients used in cosmetic products as colorants, preservatives and UV filters, only those authorised in Annexes IV, V, respectively VI to Cosmetic Regulation No 1223/2009 are listed in CosIng

CosIng may also list ingredients known to be used in medicinal products.
If, due to such ingredients, a product restores, corrects, or modifies physiological functions by exerting a pharmacological, immunological or metabolic action, the product shall be qualified as a medicinal product. However, products that, while having an effect on the human body, do not significantly affect the metabolism and thus do not strictly modify the way in which it functions, may be qualified as cosmetic products.

The qualification of a product is to be decided by the national competent authorities, under the supervision of the courts, on a case-by-case basis, taking into account all the characteristics of the product.
In addition, the use of any ingredient in cosmetic products must be supported by a safety assessment of the product.

​Cosmetic product notification portal

The cosmetic products notification portal (CPNP) is a free of charge online notification system created for the implementation of Regulation (EC) No 1223/2009 on cosmetic products. When a product has been notified in the CPNP, there is no need for any further notification at national level within the EU.

Regulation (EC) No 1223/2009 (Article 13) requires that the responsible persons and, under certain circumstances, the distributors of cosmetic products submit some information about the products they place or make available on the European market through the CPNP.

The CPNP is making this information available electronically to:

  • competent authorities (for the purposes of market surveillance, market analysis, evaluation and consumer information)
  • poison centres or similar bodies established by EU countries (for the purposes of medical treatment)

The CPNP is accessible to:
​
  • competent authorities
  • European poison centres
  • cosmetic products responsible persons
  • distributors of cosmetic products

Products containing nanomaterials

​The CPNP also contains a separate module (Article 16) for cosmetic products containing nanomaterials. This notification has to be done in addition to the notification under Article 13. If the European Commission has concerns regarding the safety of a nanomaterial, it may request the scientific committee on consumer safety to perform a risk assessment.

CPNP user manuals
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  • CPNP manual referring to Article 13 (2 MB)
  • CPNP manual referring to Article 16 (443 kB)

International cooperation

The European Commission engages in bilateral and multilateral cooperation with regulatory authorities from the United States (US), China, and other countries to enhance cooperation and promote regulatory convergence in the field of cosmetics.

U.S.
In bilateral cooperation with the US, the Commission maintains close contact with the US Food and Drug Administration (FDA) and has signed a confidentiality agreement to facilitate information sharing.

CHINA
Similarly, with China, the Commission maintains regular contact with authorities such as the State General Administration for Quality Supervision and Inspection and Quarantine (AQSIQ), the National Health and Family Planning Commission (formerly Ministry of Health, MoH), and the China Food and Drug Administration (CFDA, formerly SFDA). Cooperation frameworks have been established with AQSIQ and CFDA to facilitate collaboration.

MULTILATERAL LEVEL
​On a multilateral level, the Commission, together with regulatory authorities from the US, Canada, Japan, and Brazil, formed the International Cooperation on Cosmetic Regulation (ICCR) network. This network meets annually to discuss regulatory convergence in the cosmetic sector.

Furthermore, the Commission serves as the EU contact point for notifications under the agreement on technical barriers to trade. This agreement requires World Trade Organization (WTO) members to inform other members of proposed technical regulations and conformity assessment procedures, promoting transparency and allowing stakeholders to familiarize themselves with regulatory measures before their adoption.

These cooperative efforts aim to foster international collaboration, harmonize regulations, and ensure the safety and quality of cosmetic products in the global market.

Other International organisations involved on Cosmetics:

  • Council of Europe – cosmetics and consumer health
  • OECD – guidelines on testing of chemicals

Source:  European Union, http://www.europa.eu/, 1998-2023
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