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The safety assessments requirements of cosmetic products in the EU and worldwide

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Context - Safety assessment of cosmetic products for human health are now required from different cosmetics regulations worldwide.

What do they cover?

This is a faithful synthesis and summary of several scientific consensus reports. For the full list of sources, refer to the references.

  • Source document:EU () / US-FDA ()
  • Summary & Details: GreenFacts
Latest update: 9 February 2018

1. What is a “cosmetic product” when it comes to regulations?

Strictly speaking, a cosmetic product is any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, and/or protecting them or keeping them in good condition, and/or correcting body odours.

The exact products that fall under a “cosmetics” regulation varies between countries. For instance sunscreens are considered cosmetics in European regulations, but drugs in the USA.

2. Who is responsible for the safety of cosmetic products?

In the EU, the manufacturer is responsible for the safety of its products, and must ensure that they undergo an expert scientific safety assessment before they are sold. The European Commission is also advised on issues related to the safety and allergenic properties of cosmetic products and ingredients, by the Scientific Committee on Consumer Safety (SCCS)1 administered by the Directorate-General for Health and Consumer Protection (DG SANTE) informed by independent scientific expertise.

3. To what regulations should cosmetics products comply in Europe?

In Europe, cosmetic products have to comply with the Cosmetic Products Regulation (EC) No 1223/20092. Colorants, preservatives and UV-filters, including those that are nanomaterials, have to be explicitly authorized. In its Annex II a blacklist includes more than 1370 substances banned substances in cosmetics.

Since most of cosmetic products also belong to chemical preparations (mixtures) under REACH regulation (the EU regulation (EC) No 1907/2006 concerning the Registration, Evaluation and Authorization of Chemicals), each chemical substance or ingredient for which the annual production or import volume exceeds 1 ton has to be (pre)registered to the European Chemical Agency (ECHA).

Substances are classified by the EU Commission as ingredients3 and are also reviewed for safety by the EU Scientific Committee on Consumer Products (SCCS)4 via “Opinions”, including for example on the present development and validation of adequate alternative methodologies to the use of animals in safety testing of cosmetics5

The European Commission is also in contact with cosmetics stakeholders at EU and international level, to enable the exchange of information and ensures the smoother implementation of EU requirements in the sector6

The EU regulations require in particular that:

  • A safety assessment of the finished cosmetic product must be performed before the product can be placed on the EU market.
  • A full technical file or product information file (PIF) for a cosmetic product including requirements on labelling and languages must be kept available.
  • Notification must be done to inform the competent authorities that a cosmetic product will be placed on the EU market.

4. What are the cosmetics and ingredients that are particularly evaluated for their safety?

In the EU, cosmetics that are looked at more closely include:

  • Hair dye products,
  • Sunscreen products, particularly regarding their efficacy, since exposure to sun UV radiations is an important public health issue.
  • Tooth whitening products, which are the object of a specific EU Directive.

Among the ingredients:

  • Preservatives, including parabens7 and formaldehyde, which are ingredients that are closely regulated and that have the ability to prevent or decrease microbial growth in a cosmetic and to protect cosmetic products from contamination of microorganisms, like bacteria and fungi. See more details in “Level 2”
  • Nanomaterials”, which usually means the use of nanoparticles as ingredients. The EU legislation provides a high level of protection of human health where nanomaterials are used in cosmetic products8;
  • Some phthalates used in cosmetics as plasticizers (to keep nail polish supple), perfume solvents, fixatives and antifoam ingredients, have been the object of many scientific reviews and those that are currently in use are considered safe ;
  • Substances classified as carcinogenic, mutagenic, or toxic for reproduction. In general, the use of these substances is prohibited, apart from exceptional cases.

5. Why and how are preservatives like paraben and formaldehyde used in cosmetic products?

The availability of preservatives over a wide and safe range is one of the key challenges to the cosmetics sector.

Preservatives are present in cosmetics to reduce the risk of microbial contamination during storage and use by the consumer, and to ensure the product remains suitable and safe during shelf-life. Some may be effective against bacteria and not fungi whereas others may only be effective against fungi.

Preservatives need thus to be safe, compatible with all ingredients, soluble and well-dispersed to optimise preservation. The goal is to use a minimum concentration to obtain optimal efficacy. Preservatives must undergo rigorous evaluation, including safety assessments and quality testing, to ensure that they are safe for use.

6. How are “natural” ingredients in cosmetic products evaluated?

Intrinsically "natural" or "organic" cosmetic products or ingredient are all chemical substances, and “natural products” must undergo, as any other cosmetic product, the same level of testing to ensure that they are adequately safe for the consumer.

The fact that some certification bodies in the European Union advertise their integrated standards as the “European harmonised standard” for natural and organic cosmetics leads to unfair and misleading information for consumers and disruption of the internal market as today there is no such European harmonised standard which sets criteria for natural and organic cosmetics9. There is currently work from the European commission and by the International Organization for Standardization (ISO) to put in place these standards.

7. How are cosmetic products regulated in the US?

Among the important differences between requirements for cosmetics in the United States and various other countries, are the legal definitions of drugs and cosmetics, restrictions on the use of color additives and other ingredients, and registration requirements. The Federal Food, Drug and Cosmetics Act (FFDCA) defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance."

In the United States, some products are regulated as drugs while regulated as cosmetics in Europe, sunscreens are a case in point. There also are differences regarding prohibited and restricted ingredients, particularly color additives.

Except for such color additives and those ingredients that are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the use of the ingredient does not otherwise cause the cosmetic to be adulterated10.

Personal care products are sometimes considered as one of the least regulated industries in the US. As a matter of facts, while some countries may require cosmetic companies to register their establishments and list products and ingredients with the government, in the United States, cosmetic registration is only voluntary even if it is highly recommended11.

8. How are cosmetic products regulated elsewhere worldwide?

In Australia, a mandatory standard for ingredients labelling on cosmetics came into effect in 1991 and was last amended in 200812. The standard prescribes the information requested on the labelling and testing including listing ingredients, but does not require testing.

In Canada, by law, manufacturers cannot sell cosmetics that contain any ingredient that may cause injury when used according to the directions on the label and under normal use. Health Canada can also take appropriate compliance action if a product presents a hazard to the health or safety of Canadians by monitoring scientific literature on cosmetic ingredients, as well as information from the Chemicals Management Plan, from the European Union and the US. Food and Drug Administration (FDA).

In Brazil, the Agência Nacional de Vigilância Sanitária (ANVISA) depending on the Brazilian Health Surveillance Agency is the regulatory body responsible for cosmetic legislation applicable to manufacturers, importers, and retailers of cosmetics that have been harmonized so they can apply, like many other regulations, to the entire Mercosur (Mercado Comun del Sur ). Moreover, a Technical Regulation was set up to establish a list of authorized and restricted substances for cosmetic use, used in products such as hair dyes, nail hardeners, or used as product preservatives.

In China, cosmetics and cosmetic ingredients are regulated by a series of laws13. Imported cosmetics are divided into two classes: ordinary cosmetics and special use cosmetics. The Hygienic Standard for Cosmetics published by the Ministry of Health in 2007 has banned over 1200 chemicals in cosmetics and restricted the use of 73 chemicals, 56 preservatives, 156 colorants, 28 sun block agents and 93 dyes in cosmetics.

In South East Asia, the Association of Southeast Asian Nations (ASEAN) (Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand and Viet Nam) set up the ASEAN Cosmetic Committee (ACC) which coordinates, reviews and monitors the implementation of the ASEAN Cosmetic Directive (ACD)14. Under the ACD, cosmetic dealers are required to comply with a series of requirements in order to market a product.

1 Scientific Committee On Consumer Safety  (SCCS)
2 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Text with EEA relevance)  
3 Classification of substances as ingredients of cosmetic products  
4 List of evaluations on cosmetics by the Scientific Committee on Consumer Products (SCCS) 
5 Opinion concerning present development and validation of adequate alternative methodologies to the use of animals in safety testing of cosmetics 
6 The EU’s role in cosmetics 
7 See also:  Parabens used in cosmetics
8 EU Commission. Use of nanomaterials in cosmetics. 
See also: GreenFacts Highlights of the report Safety of titanium dioxide and zinc oxide nanoparticles in sunscreens
and GreenFacts Highlights of the report: "Is it safe to use cosmetics containing nanoform silica?"
9  Clarification of the absence of European harmonised standard for natural and organic cosmetics
10 US-FDA Guidance for Industry: Safety of Nanomaterials in Cosmetic Products 
11 Cosmetics & U.S. Law  
12 Product Safety Australia - Cosmetics ingredients labelling 
13 CFDA Registration of Imported Cosmetics in China - Hygiene License & Record-keeping Certificate 
14  ASEAN Consumer Information Handbook on Cosmetic Product

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