Are cosmetic products safe

Requirements for the safety assessment of cosmetic products in the EU and worldwide

1. What is a “cosmetic product” in the sense of the ordinances?

Strictly speaking, a cosmetic product is a substance or preparation that comes into contact with various external skin surfaces of the human body or with the teeth or the mucous membranes in the oral cavity; it is used exclusively or mainly for cleaning, perfuming, changing the appearance or protecting or maintaining their good condition or removing body odors.

The exact products that fall under a “cosmetics” regulation vary from country to country. Sunscreens, for example, belong to cosmetic products according to European regulations, in the USA they are pharmaceutical products.

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

In the EU, the manufacturer is responsible for the safety of his products and must ensure that they undergo a scientific safety assessment by experts before they are sold. The European Commission is also advised by the Scientific Committee on Consumer Safety (SCCS) on issues relating to the safety and allergenic properties of cosmetic products and ingredients.1 managed by the Directorate-General for Health and Consumer Protection (DG HEALTH AND FOOD SAFETY) and informed by independent scientific advice.

3. Which regulations must cosmetic products comply with in Europe?

Cosmetic products in Europe must comply with Regulation (EC) No. 1223/20092 correspond. Dyes, preservatives and UV filters, including those with nanomaterials, must be expressly approved. Appendix II contains a black list of 1,370 substances that are prohibited in cosmetics.

Since most cosmetic products according to the REACH regulation (Regulation (EC) No. 1907/2006 on the registration, evaluation, approval and restriction of chemical substances) also belong to chemical preparations (mixtures), every chemical substance or component, its annual production or Import volume exceeds 1 tonne must be (pre-) registered with the European Chemicals Agency (ECHA).

Substances are considered by the EU Commission as ingredients3 and also by the Scientific Committee on Consumer Safety (SCCS)4 through "opinions" including, for example, the current development and validation of suitable alternative animal testing methods for cosmetics5.

The European Commission is also in contact with cosmetics industry stakeholders in the EU and internationally to facilitate the exchange of information and the smoother implementation of EU requirements in this area6 to ensure.

In particular, the EU regulation requires that:

  • a safety assessment of the finished cosmetic product must be carried out before the product can enter the European market.
  • a complete technical file or product information (PIF) must be available for a cosmetic product including labeling and language requirements.
  • When a cosmetic product is placed on the EU market, the competent authority must be notified.

4. Which cosmetics and ingredients are particularly rated in terms of their safety?

Cosmetics that are of particular concern in the EU include:

  • Hair dye products,
  • Sun protection products, especially in terms of their effectiveness, as exposure to UV radiation is an important public health issue.
  • Teeth whitening products, which are the subject of a separate EU directive.

The ingredients include:

  • Preservatives, including parabens7 and formaldehyde, which are ingredients that are tightly regulated and have the ability to prevent or reduce the growth of microbes in cosmetics and protect cosmetic products from contamination by microorganisms such as bacteria and fungi. Further details can be found in "Level 2"
  • "Nanomaterials", d. H. usually the use of nanoparticles as an ingredient. EU legislation offers a high level of protection for human health when nanomaterials are used in cosmetic products8
  • Some Phthalatesused in cosmetics, such as plasticizers (to keep nail polish pliable), perfume solvents, fixatives and defoamers, are often the subject of scientific publications and the ingredients currently used are considered safe;
  • Substances classified as carcinogenic, mutagenic, or toxic for reproduction. In general, the use of these substances is prohibited, except in exceptional cases.

5. How and why are preservatives such as paraben and formaldehyde used in cosmetic products?

The presence of preservatives in a wide, safe area is one of the major problems in the cosmetics sector.

Preservatives are found in cosmetics to reduce the risk of microbial contamination during storage and use by the customer, and to ensure that the product remains suitable and safe throughout its shelf life. Some work against bacteria but not against fungi, while others may only work against fungi.

Preservatives must therefore be safe, compatible with all ingredients, soluble and well distributed in order to optimize preservation. The goal is to achieve optimal performance with the lowest possible concentration. Preservatives are rigorously assessed, including safety assessments and quality checks, to ensure that they are safe to use.

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

In and of themselves “natural” or “organic” cosmetic products or ingredients are all chemical substances and “natural products”, like any other cosmetic product, must undergo the same level of testing to ensure that they are reasonably safe for the consumer.

The fact that some certification bodies in the European Union advertise their integrated standards as "harmonized European standards" for organic natural cosmetics leads to unfair and misleading information for consumers and to a disruption of the internal market, as there is still no harmonized European standard the criteria for organic natural cosmetics9 certainly. The European Commission and the International Organization for Standardization (ISO) are currently working to establish these standards.

7. How are cosmetic products regulated in the USA?

Key differences between the requirements for cosmetics in the United States and various other countries include the legal requirements for drugs and cosmetics, the restrictions on the use of color additives and other ingredients, and the registration requirements. The Federal Food, Drug and Cosmetics Act (FFDCA, U.S. Federal Food Control, Drugs, and Cosmetics Act) defines cosmetics as "Articles that are intended to be rubbed, poured, sprinkled or sprayed on, inserted into or otherwise applied to the human body ... for the purpose of cleaning, beautifying, enhancing the attractiveness or changing the appearance".

In the United States, some products are regulated as medicines that are cosmetics in Europe, such as sunscreens. There are also differences in terms of prohibited and restricted ingredients, especially color additives.

With the exception of color additives and ingredients whose use in cosmetics is prohibited or restricted by regulations, a manufacturer can use any ingredient in the formulation of a cosmetic product, provided that the use of this ingredient does not otherwise contaminate the cosmetic product10.

The personal care product industry is often considered to be the least regulated industry in the United States. In fact, in the United States, while strongly recommended, cosmetic product registration is a voluntary proposition, while in some other countries cosmetic companies are required to register their companies and report their products and ingredients to the authorities11.

8. How are cosmetic products regulated in other places around the world?

In Australia there has been a mandatory standard for the labeling of ingredients on cosmetic products since 1991, which was last changed in 200812. The standard describes the information that must be on the label and the tests, including a list of ingredients; However, tests are not required.

In Canada, the law prohibits manufacturers from selling cosmetics that contain an ingredient that can cause harm if used according to label directions or under normal use. Health Canada may also take appropriate compliance measures if a product poses a threat to the health or safety of Canadian citizens by reviewing the scientific literature on cosmetic ingredients and information dated Chemicals Management Plan, from the European Union and the USA.

In Brazil it is Agência Nacional de Vigilância Sanitária (ANVISA), the national authority for health surveillance in Brazil, the regulatory authority for the harmonized cosmetics laws that apply to manufacturers, importers and retailers of cosmetics so that these laws, like many other regulations, apply to the entire common market of South America (Mercosur, Mercado Comun del Sur) can be used. In addition, a Technical regulation enacted to establish a list of approved and restricted substances for cosmetic use used in products such as hair dyes and nail hardeners, or as preservatives in products.

Hygienic Standard for Cosmetics

In China, cosmetics and cosmetic ingredients are regulated by a number of laws13. Imported cosmetics are divided into two classes: general cosmetics and special-purpose cosmetics. The one published by the Ministry of Health in 2007 Hygienic Standard for Cosmetics (Cosmetic Hygiene Standard) has banned over 1,200 chemicals in cosmetics and restricted the use of 73 chemicals, 56 preservatives, 156 dyes, 28 sun blockers, and 93 dyes in cosmetics.

In Southeast Asia the Association of Southeast Asian Nations (ASEAN, Association of Southeast Asian Nations) (Brunei Darussalam, Cambodia, Indonesia, Laos People's Democratic Republic, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam) ASEAN Cosmetic Committee (ACC, ASEAN Cosmetics Committee), which coordinates, reviews and monitors the implementation of the ASEAN Cosmetics Directive (ACD)14. According to the ACD, cosmetic retailers must meet a number of requirements in order to bring a product to market.