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

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.

    Cosmetics range from everyday hygiene products such as soap, shampoo, deodorant, and toothpaste to luxury beauty items including perfumes and makeup.

    2. Are cosmetic products submitted to safety assessments?

      In the EU, cosmetic safety assessments should be conducted according to various regulations1 while in the US they are regulated by the Food and Drug Administration (FDA)2,3, and in Asia according to the ASEAN Cosmetics Directive4. Cosmetic products should also be labelled and packaged according to the listing and warnings of the International Nomenclature for Cosmetic Ingredients (INCI).

      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 by the Scientific Committee on Consumer Safety (SCCS) administered by the Directorate-General for Health and Consumer Protection (DG SANTE) and on issues related to the safety and allergenic properties of cosmetic products and ingredients provided by independent scientific expertise.


      3. Where can factual information on cosmetic ingredients be found?

        A special database with information on cosmetic substances and ingredients, called CosIng5, enables easy access to data on these substances, including legal requirements and restrictions including all data since the adoption of the Cosmetics Directive in 1976. Cosing may also list ingredients known to be used in medicinal products.


        4. Are some cosmetic products particularly evaluated for their safety?

          In view of safety concerns in relation to the use of hair dye products, the European Commission put in place an overall safety assessment strategy for hair dye substances.

          Regarding the efficacy of sunscreen products and the basis on which such efficacy is claimed are important public health issues, all UV filters used in cosmetic products placed on the EU market have to be assessed by the Scientific Committee for Consumer Safety and authorised by the Commission.

          Regarding more particularly the safety of titanium dioxide and zinc oxide nanoparticles in sunscreens, GreenFacts has published the Highlights of a report on the subject. For cosmetic products, reference to nanomaterials or “nanotechnology” 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 products.

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

            The availability of preservatives over a wide and safe range is one of the key challenges to the cosmetics sector6. Preservatives are ingredients/ substances that have the ability to prevent or decrease microbial growth in a cosmetic, and protect cosmetic products from contamination of microorganisms like bacteria and fungi. Preservatives are thus 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-life7.

            The problem is that many cosmetic products such as creams and lotions, mascara or liquid eye liner are water-based and are typically stored and used at room temperature in moist and humid household environments (e.g. bathroom), which increases the possibility of contamination.

            Furthermore, microorganisms can also be introduced into products that are used repeatedly by consumers during application. Without preservatives, cosmetics would thus have a very limited shelf-life, would spoil quickly, or at a minimum, would need to be stored in refrigerators or be packaged in single-use applications. 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. The determination of safety of the preservative begins with the supplier of the preservative and this extends throughout the development and life cycle of the product. Preservative ingredients differ widely as per the range of microorganisms they are able to control; 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.

            For cosmetic products preservatives, the legislation of the European Commission can be found on their website.


            6. What about the safety of paraben and formaldehyde used as preservatives in cosmetics?

              Parabens are used as preservatives in many cosmetic and personal care products, including make-up, moisturizers, hair care products and shaving products. They are generally used at concentrations of 0.3% or less.

              All commercially used parabens are synthetically produced, although some parabens also occur naturally as preservatives in certain fruits (for example, blueberries and carrots).

              Parabens have been found to weakly mimic estrogens in animal studies9. While this raises a concern because of the link between estrogens and breast cancer, there are many questions and conflicting scientific studies about the effects of low level estrogen in humans. In 2012, the Canadian Health Panel reaffirmed the safety of parabens as preservatives in the present practices of use and concentration in cosmetics. Currently, there is no evidence to suggest a causal link between parabens and breast cancer

              In the EU, in a review of 2013 of the most up-to-date scientific information, the Scientific Committee on Consumer Safety (SCCS) confirmed that for the smaller paraben molecules (methyl-and ethyl paraben)10, the concentration levels specified in the Cosmetics Directive are still considered safe for human health, and for the longer paraben molecules (propyl- and butyl paraben) the SCCS confirmed its previous recommendation to lower the limit to a maximum total concentration of 0.19%11.

              In 2014, the EU Commission banned five parabens and further limited the maximum concentration of propyl-paraben and butyl-paraben to 0.14%, when used individually or together12. Furthermore, these two preservatives are being banned from leave-on products designed for the nappy area of young children below the age of three. Indeed, the Commission explains, “existing skin irritation and occlusion may allow increased penetration than intact skin.

              However, the European Commissioner for Consumer Policy also reiterated the important role of preservatives for the safety of consumers. “Preservatives in cosmetics serve a valuable function ensuring that the products we use on a daily basis are free from pathogens. We need however to ensure that the preservatives guarantee the maximum degree of protection."

              The U.S. Food and Drug Administration (U.S. FDA) continues to review published studies on the safety of parabens. By November 2017, it had no information showing that parabens as they are used in cosmetics have an effect on human health13.

              Formaldehyde-containing ingredients also are used in small amounts in hair and skin cosmetics to maintain the integrity of the product and prevent growth of microorganisms by slowly releasing very small amounts of formaldehyde to act as a preservative for the product or as a denaturant in the case of hair straightening products. Formaldehyde use has declined in recent years.

              Formaldehyde is produced industrially but also occurs naturally in fruits and some foods. As well, it is formed endogenously in humans as a normal result of metabolism.

              When inhaled at high levels, however, formaldehyde is anticipated to be a human carcinogen. Health Canada considers however formaldehyde to be safe when used in small concentrations on the skin and is permitted at a concentration of 5% or less in nail hardeners but should carry cautionary labels and directions for safe use to indicate the potential to cause skin sensitivity. Formaldehyde is also permitted in oral cosmetics at a concentration of 0.1% or less and at a concentration of 0.2% or less in non-oral cosmetics as a preservative only, the lowest possible amounts that still have an effective anti-microbial effect. However, because formaldehyde may cause sensitivity in some individuals, Health Canada concluded that due to inhalation hazards, formaldehyde is not permitted in aerosol cosmetics.

              12 Commission regulation (EU) No 1004/2014 of the European Parliament and of the Council on cosmetic products 

              7. How is the safety of tooth whitening products ensured?

                A specific directive on tooth whitening products which strengthens consumer protection with respect to these products in Europe was also adopted14. The European Cosmetics Directive only fixed a maximum authorized concentration of hydrogen peroxide – the main active ingredient in tooth whitening or bleaching products – at the level of 0.1%, while in reality tooth whitening or bleaching products widely contained levels of hydrogen peroxide higher than this maximum authorised concentration.

                According to the level of hydrogen peroxide in line with the advice from the European Scientific Committee on Consumer Safety, tooth whitening or bleaching products containing up to 0.1% hydrogen peroxide continue to be freely available to consumers on the market but products containing concentrations higher than 0.1% and up to 6% will only be sold to dentists. Products containing more than 6% are banned and persons under 18 years of age are not allowed to use these products, even under the supervision of a dentist.


                8. Are phthalates used in cosmetic products safe?

                  Regarding phthalates used in cosmetics as plasticizers (to keep nail polish supple), perfume solvents, fixatives and antifoam ingredients, many scientific reviews in Canada, the U.S. and the E.U. have shown that the phthalates most commonly used in cosmetics (diethyl phthalate - DEP – and, to a lesser extent, dibutyl phthalate - DBP–) are safe at the levels at which they are currently used in cosmetics. Available studies looked at the typical routes of exposure through normal use of cosmetics (skin absorption and inhalation).

                  In 2007, in the European Union the Scientific Committee on Consumer Products published its opinion on phthalates in cosmetic products15. While DEP in cosmetics was found to be safe at current levels of use, DBP was prohibited for use in cosmetic products.

                  In 2011, the Government of Canada published a study on concentrations and possible dermal exposure of phthalates in cosmetics and personal care products, in which it concluded: “that only DEP and DBP are present in significant quantity in cosmetic products. The overall exposure to phthalates from the use of cosmetic and personal care products was low and therefore unlikely to pose health risks to Canadian consumers”.

                  In 2012, the U.S. Cosmetic Ingredient Review Expert Panel reaffirmed its original safety assessment, stating that DBP and DEP are “safe as used” in cosmetics.

                  In 2013, the European Chemicals Agency (ECHA) concluded in its final report that no further risks were identified for other sources of exposure, taking into account the combined exposure to DINP and DIDP and therefore no additional risk management measures are needed to reduce the exposure of children and adults to DINP and DIDP.

                  9. How are natural cosmetic ingredients evaluated?

                    "Natural" or "organic" cosmetic products are not different and must undergo the same level of testing to ensure that they are adequately preserved and safe for the consumer as any other cosmetic product.

                    While some European certification bodies advertise their integrated standards as the European harmonised standard for natural and organic cosmetics, this leads to unfair and misleading information for consumers and disruption of the internal market as today there is no European harmonised standard which sets criteria for natural and organic cosmetics16.

                    This practice Is the topic of a working group established in 2010 by the DG Health and Consumers (DG SANCO, now DG SANTE), which agreed that its first objective was to develop common general criteria for all types of claims used with respect to cosmetic products, including natural and organic claims. Once general criteria established, the group will consider whether more specific criteria are necessary for natural and organic claims.

                    As a standard of the International Organization for Standardization (ISO) for natural and organic cosmetics was also developed, the group will take into account the progress on the future ISO standard and will consider whether or not to develop EU specific criteria for natural and organic claims.

                    Regarding some natural substances, the Scientific Committee on Consumer Safety (SCCS) of the EU Commission had already indicated in its opinion of 2012 that HICC, atranol and chloroatranol17, which are natural components of oak tree moss (Evernia prunastri) and treemoss (Evernia furfuracea) extracts, caused the highest number of contact allergies cases in past years and consequently, since there is a potential risk to human health, those substances should be prohibited in cosmetic products. From August 2019 cosmetic products containing one or more of these substances shall not be placed on the European Union market18.

                    17 3- and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC), with the INCI name of Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, 2,6-Dihydroxy-4-methyl-benzaldehyde (atranol) and 3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde (chloroatranol)

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

                      In Europe, cosmetic products suppliers (manufacturers/importers/exporters) who would like to put cosmetic products on the EU market have to comply with the Cosmetic Products Regulation of 2009 (EC) No 1223/200919. Colorants, preservatives and UV-filters, including those that are nanomaterials, have to be explicitly authorized.

                      A new EU regulation, enforced in 2013, included harmonized notifications, clearer provisions for the content and format of product safety assessments and product information files (PIF) and strengthened coordinated efforts of market surveillance activities among competent authorities of member states.

                      It has also taken into consideration some of the latest technological developments, including the possible use of nanomaterials. For example, nanomaterials in the cosmetic products must be mentioned on the list of ingredients on the packaging, with the names of such ingredients followed by the word “nano” in brackets20.

                      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 has to be (pre)registered with the European Chemical Agency (ECHA) if the annual production volume of the substance exceeds 1 ton.

                      EU manufacturers and importers of cosmetic products may be required to apply for prior authorization for the use of so-called “substances of very high concern” in their products and non-EU companies may appoint a “REACH only representative” to submit their pre-registration/registrations.

                      Ingredients are also reviewed for safety by the EU Scientific Committee on Consumer Products (SCCS)21 including for example an Opinion concerning present development and validation of adequate alternative methodologies to the use of animals in safety testing of cosmetics22.

                      Globally, a cooperation of the European Commission with various cosmetics stakeholders at international level enables the exchange of information and ensures the smooth implementation of EU requirements in the sector23. The Commission is for example in close contact with the US Food and Drug Administration (FDA) and with Chinese authorities, in particular the China Food and Drug Administration (CFDA), the Ministry of Health, Labour and Welfare of Japan or the Brazil National Sanitary Agency (ANVISA).


                      11. What are the main requirements of the EU Regulations?

                        The EU Regulations require in particular that:

                        • A safety assessment of the finished cosmetic product must be performed before it can be placed on the EU market. If a product which complies with the requirements of the Regulation presents or could present a serious risk to human health, the competent national authority has to take all necessary provisional measures to withdraw, recall or restrict the availability of this product on the market ;
                        • A full technical file or product information file (PIF) for a cosmetic product including requirements on labelling and languages must be kept available for inspection by authorities and include the following information:
                          • qualitative and quantitative composition of the product;
                          • the physico-chemical and microbiological specifications of the raw materials and the finished product;
                          • the method of manufacture complying with GMP;
                          • assessment of the safety for human health of the finished product etc.;

                        Notification must be done to inform the competent authorities that a cosmetic product will be placed on the EU market and non-EU companies who place EU cosmetic products on EU market shall appoint a "Responsible Person" in EU to keep safety assessment report and PIF available, and to submit pre-market notification to competent authorities.

                        12. What are the EU requirements regarding the labelling of cosmetic products?

                          Regarding labelling requirements, containers or packaging must bear information in indelible, easily legible and visible lettering including:

                          • the name or registered name and the address of the responsible person;
                          • the country of origin for imported products;
                          • the weight or volume of the content at the time of packaging;
                          • the list of ingredients, i.e. any substance or mixture intentionally used in the product during the process of manufacturing;
                          • a use-by date for products kept in appropriate conditions;
                          • precautions for use, including for cosmetics for professional use;
                          • the batch number of manufacture or the reference for identifying the cosmetic product.

                          Cosmetics legislation also contains provisions on the use in cosmetic products of substances classified as carcinogenic, mutagenic, or toxic for reproduction. In general, the use of these substances is prohibited, apart from exceptional cases.

                          Sometimes it may be unclear whether a particular product is a cosmetic product under cosmetics legislation or whether it falls under other sectorial legislation. In the case of these “borderline products”, the decision on a product’s classification must be taken on a case-by-case basis. The European Commission has published guidance documents to facilitate the application of EU legislation in these cases24

                          13. How are cosmetic products regulated in the US?

                            In the US, 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." Except for 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 adulterated25.

                            While the FFDCA includes 112 pages of standards for food and drugs, there is just a single page for cosmetics and it does not subject cosmetics or cosmetic ingredients (with the exception of color additives) to Food and Drug Administration (FDA) premarket approval in order to be marketed legally. Personal care products are thus sometimes considered as one of the least regulated industries in the US.

                            Because product filings and establishment registrations are not mandatory, voluntary submissions provide the FDA with the best information available about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution. Then the FDA uses the information made available to evaluate cosmetic products on the market.

                            Anyway, the FDA produced a guidance document “intended to assist industry and other stakeholders in identifying the potential safety issues of nanomaterials in cosmetic products and developing a framework for evaluating them” and provides contact information for manufacturers and sponsors “who wish to discuss safety considerations regarding the use of specific nanomaterials in cosmetic products with FDA”.

                            Regarding more specifically nanomaterials used in cosmetics, a Task Force recommended in 2007 to issue guidance describing safety issues that manufacturers should consider to ensure that cosmetic products made with nanomaterials are safe and not adulterated even if FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale,” or other related terms17.

                            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.

                            For instance, some products regulated as cosmetics in Europe are regulated as drugs in the United States. Sunscreens are a case in point. There also are differences regarding prohibited and restricted ingredients, particularly color additives. 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 but it is highly recommended26.


                            14. What about the cosmetic products regulations elsewhere worldwide?

                              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 take appropriate compliance action if a product presents a hazard to the health or safety of Canadians, among others by monitoring scientific literature on cosmetic ingredients, as well as information from the Chemicals Management Plan, the European Union and United States FDA.

                              To determine if an ingredient is safe for use in cosmetics, Health Canada applies evidence-based decision making, and focuses on reducing any risks to consumers if an ingredient poses a hazard27. Health Canada scientists apply the principles of risk assessment, which means that they look carefully at both the toxicological characteristics of the ingredients of a product, as well as how consumers are exposed to those ingredients. Under these principles, a particular ingredient can be considered hazardous, but safe at low doses, because exposure is low.

                              In Australia, a mandatory standard for ingredients labelling on cosmetics came into effect in 1991 and was last amended in 200828. The standard prescribes the information requested on the labelling and testing including labelling, listing ingredients, but does not require testing.

                              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 laws among which the Regulations concerning the hygiene supervision over cosmetics (1990), the Detailed Rules for the Implementation of the Regulation on the Hygiene Supervision over Cosmetics (2005), the Guideline for Risk Evaluation of Substances with Possibility of Safety Risk in Cosmetics (2010) and the Guideline for the Registration and Evaluation of New Cosmetic Ingredient (2011)29.

                              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.

                              Before companies apply for hygiene license or record-keeping certificate, companies shall make sure their formula meets this hygienic standard and also check if there is any new ingredient in their product that is not currently listed on the Inventory of Existing Cosmetic Ingredients in China (IECIC).

                              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) composed of the ASEAN National Cosmetic Regulatory Authorities and the ASEAN Cosmetic Association which coordinates, reviews and monitors the implementation of the ASEAN Cosmetic Directive (ACD)30.

                              Under the ACD, cosmetic dealers are required to comply with a series of requirements in order to market a cosmetic product in ASEAN including:

                              • Notify NRA of the products they intend to sell before making them available for sale, and ensure that the products sold are manufactured according to ASEAN Guidelines for Cosmetics Good Manufacturing Practice;
                              • Ensure that their products do not contain any prohibited substances which can cause health risk, and that only permitted colourants, preservatives and UV filters are used and ensure that restricted ingredients are used within the allowed limits and conditions of use;
                              • Keep a Product Information File (PIF) on each cosmetic product they place in the market containing important information such as product’s ingredients and data on product’s safety as well as side- effects;
                              • Label clearly key information reflecting the product’s name, ingredients, country of manufacture and expiry date (if the product has a durability of less than 30 months) or manufacturing date.

                              27 To know the essential difference between the notions of hazard and risk, watch the small animation video :  
                              29 CFDA Registration of Imported Cosmetics in China - Hygiene License & Record-keeping Certificate 

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