Europe is the largest market for personal care and cosmetic products in the world, valued at €76.7 billion at retail sales price in 2020, according to the Cosmetics Europe, a trade association for the cosmetics and personal care industry[1]. The vast majority of Europe’s 500 million consumers use cosmetic and personal care products every day, says the association. Whether soap, shampoo, toothpaste, or perfumes and makeup, cosmetics is an important sector that provides significant employment in Europe. This has attracted many international investors and cosmetics companies, especially those from the United States, to enter the EU market.
Europe is also one of the most advanced markets with a long history of regulation and enforcement on cosmetic production, labeling and advertising. Regulatory bodies in the EU have set out rules and a regulatory framework for market access, international trade relations, and regulatory convergence aiming to “ensure the highest level of consumer safety while promoting the innovation and the competitiveness of this sector.[2]” Hazardous substances or ingredients that may have an adverse effect on human health have been banned to be used in cosmetic products in the EU.
This makes it difficult for international companies, especially American companies, to sell cosmetic products in the region, because some cosmetic ingredients are banned in Europe but still being used in the US due to the different regulations in two regions. Compliance issues start to take hold and hinder the commercial success of US cosmetics companies that are trying to expand their presence in the EU. This article aims to provide insights for these companies by discussing the following topics:
- What is EU regulation on cosmetic ingredients?
- Which cosmetic ingredients are banned in the EU but not in the US?
- How does the regulatory difference affect US cosmetics companies?
- What should US cosmetics companies do to enter the EU market?
- Create a path-to-market strategy with RegASK
What is EU regulation on cosmetic ingredients?
The main regulatory framework for cosmetic products in the EU market is set out by Regulation (EC) No 1223/2009[3]. It contains specific regulations on product safety, responsible persons and their obligations, product notification, allowed and prohibited cosmetic ingredients, among other topic areas[4].
There is a special database called CosIng, which allows companies to search for common ingredient names used for the labeling of cosmetic products[5]. Listing in the CosIng database does not automatically grant authorization of the ingredient to be used in cosmetic products. Cosmetic manufacturers are required
to conduct a product safety assessment for the use of any ingredient in cosmetic products, to ensure that their products on the market are safe for human health and the environment[6]. Manufacturers are also required to submit their products’ information via the EU cosmetic products notification portal (CPNP) prior to placing their products on the EU market[7].
These regulatory requirements, along with other applicable EU legislation ensure that all cosmetics on the market are safe and suitable for human use, and protect consumers from risks such as allergic reactions, skin sensitization, and toxicity.
Which cosmetic ingredients are banned in the EU but not in the US?
From cancer or heart disease to inflammatory bowel disease and asthma, many cases are being traced back to the cluster of conditions responsible for illnesses and deaths related to toxic chemicals. In the US, at least 64 people have died from acute exposure to methylene chloride since 1980, the ingredient has been used in aerosol cosmetic products (principally hair sprays)[8].
Both the US and the EU have their own regulatory system in place to govern the world of cosmetics. Although both systems impose restrictions, there are some differences between them. In this section, we try to shed light on the differences between the two regulatory systems, by diving into the list of cosmetic ingredients banned in the two regions.
The Regulation (EC) No 1223/2009 has banned over 1,600 ingredients for use in cosmetics, even though 80% of them have not been used and never would be used as cosmetic ingredients[9]. There are nine commonly used ingredients that are already banned in the EU due to high health risks but still allowed in the US:
- Formaldehyde
- Hydroquinone
- Triclosan
- Lead
- Parabens
- Petroleum Distillates
- Phthalates
- Selenium Sulfide
- Quaternium-15
US FDA, however, only prohibits or restricts 11 ingredients that are harmful to human health[10]:
- Bithionol
- Chlorofluorocarbon propellants
- Chloroform
- Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide)
- Hexachlorophene
- Mercury compounds
- Methylene chloride
- Prohibited cattle materials
- Sunscreens in cosmetics (subject to product’s labeling)
- Vinyl chloride
- Zirconium-containing complexes
When it comes to the approval of chemicals used in cosmetics, the EU established the REACH regulation (Registration, Evaluation, Authorization and Restriction of Chemicals) which contains procedures for collecting and assessing information on the properties and hazards of substances. Manufacturers, importers and downstream users of chemicals are required to register their substances for hazard assessment by the European Chemicals Agency (ECHA). Hazardous substances that pose unmanageable risks to human health or to the environment will be banned or restricted[11].
In the US, however, “there are currently no legal requirements for any cosmetic manufacturer marketing products to American consumers to test their products for safety,” according to a statement from FDA Commissioner Scott Gottlieb, and Susan Mayne, director of the Center for Food Safety and Applied Nutrition[12]. “Ultimately a cosmetic manufacturer can decide if they’d like to test their product for safety and register it with the FDA.”
Read further on this topic on our dedicated blog post for banned ingredients in Europe.
Contact us to know more about cosmetic ingredients regulationsHow does the regulatory difference affect US cosmetics companies?
The EU has stricter cosmetic regulations than the US, which creates challenges for US manufacturers who want to sell cosmetics and personal care products in Europe. This section will explore the impacts of the EU’s cosmetic ingredients ban on US beauty brands.
The first consequence of this ban would be a limited number of US cosmetic products available to European consumers. This is because US manufacturers will no longer be able to sell their products across Europe if they contain any of the ingredients prohibited by the European Commission.
Second, there will be potential low demand for US cosmetics and personal care products among European consumers due to safety concerns. As consumers become more knowledgeable and cautious of what they purchase, they are also increasingly worried about the toxicity of the products they will consume. Some European consumers are likely to be skeptical about US brands due to the different regulatory regimes, even though there has been no evidence that American-produced cosmetics are unsafe.
Following the low demand, US cosmetics companies will be forced to lower product prices and increase advertising expenditure, which will result in lower profits.
The cost of compliance is also high for US manufacturers who are not familiar with these regulations. They will be subject to stringent safety reviews and tough penalties for violating these regulations.
Another challenge faced by the US cosmetic industry is the difficulty to provide new and innovative products since they must refrain from using over 1,600 ingredients that are deemed illegal to use in cosmetics under EU law. This adds pressure to the R&D process and slows down the launch of their new products, which could cause American beauty brands to be left behind in this competitive market.
What should US cosmetics companies do to enter the EU market?
European countries are very different from the US and other regions in the world, the marketing strategies that work well in the US may not work as well in the European market. What should US cosmetics manufacturers do if they want to enter the EU market? Here we recommend three key actions for US companies to succeed in entering the EU market.
1. Compliance is the key to success for the US cosmetic industry.
American beauty brands need to be aware of their legal obligations and ensure that they are monitoring and complying with all applicable laws in the EU and each member state. All cosmetic ingredients must undergo strict scientific safety assessments in compliance with the REACH regulation to make sure that all substances in cosmetics are safe for human health. Consequences of non-compliance for cosmetic products, other than damage to a manufacturer’s reputation and trustworthiness within the EU zone, can include: removal of the product from the EU market on a temporary/permanent basis, refusal of free movement for the product with the EU zone, product recall, and in some scenarios a blanket ban on the product within Europe or even destruction of the product.
2. Adapt your business practices and products to meet the needs of European consumers.
US companies must consider a localized path-to-market strategy that details how they can tailor their products, marketing and branding to be successful in the European cosmetics market. Within the European markets, there are a variety of factors that make each member state unique and different from each other. Companies should take these differences into account when conducting business in Europe. Operations that are not as large in size as multinationals may find that they do not have the resources to perform all of their due diligence on a country-by-country level. In this case, they should focus their efforts on specific countries or regions where there is greater potential for business opportunities or leverage local experts to help identify the best opportunity markets.
3. If you want to stay competitive, you have to think about new products.
The ever-changing regulations in the EU are forcing cosmetics companies to rethink how they formulate their products. Many companies are switching to natural ingredients that are not on the negative list, which has been a trend for the past few years, but this move will also mean new challenges for formulation chemists and product developers. To avoid getting left behind in a competitive market and keep them afloat with healthy profit margins, many companies constantly find ways to re-invent their products and make them more appealing.
Create a path-to-market strategy with RegASK
The team at RegASK has extensive knowledge and substantial experience in the areas of regulatory affairs, product development, and path-to-market strategy. We work hand in hand with clients to create a comprehensive and tailored solution for every stage of their product journey, from idea to completion.
If you want to expand your footprint specifically into the European skincare market, we help you assess the feasibility of market expansion based on your current formulation and design a geo-expansion strategy for implementation.
We specialize in:
- Finding new opportunity markets with gap and match analysis
- Providing end-to-end product and marketing strategy advice from scratch
- Examining the compliance of your product’s label and ingredients with local regulations
- Securing authorizations and approvals to enter new product categories and markets
- Managing and anticipating all regulatory affairs for you, such as monitoring regulatory changes, submitting dossiers, etc.
- Helping you build a lasting brand and pave the way for an enduring commercial success
We handle all the tedious legwork for you including complications in regulatory and legal issues, so that you can create a strategic plan and take your business to the next level. Connect with our experts today for a free consultation to help you reach your desired endpoint.
What you'll get with RegASK
- Early detection and mitigation of regulatory risks
- End-to-end regulatory support throughout your product lifecycle
- Strategic consulting to build the optimal business strategy for your commercial success
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References:
[1] Cosmetics Europe – Cosmetics and personal care industry overview
[2] European Commission – Internal Market, Industry, Entrepreneurship and SMEs – Sectors – Cosmetics
[3] European Commission – Internal Market, Industry, Entrepreneurship and SMEs – Sectors – Cosmetics – Legislation
[4] Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
[5] European Commission – Internal Market, Industry, Entrepreneurship and SMEs – Sectors – Cosmetics – Cosmetic ingredient database
[6] European Commission – Internal Market, Industry, Entrepreneurship and SMEs – Sectors – Cosmetics – Cosmetic ingredient database
[7] Entrepreneurship and SMEs – Sectors – Cosmetics – Cosmetic product notification portal
[8] Safer Chemicals, Healthy Families – U.S. deaths from methylene chloride
[9] Personal Care Products Council – U.S. and EU Cosmetics Regulation
[10] U.S. FDA – Prohibited & Restricted Ingredients in Cosmetics
[11] European Chemicals Agency – Understanding REACH
[12] U.S. FDA – Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety
