The cosmetic regulations page that will answer a lot of cosmetic regulations questions

Cosmetic Regulations: developing a cosmetic formula is an important step when considering the launch of a new product. At such an early stage of its development, the project is still fragile and requires proper care and wise decisions. This is much like the seed of a giant tree, which must be planted in good soil.

As specialists in international regulations and cosmetic products, Biorius supports cosmetics brands in launching their products in various geographical areas by proposing turnkey solutions in a one-shop-stop perspective.

Why should you trust Biorius ?

As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmetic products in various markets:

• First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries
• 50 regulatory experts, toxicologists, pharmacists, and chemists to serve you.
• A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more!
• No hidden costs: Biorius does not charge you for any question, call, or meeting.
• A best-in-class IT tool, free of charge, and saving a lot of your time.
• More than 1,500 international clients have already chosen Biorius!
• We evaluated more than 100,000 products and never had any compliance issues (fines, withdrawals from the market, etc.) in 15 years of existence.

How to sell cosmetics in UK ?

Cosmetic products definition in the UK according to the “The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, Schedule 34”, the so-called “UK Cosmetics Regulation”: any substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) 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 correcting body odours and/or protecting them or keeping them in good condition.

The United Kingdom is an important market for cosmetic products in the world (Valued at €9.9 billion at retail sales price in 2021) but is one of the most complicated cosmetic regulation in the world because the UK Cosmetics Regulation originates from the EU Cosmetic Regulation 1223/2009. The United Kingdom formally left the European Union on January 31, 2020 but the  Cosmetics companies had until December 31, 2020 (transition period) to comply with the requirements of the “UK Cosmetics Regulation”.

The UK and EU Cosmetic Regulations are more or less the same but there are indeed some minor changes (due to Brexit).
After Europe (or the other way around), you will indeed have to:

• Update the regulatory process for the UK
• Update the PIF (Product Information File)
• Make a new notification on the new British notification portal (SCPN: Submit Cosmetic Product Notification). Products sold in EU and UK indeed must be notified both in the EU CPNP (Cosmetic Products Notification Portal) and the UK SCPN (Submit Cosmetic Product Notification).
• Designate a Responsible Person located in the UK.

What is a Responsible Person cosmetics ?

As defined in Article 4 of Regulation EC No 1223/2009, a Responsible Person is a legal or natural person who ensures the compliance of each cosmetic product in the EU market with relevant obligations as set forth in this Regulation. It can be the manufacturer (if based in the EU), the importer, the distributor or a third party located in the EU who has been designated by a written mandate.

Because the UK Cosmetics Regulation originates from the EU Cosmetic Regulation 1223/2009, the UK and EU Cosmetic Regulations are more or less the same but there are indeed some minor changes (due to Brexit) but both an EU AND an UK Responsible Person (with offices in EU and UK) are legally mandatory.

The EU and UK Responsible Person will be responsible for the following:

• Protecting your brand against compliance issues
• Assisting you with legal questions related to the EU Cosmetics Regulation and UK Cosmetics Regulation
• Answering all questions from National Competent Authorities (27 EU Member States and UK)
• Managing all inspections decided by the Supervisory Competent Authorities
• Keeping a close eye on regulatory developments and keeping you up to date
• Handling all cosmetovigilance issues (undesirable effects) by following-up with the consumers and ensuring the best course of action

It is important to note that being a Responsible Person implies many responsibilities and is an important and delicate matter that should not be taken lightly, check out why. For your information, Biorius can be the EU AND UK Responsible Person.

How to sell cosmetics in USA ?

Cosmetic products definition in the USA according to the Federal Food, Drug & Cosmetic Act (FD&C Act): 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. Included in this definition are products such as skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

The United States of America is the largest beauty and personal care market with expected revenues of $91 billion in 2023 and a market size expected to reach $105 billion by 2028.

This is a strong market where indie beauty and innovative products are king, and where e-commerce and social media practices are particularly well developed. To tap into this 332 million people market, your product must comply with the legal requirements enforced in the US.

To sell in the US, you must consider the Federal cosmetics legislation that applies equally to all States, and the States provisions that are usually specific. It is a common mistake to forget this second responsibility.

On December 29^th, 2022, the biggest amendment of the U.S. Cosmetic Regulation since 1938 has been enacted. The publication of the Modernization of Cosmetic Regulation Act (MoCRA) in the USA is expected to have a large impact on the cosmetic industry, while it implies the reinforcement of FDA’s power.

Another “complication” in the US could be related to some states, California being the most complicated state with:

• California Air Resources Board
• California Safe Cosmetic Program
• Proposition 65
• Volatile Organic Compounds

How to sell cosmetics in Japan ?

Japan makes the following distinction between cosmetics and quasi-drugs:

Cosmetic products definition in Japan according to the Article 2.3 of the Pharmaceuticals Affairs Law: “The term “cosmetic” used in this law refers to articles with mild action on the human body which are intended to be applied through rubbing, sprinkling or other similar methods, and are used to clean, beautify and increase attractiveness, alter the appearance or to keep the skin or hair in good condition. Proviso: these articles shall exclude quasi-drugs and those intended concurrently for the uses specified in Paragraph 1, Item 2 or Item 3.”

Quasi-Drugs products definition in Japan according to the Article 2.3 of the Pharmaceuticals Affairs Law: “Products with mild action on the human body, they are considered as cosmetics with mild pharmacological action.”

Quasi-drug categories have been specified in Announcement No. 25 of the Ministry of Health from February 6, 2009. There are currently 27 quasi-drug categories. The following products are included in the quasi-drug category: anti-dandruff, whitening, anti-acne, anti-chapping, anti-dryness, deodorants, antiperspirants, hair-growth, hair dying, hair perming, toothpastes, bath salts, mouth washes, breath products, etc.

The process is the same for cosmetics and quasi-drugs, except for pre-approval dossier preparation for quasi-drugs. It can take up to six months to be reviewed by the Pharmaceuticals and Medical Devices Agency (PMDA).

Japan is an important beauty and personal care market with expected revenues of $7.27 billion in 2023 and a growth of 7,7%. The market is expected to grow annually by 2.51% (CAGR 2023-2028).

How to sell cosmetics in South Korea ?

South Korea makes the following distinction between Cosmetics, functional cosmetics and quasi-drugs:

Cosmetic products definition in South Korea according to the Article 2 of the Cosmetic Act: “designate products to purify, embellish, add attractiveness and illuminate the appearance in order to maintain or improve the skin or hair’s health via application, rubbing, spraying or any other similar action with superficial effects on the human body.”

Functional cosmetics are cosmetic products “that help to:

• Whiten the skin
• Decrease wrinkles
• Protect from UV rays
• Change hair color, remove hair or nourish hair
• Correct dryness, cracking or peeling skin”

Quasi-drugs are not included in the definition of cosmetics, as designed by article 2, clause 4, of the Pharmaceutical Affairs Act (drugs). These primarily include antiperspirants, toothpastes and oral care products.

How to sell cosmetics in China ?

Cosmetic products definition in China according to Article 2 – Regulation Concerning the Hygiene Supervision over Cosmetics: “chemical products that are applied on the surface of any part of the human body (such as skin, hair, nails and lips) by smearing, spraying and other similar ways to keep the body hygiene, to get rid of undesirable odors, to protect the skin, to enhance the beauty of the appearance.”

This definition does not include oral care products which are categorized as industrial products.

China regulates its cosmetics market through the National Medical Product Administration (NMPA), which serves as its main regulatory body. The NMPA is the Chinese agency in charge of regulating drugs and medical devices, formerly known as the China Food and Drug Administration (CFDA) under control of the State Administration for Market Regulation (SAMR), created in 2018.

The regulatory landscape for cosmetics in China is extremely complex compared to other regions of the world. Indeed, cosmetics are regulated by several laws, the majority stemming from the Regulation Concerning the Hygiene Supervision over Cosmetics (1989) which as been in force since 1990.

This will soon be substituted by a new regulation, known as the “Cosmetic Supervision and Administration Regulation” (CSAR), published at the end of June 2020 and set to be implemented on January 1, 2021.

The CSAR has 6 chapters and 80 articles whose aim is to reform cosmetics in China. However, it is important to remind everyone that it’s a basic regulation and that specific measures will be taken to address, for example, animal testing, risk assessment, efficacy and claims.

China is the second-largest cosmetics market (US $13,566.8m) after the US and is expected to grow annually by 11.2% (CAGR 2020-2023). This market is expected to be one of the fastest-growing and most promising markets in China in the coming years.

How to sell cosmetics in other countries ?

On top of its performance, its cost, its marketing potential, and many other aspects, the formula must comply with the legislation of all targeted countries and regions before it gets placed on the markets. This applies to all cosmetic products regardless of whether it is skincare, makeup, or another category. In addition to the product formula, the product’s toxicological profile and label are also part of the regulatory process.

Achieving regulatory compliance is a must in order to avoid any issues with or penalties from the relevant authorities and to ensure the safety of products for consumer use. It also reassures importers and distributors, which tremendously facilitates the export project. Ensuring compliance in all countries where the cosmetic product is sold is therefore critical.

As specialists in international regulations and cosmetic products, Biorius supports cosmetics brands in launching their products in various geographical areas by proposing turnkey solutions in a one-shop-stop perspective.

Biorius developed a large catalog of services dedicated to cosmetic brands. This includes a safety and regulatory evaluation of the formula for each and every targeted country: EMEA (Europe, UK, Non-EU countries & Middle East), North America (USA & Canada ), South America (MERCOSUR & CAN), Asia (Japan, China, South Korea & ASEAN), Oceania (New Zealand & Australia), … . This is a fast and cost-effective solution to guarantee the regulatory potential of a cosmetic formula.

Likewise, a great deal of attention should be paid to mandatory consumer information and marketing communications. Each country comes with its own legal requirements and a claim totally acceptable in one country may lead to serious compliance issues in another. When the intent is to develop a product with a high internationalization potential, the best approach is probably to align marketing needs and regulatory obligations at an early stage.

What are Cosmetic certifications ?

In recent years, the cosmetics industry has seen an increase in the number of labels and certificates on products. Having a product certified, however, is about more than just sticking a label on it. It requires a cosmetic brand’s commitment to operate according to meaningful and well-established standards. These standards are crafted by the certifying bodies to include a number of criteria, including legal compliance, consumer expectations, consumer safety, and specific codes of ethics.

Obtaining certification for your product is important because it allows you to share clear and transparent information regarding your product and brand ethics. This helps you gain consumer confidence in your products and increase customer loyalty. In some cases, you may also need to hold one or more certifications in order to access certain markets and attract the attention of specific consumer groups.

To obtain a cosmetic certification for your products, a series of verifications must be carried out by a team of qualified experts to ensure that the certification criteria are properly fulfilled.

Biorius also offers a certification service for cosmetics:

• Our certifications have been developed by scientists, toxicologists, various experts and laboratories and ensure compliance with cosmetic legislation all around the world
• All our certifications are valid and recognized internationally
• The Certifications can be added to the packaging, labels and/or website and offer a great added value.

Natural certification

Since the late 2000s, following a series of reports on the alleged dangers of cosmetics, consumers have shown renewed interest in products of natural origin. Biorius developed Natural Certifications therefore.

In 2016 alone, the global market for natural cosmetics accounted for more than 11 billion euros; roughly 5.5% of the cosmetics market, with this figure expected to double by 2024.

In an industry that is constantly growing and evolving, being able to rapidly adapt to market changes and consumer demands is crucial. In recent years there has been a sharp increase in beauty brands now choosing to have their products certified as natural.

In a world where people want to get back to nature, more and more consumers are in search of natural and authentic products, resulting in an increasing number of requests for ingredients from natural sources.

Nowadays, products certified as natural are at an advantage as they give consumers the option of being able to make well-informed choices about the products they choose to buy and use.

Vegan-Friendly certification

Vegan certification highlights the importance your cosmetic brand places on animal well-being and allows you to share a wider message with your consumers regarding your brand’s ethics and values.

Among other elements, a vegan-certified cosmetic product is defined as containing no animal ingredients or by-products, using no animal ingredients or by-products in the manufacturing process and no testing on animals by any company or independent contractor.

As a reminder, the European Cosmetics Regulation EC No 1223/2009 banned animal testing on cosmetic products in 2004 and on cosmetic ingredients in 2009 and 2013. Claiming that a product is “cruelty-free” is therefore illegal in the EU. As of today, there are not many ways of providing such information to the consumer without raising compliance issues. However, the claim “vegan” is an option since its definition encompasses non-animal testing, among other requirements.