Cosmetic Regulations

Cosmetic Regulations

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.

  • Is specialized in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries
  • Is mainly composed of 50 regulatory experts, specialists, toxicologists and scientists (chemists and biologists)
  • Has more than 1,500 international clients
  • Has already evaluated more than 100.000 products
  • Never had any compliance issues (fines, withdrawals of the market, etc.) in 15 years of existence.
Table of Contents

EU Cosmetic Regulations

EU Cosmetic Regulations: Europe is one of the most complicated Cosmetic Regulation in the world. Europe may be one of the most complicated Cosmetic Regulation in the world but it is also a great cosmetics market of nearly 500 million consumers. Europe is, along-side the USA, the largest market of cosmetic products in the world (valued at €80 billion at retail sales price in 2021). However ensuring that a cosmetic product complies with the EU cosmetics regulation and a number of other European or national regulatory frameworks before launching into the market can be a long and bumpy road for cosmetic brands. As nicely worded by a piece of European legislation: “No data, no market”.

Cosmetic products definition in the EU according to Regulation 1223/2009: 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.

Before being placed on the EU market, each cosmetic product has to comply with the EU Cosmetic Regulation and have an EU Responsible Person (with offices in Europe), and Biorius provides A to Z assistance for this matter. To comply with those requirements, we usually follow a 5-steps process :

  1. Formula Review
  2. Cosmetic Product Safety Report (CPSR A&B) signed by a Toxicologist
  3. Label and claims review
  4. PIF (Product Information File) preparation and EU CPNP (Cosmetic Products Notification Portal) notification
  5. Acting as your EU Responsible person

EU Cosmetic Compliance

EU Responsible Person

The EU Responsible Person (with offices in EU) is legally mandatory. Biorius can also be the EU Responsible Person and therefore will be responsible for the following:

  • Protecting your brand against compliance issues
  • Assisting you with legal questions related to the EU Cosmetics Regulation
  • Answering all questions from National Competent Authorities (27 EU Member States)
  • 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.

EU Responsible Person

UK Cosmetic Regulations

UK Cosmetic Regulations: 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 “The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, Schedule 34”, the so-called “UK Cosmetics Regulation”.

Cosmetic products definition in the UK according to 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 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.

UK Cosmetic Compliance

UK Responsible Person

The UK Responsible Person (with offices in UK) is legally mandatory. Biorius can also be the UK Responsible Person and therefore will be responsible for the following:

  • Protecting your brand against compliance issues
  • Assisting you with legal questions related to the UK Cosmetics Regulation
  • Answering all questions from National Competent Authorities
  • 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.

UK Responsible Person

USA Cosmetic Regulations

USA Cosmetic Regulations: the United States of America is the largest beauty and personal care market with expected revenues of $91 billion in 2023 and with an expected annual growth of 2.60%. This is one of the strongest growing markets and is driven by young consumers whose buying habits are impacted by the predominance of social media and e-commerce, especially when it comes to cosmetic products.

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 US is a free country (the land of the free): the key words are freedom and responsibility. It is of course forbidden to put a dangerous product in the US market and it is very important to make sure that everything is OK before selling them on the US market. But there is indeed a lot more freedom to demonstrate the safety of an ingredient with an important Toxicological work beforehand.

You need the following to sell cosmetics on the US market:

Another way to say it is: you have to make sure your products are compliant in the event of an inspection of the authorities. They may indeed ask you to present all the necessary documents (Formula Review, Label and claims review, Toxicological Risk Assessment, …) and you have to be sure you made all the necessary to avoid a long, painful and expensive lawsuit.

On December 29th, 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:

US Cosmetic Compliance

Cosmetic Regulations 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. 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.

International Cosmetic Compliance

Cosmetics 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.

All Cosmetics Certifications

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.

More information

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.

More information

Reef-Friendly certification

In recent years there has been a sharp rise in consumers caring more and more about their environmental impact and climate change. Coral reefs play a big part in providing an important ecosystem for underwater life. They act as a natural protection of coastal areas by reducing the power of waves hitting the coast and actively preventing the loss of aquatic life and shoreline erosion.

A product assessed as safe for humans does not guarantee that it is safe for the environment or harmless for the aquatic ecosystem.

Unfortunately, some ingredients and chemicals found in cosmetic products can negatively affect sea life and increase water pollution, which in turn can cause serious damage to coral reefs leading to their destruction. Studies have shown that a large number of sunscreens contain ingredients that can damage marine ecosystems.
Showing a reef-friendly claim on your sunscreen products is a good way for you, as a cosmetics brand, to let consumers know that your products are harmless to marine flora and fauna.

More information

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