By Europe and its more-than 70 billion euro cosmetic and personal-care market are a primary source of revenue and an amazing driver of growth for thousands of brand owners around the world. However, this market—and all its promises—should be put in perspective with the complex regulatory steps that need to be performed before selling your first product in the EU. This administrative burden cannot be underestimated: The consequences of compliance issues are tough, immediate and likely to damage the reputation of a cosmetic brand. Here are five things you need to know before you let the boat leave for Europe with your products on board.
1. Single Market and National Provisions
The EU Cosmetics Regulation (EC No 1223/2009) is the main piece of legislation (but not the only one) to follow if you are targeting the European single market. This is good news because under European law, “regulation” means it is immediately applicable and enforceable in all EU Member States with no transposition into national law. There is no obstacle to the free movement of cosmetics in the EU.
Also good news? This single market is actually bigger than the 28-member European Union (27 soon, due to the recent Brexit). Non-members Iceland, Lichtenstein, Norway and Switzerland adopted the EU Cosmetics Regulation and therefore have access to this single market, too.
However, keep in mind that other pieces of legislation apply to cosmetics and may be the origin of some cumbersome national specificities (for example, the ban or restriction of some substances or labelling requirements related to environment protection).
2. Consumer Protection
The EU Cosmetics Regulation focuses on consumer protection, and the safety of products has to be demonstrated with official detail. By law, this scientific evaluation has to be carried out by an expert with the appropriate qualifications and respect a well-established protocol. Do not take lightly the complexity of this work but ensure that your Cosmetic Product Safety Report is prepared according to the best standards. Compliance issues related to safety are usually very detrimental to the reputation of cosmetic brands and come with huge financial penalties—and sometimes even prison sentences.
3. Labelling, Claims and Common Criteria
European regulators also pay a great deal of attention to the protection of consumer rights. The EU Cosmetics Regulation lays down strict labelling requirements and aims to help consumers make well-informed purchasing decisions. Furthermore, the EU regulation on cosmetic claims (EU No 655/2013) provides common criteria for claims that need to be respected. Unlike other international regulations ( such as Canada’s guidelines), the EU did not make a list of acceptable versus non-acceptable claims but rather enforced a list of criteria that a claim should follow, including honesty, fairness and evidential support. This system gives more freedom to the cosmetic brands but leaves a lot of room for interpretation. The evaluation of claims is an expert job, in which experience plays an important role.
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4. Notification to the Authorities
Assessing the safety and the regulatory compliance of a product is not enough. Notifying the Competent Authorities is necessary before a product can get placed on the EU market. This notification process, named the Cosmetic Product Notification Portal (CPNP), is online, free of charge and relatively easy to manage for common cosmetic products, provided that an account has been created in the first place. A number is obtained at the end of the notification process, and this number is necessary to start selling the product. It is noteworthy that the notification is not a registration and does not mean that the Authorities have approved the product.
5. Legal Representation
Keep in mind that the Competent Authorities will probably control your products at some point in time It can be an inspection of your dossiers performed on your premises or an in-market control (a product is picked on the shelf and its label evaluated or its composition analyzed). If you are not based in the EU, you need a designated “responsible person” within the EU who will represent your company. By default it will be your importer, but many importers do not want to play this expert role. Regardless of where you come from (inside or outside Europe), it is in your best interest to find a knowledgeable consultant who will manage the Authorities’ requests for you. Do not forget that the “responsible person” is the only person to blame in case of problems.
About the Author
Fred Lebreux holds a Ph.D. in organic chemistry and a master in management. After a post-doctoral position at the Ecole Polytechnique in Paris where he developed new pathways for the synthesis of biologically active substances, he was hired by IFRA, the International Fragrance Association. After a few years at the position of IFRA Scientific and Regulatory Manager, he was promoted IFRA Scientific Projects Manager. In both positions, Fred actively contributed to defend the collective interests of the global fragrance industry.
After 5 years with IFRA, Fred joined BIORIUS at the position of Scientific and Regulatory Director. At BIORIUS, the leading consultancy company in scientific and regulatory services for the Cosmetic Industry, he developed further the competences of his team, ensured the quality of deliveries, improved important processes, created effective working relationship with Biorius’ clients and solved complex issues.
In October 2015, the Board of BIORIUS nominated Fred Lebreux as the new Chief Operating Officer, entrusting him the daily operations of the company. In his new role, Fred took over the global supervision of the Department of Operations and the Department of Scientific and Regulatory affairs and will contribute to strengthen their current organization.
About BIORIUS
BIORIUS is a scientific and regulatory consultancy company established in Belgium for more than 8 years and currently leader in its sector. Dedicated to the cosmetic and food supplement industries, BIORIUS offers a wide range of services which notably include the safety assessment and the regulatory evaluation of products from A to Z. Specialist of the European legal framework, BIORIUS also acts on a global scale and can help companies to place their products in most markets across the world.
Beyond its regulatory services, BIORIUS has integrated expertise in the safety evaluation of chemicals, natural complex substances and mixtures. Mainly dedicated to the raw material producers, this tailor-made service requires advanced skills in toxicology and extensive experience of industry’s practices and botany. Thanks to its worldwide network of experts, BIORIUS is proud to propose a wide range of services from the substance evaluation and REACH/GHS-related tasks to the legal representation of cosmetic products in Europe.
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