COSMETIC REGULATION / 21-03-24
Cosmetics regulation in the European Union
As a result of the Morhange talc case in France, the cosmetic field was taken over by the regulation since 1976. A European Directive, now a Regulation, governs the entire lifecycle of a cosmetic in the European Union (EU). The product has to comply with Regulation (EC) No. 1223(2009) in order to be put on the European market. But what does EU compliant mean? Who regulates cosmetics in Europe?
As a result of the Morhange talc case in France, the cosmetic field was taken over by the regulation since 1976. A European Directive, now a Regulation, governs the entire lifecycle of a cosmetic in the European Union (EU). The product has to comply with Regulation (EC) No. 1223(2009) in order to be put on the European market. But what does EU compliant mean? Who regulates cosmetics in Europe?
Consumer safety: the core of cosmetic regulations
The fundamental principle of European cosmetic regulations, according to the European Commission, is the consumer's safety: the use of a cosmetic product in normal or reasonably foreseeable conditions must be safe. It's the responsibility of the Responsible Person (info box 1). The Regulation (EC) n°1223/2009 (also known as the Cosmetic Regulation) applies in all concerned countries (that's how a Regulation works, unlike a Directive). This harmonization allows the free movement of products in the European economic space (28 member states, and Norway, Iceland, Liechtenstein).The Responsible Person
The concept of Responsible Person (RP) is fundamental in the EU cosmetic products Regulation. It's a natural or legal person, established in the EU. The principal responsibility of the RP is to ensure that the cosmetic product put on the market is compliant with the Regulation (EC) n°1223/2009. Without RP, there is no launch of products on the market! The RP can be :
- The manufacturer (the brand to make it simple) ;
- The importer, if the product comes from a third country ;
- The distributor, if the product is put on the market under the distributor's name or brand, or if the product is substantially modified.
A manufacturer or importer can be assigned an external RP, such as an external provider, who will handle the responsibilities.
Unlike the American cosmetic regulation (the European one strictly governs the permitted (or forbidden) ingredients. These regulatory restrictions are determined by the Scientific Committee on Consumer Safety (SCCS), a committee of independent experts who evaluates the safety of cosmetic ingredients. They work at the behest of the European Commission, sometimes on the popular cosmetic ingredient hotlist. The Cosmetic Regulation's annexes identify the forbidden substances (annex II), the restricted ones, in their use and/or concentration (annex III) and three positive lists for color additives (annex IV), preservatives (annex V) and UV filters (annex VI). A positive list implies that, for the concerned categories, only the ingredients on the list can be used, sometimes with restrictions of use and/or concentration. Often after consulting representatives from the cosmetic industry like Cosmetic Europe (Info box 2), these annexes evolve along with the state of science and SCCS's opinion when the European Commission finds it relevant. Formulating cosmetic products must take these constraints into account, and keeping an eye on ingredients is necessary when developing cosmetic products.The concept of Responsible Person (RP) is fundamental in the EU cosmetic products Regulation. It's a natural or legal person, established in the EU. The principal responsibility of the RP is to ensure that the cosmetic product put on the market is compliant with the Regulation (EC) n°1223/2009. Without RP, there is no launch of products on the market! The RP can be :
- The manufacturer (the brand to make it simple) ;
- The importer, if the product comes from a third country ;
- The distributor, if the product is put on the market under the distributor's name or brand, or if the product is substantially modified.
A manufacturer or importer can be assigned an external RP, such as an external provider, who will handle the responsibilities.
What is Cosmetics Europe?
Former Colipa, Cosmetics Europe is the European trade association of the cosmetic industry. It represents the cosmetic industry, but also the national trade associations in Europe. Its members are manufacturers. It is involved in discussions with authorities and European experts about regulatory subjects. The "Publications" section of the website offers a lot of practical documents and guidelines, recommendations (that are relevant to follow !), reports, statistics, etc.
Cosmetics Europe website: https://cosmeticseurope.eu/
Former Colipa, Cosmetics Europe is the European trade association of the cosmetic industry. It represents the cosmetic industry, but also the national trade associations in Europe. Its members are manufacturers. It is involved in discussions with authorities and European experts about regulatory subjects. The "Publications" section of the website offers a lot of practical documents and guidelines, recommendations (that are relevant to follow !), reports, statistics, etc.
Cosmetics Europe website: https://cosmeticseurope.eu/
The Cosmetic Product Safety Report (CPSR) is an integral part of European cosmetic regulations. It is the responsibility of the Responsible Party to make sure all relevant information is provided to the safety assessor so that the safety assessor can attest the product is compliant with the Regulation and its fundamental principle: to protect consumer's health under normal or foreseeable conditions of use. It is part of the Product Information File (PIF), which contains all necessary data for the RP to control the product's life: one product, one PIF ! The PIF must be kept for 10 years after the launch of the last batch. It must be accessible to the competent authorities (in France, ANSM, and DGRCCRF).
The talc Morhange case brought to light manufacturing as a critical step. That's why the Cosmetic Regulation requires that the RP certifies the compliance to the Good Manufacturing Practices (GMP) (mettre lien article BPF EN), and the certificate must be included in each product's PIF. Following the ISO 22 716 standards, which is the GMP framework, is mandatory. The standard also insists on the quality control of cosmetics.
Controlled information
Packaging is often the consumer's first contact with the product. Consumers must have access to all the information they need to make a decision, but also learn how to use it correctly (such as the ingredients list for allergic consumers or how long a product can be used after opening). That's why the cosmetics labeling (mettre lien étiquetage EN) must comply with the requirements of the Regulation (EC) n°1223/2009. This label must make it clear to the authorities where to find the PIF. Also, it is the first medium by which claims must meet the common criteria outlined in the Cosmetic Regulation.The Cosmetic Regulation does not detail directly the common criteria. They are detailed in the Regulation (EC) n°655/2013 which establishes 6 common criteria claims must adhere to:
- Legal compliance: it is forbidden to claim compliance with a regulation when putting a product on the market, as it is mandatory to do so! "Not tested on animals" is an example of a forbidden claim;
- Truthfulness: the claim must not be misleading ;
- Evidential support: you have to prove it! Test results substantiating a claim should be included in the PIF;
- Honesty: claims should not be exaggerated to mislead the consumer;
- Fairness: claims may not disparage competitors or their ingredients. Most "free from" claims go against this standard;
- Informed decision-making: claims must be understandable by the consumer.
Technical document on cosmetic claims
Animal testing
Some products have a statement on the packaging such as "not tested on animals" or "cruelty free". These claims do not conform to the first common criteria, so they're forbidden. The launch of products tested on animals (finished product or ingredients), is prohibited by the Cosmetic Regulation. Animal testing, used to assess the safety of a product or an ingredient, is now replaced by alternative methods.
Some products have a statement on the packaging such as "not tested on animals" or "cruelty free". These claims do not conform to the first common criteria, so they're forbidden. The launch of products tested on animals (finished product or ingredients), is prohibited by the Cosmetic Regulation. Animal testing, used to assess the safety of a product or an ingredient, is now replaced by alternative methods. Some products have a statement on the packaging such as "not tested on animals" or "cruelty free". These claims do not conform to the first common criteria, so they're forbidden. The launch of products tested on animals (finished product or ingredients), is prohibited by the Cosmetic Regulation. Animal testing, used to assess the safety of a product or an ingredient, is now replaced by alternative methods.
A market under surveillance
The Cosmetic Regulation introduced a new obligation: the electronic notification on the CPNP (mettre lien article CPNP EN). This portal identifies all the cosmetic products on the European market. The database allows national competent authorities (as well as poison control centers) to monitor the market and get the information they need about a product if necessary.The launch of a cosmetic product on the market does not require a marketing authorization as drugs do. So, monitoring after launch is required, in order to control the tolerance of the product during its sale. Even with adequate testing before launch, not all undesirable effects can be foreseen. According to European regulation, significant unintended effects (SUE) must be reported to the competent authorities of the country where the impact occurs (in France, this is the ANSM). The Cosmetic Regulation does not mention this "cosmetovigilance," but it's still essential. The regulation stipulates that all information gathered after market launch must be included in the CPSR, including information about any adverse effects (serious or not). Some national competent authorities have now a notification portal for undesirable effects for consumers.
