The cosmetics industry is subject to a variety of regulatory standards worldwide. This blog post will provide an overview of the regulatory requirements for the cosmetics industry in the European Union (EU), the United Kingdom (UK), and the United States (USA).
European Union (EU)
In the EU, the main regulatory framework for finished cosmetic products is Regulation (EC) 1223/20091. This regulation strengthens the safety of cosmetic products and streamlines the framework for all operators in the sector. The most significant changes introduced by the cosmetics regulation include:
Strengthened safety requirements: Manufacturers need to follow specific requirements in the preparation of a product safety report prior to placing a product on the market.
Introduction of the notion of ‘responsible person’: Only cosmetic products for which a legal or natural person is designated within the EU as a ‘responsible person’ can be placed on the market.
Centralised notification of all cosmetic products: Manufacturers will need to notify their products only once – via the EU cosmetic products notification portal (CPNP).
Reporting of serious undesirable effects (SUE): A responsible person will have an obligation to notify national authorities of serious undesirable effects.
New rules for the use of nanomaterials: Products containing nanomaterials must be explicitly authorised.
United Kingdom (UK)
In the UK, the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 amended Regulation (EC) No 1223/2009 on Cosmetic Products. The regulation sets out requirements that must be met before cosmetics products can be placed on the GB market. The key requirements include:
Safety assessment: Safety assessment requirements are listed in Article 10.
Substance restrictions: Substance restrictions are listed in Chapter IV.
Responsible persons: A ‘Responsible Person’ must be designated who makes sure safety measures are followed and legal obligations are met.
Notification: Notification via the Cosmetic Product Notification (SCPN) e-portal is required.
United States (USA)
In the USA, the Food and Drug Administration (FDA) enforces laws and issues regulations for the cosmetics industry. The FDA provides guidance documents that represent the FDA’s current thinking. Key aspects of the regulation include:
Safety assessment: Manufacturers are responsible for ensuring the safety of their products.
Labelling requirements: Cosmetic products must be labelled according to FDA regulations.
Reporting of adverse events: Manufacturers are encouraged to report any adverse events that may be associated with their products to the FDA.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expands the FDA’s authority to regulate cosmetics in the United States. It was introduced as part of the Food and Drug Omnibus Reform Act of 2022 (FDORA).
Here are some key aspects of MoCRA:
Adverse Event Reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the U.S. to the FDA within 15 business days.
Facility Registration: Manufacturers and processors must register their facilities with the FDA and renew their registration every two years.
Product Listing: Each marketed cosmetic product exported to the US must be listed with the FDA, including product ingredients, and any updates must be provided annually.
Safety Substantiation: A responsible person is required to ensure and maintain records supporting adequate safety substantiation for their products.
Mandatory Recall Authority: If the agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.
This legislation is the biggest reform to cosmetics regulation in the United States in over eight decades. It was introduced to increase consumer safety, giving the US Food and Drug Administration greater powers to mandate adverse event reporting and standardize labelling and testing in certain areas. The new rules apply to any brand into the US, including businesses exporting to the territory. Read more about MoCRA [New updates in this timeline.]
In conclusion, while the regulatory requirements for the cosmetics industry vary from region to region, they all share a common goal: to ensure the safety and efficacy of cosmetic products for consumers. It is crucial for manufacturers to understand and comply with these regulations to market their products in these regions successfully.
Here’s how we can support manufacturers in complying with relevant regulations in the cosmetics and health and beauty space:
Regulatory Advice: Crème de la Crème provides advice on the regulatory requirements for cosmetic products in the EU, UK, USA and beyond. This includes understanding the specific requirements of EU Regulation 1223/2009, which covers aspects such as safety assessment, substance restrictions, responsible persons, and product notification.
Support for Compliance: We support manufacturers in ensuring their products comply with the necessary regulations. This involves helping manufacturers understand and meet the safety requirements, navigate the product notification process, and manage any serious incident reporting.
Industry Focus: As our support is exclusively for the Cosmetics Industry, we understand, intimately the specific challenges and requirements in this sector. This industry-specific knowledge proves to be invaluable for manufacturers looking to ensure their products meet all necessary regulations.
Core and Bespoke regulatory support: From PIF file creation to acting as your adhoc regulatory compliance team, Crème de la Crème can support you with all things regulatory. Our core services include –
a. Representation
b. Good Manufacturing Practice
c. Compilation of Product Information Files
d. Cosmetic Product Safety Reports
We believe that one size doesn’t fit all and have the flexibility to provide regulatory and compliance support in parts or as a whole.
Speak to one of our consultants by sending us an email – creme@creme.uk.com or fill out this web form - https://tally.so/r/mB7d65