If there’s something that has marked 2023 in the cosmetic sector, it has undoubtedly been the regulatory changes. Don’t you think?

As we are aware that these changes and their compliance pose a significant challenge for cosmetics manufacturers and distributors, we have decided to provide you with a summary.

By doing so, you also ensure that you haven’t missed any. We are currently experiencing a paradigm shift in terms of regulations, one in which the focus is not only on the safety of individuals but also on environmental safety, with the European environmental regulation or Green Deal coming into play.

As it is important for you to comply with all legal obligations and keep all administrative procedures up to date, we are confident that this legislative overview will interest you.

So, if you market your cosmetic products in the European Union (EU) and/or the United States (US), pay close attention to everything that happened in 2023.

Let’s get started!

What have been the regulatory changes in the European Union (EU)?

Microplastics, allergens, regulation of carcinogenic, mutagenic, and toxic substances for reproduction, parabens, … Changes and more changes have proven to be quite a challenge for you.

But don’t worry; we’ll summarize them one by one for you:

  • At the beginning of 2023, the non-reusable plastic tax came into effect in Spain. With this measure, the aim was to reduce the production and consumption of single-use plastic.
  • In July 2023, Regulation (EC) 2023/1490 was published, arising from the need to comply with the update of Regulation (EC) 1272/2008 on the classification, labelling, and packaging of substances and mixtures. Better known as the Omnibus VI law, this resulted in the modification of Annex II of the Cosmetics Regulation (EC) 1223/2009, including 30 new substances (classified as carcinogenic, mutagenic, or toxic for reproduction) and the modification of entry 1024.
  • Intending to reduce the amount of microplastics released into the environment, the European Commission modified Annex XVII of Regulation (EC) 1907/2006 of REACH, prohibiting the use of those intentionally added to cosmetic products.

And finally, Regulation (EC) 2023/1545 arrived, concerning the labeling of fragrance allergens in cosmetics. This modified Annex III of the cosmetics regulation (EC) 1223/2009, involves the inclusion of 56 new allergens, bringing the total list to 81.

Lastly, throughout the year, various opinions of the Scientific Committee for Consumer Safety (SCCS) were published. In these, different ingredients were reviewed, restricted, and/or prohibited, such as benzyl salicylate, hexyl salicylate, methyl salicylate (children), hydroxyapatite nano, methylparaben, butylparaben, zinc salts in oral hygiene products, salicylic acid, etc. If you want more information, you can check this link.

And what were the regulatory changes in the US in 2023?

It could be argued that the FDA’s (Federal Drug Administration) Cosmetic Regulation Modernization Act (MoCRA) has been the most significant change in US regulatory history.

This law affects all manufacturers, importers, distributors, and packers of cosmetic products sold in the US. Only some companies are exempt from good manufacturing practices (GMP), registration, and product listing (if you have doubts, consult us).

Here are the innovations it introduces:

  • Facility registration: MoCRA establishes that manufacturers and processors of cosmetic products must register their facilities with the FDA. This registration must be updated within 60 days of any change and renewed every two years. To carry out the registration, it is mandatory to designate a Legal Agent (US Legal Agent) to act as a liaison in communications between the company and the FDA.
  • Product listing: The Responsible Person must list each cosmetic product marketed in the country, including information about the ingredients in them.
  • Allergens and additional information will be included in the labelling so that consumers can report adverse effects if they occur.
  • Obligations and penalties: Non-compliance with MoCRA provisions can result in severe sanctions, fines, and the possibility of the FDA preventing the sale of cosmetic products that do not comply with standards.

All points of the MoCRA law have been gradually implemented, with the following pending:

  • The proposal for the allergen list by June 2024.
  • Facility registration and cosmetic product listing, extended until July 2024.
  • Compliance with labelling requirements in December 2024.
  • The publication of the final Good Manufacturing Practices standard in December 2025, concluding this process.

How to anticipate MoCRA requirements?

Self-assessment: Conduct a detailed analysis of your production processes and cosmetic products to identify any aspects that need to be adjusted to comply with MoCRA.

Record updates: Ensure that your facilities are properly registered and that your product information is accurate and up-to-date.

Transparency and safety: Ensure that your products are formulated and labeled according to FDA safety and transparency guidelines.

Legal and regulatory advice: Turn to legal experts and consultants in cosmetic product regulation who can help you understand MoCRA requirements and ensure compliance.

And what can we expect in 2024?

We are confident that we will have a 2024 full of changes, such as the update of Regulation (EC) 1223/2009.

From Sigillum, we can help you ensure that your cosmetic products comply with all current standards and regulations, promoting a safe and responsible cosmetic industry.

Contact us here!