The United States is one of the most important markets for the cosmetics industry. Consequently, a change in its dynamics has repercussions on the entire supply chain, to the point of dictating real business trends that will sooner or later become so in many other Western markets. This is why the entry into force of the MoCRA (Modernisation of Cosmetics Regulation Act) is so important: this is the first major change in US cosmetics legislation at the federal level since 1938. What does the change consist of? In a nutshell: the new regulation brings cosmetics into line with other consumer products regulated by the Food and Drug Administration (FDA). President Biden’s signature on the act is 29 December 2022, but cosmetics manufacturers have been given one year to comply: MoCRA will therefore officially enter into force on 29 December 2023.
But what does this change consist of? And why can it also be relevant for cosmetics packaging companies based in Europe?
MoCRA: Basic Principles for Change in US Cosmetics Regulation
Compared to the strict and detailed European regulation, the US market is characterized by greater openness, and this also applies to cosmetics. Until now, the basic principle applied that a cosmetic product was considered valid and safe until proven otherwise; exactly the opposite of what happens in the EU, where cosmetics are required to be proven safe before they are allowed on the market. The major US cosmetics companies already applied this principle, but it was a voluntary decision, not an obligation. Why were they doing this, even though it was not mandatory? Out of prudence in their approach to the market and protection of their customers. Regulation with few ‘loopholes’ seems easier for companies, but paradoxically it can prove to be a double-edged sword: true, there are fewer ‘stakes’ at the beginning, but in the event of problems it is more difficult to defend oneself. We are not only talking about isolated problems, such as those related to allergens but also to broader situations, such as choices regarding formula, ingredients, and even cosmetic packaging.
Regulatory compliance and scientific evidence proving the safety of products in advance proved to be a safeguard for both consumers and companies, even in the event of disputes. A vision to which European companies are now accustomed but which represents a real novelty under the stars and stripes flag.
This had already been realized by the individual states, which over the years have made up for the federal vacuum through local laws, as California did in 2005 with the Safe Cosmetic Act. This, however, created regulatory fragmentation: as a result, every cosmetics company interested in distributing its products in the US had to deal with different compliance for each state. Quite a problem, especially for foreign companies.
What changes with the MoCRA?
Thanks to the MoCRA, the regulation of cosmetics is harmonized at the federal level. So more rules are coming in, but clear and shared for all. With a more ‘European’ approach, in which the safety of products must be demonstrated beforehand.
Let us see in detail what it provides:
- MoCRA: FDA registration requirement
Establishments involved in the manufacture or processing of cosmetics distributed in the United States are required to register with the FDA by 29 December 2023 (new ones have 60 days from the start of operations). Please note, registration strictly concerns establishments that manufacture finished cosmetic products: warehouses, labeling and packaging facilities, distribution centers, companies that manufacture preparations and ingredients, and product research and study centers are exempt from registration. Every two years, registration will have to be renewed. For foreign companies, the name of a representative agent on US territory will be mandatory.
- MoCRA: Identification of a ‘Responsible Person’
This is the manufacturer, packaging partner, or distributor whose name appears on the label of the cosmetic product. This person effectively becomes the ‘go-to person’ representing the company in the eyes of the regulator. Among the obligations of the ‘responsible person’ is the submission to the FDA of a list of cosmetics already on the market and their ingredients, to be renewed annually.
- Obligation to notify adverse reactions
For incredible as it may seem until now this obligation did not exist, even though it was already done voluntarily. Now the responsible person will have to notify the FDA of any serious adverse reaction following the use of a product within 15 days of the report; all cases will have to be kept in a file that will be maintained for a duration of 3 to 6 years (depending on the size of the company).
- Preventive security
The safety of the cosmetic product must be demonstrated by ‘appropriate tests’; otherwise, it will be considered non-compliant. The person in charge is called upon to keep these proofs in special records and to provide them for possible checks.
- Changes in the labeling of cosmetic products.
in addition to details of the content, any allergens, etc., the label should also include the contact details of the responsible person, to whom any adverse reactions should be reported.
Should the FDA find any irregularities or deem a product to be a health risk to consumers because of its inspections, it will allow the responsible party to request a voluntary recall of the product; if this does not happen, the FDA will issue a mandatory recall and consider suspending the product from the cosmetics establishment register. This is quite a change: previously, the FDA did not have the power to recall products directly.
For the FDA to apply clear rules, Good Manufacturing Practices (GMP) will be established by December 2024 (although the regulatory process will continue until 2025).
MoCRA: What is changing for cosmetic packaging?
Cosmetic packaging was already subject to FDA control; however, the rules were less stringent than for pharmaceutical or food packaging. With MoCRA, however, the spotlight is also turned-on packaging, and not only on labels. The task of cosmetic packaging is not only to contain and protect the product, but also to facilitate its use (a concept valid for all cosmetic products, but particularly for make-up products). This a prospect that cosmetics manufacturers will not be able to ignore, especially with the new regulations coming from the FDA in the next two years.
As a manufacturer of deformable aluminum tubes for cosmetics, pharmaceuticals, and the food industry, our company can comply with the highest product quality standards. We have over 80 years of experience working with large international companies, which has allowed us to develop a deep understanding of markets and their compliance rules. We know the US market well and are already registered and qualified with the FDA. In 2021, we became part of Perfektüp and the Bell Holding group, which has allowed us to further strengthen our production capacity.
If you are looking for a partner in cosmetic packaging, please contact us: we will be happy to answer all your questions and send you a sample of tubes.