A Quick History
The Modernization of Cosmetics Regulation Act (MoCRA) and the EU cosmetic regulations are both designed to ensure the safety of cosmetics for consumers. The former is new and comes into force at the end of 2023 – the latter has been developing since the early part of the 20th century.
In the first half of the 20th century, regulations concerning cosmetics were largely focused on preventing adulteration and misbranding. The first specific law, the French Decree of 20 July 1934, formed the basis of the French cosmetics regulation and was the precursor to European regulation.
Things kicked off in 1976: with the original Cosmetics Directive The Council Directive 76/768/EEC of 27 July 1976 was the first major pan-European legislation to govern the cosmetics industry. It aimed to standardize regulations across member states to ensure the safety of cosmetics and cosmetic products. The Directive also began the harmonization of rules on product labeling. It underwent multiple updates and amendments in the following decades. These changes often reflected the growing understanding of certain ingredients and practices.
In 2009, the European Parliament and the Council replaced the 1976 Cosmetics Directive with the Cosmetics Regulation (EC) No 1223/2009 – its provisions came into force in 2013. This represented a major shift from a directive, which requires each state to implement laws that achieve the directive’s purpose, to a regulation, which is directly applicable across all EU member states. The regulation expanded and clarified many aspects of the previous directive, such as safety assessments, responsible persons, and notification procedures.
On the whole, it has been a successful bit of legislation, though like all things it is far from perfect. It has been very influential around the world with many countries taking it as a model for their own regulations – in at least one case copying and pasting them more or less in their entirety heading numbers and all. The biggest coup in this respect is the new rules about to come into force in the United States. These adopt a lot of the philosophy and quite a bit of the detailed implementation from the European model.
What’s Different Between EU and MoCRA?
There are some key differences between the two sets of regulations, and it seems to me that the Americans have been pretty judicious in avoiding some of the more questionable bits of the EU regulations, adapting some others and flagrantly stealing the best bits.
- Premarket safety assessment: MoCRA does not require manufacturers to conduct premarket safety assessments for their cosmetics, while the EU cosmetic regulations require manufacturers to have a safety assessment for each product that they place on the market. I think this is wise. Safety assessments have achieved the goal for which they are intended, but in a way that is far more troublesome than it needs to be. That will probably need a blog post of its own at some point. In fact MoCRA does address the safety of products but in a rather more sensible way – the people who make them are required to assess safety with reference to appropriate expertise.
- Ingredient safety: MoCRA does not have a list of banned or restricted ingredients, while the EU cosmetic regulations have a list of over 1,300 ingredients that are banned or restricted. Again, I’d say our friends across the water have got this about right. Many of the banned ingredients in the cosmetic regulations would never be considered for use in cosmetics in the first place. And equally there are many materials that are not listed that certainly would not be suitable as cosmetic ingredients – so there isn’t really any rationale to the status of being banned in cosmetics. It would be more practical to keep the banned list to materials that have at some stage been used in cosmetics rather than a random subset of things that somebody has at some point thought shouldn’t be used.
- Product registration: is required by both, but it looks like MoCRA allows companies to update their portfolio once a year rather than as soon as a product goes on the market. This makes it less of a chore. It could be argued that this is not ideal. Registration is intended as a public health issue. The idea is that a health professional should be able to get access to accurate and up-to-date information about the chemical nature of a product in the event of a medical emergency. But I think the reality is that overall a once a year update is likely to be more accurate more of the time than doing it as things go along.
- Facility registration: this is required by MoCRA but not by the EU. This is a big weakness of the European system. The biggest risk to consumers in real life is the way products get made. It’s all very well having a qualified assessor making sure that the formulation is safe if made correctly, and having a responsible person (read brand holder – a responsible person is almost always a company not a human) answerable for its quality. But the missing bit of the jigsaw is ensuring the factory it is made in is up to scratch. To be sure, European factories do generally have very good procedures and things are made to very adequate standards. And levels of traceability are very high. But there is no list of all the places that they are made. It could be argued that as things are okay and as you can trace back to a particular products origin with the company’s address and the batch number then it isn’t necessary. But imagine a scenario where a factory somewhere has a source of contamination. If undetected for a period of time this could affect a large number of products from different brands. This could be traced back from the market place to its origin – but it would be a lot quicker to have a list of places cosmetics are manufactured.
Verdict on MoCRA
Overall, the EU cosmetic regulations are pretty comparable with MoCRA. It is good news that the EU and the United States are currently working to harmonizse their cosmetic regulations. This will help to ensure that consumers have access to safe and effective cosmetics regardless of where they live and save cosmetic professionals a lot of work. I predict that this is just the first stage and that we will be seeing a lot more convergence in the future – and if we converge on best practice this is to everyone’s benefit.
