Jacs from the UK asked…”Can you add a overview on how cosmetics are regulated in the rest of the world other than America please?”
Our answer comes from UK-based cosmetic chemist Colin Sanders of Colin’s Beauty Pages.
Who makes the regulations in the EU?
The obvious first question for someone outside the EU is who actually makes the rules? In fact it is a pretty good question for people inside it as well. The answer is that the regulations are drawn up by the European Commission, a body that many Europeans don’t know exists.
The commission itself is run by 28 commissioners who are delegates from each of the 28 member states and who are usually politicians with a successful career behind them. They have a staff of about 23,000 to do the actual work of drawing up legislation. The cosmetics regulations are just one of the many things the commission does, and it has been pumping them out regularly every 4 years since 1976. You can easily discover the latest version – it is online along with all other EU regulations so a bit of googling will find it.
The commission can also issue what are known as decisions, which are ad hoc rulings on specific points. These can and do override regulations in particular cases. A recent example is the change to the rules on methylisothiazolinone where a decision has tightened the restrictions on it. This means you can’t be absolutely sure the published text is up to date, which is one of the charming foibles of the way the regulations work.
What the European Commission doesn’t have is a specific department devoted to cosmetics. So the regulations are drawn up by general bureaucrats. They don’t know anything about cosmetics so they depend on advice. They got some of this from trade bodies and from interested parties. This means that the interests of the big producers are taken into account. Smaller producers? Not so much.
They also have advice from a body called the scientific committee for cosmetic safety or SCCS, which is composed largely of academics with an interest in medicine and general science.
The whole thing is pretty transparent, at least on paper. Decisions are well documented and published online for anyone to read. The opinions of the SCCS are full of detail. They quote the data they used and the reasoning they adopted. They also give the names and credentials of the people involved. So you know who they are, and they show their working. You do need to have a fair bit of background knowledge to be able to keep abreast of it all though. Neither bureaucrats nor scientists are well known for making their business easy to follow.
What are the main ways the regulations control things?
So what sort of regulations have these guys come up with between them? You don’t need to get any kind of registration of approval to launch a cosmetic, but you do need to register it on the Cosmetic Product Notification Portal. This is a simply enormous database of every cosmetic formulation on the market along with its pack copy. Registering a product on it is not tremendously difficult and is free to registrants, which inevitably means the cost of administering it comes from European taxpayers. Its stated purpose is to provide poisons centres with rapid information on the ingredients of cosmetic products in the event of some kind of medical incident. I’d love to know how often this database is referred to.
First of all, notice that you DON’T have to get approval to launch a cosmetic in the EU. That’s how it is in the US too. The registration requirement he mentioned is already voluntary in the US and the new bill would make it mandatory. And yes, the fees for this would be passed on to US tax payers.
This isn’t the only information the European Commission is collecting. There is also a requirement to notify them of any serious adverse effects on cosmetics. This is an idea that has been adopted from the pharmaceutical industry where it has been going on for a long time. This is potentially of great help in identifying problem products and problem ingredients. It has only been running since 2013 so it is a bit soon to judge how this is going to work out. But if my experience is anything to go by there aren’t going to be too many of them.
The EU has quite a long list of banned substances. This is the longest bit of the regulations and the one that almost nobody ever refers to. I have the rest of the regulations printed out in a folder on my shelf full of notes and comments. I add whatever I learn about what they mean and how they are interpreted and enforced, but I skipped the banned substance list. I don’t think there is anything on it that anybody would ever want to put into a cosmetic in the first place, so I don’t really see the point of it.
There is a list of controlled substances, which are things that you are only allowed to use up to a certain level or in particular kinds of product. There are lists of permitted preservatives, colours and so on although there is nothing to stop you using things that are not on the list so long as they are safe.
But the most significant way that cosmetic product safety is addressed is through the requirement for safety assessments. When you think about it, there are two ways you can ensure safety. You can either lay down a set of rules that everyone needs to follow, or you can require that somebody who knows what they are doing approves products before they are released. The EU uses a mixture of both. There are plenty of prescriptive rules, most of which are pretty conservative in their assessment of the risks particular ingredients pose. And you also need to get any formulation you launch signed off by a safety assessor. When safety assessments originally came out the rules about who should do them and how they should be written were pretty vague. They simply called for a suitably qualified person to assess the safety of the product. I quite liked this approach. It put the onus on the company to justify that their assessor was indeed suitably qualified.
Sadly the rules have become much more exiguous and now there is a specific format that safety assessments need to follow and some criteria for suitable qualifications for assessors. This actually makes the system a bit weaker, because anybody with a chemistry or a life sciences degree can easily meet the criteria with relatively little extra work and as long as they diligently follow the correct format laid down in the rules, they can be a safety assessor. That seems a lot easier than having to justify that you are suitably qualified to me. I’d rather have somebody who actually knows a bit about how cosmetics work personally.
How does it all work in practice?
Different European countries enforce the regulations in different ways. In the UK trading standards officers are responsible. But this is just one part of their remit to protect consumers, and their approach is generally pragmatic. They tend not to give cosmetics a huge amount of attention, probably for the very good reason that they don’t give consumers much in the way of trouble. There are other bits of legislation that they have in their toolkit which are relevant to cosmetics which they can use, so even when there is a problem they aren’t necessarily or even probably going to use specific cosmetic legislation to deal with it.
The cosmetic regulations are in fact rather unsuitable to their purposes. A good example are skin lighteners containing hydroquinone. Most people in the business are reasonably clear that article 14 of annex 3 of the EU regulations bans hydroquinone in any products except hair dyes and artificial nails, and in these you can’t use more than 0.3%. But if you look at it as it is written, it is open to the interpretation that it is limited in those products but you can use as much as you like in other products. So I wasn’t surprised to see a prosecution of a shop selling a skin lightening cream being carried out using a completely different law altogether.
This might sound like a criticism, but it really isn’t. One of the good things about the EU regulations is that they are written in language that is straight forward enough to provide guidance to anyone interested and you don’t need a lawyer to interpret them for you.
In Ireland the health department has been given the job of enforcing the cosmetic regulations, and they go about it in a rather more legalistic way presumably because their pharmaceutical training influences them to do so. If you are selling products in Ireland you need to be ready be interrogated by the someone who has read the regulations carefully if they get any complaints. Other European countries all have their own particular ways of enforcing the regulations.
Are cosmetics really dangerous or not?
So the big question is do the regulations actually do the job What are the risks that cosmetics pose to consumers? It happens that most cosmetic products are applied to the skin and the hair, which are not really vulnerable parts of the body. Unbroken skin is a pretty good barrier to most potential toxins. Even products that are used in or around the mouth like lip balm and toothpaste are used in tiny quantities. Cosmetics that did contain harmful ingredients are not going to do much harm. And there is not much incentive to use anything harmful anyway. You can make highly effective products using ingredients that are both cheap and safe. Why would you do anything different?
So the products from big, medium sized companies are likely to be both legal and completely safe. In fact given that they are all trying to build brands they are very concerned with their reputations and would probably not behave very differently if all the cosmetic regulations were withdrawn tomorrow.
There are also quite a lot of people who make cosmetics on a small scale and sell them at crafts and websites like Etsy. These people may not be quite so aware of the details of the regulations but they are motivated by a love of what they do and it is hard to imagine them doing anything harmful.
The only sector of the cosmetics business which is likely to pose any risk are products that are made on a small scale purely to make money. These tend to be distributed in ways that makes it hard for you to track back to them. Not very well known websites, direct mail and mail order adverts are typical. These people are not out to do any harm, but they can often be willing to cut corners. There was a lot of publicity recently about fake branded products. Contamination is the biggest problem, and fake products were found to contain things like rat droppings. Nobody is putting this kind of thing in their products deliberately, but they might well not follow elementary hygiene such as keeping batches covered overnight. This is exactly the kind of thing people out to make a quick buck are going to do as well. The cosmetic regulations give one option to the authorities when they are trying to stop this kind of thing going on – though there are other laws that might well be being broken at the same time.
I think the conclusion I draw is that cosmetics you buy through regular distribution channels like shops, pharmacies and the big specialised online cosmetic websites are pretty much as safe as you can expect anything to be. The regulations are respected and followed by all the big suppliers and distributors. But the actual detail of what the regulations say is probably not as important as the motivations of the people who make the stuff.
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