Call to account
The new Cosmetic Regulation requires that all cosmetic products sold in the EU meet specific criteria and that a ‘responsible person’ must be designated to legally ensure their safety. Cliff Betton runs through the implications of the EU Cosmetics Regulation
In July 2013, the EU Cosmetics Regulation (EC No. 1223/2009) came fully into force, replacing the existing national laws based on the EU Cosmetics Directive (76/768/EEC), which covered companies manufacturing and marketing cosmetics across the EU. Companies now have to ensure compliance with the new requirements for both cosmetic and medicinal products.
To work out if a product is a cosmetic or a medicine, the Medicines and Healthcare products Regulatory Agency (MHRA) provides definitions for cosmetic and medicinal products and has the final say in any cases of doubt: the various regulations define cosmetics as focusing on cleaning and changing the appearance, while medicines protect against and prevent disease. All products sold in the EU will come under one or the other of these two regulations, but not both.
The MHRA provides guidance for “borderline products”—those that may contain pharmacologically active substances or make medicinal claims and are therefore difficult to distinguish from medicines. Unfortunately this guidance can be confusing. For example, the product statement “protects against” is considered as a medicinal claim. A sunscreen can protect against sunburn, so does that make it a medicine? According to the law, it’s regulated as a cosmetic but clinically, this protection implies a medicinal claim.
Clinical trials imply a medicinal claim. However, most of the products advertised as cosmetics would be medicines if following that aspect of MRHA guidance.
Only products that comply with the Cosmetics Regulation can be placed on the EU market.
Under the new regulations, a designated “responsible person” within the EU must take control of, and legal responsibility for, all aspects of product safety. Previously, if you were marketing, importing or selling a cosmetic, you were automatically responsible. You can now however, by written mandate (or contract), pass that legal responsibility onto a third party, who then has to ensure compliance.
So who is the responsible person? If you’re manufacturing, shipping the product out and somebody else is bringing it back into the EU, the importer becomes the responsible person—something could have happened to it outside. If you’re a trader, importing the product into the EU, or a distributor taking a product already on the market and doing something to it—even just changing the name on the label—you then become the responsible person. As a basic rule of thumb, the company with their name on the product is the Responsible person.
All aspects of safety, from choosing the raw materials and their specifications and putting them together in the factory, to how the factory operates, is the responsibility in Law of this person. The management of labelling claims, testing and safety of a product is a complex and specialised task. The responsible person also has to monitor and resolve any negative findings such as customer complaints, skincare issues and adverse events related to the product.
The responsible person needs to work with all parts of the supply chain. Everybody involved in the process of making a cosmetic product has some involvement with the responsible person to ensure that the product is safe, that it complies with the various articles of the regulation and, if anything goes wrong, they can do something about it.
There also has to be an up-to-date file of information—the Product Information File or PIF—that includes all complaints related to a product and what action has been taken to resolve them, for a period of ten years following the last sale of the product; not from the day it’s put on the market, but for ten years after it has finished being sold. The PIF can be kept electronically—there is a set amount of data has to be included and it must be in a language that’s easily understood by the competent authority in the country where the file is located. However, you only have one PIF and Registration for the whole EU.
The responsible person gets involved with every aspect of product safety, not just from the specification of the raw materials right through to customer complaints, but also with the wording of marketing materials.
With respect to product claims, if you are saying that a shampoo cleans hair, you do not have to be able to prove that claim. If, however, you make a claim that a product makes consumers look ten years’ younger, such a claim must be substantiated by scientific study; it is no longer acceptable under the Regulation to extrapolate from results in-vitro for an ingredient, claim substantiation must be proven for the product.
The responsible person must also carry out a safety assessment. The product must be made to good manufacturing practice, which involves auditing factories. There is an online EU portal for registering products, following registration as an individual or a company on a separate website.
In the Regulations, restricted substances and prohibited materials are shown in the Annexes. Carcinogens, mutagens, reproductive toxins and nano-materials are specifically excluded unless they are approved by an EU committee called the Scientific Committee on Consumer Substances (SCCS), which produces opinions and reviews three or four times a year. This is a continual upgrading and monitoring process that you also have to do if you’re manufacturing or importing cosmetics into the EU. What was allowable in July may be prohibited in August so constant vigilance is necessary.
There is a complete ban on animal testing of products and ingredients, so product safety is assured on the basis of a professional assessment of available data. Animal testing hasn’t been allowed in the UK since 1995. However, the practice is common in other countries and there is misunderstanding about this issue.
The law says you cannot test on animals for the purposes of ensuring cosmetic safety according to the regulation. This means that if you are required by another Law to do animal testing for another purpose, such as selling in China where it’s mandatory to carry out animal testing, or Compliance with the REACH Regulation in Europe, it does not mean you cannot sell a product in Europe. You just have to provide a statement declaring why testing was carried out. You need to be aware of that differentiation particularly as some retailers have a policy of “no animal testing” when, in reality, historical testing has been done for most ingredients and is mandatory for new substances.
You are also required to give public access to some product information. You have to be able to tell the authorities what is in the product. You also have to survey the market constantly and liaise with authorities if something goes wrong.
A safety assessment is required, including instructions for safe use and disposal of the product and how many times a day the product is used. You don’t have to conduct the tests yourselves; other people can carry out testing as long as you make sure that they’re suitably qualified. There could be a potential conflict between the views of someone ensuring safety and the manufacturer, who says: “No, we want to sell it and make lots of money.” However, the responsible person has legal responsibility for these things, and it is they who could end up in court, not necessarily the manufacturer.
Factories should be audited, on average, once every two years. If it’s a factory with a long history of good performance, it might be every three years. If there have been problems, it might be every three to six months until you decide they’re improving or to go somewhere else.
Samples need to be taken off the production line and sent away for analysis. It needs to be proven that key ingredients are what the supplier says they are. As the responsible person, you have to do this in such a way that the supplier is aware that you’re doing it as it will keep them honest.
Information on where the product is manufactured and where it’s first imported is distributed by the EU to all the countries where it’s sold. Each EU member state will have its own regulatory authority who will look after things in their country—they then liaise with their equivalent in another country if something goes wrong.
Cliff Betton is a zoologist by training and Founder of Delphic HSE Solutions Ltd.
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products.
COUNCIL DIRECTIVE of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC)
GUIDANCE ON TOPICAL PRODUCTS FOR ANTI-BACTERIAL, ANTISEPTIC, ANTIMICROBIAL, GENERAL DISINFECTION AND CLEANSING OF SKIN Details about the work of the Medicines Borderline Section can be found under letter “B” in the A – Z search facility. At www.mhra.gov.uk