The EU has historically had the world's most rigorous standards for cosmetics labelling and claims, requiring that cosmetic product claims fulfil the six "Common Criteria": legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. Post-Brexit, suppliers and brands operating in Great Britain, Northern Ireland and on the EU-27 market will have to navigate this regime. They will also have to ensure that they are complying with the UK's own, now-independent, standards, which impose additional UK-only obligations in relation to the location and qualifications of the responsible person. Additionally, there is of course the possibility that the UK will diverge from the EU's exacting approach in the future. In this post, we break down the EU and UK's cosmetic product labelling and claims rules.
In the EU, cosmetics labelling and claims are covered by the Cosmetic Products Regulation (EC) No. 1223/2009 (EUCPR) and Regulation (EU) No. 655/2013 on the common criteria for the justification of claims (CCR).
The EUCPR sets out the framework for the EU's regulation of cosmetics. "Cosmetics" are defined at Article 2(1)(a) as " any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours". Importantly, beauty supplements are not regulated as cosmetics: Article 2(2) provides that "a substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product." There are of course separate regulatory frameworks for supplements and medicinal products.
The CCR provides that cosmetic product claims must fulfil six Common Criteria:
|Example (from the Technical Document)
||"Free from (e.g.) hydroquinone" is not permissible as hydroquinone is in fact banned, and it is misleading to convey the mere compliance with basic legal requirements as a specific benefit of the cosmetic product.
||"48 hour hydration" is not allowed if the evidence only supports a shorter period of hydration.
Results from in vitro studies should not be presented as a result from trials with individuals.
Studies should be conducted using rigorous scientific methodology
Electronically or cosmetically manipulated before and after images should not be used if the presentation is misleading as to the product's performance.
||"Free from parabens" is unfair and not permissible as this claim denigrates the entire group of parabens, when some are in fact proven to be safe to use.
||Claims should be clear and understandable to the end-user.
The EU also observes a Technical Document on Cosmetic Claims, which was agreed by the EU Commission's Sub-working Group on Claims on 3 July 2017. This document is not legally binding. What it does, however, is set out a collection of examples of acceptable and unacceptable claims, and the best practices as to the enforcement of the Common Criteria across Member States.
These rules sit on top of the existing EU regulations on misleading and comparative advertising and unfair commercial practices, which apply to all industries to protect consumers against harmful advertising including product labelling and claims. Additionally, the EU has a system of chemical control (named REACH (2006)), which ensures the safety of chemicals on the EU market. All ingredients in cosmetic products must comply with REACH regulations.
For each cosmetic product, Articles 4 and 5 of the EUCPR provide that a designated "responsible person" within the EU at the manufacturer must ensure compliance with all rules before the product is placed on the market. This includes making sure that the cosmetic product has undergone a safety assessment and ensuring that cosmetic claims are appropriate and can be evidentially supported. The Technical Document sets out best practices for substantiating claims, and emphasises that studies should employ scientific methodology and be conducted ethically.
Article 19 of the EUCPR sets out an exhaustive list of labelling requirements that cosmetic products placed on the market in the EU must fulfil. This includes giving details of the responsible person, describing the weight and content of the product, the use by date and the batch number, any precautions when using the product, the product's function, and list of ingredients. Where it is impossible to fit all of this information onto the packaging, it is permissible for it to be set out in an attached leaflet (with some exceptions).
Following Brexit, the EU's regulatory framework is mostly still applicable in the UK as a result of Brexit regulations the UK has enacted, in particular the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 and Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020.
The UK framework more or less ensures that the law the UK retained on 1 January 2021 mirrors the EUCPR and CCR. This means that cosmetic labelling and claims must adhere to the six Common Criteria set out above. However, there are some key changes that apply specifically to Great Britain (excluding Northern Ireland):
- the Technical Document does not apply (as it was not legally binding) and so the standard of "best practice" in cosmetic claims in the UK may end up diverging from the EU.
- UK-based responsible person: in order for a cosmetic product to be sold in Great Britain, a UK-based responsible person will have to be responsible for ensuring the safety of the product, and the safety assessors must have qualifications recognisable in the UK. The same continues to apply in the EU, but the requirement is for an EU-based responsible person and EU-recognised qualifications. The responsible person must also keep a product information file at the registered office address or the address detailed on the product so that it can be easily requested by the regulator in the case of a medical emergency. So now, if a product may be sold in either Great Britain or the EU, there will be a requirement to have both an EU-based and a UK-based responsible person and safety assessments undertaken by individuals with UK and EU-recognised qualifications.
- Cosmetic products for sale in Great Britain will need to feature on their labelling the name and address of the UK responsible person, as well as the country of origin. There is a two-year transition period (until 1 January 2023) before businesses will have to include the UK responsible person's details on product labels (provided that the EU responsible person's details are included), so as to enable existing stock to make its way through the supply chain.
- There is now a UK notification service (the UK Submit Cosmetic Product Notification service or UK SCPN). Products to be placed on the market in Great Britain will have to be notified to the Secretary of State using this service, rather than the EU's service. For existing products that have been previously notified to the European Commission, they must be notified using the UK SCPN by 31 March 2021 with a reduced amount of information. For new cosmetic products that have not previously been notified to the European Commission or placed on the EEA market, the UK responsible person will need to complete a full notification using UK SCPN before such products can be sold in Great Britain.
- Where a business brings in cosmetic products from the EU-27 to Great Britain, that business is now an "importer", where it would have previously been a "distributor". It will become a responsible person by default (tasked with ensuring the safety of the product), although may appoint an agent to act as the responsible person.
Crucially, the UK framework will not apply to Northern Ireland, which will remain covered by the previous EU regulations under the Northern Ireland Protocol. Cosmetic products that are placed on the Northern Ireland market can be sold within the rest of the UK with no additional approvals, save that a Northern Ireland responsible person must give notification of the product's ingredients using the UK SCPN, and should alert the regulator if the product is found to be unsafe.
Consequences for non-compliance
Errors in labelling and claims can be costly and have a significant impact on a brand's reputation. The regulators are able to take measures to stop the sale of a cosmetic product (including withdrawing/recalling one that is already available). This can happen when a product's labelling and claims do not comply with the regulations, if the responsible person does not fix any issues or if there is a serious risk to human health.
With the added complexity that Brexit provides for brands seeking to manufacture and/or sell cosmetics in the UK and Northern Ireland, it is advisable to ensure that there is another person (beyond the "official" responsible person) who is experienced in the UK and EU cosmetics regulations. Taking these steps to review packaging and product claims will help to avoid any serious errors and the adverse publicity of a product recall.