Product labelling and claims

EU and UK cosmetics labelling requirements

Just as attractive labelling is one of the most important features of the product when it comes to sales, so is correct labelling essential for the compliance of the cosmetic product with the cosmetics Regulation 1223/2009/EC and the UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, as labelling is an important part of the product information file.

The regulation contains various cosmetic labelling requirements and very specific rules regarding labelling, which have to be followed and are described in article 19 of the regulation. The notification of cosmetic products is not possible without the compliant product labels.

Without prejudice to other provisions in this Article, cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering… (EU Regulation 1223/2009, Article 19.1)

According to the regulation, the container and the outer packaging of cosmetic products have to bear the following information in indelible, easily legible and visible lettering:

The name and address of the responsible person

The country of origin if the product is imported from countries outside of the EU/UK

Nominal content of the product at the time of packaging, given by weight or volume

Date of minimum durability or period after opening

Precautions for use

Batch number of manufacture or the reference for identifying the cosmetic product

Function of the cosmetic product, unless it's clear from its presentation

List of ingredients (which may be indicated on the outer packaging alone)

Some of these elements may also be mentioned on an enclosed or attached leaflet, label, tape, tag or card if it's impossible to list them on the labels. In that case an open book symbol should be placed on the label, which indicates that some information about the product can be found elsewhere.

The open book symbol indicates that some information about the product can be found elsewhere.

Cosmetics regulatory services

The EU consists of 27 different countries and the cosmetic labelling laws require certain information on the labels to be translated into different languages. Some countries have more than one official language, which further complicates things and requires that certain information appear in more than one language on the labels.

Cosmetics regulatory servicesCosmetics regulatory services

Required languages for cosmetic labels (In the EU and EFTA)

CountryRequired language (s)
AustriaGerman
BelgiumFrench and Dutch
BulgariaBulgarian
CyprusGreek
CroatiaCroatian
Czech RepublicCzech
DenmarkDanish
EstoniaEstonian
FinlandFinish and Swedish
FranceFrench
GermanyGerman
GreeceGreek
HungaryHungarian
IrelandEnglish
ItalyItalian
LatviaLatvian
CountryRequired language (s)
LithuaniaLithuanian
LuxembourgGerman or French or Luxemburgish
MaltaMaltese or English
NetherlandsDutch
PolandPolish
PortugalPortuguese
RomaniaRomanian
SlovakiaSlovak
SloveniaSlovene
SpanSpanish
SwedenSwedish
UKEnglish
IcelandIcelandic
LiechtensteinGerman
NorwayNorwegian
SwitzerlandFrench and German and Italian

Cosmetic product claims

Every claim that appears on the cosmetic product label, on the website where the cosmetic product is presented, in TV commercials etc. has to be substantiated unless it's a clear exaggeration or it's obvious for the type of the cosmetic product. It is a responsible person's task to ensure that all of the claims made regarding the product are substantiated.

In the labelling, making available on the market and advertising of cosmetic products, text, names, trademarks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have. (EU Regulation 1223/2009, Article 20)

The EU published a separate regulation (Regulation 655/2013), which deals specifically with cosmetic product claims and is laying down 6 common criteria for the justification of claims used in relation to cosmetic products:

Legal compliance

Truthfulness

Evidential support

Honesty

Fairness

Informed decision-making

These common criteria are set in order to assess whether or not the use of a claim is justified. Regulation 655/2013 also provides guidance on the use of “free from claims” and hypoallergenic claims.

Additionally, there are is also a number of various guidelines for the so-called borderline products, which can also help determining which claims can be made for cosmetic products (as opposed to medical devices, biocides…) or how they should be phrased in the product is to be classified as a cosmetic.

Cosmetics regulatory servicesCosmetics regulatory services
Cosmetics regulatory servicesCosmetics regulatory services

How to prove cosmetic product claims

Best practices for claim substantiation evidence are also described in the Regulation 655/2013. Evidence for substantiation the claims can in general be based on:

Experimental studies (in silico, in vitro, ex-vivo, with instrumental or biochemical methods, sensory evaluations, etc.)

Consumer perception tests

Evidential support

Use of published information

Where a claim is based on scientific research or testing, that work should have been conducted in accordance with best practice (consult independent experts).

If you would like to find out more about the labelling requirements in the EU and UK and check if your product labels are indeed compliant with the EU and UK Cosmetics Regulation, please don't hesitate to contact us.

Contact us to find out which claims we can help you prove

And what do they say about us?

Pharmaplast began to work with CE.way almost one year ago. CE.way is our cosmetics consultant who look after compilation of PIF, safety assessments and CPNP notifications. In addition to this, CE.way is our European representative as our company is not located in Europe. Working with CE.way has been a joy so far. Their replies are very swift and Mr Tadej is very cooperative, helpful and with a deep knowledge about the cosmetics regulations. In addition to this, CE.way is very cost effective company in comparison with their European counterparts. For all the above reasons, I really recommend CE.way to other cosmetic product manufacturers.

Mena, Egypt

Pharmaplast

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