Your resource for cosmetic safety standards in Europe

To bring cosmetic products into the European market, there are a number of criteria, assessments and steps to be completed to make sure the cosmetic and personal care products are safe for European consumers.

Read about them here.

What is a EU product registration or CPNP?

The Cosmetic Products Notification Portal (CPNP) is the online notification system to implement Regulation 1223/2009 on cosmetic products. European regulation 1223/2009 (Article 13) states that all cosmetic products placed in the European Union market need to be registered into CPNP prior to being placed on this market.

Notification is a pre-market requirement where the Responsible Person informs the EU Commission and the EU member states that the product will be placed on the EU market. It must be done after the cosmetic products are compliant with the relevant legislation (their Product Information File is completed and compliant).

Under EU Regulation 1223/2009 (applicable since 11 July 2013) the notification process was simplified by creating only one electronic centralised notification system (the CPNP – Cosmetic Product Notification Portal) for all the EU countries, which started operating on 11 January 2012.

Prior to placing the cosmetic product on the market the Responsible Person must submit the following to the EU Commission:

  • The category of cosmetic product and its name or names, enabling its specific identification
  • The name and address of the Responsible Person where the Product Information File is made readily accessible
  • The country of origin in case of import
  • The member state in which the cosmetic product is to be placed on the market
  • The contact details of a physical person to contact in case of necessity
  • The presence of substances in the form of nanomaterials
  • The name and the Chemical Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under part 3 of Annex VI to Regulation (EC) No 1272/2008
  • The frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties
  • The original labeling, and, where reasonably legible, a photograph of the corresponding packaging

It is important to know that all products placed on the EU market before July 2013, which were notified according to the old EU cosmetics Directive, have to be notified again – to the Cosmetic Product Notification Portal CPNP, to continue to circulate in the EU market.

To enhance the safety of cosmetic products and strengthen market surveillance, cosmetic products placed on the market after the date of application of this Regulation should comply with its obligations regarding safety assessment, the product information file and notification, even if similar obligations have already been fulfilled under Directive 76/768/EEC. (EU Regulation 1223/2009, 68)

Cosmetic Product Safety Report (CPSR)

Cosmetic Product Safety Reports are required for each cosmetic product on the European market. Tox24 has many years of experience in conducting Safety Assessments for cosmetic products to meet the EU cosmetics regulation 1223/2009.

With our extensive dermatology knowledge and experience TOX24 has in-depth knowledge about the interaction between the skin and a product’s ingredients. We look at the product, the production process, the quality of raw materials, manufacturing process and the use of additives.

A safety certificate is issued only if it has been proven that the product can be used without side effects. There are a variety of safety assessments that must be completed for each cosmetic product. We work with all types of cosmetic products and our safety reports are:

  • Scientifically based
  • Delivered promptly
  • Conducted by a certified safety assessor
  • In accordance with European Regulation 1223/2009

What is a Product Information File (PIF)?

A Product Information File (PIF) is required for each cosmetic product on the European market. The file contains all information on the product, from manufacturing to labeling. According to the EU Cosmetics Regulation 1223/2009/EC, these include:

  • Product Description
  • Safety Report:
    • Part A: Cosmetic Product Safety Information
    • Part B: Cosmetic Product Safety Assessment Report
  • Method of Manufacturing
  • Evidence of compliance with Good Manufacturing Practices (GMP)
  • Proof of the effect claimed (where justified)
  • Data on Animal Testing
  • Labeling (taking into account the container and outer packaging)
  • Data on Serious Undesirable Effects

The PIF is kept by the Responsible Person at the address specified on the label (within the European Community) for 10 years after the last batch was put on the market. The PIF should be held in a safe storage location, readily accessible to the Competent Authorities in electronic or other format.

TOX24 knows exactly how a Product Information File should be compiled. We will gladly do this for you! We can also augment, check or conform files. Our PIFs are guaranteed to comply with all legal requirements, compiled by a professional team and contain a scientifically substantiated Safety Assessment.

Stability testing
We perform stability testing on cosmetics to make sure they maintain their function and appearance as well as physical, chemical and microbiological quality when stored under appropriate conditions. Testing can be undertaken under controlled accelerated or real-time conditions.
Most products require an accelerated stability test, which means we subject them to much more severe conditions. This test is a predictive study that we use to estimate the expiry date of the product.We perform stability testing to ensure:

  • Stability and physical integrity of the products under appropriate conditions for storage transport and use.
  • Chemical stability
  • Compatibility between the product and packaging

Microbial testing of possible contaminated product
Cosmetics can be spoiled or undergo chemical changes if there is microbial contamination, which can cause spoilage or chemical changes. If this happens, the cosmetics are no longer safe for consumers to use.
When people use cosmetics products and health, the products are “challenged” — or contaminated — by unclean hands. That’s why it is important to make sure all products are free of pathogenic (harmful) microorganisms and are safe for consumer use.
Some of the microbial testing we perform with set time parameters include Aerobic Plate Count (APC), Yeast and Mold count, Enrichment Method for specific pathogen screening and Total Gram Negative test.
The Total Gram Negative test looks for Gram negative organisms, including:

  • Pseudomonas aeruginosa
  • E. coli, Salmonella
  • Serratia, Enterobacter
  • Klebsiella pneumoniae
  • and others

The Total Gram Positive Test looks for Gram positive organisms of medical interest:

  • Staphylococcus (cocci)
  • Streptococcus (cocci)
  • Enterococcus ((diplococci)
  • Bacillus (rod-shaped)
  • Clostridium (rod-shaped)
  • Listeria (bacilli/rods)
  • and others

Antimicrobial Preservative Effectiveness Test (Challenge Test)

To evaluate the effectiveness of an antimicrobial preservative in the health, beauty, personal care or cosmetic product, we subject cosmetic products to known microorganism strains at different intervals to determine the survival of the organisms. Microbial testing at Tox24 is performed in according to the high European standards. The test demonstrates the efficacy of the product to stop the growth of pathogenic organisms such as:

  • Staphylococcus aureus
  • Escherichia coli
  • Pseudomonas aeruginosa
  • Candida albicans
  • Aspergillus niger

Chemical analysis on product

To ensure the safety of finished cosmetic products, products undergo chemical analysis. Despite safety measures taken by manufacturers, impurities may still occur in cosmetics.
Using chemical analysis, occurence and levels of impurities are measured in the finished product. An example of such a test is Mass Spectrometry. We check whether levels of impurities comply with regulatory standards, and assess the safety by using the information in our database. Aside from assessing all impurities, we take special care when we find impurities which contain heavy metals, or are carcinogenic, mutagenic or toxic to reproduction (CMR substances).

Chemical analysis on raw material

To ensure the safety of ingredients used in cosmetics, raw materials undergo chemical analysis. Despite safety measures taken by producers, impurities may still occur in the raw materials.
Using chemical analysis, occurence and levels of impurities are measured in the raw materials. An example of such a test is Mass Spectrometry. We check whether levels of impurities comply with regulatory standards, and assess the safety by using the information in our database. Aside from assessing all impurities, we take special care when we find impurities which contain heavy metals, or are carcinogenic, mutagenic or toxic to reproduction (CMR substances).

What documentation is required on raw materials?
To comply with EU regulation 1223/2009, documentation on all used raw materials must be provided. The manufacturer of the raw materials is responsible for providing all needed documentation.
The following documents are required:

  • Material Safety Data Sheet (MSDS) with information on purity grade or intended use
  • Certificate of Analysis (CoA) with at least present impurities
  • Statement of non-animal use in manufacturing or testing
  • A document stating INCI’s and their concentration in the raw material (can be in the MSDS)
  • When the raw material is a parfum or parfum substance: statement of compliance to IFRA guidelines

What are Cosmetic claims?

Cosmetic claims are used to market the final product and appear on the label as well as ads, magazines, etc. They describe the effects of a product, help consumers choose a product and can make it seem more appealing than the competition.

Cosmetic product claims are mentioned in article 20 of Regulation 1223/2009: “In the labeling, 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.”

The European commission has published a regulation specific to cosmetic claims (EC: 655/2013) as well as guidelines to improve the understanding of these rules by the Industry. The European regulation 655/2013 is to ensure that the information provided to consumers useful, understandable and reliable.

EU Claims must comply with six common criteria
Each claim on the product has to be in compliance with Annex II of the guidelines to commission Regulation 655/2013. Tox24 will advice you to meet the following criteria.

1- Legal compliance
It’s prohibited to claim “that a product has been approved or authorised by a competent authority”. Or to claim the “specific benefit of a product when this benefit is mere compliance with minimum legal requirements”. Claims should “be based on the perception of the average end user of a cosmetic product”.

2- Truthfulness
If you claim your product “contains a specific ingredient, then it must be deliberately present”. “Ingredient claim referring to properties of a specific ingredient must not imply that the finished product has the same properties when it does not”. If you use opinions for marketing purposes, then they must be truthful.

3- Evidential support
Cosmetic product claims must be supported by adequate and verifiable evidence. These can in various forms including:

  • Experimental tests: in vitro or in silico or clinical
  • Consumer perception tests
  • Published scientific data and market data

4- Honesty
Claims must not go beyond the actual performance of the product. You cannot market your product as “unique” if similar products have the same specificities. It must be clear if your product requires specific conditions of use or if it must be used with other products.

5- Fairness
Cosmetic products claims must “be objective and must not denigrate the competitors, or ingredients that are legally used”. Claims for cosmetic products must “not create confusion with the product of a competitor”.

6- Informed decision-making
Claims must be “clear and understandable” to the average consumer. “Marketing communication must take into account the capacity of the target audience to comprehend” and must be “clear, precise, relevant and understandable by the target audience”.

Product Labelling

Cosmetic product labeling must reflect its product formula. The final artwork must contain the following information.

  1. Full Commercial Name
  2. Product function (must be translated)
  3. Particular precautions for use (must be translated)
  4. Ingredients list
  5. Expiration date: open jar symbol or hourglass
  6. Responsible person name and address: Tox24
  7. Manufacturer Name and Address
  8. Batch number
  9. Product’s country of origin
  10. Nominal quantities

What is EU Regulation 1223/2009?

The new European Cosmetics Regulation, EC 1223/2009, was published in the official journal of the European Commission in 2009. It came into effect in 2013, and replaced the previous Cosmetics Directive 76/768/EEC law. It covers gaps from the previous Directive and to once again, harmonise the European Market.

The Cosmetics Regulation 1223/2009/EC aims, same as the Cosmetics Directive 76/768/EEC did, at the free movement of cosmetic products within the EEA market but also and as important at ensuring the safety of the users of cosmetic products in Europe. Cosmetics free to circulate within the market must acquire evidence to their conformity with the stipulated requirements in their respective Product Information File.

The novelty comes from assigning a greater responsibility to the EU Responsible Person (RP) by clearly indicating that cosmetic products may be placed on the EU market only if an EU Responsible Person (RP) has been designated towards them;

“Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market” (Art.4, p.1).

Furthermore, the regulation brings a new centralized pre-market notification system. This implies that national notifications will not be completed anymore but instead the notification will be electronical towards the European Commission Cosmetic Products Notifications Portal (CPNP). Once a product will be notified by the Responsible Person to the CPNP, the product may circulate in all EU Member States.

The Responsible Person is to ensure compliance with the relevant obligations set out in the Regulation: Safety, Good Manufacturing Practices (GMP), Product Information File (PIF), Composition-Restricted Substances, Nano-Materials, Labeling, Claims, Serious Undesirable Effects (SUE), Animal Testing and EU Pre-Market Notifications of Cosmetic Products;
“Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24” (Art.5, p.1).

What are Good Manufacturing Practices (GMP)?

When we compile a Product Information File for a cosmetic, we need to provide evidence of Good Manufacturing Practices (GMP). These make sure the manufacturing method meets health requirements. We require GMP certification as condition for EU clearance.

The GMP refers to the producer of the product. Any entity that places cosmetic products on the EU market under its name must have GMP evidence (in reference to its different producers) as part of their Product Information File. This has to be certificated by a third-party, SGS or Intertek, in reference to an on-site audit

These require different criteria:

  • Cosmetics Europe: Cosmetic Good Manufacturing Practices
  • Council of Europe: Guidelines for good manufacturing practice of cosmetic products
  • CEN/ISO norm 22716

European regulation directs that the CEN/ISO Norm 22716 serves as presumption of conformity towards GMP.

Non-animal statement

Under EU Regulation 1223/2009 use of animals during any stage of product development or testing is prohibited. When assessing the safety of ingredients, animal studies done prior to 2013 are allowed for use. Any products tested on animals may not be sold within the EU. A document stating no animals are used is required when selling cosmetics in the EU.