Safety and Toxicology

Safety is nonnegotiable especially when concerning Cosmetic Products which come in direct contact with skin and eyes. Various risks related to both have to be taken into consideration at the time of testing and are to be mentioned in CSPR (Cosmetic Product Safety Report) which is mandatory according to European and United Kingdom regulations and is an important component of the Product Information File.

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What is the Safety and Toxicology Test?

A cosmetic product comprises various components that may not be toxic in their capacity but the mixture obtained may possess some unidentified risks for the end user. To assess those risks in advance, Safety and Toxicology tests are mandatory for Cosmetic Products to be legally marketed. Safety tests ensure that cosmetic products are safe for human use under various conditions.

Toxicology tests have the purpose of making sure products cause no toxicity when in contact with human skin or eyes and don’t lead to issues like Skin Irritation, sensitization, eye irritation, phototoxicity, or acute toxicity.

According to European Cosmetic Product Regulation (EC) No 1223/2009 “Regulation (EC) No. 1223/2009, a full cosmetic safety assessment needs to be performed and included in a Product Information File kept at the company. This file also includes a description of the product, the product safety report, information about the manufacturing methods, and proof of effects claimed.“

In order to comply with the regulation, a Cosmetic Product Safety Report (CPSR) needs to be submitted which showcases the safety of the product and is also one of the most important elements of the Product Information File. It is also required by the United Kingdom Cosmetic Regulations.

What are the contents of the Cosmetic Product Safety Report (CPSR)?

It contains every relevant detail related to the safety of the product and outlines each and every safety information related to the product like the formulation, and manufacturing techniques used.

A CPSR must contain two parts :
Part A contains information about product safety information to justify the safety of the product.
Part B contains information about product safety assessment is the actual evaluation of the safety of the product.

Here are the contents of Part A:
  • Quantitative and qualitative composition of the product
  • Chemical and physical stability of cosmetic products and it’s characteristics
  • Microbiological specifications of the cosmetic product
  • Information about the packaging material, such as impurities, traces of prohibited ingredients, etc.
  • Foreseeable use of the product
  • Exposure to the cosmetic product and its secondary exposure routes
  • Exposure to the substances
  • Toxicological effects of the ingredients
  • Undesirable effects and serious undesirable effects
  • Data related to the cosmetic product

  • Part B consists of notes from the Cosmetic Safety Assessor on the safety of the product and has 4 sections.

  • Conclusion of the safety assessment
  • Instructions and warnings regarding the usage and labelling of the product
  • Reasoning
  • Assessor’s credentials and approval of part B

General Information Required in the Cosmetic Product Safety Report (CSPR) of the EU and UK

1) information about the Cosmetic Product 
This contains information about the intended use, its category, description, and contact details of the responsible person

2) Formulation used in the Product
It refers to the detailed list of ingredients along with their specific concentrations

3) What manufacturing processes are used
It is a detailed description of the manufacturing process which is used to make the final product.

4) Safety Assessment
In this part, potential risks of the ingredients and product on the end user have to be considered, and risk assessment has to be done.

5) Post Marketing Surveillance
This includes what measures are taken by the manufacturer to ensure that the product is safe after being placed on the market.

What are some Other Common Tests?
Here are the most common tests used to asses cosmetic product safety :  

(i) Microbiological test
It is done on raw materials to ensure there is no growth of unwanted organisms (bacteria, fungi, and yeast) that may harm the end user or change the chemical composition of the cosmetic product in the long term.

(ii) Stability test 
To check whether the product is stable enough in the long term (i.e. it maintains its odour, colour, and other functional properties) when placed under claimed conditions by the manufacturer.

(iii) Performance test 
The claims put forward by the manufacturers are substantiated with scientific evidence in this test. Example: If a product is claiming ‘skin – whitening’, then it will be assessed whether it withstands the intended purpose.

(iv) Compatibility test with packaging 
This test aims to assess what happens when the packaging material comes in contact with the cosmetic product for a long period. It also judges whether these changes affect the end user negatively.

All the tests mentioned for your specific product type are necessary and should be included in your Product Information  File to ensure that your products can be marketed legally. It is important to be aware of the specific testing requirements in advance. To know the complete lists of tests for your specific products, send us a query and our experts will help you out.

Risk of Non-Compliance

If the CSPR does not comply with the regulations, then strict actions are taken against the manufacturer by the relevant authorities. These actions can be high penalties, Product recalls or even bans for a certain duration in severe noncompliance. These can result in loss of brand reputation and limited market access to Cosmetic Manufacturers.

Cert3global : Your Partner in Safety and Toxicology Tests

Complying with the regulations of the European Union and the United Kingdom requires a careful eye fueled with experience and competence. We at Cert3global have been fortunate to assist successful brands in helping them prepare their Product Information File.

Our team consists of specialised experts and has technically streamlined processes in place with high standards for data security and confidentiality. Hence providing all the assistance you need at the right time.

We can help you prepare the Cosmetic Product Safety Report for your products with the best practices .All you need to do is to send us a query with your details.