How to get cosmetic CPSR?

CPSR is a report on cosmetics, indicating whether the product is safe, it’s a “passport” for cosmetics to enter the EU market.

What is CPSR?

CPSR stands for Cosmetic Product Safety Report, which is a detailed safety assessment of a cosmetic product that must be carried out before it can be placed on the market in the European Union. The CPSR is required by law under the EU Cosmetics Regulation (EC) No 1223/2009.

A CSPR consists of:

Part A: cosmetic safety information

Cosmetic safety information is all data collected for safety assessment, including the following 10 parts：

• The quantitative and qualitative composition of cosmetics:

It’s the formula, all substance’s chemical characteristics(chemical name, INCI, CAS, EINECS, function).

• Physical/chemical properties:

Color, odor, appearance, viscosity, Solubility, pH, flammability, etc., and the stability of cosmetics under reasonably foreseeable storage conditions.

• Microbial quality:

Through challenging tests to ensure the absence of harmful microorganisms, such as bacteria, fungi, and viruses.

• Impurities, traces, information about the packaging material:

The characteristics of packaging materials, especially purity and stability. If there are traces of prohibited substances, then proves that they are technically inevitable.

• Normal and reasonably foreseeable use:

This includes conducting appropriate safety and efficacy testing, selecting safe and appropriate ingredients, and providing clear instructions for use and any potential risks associated with the product.

• Exposure to the cosmetic product

The level and duration of exposure to a cosmetic product can vary depending on the type of product, the frequency of use, the amount applied, and the individual’s habits and lifestyle. For example, a person who frequently uses a leave-on cosmetic product, such as a moisturizer or sunscreen, may have a higher level of exposure than someone who uses a rinse-off product, such as a shampoo or body wash.

To ensure the safety of cosmetic products, manufacturers must conduct appropriate safety testing to evaluate the potential risks associated with the product and provide clear labeling and instructions for use to minimize the risk of adverse effects from exposure.

• Exposure to the substances

The level and duration of exposure to individual substances in cosmetics can vary depending on the product formulation, frequency of use, the amount applied, and the individual’s habits and lifestyle. Some ingredients may be more likely to cause adverse effects than others, depending on their toxicity, sensitizing potential, and concentration in the product.

Manufacturers must assess the safety of individual ingredients, as well as the safety of the final product formulation, through appropriate safety testing. This includes evaluating the potential risks associated with individual ingredients, such as skin irritation, sensitization, and toxicity, as well as any potential interactions between ingredients.

• Toxicological profile of the substances

The threshold value indicates under what exposure conditions the substance is harmful, and the actual exposure amount refers to the normal use situation. The difference between the two is referred to as the Margin of Safety (MoS). In cosmetics, if the actual exposure level of a substance is at least 100 times lower than the harmful exposure level, then the ingredient is safe.

Manufacturers should consider all important absorption toxicological pathways and calculate the system impact and MoS based on the level of unobserved adverse effects (NOAEL). If these considerations are not present, appropriate justification should be provided.

• Undesirable effects and serious undesirable effects

Manufacturers are required to report serious undesirable effects to the relevant regulatory authorities. These reports help to identify potential safety issues with cosmetic products and can lead to product recalls or other regulatory action to protect consumers.

• Information on the cosmetic product

Other relevant information, such as the correct confirmation and confirmed results of existing research from human volunteers or risk assessments conducted in other relevant fields.

Part B: safety assessment

• Conclusion: safe or not safe

Is this product safe or not safe?

• Label warnings and instructions for use

A statement stating the need to mark any special warnings and instructions for use.

• Reasoning

This is a scientific explanation of the first and second points. This explanation should be based on the description in Part A.

• Assessor’s credentials and approval of part B

The assessor shall certify that he/she is qualified to conduct a safety assessment, approve the safety assessment, and sign the date.

What documents should be provided for CPSR?

CPSR is part of the Product Information File (PIF), which should be kept for 10 years, starting from the date the last batch of products was placed on the market, and it must be conducted by a qualified safety assessor who should have a university diploma (or other formal qualification) in pharmacy, toxicology, medicine, or similar disciplines (recognized by Member States as equivalent).

• Product information(for final product)

Product name, product description (such as physical state, color, intended use, etc.)

• Ingredient list(for final product)

Each raw material’s INCI name, CAS, EN, proportion, function, supplier(non-essentials).

• MSDS(for both final product and raw material)

A qualified MSDS should provide essential information about the potential hazards of a substance, including physical, chemical, and health risks, as well as guidelines for safe handling and use.

• COA/TDS(for both final product and raw material)

Certificate of analysis, typically issued by a manufacturer, includes details about the product’s physical and chemical properties, as well as any analytical testing.

• BOM(for final product)

A bill of materials (BOM) is a document that lists all the materials, components, and sub-assemblies needed to manufacture a product.

• Microbiological test report(for final product)

The information about the presence, type, and quantity of microorganisms in a sample. colony total, molds and yeasts total, Staphylococcus aureus.

• Challenge test report(for final product)

A specific type of microbiological testing used to evaluate the antimicrobial efficacy of a cosmetic, it can be simply understood that this is a test for preservatives.

• Heavy metal test report(for final product)

To detect if the product contains Pb, Cr, Hg, As, Sb, Ni.

• TRA test report(for final product)

Toxicological Risk Assessment, to evaluate their potential or other adverse reactions in humans, such as acute oral toxicity, corrosivity and skin and eye irritation, strong sensitization, chronic toxicity.

• Stability test report(for final product)

It involves subjecting cosmetic products to various stress factors, such as temperature, humidity, and light, to assess their stability and shelf life.

• Compatibility test report(for final product)

In fact, it is similar to a stability test report, except that the purpose of this report is to see if the content is compatible with the packaging material.

• IFRA Analysis(for fragrance)

Analyzes the chemical composition of fragrances and determine their potential risk to human health and the environment. There are our categories: Prohibited, Restricted, Annex III, Not restricted.

• Allergen List(for fragrance)

If your fragrance contains allergens that are on the 26 fragrance allergens list, you have to list them on the product label.

The manufacturer/supplier also need to provide below certificate or statement:

• GMPC-ISO 22716

• Description of Manufacturing Method

• No Animal Test Statement

• Statement on CMR

• Statement on nanomaterials

Which tests are required for CPSR and what is the cost？

What tests need to be done largely depends on your product type. For example, bath bomb is self-presentive, so microbiological and challenging tests can be avoided. Overall, TRA, microorganisms, heavy metals, and stability are common tests that require third-party testing.

The costs mainly involve third-party testing and review fee. Generally, manufacturers have the conditions to do stability reports, if you can accept that, then this cost can be saved. Below is the rough cost to get CPSR report:

What to pay attention to when getting CPSR?

• Start too late

It must be noted that the testing cycle for CPSR is very long, for example, strictly speaking, stability testing must take 3 months. This must be fully considered when planning for product launch.

• Invalid documents

For example, MSDS typically needs to be updated every three years, but you provided a version that is over three years.

• Animal testing

In the MSDS of some ingredients, TRA involves animal testing， this is not allowed.

• Different supplier

For raw materials, the MSDS is from A supplier, while COA is from B supplier.

• Changes in regulations

Pay attention to the update on regulations, for example, the limit for certain ingredients is 5%, but in the second year it was reduced to 2%, and your product is still in shelf life.