What is CPSR evaluation? CPSR evaluation

What is CPSR

CPSR stands for Cosmetic Product Safety Report. Cosmetics sold in the EU market must comply with cosmetic regulations, including submitting CPSR.

Applicable Products

The cosmetics covered by CPSR include: pressed powder, liquid foundation, concealer, setting powder, loose powder, blush, lip gloss, lipstick, lipstick, eye shadow, mascara, eyeliner, liquid eyeliner, eyeliner cream, nail polish, nail polish remover, toner, facial cleanser, lotion, face cream, eye cream, skin care essence, BB cream, primer, hand cream, makeup remover oil, makeup remover water, facial mask, shampoo, conditioner, hair dye, hair mask, shower gel, body lotion, sunscreen, perfume, teeth whitener/powder, soap, essential oil, etc.

Contents include

CPSR is an independent cosmetic safety assessment opinion. Before entering the EU market, cosmetics must be assessed to ensure that they are safe for use under normal and reasonably foreseeable circumstances and comply with cosmetic regulations. A complete CPSR is divided into two parts: cosmetic safety information and cosmetic safety assessment, including:

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

1. Quantitative and qualitative composition of cosmetics

2. Physical/chemical properties and stability of cosmetics

3. Microbiological quality

4. Information on impurities, trace substances and packaging materials

5. Normal and Reasonably Foreseeable Use

6. Cosmetic exposure information

7. Exposure to substances

8. Toxicological studies of substances

9. Adverse reactions and serious adverse reactions

Information about cosmetics

The cosmetic safety assessment is the safety assessor's opinion on the safety of the product, which includes 4 parts:

1. Evaluation conclusion

2. Label warnings and instructions for use

3. Inference

4. Qualification and approval of assessors

CPSR Required Materials

Due to the strict data requirements and complex test items, a series of correct and complete materials need to be submitted to complete the CPSR, including:

§ Application form, including product name, product description (e.g. physical state, color, intended use);

§ List of ingredients, including the CAS number and percentage of each ingredient, and the intended function of each ingredient;

§ Material Safety Data Sheet (MSDS) of all ingredients;

§ Certificate of Compliance (COA) or specification;

§ 26 allergy-resistant fragrance test reports and IFRA (International Fragrance Association) certificate;

§ Microbiological quality test report of the product;

§ Preservative challenge test report of the product;

§ Product stability test report;

§ Product packaging compatibility test report, inner packaging material information, and heavy metal test report;

§ Heavy metal test report of the product (formula), including lead, arsenic, mercury, antimony, cadmium, and nickel;

§ Testing of products (formulations) for risky substances;

§ Product photos and label artwork of the final product;

§ Good Manufacturing Practice Certificate (GMP) or audit report;

§ No nanomaterials declaration;

§ If you already have valid data for all the above materials, you can check and review these data, conduct cosmetic safety assessment, and provide the final CPSR. If there is no relevant data or the data is incomplete, the cosmetic safety assessor will preview the product formula for adjustment, recommend a test plan for you, and then conduct necessary tests and provide corresponding data support.

Brief introduction of relevant test items

1) Stability test

EU Cosmetics Regulation (EC) No 1223/2009 requires products to provide stability information under normal storage conditions. This test determines whether the product has changes in appearance, physical and chemical properties, microorganisms and components over a period of time by increasing temperature and humidity, thereby achieving the purpose of stability testing.

2) Microbial contamination test

The microbiological indicators of the microbiological test evaluation mainly include: total bacteria count, molds and yeasts, Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Salmonella, Candida albicans, Clostridium, Enterobacter, Gram-negative bacteria and bile-tolerant Gram-negative bacteria.

According to the European Pharmacopoeia (EP 2.6.12 & 2.6.13) / British Pharmacopoeia (BP Appx. XVI B) / United States Pharmacopoeia (USP61&62) / European Cosmetics and Fragrance Association Guidelines (Cosmetics Europe) Cosmetics and Fragrance Association (TFA) method.

3) Heavy metal element analysis

The US FDA's heavy metal testing is mainly for lead and mercury, while the EU REACH (1907/2006) regulations cover heavy metals such as lead, cadmium, mercury, arsenic, antimony, and nickel.

Mercury is usually found in whitening cosmetics. The limit of mercury in EU regulations is 1mg/kg for general products and 70mg/kg for eye products (containing mercury preservatives); the US FDA stipulates that the limit of mercury in general products is 1mg/kg and 65mg/kg for eye products (containing mercury preservatives).

4) Toxicity risk assessment

Toxicological Risk Assessment (TRA) evaluates the toxicological properties of each ingredient in the product and the toxicological properties of these ingredients mixed in the finished product, as well as the characteristics and risks exposed to the product during use, and also considers the requirements for product safety in the cosmetics regulations of various countries. Applicable countries or regions include the European Union (before July 2013), the United States, Canada, Australia, ASEAN, the Middle East (SASO) and Hong Kong. The Toxicological Risk Assessment (TRA) report must be signed by a qualified toxicologist.

Toxicity risk assessment has become a regulatory requirement for some consumer products, such as cosmetics exported to EU countries must pass toxicity risk assessment. Many large-scale buyers have also included toxicity risk assessment as one of the consumer product testing items to demonstrate their prudent and responsible attitude and attention to consumer health. Toxicologists evaluate the safety and risks of products under normal and predictable conditions of use by considering the use route, quantity and frequency of sample ingredients, the area and part of the skin in contact with the skin, etc.

Toxicity risk assessment is an alternative to animal testing and has the advantages of being faster and less expensive.

It is a safety review of the product formulation to assess whether the product will cause adverse reactions to the user under normal and reasonably foreseeable conditions of use.

Toxicologists will determine whether the formula contains any adverse effects on the patient's health, such as acute or chronic toxicity, irritation or allergic reactions.

Comprehensive conclusions are drawn based on the toxicological properties of the various ingredients, their interactions after mixing, and the characteristics and risks of exposure during use.

5) Toxicology files of cosmetic ingredients/raw materials

Annex 1, Article 8 of the EU Cosmetics Regulation (ECNO1223/2009) stipulates that all ingredients and raw materials used in cosmetics must be provided

Provide a separate toxicological profile of the substances, mainly including the following contents

1. Local toxicity (skin and eye irritation, skin sensitivity and phototoxicity, etc.)

2. Systemic and long-term toxicity (calculation of safety margin)

3. Particle size and its effect on toxicity

4. Impurities and their impact on toxicity

5. Interactive substances and their effect on toxicity.

6) Preservative effectiveness test

The product's stability and antimicrobial preservative effectiveness test is to inoculate the sample with prepared target bacteria and observe the changes in the number of microorganisms at different times to determine whether the preservative has achieved the specified antiseptic and antimicrobial effect. The inoculated target bacteria are the following five: Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Aspergillus niger and Cannabis sativa.

The test is mainly based on

EP (5.1.3)

BP (Appx. XVI C)

USP(51)

COLIPA

CTFA, etc.

7) Cosmetic Safety Report

After the EU Cosmetics Regulation (CNO1223/2009) was officially implemented on July 11, 2013, all cosmetics entering the EU market must provide a product safety report (CPsR, Cosmetic Product Safety Report)

8) EU Cosmetic Product Notification

According to the EU Cosmetics Regulation EC No 1223 2009, cosmetics must be notified on their official website (e-Notification) before they can enter the EU market.

This service helps companies collect and organize the necessary information and make notifications based on regulatory requirements and relevant guidance documents from Cosmetic Europe, so as to quickly enter the EU market.

References

• 1. GPSR assessment for cosmetics entering the EU market: Certification Network [reference date 2019-11-14T16:00:00.000Z]