Cosmetic Product Safety Reports EU

We are team of experts from fields of chemistry, pharmacy, biotechnology medicine and toxicology with years of experiences and hundreds of finished safety assessment documentations. Our constant education and contact with inspectors from almost all EU countries gives us valuable up to date experiences and focus on details. Our team can help you to start selling your cosmetic products all around Europe.

Safety assessment of cosmetic products is a required procedure in EU by the Regulation (EC) No 1223/2009. The legislation sets standards and ensures that every ingredient in cosmetic products is safe to use on the human body in a rinse-on or rinse-off products like face creams or shower gels. Documentation of Safety assessment of cosmetic products must be made before cosmetic product is placed on the marked or imported into EU. Documentation can be only made by a person with the proper education from natural sciences, which ensures quality and safety of the products with finished assessment.

Safety assessment of cosmetics consists of:

PART A:

Quantitative and qualitative composition of the cosmetic product
Physical/chemical characteristics and stability of the cosmetic product
Microbiological quality
Impurities, traces, information about the packaging material
Normal and reasonably foreseeable use
Exposure to the cosmetic product
Exposure to the substances
Toxicological profile of the substances
Undesirable effects and serious undesirable effects
Information on the cosmetic product

PART B:

Assessment conclusion
Labeled warnings and instructions of use
Reasoning
Assessor’s credentials and approval of part B

We will also advise / offer services about:

EU labeling and packaging compliance (usually done within PIF preparation)
All required stability and compatibility tests (if required)
Responsible person for producer and/or distributor (if required)
Cosmetic products notification portal (CPNP) management (if required)

The procedure

The process of safety assessment is based mostly on collecting required documentation and investigating safety data of individual substances. Each assessment requires a different time of completion. Report is intended to gather the data necessary to prove that the cosmetic product is safe.

Preparation time

Preparation time is highly dependent of number and complexity of your products. It is also important if we include any outsourced laboratories services (for example microbial tests, etc). We will state approximately preparation time for each project individually. Ask us for quote.

Prices

The PRICE of safety assessment varies with the amount and complexity of ingredients and the availability of required data. We quote each customer individually. Usually is more for more complex products, with many ingredients. If you order multiple safety assessments at the same time you can get a discount. In case products are 100% different to each other, every product is a MAIN formula. Same formulations with minor changes, like color, perfume, are considered VARIANTS of main formula. The price for multiple different variants is lower than the price for multiple different main formulas. Contact us on our e-mail address to inquire about the precise costs.

Necessary documents for the Safety Assessment and the Product Information File (PIF) compilation according to Regulation (EC) 1223/2009:

1. RESPONSIBLE PERSON

Producer’s and/or distributor’s full address. Contact person complete information. This is the one who acts as responsible person in the company (name, phone, email, etc.)

2. DESCRIPTION

General specification of final product, such as full product name, appearance, pH, packing, volume, color, odor, viscosity, how the product is to be used (how often, which part of the body, washed-off or left on), what particular group of people it is aimed at (adults, baby,..), when the product was first launched and in which country if not new, etc.

3. FORMULA AND INCI

Formula in percentage by weight for each ingredient and INCI names of the ingredients. Note that it has to be detailed at least on preservatives, UV filters, colors (CI index), essential oils and/or perfumes or ingredients under limitation of use.

4. RAW MATERIALS

We need complete specifications of raw materials. This includes certificates of analysis, SDS, list and quantity of allergens for essential oils and/or fragrances, IFRA certificate for perfuming components, Percentage breakdown of trade named ingredients that are mixtures of more than one INCI names.

5. PACKING

Name of the packaging supplier and all required specifications of the packaging materials (jar, pump spray, tube,…) with conformity statements. The most important focus is on the actual materials used in the contact with raw cosmetic product. For example if it is a plastic we need to know the exact type.

6. PRODUCTION

Production method, it can be descriptive, not detailed.

7. GMP

Good Manufacturing Practice (GMP) certification of the producer (if available) or producer’s statement that company has implemented internal GMP standard for cosmetics.

8. STABILITY

Stability data of the final product is required. This is meant for both physical/chemical stability and microbiological stability. Microbiological specifications need to be provided for cosmetic products that are placed on the EU market. It is vital component of PIF for ensuring cosmetic product safety. We offer our internal laboratory solutions for some tests or/and we can also forward you to outsourced accredited laboratory for microbial tests, preservation efficacy test, challenge testing (if required), etc.