EU Cosmetic Safety Assessment
All cosmetic products sold in the EU must be assessed for their safety and compliance with the legislation by a qualified safety assessor with appropriate qualifications in line with the legal requirements of the EU Cosmetics Regulation 1223/2009. Safety Assessment Experts looks after your compliance and regulatory needs making it a stress free experience for you. Based on the specifications and tests of the cosmetic product we perform a thorough cosmetic product safety assessment to ensure your product is safe and legal for sale, and thereby complete your product’s cosmetic product safety report (CPSR).
Why are we your best EU cosmetics safety assessment partner?
INCREDIBLY FAST TURNAROUND TIME
Time is money, and we are aware of that. The sooner you can start selling your products, the more money you earn. That’s why we do everything we can to do the safety assessments as fast as possible. We created our own extensive database of raw materials’ toxicological profiles as well as built our own software that enables us to make the safety assessments faster. Other safety assessors usually take weeks to do the safety assessments, while our average turnaround time is only a few days from the time when we receive all of the necessary documents from you.
INDUSTRY EXPERTS
Not all safety assessments are of the same quality and not even all of the safety assessors are capable of making safety assessments that are compliant with the EU cosmetics regulation. Our principal safety assessor has years of experience, holds masters in pharmacy, a certificate from Vrije Universiteit Brussel in safety assessment of cosmetics in the EU, and a Society of Cosmetic Scientists diploma in cosmetics. You can therefore be sure that your safety assessment is in compliance with part B of the cosmetic product safety report (CPSR) as described in the EU cosmetics regulation 1223/2009.
AFFORDABLE PRICING
Do fast turnaround times and expertly qualified safety assessor result in an extremely high price for cosmetics safety assessments? Not at all! We maintain fair and reasonable prices. Our clients are not only big corporations, we also work with complete beginners and SMEs, and we know how hard it is for them to secure a budget in order to do everything necessary to be able to sell in the EU. If your product couldn’t pass the safety assessment, we also work with you to determine what should’ve been changed, so that you could start selling your cosmetic products in the EU – free of charge.
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EU Cosmetic Safety Assessment
One of the legal requirements before placing a cosmetic product on the EU market is to have a safety assessment of the product. This means that there should be an evaluation by a qualified professional to guarantee the safety of the cosmetic product and its ingredients. As stated in Article 10.1 of Cosmetic Regulation (EC) No. 1223/2009, the safety assessor should possess a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by an EU Member State.
But how is the assessment of the safety of cosmetic products done? The safety assessment is made based on the cosmetic product safety information in Part A of the Cosmetic Product Safety Report (CPSR). The safety assessor takes into account the product’s quantitative and qualitative composition, physical and chemical characteristics, stability, microbiological quality, packaging material, normal and reasonably foreseeable use, data on undesirable effects and the anticipated systemic exposure to individual ingredients in a final formulation. He/she uses an appropriate weight-of-evidence approach for reviewing data from all existing sources and takes particular consideration to the toxicological profile of the substances contained in the product.
The safety assessor makes a conclusion on the safety of the cosmetic product and provides an explanation of the scientific reasoning leading to the assessment conclusion. Where relevant, margins of safety, possible interactions of the substances contained and the impacts of the stability on the product’s safety shall be assessed and discussed. He/she also states whether there is a need to label any particular warnings and instructions of use in accordance with Article 19.1(d). For cosmetic products intended for use on children under the age of three (3) and for cosmetic products intended exclusively for use in external intimate hygiene, a specific assessment inter alia shall be accomplished.
The duly signed safety assessment and the proof of credentials of the safety assessor are then included in Part B of the CPSR which is compiled in the product’s Product Information File (PIF). Upon placing the product on the market, the safety assessment shall be kept up to date in view of additional relevant information generated.
What do our customers say
FREQUENTLY ASKED QUESTIONS
How does the process work?
We first agree on the number of safety assessments that have to be performed. Then we send you instructions on which documents need to be supplied from your side, review them once you send them, and conduct the safety assessment.
How long does it take to perform the safety assessment?
It takes a couple of days from the time when you send us all of the requested documents. Usually only 1-2 days, but depending on the complexity of the product and on the current workload, it may sometimes take a bit longer.
Which documents do I need to send?
Briefly, the following: product formula, specifications of the packaging materials, ingredients and the finished product, stability and compatibility test, challenge test, product label. We send you thorough instructions once you start working with us.
Do I have to send product samples for the safety assessment?
No, we don’t require product samples in order to perform the safety assessment. Safety assessment is a paper based assessment, based on various documents and test results that you have to send us.
Does each colour or perfume product variation require a separate safety assessment?
If you have products where only colours change, while the base formula remains the same, we can do just one safety assessment for all of your colour shades. On the other hand, even if only the perfume changes in the product, a separate safety assessment is required because of the differences in allergens in different perfumes.
Do products in various sizes require a safety assessment for each size?
No, if the formula remains the same, then various sizes or quantities don’t have any influence on the number of safety assessments.No, we don’t require product samples in order to perform the safety assessment. Safety assessment is a paper based assessment, based on various documents and test results that you have to send us.