Cosmetics safety assessment (CPSR)

What is the cosmetics safety assessment, why do you need it and how is it performed?

Cosmetics Regulation 1223/2009 and UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 aim to ensure the safety of cosmetic product consumers. This means that each cosmetic product must be the subject of a safety assessment performed by a qualified person, before the product can be placed on the EU/UK market.

Safety assessment forms part B of the cosmetic product safety report (CPSR), and therefore is a vital part of the product information file. Cosmetic product safety assessment is conducted based on part A of the CPSR, which gives cosmetic product safety information and includes documents such as:

the cosmetic product formula (the qualitative and quantitative composition of the product)

raw material specifications and toxicological profiles of the substances used

physical and chemical specifications of the finished product

microbiological quality and the results of the preservation challenge test (if relevant)

stability of the cosmetic product and its compatibility with the packaging

information about the packaging material

information about the normal and reasonably foreseeable use of the product

exposure to the cosmetic product and the substances and

any other information on the cosmetic product that may be available to the product manufacturer

The safety assessor reviews these documents, checks whether the ingredients used in the product are restricted or banned in the EU/UK, checks that the other information about the cosmetic product is in order and checks that the tests were conducted properly. Based on the no observed adverse effects level (NOAEL), he or she then calculates the margins of safety (MoS) and prepares the cosmetics safety assessment report.

In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I. (EU Regulation 1223/2009, Article 10.1)

CE.way can deliver the CPSR in 3 working days.

What is included in CPSR?

The cosmetic product safety assessment must include the following.

Conclusion as to whether the product is safe and in conformity with the EU/UK cosmetics regulation or not

The safety assessor's scientific reasoning that led to such a conclusion

A list of any warnings and precautions for use that must appear on the label

The assessor's credentials and approval

It is worth mentioning that the same, or very similar, cosmetic safety assessments are also required in many other countries or regions around the world. These include, among others, Turkey, Israel, the ASEAN region, some South American countries and South Africa.

Cosmetics regulatory servicesCosmetics regulatory services
Cosmetics regulatory services

Safety assessor requirements

The EU cosmetics regulation also lists requirements for the safety assessors. The safety assessor should firstly, of course, be knowledgeable about the EU/UK cosmetics regulation, but that is not sufficient. The regulation also stipulates some additional requirements.

It states that the cosmetics safety assessment must be carried out by a person in possession of 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, from the EU/UK, or a course recognized as equivalent in the EU/UK.

CE.way cosmetics safety assessment team

CE.way's safety assessors are highly skilled and fulfil the criteria mentioned above. They have degrees in pharmacy or cosmetic science, they have completed the 'Safety Assessment of Cosmetics in the EU' course in Brussels and have years of experience in conducting cosmetic product safety assessments. Therefore, you can be sure that their cosmetics safety assessments will be accepted by the competent authorities.

As well as the quality of our services, we are also proud of the speed at which we provide them. Due to CE.way's extensive database of toxicological profiles of the substances commonly used in cosmetic products, together with the software that we have developed, we can prepare cosmetic product safety assessments in up to three working days from the time when we receive all of the documents from part A of the cosmetic product safety report.

Cosmetics regulatory services

And what do they say about us?

Pharmaplast began to work with CE.way almost one year ago. CE.way is our cosmetics consultant who look after compilation of PIF, safety assessments and CPNP notifications. In addition to this, CE.way is our European representative as our company is not located in Europe. Working with CE.way has been a joy so far. Their replies are very swift and Mr Tadej is very cooperative, helpful and with a deep knowledge about the cosmetics regulations. In addition to this, CE.way is very cost effective company in comparison with their European counterparts. For all the above reasons, I really recommend CE.way to other cosmetic product manufacturers.

Mena, Egypt


We were looking for a stand-alone service, not too sure what to expect... The professionalism, the assistance and the responsiveness were very much appreciated, amongst the best we have ever experienced.

Carol, Switzerland


We are a small manufacturing company located in the US. We recently used CE.way Regulatory Consultants to help guide us through the Cosmetic regulatory changes that have taken place in the EU. They were instrumental in helping us understand the new laws and streamline the entire process. I would highly recommend their services.

Lena and Clay, USA


We didn't have any knowledge about the registration process for cosmetics in EU and were very concerned about this, but we met CE.way and they gave us whole packages of consultation and support. It was really helpful and we could do the registration without any problem. We will definitely ask CE.way again when we have new product to register in EU.

Masa, Japan

Nash Corporation

We used Tadej and CE.way for EU compliance with our products. He was very helpful and worked directly with our lab which made the process much easier for us. Tadej worked with me directly on all of our products to make sure I had the right documents. I really liked the attention to detail and how I could work with the owner of the company directly. I would highly recommend their services.

Steve, Canada

Curly Hair Solutions

Tadej from CE.way is the best consultant I've ever worked with. It's a great luck that we've found him. He is knowledgeable, fast, helpful & always ready to answer a million questions that we have. We had no exposure to cosmetics market before, so we didn't even know where to start. So he helped us to do EVERYTHING. The quality of service for the amount of money that we pay is absolutely the best! BIG THANK YOU to you Tadej & we'll definitely keep working with you!

Natalia, USA

Hi Tadej, Thank you for your highly professional approach, extremely helpful information and advice on getting our product registration under way and completed in record time! What we thought to be a very tiresome and laborious task was made quick and simple. Thank you again! The Thermitek Team.

Rene, Greece


It's been our first time lodging an application for EU Compliance. Although a big task, Tadej from CE.way made it as painless as possible. His patience and help were invaluable. He was so responsive and was available at all times to work with myself and my manufacturers. We now have our first round of product successfully assessed and notified. I will be placing our next round asap for notification, I can't recommend CE.way highly enough, thanks Tadej - Heather Spierings Eye of Horus Cosmetics.

Heather, Australia

RA Cosmetics

CE.way offers professional and reliable service. The team is diligent and extremely helpful throughout the whole process. We are very satisfied the way the work was executed. We definitely recommend CE.way to others.

Tamar, USA


CE.way made the whole EU process easy to understand. They were very responsive to all our needs.

James, USA


This is a major investment for a small business like ours and it took me a few years to find a company (CE.way) that I felt comfortable working with! That speaks volume to my appreciation of the quality of your communications with me.

Vivian, USA

VB cosmetics

Our company had a great experience with CE.way. They were very organized and provided us with a detailed roadmap of exactly what we needed to gather on our end for them to put together our Product Information File and complete the notification process for the EU. They continued to help us along the way, providing quick feedback on any changes we needed to make to a document for it to work and reminders on what we still needed to provide. They are organized, knowledgeable, fast, and attentive; I would absolutely recommend them to any companies looking to get their products approved in the EU.

Cyrus, USA


CE.way's assistance was tremendous, helping our company navigate the EU cosmetic regulation and efficiently get products to market.

Mike, USA


Our cooperation with Tadej and his team at CE.way Consultants aimed to assist us to launch our products in UK for the first time. Tadej is a very hands on and always quick with his responses. The process was smooth and beyond our expectations in terms of cost savings and the speed with which we accomplished our goal. We look forward to working with them again.

Ruta, UK

Art de Parfum

We are really appreciate your speedy replies and clear and understandable guide. As there are a lot of differences in cosmetic regulations between Japan and EU first we thought that it would be hard to make all necessary procedures for our products compliance with EU laws, but thanks for your prompt support, all procedures were made smoothly. And now we are successfully selling MT Metatron in EU. We also thinking to expand our other brands in EU and when we start - definitely will ask your company for assist again.

Olga, Japan

MT Cosmetics, Inc.

After a less than pleasurable experience with another company, we found CE.way and we can honestly say that it could not be more beneficial for our brand. The whole notification process is made as easy as possible. The people at CE.way are all very accessible, knowledgeable and always ready to answer questions. CE.way is a great asset to our company and we are grateful for all the help and support we receive. Navigating through all rules and regulations alone is impossible, with the team at CE.way, we have the best support that we could ask for. Highly recommended in all aspects from their support to their reliable service!

Daniel, USA



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