The production of cosmetic must comply with good manufacturing practice and be in line with ensuring the objectives of Article 1.2. , Regulation 1223, 2009.
Compliance with good manufacturing practice shall be presumed where the manufacturing process is in accordance with relevant harmonised standards, the references for which are published in the Official Journal of the European Union.
A standard widely accepted by regulators is ISO 22716:2007 which provides a unified standard/guidance for the production, control, storage and shipment of cosmetic products and delivers a quality framework for all aspects of the cosmetic industry. Even though ISO 22716 is an accepted guideline, a cosmetic manufacturer is not obliged to follow it, however, following good manufacturing practice and a statement of GMP is obligatory.
Cosmetic Product Safety Report You might also see it referred to as a ‘safety assessment’.
Yes. It is the law for any cosmetic product to have a CPSR completed by a qualified safety assessor before your product goes on sale in the UK and EU.
A CPSR has 2 parts:
Part (A) Cosmetic Product Safety Information
Here, we need to compile the product information, test data and documents, which will be assessed in Part (B). It includes important data on the formula, the raw materials, stability & microbiology tests, the packaging and the use of the product. Click here for detail.
It is likely that you or your manufacturer will hold much of this information already as it is required for the PIF (product information file). Unsure about anything? We can partner with you to ensure that everything is present and correct, and that the entire process is smooth and hassle free!
Part (B) Cosmetic Product Safety Assessment
Our fully qualified expert safety assessor will review the required documents. The team will check to see if there are any issues with the ingredients or formula using the latest in up to date cloud technology and drawing on extensive professional experience. You will be provided with:
An appropriately qualified safety assessor. This is a highly trained, professionally qualified person with a relevant degree from a recognised university.
“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 or a course recognised as equivalent by a Member State”. (Article 10 (2) of Regulation (EC) n° 1223/2009).
At PCR, we ensure that all our assessors’ credentials are up to date with EU and UK requirements. Furthermore, we have full indemnity insurance for complete peace of mind.
We don’t think so! There are many different versions of the CPSR (or safety assessment reports) on the market. At PCR, we pride ourselves on striking the right balance between quality and value. We don’t just believe in ticking a box. Every report is based fully on EU guidelines (2013/674/EU) and you will be guided from beginning to end by our team of qualified experts. Our thoroughness and expert guidance will enable you to confidently claim that you have reached the highest standards of quality and safety for your brand.
We will only undertake the formal safety assessment once we’ve looked through all the information. If there are any issues, we will talk to you about them, and help you understand how to meet the required standards. We have high standards, but our aim is to help you get to market with a diligent evaluation of your product’s safety. The result will be confidence that your product is safe and compliant for sale.
Much of the time taken in completing the CPSR is taken up with compiling the required information. We can help to coordinate this for you, contact us to discuss your requirements.
Not quite. There are a number of other steps you need to take before your product can legally go on sale. Click here for our ‘must do’ checklist.
Read up on cosmetic regulation (EC) No 1223/2009. Here’s the headline: “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.”
Or contact us to talk about your requirements and find out how we can support you and your business.
