CSA official partner: CE.way Regulatory Consultants Limited
CE.way Regulatory Consultants Limited is a provider of EU Responsible person services and other services for cosmetic companies. Visit their website to find out more: www.ceway.eu
CSA WEBSITE PURPOSE
It may sometimes be difficult to find an appropriate and qualified cosmetics safety assessor to conduct safety assessments for your cosmetic products. This task is proving to be especially challenging for non-EU cosmetic companies, mainly due to the requirements regarding the safety assessor qualifications posed by the EU regulation 1223/2009. However, also EU cosmetic manufacturers can have difficulties finding and choosing a qualified, reliable, and, not the least, also a safety assessor suitable for their budget.
Therefore, in order to make this task easier, save companies the time they spend searching for qualified safety assessors, and give them more options to choose from, we have compiled a list of qualified cosmetics safety assessors.
This is by no means a definite list of qualified safety assessors or companies performing cosmetics safety assessments according to the EU regulation 1223/2009. CSA Cosmetic Safety Assessors also can’t make any guarantees regarding the quality or current availability of their services, and we do not intend to promote the services of any individuals or companies listed.
Therefore we kindly invite safety assessors who are not currently included in this list to send us an email, and we are going to include them in the list.
Therefore, in order to make this task easier, save companies the time they spend searching for qualified safety assessors, and give them more options to choose from, we have compiled a list of qualified cosmetics safety assessors.
This is by no means a definite list of qualified safety assessors or companies performing cosmetics safety assessments according to the EU regulation 1223/2009. CSA Cosmetic Safety Assessors also can’t make any guarantees regarding the quality or current availability of their services, and we do not intend to promote the services of any individuals or companies listed.
Therefore we kindly invite safety assessors who are not currently included in this list to send us an email, and we are going to include them in the list.
EU COSMETICS SAFETY ASSESSMENT & SAFETY ASSESSOR REQUIREMENTS UNDER REGULATION 1223/2009
The aim of the EU Regulation 1223/2009 is to ensure the safety of cosmetic product consumers. Therefore, before placing any cosmetic product on the EU market, each cosmetic product has to be the subject of a safety assessment performed by a qualified person (cosmetics safety assessor).
Cosmetic manufacturers have to compile a Product information file for each of their products, which has to include a safety report. Safety assessment is a vital part of the safety 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)
The new EU Regulation 1223/2009 brings a new safety assessment and clarifies the information that needs to be included in the safety assessment. This safety assessment is different from the one under the Cosmetics directive 76/768/EEC. Therefore it is important to remember that safety assessments will have to be performed again even for products already on the market, which only passed the safety assessment according to the Directive 76/768/EEC.
The Safety Assessment must include:
- Assessment conclusions
- Labelled warnings and instructions for use
- Reasoning
- Safety assessor's credentials and approval
EU Regulation 1223/2009 also clarifies the requirements regarding the qualifications of the safety assessor. The safety assessment has to be carried out by a safety assessor with relevant qualifications.
The cosmetic product safety assessment, as set out in Part B of Annex I shall 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, or a course recognized as equivalent by a Member State. (EU Regulation 1223/2009, Article 10.2)