What We Do
2013 saw Regulation EU 1223/2009 replace Directive 76/768/EC as the main regulatory framework for finished cosmetic products when placed on the EU market. It strengthens the safety of cosmetic products and streamlines the framework for all operators in the sector.
The evolution of this regulation also saw the introduction of a “Responsible Person” resident within the EU to be designated for every cosmetic product designed to be sold commercially or used in treatments or even free samples to the general public. The inspiration for The Responsible People Ltd was born out of a requirement for this RP EU residency following the UK’s exit from the EU. So to this end we have based the Company in the Republic of Ireland, which remains in the EU. Subsequently we have been approached by a number of EU clients who export and sell product in the United Kingdom who require an RP in the UK, which has also become a requirement after Brexit, so since this service requires the same knowledge and detail we have added this service to our offering . ‘The Responsible People Ltd’ take a very serious approach to the legal responsibility that they will acquire on assuming this role. This will involve close scrutiny of clients existing documentation from every angle.
As a Compliance team we are all well versed in managing the complexities of the EU Compliance Process and have been involved at every stage since it became a legal requirement in 2013
However up until now the RP has effectively very often been the Brand Owner themselves who took the RP Status and who shouldered the Legal responsibility of ensuring every element of their product, its manufacture and its documentation, its copy, both on labelling and in marketing were correct.
This will now pass to The Responsible People Ltd provided all these areas of responsibility are found to be correct and all documentation in order
To this end we have several points to cover before we can proceed and accept the full and legal responsibility of your RP. Each step has a set of charges which depend on how much or how little is already in place
Stage 1 For each product, we would assess the current compliance status and the availability and quality of the information necessary for us to assume the EU RP obligations.
Stage 2 We would then work with you to address any issues that we have identified.
Stage 3 On approval, we would accept, in writing, the role of EU RP for the particular product/products and implement all the necessary procedures.
Stage 4 We would fulfil the continuing obligations of the EU RP
The Duties and Responsibility of the Responsible Person
The duties of the RP are many and varied with regards to the EU Cosmetic Products Regulation, the function of the Responsible Person is ensure that product made available on the market is safe for human health when used under normal or reasonably foreseeable conditions of use. The EU Cosmetic Products Regulation lists the obligations of the Responsible Person necessary to fulfil this principal requirement.
The Responsible Person must ensure that:
The manufacture of the product conforms to the principles of Good Manufacturing Practice (GMP).
The cosmetic product has undergone a safety assessment on the basis of the relevant information to generate a Cosmetic Product Safety Report (CPSR).
A Product Information File (PIF) exists for the cosmetic product containing all the elements specified in the Regulation. This must be made available to the appropriate Enforcing Authority on request
That sampling and analysis of the cosmetic product is performed in a reliable and reproducible manner
That the all data specified in the EU Cosmetic Products Regulation relating to the cosmetic product be notified on the EU Cosmetic Products Notification Portal (CPNP).
That the formulation of the cosmetic product conforms to the prohibitions and restrictions on ingredients as specified in the annexes to the EU Cosmetic Product Regulations.
That, apart from permitted exceptions, formulation does not contain substances listed as Category 2 CMR (Carcinogenic, Mutagenic or toxic to Reproduction).
That, for every cosmetic product that contains nanomaterials, a high level of protection of human health is ensured.
That any technically unavoidable traces of prohibited substances stemming from impurities in raw materials, packaging, etc., do not degrade safety of product.
That neither the cosmetic product nor its ingredients have been tested on animals in order to meet safety requirements of the EU Cosmetic Products Regulation.
That labelling includes all the mandatory elements specified in the Regulation in the format and language required.
That the labelling doesn’t imply that the product has characteristics or functions that it does not.
The Responsible Person must also:
Make publicly available, on request, qualitative and limited quantitative information on the formulation.
Immediately inform relevant competent authority of any reported Serious Undesirable Effect from the cosmetic product.
If requested, provide competent authority with information on distributors and supply chain for any particular batch of the product.
If you are interested in either EU RP Service or UK RP services or any part thereof please contact one of the team via the email below and the corresponding member of the team will respond