Cosmetic UK Responsible Person
Your product must comply with Regulation (EC) No. 1223/2009 on Cosmetic Products, as modified by the Product Safety and Metrology (Amendment etc.) (EU Exit) Regulations 2019, before it may be sold in the UK.
According to the European Cosmetic Regulation EU 1223/2009, each of your goods must have a “Responsible Person” named in the UK. The UK distributor will ultimately be in charge of the UKRP, however, the distributor may assign that responsibility to another entity.
The “Responsible Person” is responsible for ensuring that the products are in conformity, notably with Article 4 of the UK Cosmetic Product Regulations, which deals with consumer information, consumer safety, and human health.
To make sure you are compliant, Patient Guard can act as your Responsible Person. The tasks we carry out on your behalf include:
- Assembling and preparing product information files (PIF). This covers regulatory support for labelling specifications, prohibited drugs, and claims.
- The PIF files are kept by us and are updated.
- With regard to banned substances, we will support you, including notice.
- We notify the FDA of any nanomaterials or compounds that are known to be carcinogenic, mutagenic, or hazardous to the developing foetus via SCPN (Submit Cosmetics Product Notification).
- When adverse effects are reported, we let SCPN know.
- Provide you direction on adhering to Good Manufacturing Practice (GMP) or ISO 22716
Cosmetic EU Responsible Person
With our EU Responsible Person service and cost-effective consulting support, Patient Guard has been in the forefront of assisting businesses in adapting to the EU 1223/2009 Cosmetics Regulation.
A “Responsible Person” must be named inside the European Union (EU) for each product placed on the market as a result of the implementation of the European Cosmetic Regulation EU 1223/2009 in 2013.
The “Responsible Person” is responsible for ensuring that the products adhere to the standards outlined in the Cosmetic Regulation. in particular compliance with laws governing consumer information, consumer safety, and human health.
As your Responsible Person, Patient Guard provides the following services:
- Product Information Files (PIF) must be created and assembled in accordance with Article 11 of Cosmetic Regulation EU 1223/2009.
- Regulatory support for labelling specifications, prohibited drugs, and claims.
- Offer Safety Assessments through the use of one of our registered, certified, and external partners to guarantee compliance with Article 10 of the Cosmetic Regulations EU 1223/2009.
- In order to incorporate notifications of nanomaterials (Article 16) or compounds categorised as carcinogenic, mutagenic, or dangerous for reproduction (Article 15), you must register your cosmetic goods via the EU Commission's Cosmetic Products Notification Portal (CPNP) system.
- Monitoring and reporting complaints to the EU commission. Advice on remedial measures and product recalls (Article 23).
- Advice on adhering to ISO 22716 or Good Manufacturing Practice.
