Authorised Representative & UK Responsible Person (Cosmetics)
Manufacturers of Cosmetics must comply with the essential requirements of the Regulation (EC) No 1223/2009 on cosmetic products, or the UK Cosmetic Products Enforcement Regulations 2013, which have been amended by the Product Safety and Metrology etc (Amendment etc) (EU Exit) Regulations 2019.
It is an offence for a UK responsible person to supply a cosmetic product that may cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking into account:
- Its presentation (and in particular, its form, odour, colour, appearance, packaging, labelling, volume or size) should not endanger the health and safety of consumers due to confusion with foodstuffs
- Its labelling
- Any instructions for its use and disposal
- Any other information provided by the responsible person
If a manufacturer is from outside the EU or UK, then the manufacturer needs to appoint a European Authorized Representative or UK Responsible Person to complete the mandatory tasks.
International Associates is able to act as both your EU or your UK Responsible Person.
The requirements on the responsible person
The obligations of the cosmetics Responsible Person are described in the Article 5 of the Regulation (see what they’re referring to in the table below).
Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1), (2)and (5), as well as Articles 20, 21, 23 and 24. (EU Regulation 1223/2009, Article 5.1.)
The Responsible person, therefore, has to provide or ensure the following:
- Registered address in the UK/EUwhere the Product Information Fileis kept readily accessible to the competent local authority in a language easily understood by that competent authority for inspection even 10 years after the last batch of the product has been placed on the market.
- Product claims substantiation
- Correct cosmetic product labelling
- Product Information File (PIF) compliance with the Regulationthat the products were produced according to Good manufacturing practice (GMP), that the safety assessment has been conducted etc.
- CPNP / UK CNPN notification of cosmetic products
- Communication of any undesirable or serious undesirable effectsto the competentauthorities.
- In case of non-conformity of the product with the EU regulation, take any appropriate measuresincluding recall, removal of the products or taking corrective action to bring that product into conformity. At the request of the competent authorities, the Responsible person must cooperate with the former to eliminate the risk posed by cosmetic products which they are the Responsible person for.
Guidance on the regulations for the UK and Northern Ireland can be found here
And guidance for the EU can be found here
Changing your Authorised Representative.
Changing your Authorised Representative is a fairly straightforward process. First of all, this change should appear in the agreement between the manufacturer and the Authorized Representative (Outgoing and incoming).
To be compliant, the manufacturer should address the following aspects:
The date of termination of the outgoing Authorized Representative and the date of start of the incoming one.
The date until which the manufacturer can show the outgoing AR on the information or promotional material.
The transfer of documents, including confidentiality aspects and property rights
The obligation to the outgoing Authorized Representative to send to the manufacturer or incoming Authorized Representative, any complaints or reports from healthcare professionals and patients or users about suspected incidents related to the device for which it has been designated.