EU AUTHORISED REPRESENTATIVE & UK RESPONSIBLE PERSON (COSMETICS)

Manufacturers of Cosmetics must comply with the essential requirements of 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, odor, color, 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 effects to the competent authorities.
• In case of non-conformity of the product with the EU regulation, take any appropriate measures including 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.

PRODUCT INFORMATION FILE (PIF)

The product information file (PIF) must include all of the following:

• The qualitative and quantitative composition of the product. For perfume or perfume compositions in the product, you are only required to keep the name, code number and supplier identity. Qualitative information for all composites, and quantitative information in relation to dangerous substances, must also be made easily available to the general public.
• The physicochemical and microbiological specifications of the raw materials and the finished product, and the purity and microbiological control criteria of the cosmetic product.
• The method of manufacture, which must be in accordance with good manufacturing practice
• An assessment of safety for human health of the finished product, in the form of a 'cosmetic product safety report' (CPSR), signed by a qualified safety assessor, according to the criteria as stipulated in the Regulation. In addition, a specific safety assessment is required for cosmetic products intended for use on children under the age of three, and for cosmetic products intended exclusively for use in external intimate hygiene.
• The presentation of the cosmetic product must take into account the requirements of the Food Imitations (Safety) Regulations 1989, which concern dangerous imitations.
• Existing data on the undesirable effects on human health resulting from the use of the product. This information must also be made easily available to the general public.
• Evidence to justify any claims made by the product
• Data on any animal testing performed by the manufacturer, their agents or suppliers, relating to the development or safety evaluation of the product or its ingredients

The PIF must be maintained at the UK / EU address, and made available to market surveillance and enforcement authorities.

EU REGISTRATION

• Regulation (EC) No 1223/2009 (Article 13) requires that the responsible persons and, under certain circumstances, the distributors of cosmetic products submit some information about the products they place or make available on the European market through the CPNP.
• The cosmetic products notification portal (CPNP) is a free of charge online notification system created for the implementation of Regulation (EC) No 1223/2009 on cosmetic products. When a product has been notified in the CPNP, there is no need for any further notification at the national level within the EU.

UK REGISTRATION

The products must be Notified to the Office for Product Safety and Standards (OPSS) about cosmetic products available to consumers in Great Britain (GB).

Prior to placing the cosmetic product on the market, the responsible person must submit the following information to the UK Government through the UK's Submit Cosmetic Product Notifications service (SCPN):

• The category of cosmetic product and its name or names, enabling its specific identification.
• The name and address of the responsible person (if the product information file is made readily accessible)
• The contact details of a physical person to contact in the case of necessity (if the cosmetic product has been imported into the UK).
• The presence of substances in the form of nanomaterials and their identification.
• The frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.

UK LABELLING

When the cosmetic product is placed on the market, the responsible person must notify to the UK Government the original labelling, and, where reasonably legible, a photograph of the corresponding packaging.