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Responsible Person

Oxford Biosciences can fulfil the role of Responsible Person, and the RP fee is charged annually per product.  Having an EU-based and/or UK Responsible Person enables individuals or companies in countries outside the EU to sell products in the EU without having to have a corporate location within the EU or UK.  We provide a physical address for the PIF files in our satellite office in Oxford and/or Cork, Ireland.  Please note, this is not at our Oxford Science Park address.

responsible person must be designated for each product placed on the market. This person shall ensure compliance of the products with the rules set out in the Regulation. In particular, they shall ensure compliance with requirements relating to human health, safety and consumer information. They shall maintain a product information file accessible to the public authorities.

In order to ensure product traceability, responsible persons shall identify the distributors to whom they supply the cosmetic product: for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor. The same applies to all other persons involved in the supply chain.

In case of product non-compliance, the responsible person shall take measures to render it compliant, withdraw it from the market or recall it to the manufacturing company in all Member States where the product is available. Where the responsible person does not take all appropriate measures, the competent national authorities may take the necessary corrective measures.

If a product which complies with the requirements of the Regulation presents or could present a serious risk to human health, the competent national authority shall take all necessary provisional measures to withdraw, recall or restrict the availability of the product on the market.

Cosmetic items made in the UK should have a person responsible or point person to maintain appropriate information about the products. Such content should be at the registered address listed on the product and should be easily accessible. This information can be requested by a number of organisations, authorities or in the event of a medical emergency. Such information should be written in English or the language understood by the responsible person.

On 13 September the UK Government released new technical notices to provide information on what a no-deal could mean to economic operators and the public.

These papers are particularly important for non-UK businesses (or non-UK based responsible person) exporting goods to the UK market. The most relevant paper for the cosmetics industry is:

  • Appointing nominated persons to your business if there’s no Brexit deal: specifically mentions the Cosmetics Regulation and clarifies that
    For cosmetics, responsible persons based in an EU country will no longer be recognised by the UK after March 2019 (Regulation (EC) N° 1223/2009 is the main EU legislation covering cosmetics and covers the role of the responsible person). Businesses wishing to place cosmetics on the UK market will need to appoint a UK-based responsible person. This is due to specific legal duties assigned to the responsible person and their importance on ensuring the safety of products placed on the market.

For companies worldwide wishing to place their products on the market in the UK, we offer Responsible Person services as above, as well as our standard CPSR services.

For companies worldwide wishing to place their products on the market in the other EU countries, we offer Responsible Person services as our sister company, Oxford Éireann Ltd, based in Cork, Ireland.

Oxford Éireann Ltd  ensures that companies remain compliant with both UK and EU laws.

A responsible person is defined as one of the following:

  • Manufacturer of the cosmetic item
  • Manufacturer’s agent
  • Individual or group who ordered the product’s manufacture: i.e. Store brand is often made by third-party manufacturers
  • Individual who supplies the product in the UK (i.e. if the above list is located outside of the EC).

The responsible person should have the necessary experience and qualifications as listed by UK legislation.

  • Information about the composition of the product should be on hand. This includes both quantitative and qualitative information. This is especially important for any dangerous substances. Information for perfume compositions should include the name of such items, supplier name and code number.
  • Information about physic-chemical and microbiological specifications in the product: from raw materials to the cosmetic item.
  • Criteria about the criteria and regulations for purity and microbiological control
  • Method or procedure for the manufacture of the cosmetic items.
  • Safety assessment of health effects of the finished cosmetic products. Items put on the market after 11th September 2004 should include additional information about whether or not children under the age of three can use the product.
  • Title, name, and qualifications of the person who administered any and all testing and assessments of the cosmetic products
  • Any data that relates to negative effects of a product on a user’s health. Such information should be easy to access not only by government groups and the industry but also by the general public.
  • Specific evidence that proves a product’s claims affecting health, beauty, etc.
  • All items made and sold after 11th September 2004 should include information animal testing of any item’s safety, development or use

If items are made outside of the UK or in another EC nation, item information can reside outside of the UK if there is an approved authority present at the given address and the information is in English.