Brexit's Impact on Cosmetics

Since 1 February 2020, the United Kingdom is no longer a member of the European Union, and has become a ‘third country’, after 47 years of EU membership. With the entry of force of the Withdrawal Agreement, the EU legislation in its entirety applies to and in the United Kingdom during the transitional period – until 31 December 2020.

During this transitional period, the United Kingdom and the European Union will be negotiating an agreement on a new partnership. However, it is still unclear whether the agreement will be concluded and whether it will enter into force at the end of the transition period.



EUROPE


1. END OF THE TRANSITION PERIOD – LEGAL SITUATION


At the end of the transition period, EU rules on cosmetics, in particular the Regulation (CE) No. 1223/2009, will no longer apply to the United Kingdom. This will lead to the following consequences:


a. Responsible Person


According to Article 4 of the Regulation 1223/2009, only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market. The responsible person shall ensure compliance with the relevant obligations set out in Article 5 of the Regulation.

In accordance to the Regulation 1223/2009 Article 4 (3), for a cosmetic product manufactured within the EU, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person, by default. However, the manufacturer may designate, by written mandate, a person established within the EU as the responsible person who shall accept in writing.

According to the Article 4 (5) of Regulation 1223/2009, for an imported cosmetic product into the EU from a third country, each importer shall be the responsible person for the specific cosmetic product he places on the market, by default. The importer may, by written mandate, also designate a person established within the EU Community as the responsible person who shall accept in writing.


At the end of the transition period, responsible persons can no longer be established in the UK. Instead:


  • If the cosmetic product is manufactured in the UK, the importer in the EU becomes the responsible person by default, or can designate by written mandate a person established within the EU as the responsible person who shall accept in writing;

  • If the cosmetic product is manufactured in another third country, imported into the UK and subsequently imported into the EU, the same as above is applied.


In the case of a responsible person established in the UK is currently designated by an EU manufacturer/importer, that manufacturer/importer should take the necessary steps and measures to ensure that, at the end of the transition period, a responsible person is established in the EU.


b. CPNP Notification


In accordance to Regulation 1223/2009 Article 13 (1), prior to placing the cosmetic product on the market the responsible person shall submit a list of information relating to the cosmetic product to the Commission, through the Cosmetic Product Notification Portal (CPNP).

At the end of the transition period, the new responsible in the EU will have to notify the cosmetic product in the CPNP, prior to placing it on the EU market.

Regarding the existing notifications before the end of the transition period by a responsible person established in the UK, the CPNP offers the possibility to transfer notification to another responsible person. Thus, a responsible person established in the UK can transfer an existing notification to the future responsible person in the EU. Then, this EU responsible person will be able to edit the notification and complete it by adding its own required information, such as the name and address of the responsible person, and the new labelling. Note that, however, this transfer in CPNP is only possible before the end of the transition period. At the end of the transition period, the UK responsible person will no longer have access to the CPNP.

The new EU responsible persons can already indicate before the end of the transition period that the cosmetic product manufactured in the UK will be imported into the EU from the UK as a country of origin.


c. PIF


In accordance to Article 11 of Regulation 1223/2009, when a cosmetic product is placed on the market, the responsible person shall keep a Product Information File (PIF) for the cosmetic product, and it shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

The responsible person shall make the PIF readily accessible in electronic or other format at his address, as indicated on the label of the product, to the competent authority of the Member State in which the file is kept. In addition, the information contained in the PIF shall be available in a language which can be easily understood by the competent authorities of the Member State.

At the end of the transition period, the PIF has to be made available at the address of the EU responsible person, and adapter in terms of language requirements.


d. Labelling


According to Regulation 1223/2009, Article 19, the name and address of the responsible person shall be indicated on the label of the cosmetic product. The country of origin shall be specified for imported products.

At the end of the transition period, cosmetic products manufactured in the UK and placed on the EU market will be a cosmetic product important to the EU from a third country. Therefore, the country of origin will need to be specified for these cosmetic products.


e. Safety Assessor


In accordance to Article 10 (1) of Regulation 1223/2009, in order to demonstrate that a cosmetic product complies with Article 3 (safety), the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I to Regulation 1223/2009. The cosmetic product safety assessment report is part of the PIF.

As set in the Article 10 (2), the cosmetic product safety assessment shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.

At the end of the transition period, qualifications from the UK which have not been recognised as equivalent by an EU Member State can no longer be relied on for the purpose of fulfilling the requirements. For any cosmetic placed on the EU market until the end of the transition period, the safety assessment must have been carried out by a safety assessor who, on the date of placing on the market, fulfils the requirements of Article 10 (2), i.e. hold the necessary qualifications from an EU Member State.



UNITED KINGDOM – ‘NO DEAL’ BREXIT


2. END OF THE TRANSITION PERIOD – LEGAL SITUATION


At the end of the transition period, EU rules on cosmetics, in particular the Regulation (CE) No. 1223/2009, will no longer apply to the United Kingdom. This will lead to the following consequences:


a. Responsible Person


There must be a Responsible Person established in the UK. However, there will be a 2-year transition period (after the UK leaves the EU) before business need to include the UK Responsible Person details on product labels, as long as the name and address of the EU responsible person are included, allowing existing stocks to be used.

Business who bring cosmetic products into the UK from an EU Member State will, in most cases, become importers where they would previously have been distributors. The importer of the cosmetic product, whether from the EU or another country, becomes a Responsible Person by default, although they may appoint an agent to act as the Responsible Person for them.


b. Product Notification


The UK Government has established a cosmetic product notification service to replace the CPNP in the UK. In the case of a Responsible Person continues to place their products on the UK market, the products need to be notified to the Secretary of State.

For products already in the EU market, and notified in the CPNP, if a UK Responsible Person places the product on the market within 90 days of exit they will need to provide to the Secretary of State within those 90 days of exit the following information:


  • Category of the cosmetic product and its name, enabling its specific identification

  • Name and address of the responsible person (at which the PIF is kept);

  • Contact details of a natural person to contact in case of urgency;

  • Frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties;


This information should be provided by the notification system mentioned above.


For products that have not been notified previously on the CPNP or have not been placed in the EU market after 90 days after exit, it will be necessary to provide the information above in addition to the following information before the product is placed on the UK market:


  • Presence of substance in the form of nanomaterials (where applicable) and the identification (including the chemical name) and the reasonably foreseeable exposure conditions;

  • Name and CAS or EC number of substances classified as CMR (carcinogenic, mutagenic or toxic for reproduction) of category 1A or 2B under Regulation (EC) No 1272/2008;

  • Original labelling and a photograph of the corresponding packaging (if reasonably legible).


As in CPNP, this information is to be made available to poison centres and market surveillance authorities.


c. PIF


As in Europe, the PIF has to be made available at the address of the UK responsible person.


3. BEFORE THE END OF THE TRANSITION PERIOD – PLACING ON THE MARKET


The Withdrawal Agreement provides that an existing and individually identifiable good legally placed on the EU or UK market before the end of the transition period may be further made available on the EU or UK market and circulated between these markets until reaching the end-user.

The economic operator who invokes this provision bears the burden of proof, based on any relevant document that the goods were placed on the EU or UK market before the end of the transition period.


Summing up:


Responsible person

Cosmetic products placed on the UK market will need a responsible person established in the United Kingdom.

Cosmetic products placed on both in the EU and UK market will need a Responsible Person for both EU and UK markets.


Labelling

Name and Address of the Responsible Person

If the product is sold on the UK market, the name and address of the UK responsible person will need to be placed in the labelling of the cosmetic product.

If the cosmetic product is sold in both the UK and EU market, both EU and UK responsible persons have to appear on the label of the product.


Country of origin

In accordance with Regulation 1223/2009, the country of origin shall be specified for imported cosmetic products from a third country.

If the product is manufactured in the UK and placed on the EU market, the United Kingdom will be the country of origin and should be indicated on the product label.

The same applies to a product which is manufactured in the EU and placed on the UK market - the EU will be the country of origin and should be indicated on the product label, as well.


Notification

Products placed on the UK market will need to be notified on a new UK notification system.

Cosmetic products placed on both EU and UK markets will need to be notified in both CPNP and UK notification system.

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