The end of the transition period is approaching: as of 1 January 2021 the United Kingdom will terminate its accession to the European internal market and customs union.
Given the latest updates, which suggest an increasingly possible “no deal” and consequent “hard Brexit”, it is good to remember what are the guidelines stipulated by the European Commission with regard to cosmetics, regardless of whether or not an agreement is reached to harmonize the parties.
In fact, on March 13, 2020, the European Commission published a “Notice to stakeholders” entitled “UK withdrawal and EU standards in the cosmetics sector”.
At the end of the transitional period, the Sectoral Regulation 1223/2009 will no longer be applicable in the United Kingdom.
This has several consequences; the main changes will concern responsibilities for importers, responsibilities for sellers in the UK, notifications to the Cosmetic Products Notification Portal (CPNP), product information and labelling.
What happens to products manufactured in the UK and sold in the EU?
- The Responsible Person, in accordance with Article 4 of the Regulation, may no longer be a person established in the United Kingdom; if a cosmetic product from the United Kingdom is to be placed on the European market (because it is manufactured in the UK or because it is imported into the UK from a third country and only subsequently re-exported from the UK to the EU), paragraph 5 of Reg.1223 will apply and consequently the importer will become the EU Responsible Person, subject to the possibility of designating by mandate and acceptance, both in writing, a different person established in the EU.
- Article 13(1) of the Regulation requires that, before placing the product on the internal market, the responsible person must notify the Commission of a list of information through the Cosmetic Products Notification Portal (CPNP). From the date of the United Kingdom’s exit from the Union, before placing a cosmetic product on the market, the newly designated responsible person must submit a new notification to the CPNP.
For notifications made before 31 December 2020 by a responsible person established in the United Kingdom, the CPNP offers the possibility to transfer the notifications to the new responsible person established in the EU. However, this operation will only be admissible until 31 December 2020, as responsible persons established in the United Kingdom will then be denied access to the CPNP.
- According to Article 11 of the Regulation, when placing a cosmetic product on the internal market, the responsible person must keep the product information file (PIF) for a period of ten years. At the end of the transitional period, the BIP must be made available at the address of the new responsible person and translated into the language of the Member State where the responsible person is established.
- Finally, in accordance with Article 19 of the Regulation, the name and address of the responsible person must be indicated on the label of the cosmetic. In addition, when the product is imported from third countries, the country of origin of the imported cosmetic must also be indicated on the label. After Brexit, cosmetics from the United Kingdom will be considered the same as those from a third country and, therefore, the country of origin must be specified on the label of the product or must be marked MADE IN UK.
- Furthermore, as part of the safety assessment referred to in Article 10 of the Regulation, UK qualifications not recognized as equivalent by a Member State of the Union may no longer be invoked. Consequently, the safety assessment of any cosmetic product placed on the European market at the end of the transitional period must have been carried out, and the safety report drawn up, by a person who, on the date of placing on the market, has the necessary qualifications established by a Member State.
What happens to products manufactured in the EU and sold in the UK?
In order to avoid that the official exit of the United Kingdom from the European Union creates problems for companies in adapting to a new legal system, the general policy of the British government is to maintain the European legislation incorporated in the British body of law as “retained EU law” until such time as it is amended or repealed in the future.
The Product Safety and Metrology etc. (Amendment etc.) (EUExit) Regulations 2019 – UK Statutory Instruments no 696, Schedule 34 contains all amendments to Regulation 1223/2009 and will enter into force on 1 January 2021.
In particular, articles 4 and 13 of Regulation (EC) no. 1223/2009 will be modified by Product Safety and Metrology etc. (EUExit) Regulations 2019 – UK Statutory Instruments no. 696. (Amendment etc.) (EU Exit) Regulations 2019.
Responsible person (art.4)
In order to be sold on the UK market, a cosmetic product must have a responsible person established in the UK.
If the customer also intends to sell cosmetics in the EU, he or she must appoint another EU-based responsible person.
Therefore, the mutual recognition of the responsible person between the UK and the EU is missing. In the UK the “responsible person” can be
- The manufacturer of cosmetics if it is established in the United Kingdom
- the person performing the import (e.g. from the EU), if they are established in the UK.
- the manufacturer and the importer may still choose to appoint (in writing) another person, provided that this person is established in the United Kingdom and accepts (always in writing) the appointment
- A distributor for those products that are sold under his name or trademark (case of private label – the cosmetic produced in Italy, is sold under the distributor’s trademark in the UK), or in case you modify products already on the market.
Notification (art. 13)
Before putting a cosmetic on the market, the responsible person must communicate some product information to the Secretary of State.
This information is mostly similar to the information to be notified to the European Commission, and generally includes the category of cosmetic, the name of the product and of the responsible person, the address where to find the files on the product, the contact details of a natural person in case of emergency, some details on the chemical substances present in the product (e.g. the presence of nanomaterials) and the formulation of the product in order to allow an adequate medical intervention when necessary.
The notification to the Secretary of State also includes details of the packaging and labels and, in some cases, the photograph.
The responsible person must therefore communicate also for the stock existing at 31/12 all the information required, if there is the intention to keep those products on the market after 31 December 2020.
In a circular (a document with secondary legal value with respect to the law referred to), of the Office for Product Safety and Standards, it was then specified that if the products already exist in the UK market, the Responsible person has 90 days from the “exit”. (therefore until March 31, 2021) to make the completion of the notification.
While for new products (those that had not already been registered in the European system), notification must be made before they are placed on the market.
The responsible person can satisfy this new art. 13 by providing the Secretary of State before 31.12. 2020 with all the required information, also specifying that the product had already been put on the market in compliance with the European pre-Brexit regulation.
The Secretary of State may also request details of the chemicals in the product from the responsible person if he or she deems it necessary.
Art. 13 requires that the communication to the Secretary of State of the above information is made “by electronic means”.
At the moment there are no details about this, however the expectation of the sector is that in the coming weeks the United Kingdom will introduce a national database on which to communicate to the Secretary of State. However, it is good to prepare for the imminent task with the files ready to store the information in the format required by the British government (.xml file format).
- The Responsible Person UK, will have to appear on the label of cosmetics
- The UK Responsible Person must also hold the PIF and make it accessible to the UK authorities at the notified address.
- The PIF must be in English.
- The safety assessment of any cosmetic product placed on the UK market at the end of the transition period must have been carried out by a safety assessor with a qualification recognised by the UK authorities.
It should be noted that goods legally placed on the EU or UK market before the end of the transitional period may continue to be marketed on their respective markets and circulate until they reach the end user. However, the economic operator will have the burden of proving, through any relevant document, that the goods have been placed on the market before the end of the transition period.