13 Sept 2019
Brexit: EU Commission Publishes Preparedness Notice in the Field of Cosmetics
The EU and Member States are preparing for Brexit and encourage stakeholders to do so as well. The European Commission recently published a preparedness notice for the cosmetics industry laying out the consequences of a no-deal Brexit and containing important changes with regard to “responsible person”, notifications in the CPNP (the cosmetics portal), product information file, labelling and safety assessor.
Since the United Kingdom notified its intention of withdrawing from the EU in March 2017, both Member States and EU bodies have been preparing for various Brexit scenarios. The European Commission published notices to stakeholders in order to allow economic operators to prepare for the withdrawal in the event the United Kingdom withdraws from the EU without a formal ratified agreement (‘no-deal Brexit’). The Commission has addressed several subject matters and regularly updates its Brexit preparedness notices. The latest update concerns the cosmetics industry.
Hong Kong traders of cosmetic products may already be familiar with the EU rules in this field, particularly Regulation 1223/2009 (‘the Cosmetics Regulation’). It is important to note that the United Kingdom will become a third country as of the withdrawal date, which is currently scheduled for 31 October 2019. In the event of a no-deal Brexit, as from that date, EU legislation, including the Cosmetics Regulation, will no longer apply to the United Kingdom. This carries implications, among others, for the placing on the market and labelling of cosmetics.
According to the Cosmetics Regulation, a ‘responsible person’, that is to say a legal or natural person established in the EU, shall ensure compliance with the relevant legislation. Only cosmetic products for which a responsible person is designated shall be placed on the market. For cosmetic products manufactured within the EU, the responsible person by default is the manufacturer, who can designate another person established within the EU by written mandate. For cosmetic products manufactured outside of the EU, the responsible person by default is the importer who can designate another person established within the EU by written mandate.
As of the withdrawal date, the designated responsible person can no longer be established in the UK. The notice suggests that any manufacturer or importer whose current responsible person is established in the United Kingdom take the necessary measures to ensure that a responsible person will be established in the EU-27 after the withdrawal date.
According to the Cosmetics Regulation, the responsible person shall notify a list of information relating to the cosmetic product to the European Commission before placing such product on the market. The notification shall be submitted through the Cosmetic Product Notification Portal (‘CPNP’).
Already existing notifications made before the withdrawal date by a UK-based responsible person may be transferred to the future EU-27 responsible person. This new responsible person will then be able to edit the notification and complete it by adding its own required information, such as name and address. However, this transfer in CPNP is only possible until the withdrawal date. As of the withdrawal date, the former UK-based responsible person will no longer have access to the CPNP.
New notifications shall be transmitted by the new responsible person in the CPNP. The new responsible person may already indicate that cosmetic products manufactured in the United Kingdom as country of origin will be imported into the Union as of the withdrawal date.
According to the Cosmetics Regulation, a responsible person shall keep a product information file (‘PIF’) for the cosmetic product for a period of ten years. The PIF shall be readily accessible in electronic or other format at the address of the responsible person to the competent authority of the respective Member State where the responsible person is based in a language that can be easily understood by the competent authority. In case of a change of responsible person, the requirements with regard to the PIF, particularly the language requirements, may need to be adapted.
According to the Cosmetics Regulation, the name and address of the responsible person shall be indicated on the label of cosmetic products. For imported cosmetic products, the country of origin shall be specified. As of the withdrawal date, cosmetic products manufactured in the United Kingdom will be considered as cosmetic products from a third country. In the event of a change of the responsible person as set out above, and in the event of imports from the United Kingdom, the labels need to be adapted accordingly.
According to the Cosmetics Regulation, the responsible person shall ensure that a safety assessment is conducted for a cosmetic product before placing it on the market. As a result of the safety assessment, a product safety report shall be drawn up in accordance with Annex I to the Cosmetics Regulation, which is to be included in the PIF along with the proof of the safety assessor’s qualification (i.e. copy of the diploma and, where needed, proof of equivalence).
As of the withdrawal date, qualifications from the United Kingdom, which have not been recognised as equivalent by an EU-27 Member State can no longer be relied upon for the above purpose. However, safety assessments carried out and safety reports drawn up before the withdrawal date by a safety assessor holding qualifications from the United Kingdom will remain valid for a cosmetic product placed on the Union (EU-27) market before the withdrawal date. Any cosmetic product placed on the Union (EU-27) market as of the withdrawal date needs to be assessed by a safety assessor who, on the date of placing on the market, holds the necessary qualifications from an EU-27 Member State.
The full notice can be accessed on the European Commission’s website.