On 29 November 2018 the European Commission published a Notice to Stakeholders detailing the changes to the regulation of the cosmetics industry (the Commission Notice) when the UK exits the European Union (EU), be that at the end of a transitional period following the Withdrawal Agreement or in the event of no deal on 29 March 2019. Currently, the industry is governed at EU level by Regulation (EC) No 1223/2009 (the Cosmetics Regulation), which has direct effect in the UK.
When the UK leaves the EU, the Cosmetics Regulation will no longer apply domestically. At this point the UK will be designated a ‘third country’ under EU law, meaning a country not part of the EU.
Under section 3 of the European Union (Withdrawal) Act 2018 the Cosmetics Regulation will, however, be effectively transferred into UK law and under Schedule 8 of the Act all references to EU law shall be read as if they are a reference to the domestic equivalent. Notwithstanding this, the UK’s change in status at EU level means preparations will need to be made by the cosmetics industry for continued supply to the EU market. In this article, we discuss the consequences of Brexit for the cosmetic industry as outlined in the Commission Notice.
Each cosmetic product must have a legal or natural person established within the EU who is designated as the responsible person under Article 4 of the Regulation. The responsible person is either the manufacturer, if based in the EU, or importer of the product into the EU, unless the responsible person’s function is transferred by written notice to another person established in the EU.
From the withdrawal date, the responsible person can no longer be established in the UK but must be established in the EU27. For manufacturers based in the UK, this means that the responsible person designation will automatically transfer to the importer into the EU27. The same rule applies if the cosmetic product is manufactured in another third country, imported into the UK and subsequently sent to the EU27. This will also necessitate a related change in labelling due to the requirement under Article 19 of the Regulation that the responsible person’s details (including address) appear on the product.
Cosmetic product notification portal
Withdrawal from the EU will also impact on information sharing. Prior to placing a product on the market, the responsible person must notify certain information through the Cosmetic Product Notification Portal (CPNP) to the Commission, in accordance with Article 13 of the Regulation. After the withdrawal date, the new responsible person will have to make this notification if the product is to be placed on the EU27 market.
The Commission also states that up until the date of withdrawal, an existing product notification can be transferred from a UK responsible person to an EU27 responsible person. The notification can be edited so that the EU27 responsible person can add their name and address and amend the labelling. After the withdrawal, the UK responsible person will no longer have access to the CPNP.
This is not welcome news to the cosmetics industry. In a position paper published in June 2018, the Cosmetics, Toiletry & Perfumery Association (CTPA), which represents the industry at national level, said that access to the CPNP by the UK authorities is essential in order to avoid the administrative burden of a dual portal and dual submissions.
Product information file and country of origin
Companies will also have to make adjustments to comply with Article 11 of the Regulation, meaning that the product information file must be moved to the address of the responsible person in the EU27 and must be available in a language easily understood by the competent authority of that Member State. Therefore, companies who currently hold their product information file in the UK will need to consider their options in terms of moving them to an EU27 location.
Finally, from the date of withdrawal, cosmetic products manufactured in the UK will have to indicate the UK as the country of origin under Article 19 of the Regulation. The CTPA warned in its June paper that this would introduce bureaucracy, additional costs and delays in cross-border trade.
Draft Withdrawal Agreement
The situation outlined in the Commission’s notice is subject to the transition period provided for in the Withdrawal Agreement , which in the draft published on 14 November 2018 extends from 30 March 2018 until 31 December 2020. In this draft, goods would still be able to circulate between the EU27 and UK. But so far the UK Government has been unable to gather enough support to obtain Parliamentary approval for the Withdrawal Agreement.
If the current version of the Agreement is approved, which looks unlikely, then under Article 41 any good placed lawfully on the EU or UK market during the transition period can be traded freely until it reaches its end-user. Goods placed on the market must meet the EU requirements for the marketing of goods, which means compliance with current Union law and a continuance of the current regulatory arrangements.
Under Articles 43 and 44, marketing surveillance information and relevant documents and files respectively, would be shared ‘without delay’ between the EU and UK.
In response to the Commission Notice, the CTPA says that a ‘no deal’ Brexit would have ‘disastrous consequences’ on the industry as it could result in legislative gaps and products being stopped at borders.
The CTPA highlighted that over 30 EU Regulations apply to cosmetics meaning that the entire supply chain would be impacted in the event of no deal. However, the Commission Notice only addresses the Cosmetics Regulation and does not address other key pieces of legislation such as the REACH Regulation, the Classification, Labelling and Packaging Regulation and Biocidal Products Regulation.