Brexit outside and inside

By Nick Shaw
International Regulatory Consultant
cosmeticsinMind

Brexit – from the UK

• Responsible person for cosmetic products.

The government issued back in 2018 several Technical Guidance trying to cover certain aspects of Regulations present in the EU which will no longer be applicable in a post-Brexit scenario.

As such, the Guidance “Trading goods regulated under the ´New approach´ if there´s no Brexit deal” it states that goods placed on the market before Brexit will be allowed to circulate the UK, and goods made and assessed against EU requirements can continue to be placed on the market for a limited time (although there is no mention on the length of this period).

However, the responsible person based in the EU country will no longer be recognised once Brexit has been enacted, since the Responsible person hold specific duties regarding product safety on the market. It also reminds businesses that to appoint a new representative in the UK market, the representative must be located within the UK but will not be able to carry out task relating to product placed in the EU market.

Essentially, the relationship will be broken from both sides, and the UK´s government position is clear in this respect.

There is yet to be an indication as to a system that is to be implemented. Currently, cosmetics fall under the supervision of the National Trading Standards.

• CPNP

Where the Responsible person in a EU country had notified products on the CPNP, the accounts for UK base businesses and RPs will most likely be deactivated. This means that users will no longer have access to the notifications unless they have transferred the accounts and businesses to appoint a EU based entity or legal representative. This must happen before the 29 March 2019.

• REACH

Importers of products and mixtures that had registered substances using a UK based registrant, will no longer be recognised under EU law.

The main body of the legislation will be transposed into UK law, creating what has been named as UK REACH. UK registration holders wanting to continue having activity in the UK market will need to complete a pre-registration within 60 days from Exit day, with an extension of up to 2 years to complete the whole registration process. Pre-registration will not include any fees, but the complete registration is expected to entail the same amount as current ECHA fees.

Where Raw Materials were bought from EU suppliers, there is a risk of becoming an importer when continuing to purchase these materials and shipping them across to the UK, under which the UK REACH legislation on registration of chemical substances and mixtures would apply.

The Department for Environment, Food and Rural affairs is already looking into the creation of systems to be implemented in the case of a UK-REACH

• OTHER IMPLICATIONS

By exiting the EU, there are other trade implications which must be considered. This exit will mean that all transport across the UK-EU border will be taxed and there will be no free movement of goods. Additionally, the rules or origin which are in place for preferential treatment will need to be revised and documents such as long-term supplier declarations relating to the origin of the goods must be reviewed and issued where appropriate.

Brexit – from the EU

• Responsible person for cosmetic products.

From the EU, the recognition of the UK based Responsible Person will cease. Companies or legal representatives must be based in one of the EU countries and be able to provide a valid address within the European Union.

The European Union does not take into consideration grace periods or allowances, just as the UK. The legal responsibilities of the RP mean that the designation must be prior to the 29 March 2019 to be compliant.

This carries additional implications within the products on the market themselves, since the address on the label of products manufactured by a UK entity and placed in the market in different countries of the European Union might bear, as per the labelling requirements, the UK address on the label. In this case, this label would be non-compliant on the 30 March 2019. To avoid this, measures are to be taken prior to this date to ensure that the labelling is compliant. These strategies can go from manufacturing specific EU stock, to overstickering or reaching out to the local authorities in the country where the new RP is based to work collaboratively.

There will be no changes as to the way the RP works in the EU.

• CPNP

All UK accounts are expected to be blocked or deleted after the 29 March, after which the information would no longer be accessible.

New notification will have to be created for products that are to be imported in the market using the EU-based representative. While the UK is still a member of the EU and with full access and rights within the CPNP, we must remember that we can still transfer the RP responsibility and notification between entities and this might be the most effective way of going forward.

• REACH

All chemicals and mixtures registered under a UK business will no longer be recognised, and transfer of the registration should be passed onto a EU business or the registration be completed again to be compliant with the current legislation.

It is important to remember that monitoring of the substances that cross the UK-EU border will now have to be contemplated into the calculation of annual volumes introduced into the market. Where supply of a raw material or cosmetic product came from a UK based manufacturer or distributor, these substances will have to now be included into the REACH obligations.

• OTHER IMPLICATIONS

Regarding the same points, customs tax will be applicable and with every movement of existing stock of both ingredients and finished goods. This might make the supply of products to the EU market difficult and precautionary steps put in place.