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UK - Regulation

The UK has formally left the EU at 23:00 GMT on 31st January 2020 with a Withdrawal deal.

This has only marked the next step in the Brexit process. Post-Brexit, the UK has now entered a transition period until 31st December 2020 (also known as the implementation period (IP) completion day). During this period, the UK's trading relationship with the EU will remain the same while the two sides negotiate a free trade deal. Prime Minister Boris Johnson’s priority is to negotiate a trade deal with the EU during this transition period as the UK wants as much access as possible for its goods and services to the EU. The EU may take weeks to agree on a formal negotiating mandate and all the remaining 27 member states and the European Parliament must agree. At the same time, many other aspects of the UK's future relationship with the EU - including law enforcement, data sharing and security - will have to be agreed.

The negotiations between the UK and the EU for a vital trade deal have begun from 2nd March 2020. The UK and the EU have ruled out the possibility to extend the transition period beyond December 2020 and the UK will now exit the transition period on the said date, 31st December 2020. The UK has also released policy papers on its draft UK-EU comprehensive free trade agreement (CFTA) and the annexes on its plans for future trade relationship with the EU.  The draft specifically does not mention about REACH, but it proposes to cooperate on chemicals regulation, share data and align approaches towards classification and labelling. The draft annex suggests that both parties would agree to continue and strengthen their cooperation on chemicals regulation to facilitate trade in a way that benefits consumers, businesses and the environment and provides for the protection of human and animal health. This may include promoting and encouraging cooperation between the respective public or private organisations responsible for the manufacture, distribution, sale or regulation of chemicals.

In a private and very recent (June 2020) communication of Global Product Compliance (Europe) AB with the Health and Safety Executive (HSE), they have indicated that during this transition period, the UK businesses need to continue to comply with EU REACH in their current roles and in their supply chains. The UK authorities have indicated that, the extent to which the provisions in UK REACH will come into effect at the end of the transition period will largely depend on the outcome of the UK-EU trade deal negotiations. Based on the outcome of negotiations, the authorities might need to change some or all the provisions and any transitional provisions will give sufficient time span for the companies to comply.

UK REACH - What needs to be done?

Post transition period, the EU REACH Regulation will be brought into UK law by the European Union (Withdrawal) Act 2018. This Regulation, and related legislation, will be retained in the UK with the changes necessary to make it work in the domestic context. The key principles of the EU-REACH Regulation, including its fundamental principle of ‘no data, no market’, and its provision for Only Representatives (ORs) will, therefore, be retained. The EU REACH Regulation, after amendment in the UK, will be referred to as the UK REACH Regulation, and the regulatory system it creates will be referred to as UK REACH-IT.

By doing this, the UK will continue to be able to monitor and evaluate chemicals in the UK to reduce the risks posed to human health and the environment. It will also minimise disruption to the supply of chemicals. Existing standards of protection of human health and the environment would be maintained. Post transition period or the IP completion day, the Health and Safety Executive (HSE) would act as the lead UK regulatory authority, building on its existing capacity and capability.

The new regulatory framework will:

  • Enable the registration of new chemicals through a UK IT system that is similar to the existing EU IT system;
  • Provide specialist capacity to evaluate the impact of chemicals on health and the environment;
  • Ensure sufficient regulatory and enforcement capacity in the HSE, the Environment Agency (EA) and other regulators, enabling them to recommend controls in response to the hazards and risks of substances; and
  • Provide for an appropriate policy function in the Department for Environment, Food & Rural Affairs (Defra) and the devolved administrations.

Ensuring continued access to the UK market and maintaining existing standards of protection for human health and the environment

If companies are supplying and purchasing substances, mixtures or articles to and from the EU/EEA and the UK, they will need to ensure that the substances, or substances within a mixture/article, are registered with both agencies (ECHA and the UK Agency, i.e. the HSE) separately, by an actor within their supply chain, to maintain or gain access to both markets.

The exact details of registration under UK REACH will, however, be clear once UK REACH-IT opens after the IP completion day. The Health and Safety Executive (UK Govt.) has also informed that during the transition period, the UK will remain within the EU REACH regulatory framework. UK REACH and the UK REACH IT system ‘Compliance with UK REACH’ are currently non-operational and the guidance on how to register under UK REACH will be released by them in the due course of time”.

Global Product Compliance (Europe) AB has already set up a UK based OR entity “GPC UK”, to support its existing and new potential clients, to be able to comply with the challenges posed because of Brexit on substance exports to the UK.

Companies seeking to export an EU-registered substance to the GB market, who also placed that substance on the GB market in 2019-2020: 

Such exporters may submit a Downstream User Import Notification (DUIN) to HSE. By notifying their substance via DUIN, exporters will maintain access to the GB-market while deferring the registration of their substance by 2, 4 or 6 years (depending on the tonnage band and risk profile of the substance).

To submit a DUIN, non-GB based exporters need to appoint a GB-based Only Representative. The deadline for DUIN expired on 27 October 2021, however late-DUINs can still be submitted.

 

Companies seeking to export an EU-registered substance to the GB market for the first time

These exporters may benefit form a simplified registration process named New Registration of an Existing Substance (NRES). NRES requires exporters to:

  1. Submit an Inquiry
  2. Pay HSE’s registration fee
  3. Submit a simplified registration dossier (which does not need to include the LoA)

Once these steps have been completed the substance can be placed on the GB-market. The full registration dossier will have to be submitted within 2, 4 or 6 years form 27 October 2021 (depending on the tonnage band and risk profile of the substance)

Please note that NRES only applies to substances that were registered under EU REACH before 31st December 2020.

Exporters of a non-EU-registered substance wishing to access the GB market: 

Exporters who do not qualify for DUIN or NRES must register their substances under UK-REACH before they may place that substance on the GB-market. Non-GB based exporters must appoint a GB-based OR to complete the full registration of the substance. To register, exporters need to

  1. Submit an Inquiry
  2. Pay HSE’s registration fee
  3. Submit a full registration dossier (including the LoA)

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Cosmetics Directive - The Directive 76/768/EC has been governing the composition, labelling and packaging of finished cosmetic products in the European Union since 1976 and is now replaced by the Cosmetics Regulation (EC) 1223/2009.

Cosmetics Regulation - Regulation (EC) 1223/2009, on cosmetic products, entered into force on 11 January 2010. From 11 July 2013, it completely replaced Directive 76/768/EEC, on the approximation of the laws of the Member States relating to cosmetic products. Being common to all Member States, the Regulation sought to address the remaining gaps among national transpositions of the Directive and to streamline procedures.

Since Brexit, companies that want to place products on the Great Britain’s market (England, Scotland and Wales) need to respect the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, Schedule 34. This amendment gives new guidelines related to the responsible person, the label requirements and the notification portal in GB.

The Responsible Person in GB 

A cosmetic product cannot be placed on the GB market unless there is a Responsible Person established in the UK in respect of that cosmetic product. Like for the EU market, the Responsible Person will have to ensure compliance with the Regulation and that a safety assessment is completed. The name and address of the Responsible Person will have to be printed on the primary and secondary packaging of each product for which hi/it takes responsibility. It is possible for a Manufacturer or Importer to authorise a third party to act as the Responsible Person via a written mandate. 

The SCPN notification for GB market 

The SCPN works for GB in the same way as CPNP for EU. Before the product is placed on the GB market, the Responsible Person must notify the Secretary of State through the Submit Cosmetic Product Notification service. This platform is only accessible by the authorities and the Responsible Person.

GPC can :

  • Act as a Responsible person for UK 
  • Gather all the documents required for the elaboration of PIF 
  • Review your formulation 
  • Test the physic-chemical properties of your product 
  • Test the microbiology of your product 
  • Review your label 
  • Review your claims according to regulation (EU) No 655/2013 
  • Perform a safety assessment 
  • Create and update the PIF 
  • Notify your product on the SCPN 
  • Assist with customer complaints if any 
  • Perform regulatory monitoring 
  • Regulatory consulting 

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