Purposes of UK REACH

 

The UK REACH regulation was introduced with the aim of reducing the risks posed by chemicals and ensuring their safe use within the UK. The main purposes of UK REACH are:

 

1. Protecting human health: UK REACH aims to protect human health from the potential risks posed by chemicals, by ensuring that new and existing chemicals used in the UK are thoroughly assessed for their safety.

2. Preserving the environment: UK REACH also aims to protect the environment from the risks associated with chemical substances. By assessing the potential environmental impact of chemicals and placing restrictions on their use when necessary, UK REACH helps to minimize the impact of chemicals on the environment.

 3. Enhancing the competitiveness of UK businesses: UK REACH aims to create a level playing field for businesses operating in the UK by ensuring that they all have to comply with the same regulations. This can help to reduce regulatory burdens on businesses and increase their competitiveness.

 4. Ensuring the free movement of chemicals: UK REACH is designed to ensure that chemicals can continue to be traded between the UK and the EU after Brexit, by aligning the UK's chemical regulations with those of the EU to a certain extent.

 Overall, UK REACH seeks to ensure a high level of protection for human health and the environment while facilitating the use of chemicals in a way that supports innovation and competitiveness.

Ensure that chemicals are used in a way that protects both human health and the environment, hold manufacturers and importers of chemicals accountable for understanding and managing the risks associated with their use, and encourage the use of alternative methods for determining whether a substance is hazardous, such as quantitative structure-activity relationships (QSAR) and read across.

 

What is UK REACH?

 

UK-REACH stands for UK Registration, Evaluation, Authorization and Restriction of Chemicals. It is a UK-specific version of the European Union's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, which outlines procedures for the safe use of chemicals throughout the EU. The UK implemented its own version of this regulation on January 1, 2021, following its departure from the EU.

 

The implementation of UK-REACH requires companies in England, Scotland, Wales, and Northern Ireland that manufacture or import a chemical substance into the UK market to register it with the UK Health and Safety Executive. The HSE will then evaluate the data submitted by companies to determine whether the substance is safe to use and whether it can be placed on the UK market. Companies must meet the same industry standards and requirements mandated under the EU REACH regulation.

 

UK-REACH aims to reduce the potential risks posed by chemicals and ensure their safe use within the UK whilst protecting human health and the environment. It aims to create a level playing field for businesses operating in the UK by ensuring that they all have to comply with the same regulations. UK-REACH is intended to align the UK's chemical regulations with EU REACH to a certain extent in order to ensure the free movement of chemicals between the UK and the EU after Brexit.

 

Duties under UK REACH

 

UK REACH is the UK-specific version of the European Union's REACH regulations. It requires businesses to identify and manage the risks posed by the substances they manufacture and place on the market in Great Britain (GB). This includes substances produced in the UK, imported into the UK, or exported to other countries.

 

Under UK REACH, businesses must register their substances with the new UK REACH IT system if they meet certain criteria, such as if they are manufactured or imported in quantities greater than one tonne per year. They must also submit data to support the safe use of the substance, as well as comply with restrictions and authorization requirements if applicable.

 

In summary, UK REACH places responsibility on businesses to ensure that the substances they are placing on the market do not harm human health or the environment. Companies must take action to understand and manage the risks associated with their substances, and comply with the regulations to ensure the safety of their customers and the general public.

 

You must be able to demonstrate how the substance can be used safely and communicate risk management measures to users.

 

You will need to consider how you use chemicals to determine your role and obligations in the UK supply chain. Your previous role under EU REACH may have changed significantly under UK REACH, so you should review your roles (previous UK downstream users under EU REACH can now be importers under UK REACH).

 

UK’S REACH IS IN ACTION ?

 

Yes, UK’s REACH is in action. The UK has implemented its own version of the EU's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, known as UK REACH. UK REACH came into effect on January 1, 2021, following the UK's departure from the European Union.

 

The implementation of UK REACH means that companies in England, Scotland, Wales and Northern Ireland that manufacture or import a chemical substance into the UK market must register it with the UK Health and Safety Executive (HSE). They must also meet the same standards and requirements that were previously mandated through EU REACH.

 

The HSE evaluates the data submitted by companies and decides whether the substance is safe to use within UK legislation. It will also review decisions made by the European Chemicals Agency (ECHA), under the EU REACH regulation, for chemicals that were registered before the end of the Brexit transition period.

 

Therefore, UK REACH is currently in action in England, and the rest of the UK, in order to regulate the use of chemicals and protect human health and the environment from harmful impacts.

 

 From 1 January 2021, the UK REACH regulation comes into force in Great Britain (England, Wales, and Scotland); this allows some compliance tasks to be carried out by companies based in Northern Ireland. Therefore, UK-based companies will need to comply with UK REACH registration obligations if they manufacture or import 1 tonne or more per year of substances subject to UK REACH registration requirements, as is or as part of mixtures. Manufacturers/ formulators not based in the UK can register their substances through the UK Only Representative.

 

UK-based companies that have registered their substances under EU REACH have grandfathered these substances into the UK system. At the same time, UK downstream users/importers relying on EU-REACH suppliers' registrations can submit Downstream User Import Notifications (DUINs) to the UK-appointed authority (HSE) for known substances and benefit from extended registration deadlines.

 

Which items Excluded for UK REACH ?

 

Under the UK REACH regulation, a few items are specifically excluded from registration requirements. These items include:

 

1. Radioactive substances: Substances regulated under the Nuclear Safeguards Act 2018 and designated as radioactive source materials or special fissile materials are excluded from registration.

 

2. Waste: Waste that falls under the scope of the EU Waste Framework Directive is excluded from registration under UK-REACH.

 

3. Non-isolated intermediates: Non-isolated intermediates that are manufactured and used under strictly controlled conditions are also excluded from registration.

 

4. Polymers: The polymer itself is exempt from registration under UK-REACH, but specific monomers and additives that may have hazardous properties are subject to registration requirements.

 

It is important to note that, although certain items are excluded from registration requirements under UK-REACH, companies must still ensure that they comply with all applicable safety and environmental standards for these items.

 

What is the diffrence of EU and UK REACH

 

The main difference between EU REACH and UK REACH is that they are two separate regulatory frameworks governing the use and management of chemicals. EU REACH is an EU-wide regulation that regulates the production, importation and use of chemicals across all member states of the European Union. UK REACH is a UK-specific version of the EU REACH regulation, which came into effect on 1 January 2021 when the UK left the EU.

 

Here are some key differences between EU REACH and UK REACH:

 

1. Role of the European Chemicals Agency (ECHA): Under EU REACH, the ECHA serves as the central regulatory agency responsible for managing the registration, evaluation, authorization, and restriction of chemicals. Under UK REACH, the Health and Safety Executive (HSE) has taken on this responsibility for chemical management and regulation in the UK.

 

2. Data sharing: One significant difference is that UK REACH no longer provides automatic access to European databases, which may require companies to submit data separately to the European Chemicals Agency (ECHA) for use under EU REACH.

 

3. Registration requirements: The registration and notification requirements of companies under UK REACH are different from the requirements under the EU-REACH regulation.

 

4. Retention of existing registrations: Existing registrations under EU REACH have been retained for ongoing supply into the European market, however, new registrations are required under UK REACH for those materials supplied into Great Britain.

 

Overall, UK REACH differs from EU REACH in several areas to reflect the specific needs of the UK. While the general principles of REACH remain the same between the two regulations, companies that manufacture or use chemicals in both the UK and EU will need to comply with two different sets of regulations that overlap in many areas but diverge in some critical areas.

 

What is the DUIN on UK REACH?

 

DUIN stands for Downstream User Import Notification, which is a requirement under UK REACH for downstream users that import chemical substances into the UK from the EU/EEA or from other countries.

 

Under UK-REACH, downstream users must register their use of specific substances and notify the HSE of their use cases. Before downstream users can use new substances, they must provide the HSE with a notification about their intended use of the substance, which is known as the DUIN notification.

 

The DUIN notification provides the HSE with information on how the substance will be used, as well as the downstream user's contact details. It also helps downstream users understand their obligations under UK REACH and how they can use the substance legally and safely.

 

The DUIN requirement applies to downstream users that import substances above one tonne per year from countries outside the UK or the EU/EEA if those substances are not registered by a company within the EU/EEA. 

 

Therefore, if a company is a downstream user and imports a chemical substance from outside the UK or the EU/EEA, it must provide a DUIN notification to the HSE before it can start using that substance in the UK market.

 

What is Guidance for new registrant ?

 

The Health and Safety Executive (HSE) is responsible for the implementation and enforcement of UK REACH, the UK's regulatory framework for the registration, evaluation, authorization and restriction of chemicals. HSE provides guidance for new registrants under UK REACH to help companies navigate the registration process and comply with the regulation.

 

The guidance covers a range of topics, including:

 

1. Overview of the registration process: This includes what UK REACH is, who needs to register, what needs to be registered, and how to register.

 

2. Preparing and submitting a registration dossier: This covers the key elements of a registration dossier, including data requirements, assessment of risks, and how to prepare a robust substance identity profile.

 

3. Compliance tips for new registrants: This guidance provides tips for compliance with UK REACH, including selecting the correct tonnage band, meeting the deadlines for registration, providing complete and accurate information, and preserving confidential business information.

 

4. Understanding your legal obligations: This includes information on how to comply with the UK REACH regulation, including indicating uses, communicating information, assessing risks and providing data.

 

The guidance for new registrants under UK REACH is a comprehensive resource for companies seeking to understand and comply with the regulation, and it is intended to provide clear, practical advice to help companies navigate the registration process.

 

Comply with UK REACH?

 

The UK REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation is the UK's standalone chemical regulation post-Brexit.

 

The following are the steps to comply with UK REACH:

 

1. Determine your obligations: Identify whether you have a duty to register with UK REACH by checking the substance inventory and determining if the requirements apply to you.

 

2. Collate data: Gather data related to your substances, such as usage, properties, and impacts on human health and the environment.

 

3. Register: Submit a registration application with the required data on the UK REACH IT system by the applicable deadline.

 

4. Appoint an Only Representative (OR): If you are not based in the UK, appoint an OR to register your substances in the UK.

 

5. Evaluate your substances: Your substance will be evaluated by the UK Health and Safety Executive (HSE) or by a third-party evaluator appointed by them.

 

6. Comply with restrictions: Ensure that you comply with any restrictions on the use or sale of your substance in the UK.

 

7. Communicate with customers: Provide relevant safety information and instructions for safe use to customers and supply chain partners.

 

8. Maintain records: Keep records of all substances registered with UK REACH and maintain detailed records of compliance with the regulation.

 

By following these steps, businesses can comply with UK REACH and continue to sell and use substances in the UK.

 

Essentials of UK REACH

 

UK REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is a standalone chemical regulation introduced in the UK to ensure a high level of protection for human health and the environment from chemical risks.

 

The following are the essentials of UK REACH:

 

1. Registration: Any chemical substance manufactured or imported into the UK, either alone or as part of a mixture, in quantities of one tonne or more per year, must be registered. This includes substances used in industrial processes, professional use, and consumer use.

 

2. Evaluation: The UK Health and Safety Executive (HSE) will evaluate registered substances to check if they comply with the regulatory standards, and any risks posed by the substance will be assessed.

 

3. Authorization: If a substance is deemed to have a significant risk, its use may be restricted or subjected to an authorization requirement. Companies must apply for the authorization to use such substances.

 

4. Restriction: UK REACH will restrict the use of certain hazardous substances in various sectors to protect human health and the environment, as well as ensure sustainable use.

 

5. Data sharing: Under UK REACH, companies must share data needed to ensure that the use of chemicals is safe. This can include data on the physico-chemical, toxicological, and ecotoxicological properties of a substance.

 

6. Communication: Manufacturers and importers must communicate with their downstream users with relevant safety information about the substances they use.

 

7. Only Representative (OR): Companies not based in the UK must appoint an Only Representative (OR) based in the country to register their substances under UK REACH.

 

By complying with UK REACH essentials, businesses can ensure a high level of protection for human health and the environment, and continue to manufacture and market their substances within the regulatory framework.

 

Marketing in the UK -NRES

 

In the UK, marketing a substance as a new registrant of an existing substance requires compliance with the requirements of the UK Registration, Evaluation, Authorization, and Restriction of Chemicals (UK REACH) regulation.

 

As a new registrant, you will need to submit a registration application with the UK REACH IT system and provide all the necessary data about your substance, including its properties, uses, potential hazards, and environmental impact. You will also need to pay a registration fee.

 

You should be aware that as a new registrant, you will not be the data owner of the substance, so you will need to negotiate with the existing registrants to share the data needed to support your registration. This can involve negotiations on data sharing and joint submission of data.

 

Once your substance is registered, you also need to comply with any restrictions or conditions imposed on the substance. You should communicate relevant safety information to your customers and provide instructions for safe use.

 

In terms of marketing, you can promote your substance within the limited scope of the UK REACH regulation. You may make available your registration and associated information to downstream users, and this information may also be added to the Substance Information Exchange Forum (SIEF) database.

 

Overall, as a new registrant of an existing substance, compliance with the UK REACH regulation is critical for marketing your substance in the UK. Ensuring that you have fulfilled all the necessary requirements will help you promote your substance and maintain your business reputation

 

Authorisation decisions

 

Under the UK REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, authorization decisions are made when certain chemical substances pose a significant risk to human health or the environment. The following are the key points to understand regarding authorization decisions under UK REACH:

 

1. Authorization requirement: For substances of very high concern, a company must apply for an authorization to use or place it on the market in the UK.

 

2. Application process: To obtain an authorization, the company must submit a detailed authorization application, including information about the chemical substance, its uses, and potential alternatives.

 

3. Evaluation: The UK Health and Safety Executive (HSE) and the Committee on Authorization (COA) evaluate the application and assess the risk posed by the substance.

 

4. Decision: The COA will make an authorization decision based on the evaluation and take into account the socio-economic implications of the potential restrictions.

 

5. Conditions: If the authorization is granted, it will be subject to specific conditions that must be followed to ensure the safe use of the substance.

 

6. Review: The authorization may be reviewed periodically to assess the need for continued use and to consider any new scientific or technical developments.

 

7. Sunset date: Every authorization will have a sunset date, after which the use of the substance is prohibited unless it is renewed or replaced with a safer alternative.

 

In summary, authorization decisions regarding chemical substances under UK REACH help to ensure that any substance posing a significant risk to human health or the environment is subject to strict controls. With compliance, companies can continue to use or market substances in the UK while ensuring the protection of human health and the environment.

 

ARTICLE 26 INQUIRY

 

Under the EU's REACH regulation, Article 26 requires the European Chemicals Agency (ECHA) to make an inquiry to determine whether a substance that has not been registered should be registered. This inquiry is known as a "substance evaluation" and is intended to ensure that substances that are potentially hazardous to human health or the environment are identified and appropriately regulated.

 

The Article 26 inquiry may be triggered by various factors, including the potential for the substance to cause serious health or environmental impact, its volume of manufacture or import, or its uses. Typically, the inquiry involves requesting data from manufacturers, importers or downstream users of the substance, which then undergoes a technical review to determine the substance's hazard and risk profiles.

 

If the inquiry finds that the substance requires registration, the manufacturer or importer may be required to submit a registration dossier containing the necessary information and documentation to ensure the safe use of the substance. They may also be required to undertake further testing or risk assessments to ensure compliance with REACH regulations.

 

New Registrations: Article 26 inquiry is important in ensuring that substances that present risks to human health and the environment are identified and appropriately regulated, and that manufacturers and importers comply with REACH regulations.

 

Article 26 of the EU REACH regulation required the European Chemicals Agency (ECHA) to make an inquiry to determine whether a substance that had not been registered should be registered. However, in the UK, this function has been replaced by the "UK Prior Informed Consent" (PIC) regime, which is a separate regulatory framework introduced on January 1, 2021, alongside UK REACH.

 

Under UK PIC, companies that want to import certain chemicals into the UK or export them to non-EU countries must notify the UK authorities before doing so. The UK PIC regime operates in a similar way to the previous EU regime and covers chemicals listed in Annex I of the Rotterdam Convention. Under the UK PIC regime, the Health and Safety Executive (HSE) is responsible for managing the import and export notifications of certain chemicals.

 

Therefore, the UK does not have a direct equivalent of the Article 26 inquiry in UK REACH. However, chemical companies operating in the UK must meet the UK PIC requirements when importing chemicals into the UK or exporting them to non-EU countries. Failure to comply with these requirements may result in enforcement action being taken by the HSE.

 

OR Service in the UK

 

An Only Representative (OR) is a legal entity appointed by a non-EU manufacturer to act for them under the EU REACH regulation. The OR takes on the responsibilities of the non-EU manufacturer for fulfilling the obligations of REACH, which include registration, evaluation, authorization, and restriction of chemicals.

 

In the UK, as a result of the Brexit agreement, a UK-based OR may be required for companies that previously appointed an EU-based OR to comply with REACH regulations in the EU. It is advisable for companies to appoint a UK-based OR to ensure that they can continue operating in the UK as smoothly as possible.

 

To act as an OR in the UK, the legal entity should be based and incorporated in the UK and have the expertise and resources to fulfill the OR duties under UK REACH. The OR should have the capability to manage the registrations of non-UK manufacturers within the UK REACH regulations and communicate with the UK authorities effectively.

 

It's important to note that appointing an OR does not remove the responsibility of compliance from the non-EU manufacturer. The non-EU manufacturer is ultimately responsible for ensuring that their substances comply with UK REACH regulations, which includes providing the necessary data and documentation to the OR for registration.

 

In summary, appointing a competent UK-based OR is crucial for non-UK manufacturers to comply with UK REACH. The OR should possess the expertise to manage the registration process and communicate with regulatory authorities effectively to ensure compliance.

 

Where do I start to comply with?

 

The first step to comply with UK-REACH is to determine if your business is affected by the regulation. UK-REACH requires companies to register substances manufactured, imported, or used in the UK over one tonne per year.

 

Next, businesses need to identify the specific requirements they need to comply with, such as substance registration, safety data sheet provision, and hazard communication.

 

It's recommended to seek expert advice and support to ensure full compliance with UK-REACH. There are several organizations and consultants available to assist businesses with meeting regulatory obligations.

 

Finally, businesses need to develop a compliance plan and implement necessary changes to ensure they meet UK-REACH requirements. This may include changes to production processes, substance documentation, or hazard communication practices.

 

Overall, compliance with UK-REACH requires a thorough understanding of the regulation, assessment of business operations, and effective planning and implementation of compliance measures.

 

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It is difficult to give an exact timeframe for compliance with UK-REACH. Compliance timelines will depend on your company's size, the number of substances produced or imported, and the level of preparation already in place.

 

The registration deadline for the first phase of UK-REACH is January 28, 2021. The registration deadline for the second phase is January 27, 2024. These dates may change depending on government decisions.

 

It is recommended to start preparing as soon as possible to ensure that you meet the registration deadlines and have enough time to implement any necessary changes to your business operations. It can be a lengthy process to identify the substances that require registration, gather the necessary data, and prepare and submit the registration dossier. Seeking expert advice and support is also beneficial to ensure full compliance with UK-REACH.

 

Overall, the compliance process can take several months to a few years, depending on the complexity of your company's operations and the number of substances to be registered