EU REACH Registration Services

What is REACH Registration?

REACH stands for “Registration, Authorisation, and Restriction of Chemicals (REACH)”. It is a regulation that aims to minimize the adverse effects of chemicals on human health and the environment.

According to the REACH Regulation, manufacturers and importers must provide detailed information about the chemicals they produce or import. This information should be submitted through the European Chemicals Agency (ECHA). This is essential for companies working with chemicals in the European market to ensure compliance and chemical safety. REACH covers a wide range of products including:

• Furniture
• Kitchen utensils
• Electronics
• Textiles
• Packaging materials

Guidance on REACH Registration

What is the aim of REACH Registration?

According to ECHA’s Guidance on REACH Registration, the main aim of it is to ensure that manufacturers, importers and downstream users use, manufacture or place on the market substances that are safe for human health and the environment. That is why natural or legal persons who take part in the manufacture, import, place on the market or use of such substances are held responsible for REACH compliance.

The REACH Registration is a means to ensure that natural or legal persons in question meet the related obligations.

How to do REACH Registration?

REACH Registration is preparing a registration dossier in IUCLID format and submitting it to ECHA via the REACH-IT system. According to ECHA, the registration process can be divided into five steps:

1. Information requirements;
2. REACH registration dossier;
3. Joint submission of data;
4. Confidentiality and electronic public access to registration information;
5. Access to documents.

These steps are discussed below.

1. Information Requirements
   The first step of the registration process involves obtaining the necessary information. Manufacturers and importers are required to submit the related data which will be used to assess the risks and take precautions if necessary.
   This information is expected to be involved in the REACH registration dossier. In the process of obtaining this information, some tests and analyses may be required, which must comply with GLP principles.
   
2. REACH Registration Dossier
   A registration dossier consists of two main components: a technical dossier and a chemical safety report. The details of each are stated below:
   
   • Technical dossier
     According to the ECHA’s Guidance on REACH Registration, a technical dossier is always required for all substances subject to registration obligations.
     It includes information on:
     • The identity of the manufacturer/importer;
     • The identity of the substance;
     • Information on the manufacture and use of substance;
     • The classification and labelling of the substance;
     • Guidance on its safe use;
     • Study summaries of the information on the intrinsic properties of the substance;
     • Robust study summaries of the information on the intrinsic properties of the substance, if required;
     • An indication as to whether the information on manufacture and use, the classification and labelling, the (robust) study summaries and/or, if relevant, the chemical safety report has been reviewed by an assessor;
     • Proposals for further testing, if relevant;
     • For substances registered in quantities between 1 and 10 tonnes, information on exposure;
     • A request as to which information should be considered confidential, including a justification.
       
   • Chemical Safety Report
     Substances that are manufactured or imported by the registrant in quantities of 10 tonnes or more per year are subject to chemical safety assessment (CSA) requirements. After CSA is completed, it must be documented in a chemical safety report, known as CSR.
     However, there are some exemptions. According to ECHA, a CSR is not required for a substance present in a mixture if the concentration of the substance in the mixture is less than the lowest of the values defined in Article 14(2). In addition, for uses in food contact and cosmetics, the chemical safety report is not required to address human health as it is addressed under other legislation.
     
3. Joint Submission of Data
   In cases where multiple individuals wish to register the same substance, they must take part in a joint submission. According to ECHA, the joint submission includes a discussion of the data, sharing its costs, and submitting the information that is required under Articles 11(1) and 19(1) of REACH jointly.
   This way, the costs of registration are minimized, and duplication of the test is avoided. These registrants can also benefit from reduced registration fees.  
   The three cases regarding information in a joint submission are summarized in the table below:

Registrants are required to submit jointly the following information	Registrants may decide to submit jointly or separately	Registrants must submit separately in their dossier
Classification and labelling of the substance	Guidance on the safe use of the substance	Their identity
(Robust) study summaries and proposals for testing	Chemical safety report (CSR) when required	The identity of the substance
Indication as to which of the submitted information on classification and labelling study summaries and robust study summaries have been reviewed by an assessor chosen by the registrant and having appropriate experience	Indication as to which of the information submitted for the CSR has been reviewed by an assessor	Information on the manufacture and uses
		Exposure information for substances in quantities of 1 to 10 tonnes
		Indication as to which of the information on manufacture and use has been reviewed by an assessor

In a joint submission, there are two types of registration dossiers: lead dossier and member dossier.

According to ECHA, the lead dossier involves information on the lead registrant and the data set required in REACH for the highest tonnage band covered by the jointly submitted data. Member dossier, on the other hand, is the dossier that each of the registrants of the joint submission must submit individually.

Below, there is a table including details of the dossiers:

4. Confidentiality and electronic public access to registration information

In addition to ensuring chemical safety, the REACH Regulation also ensures the safety of information held by ECHA. According to ECHA’s Guidance on Registration, such information shall be either disclosed upon request or made publicly available on the ECHA website.

Guidance on how to request confidentiality in registration may be found on the ECHA’s manual page with the title ‘Dissemination and confidentiality under the REACH Regulation”.

5. Access to documents

ECHA states that documents held may be granted based on a case-by-case assessment as it is foreseen in ATD Regulation. According to ATD Regulation, ECHA must consult the author of the document on whether it should or should not be disclosed.

EU REACH Registration Fees

The REACH registration process incurs certain fees, which vary based on the substance’s tonnage and type of registration. Companies need to plan their budget accordingly to avoid non-compliance penalties. Late registrations may result in financial penalties, making timely action crucial. We advise companies not to delay their registration process to avoid extra costs. For information regarding REACH registration fees for your substances, you can contact us.

Restricted Substances Under REACH

REACH Regulation places certain restrictions for chemicals, heavy metals and pollutants in all products. Products that are restricted under REACH cannot be imported and sold within the single market legally. This application aims to prevent the dangerous use of chemicals and ensure safety against hazardous substances.

Substances that are restricted may include lead, phthalates, cadmium and mercury. All of them are stated in the ECHA’s Restricted Substances List.

Achieving REACH Compliance

By achieving the steps above correctly, you can ensure legal compliance with the REACH Regulation. If you don’t have the necessary expert workforce in-house, it is recommended that you retrieve some outside support from trustful consultancy companies.

We provide comprehensive support to companies in the chemical industry, ensuring a smooth and accurate REACH registration process. Our experienced team handles the preparation of the required technical dossiers and offers expert guidance at every step, ensuring quick and correct completion of the process.

Ensure your company’s REACH obligations are met with ease by partnering with us. We offer expert support to help you maintain compliance and gain a competitive advantage in the market.

Contact us now for more information and to start your registration process.

Frequently Asked Questions