What is REACH Compliance & How is it enforced ?

REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) is a European Union (EU) regulation that aims to protect human health and the environment from the risks that can be posed by chemicals. REACH compliance refers to a company's adherence to the requirements and regulations set forth by the REACH regulation.

REACH mandates that businesses that produce, import, or use chemicals inside the EU register the substances they use, assess any potential risks, and request authorization for those uses as needed. Companies must also provide information on the proper use of the substances they produce or import to comply with REACH regulations, as well as notify the appropriate authorities of any incidents involving hazardous chemicals.

Brief history of EU REACH Regulation

EU REACH was adopted in 2006 and entered into force in 2007. It is based on the principle that manufacturers and importers of chemicals are responsible for assessing the risks posed by their chemicals and for managing those risks.

Before the adoption of REACH, the European Union had many separate regulations governing the use of chemicals, and there was no central system for the registration and evaluation of chemicals. REACH was designed to address this by establishing a single system for the registration, evaluation, authorization, and restriction of chemicals in the EU.

REACH was developed through a long process of consultation and negotiation, involving both the European Commission and the European Parliament. It was adopted as a regulation, rather than a directive, which means that it is directly applicable in all EU member states without the need for national implementation.

Since its adoption, REACH has undergone several changes and updates, including the addition of new substances to the Candidate List (SVHC) and the Authorisation List (Annex XIV), and the introduction of new restrictions on the use of certain substances. However, the fundamental principles of REACH have remained the same, and it continues to be a key piece of legislation governing the use of chemicals in the European Union.

The REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation is a comprehensive framework established by the European Chemicals Agency (ECHA) to ensure the safe use of chemicals within the European Union (EU). The regulation covers various aspects of chemical substances, including their registration, assessment, authorization, and restriction.

Here are the key components of the REACH regulation framework:

• Candidate List:

Definition: The Candidate List is a compilation of substances that ECHA is currently evaluating due to their potential adverse effects on human health or the environment.

Purpose: These substances are under consideration for inclusion in the Authorization List. Firms using substances from the Candidate List are encouraged to explore alternative, safer options.

• Authorisation List:

Definition: The Authorisation List (Annex XIV) consists of substances that have been identified as having serious effects on health or the environment.

Purpose: Substances listed in Annex XIV require explicit authorization for their use. Companies must apply for authorization to continue using these substances, and there is a sunset date after which use without authorization is prohibited.

• Restricted List:

Definition: The Restricted List (Annex XVII) comprises substances that ECHA has either banned or restricted in specific situations or for certain uses.

Purpose: Restrictions may include limitations on concentration levels or usage in specific applications to mitigate risks to human health and the environment. Compliance with the restrictions outlined in Annex XVII is mandatory.

Five-Step Guide to EU REACH Compliance

• Product Information Collection and Analysis

The initial step involves gathering information on substances falling under EU REACH regulation, manufactured or imported in quantities exceeding 1 tonne annually. Collect data from suppliers, utilizing various documents like Full Materials Declarations (FMDs), certificates, safety data sheets, and test reports. Evaluate the hazards and potential risks associated with these substances.

• Registration of Substances

Create a registration dossier containing hazard information, risk assessments, and risk management details for each substance. The "one substance, one registration” principle mandates joint submissions by manufacturers and importers of the same substance. Exceptions apply to already-regulated chemical substances, which may be partially or completely exempt.

• ECHA Registration Evaluation

After submitting the registration dossier, ECHA assesses its compliance with regulatory requirements. ECHA and EU member states review the quality of dossiers and proposed testing methods to determine if a substance poses risks to human health or the environment. If necessary, companies may be asked to provide additional information.

• Ruling on Substances by ECHA

If risks are identified, ECHA may impose restrictions, bans, or categorize substances as Substances of Very High Concern (SVHCs). SVHCs, if not restricted, banned, or authorized for specific purposes, must be reported when present in products at concentrations above 0.1% w/w. Companies must disclose SVHC names, concentration levels, and safe use information. Some substances receive authorization for specific uses even if initially restricted.

• REACH Certification

Upon successful evaluation of the registration dossier, ECHA issues a REACH certificate with a unique registration number. This certificate serves as proof of compliance with EU REACH regulations. It signifies that the company has followed the necessary steps, met the criteria, and can continue using the registered substances in their products.

By following these five steps, companies can navigate the complexities of EU REACH compliance, ensuring the safety of their products and contributing to the protection of human health and the environment.

How is REACH Regulation Enforced?

The REACH regulation is enforced by the European Chemicals Agency (ECHA), which is responsible for the implementation and enforcement of REACH. The ECHA has many tools and powers at its disposal to ensure compliance with REACH, including:

• Registering and Evaluating Chemicals: The ECHA maintains a central database of information on chemicals registered under REACH and conducts evaluations of the risks posed by these chemicals.
• SCIP Database: Companies supplying articles containing substances of very high concern (SVHCs) on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market have to submit information on these articles to the ECHA SCIP database.
• Providing Guidance and Support: The ECHA provides guidance and support to companies on how to comply with REACH, including through the provision of information, training, and other resources.
• Carrying out Inspections: The ECHA has the power to carry out inspections of companies to ensure compliance with REACH, including the inspection of facilities, records, and documents.
• Taking Enforcement Action: If a company fails to comply with REACH, the ECHA can take enforcement action against them. This can include issuing warnings, imposing fines, or taking legal action.

How does REACH Regulation apply for Article Manufacturers (Electronic/Electrical/Mechanical) compared with Chemical /Mixture Manufacturers?

The same rules that apply to manufacturers of chemicals and mixtures also apply to manufacturers of articles. The European Chemicals Agency (ECHA) requires all manufacturers to register the chemicals they create or import, as well as to provide details on their uses, potential risks, and physical and chemical characteristics.

REACH does include some particular specifications for article manufacturers. For instance, if a substance on the Candidate List (SVHC) is present in an article in a concentration greater than 0.1% weight by weight, the manufacturer is required to give customers access to information about that substance upon request. Additionally, article producers must ensure that the chemicals they use are used by industry standards, and they must inform their clients, and notify SCIP database and downstream users of the safe use of their products.

Overall, even though the requirements for manufacturers of articles may differ slightly from those for manufacturers of chemicals and mixtures, all manufacturers must ensure compliance with REACH because the fundamental principles of the regulation apply to all manufacturers.

Make EU REACH Compliance Effortless with Acquis

Navigating EU REACH compliance can be challenging due to its complexity and constant updates. Manual supplier outreach and data collection at the article level not only consume valuable resources but also pose a risk of errors.

Enter the Acquis Compliance Tool – your key to streamlined EU REACH compliance. Our platform simplifies the process by automating supplier data collection, ensuring accuracy through validation, and presenting consolidated data for easy reporting. Whether you seek a comprehensive solution with expert management or simply software support for your compliance efforts, we customize our services to meet your unique needs.

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