REACH Regulation (EC) No 1907/2006

The REACH Regulation (EC) No 1907/2006 is a comprehensive framework aimed at ensuring the protection of human health and the environment from the risks posed by chemicals. It also works to enhance the competitiveness of the EU chemicals industry, promoting safer chemical use while encouraging the substitution of hazardous substances. The regulation creates transparency and boosts the flow of information about the properties and uses of chemicals.

Objective of REACH

The core objective of REACH is to ensure a high level of protection for human health and the environment by:

1. Promoting responsible chemical use

2. Encouraging the substitution of hazardous substances with safer alternatives

3. Enhancing transparency about chemical properties and uses.

In addition to improving environmental and health safety, REACH aims to boost the competitiveness of the EU chemicals industry by allowing the free circulation of chemicals within the internal market while simplifying administrative burdens through a unified regulatory framework.

Scope of REACH

REACH applies to:

• Substances and mixtures in quantities of one tonne or more per year, intended to be released under normal or foreseeable use.

• Manufacture, import, and use of these substances, requiring registration with the European Chemicals Agency (ECHA) in Helsinki.

However, there are exemptions in place for:

• Radioactive substances

• Certain products like medical, veterinary, alimentary, and cosmetic products

• Polymers and isolated intermediates

REACH does not apply to:

• Substances in waste

• Dangerous substances in transit

• Substances occurring in nature, unmodified or non-dangerous substances.

Key Provisions of REACH

• Substance Registration: Manufacturers and importers must register substances that meet the criteria (≥1 tonne/year) with the ECHA. Detailed data regarding the chemical’s hazards, risks, and safety measures must be submitted.

• Chemical Safety Assessment: For substances ≥10 tonnes/year, a chemical safety assessment is required, which evaluates:

• Human health hazards

• Physicochemical hazards

• Environmental hazards

• Persistent, bioaccumulative, and toxic (PBT) criteria

• Safety Data Sheets (SDS): Suppliers must provide SDS to recipients if their substances meet certain hazardous criteria, ensuring the safe handling, use, and disposal of chemicals.

• Evaluation and Authorisation:

• Substances deemed hazardous or classified as PBT/vPvB require further evaluation and potential authorisation.

• Authorisations must be listed on product labels for substances under restriction (Annex XVII).

• Substance Restrictions: Certain substances may be restricted under Annex XVII of REACH, ensuring that they are not produced or used unless specific conditions are met, excluding scientific research and development.

Roles and Responsibilities Under REACH

Manufacturers, importers, and suppliers are required to:

• Register chemicals with ECHA.

• Provide safety data sheets to downstream users for hazardous substances.

• Ensure the safe use of chemicals through risk management measures.

• Maintain records for at least 10 years.

Downstream users must:

• Identify and apply risk controls based on exposure scenarios.

• Prepare chemical safety reports for uses outside recommended conditions.

Key Benefits of REACH

1. Environmental and Health Protection: REACH ensures that chemicals are assessed for their risks to human health and the environment, thus fostering a safer market for both people and the planet.

2. Enhanced Transparency: The regulation improves the availability of information about chemicals, making it easier for businesses and consumers to make informed choices.

3. Increased Competitiveness: By standardizing requirements, REACH helps businesses meet international regulatory expectations, ensuring continued access to the EU market.

4. Innovation and Substitution: The regulation encourages innovation by promoting the development of safer alternatives to hazardous substances, driving the chemical industry toward greener solutions.

REACH is a vital piece of legislation in the EU that not only protects human health and the environment but also provides a competitive advantage to businesses that comply with its standards. Through robust chemical safety assessments, transparent reporting, and strict regulations on hazardous substances, REACH helps ensure that the chemicals used in products across industries are safe and responsibly managed.

By adhering to REACH, businesses can align themselves with European sustainability goals and regulatory expectations, paving the way for a healthier, more sustainable future.