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REACH FAQ

REACH FAQ

A solid understanding of the laws is essential when dealing with environmental regulations and how to comply with them. REACH is one of the most comprehensive chemical regulations, especially in Europe. Here we discuss some of the REACH FAQ.

REACH FAQ

General REACH FAQ

What is REACH?

REACH stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals. It is a regulation of the European Union (EU) adopted in 2006 (EC 1907/2006) to improve the protection of human health and the environment from the risks posed by chemicals. Administered by the European Chemicals Agency (ECHA), REACH applies to all chemical substances—not just those used in industrial processes, but also those found in everyday products, such as cleaning agents, paints, clothes, electronics, and furniture.

Why Does REACH Regulation Matter?

  • Human Health Protection

    • REACH helps ensure that people are not exposed to harmful chemicals that can cause cancer, reproductive disorders, hormonal disruption, or other health risks.

    • Manufacturers and importers must demonstrate that their substances can be used safely, based on detailed scientific data.

  • Environmental Safeguards

    • It aims to prevent the release of hazardous substances into air, water, and soil, reducing the long-term impact on wildlife and ecosystems.

  • Accountability for Industry

    • Under REACH, the burden of proof is on companies. Businesses manufacturing or importing chemical substances into the EU in quantities over 1 tonne per year must register these substances with ECHA, including information on their properties, uses, and safe handling.

  • Control of Substances of Very High Concern (SVHC)

    • REACH identifies SVHCs, such as carcinogens, mutagens, or endocrine disruptors. These substances are candidates for authorisation and may eventually be restricted or banned unless a company can justify their safe use.

    • Companies must notify customers and consumers if an article contains more than 0.1% by weight of an SVHC listed on the Candidate List.

  • Promoting Safer Alternatives

    • One of REACH’s goals is to encourage innovation by promoting the use of less hazardous alternatives to dangerous chemicals.

  • Global Impact

    • Although REACH is an EU regulation, it affects companies worldwide that sell products into the EU market. Non-EU manufacturers must comply by working with Only Representatives or ensuring their supply chains are REACH-compliant.

What are the hazardous substances restricted under REACH?

REACH restricts substances that pose unacceptable risks to human health or the environment. These restrictions are listed in Annex XVII of the REACH Regulation.

 Commonly Restricted Substances Include:

  1. Carcinogens, Mutagens, and Reproductive Toxins (CMRs)
    • Example: Trichloroethylene – a known carcinogen used in industrial degreasing.

    • Restrictions: Use in consumer products or general industry may be banned or limited.

  2. Persistent, Bioaccumulative, and Toxic (PBT) / very Persistent and very Bioaccumulative (vPvB) substances

    • Example: Short-chain chlorinated paraffins (SCCPs) – used in flame retardants and lubricants.

  3. Heavy Metals

    • Lead and its compounds – restricted in paints, jewelry, and plastics.

    • Cadmium – restricted in plastics, jewelry, and solder.

    • Mercury – restricted in batteries, measuring devices, and lamps.

  4. Phthalates (used as plasticizers)

    • Example: DEHP, DBP, BBP, DIBP

    • Restrictions: Banned in many consumer products, particularly toys and childcare articles.

  5. PAHs (Polycyclic Aromatic Hydrocarbons)

    • Found in rubber and plastics (e.g., handles, shoes, tools).

    • Restricted due to their carcinogenic potential.

  6. Azodyes and azo colourants

    • Banned in textiles and leather goods if they can release carcinogenic amines.

  7. Nonylphenol and Nonylphenol Ethoxylates

    • Restricted in textile processing and cleaning products due to environmental toxicity.

Who Must Comply with REACH regulation?

  • EU manufacturers of chemicals or products containing chemicals.

  • Non-EU suppliers importing goods into the EU.

  • Downstream users (e.g., formulators, industrial companies).

Example: A U.S.-based electronics manufacturer exporting cables to Germany must comply with REACH if those cables contain regulated chemicals.

What is a REACH Certification?

There’s no official “REACH certificate” issued by the European Union or ECHA. However, in industry, “REACH certification” usually refers to a declaration or document provided by a company stating that their product complies with the requirements of the REACH Regulation (EC 1907/2006).

What Does a REACH Certificate Typically Include?

A REACH Declaration of Conformity or REACH Certificate may confirm that:

  1. The product does not contain any SVHCs (Substances of Very High Concern) above the 0.1% weight threshold.

  2. All substances used are registered with ECHA if required.

  3. The product does not contain any restricted substances listed in Annex XVII of REACH.

  4. The product meets the requirements for safe use and communication down the supply chain.

Who Provides the REACH Certificate?

  • Manufacturers, importers, or suppliers prepare the certificate themselves or hire third-party consultants to evaluate compliance.

  • It’s not mandatory to have a certificate, but proof of compliance is required, especially for trade and customs or B2B assurance.

What Are REACH Standards? REACH FAQ

REACH standards refer to the set of legal requirements and obligations established under the REACH Regulation (EC 1907/2006)—which stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals.

These “standards” aren’t like ISO or ASTM technical standards. Instead, they are regulatory criteria that companies must follow to ensure safe chemical use in the European Economic Area (EEA).

Main Elements of REACH Standards

  • Registration

    • Companies must register substances they manufacture or import (≥1 tonne/year) with the European Chemicals Agency (ECHA).

    • Registration requires detailed information on chemical properties, uses, and safety data.

  • Evaluation

    • ECHA and EU Member States evaluate the information submitted in registrations to clarify risks or request more data.

  • Authorisation

    • Certain hazardous substances (SVHCs) need special authorisation to remain on the market.

    • The goal is to eventually replace them with safer alternatives.

  • Restriction

    • Substances that pose unacceptable risks can be restricted or banned through Annex XVII of REACH.

  • Communication

    • Suppliers must provide Safety Data Sheets (SDS) and communicate if a product contains an SVHC above 0.1% w/w.

    • Consumers have the right to ask if an article contains any SVHCs.

  • Candidate List and Annexes

    • Substances of Very High Concern (SVHCs) are listed in the Candidate List.

    • Restricted substances are in Annex XVII.

    • Authorised substances are in Annex XIV.

What Are SVHCs, and How Do They Impact My Business? REACH FAQ

Definition of SVHCs - REACH regulation

Substances of Very High Concern (SVHCs) are chemicals that pose serious risks to health or the environment, such as:

  • Carcinogens, mutagens, or reproductive toxins (CMRs).

  • Persistent, bioaccumulative, and toxic (PBT) substances.

  • Endocrine disruptors.

SVHC Compliance Rules

  • If your product contains an SVHC above 0.1% weight/weight, you must:

    • Notify ECHA via the SCIP database (for articles).

    • Provide safety information to customers.

    • Apply for authorization if the substance is on the Authorisation List (Annex XIV).

What Is the SCIP Database, and Who Must Submit Notifications?

SCIP Requirements - REACH regulation

Under the Waste Framework Directive (WFD), companies must submit SCIP (Substances of Concern In Products) notifications if:

  • Their product contains an SVHC >0.1%.

  • They supply products to the EU market.

Key Deadlines

  • Since January 2021, SCIP submissions have been mandatory.

  • Non-compliance can lead to fines or market bans.

How Does REACH Differ from RoHS?

Aspect

REACH

RoHS

Scope

All chemicals in products

10 restricted substances in electronics

Focus

SVHCs, authorization, and restrictions

Heavy metals and flame retardants

Reporting

SCIP notifications for SVHCs

Technical documentation

Enforcement

ECHA + EU member states

National authorities (e.g., UKCA, CE)

Note: A product may comply with RoHS but still fail REACH if it contains unregistered SVHCs..

What Are the Penalties for Non-Compliance with REACH Regulations?

REACH enforcement varies by EU country, but penalties include:

  • Fines (e.g., up to €50,000 in Germany).

  • Product recalls or bans.

  • Legal action from authorities or competitors.

Example: In 2022, a French company was fined €30,000 for failing to register an imported chemical.

How Can Enviropass Help with REACH Compliance?

We offer end-to-end REACH compliance solutions:

  • SVHC Screening – Lab testing & supply chain audits.
  • SCIP Notifications – ECHA-compliant submissions.
  • EU Regulatory Monitoring – Stay updated on new SVHCs.

REACH FAQ (Quick Answers)

Q: Does REACH apply to products outside the EU?

A: Only if they are imported into the EU.

Q: How often is the SVHC list updated?

A: ECHA adds new substances twice a year (June & December).

Q: Can small businesses get exemptions?

A: No, but simplified registration applies for 1-10 tonnes/year.

Q: Is REACH the same as UK REACH?

A: No, post-Brexit, the UK has its own UK REACH regulation.

Conclusion on REACH Compliance FAQ

REACH is a critical regulation for any business dealing with chemicals in the EU. Non-compliance risks fines, recalls, and lost market access.

Enviropass simplifies REACH compliance with:

  • Expert regulatory guidance
  • SVHC testing & SCIP notifications
  •  Ongoing compliance monitoring

Contact Enviropass to learn more about REACH and how to assess your products against it.