What Are RoHS and REACH Certificates?

If you are considering importing products into the EU, you may have come across REACH and RoHS.  

The new compliance requirements under RoHS 2 and RoHS 3 were implemented in July 2019, impacting all manufacturers subject to this standard. These updates introduced new restricted substances, labeling requirements, and regulated product categories.

Additionally, the European Chemicals Agency (ECHA) recently announced plans to quadruple REACH compliance inspections, making REACH testing and compliance more critical than ever. Below, we provide a detailed explanation of these standards to ensure your products fully comply with EU market regulations.

What Is REACH Certification?

REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is an EU regulation under EC 1907/2006 designed to protect human health and the environment from chemical hazards. Effective since June 1, 2007, it is one of the primary compliance requirements for the EU.

Scope of REACH  

REACH applies to the manufacture and use of all chemical substances. Even if you don’t think your product contains chemicals, it may still fall under REACH requirements. For instance, products such as clothing, furniture, cleaning supplies, paints, toys, and electronic devices may contain chemicals and thus require compliance.

REACH SVHC (Substances of Very High Concern)  

REACH specifically regulates chemicals classified as Substances of Very High Concern (SVHC). These substances include:  

1. Chemicals that are carcinogenic, mutagenic, or toxic to reproduction (CMR substances).  

2. Chemicals that are persistent, bioaccumulative, and toxic (PBT substances), meaning harmful chemicals that do not easily degrade in the environment.  

3. Other substances that pose serious risks to human health or the environment in specific cases.  

The EU controls SVHCs through three regulatory lists:  

- Candidate List: Substances that may eventually be included in the Authorization List. Their concentration in products must not exceed 0.1% by weight. The current list contains 197 substances.  

- Authorization List (Annex XIV): Substances that cannot be used or imported into the EU without prior ECHA authorization after a specific "sunset date." This list includes 69 substances.  

- Restriction List (Annex XVII): Substances that pose unacceptable risks to human health or the environment, subject to strict use limitations or outright bans.  

REACH Compliance Requirements  

- Companies importing more than 1 ton of SVHC annually must register with ECHA and submit a dossier including hazard information and a risk assessment for the substance.  

- While a REACH certificate is not a legal requirement, many importers provide such certificates as part of their compliance efforts. These typically include REACH test results and self-assessments of conformity.

What Is ROHS certification?

RoHS (Restriction of Hazardous Substances Directive) aims to reduce the amount of toxic electronic waste and regulates the use of certain chemicals in products.  

- Scope: RoHS applies exclusively to electrical products, including household appliances, IT equipment, consumer electronics, lighting, medical devices, and more.  

- Legal Nature: Unlike REACH, RoHS is a directive, meaning EU member states must create their own laws to implement its requirements. However, the restricted substances and limits are consistent across the EU.

Evolution of RoHS  

1. RoHS 1 (2002/95/EC): Introduced in 2002.  

2. RoHS 2 (2011/65/EU): Revised in 2011 to expand its scope.  

3. RoHS 3 (2015/863): Amended in 2015 to include additional restricted substances.  

Restricted Substances and Limits under RoHS

The following substances must not exceed the specified concentration limits in any "homogeneous material" of a product:

Substance | Limit (mg/kg) | Limit (weight percentage)

· Lead (Pb): 1000 mg/kg (0.1%)

· Mercury (Hg): 1000 mg/kg (0.1%)

· Hexavalent Chromium (Cr(VI)): 1000 mg/kg (0.1%)

· Cadmium (Cd): 100 mg/kg (0.01%)

· Polybrominated Biphenyls (PBBs): 1000 mg/kg (0.1%)

· Polybrominated Diphenyl Ethers (PBDEs): 1000 mg/kg (0.1%)

· Di(2-ethylhexyl) phthalate (DEHP): 1000 mg/kg (0.1%)

· Dibutyl phthalate (DBP): 1000 mg/kg (0.1%)

· Benzyl butyl phthalate (BBP): 1000 mg/kg (0.1%)

· Diisobutyl phthalate (DIBP): 1000 mg/kg (0.1%)

For compliant products, the content of restricted substances must not exceed 0.1% in any homogeneous material, except for cadmium, which is limited to 0.01% (100 ppm).

Restricted Substances and Limits Under RoHS  

RoHS restricts the use of several hazardous substances in electrical products. Products must not exceed 0.1% (1,000 ppm) concentration for most restricted substances and 0.01% (100 ppm) for cadmium.

How to Ensure Compliance with REACH and ROHS Testing?

Responsibility  

Companies importing products into the EU are responsible for ensuring compliance. If a product is found non-compliant, the importer may face legal consequences.

Common Testing Methods  

1. REACH Testing:  

   - SVHC Screening: Quickly detects the presence and location of SVHCs in the product.  

   - Restriction List Testing: Tests specific restricted substances based on Annex XVII regulations.  

2. RoHS Testing:  

   - X-Ray Fluorescence (XRF) Screening: Rapidly detects restricted substances and their locations.  

   - Chemical Analysis: Verifies non-conformities identified during XRF screening.  

Testing Strategies  

- Most importers begin with "screening tests" to reduce costs. If no issues are identified, further analysis is often unnecessary.  

- If potential risks are found, detailed testing is required. Additionally, importers should obtain material declarations and compliance certificates from suppliers.

Consequences of Non-Compliance

1. "No Data, No Market" Policy: Products without compliance data cannot be distributed in the EU.  

2. Legal Penalties: Violations may result in significant fines or criminal charges, with penalties as high as €55 million and imprisonment of up to 8 years.

Ensuring compliance with REACH and RoHS standards is crucial for importers:  

- Familiarize yourself with applicable regulations and verify supplier material declarations.  

- Conduct independent testing through reliable laboratories to reduce risks.  

When it comes to REACH and RoHS Compliance, do not take unnecessary risks. Engage a professional and trustworthy independent laboratory to detect restricted substances before your product enters the EU market.