REACH Testing

REACH Testing (Registration, Evaluation, Authorization and Restriction of Chemicals) refers to a comprehensive EU regulation (EC 1907/2006) governing chemicals and downstream articles. It aims to protect human health and the environment and facilitate the safe use of chemicals. The regulation entered into force formally on June 1, 2007 with a wide coverage. It applies not only to chemicals themselves, but also to consumer goods and industrial articles containing chemicals. It constitutes a critical compliance requirement for enterprises exporting products to the EU market.


The REACH Regulation takes "Registration, Evaluation, Authorization and Restriction of Chemicals" as its core framework, covering the following key procedures:


  1. Registration
    Manufacturers or importers are required to submit registration dossiers to the European Chemicals Agency (ECHA) for substances (pure substances or substances contained in mixtures) with an annual production or import volume exceeding 1 tonne. The dossier shall include physicochemical properties, toxicity data, intended uses and risk control measures to demonstrate safe use of the substance.

    • Registration is implemented in phases. The scope of required test data and documentation varies according to production volume (1 tonne/year, 10 tonnes/year, 100 tonnes/year, 1000 tonnes/year, above 10000 tonnes/year) and risk classification.

  2. Evaluation
    ECHA or competent authorities of EU Member States evaluate registered substances, including:

    • Dossier Evaluation: verifying the completeness and compliance of registration dossiers;

    • Substance Evaluation: assessing whether a substance poses risks to health or the environment and requesting supplementary test data where necessary.

  3. Authorization
    Enterprises must apply for authorization to continue using substances identified as Substances of Very High Concern (SVHC) with available alternatives. Substances without granted authorization are prohibited from being manufactured, imported or used within the EU market.

  4. Restriction
    If a substance presents unacceptable risks to human health or the environment, the EU may impose restrictions to ban or limit its production, placing on the market and use (e.g. restrictions on lead in paints).


Within the REACH Regulation, Substances of Very High Concern (SVHC) constitute the core regulated objects, mainly including the following categories:


  • Carcinogenic, Mutagenic and Reprotoxic substances (CMR);

  • Persistent, Bioaccumulative and Toxic substances (PBT);

  • very Persistent and very Bioaccumulative substances (vPvB);

  • Other substances of equivalent level of concern (e.g. endocrine disruptors).


The SVHC Candidate List is dynamically updated by ECHA (As of May 2024, the list has been updated to the 29th batch containing a total of 235 substances). Enterprises shall track revisions to the list and fulfil the following obligations:


  1. Communication of Information: If the SVHC concentration in an article exceeds 0.1% (w/w), information on safe use shall be provided to customers and consumers;

  2. Notification Obligation: If the SVHC concentration in an article exceeds 0.1% and the annual export volume is above 1 tonne, notification shall be submitted to ECHA within six months after the substance is included in the Candidate List;

  3. Supply Chain Management: Enterprises shall verify the presence and concentration of SVHCs in articles through testing or supplier declarations.


Scope of Application
  • Chemicals (pure substances, mixtures);

  • Electrical and electronic products (such as home appliances, mobile phones, computers, covering components including plastics, metals, coatings, etc.);

  • Textiles, garments and footwear (involving dyes, auxiliaries, adhesives, etc.);

  • Toys and children’s articles (involving plastics, rubber, coatings, etc.);

  • Furniture and construction materials (involving wood preservatives, adhesives, paints, etc.);

  • Automobiles and auto parts (involving plastics, rubber, metal treatment agents, etc.).

Regulation

Core Controlled Objects

Scope of Application

Core Purpose

REACH

Chemicals and SVHC substances (235 items, updated dynamically)

Nearly all products

Control risks throughout the entire lifecycle of chemicals

RoHS

10 hazardous substances contained in electrical and electronic products

Electrical and electronic equipment

Restrict hazardous substances in electronic waste

California Proposition 65

Chemicals known to cause cancer or reproductive toxicity

Consumer goods sold on the California market

Warn consumers of potential health risks

 

Service Process

1. Identify Test Objects

Split test units according to product materials (such as plastics, metals, textiles, coatings, etc.). Different materials shall be tested separately.

2. Select Test Items

Testing is generally carried out against the currently valid SVHC Candidate List. Full testing or targeted testing can be selected based on product characteristics and applications (e.g., electronic products focus on heavy metals, flame retardants, etc.).

3. Sample Preparation

Provide representative samples (approximately 50-100g for each test unit, subject to the requirements of the testing laboratory) and ensure that the samples are free from contamination.

4. Test Methods

Chemical analysis methods are adopted, as follows:

Heavy metals (e.g., lead, cadmium, mercury): ICP-MS (Inductively Coupled Plasma Mass Spectrometry), AAS (Atomic Absorption Spectroscopy);

Organic substances (e.g., polycyclic aromatic hydrocarbons, phthalates, flame retardants): GC-MS (Gas Chromatography-Mass Spectrometry), HPLC (High Performance Liquid Chromatography).

5. Issue Test Report

The testing laboratory issues a report based on test results, clarifying whether the concentration of each SVHC exceeds 0.1% and providing compliance judgment.


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