EU REACH

The EU REACH Regulation (EC) No 1907/2006, fully titled "Registration, Evaluation, Authorisation and Restriction of Chemicals", is a regulation of the EU concerning the registration, evaluation, authorisation, and restriction of chemicals. This regulation officially came into effect on June 1, 2007, and was implemented on June 1, 2008. Click to download the original text of the REACH regulation.

The REACH regulation replaces EU regulations or directives such as (EEC) No 793/93, (EC) No 1488/94, and 76/769/EEC, becoming a comprehensive regulation for the unified preventive management of all chemicals entering the EU market. The implementation of this regulation has a significant impact on exports to the EU, including from China, especially in industries such as chemicals, electromechanical, textiles, dyeing, rubber, plastics, toys, and furniture.

Main contents of the REACH regulation

1. Registration: All chemical substances produced or imported in quantities exceeding 1 ton per year must be registered, and substances produced or imported in quantities exceeding 10 tons must also submit a chemical safety report.

2. Evaluation: This includes dossier evaluation and substance evaluation. Dossier evaluation is to verify the completeness and consistency of the registration dossier submitted by the enterprise; substance evaluation is to confirm the risks of chemical substances to human health and the environment.

3. Authorisation: Authorisation is required for the production and import of chemical substances that have certain hazardous properties and are of high concern, including CMR, PBT, vPvB, etc.

4. Restriction: If it is believed that the manufacture, placing on the market, or use of a certain substance, mixture, or article poses risks to human health and the environment that cannot be adequately controlled, restrictions will be placed on its production or import within the EU.

Responsibilities and obligations under the REACH regulation

1. Substances/Mixtures

Unless otherwise specified by REACH, any manufacturer or importer of substances within the EU that are present in quantities greater than or equal to 1 ton/year, whether on their own or in one or more mixtures, must submit a registration to ECHA.

2. Articles

(1) If a product contains substances intended to be released, and the annual export volume of that substance exceeds 1 ton, registration is required.

(2) If a product does not contain substances intended to be released, the following conditions must be assessed:

A. If the product contains substances of very high concern (SVHC) and the concentration is less than 0.1%, there is no obligation to notify or actively communicate information, but if requested by the importer or consumer, relevant information must be provided;

B. If the product contains SVHC and the concentration is greater than 0.1%, and the annual export volume is less than 1 ton, the downstream importer must be informed and relevant information must be communicated, along with relevant documentation, which typically includes SDS safety data sheets;

C. If the product contains SVHC and the concentration is greater than 0.1%, and the annual export volume exceeds 1 ton, it must be reported to ECHA. Click to view SVHC reporting requirements;

D. At the request of consumers, all suppliers of the article must provide sufficient information to consumers within 45 days of the request to ensure safe use of the article. This information must at least include the name of the substance.

(3) Substance restrictions, namely the restrictions on the manufacture, placing on the market, and use of certain hazardous substances, mixtures, and articles as outlined in Annex XVII of the REACH regulation, are important tasks beyond SVHC.

What is SVHC?

According to Article 57 of the REACH regulation, substances that meet one or more of the following hazardous characteristics can be identified as substances of very high concern (SVHC).

1. Category 1 and 2 carcinogenic, mutagenic, or toxic for reproduction substances, i.e., CMR1/2 substances;

2. Persistent, bioaccumulative, and toxic substances, i.e., PBT substances;

3. Very persistent and very bioaccumulative substances, i.e., vPvB substances;

4. Substances with endocrine-disrupting properties, or persistent, bioaccumulative, and toxic, or very persistent and very bioaccumulative but do not meet the criteria of 2 and 3, and for which there is scientific evidence that they cause serious effects on human health or the environment.

SVHC Candidate List

Competent authorities or institutions of member states can propose substances to be included in the SVHC candidate list by submitting dossiers of substances that meet the above characteristics. Stakeholders will be invited to comment on the substances in the dossier, and after discussion, the substance will be confirmed as an SVHC, i.e., a candidate for authorisation.

Authorised substances are selected from the candidate substances, i.e., SVHC, and listed in Annex XIV (Authorisation List). Manufacturers, importers, or downstream users in the supply chain must submit an authorisation application to ECHA 18 months before the sunset date to obtain the right to use or place on the EU market.

Latest SVHC list:https://echa.europa.eu/-/four-new-substances-added-to-candidate-list

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