Certification and Registration
REACH Regulation
Category:
REACH
SVHC
What Is REACH?
REACH Regulation (EC) No. 1907/2006, with the full name Registration, Evaluation, Authorisation and Restriction of Chemicals, is a chemical regulatory system established by the European Union. It entered into force on June 1, 2007, and regulates the content of chemicals and heavy metals in all consumer products sold within the European Union. For example, products containing lead or cadmium exceeding the specified limits are prohibited from being imported into and sold in the EU market. In addition, the European Chemicals Agency (ECHA) adds new substances to the REACH list every year.
REACH Scope of Application
REACH testing is not only applicable to industrial products but is also widely applied to everyday consumer products. The primary purpose of REACH is to ensure that daily consumer products do not contain chemicals that may harm human health. Therefore, all products manufactured within the EU or imported into the EU market must undergo testing for hazardous chemical content. Products that fail to meet the requirements cannot be sold in the EU market.Products subject to REACH testing include:
◉ Apparel & Textiles
◉ Luggage and Bags
◉ Jewelry and Accessories
◉ Electronic Products
◉ Furniture
◉ Kitchenware
◉ Pet Products
◉ Sports Accessories
◉ Stationery Accessories
REACH Controlled Substances
The number of substances controlled under REACH is extensive. For example, SVHC (Substances of Very High Concern) currently includes 223 substances, while Annex XVII contains 71 substances. These controlled substances include certain heavy metals, phthalates, polycyclic aromatic hydrocarbons (PAHs), and other chemicals.
If the content of any SVHC substance in a material exceeds 0.1% and the annual export volume exceeds 1 ton, an ECHA notification is required. If the content exceeds 0.1% but the annual export volume is less than 1 ton, relevant information must be communicated to consumers.
* In practice, manufacturers usually control SVHC substance content to below 0.1% as part of their material management requirements to avoid compliance risks.
REACH Non-Compliant Cases
The European RAPEX (Rapid Alert System for Non-Food Consumer Products) regularly publishes non-compliance cases, including REACH violations. REACH non-compliance cases often involve excessive levels of lead, cadmium, or phthalates. The following is a notified REACH non-compliance case reported by RAPEX:
◉ Product: Plastic doll.
◉ Non-compliance: The phthalate (DEHP) content exceeded the limit, reaching as high as 28.6%, and did not comply with REACH requirements.
◉ Hazard: This phthalate may pose health risks to children and may damage the reproductive system.
◉ Corrective measures: A risk warning was issued to the market and the product was withdrawn from the market.
Relationship Between REACH SVHC, ANNEX XIV, and ANNEX XVII
1. SVHC
SVHC is the abbreviation for Substances of Very High Concern.
SVHC substances generally possess one or more of the following characteristics:
◉ Carcinogenic, mutagenic, or toxic for reproduction (CMR) Category 1A/1B substances: Substances classified as carcinogenic, mutagenic, or toxic to reproduction.
◉ PBT substances: Substances that are persistent, bioaccumulative, and toxic.
◉ vPvB substances: Substances that are very persistent and very bioaccumulative.
◉ Substances with equivalent levels of concern: Substances supported by scientific evidence showing hazards equivalent to those mentioned above, including endocrine disruptors, persistent, bioaccumulative, and toxic substances, highly persistent and highly bioaccumulative substances that do not fall under PBT or vPvB classifications, and substances that may cause serious harm to human health or the environment.
2. ANNEX XIV
ANNEX XIV (Appendix 14) lists substances known as authorisation substances, meaning they may only be placed on the market or used after obtaining official authorization.
Substances listed in Annex XIV are selected from SVHC substances and officially authorized; therefore, the Annex XIV list is known as the List of Authorised Substances, while the SVHC list is officially referred to as the Candidate List.
3. ANNEX XVII
ANNEX XVII (Appendix 17) lists substances known as restricted substances, meaning their use in products is subject to restrictions.
Restricted substances are mainly substances that pose unacceptable risks to human health or the environment.
4. Relationship Between SVHC, ANNEX XIV, and ANNEX XVII
|
Distinction |
SVHC Substances of Very High Concern (Candidate List) |
ANNEX XIV Appendix 14 (List of Authorized Substances) |
ANNEX XVII Appendix 17 (List of Restricted Substances) |
|
Material properties |
1)CMR1A/1B 2)PBT 3)vPvB 4) There is scientific evidence indicating substances with equivalent hazards. |
Same as SVHC |
Substances that pose an unacceptable risk to human health or the environment |
|
Material Quantity (as of January 2022) |
223 one |
126 one |
71 one |
|
Regulatory requirements |
1) If the concentration exceeds 0.1% and the annual export volume is greater than 1 tonne, notification to ECHA is required. 2) If the concentration exceeds 0.1% and the annual export volume is less than 1 ton, relevant information must be communicated to consumers. |
Use is prohibited after the specified date (which the regulations refer to as the “sunset date”). |
Controlled in accordance with the requirements of Annex 17; products exceeding the limits cannot enter the EU market. |
|
Association of the Bill of Materials |
It is a candidate substance for authorization. |
1) From the candidate substance 2) May become a restricted substance after the date of sunset. |
Some substances are derived from authorized substances. |
REACH testing generally focuses on SVHC substances and Annex XVII restricted substances. Annex XIV substances usually do not require separate testing because they are already included in the SVHC list.
SATISFY provides a one-stop REACH testing service, including product evaluation, test follow-up, report interpretation, and corrective action recommendations. For more information, please contact SATISFY customer service.
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