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◉ Certification Introduction
The full name of EU REACH regulation is "Registration concerning the Registration, Evaluation, Authorization and Restriction of Chemicals" (REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals), which came into effect on June 1, 2007, and came into force on June 1, 2008 , almost all products put on the EU market are under the control of REACH regulations.
REACH regulation is a set of management system for the production, trade and use of chemicals. It has 15 volumes and 17 annexes, mainly involving four parts: registration, evaluation, authorization and restriction. The content is complete, systematic and rigorous, and there are existing legal provisions. , there are technical standards, a large amount of information, and strong professionalism, covering about 30,000 chemical products in the EU market and their downstream textiles, light industry, pharmaceuticals and other products.
◉ Main Content
1. Registration: All chemical substances with an annual output or import volume exceeding 1 ton need to be registered, and a chemical safety report (CSR) should also be submitted for substances with an annual output or import volume of more than 10 tons. Non-EU producers must submit registration to the EU through the EU Only Representative (OR).
After successfully submitting the registration dossier of chemical substances to the European Chemicals Agency (ECHA), a company can obtain a registration number registered with 18 digits. Substances that fail to obtain a registration number cannot continue to be placed on the EU market.
2. Evaluation: including file evaluation and substance evaluation. File evaluation is to check the completeness and consistency of registration dossiers submitted by enterprises; substance evaluation is to confirm the risk of chemical substances harming human health and the environment.
3. Authorisation: Authorisation for the production and import of chemical substances with certain dangerous properties that attract people's attention. For substances listed in the list of authorized substances (Annex XIV of the REACH regulation), manufacturers, importers or downstream users in the supply chain must submit an authorization application to ECHA 18 months before the deadline before they can be used or placed on the EU market. s right.
4. Restriction: If a substance, preparation or article is considered to be manufactured, placed on the market or used so that risks to human health and the environment cannot be adequately controlled, its production or import within the EU will be restricted. [Annex XVII of the REACH Regulation sets out restrictions on the manufacture, placing on the market and use of certain hazardous substances, mixtures and articles, known as the Restricted Substance List]
◉ Supply Chain Obligations
REACH covers almost all products exported to the EU (except food, medicines and pesticides). In response to the requirements of REACH regulations, all links in the supply chain need to undertake corresponding obligations:
1. Chemical suppliers: transfer chemical information and provide SDS
2. Raw material suppliers: collect chemical information, transmit chemical information, and check for the presence of SVHC
3. Non-EU article manufacturers: collect chemical information, transmit chemical information, pre-register as required, and notify existing SVHC
4. Brand owners: pre-register as required, collect/notify existing SVHC, collect SDS for preparation, notify calculation, and prove due diligence
5. Retailers: Pre-register as required, collect/notify existing SVHC, collect SDS for preparation, notify calculation, and prove due diligence
◉ Scope of Control
The scope of REACH regulation is quite extensive, it covers the production and use of chemical substances in almost all industries, including not only chemical substances in industry, but also products produced by using chemical substances in our daily life, such as detergents, paints, Clothing, furniture, electrical and electronic products, etc. Therefore, it will have a huge impact on various industries around the world, including the electrical and electronic industry.
◉ Examples of Projects Involving Electrical and Electronic Products
|
Item |
Major Restriction Requirements |
Common Uses |
|
Asbestos fiber |
Intentional addition of mixtures and articles is prohibited. |
Thermal insulation material |
|
Organotin compounds |
Tri-substituted organotin compounds shall not be used in any article or part of an article in excess of 0.1% (by weight of tin) after July 1, 2010; |
As heat stabilizer, catalyst, insecticide for textiles, wood, leather, coatings, etc. |
|
Nickel and its compounds |
For accessories used for puncturing human body parts, the nickel release rate is less than 0.2 μg/cm2/week; The release rate of nickel in products with direct and long-term contact with the skin shall not exceed 0.5 μg/cm2/week. |
coating, alloy |
|
Polycyclic Aromatic Hydrocarbons PAH |
Under normal or reasonably foreseeable conditions of use, the content of any one of the 8 PAHs in products whose plastic or rubber parts can repeatedly come into direct contact with human skin or oral cavity for a long or a short period of time shall not exceed 1 mg/kg; Toys, including children's sports equipment and children's products, under normal or reasonably foreseeable conditions of use, plastic or rubber parts that can be in direct contact with human skin or oral cavity for long or short periods of time, if they contain any of the 8 PAHs, the content shall not be allowed. more than 0.5 mg/kg. |
plastic, rubber |
|
Phthalates |
From July 7, 2020, the combined concentration of DEHP, DBP, BBP and DIBP in the plasticized materials in the article is less than 0.1%; Among the plasticized materials on toys and child care products that can be imported, DINP+DIDP+DNOP≤0.1%. |
As a plasticizer for plastic materials, etc. |
|
Dimethyl Fumarate (DMF) |
The content of DMF in articles and their parts shall not exceed 0.1mg/kg. |
mildew inhibitor |
◉ EU REACH Annex XIV--List of Authorized Substances
EU REACH Annex XIV, the List of Authorized Substances, when an item is included in the list, the substance will not be placed on the market or used from the "sunset of authorization" stipulated by the substance, unless it is intended for a specific purpose. Authorization has been obtained or the application has been completed by the "Application Deadline for Authorization" specified for the substance. Unapplied authorised substances will be banned from the EU market after the "authorisation sunset" date. Also, this requirement is not limited by the tonnage of the substance placed on the market or used. The EU REACH regulation authorization requirements are mainly aimed at the market and use of substances in the EU. Therefore, for EU imports, the authorization requirements are only for substances and mixtures. If any authorized substances contained in EU imports are added outside the EU, the article is not subject to the authorization requirement. In accordance with REACH regulations, the authorization list is updated at least every two years.
REACH regulations designate SVHC as candidate substances for Authorization Substances (REACH Annex XIV).
◉ EU REACH Annex XVII - Restrictions on the Manufacture, Placing on the Market and Use of Certain Hazardous Substances, Mixtures and Articles
REACH Annex XVII (Restrictions) is the EU's tool to protect its public health and the environment from unacceptable risks posed by chemicals. According to Article 67.1 of the REACH Regulation, when a chemical substance is included in the EU REACH Annex XVII (Restriction) for restriction control, the products involving the substance must comply with the restriction conditions stipulated by it before it can be produced, used and controlled in the EU. Target market. The EU's control of chemicals is a continuous process. REACH Annex XVII has undergone dozens of updates and revisions since the REACH regulation came into effect, and officials have been evaluating adding more restrictions. At the same time, it should be noted that there is a big difference in the management and control of REACH Annex XVII and SVHC, which is mainly reflected in the following two aspects:
1. Scope of control: The control requirements of SVHC are applicable to products manufactured in the EU or exported to the EU, while REACH Annex XVII has specific provisions for the scope of application of products for different clauses.
2. Control requirements: When the SVHC content in a product exceeds the threshold, as long as the relevant enterprises fulfill their responsibilities and obligations to notify the official or transmit supply chain information, the product can still enter the EU market. For products involving REACH Annex XVII restricted substances, they must comply with the restriction conditions (such as the limit requirements of the substance, etc.) before they can be produced, used and placed on the market in the EU.
◉ Compliance Services
As a professional third-party testing and certification service organization, Jiayu Testing has qualifications such as CMA, CNAS, CPSC, and has obtained laboratory accreditation from multiple authoritative certification agencies at home and abroad. The laboratory is strictly built and managed according to standards, equipped with advanced instruments and equipment, and has a skilled professional technical team with rich industry service experience and strong testing technology capabilities. It is proficient in various regulatory standards. Jiayu Testing has rich project experience in the field of REACH hazardous substance control, providing customized raw material and whole machine restricted substance testing solutions for customers, assisting enterprises in actively responding to regulatory requirements, helping enterprises achieve hazardous substance risk control, and effectively improving product compliance. Welcome to contact us at 400-9269-886!
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