What is REACH? REACH Review

REACH (REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals) is the abbreviation of EU Regulation “Registration, Evaluation, Authorization and Restriction of Chemicals”. It is a chemical regulatory system established by the European Union and implemented on June 1, 2007.

About REACH

REACH is a regulation that ensures the safe entry and use of chemicals into the EU market. It aims to protect human health and environmental safety, maintain and enhance the competitive advantage of the EU chemical industry, improve the innovation capabilities of enterprises, and achieve the goal of sustainable social development.

The European Parliament and the European Council passed the new EU chemical management law, namely the Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) on December 13 and December 18, 2006 respectively. The regulation will come into force on June 1, 2007.

According to the EU REACH regulations, from June 1, 2018, unregistered chemicals with an annual import volume of more than 1 ton will not be allowed to be placed on the EU market.

Registration

According to the REACH regulations, non-EU companies that export more than 1 ton of chemicals to the EU cannot register with the European Chemicals Agency on their own. They can only complete the registration process in two ways: one is to register by a chemical importer located in the EU. In order to complete the relevant registration procedures, the importer requires the exporter to provide as much detailed information as possible on the composition and characteristics of the chemicals; the other is for the exporter to designate an "only representative" in the EU to register on its behalf. However, no matter which registration method is used, the exporter is obliged to provide the relevant information required for registration. Companies that register the same chemicals must share data, share related expenses, and jointly submit relevant information.

Registration Object

According to Article 6 of REACH, all chemical substances and chemical substances in preparations produced in the EU or entering the EU market in quantities ≥ Ý1 ton/year. There are separate regulations on the registration of chemical substances contained in products.

Registration responsible person

Manufacturers and importers within the EU; agents within the EU appointed by manufacturers outside the EU.

Registration Information

The basic registration information provided by the applicant includes: the applicant's name and contact information, substance name, quantity, production and use information, substance grade and characteristics, safe use instructions, situation statement, research data summary, quality and safety data, and confidentiality requirements.

Registration Procedure

The applicant submits the prepared registration documents together with the registration fee to the European Chemicals Agency. The agency reviews the completeness of the documents and requires the applicant to provide additional information if necessary. The Chemicals Agency reviews the registration information of chemicals already in circulation on the market for three months. If the registration documents are complete, the applicant will receive a registration number.

Registration Fees

REACH registration fees include the following three aspects: administrative fees paid to ECHA, agency fees paid to the agency, and data fees (including data sharing fees, data fees, testing fees, etc.). Among the overall registration fees, data fees often account for the largest proportion; when the tonnage level of the substance is high, administrative fees are also a large expense.

Applicants should pay fees to the European Chemicals Agency when submitting registration and licensing applications. Specific charging standards and methods are yet to be formulated. What is certain at present is that if the registration information provided is complete, the registration fee of 1-10 tons can be waived. No fee is required for pre-registration.

Certification Application

1. Application fee for REACH testing:

The price of REACH testing is generally not high, and the price varies for different products.

2. Validity period of REACH certificate:

If the product design and directive requirements have not changed, the REACH certification report can remain valid, unless the buyer has special requirements.

3. REACH 169 test cycle:

Generally, it takes 7-10 working days to issue a REACH test report

4. Instructions for filling out the REACH test application form:

1. The handwriting must be clear, such as the number 0 and the English letter O, the number 5 and the English letter S, the number 1 and the English letter I, the number 9 and the English letter P, and the number 2 and the English letter Z must be clearly marked.

2. Fill in the test requirements clearly and try to indicate the standards or test methods used.

3. Clearly select the nature of the service; working days are the time for verbal notification of results, excluding holidays, sample delivery, receipt, report printing and mailing time.

4. Please clearly select the method to pick up the report and fill in the Chinese address for report delivery so that the report can be delivered accurately.

5. Signature and official seal.

6. For each test, we will provide an English report or a Chinese report. Please indicate which version you need when filling in the application form (indicated in the upper right corner of the application form). If you need both Chinese and English reports, a fee of RMB 200 will be charged.

7. Please fill in the company name, address, and product name in both Chinese and English. If there is no English company name and address and the translation is difficult, you can entrust our company to translate it; items such as item number and destination country can be selected by the customer according to their requirements and are not mandatory items.

8. Once the formal test report is printed, if the test report is printed incorrectly due to the customer filling in the test application form incorrectly or missing it, the customer shall bear the consequences. The modification fee for each report is RMB 200.

9. Pay the testing fee when sending samples. If the samples are delivered to our company by express, the relevant personnel will first fax the payment notice to the customer. The customer must remit the testing fee to our company's account and fax the remittance voucher to our company for record. We will arrange the test after confirming the receipt of the testing fee.

10. After the test is completed, the laboratory staff will first send the PDF electronic report to your company. Customers who apply for paper reports will then process the report according to the method selected by the customer on the application form.

Evaluate

The evaluation is mainly undertaken by the European Chemicals Agency and relevant agencies of each member state. The evaluation includes two aspects: one is the review of registration information, and the other is the review of chemical substances.

1. Data review: The European Chemicals Agency is responsible for reviewing the test recommendations proposed in all registration materials, especially those involving CMR, PBT, vPvB and particularly hazardous substances, as well as the registration of hazardous substances with a quantity exceeding 100 tons/year. The European Chemicals Agency also reviews whether the registration materials comply with REACH requirements. If the information is incomplete, the Chemicals Agency shall request additional information from the applicant within 12 months after the start of the review.

2. Chemical substance evaluation: The European Chemical Agency proposes a three-year plan for chemical substance evaluation based on the risk level of the chemical, the depth of existing information and the number of registrations. The relevant agencies of the EU member states select the substances to be evaluated in their own countries. The Chemical Agency is responsible for coordinating the evaluation selection of various countries. The relevant agencies of each country should request additional information from the registrant within 12 months after the start of the evaluation, and should complete the evaluation within 12 months after the submission of the additional information. The relevant agencies will decide whether to take restrictive measures or issue a license based on the evaluation results.

limit

If the production, sale and use of a chemical substance poses unacceptable risks to human health and the environment, production restrictions, sales restrictions and use restrictions will be imposed on it.

The process for deciding on restrictive measures is:

1. The European Commission requires the European Chemicals Agency to submit information on restrictions, and member states can submit such information at any time;

2. The Chemicals Agency will publish online the list of chemicals for which information is to be submitted and propose solutions within 12 months;

3. The risk assessment committee evaluates the information;

4. The Chemicals Agency publishes the approved information online and solicits opinions from relevant stakeholders;

5. The Risk Assessment Committee shall make a response within nine months after the announcement;

6. The Socio-Economic Analysis Committee will make preliminary comments and immediately publish them online for comments within 60 days;

7. The Socio-Economic Analysis Committee shall make its opinion;

8. Publish the opinions of the two committees online.

Annex XVII of REACH lists the chemicals that need to be restricted.

The member states' respective restrictive measures will remain in place until June 1, 2013.

license

For carcinogens, substances that change genes or affect reproduction (CMR), substances that cannot be naturally decomposed and accumulate in living organisms and cause chronic toxicity (PBT) and particularly persistent and particularly bioaccumulative substances (vPvB), as well as chemical substances that have been proven to have serious consequences for human health and the environment, regardless of their quantity, they need to obtain a license before they can enter the market.

To obtain a license, manufacturers and importers should apply to the European Chemicals Agency for a license and prove that the risks of the method of use applied for are controllable, or there are no alternative products or technologies, and that the social and economic benefits of the use outweigh the risks. The European Commission will decide to issue a license based on this. If the license application includes such use, its downstream users can cite this license and file it with the European Chemicals Agency. If such use is not included, the user should apply for a license himself. The European Chemicals Agency will publish a list of uses included in the license on its website.

Annex XIV of REACH specifies the list of chemicals that require authorization.

The licensing system came into effect on June 1, 2008.

However, isolated intermediate products (Article 2) and chemicals used for scientific research, plant protection, fuel, cosmetics, food-related materials and mixed products with a content of less than 0.1% do not require a license.