What is the EU REACH? EU REACH registration

"Registration, Evaluation, Authorization and Restriction of Chemicals" is the EU's regulation on the preventive management of all chemicals entering its market. It was officially implemented on June 1, 2008. The regulations are 849 pages long, which took 7 years to complete. It is known as the most complex regulation in the history of the European Union, and also the most important regulation in the past 20 years.

objective

Protect human health and the environment; Maintain and improve the competitiveness of EU chemical industry; Increase the transparency of chemical information; Reduce vertebrate test; It is consistent with the EU's international obligations under the WTO framework.

In essence, REACH regulations will promote the innovation of the chemical industry, enable it to produce safer products, and stimulate competition and growth. Different from the current complex regulatory system, REACH will create a unified chemical management system within the EU to enable enterprises to produce new chemicals and their products in accordance with the same principles.


primary coverage

Registration: All chemical substances with an annual output or import volume of more than 1 ton shall be registered, and chemical safety reports shall also be submitted for chemical substances with an annual output or import volume of more than 10 tons.

Evaluation includes file evaluation and material evaluation. Archives evaluation is to check the integrity and consistency of the registration files submitted by enterprises. Substance assessment refers to confirming the risk of chemical substances endangering human health and the environment.


Authorization authorizes the production and import of chemical substances with certain hazardous characteristics that attract great attention, including CMR, PBT, vPvB, etc.


Restriction: If it is believed that the risk to human health and the environment cannot be fully controlled due to the manufacturing, placing on the market or use of a substance or its configuration, products, it will restrict its production or import in the EU.


Note: PBT persistence, bioaccumulation and toxic chemicals

VPvB highly persistent and bioaccumulated chemicals

CMR carcinogenic, mutagenic and biotoxic substances

register

Registration

It is required to register the basic information of all existing and new chemicals with an annual output of more than 1 ton and chemical substances used in various products. Only registered substances can be produced or imported in the EU.

The manufacturer and importer of each substance shall submit the registration file of the substance to the Chemical Administration and pay the corresponding fee. However, it is required to jointly submit the registration information of the same substance, that is, follow the principle of "one substance, one registration". As a member of joint registration, it can share the cost of registration with other members.

In order to be easy to manage and accept the submission of a large number of registration files, the registration files submitted to the Chemical Administration need to be processed electronically. The Chemical Administration will give each registration file received a registration number and registration date, and immediately transmit the information to the registrant.

Within three weeks after the registration document is submitted, the Chemical Administration will make a confirmation on the completeness of the submitted registration document to confirm that the file meets the requirements of REACH registration. If the registration file is incomplete, the Chemical Administration will notify the registrant to submit further information within the specified time limit within three weeks from the date of registration submission to supplement the registration file.

For phase in substances, a pre registration procedure is provided. The pre registered substances can continue to be produced and sold in the EU, and only need to be officially registered before the specified deadline.

For phase in substances, a large number of registrations need to be completed during the period. Therefore, the Chemical Department needs to check whether the registration information is complete within 3 weeks for each registration submitted; However, for each registration submitted within 2 months before the deadline, the EU will check whether the registration is complete within 3 months.

The registrant shall submit the updated file to the Chemical Administration within the set time limit, and request to submit the missing information. The Chemical Administration then determines the submission date of these information and further checks the integrity of the updated files within three weeks.

If the registrant fails to complete the registration within the time limit, the registration will be rejected by the Chemical Administration, and the manufacturer or importer will not be able to start or continue the manufacture or import of the substance.

If necessary, the Chemical Agency will transmit the registration file, registration number and date, and the results of integrity inspection to the authorities of the Member States, and the manufacturer and importer will confirm that they can take action. The supplementary information submitted for incomplete archives shall be submitted to the competent authority together with the results of the second integrity inspection.

All the exisiting, new chemical substances itself and which applied to every manufacture need to registrate basic information when the output in quantities of 1 tonne or more per year.Only registered substances are allowed to be manufactured or imported.

Each manufacturer or importer of a substance shall submit his registration dossier for the substance to the Agency, accompanied by a fee.But they should submit the information of the same substance jointly,that is”one subject,one registration”.As a consortium member he only has to pay one third of the registration fee.

The registration dossiers submitted to the Agency will be handled electronically to facilitate the management of the expected amount of registrations that will be submitted. The Agency assigns a registration number and a registration date to each registration dossier received and immediately communicates this information to the registrant.

Within 3 weeks of the registration date, the Agency performs an automated completeness check of the dossier to ascertain that all elements required for the registration are included. If the registration is incomplete, the Agency will inform the registrant within these 3 weeks from the registration date about which further information is needed and will set a deadline for completion of the dossier.

For phase-in substances, a considerable number of registrations are expected to arrive just before the deadlines for the registrations. Therefore, the Agency is given 3 months from each registration deadline to check the completeness of those registrations that have been submitted within 2 months of the deadlines. However, the Agency will have to check the completeness of registrations submitted more than 2 months before the deadlines, within 3 weeks of receipt.

The registrant needs to submit the requested missing information in an updated dossier to the Agency within the set deadline. The Agency then confirms the submission date of this information and makes a further completeness check within 3 weeks of receipt of the updated dossier.

If the registrant fails to complete his registration within the set deadline, the registration will be rejected by the Agency and the manufacturer or importer is not allowed to start or continue manufacture or import of the substance.

The Agency will forward the registration dossier, the registration number and date, and the result of the completeness check to the authorities of the Member States in which the manufacturers and importers are established to enable enforcement action, if necessary. Also the further information that is submitted for completion of the dossier will be forwarded to the competent authority together with the result of the second completeness check.