What are the European REACH electronic cigarettes? EU REACH registration process


The REACH Regulation of the European Union, fully referred to as the Registration, Evaluation, Authorization and Restriction of Chemicals (hereinafter referred to as REACH Regulation), is an EU regulation on the preventive management of all chemicals entering its market, which was implemented on June 1, 2008.


Competent authority

European Chemical Agency (ECHA)

REACH Regulation Registration

REACH regulation stipulates that enterprises shall submit to the European Chemical Administration (ECHA) for registration the chemical substances (substances in the substance itself, mixtures or substances intentionally released in articles) with an annual output or import volume of more than 1 ton in the EU. Otherwise, enterprises shall not continue to manufacture, import or sell the chemicals within the EU.



Registration is the most important obligation of laws and regulations. After successfully submitting the registration dossier of chemical substances to the European Chemical Administration (ECHA), enterprises can obtain a registration number consisting of 18 digits. Enterprises that fail to complete the registration before the deadline cannot continue to put their corresponding products on the EU market.


Registered tonnage division

1-10 tons/year; 10-100 tons/year; 100-1000 tons/year; 1000+tons/year.



Registration statistics


As of September 30, 2021, according to the registration statistics released on the official website of ECHA, from the formal implementation of REACH regulations to the end of September 2021, more than 100000 registrations have been made, covering 22723 substances, 15596 registered companies and 6540 non EU manufacturers among the registered enterprises.


The number of registrations with importers as registrants in the EU accounts for the highest proportion, up to more than 30000, involving more than 8000 substances. In terms of tonnage, the registered tonnage of 1~10 tons and above 1000 tons is the largest, indicating that high tonnage also occupies a certain market share.


It can be seen that the whole EU market has a large demand for import trade. Even in the year 2020, when the epidemic hit hard, China EU trade still showed a counter trend growth. The EU's imports from China increased by 5.6%, and China replaced the United States for the first time as the EU's largest trading partner.


Registration process

EU REACH Regulation Registration Process

CSR preparation of chemical safety report

REACH regulations require that if the chemical substances manufactured or imported exceed 10 tons/year, the chemical safety assessment (CSA) shall be conducted for the substances. A Chemical Safety Report (CSR) shall be prepared and submitted as part of the registration dossier. Chemical safety assessment includes: human health assessment, physical and chemical assessment, environmental hazard assessment, PBT and vPvB assessment. If the substance is assessed to conform to the classification standard of 67/548/EEC on hazardous substances, or is assessed to be PBT and vPvB substances, the chemical safety report of the substance shall be attached with: exposure scenarios, exposure assessment and risk characterization for all identified uses. This exposure scenario shall be attached to the Safety Data Sheet (SDS) as an attachment.


Lead Registrant

The leading registrant in REACH regulations is called Lead registrant (LR for short). When multiple registrants register the same substance, in order to ensure the principle that one substance corresponds to one dossier, one registrant shall obtain the consent of other registrants and submit the core data of the dossier on behalf of their registrants, namely, classification label, physical and chemical properties, toxicological data and ecotoxicological data, The registrant who plays this role is the lead registrant.

REACH Regulation Evaluation

Assessment process

When REACH regulations enter the evaluation stage, enterprises will receive the information that their registration materials accept the ECHA evaluation, and will also receive the ECHA resolution, requiring enterprises to supplement data and pay corresponding fees.

REACH Regulation Evaluation

File evaluation

The file evaluation is to verify the integrity and consistency of the registration file submitted by the enterprise, including the composite review, which will involve the identification information, spectrum information, toxicology information, ecotoxicology information, safe use information related to the file, etc.

● 1900 substances were screened, 38% of which have a registered tonnage of more than 100 tons/year;

● 271 compliance audits were conducted;

● 258 substances were covered, a total of 2500 files were involved, and 240 resolutions were issued;

● There are 1365 experimental testing requirements, requiring enterprises to provide data on long-term effects on human health or the environment, including effects on fetal development, reproductive toxicity or gene mutation; Or describe the persistence, bioaccumulation and toxicity of chemicals in the environment.


Material assessment

The substance assessment is completed by EU member states to assess whether the substance poses a hazard to human beings or the environment.

● Issued assessment resolutions for 30 substances, including 13 substances, which may require further regulatory action at the EU level;

● 18 substance assessment decisions were issued, requiring enterprises to provide further information to assess the safety of substances that may cause concern.


Evaluation of test proposal

The data in Annex 9 and Annex 10 of the registration dossier of more than 100 tons/year are submitted in the form of test proposal. ECHA will evaluate the test proposal. The main focus nodes include gene toxicology research, repeated dose toxicity research, prenatal toxicity research, reproductive toxicity research, carcinogenicity research, long-term aquatic biological toxicity research, biodegradation research, bioaccumulation research, etc. After completing the above evaluation, if supplementary information needs to be submitted, it refers to the test report of the above data nodes.


Implementation of resolutions

ECHA will send the draft resolution to the registered enterprise, and the enterprise shall reply within 30 days. ECHA will revise the draft resolution based on the reply of the enterprise and submit it to the member state committee, which will decide whether to reach an agreement on the amendment of the draft resolution within 60 days. When all parties reach an agreement, ECHA issues the final resolution and clearly informs the enterprise of the deadline for submitting updated files. After receiving the final decision, the registered enterprise shall determine the executor to carry out the supplementary test (generally undertaken by LR or joint registered members), and report this decision to ECHA within 90 days. The corresponding test expenses and other expenses shall be shared by each test member.


After the deadline for supplementary data submission, ECHA will evaluate the supplementary information submitted by the enterprise. If the information submitted meets the requirements of the resolution, the assessment will be completed. If the enterprise does not submit supplementary information, or the information submitted does not meet the requirements of the resolution, ECHA will notify the relevant Member States and law enforcement agencies, and if necessary, the Member States and law enforcement agencies will take legal measures against this violation.


Suggestions on Chinese Enterprises' Response to REACH Regulation Assessment

● Estimated additional costs for response assessment (expanded generation reproductive toxicity test, carcinogenicity plus chronic toxicity, 90 day subchronism, prenatal developmental toxicity);

● Assess the importance of the EU market;

● Reduce tonnage before receiving Draft Decision (DD);

● If it is decided not to respond, cancel the registration number after receiving the Draft Decision (DD);

● After receiving the Final Decision (FD), we must deal with it and fulfill the assessment requirements.