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The Eurasian Economic Union (EEU) is establishing a new notification system and registry for chemicals and mixtures.
On 6 September 2018, at the 29th meeting of the Eurasian Economic Commission's Advisory Committee on technical regulations, sanitary, veterinary and phytosanitary measures, draft documents were introduced related to the EEU Technical Regulation on Safety of Chemical Products (049/2017). The discussion included:
- The process of notifying new chemicals;
- The establishment of the EEU Register of Substances and Mixtures; and
- The related supporting guidance documents and templates.
According to the proposed draft of the regulation, titled Formation and maintenance of the register of chemicals and mixtures, the Union Register will contain two main parts: a Register for Chemicals and a Register for Mixtures.
Register of Substances
The EEU member states should complete their parts of the Union Register of Substances no later than 1 March 2020. If a chemical substance was in circulation on the territory of the Union before 2 June 2021, a request can be sent until 2 June 2021 to the competent authority (organization) to include the substance in the Register without notification.
Register of Mixtures
The Register for Mixtures must be ready by 1 June 2026.
Unique serial numbers
For each individual chemical substance or mixture included in the Register, an information file will be created and a unique nine-digit serial number will be assigned, where the first digit is the chemical category designation (chemical/mixture) followed by the 8-digit number of the chemical/mixture in the respective register.
State registration of chemical products
State registration of chemical products will be conducted by the authorized body in the EEU member state chosen by the applicant. Depending on the status of the chemical product, either a Permission type or Notification type of registration has to be performed.
The process of notification is established in the draft Rules of Notification of New Chemical Substances. Notifications will be performed after entry into force of the Technical Regulations for Chemicals, to include components of mixtures placed in circulation in the EEU customs territory, for which there is no information in the Register of Chemicals and Mixtures as "new chemicals." Polymers are notified by the monomers and are not subject to notification. A joint submission of data by several applicants is allowed during notification of new chemicals.
New chemical information is entered in the Register in accordance with the established procedure on the basis of the documents submitted by the applicant and is subject to publication in accordance with the Procedure for the Formation and Maintenance of the Register.
In case of confidential information, the information will be included in the closed part of the Register and will be available only to the authorities for the purpose of registration.
The next steps in the process of finalizing the second-tier documents will include:
- The draft decision of the Council;
- The drafts of the procedures which should be finalized in accordance with the Consolidated Information, following the results of the 4th meeting of the expert working group.
Once complete, the drafts will be sent to the members of the EEC Advisory Committee. This set of documents will also be sent to members of the Working Party so that they may prepare an opinion as part of the assessment of the regulatory effects of the regulation, in accordance with the Commission Rules of Procedure. The opinion will be sent to the members of the EEC Advisory Committee as part of the additional materials for consideration.
Affected companies should expect the Register of Substances on the national level to be completed no later than 1 March 2020. The deadline for the completion of the Register of Mixtures is mid-2026.