Opinions Industry legislation 15 March 2023
The law will enter into force only in the summer of 2024, but now it is necessary to begin its gradual implementation
On December 1, 2022, the Verkhovna Rada adopted law «On chemical safety and management of chemical products». On December 24, this document was returned with the President’s signature. The law will come into force on June 26, 2024. Business already now insists on the speedy approval of the roadmap for the implementation of this law.
The essence of the document
This legislative act contains 12 sections with a legal framework regarding the production, storage, import, export, circulation, use of chemical products and processing of their waste. All chemical products produced or placed on the Ukrainian market will have to comply with this new legislation with some exceptions.
Exceptions are active pharmaceutical ingredients, medicines, psychotropic substances, their analogues and precursors, pesticides and agrochemicals, biocides, disinfectants, tobacco products, nicotine-containing and finished cosmetic products.
Also, the law will introduce mechanisms of restrictions and prohibitions for products containing carcinogens, mutagens, bioaccumulative and environmentally toxic substances.
To implement this law, Ukraine will create a single database with an international classification of chemicals, divided into banned, restricted, hazardous chemicals, dual-use chemicals, etc.
The document cancels the licensing of the production of highly hazardous chemicals that do not meet EU requirements, and also introduces a number of new licensing documents and administrative services. In addition, when assigning a state duty for state registration, a reduction in duty is provided for substances already registered in the EU.
The implementation of the law will allow Ukraine to fulfill part of the obligations under the Association Agreement with the EU. The responsible body is the Ministry of Environmental Protection and Natural Resources of Ukraine (Mindovkillya).
Until 2014 the handling of chemicals in Ukraine was regulated by a government decree of 1995. Now this issue is settled only by a few point laws and outdated regulations. At the same time, the Advice and Coordination Center for EU legislation on the registration, evaluation and authorization of chemicals (REACH) under the Cabinet of Ministers was established in 2007.
Implementation of regulations
The law will allow the implementation of the basic technical Regulations REACH and CLP in force in the EU. The Law is not a REACH Ukraine Regulation, but establishes a framework for the implementation of both REACH Ukraine and Ukraine’s CLP.
REACH requires mandatory registration of all chemicals. The logic of registration of chemicals is in line with the EU REACH Regulation and means that chemicals produced, imported or placed in Ukraine in quantities of one ton per year or more must be registered.
In turn, CLP provides for the classification of chemicals and mixtures according to 27 hazard classes, as well as mandatory labeling and packaging requirements for chemical products. The law defines the requirements for identification, classification and safety data sheets. It is assumed that the classification will be based on the CGS (centimeter-gram-second) and presumably in the form of implementation of the EU Regulation CLP as Ukrainian CLP.
The position of state bodies in connection with this law can still be described by the word silence. At the moment, the business is brewing specific practical issues, namely:
- A step-by-step procedure for preparing a producer and importer for full compliance with REACH requirements in Ukraine.
- What are the main regulatory steps from point 1 and documents? (except for the law, in which everything is general, without specifics)
- Deadlines for each step.
- What official bodies are authorized to provide clarifications for each step and monitor these actions?
- Who can act as an official consultant?
- What list of documentation is required for material produced, imported or stored in Ukraine? What must be in the package of accompanying documents on REACH?
As of today, it is not possible to get answers to these questions.
In turn, the Advice and Coordination Center for EU legislation on the registration, evaluation and authorization of chemicals (REACH) is faced with the lack of clear guidance on action from the regulatory authorities, which, accordingly, leads to the impossibility of high-quality advice to Ukrainian companies.
What to do?
In the absence (unpreparedness) of the necessary regulations and by-laws regulating such activities, Ukrainian companies in various industries may not comply with the requirements of the law within the prescribed period. This can potentially have consequences in the form of the impossibility of production, storage, import, export, circulation, use of chemical products and processing of their waste in Ukraine. These are chemicals (excluding excluded substances) which annual turnover will exceed one ton.
Therefore, it is necessary to prescribe a roadmap for Ukrainian companies as soon as possible in order to timely and correctly prepare enterprises for the entry into force of this law.
Access to the Turkish market
To date, this legislation has already been adopted by Turkiye and Ukraine. Turkiye is implementing legislation similar to the European REACH – KKDIK. At the moment, Turkish producers and importers are busy preparing for the start of the law (from 01/01/2024). Thus, Ukrainian producers exporting products to the Turkish market should also think about registering their substances, appointing a single producer in order to continue unimpeded exports to this country.