Updated: 19.08.2024
What regulations in Poland cover the chemicals market?
Regulation (EC) No 1907/2006, known as REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals), introduces a comprehensive legal framework for restricted substances and chemicals manufactured and used in the European community.
The objective of this regulation is to shift the responsibility for chemical safety from public authorities to industry, which must ensure that all chemicals manufactured, sold, and used in the European Union are safe for human health and environment.
EU chemicals industry – Key objectives of REACH regulation
The REACH regulation has several key objectives:
- Promoting alternative methods to animal testing – encourages the use of technologies and research methods that minimize or eliminate the need for animal testing,
- Creating a single market for chemical substances,
- Supporting innovation and competitiveness,
- Establishing the European Chemicals Agency (ECHA) to oversee the implementation of the regulation and ensure its effective enforcement.
The REACH regulation covers all chemicals manufactured, imported, sold, and used in the EU chemicals industry, both on their own and in mixtures and products.
Obligation to register all chemical substances
Companies in the EU market must register all chemicals they manufacture or import in quantities of at least 1 tonne per year in a central database managed by ECHA.
Companies are also required to identify and control risks associated with the chemicals they produce and sell. They must indicate ways of safely using these chemicals and inform users of any risk control measures.
National authorities have the right to restrict the production or use of certain substances if they believe that the risks associated with them are not adequately controlled. The REACH regulation also promotes the substitution of the most dangerous substances for human health and environment with safer alternatives, where available.
What other regulatory requirements are important for avoiding very high concern chemicals?
Noteworthy regulations also include:
- Directive 2012/18/EU on the control of major-accident hazards involving dangerous substances, particularly chemicals (the Seveso European Directives),
- Regulation (EC) No 1272/2008 on classification, labelling, and packaging of substances and mixtures,
- Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market,
- Regulation (EC) No 648/2004 on detergents,
- Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals,
- Act on chemical substances and their mixtures.
FAQs on Environmental Protection and Chemical Production in Poland
What are the key regulatory requirements for chemical substances in Poland to protect human health and the environment?
In Poland, the primary regulatory framework governing chemical substances is the REACH regulation (Regulation (EC) No 1907/2006). This regulation aims to protect human health and the environment by ensuring that all chemicals produced, imported, and used within the EU meet strict safety standards.
Companies must register substances present in quantities greater than 1 tonne per year with the European Chemicals Agency (ECHA). This includes providing relevant information on the intrinsic properties of the chemical substances and conducting risk assessments to control and mitigate associated risks.
Further information on safety data sheets and hazard information must be provided to downstream users and EU-based customers to ensure safe usage.
How does the REACH regulation address substances of very high concern (SVHC)?
The REACH regulation includes specific provisions for substances of very high concern (SVHC). Such substances are identified and listed on the candidate list by the European Chemicals Agency (ECHA). Before placing these chemicals on the market, companies must conduct thorough substance evaluation and obtain prior authorisation from ECHA.
This process involves submitting detailed registration dossiers that demonstrate the measures taken to control risks associated with the use of these hazardous substances. The regulation also promotes the substitution of SVHC substances with safer alternatives to protect human health and the environment.
What are the obligations of non-EU manufacturers under the REACH system for exporting chemicals to the EU?
Non-EU manufacturers intending to export chemical substances to the EU must comply with the REACH regulations. This includes appointing an Only Representative based in the EU to fulfill the registration requirements on their behalf.
The Only Representative is responsible for submitting the necessary registration dossiers and ensuring that the chemical substances comply with all relevant REACH provisions, including risk assessments and providing safety data sheets.
Additionally, non-EU manufacturers must ensure that their substances are pre-registered to avoid disruptions in the supply chain and maintain free movement within the EU market. Failure to comply with these obligations can result in restrictions or bans on the import of these substances into the EU.
