Ensuring the safety of products placed on the market is a fundamental commitment to protecting consumers and the environment.
The key EU regulations that businesses must carefully consider to achieve this goal include:
- Regulation (EU) 2019/1020 (market surveillance and compliance of products), effective since July 16, 2021
- Regulation (EU) 2023/988 (general product safety), effective from December 13, 2024
- Directive 2024/1203 (criminal environmental protection), to be transposed in national legislation by May 21, 2026
These regulations establish compliance and safety requirements for products and impose penalties for violations, promoting a safe and sustainable environment for all.
Regulation (EU) 2019/1020 provides a framework to ensure that products placed on the market comply with EU regulations. It identifies 70 applicable regulations for various product categories and aims to strengthen market surveillance to protect consumers and economic operators by ensuring product compliance.
Regulation (EU) 2023/988 ensures that products placed on the EU market, both in physical stores and online, are safe for consumers. It sets specific requirements for consumer products and assigns responsibilities to the operators involved.
Directive (EU) 2024/1203 aims to protect the environment and public health through criminal enforcement, introducing severe penalties for violations related to the offenses listed in Article 3. Examples include violations involving substances, whether as such or contained in mixtures or articles, under the scope of the following regulations:
- Regulation (EC) 1907/2006 – REACH (authorizations or restrictions)
- Regulation (EC) 1272/2008 – CLP (hazardous substances and mixtures)
- Regulation (EU) 528/2012 – BPR (biocides)
- Regulation (EC) 1107/2009 (phytosanitary products))
- Regulation (EU) 2019/1021 (persistent organic pollutants, POPs)
The target audience for these three “framework” regulations includes all businesses operating with regulated chemicals, i.e., Manufacturers, Importers, and Distributors of products and raw materials (substances, mixtures, and articles) within the European Union.
Through an integrated approach and extensive sector experience, Flashpoint offers comprehensive support to ensure product compliance and safety according to the regulations mentioned above. We assist companies starting from the definition of an organizational system and the drafting of tailored procedures encompassing roles, skills, and responsibilities of key functions: Procurement, R&D, Quality, Regulatory, Manufacturing, and Marketing-Sales. We also define specific training needs and deliver customized training courses.
We support companies in preparing the required documentation and reporting, carrying out compliance audit, analyzing materials, and managing product compliance verification.
Our activity is aimed at ensuring that manufacturing phases, raw material procurement, and final distribution comply with current regulations. This includes risk assessments, regulatory management of hazardous substances, evaluation of raw materials and finished products entering the supply chain, supplier management based in EU and non-EU countries, authoring and distribution of Safety Data Sheets definition of legal responsibilities, and integration of technical clauses into supply and sales contracts, among other services.