Strategic Analysis and Compliance Solutions
In a constantly redefining global landscape, the proactive management of Regulatory Affairs and Technical Compliance is crucial. Maintaining an informed and critical perspective on environmental, chemical, and regulatory challenges is not just an obligation, but a strategic imperative for operational continuity and market trust.
In this section, we provide the vision and support for emerging topics that directly impact product safety, industrial sustainability, and the protection of public health, with a particular focus on developments in European legislation concerning chemical substances and materials.
We will support you in keeping pace with regulatory and scientific evolutions to strengthen the trust of clients and consumers and guarantee sustainable production. Contact us to explore the implications of these topics for your business:
REACH & CLP: THE BACKBONE OF EU CHEMICAL COMPLIANCE
The European Regulatory Landscape
The European Union is at the forefront of chemical substance regulation to ensure the safety of the internal market and to protect human health and the environment.
The Regulatory Pillars: REACH and CLP
Knowledge of these two regulations represents a competitive advantage in the European market:
- REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals):
- It is the European regulation on chemical substances and aims to ensure a high level of protection for human health and the environment, while promoting innovation.
- It requires companies to register the chemical substances they produce or import, assessing the risks and communicating management measures.
- It provides the mechanisms for the authorisation (for Substances of Very High Concern – SVHC) and restriction (prohibition or limitation of use) of the most hazardous substances.
- CLP (Classification, Labelling and Packaging):
- It ensures that the hazards of chemical substances are clearly communicated to workers and consumers through the use of pictograms and standardised phrases on labels.
- It is based on the United Nations Globally Harmonised System (GHS), ensuring consistent classification and labelling at an international level.
MICROPLASTICS: ENVIRONMENTAL CONCERNS AND MITIGATION STRATEGIES
Scenario and Risk Management
Microplastics are defined as polymeric fragments with a size of less than 5 millimeters. Their origin is twofold:
- Primary Microplastics: Intentionally added to certain products (e.g., cosmetics, detergents, paints).
- Secondary Microplastics: Resulting from the fragmentation and degradation of larger plastic objects dispersed in the environment.
They are ubiquitous in the environment (air, water, soil) and, consequently, in the food chain and drinking water. Although the long-term effects on human health are still under study, their presence raises concerns due to potential toxicity and their role as vectors for other chemical contaminants.
Regulatory Scenario and Compliance Implications
The management of microplastics is a high-priority issue on the European Union’s agenda, destined to generate new and significant regulatory pressure for companies:
- Immediate Restrictions (Intentional Microplastics): The REACH Regulation has already introduced measures limiting the use of microplastics intentionally added to products placed on the EU market, with progressive deadlines depending on the matrix and sector of application (e.g., rinse-off cosmetics).
- Future Perspectives (Secondary Microplastics): The regulatory trend will focus on mitigating the sources of secondary microplastics. This will impact:
- Sector-Specific Regulation: Revisions in the textile (release during washing), tires (abrasion) and construction materials sectors.
- Environmental Regulations: Strengthening of directives on waste management, water discharge, and marine/water pollution, imposing new filtration and recycling standards.
EMERGING SUBSTANCES: PFAS AND BISPHENOLS IN THE EUROPEAN REGULATORY AGENDA
Emerging Hazardous Substances and Chemical Risk Management
The safety and quality of raw materials and finished products are threatened by complex contaminants, the regulation of which is rapidly evolving at the EU level.
1. PFAS (Poly- and Perfluoroalkyl Substances), “Forever Chemicals”
- Context: Known as “forever chemicals” due to their extreme persistence, PFAS are used to make products resistant to water, oils, grease and heat (e.g. non-stick cookware, firefighting foams, waterproof textiles). Their contamination is a global emergency, particularly in aquifers.
- EU Regulatory Evolution: Due to their ubiquity, the European Union, through the REACH Regulation, is moving toward a proposal for an almost total restriction of the majority of PFAS. This marks a paradigm shift from a reactive, substance-by-substance approach to a risk management strategy for entire classes of compounds.
- Additional Implication: The New Drinking Water Directive imposes extremely stringent concentration limits (to be achieved by 2026) for PFAS in water intended for human consumption, with repercussions for the water supply chain and industrial processes.
2. Bisphenols
- Context: Compounds used in the production of polycarbonate plastics (such as bottles and food containers) and in the epoxy resins that line the inside of cans. Bisphenol A (BPA) is the most well-known and although its use has been limited in many products (especially those for children), other bisphenols have already been evaluated or are under scrutiny because they are considered hazardous.
- EU Regulation: The EU has formalized significant restrictions with Regulation (EU) 2024/3190, which introduces a prohibition on the intentional use of BPA in the production of most Food Contact Materials (FCMs), extending the restriction to other hazardous bisphenols as well.
SAFETY AND COMPLIANCE: THE NEW EUROPEAN STANDARDS FOR DRINKING WATER CONTACT MATERIALS
Materials in contact with drinking water
Ensuring that the materials used in pipes, taps, valves, and tanks for drinking water do not release contaminants is crucial for public health.
The challenge: to ensure that materials (metals, polymers, coatings, cements) are inert and do not transfer chemical substances, heavy metals (such as lead or nickel) or organic compounds (such as Bisphenols) into the water in quantities that are harmful or that alter the water’s taste/odor.
New regulations: The European regulatory landscape is converging toward more stringent standards that were previously managed at the national level. The Drinking Water Directive (Directive (EU) 2020/2184), transposed into Italian law by Legislative Decree 23 February 2023, No. 18, introduces the obligation to establish EU-wide hygienic requirements for materials intended to come into contact with drinking water, a fundamental step toward water quality.
This harmonization is implemented through specific acts:
- Implementing Decision (EU) 2024/367: Establishes the European Positive Lists of authorized starting materials, compositions, and constituents (the “list of approved ingredients”).
- Implementing Decision (EU) 2024/368: Defines the standardized testing procedures and methods for testing and accepting the final materials and products.
- Delegated Regulation (EU) 2024/370: Lays down the conformity assessment procedures and the rules for the designation of the Notified Bodies (the certification mechanism).
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