EU Chemical & Product Safety Domain

The REACH Regulation (Regulation (EC) No 1907/2006) is a comprehensive EU regulatory framework covering all chemical substances manufactured or imported within the EU in quantities of one tonne or more per year, aimed at protecting human health and the environment while maintaining the competitiveness of the EU's chemical industry. It requires companies to identify and register information on chemical hazards, and functions as the central pillar of chemical substance control across GRI's chemical-related regulations, including the CLP Regulation, ESPR, the EU Battery Regulation, and the F-Gas Regulation. REACH operates through five pillars: registration (requiring companies that manufacture or import one tonne or more of a chemical substance per year to register its safety information with ECHA); evaluation (the process by which ECHA and member state authorities scrutinize the quality and consistency of registration data along with safety assessment data); authorisation (a system prohibiting the use or placing on the market of substances of very high concern identified as posing particularly high risk, unless individually authorized by the European Commission); restriction (measures limiting or banning the use or placing on the market of specific hazardous substances, for specific uses or entirely); and the obligation to communicate information through the supply chain for substances listed on the Candidate List of substances of very high concern (SVHCs).

The EU RoHS Directive (Restriction of Hazardous Substances) restricts the use of specific hazardous substances in electrical and electronic equipment. Because the list of restricted substances and the scope of exemptions are reviewed periodically, companies must maintain ongoing product compliance management.

This regulation (Regulation (EU) 2024/573) is a comprehensive framework for controlling air emissions and refrigerants, part of the European Green Deal's climate strategy, aimed at curbing and reducing emissions of fluorinated greenhouse gases (F-gases: HFCs, PFCs, SF6, and others), which are potent contributors to climate change. It serves as the foundational regulation governing the full lifecycle of refrigerants, air conditioning equipment, and electrical equipment — from manufacturing and placing on the market through use and recovery — and is closely linked with REACH (managing the toxicity of PFAS and alternative refrigerant chemicals), the ESPR (requirements for low-GWP refrigerants in air conditioning equipment), and the Industrial Emissions Directive (IED, controlling air pollutant emissions from manufacturing facilities). The framework rests on three main pillars. First, a phase-down system that progressively reduces the quantity of HFCs (hydrofluorocarbons) permitted to be placed on the market, aiming for zero consumption by 2050. Second, use-specific restrictions that impose bans or limits on the use of substitute fluorocarbons based on Global Warming Potential (GWP) thresholds, applied by application — including refrigeration and air conditioning equipment, heat pumps, foam blowing agents, aerosols, and electrical equipment such as SF6-based switchgear. Third, a leak prevention and technician certification regime, covering mandatory periodic leak inspections of F-gas-containing equipment, requirements to install automatic leak detectors, recovery obligations, and a technician certification system.

The EU Medical Device Regulation (MDR, Regulation (EU) 2017/745) is a directly applicable regulation governing the safety and performance of medical devices placed on the EU market, and became fully applicable on May 26, 2021. Beyond quality and safety standards, the regulation includes strict content-restriction requirements for chemical substances used in medical device components (Annex I, Section 10.4), setting a hazardous substance management standard that goes beyond the RoHS Directive for medical device manufacturers. For components and parts that enter the patient's body, form part of a pathway for transporting or introducing fluids, or come into direct contact with the human body, the concentration of carcinogenic, mutagenic, or reprotoxic substances (CMR substances classified as Category 1A or 1B under the EU CLP Regulation) and endocrine disruptors (EDs, including certain phthalate plasticizers) must not exceed 0.1% by weight (1,000 ppm).

The revised EU Industrial Emissions Directive (IED 2.0, Directive (EU) 2024/1785) is an EU legal framework for comprehensively preventing and reducing pollutant emissions to air, water, and soil from large industrial installations. It substantially overhauls the former IED (2010/75/EU), adopted in 2010, and entered into force on August 4, 2024. In support of the European Green Deal's Zero Pollution Ambition, the Directive strengthens the application of emission limits based on Best Available Techniques (BAT-AELs) and expands the range of covered sectors beyond chemical plants, steel mills, and power stations to include large-scale livestock farming, battery manufacturing plants (gigafactories), and large-scale mining. It also requires operators to introduce environmental management systems (EMS), meet mandatory targets for resource efficiency, energy efficiency, and water conservation, and prepare plans to reduce and substitute the use of chemical substances — imposing comprehensive compliance obligations on companies operating manufacturing sites in Europe.

The EU Water Framework Directive (Directive 2000/60/EC) is the foundational framework law aimed at ensuring good chemical and ecological status for all surface water and groundwater within the EU. Under its subsidiary instruments — the Environmental Quality Standards Directive (EQSD, 2008/105/EC) and the Groundwater Directive (GWD, 2006/118/EC) — discharge and environmental concentration standards are set for "priority substances" and "priority hazardous substances" that pose particularly high risk to the water environment. Under the ongoing revision (a proposal to jointly amend the WFD, EQSD, and GWD), PFAS (per- and polyfluoroalkyl substances, with a combined limit covering 24 substances), certain pharmaceuticals (such as analgesics and antibiotics), pesticides, and endocrine disruptors such as bisphenol A are set to be newly added to, or have their limits strengthened on, the priority substances list. This will substantially tighten chemical monitoring and permissible discharge concentration standards at manufacturing plant outfalls.

The EU Urban Waste Water Treatment Directive (UWWTD) regulates the collection, treatment, and discharge of urban wastewater and industrial wastewater from specific industrial sectors to protect the water environment. A comprehensively revised Directive ((EU) 2024/2836) formally entered into force in November 2024, superseding the former Directive (91/271/EEC) adopted in 1991. The most significant feature of the revision is the introduction of "quaternary treatment" to remove micropollutants contained in pharmaceuticals and cosmetics, together with the accompanying Extended Producer Responsibility (EPR) scheme. Pharmaceutical, chemical, and cosmetics manufacturers that supply the EU market with pharmaceuticals and cosmetics are required to fund at least 80% of the cost of advanced treatment at urban wastewater treatment plants. The revision also includes energy-neutrality targets (such as the adoption of renewable energy) for treatment plants serving populations of 150,000 or more, and mandatory monitoring of microplastics and PFAS.

The EU Food Contact Plastics Regulation (Commission Regulation (EU) No 10/2011) sets out a positive list of chemical substances permitted in plastic materials and articles intended to come into contact with food within the EU, along with migration limits and purity requirements for certain additives. Carbon black (FCM Substance No. 411) — widely used as a colorant and as a conductive or reinforcing filler in packaging, cookware, and resin components of food-processing lines — is subject to particularly strict specification requirements set out in Annex I. Under the Regulation, carbon black may be used up to a maximum of 2.5% by weight in plastics only if it meets purity specifications including a primary particle size of 10–300 nm, toluene-extractable matter of no more than 0.1%, benzo[a]pyrene (BaP) content of no more than 0.25 mg/kg, and total polycyclic aromatic hydrocarbon (PAH) content of no more than 5 mg/kg. Furthermore, based on the latest European Food Safety Authority (EFSA) assessments — including those reflected in the amending Regulation (EU) 2023/1442, published in July 2023 — the evaluation criteria for nanoparticle forms and carcinogenic aromatic impurities continue to be strengthened, making rigorous analysis and maintenance of compliance documentation essential across the supply chain for food packaging materials and manufacturing equipment components.

This is the foundational law implementing the UN Globally Harmonized System (GHS) for the classification and labelling of chemicals across the EU. It sets out how to identify the hazards of substances and mixtures, requirements for pictograms and hazard statements on labels, packaging requirements, and the obligation to submit poison centre notifications (PCN).

This regulation implements the Stockholm Convention on Persistent Organic Pollutants (POPs) within the EU. It strictly bans or restricts the manufacture, placing on the market, and use of POPs substances that are persistent, highly bioaccumulative, and capable of long-range transport, such as PFOS, PFOA, PFHxS, short-chain chlorinated paraffins (SCCPs), and decaBDE.