EU REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals)

The SCIP (Substances of Concern In articles as such or in complex objects, Products) database is an information platform established and operated by the European Chemicals Agency (ECHA) under the revised Waste Framework Directive (2008/98/EC). Under Article 9(1)(i) of the revised Waste Framework Directive (Directive (EU) 2018/851), Member States must ensure that, from January 5, 2021, any supplier of an article containing a REACH Candidate List substance of very high concern (SVHC) above 0.1% by weight provides ECHA with the information required under Article 33(1) of REACH. The requirement is designed to provide safety information to waste operators and improve chemical transparency.

Under the "Authorization" regime of the REACH Regulation (Regulation (EC) No 1907/2006), a substance of very high concern (SVHC) posing an especially serious risk to human health or the environment, once added to ECHA's Authorization List (Annex XIV), is in principle banned from manufacture, import, or use within the EU unless a company obtains European Commission authorization for that specific use. To obtain authorization, applicants must rigorously demonstrate either that no suitable alternative exists, or that the socio-economic benefits of continued use substantially outweigh the risks. After the sunset date, any use without authorization is banned entirely.

Cobalt octoate (cobalt bis(2-ethylhexanoate)) is an organometallic compound widely used as a curing accelerator and drying agent in oil-based paints, printing inks, and unsaturated polyester resins. Following its harmonized classification as reproductive toxicity Category 1A under the 17th ATP amendment to the EU's CLP Regulation, ECHA identified and added cobalt octoate to the REACH Candidate List of substances of very high concern (SVHC) in October 2023. This creates communication and SCIP-notification obligations wherever the substance is present above 0.1% in an article or mixture, and is accelerating a shift in the paint and ink industry toward non-cobalt driers based on manganese or iron complexes.

The European Commission adopted Commission Regulation (EU) 2024/1328, amending REACH Annex XVII, substantially tightening restrictions on the manufacture, placing on the market, and use of the cyclic siloxanes D4 (octamethylcyclotetrasiloxane), D5 (decamethylcyclopentasiloxane), and D6 (dodecamethylcyclohexasiloxane). Because D4, D5, and D6 exhibit PBT (persistent, bioaccumulative, and toxic) and vPvB (very persistent, very bioaccumulative) properties, the restriction now extends beyond rinse-off cosmetics and detergents (already restricted) to cover leave-on cosmetics, dry cleaning, and residual monomer concentrations (each above 0.1% by weight) in the manufacture and molding of industrial silicone rubber, elastomers, and sealants.

The European Commission adopted Commission Regulation (EU) 2020/1149, amending REACH Annex XVII, introducing strict restrictions on diisocyanates (TDI, MDI, HDI, and others) — substances widely used as raw materials in polyurethane foam, paints, adhesives, sealants, and coatings — to prevent respiratory sensitization and asthma risk. Since August 24, 2023, workers and companies handling diisocyanates above 0.1% by weight, alone or in mixtures, for industrial or professional use, are legally prohibited from using or working with the substance unless they have first completed and passed accredited Mandatory Safety Training. Product containers must also carry a specific label prompting completion of the training.

The European Commission adopted Commission Regulation (EU) 2023/923, amending REACH Annex XVII, substantially tightening restrictions on the use and placing on the market of lead and its compounds used as heat stabilizers in polyvinyl chloride (PVC) articles and compounds. Under the regulation, placing on the market or using PVC articles or compounds containing lead above 0.1% by weight (1,000 ppm) is, in principle, entirely banned within the EU. The aim is to eliminate lead from PVC products such as building materials (window frames, pipes, and sheeting), wire insulation, and everyday goods, and to promote safe recycling in the circular economy. Transitional measures and labeling requirements apply to certain uses of recycled PVC.

Based on a proposal from the European Chemicals Agency (ECHA), the European Commission amended REACH Annex XVII to adopt a restriction (Regulation (EU) 2023/2055) that, in principle, bans placing on the market any organic, synthetic, solid polymer particles under 5mm (microplastics) intentionally added to products. The regulation is designed to prevent pollution from microplastics that escape into marine and terrestrial ecosystems and do not degrade. Covered products span a very broad range, including cosmetics, detergents, waxes, adhesives, paints, agrochemicals, and infill material for artificial turf, and the regulation restricts intentionally formulating covered substances into products at 0.01% by weight or more. Depending on the product's use and the state of alternative development, phased transition and derogation periods of up to 12 years from entry into force apply.

On September 19, 2024, the European Commission adopted Commission Regulation (EU) 2024/2462, which was published in the Official Journal on September 20, 2024. It adds entry 79 to Annex XVII of the REACH Regulation, restricting PFHxA (undecafluorohexanoic acid), its salts and PFHxA-related substances. The entry prohibits placing on the market or using these substances at concentrations of 25 ppb or more (PFHxA and its salts combined) or 1,000 ppb or more (PFHxA-related substances combined) in the products it lists. The recitals describe PFHxA as very persistent and mobile in the aquatic environment, and note that large quantities of PFHxA-related substances are used in food-contact paper and cardboard, textiles and firefighting foams.

The "Universal PFAS Restriction Proposal" under the REACH Regulation is a landmark restriction proposal that, using a broad definition of PFAS (any substance containing at least one fully fluorinated methyl or methylene carbon atom), would in principle ban the manufacture, import, placing on the market, and use of more than 10,000 substances across the EU. The proposal sets either a full ban (with only an 18-month transition period) or time-limited, use-specific derogations (of 5 or 12 years) for particular applications. Even industries where no substitute currently exists — such as medical devices, semiconductor manufacturing, hydrogen energy, and vehicle batteries — would only receive transitional measures with a set expiry.

This card serves as a comprehensive hub summarizing the state of EU-wide organofluorine chemical regulation, centered on the "Universal PFAS Restriction Proposal" under the REACH Regulation. The restriction proposal, jointly submitted in January 2023 by five countries — Germany, the Netherlands, Denmark, Sweden, and Norway — covers more than 10,000 PFAS (per- and polyfluoroalkyl substances) and would, in principle, ban their intentional manufacture, placing on the market, and use entirely. The proposal has unprecedented implications for supply chains across semiconductors, automotive, medical devices, fluoropolymers, fluorinated lubricants, and water-repellent textiles, among many other industries.

This is a proposed restriction under REACH Annex XVII to comprehensively ban or restrict the use of bisphenol A (BPA), an endocrine disruptor, and roughly 30 structurally similar bisphenols such as BPS, BPF, and BPAF, in thermal paper, polycarbonate resin, epoxy resin coatings, food contact materials, and consumer products.