REACH Restrictions on Adhesive Raw Materials: Isocyanates, Solvents, and Plasticisers

What REACH Is and Why It Matters for Adhesive Formulators

REACH was adopted on 18 December 2006 and came into force on 1 June 2007, replacing a fragmented patchwork of earlier EU chemicals legislation with a single, unified framework. Its core premise is that manufacturers and importers bear responsibility for demonstrating the safety of chemicals they place on the EU market — a reversal of the previous regulatory assumption that substances were safe until proven otherwise. The regulation operates across four main areas: substance registration with ECHA (Title II); hazard and risk evaluation by competent authorities (Title III); authorisation of substances of very high concern before use in new applications (Title VII); and restriction of specific uses of substances that pose unacceptable risks to human health or the environment (Title VIII and Annex XVII).

For adhesive formulators, REACH matters primarily through three overlapping compliance obligations. First, raw materials sourced from EU-based or EU-importing suppliers must have valid REACH registrations — sourcing from an unregistered supply chain creates downstream liability. Second, formulated adhesive products that are hazardous or contain SVHCs require compliant Safety Data Sheets (SDS) under Article 31, updated each time a new SVHC is added to the Candidate List if present above threshold. Third, and most directly affecting formulation design, Annex XVII restrictions prohibit or condition specific uses of certain substances, meaning legacy formulations must be screened for compliance and may require reformulation when new restrictions enter into force. The restriction landscape for adhesive raw materials has shifted significantly since 2020, with major restrictions on diisocyanates, DMF, phthalates, and NMP all taking effect within a three-year window.

Scope: Who REACH Applies To in the Adhesive Supply Chain

REACH applies to any substance, mixture, or article manufactured in or imported into the EU, regardless of company size or end market. For the adhesive sector, this means the regulation applies to raw material suppliers providing substances or mixtures; adhesive formulators who compound those raw materials into finished adhesive products; converters and assemblers who apply adhesives to create bonded articles; and brand owners who import finished adhesive products or adhesive-bonded articles from outside the EU. Each actor in the chain has distinct obligations, and the same adhesive substance can trigger obligations at multiple levels simultaneously.

The threshold of 0.1% by weight is particularly significant for adhesive compliance: it applies to SVHC candidate list communication obligations in both mixtures and articles, to the phthalate restriction in plasticised materials, and to the diisocyanate training restriction. Understanding which threshold applies at which level of the supply chain — mixture weight, article weight, or plasticised material fraction — is one of the most common sources of compliance ambiguity in the adhesive sector.

Key REACH Restrictions by Adhesive Raw Material Class

Three Annex XVII restriction entries represent the highest-priority compliance obligations for adhesive formulators as of 2026, along with the broader SVHC Candidate List screening obligation that applies across all raw material classes. Each restriction has a distinct scope, threshold, and compliance mechanism that must be understood separately before assessing how it affects a specific formulation.

Diisocyanates — Annex XVII Entry 74

The diisocyanate restriction, which took full effect on 24 August 2023, applies to all industrial and professional uses of substances or mixtures containing diisocyanates at concentrations at or above 0.1% by weight. The restriction covers all commercially relevant diisocyanates used in PU adhesive systems: MDI (methylene diphenyl diisocyanate), TDI (toluene diisocyanate), HDI (hexamethylene diisocyanate), IPDI (isophorone diisocyanate), H12MDI, and others. The restriction does not ban these substances; instead, it mandates that any person using such mixtures industrially or professionally must have completed appropriate training, and that suppliers must include a mandatory statement on labels confirming training is required before use. Three training levels are defined — basic (online, for general handling), intermediate (for tasks involving open handling), and advanced (for high-exposure tasks or tasks requiring specialist knowledge) — with the required level determined by the specific use and exposure scenario. Adhesive manufacturers supplying PU adhesives and sealants to professional or industrial customers must verify that their customers have completed appropriate training and communicate the training requirement explicitly in product documentation and labelling. For polyurethane sealants and adhesives, this restriction has fundamentally changed how products can be supplied and used.

DMF (N,N-Dimethylformamide) — Annex XVII Entry 71a

The DMF restriction, applicable since 1 December 2023, restricts the placing on the EU market of articles in which the concentration of DMF exceeds 0.3% by weight. DMF was the conventional solvent carrier for polyurethane adhesives used in shoe and leather goods manufacturing, where its excellent solvating power for polyurethane polymers made it the industry standard. The compliance challenge is that the restriction applies to the finished article — the shoe, the leather goods item — rather than to the adhesive mixture itself. This means an adhesive manufacturer supplying a DMF-based system to an article manufacturer remains indirectly constrained: if applying the adhesive to create an article results in a finished article containing DMF above 0.3%, that article cannot enter the EU market. In practice, the shoe and leather goods industry globally has largely transitioned to DMF-free waterborne PU or reactive hotmelt adhesive systems for EU-bound production, but compliance verification of DMF residue levels in articles is still required for any supply chain that uses DMF-based adhesive systems anywhere in the manufacturing process. Our overview of contact adhesive chemistry covers solvent-borne adhesive alternatives in this context.

Phthalate Plasticisers — Annex XVII Entry 51

Four phthalate plasticisers — DEHP, DBP, BBP, and DIBP — are restricted under Entry 51 in all articles where their individual or combined concentration exceeds 0.1% by weight in the plasticised material, a restriction extended to all article types from 7 July 2020. For the adhesive sector, the most affected systems are plastisol adhesives (PVC-based), pressure-sensitive adhesives that use phthalate plasticisers for tack and flexibility, and certain sealant formulations. Beyond the Annex XVII restriction, three of these phthalates — DEHP, DBP, and BBP — are listed on REACH Annex XIV (the Authorisation List), meaning their continued use in any new application in the EU requires a formal authorisation from the European Commission, with sunset dates specifying when use without authorisation must cease. Adhesive formulators still using phthalate plasticisers should urgently review their formulations against current Annex XIV status and, if any listed phthalate is used, assess whether an authorisation is in place or whether reformulation to a non-restricted plasticiser is the appropriate compliance route.

NMP (N-Methyl-2-Pyrrolidone) — Annex XVII Entry 71

NMP, a powerful polar aprotic solvent used in some adhesive lamination and coating systems, is restricted for consumer use in adhesive applications at concentrations above 0.3% by weight. For industrial and professional use, NMP-containing adhesive products are not banned but are subject to strict occupational exposure controls: employers must ensure worker dermal and inhalation exposure remains below the occupational exposure limit, which requires engineering controls, process enclosure, and where residual exposure remains, appropriate personal protective equipment. The practical consequence for adhesive formulators supplying professional users is that NMP-containing products above 0.3% cannot be supplied for consumer applications, and professional-use products must carry appropriate hazard communication and exposure control guidance in the SDS.

Documentation and Safety Data Sheet Obligations

REACH documentation obligations for adhesive formulators fall into two categories: the Safety Data Sheet (SDS) supply chain obligations under Article 31, and the SVHC communication obligations under Article 33. Both are dynamic requirements — they are not satisfied by a one-time compliance exercise but must be updated on a rolling basis as the SVHC Candidate List is updated and as formulation changes are made. Failure to maintain current documentation is one of the most commonly cited REACH enforcement findings across the chemical sector.

Safety Data Sheet Requirements

An SDS must be supplied with any hazardous mixture, any mixture containing an SVHC above 0.1% by weight, and any mixture for which the customer requests one. The SDS must follow the 16-section format prescribed in REACH Annex II (as updated by Commission Regulation (EU) 2020/878, applicable from 1 January 2023), and must be written in the official language(s) of the member state(s) where the mixture is placed on the market. Section 15 of the SDS must specifically address REACH regulatory status — identifying any SVHC present above threshold, flagging Annex XVII restrictions applicable to the mixture, and noting any Annex XIV authorisation requirements. For adhesive systems containing diisocyanates, the SDS must also include the mandatory training statement and relevant exposure scenario for diisocyanate handling. SDS updates are required within 12 months of a new SVHC being added to the Candidate List if that substance is present above 0.1% in the formulation. See our guide to adhesives and sealants technology for formulation context that informs SDS hazard classification decisions.

SVHC Article 33 Communication in Articles

When adhesive formulators or their customers produce bonded articles — taped assemblies, laminated films, structural components, footwear, or textiles — and those articles contain an SVHC above 0.1% by weight of the article, Article 33 of REACH requires communication of that information to the recipient of the article and, upon request, to consumers. The communication must include at minimum the name of the SVHC, instructions for safe use, and whether the article can be safely used. Since June 2021, ECHA's SCIP database also requires suppliers of articles containing SVHCs above 0.1% to submit that information to the SCIP (Substances of Concern In articles as such or in complex objects Products) database, enabling waste management authorities to handle those articles at end of life. This SCIP notification obligation applies to suppliers of articles to other businesses within the EU, and is now a parallel documentation obligation running alongside the commercial supply chain communication.

Step-by-Step REACH Compliance Pathway for Adhesive Formulators

REACH compliance for an adhesive product is not a single authorisation process — it is an integrated set of ongoing obligations that must be built into formulation, sourcing, and supply chain management processes. The following sequence represents the structured approach to establishing and maintaining REACH compliance for an adhesive or sealant product intended for the EU market, covering the obligations most relevant to the raw material restrictions discussed above.

1. Screen all raw materials against current REACH Annex XVII. For every substance in the formulation (including co-formulants, solvents, plasticisers, crosslinkers, and additives), check current Annex XVII for applicable restrictions. Pay specific attention to the three high-priority entries for adhesives: Entry 74 (diisocyanates ≥0.1%), Entry 71a (DMF in articles ≥0.3%), and Entry 51 (phthalates in plasticised materials ≥0.1%). Verify concentration thresholds at the relevant level — mixture weight or article weight as appropriate.
2. Screen all raw materials against the current SVHC Candidate List. Download the current Candidate List from ECHA (echa.europa.eu/candidate-list-table) and check all CAS/EC numbers against it. Where an SVHC is present above 0.1% in the formulated mixture, update the SDS to reflect this and prepare Article 33 communication templates for downstream customers who receive articles containing the substance above 0.1% in the article.
3. Verify raw material REACH registration status. Confirm with each raw material supplier that their substance has a valid REACH registration for the relevant tonnage band and that your intended use is covered by the exposure scenario in their Chemical Safety Report. Request the extended SDS (eSDS) with exposure scenarios if your supplier has conducted a CSA. If your use is not covered, either notify ECHA as a downstream user under Article 38 or prepare your own Chemical Safety Assessment for that use.
4. Assess Annex XIV (Authorisation List) obligations. Check whether any substance in the formulation appears on Annex XIV. Substances on this list require formal authorisation from the European Commission for each use. If a listed substance is identified, determine whether an existing authorisation covers your use, or whether the sunset date has passed and the use is no longer permitted without authorisation. Replace listed substances where authorisation is not feasible.
5. Implement diisocyanate training requirements if applicable. If the formulation contains diisocyanates at or above 0.1% by weight, update product labelling to include the mandatory training statement, add the diisocyanate training requirement to Section 1 of the SDS, and establish a customer training verification process. Define the appropriate training level (basic, intermediate, or advanced) for each customer use scenario and document the basis for that determination.
6. Prepare and maintain compliant SDS documentation. Prepare the SDS in the 16-section Annex II format (updated per Commission Regulation (EU) 2020/878), including Section 15 regulatory information covering SVHC status, Annex XVII restrictions, and Annex XIV status. Establish a review trigger to update the SDS within 12 months of any new SVHC Candidate List addition that affects the formulation.
7. Submit SCIP database notifications for article-containing products. Where the adhesive is used to produce articles that are supplied to other EU businesses, and where SVHCs are present above 0.1% in those articles, prepare and submit SCIP notifications to ECHA for each affected article type. Establish a process to update SCIP notifications when Candidate List updates add new relevant substances.

Timeline and Cost Expectations for REACH Compliance

REACH compliance for an adhesive formulation is not a one-time project with a defined completion date — it is an ongoing operating cost that includes both initial compliance establishment and continuous monitoring. Understanding the cost structure helps formulators build an accurate compliance budget and avoid the common error of treating initial SDS preparation as the full extent of REACH obligations.

Initial compliance establishment for a new adhesive formulation — covering raw material REACH registration verification, Annex XVII screening, SVHC Candidate List screening, SDS preparation to Annex II format, and SCIP notification where applicable — typically requires specialist regulatory input over several weeks. Where reformulation is required to address a restriction (for example, replacing a phthalate plasticiser with a compliant alternative or substituting a DMF-based adhesive system with a waterborne equivalent), development, testing, and customer re-approval costs are added to the compliance investment. These reformulation costs often dwarf the pure regulatory documentation costs, and are the primary driver of the significant industry investment triggered by the 2020–2023 wave of restriction entries. Ongoing compliance costs include biannual SVHC Candidate List monitoring (two formal screening exercises per year against ECHA's updated list), SDS update cycles, SCIP notification maintenance, and — for diisocyanate-containing products — customer training verification programmes. Companies supplying products to multiple EU member states also incur multilingual SDS translation and maintenance costs. For small adhesive manufacturers, specialist regulatory subscriptions or outsourced compliance monitoring services represent a proportionate ongoing investment compared to the enforcement and market access risk of non-compliance.

Common Mistakes Adhesive Manufacturers Make — and How to Avoid Them

REACH non-compliance in the adhesive sector follows recognisable patterns across enforcement cases, market surveillance findings, and customs holds on imported adhesive-bonded articles. The following failures appear repeatedly and are largely preventable with structured compliance processes.

Treating SVHC Screening as a One-Time Exercise

The single most common compliance gap across all adhesive manufacturers is failing to update SVHC screening and SDS documentation when new substances are added to the ECHA Candidate List. A formulation that passed a thorough SVHC screening in 2022 may now contain multiple Candidate List substances added in subsequent updates — without any change to the formulation itself. ECHA adds substances to the Candidate List approximately twice per year. Every update must be screened against all current formulations, and SDS and Article 33 communications must be updated within 12 months of any relevant addition. Automated screening tools that match raw material CAS numbers against the live ECHA Candidate List are the most efficient defence against this gap. For technical context on PU-based adhesive chemistry that commonly involves SVHC-relevant raw materials, see our guide to polyurethane sealant chemistry and formulation.

Misapplying the 0.1% Threshold Level

The 0.1% threshold appears repeatedly across REACH obligations but applies at different levels — mixture weight, article weight, or the weight of plasticised material within an article — and the distinction matters significantly for compliance assessment. For the diisocyanate training restriction, the 0.1% threshold applies to the weight of the mixture (the adhesive product). For the phthalate restriction, it applies to the weight of plasticised material within the article, which may be a sub-fraction of total article weight. For SVHC Article 33 obligations, it applies to the weight of the finished article as a whole. Adhesive manufacturers who apply a single threshold rule across all obligations without differentiating by assessment level regularly either over-comply (triggering unnecessary obligations) or under-comply (missing obligations because the substance appears below threshold in the mixture but above threshold in the final article or plasticised fraction).

Overlooking the Diisocyanate Training Documentation Obligation

Several adhesive manufacturers have implemented the August 2023 diisocyanate training restriction partially — updating labels and SDSs — but have not established the supply chain documentation process to verify and record that customers have completed appropriate training before using the product. The restriction requires not just that training be communicated but that the supplier ensures training has been completed. This creates a practical obligation to request and retain training certificates or equivalent confirmation from professional and industrial customers before supplying diisocyanate-containing products. Failure to maintain this documentation makes the entire supply chain of a diisocyanate adhesive product potentially non-compliant. Our overview of contact adhesive systems covers the chemistry context for adhesives that commonly rely on isocyanate-based crosslinking.

Importing Articles Without DMF Residue Verification

Brand owners and importers bringing footwear, leather goods, or textiles manufactured outside the EU using DMF-based adhesive systems regularly underestimate or overlook the DMF article restriction. The restriction applies at the EU border regardless of where the article was manufactured and regardless of whether the adhesive system is listed as DMF-free by the manufacturer. Market surveillance authorities in several member states have issued formal warnings and product recalls for footwear and textile articles where DMF residue testing revealed concentrations above 0.3% in the finished article. The only reliable defence is independent residue testing of finished articles from DMF-risk manufacturing supply chains before EU market entry. For articles manufactured using waterborne or reactive hotmelt adhesive systems — systems known to be DMF-free — supplier declarations and formulation documentation are generally sufficient.