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Dmf Svhc Scip What Eu Buyers Must File And When

N,N-Dimethylformamide (DMF, CAS 68-12-2, EC 200-679-5) is a polar aprotic solvent used in polyurethane coating, synthetic leather coagulation, acrylic fibre spinning and pharmaceutical crystallisation. The harmonised classification under Regulation (EC) No 1272/2008 Annex VI assigns Flam. Liq. 3, H226; Acute Tox. 4, H312 and H332; Eye Irrit. 2, H319; and Repr. 1B, H360D. The inclusion of DMF in the REACH Candidate List under Article 59 due to reproductive toxicity under Article 57(c) occurred in the June 2018 Candidate List update. Procurement and regulatory teams should treat the following as the core compliance question: DMF SVHC & SCIP: What EU Buyers Must File and When.

The distinction between substance, mixture and article governs the filing route. Bulk DMF imports are not filed in the SCIP database. DMF present as a residual solvent in an imported article above 0.1% w/w is filed in SCIP. DMF in a formulated mixture may trigger safety data sheet duties under REACH before any article is formed.

What EU buyers must file in the SCIP dossier after the 5 January 2021 start date

SCIP is the database established under Directive 2008/98/EC Article 9(1)(i), operational since 5 January 2021. The obligation applies to any supplier of an article placed on the market after that date when DMF is present in the article as supplied above 0.1% w/w. The presence may be in a component article within a complex product, and the threshold is applied to each article or component article rather than averaged across an assembled product. Bulk DMF imports, including tank containers and drums, do not trigger SCIP because they are not articles within REACH Article 3(3).

The filing entity submits a SCIP dossier through ECHA’s submission portal using the SCIP format. The primary data fields required by Directive 2008/98/EC Article 9(2) are the article identity, the SVHC identity, the concentration range, the location of DMF in the article, and safe use information. A SCIP dossier is not a one-time communication to a customer; it is a database submission to ECHA. Updates are required when the concentration band or article composition changes.

Core SCIP data fields for a DMF-containing article under Directive 2008/98/EC Article 9(2)
SCIP fieldRequired content for DMFLegal reference
Article identityPrimary article identifier, article category, material compositionDirective 2008/98/EC, Article 9(2)
SVHC identityN,N-Dimethylformamide; CAS 68-12-2; EC 200-679-5Directive 2008/98/EC, Article 9(2)
Concentration rangeSelected ECHA concentration band above 0.1% w/wDirective 2008/98/EC, Article 9(2)
Location in articleSpecific component article, coating layer, or polymer matrixDirective 2008/98/EC, Article 9(2)
Safe use informationHandling, installation, disposal, thermal processing controlsDirective 2008/98/EC, Article 9(2)

The operational workflow for an EU buyer starts with article-level testing or supplier declarations. A supplier declaration alone is not a SCIP dossier; the importer must ensure that the ECHA dossier exists for the DMF-containing article. If the EU buyer is a distributor or downstream user rather than importer, the SCIP duty remains with the EU producer or importer, but Article 33 communication continues along the supply chain. The confirmation of a successful SCIP submission should be retained in the compliance file.

Residual DMF in polyurethane-coated textiles and synthetic leather is the most common article-level trigger for EU buyers. On a polyurethane wet-coagulation line, DMF is cast into a water bath where solvent exchange forms a porous polymer matrix. Residual DMF removal depends on multi-stage countercurrent water extraction, downstream drying temperature, line speed, and DMF recovery vacuum distillation. If the residual concentration in the finished article exceeds 0.1% w/w, the article is in scope for SCIP even when DMF is not an intended formulation component at the point of sale. Because residual solvent levels can vary between batches, EU buyers should not rely on a bill of materials alone; extractables testing may be required to determine whether a SCIP dossier must be filed.

For an assembled product containing a DMF-bearing polyurethane component, SCIP data must identify the specific component article. The safe use information field should address thermal processing during installation or end-of-life treatment, because DMF-bearing polymer matrices may release volatile decomposition products when heated. Ventilation and local exhaust controls should be specified. Published data for line-specific residual variability in polyurethane-coated textiles is limited; process capability studies on the actual coating line are the basis for concentration-band selection.

Substance and mixture duties activate before the article phase

An EU buyer importing DMF as a substance or within a mixture faces REACH classification, SDS, and authorisation-status duties rather than SCIP. A mixture containing DMF at 0.3% w/w or above is classified as Repr. 1B, H360D under the general concentration limit in CLP Annex I, and an SDS is mandatory under REACH Article 31(1). At DMF concentrations from 0.1% w/w to 0.3% w/w, the mixture may not be classified as a reproductive toxicant, but SDS must be provided on request under Article 31(3) because DMF is a Candidate List SVHC. The SDS must include the harmonised classification, the Candidate List status in Section 15, and relevant exposure controls from the registrant’s chemical safety report.

REACH Article 7(2) applies separately to EU producers or importers of articles containing DMF above 0.1% w/w when the total DMF quantity in articles exceeds 1 tonne per annum per actor. That notification is made through REACH-IT. For DMF, the Article 7(2) deadline for actors active at the June 2018 inclusion was no later than six months after inclusion, meaning December 2018; new actors should verify ECHA guidance on late notifications. Article 7(2) does not apply to bulk DMF imports. Candidate List inclusion itself does not create an authorisation requirement under REACH Title VII; if DMF is later added to Annex XIV, the applicable ECHA publication must be checked before use.

DMF storage and processing boundaries must be reflected in the SDS and in downstream process controls. DMF is incompatible with strong oxidizing agents, strong acids, acid chlorides, and halogenated hydrocarbons. At elevated temperatures, moisture and acidic or basic conditions accelerate hydrolysis to dimethylamine and formic acid. These reaction products raise vapour-phase amine levels and can shift pH in aqueous waste streams. A closed-loop DMF recovery system with vacuum distillation is typical on polyurethane coating lines. The operational set points for vacuum and sump temperature should maintain residual DMF below the 0.1% w/w article threshold where the finished article is within scope of SCIP. Containers should remain closed and protected from moisture because DMF is hygroscopic.

When dimethylformamide concentration crosses 0.1% by weight in an imported article

Article 33 communication is immediate and applies without a tonnage threshold. The supplier of an article containing DMF above 0.1% w/w must provide the recipient with sufficient information, available to the supplier, to allow safe use of the article; at minimum the substance name must be supplied. For requests from consumers, the information must be provided free of charge within 45 days of receipt. For DMF, this duty has applied since the June 2018 Candidate List inclusion for articles supplied after that date. A communication under Article 33 does not discharge the separate SCIP filing obligation.

SCIP filing under Directive 2008/98/EC requires submission of the dossier to ECHA, not merely a supply-chain letter. The filing entity should select the correct concentration band from ECHA’s predefined ranges. If the DMF concentration changes from one band to another or the article composition changes, the SCIP dossier must be updated. EU buyers that import identical articles with different coatings or production sites should treat each distinct article as requiring its own SCIP data set when the DMF concentration exceeds 0.1% w/w.

DMF SVHC and SCIP filing checklist for EU buyers
ObligationTriggerDeadline or timingLegal basis
SDS for classified mixtureDMF at 0.3% w/w or aboveBefore first supplyREACH Article 31(1); CLP Annex I
SDS on request for non-classified mixtureDMF from 0.1% w/w to 0.3% w/wOn requestREACH Article 31(3)
Article notificationDMF above 0.1% w/w and 1 tonne per annum6 months from Candidate List inclusion for active suppliers; verify for later startREACH Article 7(2)
Article communicationDMF above 0.1% w/w in articleImmediate; consumer request within 45 daysREACH Article 33
SCIP dossierDMF above 0.1% w/w in articleFrom 5 January 2021; update after changesDirective 2008/98/EC Articles 9(1)(i) and 9(2)

To determine whether DMF crosses the SCIP and Article 33 threshold, extraction followed by gas chromatography with flame ionisation detection is used for polyurethane and textile matrices. The analytical method must achieve a reporting limit below 0.1% w/w to support a decision that no filing is required. Because DMF is hygroscopic and partially water-soluble, sample preparation should prevent moisture uptake. Published harmonised extraction standards for every article matrix are limited; EU buyers should specify an ISO/IEC 17025-accredited method and require the laboratory to validate recovery at the regulatory threshold.

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