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REACH 1907/2006: chemical substances and SVHC

Guide · REACH

Adopted on 18 December 2006 and applicable since 1 June 2007, Regulation (EC) No 1907/2006, known as REACH, is the cornerstone of European chemicals legislation. It consolidated some forty earlier directives and established a unified framework for the registration, evaluation, authorisation and restriction of substances. Twenty years after its adoption, REACH also shapes the compliance of electronic products, via the SVHC candidate list, the communication obligation of Article 33 and the SCIP database. This guide presents the architecture of the four pillars, the relationship between candidate list, Annex XIV and Annex XVII, the scope of SCIP, REACH-like regimes outside the Union and the timeline of the universal PFAS restriction now under examination.

Before REACH, European chemicals legislation was a mosaic of sectoral directives, including Directive 67/548/EEC on the classification of dangerous substances and Regulation 793/93/EEC on risk assessment. Substances placed on the market before 18 September 1981 were treated as existing and had never undergone full evaluation: more than 100 000 substances circulated without structured toxicological data. The 2001 Commission White Paper proposed a radical overhaul, leading to the adoption of Regulation 1907/2006.

Four objectives are set out in Article 1. The first is protection of human health and the environment against the risks of chemical substances. The second is the free movement of these substances within the internal market. The third is innovation and competitiveness of the European chemical industry. The fourth is the promotion of alternative methods to animal testing.

The guiding principle is captured in the formula no data, no market: an unregistered substance cannot be manufactured or imported above one tonne per year. The burden of proof shifts to industry, which must demonstrate the safety of each substance before placing it on the market.

REACH is administered by the European Chemicals Agency (ECHA) based in Helsinki, established by the regulation itself. The agency manages registration dossiers, evaluates substances together with Member States, and maintains the public lists.

The architecture of the regulation rests on four complementary mechanisms, which give the act its acronym.

PillarKey articlesObjectEffect on industry
Registration (R)art. 5-24Submission to ECHA of a technical dossier per substance, including physicochemical, toxicological and ecotoxicological dataPrecondition for any manufacture or import above 1 t/year
Evaluation (E)art. 40-54Examination of dossiers by ECHA and Member States, with possible request for additional informationPossible substance evaluation (CoRAP) with risk management measures
Authorisation (A)art. 55-66Procedure for listing the most concerning substances on Annex XIV, with sunset dateUse ban after expiry date, unless a specific authorisation (AfA) is granted
Restriction (R)art. 67-73Listing on Annex XVII of substances whose placing on the market or use is banned or conditionalImmediate sectoral bans or thresholds

The last two pillars (authorisation and restriction) are the most visible regulatory levers for the downstream supply chain, including electronics. The first two structure the work of substance and mixture manufacturers upstream.

Any European manufacturer or importer of a substance, as such or in a mixture, above one tonne per year must submit a registration dossier to ECHA via the REACH-IT portal and the IUCLID software (International Uniform Chemical Information Database). The dossier includes a unique chemical identifier, physicochemical data, classification and labelling, identified uses, exposure scenarios and risk management measures. Above ten tonnes per year, a chemical safety report (CSR) is required.

The initial registration calendar ran from 2008 to 2018, with three tonnage-band deadlines. Since 2018, the obligation is continuous: every new substance must be registered before being placed on the market above the threshold.

For articles, registration remains exceptional. It is required only for substances intended to be released under normal conditions of use, above one tonne per year per importer (for example ink cartridges, but also some polymer films with intended release). Substances simply contained in an article are not registered as such, but fall under SVHC communication.

Evaluation has two components. Dossier evaluation by ECHA checks compliance and data relevance. Substance evaluation is conducted by Member States on the basis of the CoRAP (Community Rolling Action Plan), a three-year programme updated annually. An evaluated substance may give rise to risk management measures, a restriction proposal or an SVHC identification.

Authorisation is the most constraining mechanism. A substance identified as SVHC may be listed in Annex XIV by the Commission, after the opinion of the Member State Committee and public consultation. The listing fixes a sunset date: from that date, the substance may no longer be placed on the market or used in the Union, unless an Application for Authorisation (AfA) has been filed for a specific use and granted.

The AfA rests on two routes: the adequate control route, where the operator demonstrates that exposure is controlled, and the socio-economic route, where the economic and social benefits of use justify continued use despite the risk, in the absence of an alternative. The dossier is reviewed by the ECHA RAC and SEAC committees, then the Commission decides.

Annex XIV originally contained six substances in 2011 (including the phthalates DEHP, BBP, DBP). It now lists more than fifty entries, dominated by chromium VI compounds (chromium trioxide, chromates), phthalates and certain lead compounds.

Annex XVII lists substances subject to restriction: use ban, placing-on-the-market ban above a threshold, conditional use. Entries range from white lead (historical case) to intentionally added microplastics (entry 78, restriction adopted in 2023), via cadmium in jewellery (entry 23), lead in ammunition in wetlands (entry 76) and nonylphenols in textiles (entry 46).

For electronics, several recent entries have practical effect: restriction of diisocyanates (entry 74), which affects some adhesives and foams, restriction of microplastics (entry 78), which affects some encapsulants and resins, and restriction of lead in ammunition and weights, which does not directly affect EEE but clarifies scope.

A Substance of Very High Concern (SVHC) is a substance presenting at least one of the properties set out in Article 57 of the regulation.

CriterionReferenceExample
CMR category 1A or 1Bart. 57(a)(b)(c)DEHP, formaldehyde
PBT (persistent, bioaccumulative, toxic)art. 57(d)HBCDD, certain PFAS
vPvB (very persistent, very bioaccumulative)art. 57(e)Certain long-chain alkyls
Endocrine disruptorart. 57(f)4-nonylphenol, bisphenol A
Equivalent level of concernart. 57(f)Some lead compounds

Identification follows a formal procedure. A Member State or ECHA prepares an Annex XV dossier demonstrating the SVHC character of the substance. A 45-day public consultation is opened. The Member State Committee (MSC) examines the dossier and decides by consensus or, failing that, refers to the Commission. The candidate-list entry is then made by ECHA decision.

The candidate list is updated roughly twice a year, in January and June or July. As of 1 January 2026, it contains more than 240 substances. Each update triggers, for suppliers, a screening exercise on their articles: composition data in MDS, BOMcheck or equivalent, identification of compositions above 0.1 %, update of declarations.

Listing on the candidate list does not ban placing on the market: it triggers the obligations of communication (Article 33) and SCIP notification. It is also the antechamber to Annex XIV: only candidate-listed substances may be proposed for authorisation.

Article 33: SVHC communication in articles

Section titled “Article 33: SVHC communication in articles”

Article 33 of the regulation establishes a communication obligation throughout the supply chain. It is simply worded, but its operational consequences are substantial.

A supplier of an article containing an SVHC above 0.1 % weight by weight of the article must communicate to its professional customer:

  • the name of the substance;
  • as a minimum, information sufficient to ensure safe use.

For a consumer, the obligation applies on request, within 45 calendar days, free of charge.

Two questions long divided industry and authorities: how to compute the percentage, and what is an article. The Court of Justice of the European Union ruling of 10 September 2015 (case C-106/14, once-an-article-always-an-article) settled the matter: the 0.1 % threshold is calculated against each article in the meaning of the packaging directive, not against the final assembled product. For an electronic product, each screw, capacitor and cable is assessed individually. A connector containing 0.15 % of a phthalate SVHC triggers the obligation, even if the assembled product contains well below 0.1 % expressed against its total mass.

This interpretation fundamentally reshaped REACH management in electronics: declaring a finished product is no longer enough; a component library with declared composition must be maintained, and SVHCs traced at sub-assembly level.

The SCIP database (Substances of Concern In articles, as such or in complex objects (Products)) has been operational since 5 January 2021. Its legal basis is not REACH directly, but Article 9(1)(i) of the Waste Framework Directive 2008/98/EC, amended in 2018. The purpose is to ensure SVHC traceability throughout the life cycle, down to recycling and waste management operators.

Every economic operator placing an article containing an SVHC above 0.1 % weight by weight on the Union market must declare:

  • article identification (trade name, identifier, image, TARIC category);
  • ECHA identifier of the SVHC present and its concentration;
  • safe-use instructions where necessary;
  • composition of the article and, if applicable, its sub-components.

The scope is broad: importers, distributors, assemblers are covered, as long as they place an article on the Union market. End-of-chain retailers selling to consumers are exempted. Declarations are public, accessible through an ECHA SCIP search.

  1. Inventory of affected articles (enriched BOM, supplier MDS sheets).
  2. Identification of SVHCs present above 0.1 % per article.
  3. Preparation of IUCLID dossiers in SCIP format with the required fields.
  4. Submission via the ECHA Submission Portal.
  5. Update at each composition change or new candidate-list entry.

For an electronics manufacturer with several hundred components in its catalogue, the initial workload is substantial. Product lifecycle management (PLM) tools now integrate SCIP connectors to limit data re-entry.

REACH and RoHS are often conflated, whereas their logic and scope differ fundamentally. The table below summarises the main operational differences.

AxisREACHRoHS
Type of actRegulation (EC) 1907/2006Directive 2011/65/EU (recast of 2002/95/EC)
Product scopeAll substances, mixtures, articlesElectrical and electronic equipment
Substance scopeAll, hundreds in Annex XVII10 specific substances
Threshold0.1 % weight by weight of the article (SVHC)0.1 % or 0.01 % weight by weight of homogeneous material
MarkingNo product markingCE marking and EU declaration of conformity
UpdatesCandidate list biannuallyExemptions updated by delegated acts
DocumentationArticle 33 communication, SCIPCE technical file
EnforcementMember State (CRGS in France)Member State (DGCCRF in France)

RoHS is closed and sectoral: ten substances, fixed thresholds, defined EEE scope. REACH is open and horizontal: hundreds of substances subject to restriction or authorisation, all-product scope, evolving candidate list. The two regimes coexist for the same electronic product: an assembly must be RoHS-compliant on the ten substances and REACH-compliant on SVHCs and Annex XVII entries.

REACH-like regimes outside the European Union

Section titled “REACH-like regimes outside the European Union”

REACH has inspired several national or regional regimes, without any mutual recognition. A product targeting multiple markets must therefore satisfy local requirements in parallel.

Country / regionActAuthoritySpecificity
South KoreaK-REACH (Act on Registration and Evaluation of Chemicals, 2015)Ministry of Environment, KEITIOwn registration and SVHC notification
ChinaMEE Order 12 (2020, replaces MEP Order 7)Ministry of Ecology and EnvironmentNotification of new chemical substances, no unified public SVHC list
TurkeyKKDIK (Kimyasallarin Kaydi, Degerlendirilmesi, Izni ve Kisitlanmasi, 2017)CSBNear-full transposition of REACH, with its own deadlines
United KingdomUK REACH (since 2021, post-Brexit)HSE, DEFRASeparate national registry, transitional arrangements through 2030
United StatesTSCA (Toxic Substances Control Act, 1976, reformed 2016)EPAInventory logic, no SVHC equivalent list
JapanChemical Substances Control Law (CSCL)METI, MHLW, MOENotification, classification, sectoral restrictions

For a European manufacturer exporting abroad, the mapping is strategic: a REACH-compliant product is not automatically K-REACH or KKDIK compliant. Listed substances, thresholds and declaration obligations differ.

Universal PFAS restriction: a dossier under review

Section titled “Universal PFAS restriction: a dossier under review”

In January 2023, five national authorities (BAuA for Germany, RIVM and NVWA for the Netherlands, EPA for Denmark, KEMI for Sweden, Miljodirektoratet for Norway) submitted to ECHA a universal restriction proposal covering all per- and polyfluoroalkyl substances, approximately 10 000 substances in the PFAS family. The Annex XV dossier proposes a ban on manufacture, placing on the market and use, with sectoral derogations to be discussed.

The proposal has been under review by ECHA's RAC (Risk Assessment Committee) and SEAC (Socio-Economic Analysis Committee) since 2023. A public consultation collected more than 5 600 contributions. The joint opinion of the two committees is expected progressively between 2025 and 2027, by sectoral block. The Commission will then decide by implementing act or amendment to Annex XVII.

The electronics industry is affected on several counts:

  • PFAS in soldering fluxes: some RMA and low-residue fluxes use perfluorinated additives.
  • PFAS in coatings: hydrophobic PCB protection, encapsulants, varnishes.
  • PFAS in lithium-ion batteries: separators and binders (PVDF, PTFE) are fluoropolymers, classified as PFAS polymers in the proposal.
  • PFAS in semiconductors: process auxiliaries in lithography (photoresists, anti-reflective materials).
  • PFAS in cables: high-frequency insulation in FEP, ETFE.

The determination of essential versus non-essential use will be central. The committees are working on a dozen blocks (consumer electronics, semiconductors, medical devices, batteries, transport, energy, etc.) to characterise, block by block, the existence of alternatives, criticality and residual risk. Several time-limited derogations are envisaged for blocks without immediate alternatives.

For ongoing designs, the precautionary principle leads to anticipating substitution. PFAS-by-BOM reviews are now embedded in design reviews at engineering offices, even though the final restriction has not yet been adopted.

The candidate-list update rhythm is stable: two additions per year, between 2 and 12 substances per batch. A few recent substances are directly relevant to electronics:

  • 2024: addition of bumetrizole (UV-326, UV absorber), bis(2-ethylhexyl) tetrabromophthalate and diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (TPO, photoinitiator).
  • 2023: addition of 2,4,6-tri-tert-butylphenol (additive), diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (TPO), melamine (resin, under conditions).
  • 2022: addition of bisphenol S (BPS), trimethyl borate (electrolyte additive), N-(hydroxymethyl)acrylamide.

Each addition prompts a product review at suppliers and a possible trigger of Article 33 communication and SCIP notification. Full Material Disclosure (FMD) tools become indispensable above a certain catalogue size.

REACH is not a harmonisation act under the New Legislative Framework. It does not give rise to direct CE marking, nor to assessment by a notified body. But it interacts with several acts that electronics manufacturers encounter routinely.

RoHS (Directive 2011/65/EU) applies in parallel to its ten substances in EEE. For CE marking and documentation, see the CE marking guide and the CE scope.

Battery Regulation 2023/1542 (see the Battery Regulation guide) carries over and tightens certain hazardous substance thresholds (mercury, cadmium, lead) for batteries, while preserving REACH applicability to other substances (electrolytes, additives, separators).

Toy Regulation 2009/48/EC refers to REACH for chemical substances. Electronic toys are also subject to RoHS and to the Battery Regulation for the energy component. See the EN 71 EU toy safety guide for the overall framework.

Cyber Resilience Act (CRA) (see the Cyber Resilience Act guide) does not address chemistry. But for a connected product, the coexistence of regimes (CE-CRA for cyber, REACH for chemistry, RoHS for EEE) must be tracked in a single technical file.

Waste Framework Directive 2008/98/EC is the legal basis for SCIP, and anticipates the WEEE Directive for the EEE component. End-of-life management now integrates a SCIP reading of declared SVHCs.

The spilma glossary covers the abbreviations SVHC, AfA, RAC, SEAC, CoRAP, MDS, FMD with their reference definitions.

RiskConsequenceAction
Confusing finished-product threshold with per-article thresholdUnder-reporting of Article 33 and SCIPApply once-an-article-always-an-article at component level
Missing biannual candidate-list updatesSubstance becomes SVHC without communicationInscribe the ECHA alert in the biannual product review
Postponing SCIP notificationArticle withdrawn from market, Member State sanctionOpen the ECHA Submission Portal account as soon as an SVHC is identified
Neglecting REACH-like regimes for exportCustoms refusalMap K-REACH, KKDIK, UK REACH for each target market
Underestimating the PFAS restrictionHot materials rework without industrial planningPFAS inventory BOM by BOM from 2025-2026
Treating REACH as extended RoHSGaps on Annex XVII, lead, chromium VITreat REACH as a horizontal registry, not a closed list
Forgetting the Article 33 consumer requestConsumer or NGO complaint, enforcement actionSet up a dedicated 45-day contact channel

Sanctions are set by each Member State. In France, oversight falls on the Conseil regional for substance management (CRGS) and the DGCCRF. Sanctions may include administrative fines, withdrawal orders and criminal prosecution for serious failures.

Sources & references

  1. Regulation (EC) No 1907/2006 (REACH) , EUR-Lex eur-lex.europa.eu/eli/reg/2006/1907/oj
  2. ECHA, European Chemicals Agency , ECHA echa.europa.eu/
  3. ECHA, candidate list of substances of very high concern , ECHA echa.europa.eu/candidate-list-table
  4. ECHA, SCIP database , ECHA echa.europa.eu/scip-database
  5. ECHA, universal PFAS restriction dossier , ECHA echa.europa.eu/registry-of-restriction-intentions/-/dislist/details/0b0236e18663449b
  6. Directive 2008/98/EC Waste Framework (legal basis for SCIP) , EUR-Lex eur-lex.europa.eu/eli/dir/2008/98/oj