What is the REACH Regulation and Why Monitoring is Critical
REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is the European regulation governing the registration, evaluation, authorization, and restriction of chemicals. Managed by the European Chemicals Agency (ECHA) based in Helsinki, REACH applies to all chemicals produced or imported into the EU in quantities of 1 ton/year or more.
REACH is not static: regulatory lists are updated several times a year. A substance present in your formulations may be added to the SVHC Candidate List, included in Annex XIV, or subject to new restrictions in Annex XVII without sufficient notice for those who do not actively monitor. The consequences of non-compliance include:
- Blocking of placing on the market — Obligation to withdraw products containing unauthorized substances
- Administrative and criminal penalties — Up to hundreds of thousands of euros per violation, varying by Member State
- Communication obligation — Art. 33 REACH: automatic obligation to inform professional recipients about the presence of SVHC > 0.1% w/w in articles, and obligation to respond to consumers within 45 days of request
- Reputational risk — Loss of trust from customers and business partners
- Exclusion from supply chains — Large industrial groups require documented REACH compliance
REACH Regulatory Lists Monitored by kemXpro
SVHC (Substances of Very High Concern) Candidate List
The Candidate List is the list of substances identified as SVHCs (Substances of Very High Concern) by ECHA that are subject to authorization. As of February 2026, it contains over 240 substances. The criteria for inclusion are:
- CMR — Carcinogenic, mutagenic, or toxic to reproduction (category 1A or 1B)
- PBT — Persistent, bioaccumulative, and toxic
- vPvB — Very persistent and very bioaccumulative
- Equivalent concern — Endocrine disruptors, respiratory sensitisers, etc.
Inclusion in the Candidate List entails immediate obligations: communication in the supply chain (Art. 33), notification to ECHA for articles (Art. 7.2), and updating of SDSs (Section 15). kemXpro automatically cross-references your formulations with the Candidate List and alerts you instantly when a substance present in your products is added.
Annex XIV — Authorization List
Annex XIV of REACH lists substances whose use requires specific authorization from the European Commission. Substances move from the Candidate List to Annex XIV through a recommendation by ECHA, with a sunset date after which use is prohibited without authorization. The authorization process is long and expensive (18+ months, costs that can exceed hundreds of thousands of euros considering ECHA fees, studies, and consulting).
kemXpro monitors:
- ECHA recommendations for the inclusion of new substances in Annex XIV
- Sunset dates and latest application dates for each substance
- The status of authorizations granted and the related conditions of use
- Exempted uses and specific derogations
Annex XVII — Restrictions
Annex XVII of REACH contains restrictions on the manufacture, placing on the market, and use of certain substances, mixtures, and articles. Each entry specifies the conditions of restriction: maximum concentrations, prohibited sectors, additional labeling requirements, analytical requirements.
Examples of critical restrictions monitored by kemXpro:
- Entry 27 — Nickel: restrictions in articles in prolonged contact with the skin
- Entry 43 — Azo dyes: prohibited in textiles and leather in contact with the skin
- Entry 50 — IPA: restrictions in extender oils and tires
- Entry 51 — Phthalates: restrictions in plasticized articles
- Item 63 — Lead: restrictions in jewelry and children's articles
- Item 68 — PFOA: restriction on perfluorooctanoic acid (PFOA), its salts, and PFOA-related substances
- Item 72 — Diisocyanates: training requirements for professional users
- Item 75 — Microplastics: restriction on the intentional addition of microplastics
CoRAP (Community Rolling Action Plan)
CoRAP is the Community's rolling action plan for substance evaluation. Substances included in CoRAP are under scrutiny for potential risks. Inclusion in CoRAP often precedes future restrictions or reclassifications. kemXpro monitors CoRAP and flags substances in your formulations that may be subject to new regulatory measures.
PACT (Public Activities Coordination Tool)
kemXpro also monitors ECHA's PACT, the public activities coordination tool that tracks the regulatory intentions of Member States and ECHA itself: CLP harmonization proposals, restriction proposals, ongoing SVHC identification, substance evaluations.
How REACH Monitoring Works in kemXpro
Automatic Synchronization with ECHA Databases
kemXpro maintains an internal database synchronized with ECHA databases. Every update—new substances in the Candidate List, changes to Annex XVII, new sunset dates in Annex XIV, CoRAP updates—is automatically acquired and compared with your inventory of substances and formulations.
Formulation Screening
Each formulation in the kemXpro database is automatically analyzed against all REACH lists. The system checks for:
- Presence of SVHCs with a concentration > 0.1% w/w (Art. 33 threshold)
- Compliance with applicable Annex XVII restrictions
- Need for authorization for Annex XIV substances
- Substances under CoRAP evaluation
- Substances with harmonized classification under review
Real-time alerting system
When a match is detected between your substances and a regulatory update, kemXpro generates an immediate alert with:
- Details of the regulatory change — Which list, which substance, what has changed
- Affected products — List of all formulations and products containing the substance
- Recommended actions — SDS update, customer communication, search for alternatives
- Regulatory deadlines — Sunset dates, notification deadlines, transition periods
- Regulatory references — Link to the original ECHA document
REACH Compliance Dashboard
The kemXpro dashboard provides a centralized view of the REACH compliance status of your entire product portfolio: how many products contain SVHCs, how many are affected by restrictions, how many require action by specific deadlines. Reports can be exported to PDF for audits and inspections.
REACH registration and IUCLID dossiers
In addition to monitoring, kemXpro supports the REACH registration process through integration with the IUCLID format. Companies that manufacture or import chemicals can:
- Import existing IUCLID dossiers into the kemXpro system
- Export data in a format compatible with REACH-IT
- Manage registration information alongside daily compliance
- Track volumes by tonnage band and related reporting obligations
Automatizza il Monitoraggio REACH
Non rischiare la non conformità. kemXpro monitora Candidate List, Allegato XIV, Allegato XVII e CoRAP in tempo reale. Richiedi una demo.
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