SVHC Substance in Your Product. REACH Obligation & Deadline.

REACH (Regulation EC 1907/2006) governs the registration, evaluation, authorisation and restriction of chemical substances. Its focus is on chemical risk management throughout the supply chain. CLP (Regulation EC 1272/2008) governs the classification, labelling and packaging of hazardous substances and mixtures, aligning EU legislation with the United Nations Globally Harmonised System (GHS). Both regulations are interrelated: REACH identifies which substances are of concern and CLP determines how hazards are communicated. IgeraIndustria has both regulations indexed and clearly indicates in each answer which regulation applies to the requirement being queried.

The CLP Regulation applies to all substances and mixtures placed on the EU market. Substances with harmonised classification are listed in Annex VI of CLP and must mandatorily use that classification. For substances and mixtures without harmonised classification, the manufacturer, importer or downstream user must carry out a self-classification based on available data. Labelling must include: product identification, supplier details, applicable GHS hazard pictograms, signal words, hazard statements (H phrases) and precautionary statements (P phrases), plus any additional elements required under Annex II of CLP. IgeraIndustria verifies the CLP classification of each substance and generates the complete list of required labelling elements.

The SVHC (Substances of Very High Concern) list is the so-called Candidate List published by ECHA. It includes substances with CMR properties (carcinogenic, mutagenic or toxic for reproduction category 1A or 1B), PBT (persistent, bioaccumulative and toxic), vPvB (very persistent and very bioaccumulative) or endocrine disrupting (ED) properties with sufficient scientific evidence. As of June 2026 the list exceeds 240 substances. ECHA updates it twice a year: typically in June and in January/December. Inclusion in the Candidate List immediately triggers communication obligations under Article 33 of REACH, even if the substance is not yet in Annex XIV (subject to authorisation). IgeraIndustria can be automatically re-indexed after each ECHA update.

Under Article 33 of the REACH Regulation, you must communicate to your professional customers the presence of an SVHC in an article when two conditions are met: the concentration of the SVHC exceeds 0.1% by weight of the article (w/w) and the substance is included in the Candidate List at the time of delivery. The response deadline when a customer requests information is 45 days. For end consumers (members of the public), the obligation to inform exists without the need for a prior request. Additionally, if the article contains an SVHC at a concentration above 0.1% w/w and you produce or import more than 1 tonne/year of that article, you must notify ECHA through the SCIP portal (database of articles containing SVHCs). IgeraIndustria automates tracking of these obligations for all articles in your portfolio.

The Safety Data Sheet (SDS) compliant with Regulation 2020/878 (which updates Annex II of REACH) must contain 16 mandatory sections: 1) Identification of the substance/mixture and of the company/undertaking; 2) Hazard identification; 3) Composition/information on ingredients; 4) First aid measures; 5) Firefighting measures; 6) Accidental release measures; 7) Handling and storage; 8) Exposure controls/personal protection; 9) Physical and chemical properties; 10) Stability and reactivity; 11) Toxicological information; 12) Ecological information; 13) Disposal considerations; 14) Transport information; 15) Regulatory information; 16) Other information. Many supplier SDS fail to meet specific requirements in sections 11 and 12 or do not include exposure scenarios as an annex. IgeraIndustria analyses SDS and identifies non-compliant sections.

Importers of chemical substances into the EU (from third countries) are treated as equivalent to manufacturers under REACH: they must register substances they import in quantities of 1 tonne/year or more, comply with SVHC communication obligations for imported articles and ensure that the SDS provided to their customers comply with Regulation 2020/878. Export of substances and mixtures to third countries is subject to the requirements of the PIC Regulation (EC 649/2012) for substances on the PIC list, which requires Prior Informed Consent (PIC) notification before each export. IgeraIndustria has indexed REACH, CLP and PIC regulations applicable to importers and exporters, with exact article citation for each obligation.