ECHA Candidate List: 0.1% Threshold, Article 33, and SCIP

If you produce, import, or supply an article containing a substance on the ECHA Candidate List above 0.1% by weight, your ECHA Candidate List SVHC obligations are four: pass hazard information to professional customers automatically under REACH Article 33(1), answer consumer requests within 45 days under Article 33(2), notify ECHA under Article 7(2) when tonnage and concentration triggers are both met, and submit article data to the SCIP database. Each has its own trigger, its own deadline, and its own penalty exposure across EU member states.

The 0.1% Threshold and What Counts as an Article

Almost every obligation below turns on one calculation, so it has to be done correctly. Under REACH, an “article” is any object given a specific shape, surface, or design that determines its function more than its chemical composition does. A plastic casing, a textile, a metal fastener, or an electronic circuit board qualifies. A paint or a cleaning fluid does not; those are mixtures.

The 0.1% weight-by-weight threshold is calculated by dividing the weight of the SVHC by the weight of the article it sits in. The detail that trips companies up: for a complex product made of many components, the 0.1% calculation applies to each individual component that is itself an article, not to the finished product as a whole. A laptop contains dozens of articles. If a single circuit board within it holds an SVHC above 0.1% w/w, the communication and notification duties apply, even if the substance is a rounding error against the laptop’s total mass.

Because the Candidate List grows with each update, the substances relevant to your products today may not be the same ones relevant six months from now. ECHA typically publishes updates twice a year, and each update can add several substances at once.1European Chemicals Agency. Candidate List of Substances of Very High Concern for Authorisation

Supply Chain Communication Under Article 33(1)

Once an article contains a Candidate List substance above 0.1% w/w, Article 33(1) requires you to provide information to every professional recipient in your supply chain. Industrial users, professional users, and distributors receive the data automatically at the point of delivery. You don’t wait to be asked.

The information must include, at minimum, the name of the SVHC and enough detail for the recipient to handle the article safely. In practice that means clear handling and disposal instructions where relevant. The duty is triggered immediately when a substance is added to the Candidate List, so companies need a system for monitoring updates and firing off communications promptly.

Documentation matters. Keep records of what was communicated, to whom, and when. Enforcement authorities auditing your file will want to see that you identified the SVHCs in scope and passed the information downstream in a timely manner. Material safety data sheets and third-party lab reports showing concentration levels form the evidentiary backbone of most compliance files.

Consumer Requests Under Article 33(2)

Article 33(2) gives consumers a separate right to ask about SVHCs in any article they have bought or are considering buying. This one is triggered by the consumer’s request rather than by delivery. Once you receive that request, you have 45 days to respond with the name of the SVHC and enough information for safe use, free of charge.2GOV.UK. Review of Article 33, Duties on Suppliers to Provide Information and Consumers’ Rights to Request Information on Substances of Very High Concern (SVHCs) in Articles

The 45-day deadline is strict, and the consumer doesn’t have to justify the request. Smartphone apps such as AskREACH let consumers scan a barcode and send a request in seconds, which has driven up inquiry volumes for retailers and manufacturers selling directly to consumers. Companies without an internal routing process for these requests routinely miss the deadline.

Notification to ECHA Under Article 7(2)

A separate notification obligation under Article 7(2) requires producers and importers to notify ECHA directly when both of the following apply:

  • The SVHC is present in the articles at a concentration above 0.1% w/w, and
  • The total quantity of the substance across all articles produced or imported exceeds one tonne per year.

This notification goes to ECHA itself, not to your supply chain partners. It feeds into the Agency’s view of how SVHCs are used across the EU market and supports its prioritisation decisions for the Authorisation List.

Two exemptions narrow the scope. If you can demonstrate that exposure to humans or the environment is excluded during normal and reasonably foreseeable use, including disposal, notification isn’t required, but you must provide appropriate instructions to the recipient. And if the substance has already been registered under REACH for the use in question, notification is unnecessary. Companies often overlook Article 7(2) because they focus on the more visible Article 33 duties, but ECHA does follow up on missing notifications.

SCIP Database Submissions

The Waste Framework Directive added a reporting obligation that runs parallel to REACH. Since January 5, 2021, any supplier placing an article containing a Candidate List substance above 0.1% w/w on the EU market must submit information to ECHA’s SCIP database. SCIP stands for Substances of Concern In articles as such or in complex objects (Products), and the database now holds over four million article notifications.3Publications Office of the European Union. Requirements for SCIP Notifications

The purpose differs from Article 33. SCIP exists mainly to support waste treatment operators by giving them information about hazardous substances in products that will eventually reach the waste stream. The data you submit needs to be useful for someone deciding how to recycle or dispose of an article, not only for a professional buyer.

How the Submission Works

Submissions are prepared using IUCLID (International Uniform Chemical Information Database) software and uploaded through ECHA’s submission portal. ECHA provides a Candidate List reference substances package that standardises how substances are identified in submissions, and you should import this package into your IUCLID instance for consistency.4European Chemicals Agency. Candidate List Package

Required fields include the article’s primary identifier (trade name, article number, or barcode), a description of the article category, and the identity and concentration range of the SVHC. The system validates before accepting. Once accepted, each entry receives a unique SCIP number. Keep a central record of those numbers; retailers, waste operators, and enforcement authorities will ask for them.

Keeping Submissions Current

A SCIP notification is not a one-time filing. When ECHA adds a new substance and that substance is present in an article you have already notified, you update the dossier and resubmit. The SCIP reference number for the product stays the same, but the data must reflect the new SVHC.

Changes to subcomponents within a complex product also need attention. Updating a detail for one component article in IUCLID does not automatically propagate to the parent product’s SCIP submission; you have to recreate and resubmit the dossier for the complex object. Spare parts and replacement components sold separately into the EU market need their own SCIP notifications, even where the original parent product was already notified. Aftermarket suppliers get caught out on this one often.

If Your Company Is Outside the EU

A non-EU company cannot submit SCIP notifications directly. The legal duty falls on the EU-based entity that imports the article into the EU market. ECHA treats importation as placing on the market, which means the importer inherits both the Article 33 communication duties and the SCIP notification requirement.5CIRCABC. REACH Law Comments on Import for Own Use

This holds even when the importer brings the article in for internal use rather than resale. A European manufacturer importing analytical equipment from Japan for its own laboratory still has a SCIP notification duty for that equipment if it contains SVHCs above the threshold.

Non-EU manufacturers can appoint an Only Representative (OR) to handle REACH registration on their behalf. Once appointed, the OR takes on the registration role and EU importers become downstream users. The appointment must be in writing, and the representative needs adequate technical expertise and resources.6Health and Safety Authority. Only Representative An OR can manage REACH registration, but responsibility for SCIP notification content stays with the EU importer, even where the importer contracts with the non-EU supplier to prepare the data.

Enforcement and Penalties

REACH enforcement sits with individual EU member states, and penalty ranges vary enormously. The penalties report commissioned by the European Commission found that most countries set maximum fines for a first infringement between €50,000 and €1,000,000, with outliers on both sides.7Ministry of Environment and Energy Security (MASE). Report on Penalties Applicable for Infringement of the Provisions of the REACH Regulation

At the lower end, a handful of countries set maximums below €50,000. At the upper end, Portugal’s maximum reaches €2,500,000 for serious violations; Ireland’s can reach €3,000,000 with possible imprisonment; and the Netherlands allows fines up to €740,000 combined with up to six years of imprisonment for consumer information violations. Some member states impose daily penalty payments for continuing non-compliance, which accumulate quickly.

Beyond fines, market surveillance authorities can order product withdrawals or restrict market access for non-compliant articles. For companies selling across multiple EU member states, the operational risk of a product flagged in one jurisdiction, and the customer conversations that follow in others, often outweighs the fine itself.

Building an Ongoing Monitoring Process

Most compliance failures come not from ignoring the rules, but from not knowing which SVHCs are actually in the products. Start by downloading the current Candidate List from ECHA’s website and cross-referencing it against your product compositions. Each substance carries a CAS number (Chemical Abstracts Service) and an EC number that can be matched against your material declarations and supplier data.

Where supply chain data is incomplete, which is common for complex products with many component suppliers, third-party laboratory testing may be needed to verify SVHC concentrations. Testing a single article can run from a few dozen to several hundred euros depending on the number of substances screened and the analytical methods required. For large product portfolios, a phased approach prioritising high-risk components usually beats blanket testing on cost.

Build the internal process around the Candidate List update cycle. When ECHA publishes an update, your compliance team should be able to run the new substance entries against existing product data within days, not months. Companies that treat SVHC compliance as an annual audit rather than an ongoing monitoring function are the ones that end up scrambling.