The REACH Regulation: A Practical Guide for Product Companies

If your company manufactures, imports, or sells physical products in the EU, the REACH regulation is one of the regulatory frameworks you cannot ignore. REACH governs the use of chemical substances and imposes requirements across the entire supply chain — from raw material suppliers to final product manufacturers. In this guide, we provide a practical overview of what REACH entails and what you specifically need to do to ensure compliance.

What Is REACH?

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals and is EU Regulation (EC) No. 1907/2006 on chemicals. The regulation entered into force in 2007 and is administered by the European Chemicals Agency (ECHA), headquartered in Helsinki.

The purpose of REACH is to protect human health and the environment from the risks posed by chemical substances, while maintaining the free movement of goods within the EU internal market. The central principle is that it is the responsibility of companies to identify and manage the risks associated with the substances they manufacture, import, or use.

For you as a product company, this means you must have control over which chemical substances your products contain — and whether those substances are subject to restrictions or supply chain communication requirements.

SVHC Substances and the Candidate List

One of the most central elements of REACH is the concept of SVHC — Substances of Very High Concern. These are substances that ECHA has identified as particularly problematic because they are, for example, carcinogenic, mutagenic, toxic to reproduction, persistent and bioaccumulative, or endocrine-disrupting.

SVHC substances are placed on the so-called Candidate List, which ECHA updates twice a year. As of today, the list contains over 200 substances, and it continues to grow. When a substance is added to the Candidate List, it triggers a number of obligations for companies marketing articles that contain the substance at a concentration above 0.1% by weight:

• Duty to inform: You must inform your customers about the presence of the SVHC substance and provide sufficient information for safe use of the product.
• Notification duty: If your product contains an SVHC substance above the threshold and you import or produce more than 1 tonne of the article per year, you must notify ECHA.
• Consumer duty: Consumers have the right to ask whether a product contains SVHC substances, and you must respond within 45 days.

It is important to understand that the Candidate List is dynamic. A substance that is not on the list today may be added tomorrow — and the obligations apply immediately. Therefore, ongoing monitoring is essential. Read our guide to RoHS compliance to understand how REACH and the RoHS Directive overlap, and what that means for your product strategy.

Annex XVII: Restrictions on Chemical Substances

In addition to the Candidate List, REACH contains an Annex XVII that sets out specific restrictions on the manufacture, marketing, and use of certain substances. These restrictions apply regardless of SVHC classification and may include:

• A total ban on the use of a substance in certain product categories.
• Concentration limits for a substance in specific articles.
• Labelling or special packaging requirements.

Examples of substances regulated under Annex XVII include lead in jewellery, nickel in products with prolonged skin contact, cadmium in plastic materials, and various phthalates in toys. Annex XVII is continuously updated, and new restrictions can have direct consequences for your existing products.

Roles in the Supply Chain

REACH imposes different obligations on different roles. It is important that you know your own role:

Manufacturer of Substances

If you manufacture chemical substances in the EU in quantities above 1 tonne per year, you must register the substance with ECHA. Registration requires a technical dossier with data on the substance’s properties, hazards, and safe use.

Importer

If you import chemical substances or mixtures from countries outside the EU in quantities above 1 tonne per year, the same registration requirements apply as for manufacturers. If you import finished articles, you must ensure that any SVHC substances are identified and communicated correctly.

Downstream User (Formulator/Article Producer)

If you use chemical substances or mixtures to manufacture your own products, you are a downstream user. You must ensure that your use of the substances is covered by the existing registration, and you must follow the instructions in the extended safety data sheet.

Distributor

As a distributor, you handle products without altering their chemical composition. You must pass on safety data sheets in the supply chain and respond to inquiries about SVHC content.

Practical Steps to REACH Compliance

Achieving and maintaining REACH compliance requires a systematic approach. Here are the most important steps:

1. Map the Chemical Content of Your Products

Start by identifying which chemical substances your products contain. This requires close collaboration with your suppliers, as you are typically dependent on information from earlier stages of the supply chain. Request Material Declarations and Full Material Disclosure (FMD) from your suppliers.

2. Screen Against the Candidate List and Annex XVII

Compare the chemical content of your products with the current Candidate List and the restrictions in Annex XVII. This screening must be carried out regularly, as both lists are updated on an ongoing basis. A semi-annual review is recommended at minimum, but with over 200 SVHC substances and numerous restrictions, it can quickly become an unmanageable manual task.

3. Establish Supply Chain Communication

Ensure that relevant information about SVHC substances is communicated to your customers — both business customers and end consumers. This communication must be proactive for business customers and within 45 days upon request from consumers.

4. Document and Archive

All documentation relating to REACH compliance should be stored systematically and be easily accessible during regulatory inspections. This includes supplier declarations, test results, SVHC screening records, and correspondence with ECHA. Understand CE marking and your obligations to see how REACH documentation connects with your other product documentation.

5. Monitor Legislative Changes

REACH is a living regulation. New substances are added to the Candidate List, restrictions are tightened, and the scope of the Authorisation List is expanded. If you don’t keep up, you risk selling products that are suddenly in breach of the law.

Conphora Automatically Screens Against the SVHC List

Manual SVHC screening is time-consuming and error-prone — especially if you have many product variants or a complex supply chain. This is where Conphora can save you significant effort.

Conphora integrates the latest version of ECHA’s Candidate List and Annex XVII restrictions directly into the platform. When you register your products’ chemical composition, the system automatically screens against the applicable lists and alerts you if a product contains substances above the threshold values. You are notified when the Candidate List is updated and can quickly assess whether your existing products are affected.

The result is that you always have an up-to-date overview of your REACH status — without spending hours on manual cross-checking of substance names and CAS numbers.

Start free with Conphora and experience how simple REACH compliance can be.

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