REACH Regulation
REACH Regulation (EC) No. 1907/2006: Analytics for REACH Compliance
Scope of the REACH Regulation and Key Terms
The REACH Regulation is a European regulation and serves as the central chemical law of the EU. As one of the most important chemical regulations worldwide, it has significant influence far beyond Europe. REACH governs the handling of substances, mixtures, chemicals, and articles throughout their entire supply chain. Its objectives are to minimize risks to human health and the environment, create transparency, and establish clear obligations for manufacturers, importers, registrants, and downstream users. Companies must ensure that all requirements for registration, authorization, restriction, and information obligations are met. This requires detailed knowledge of ingredients and material composition, which is why comprehensive analytical characterization of substances and mixtures is mandated by authorities.
Substances, Mixtures, and Articles – Definitions and Scope of Application
The REACH regulations make a clear distinction between substances, mixtures, and articles. Within these categories, it must be determined whether there are obligations for registration, restriction, or specific information duties. While substances and mixtures, as chemicals, are primarily assessed based on their chemical properties, the focus for articles lies on their finished form, function, and the possible presence of substances of very high concern (SVHCs).
Companies, Manufacturers, Importers, and Downstream Users in the EU
Each actor within the supply chain has specific REACH obligations. Manufacturers and importers must register chemicals and substances produced or imported at 1 tonne or more per year to fulfill their registration obligations, while downstream users must ensure that risks arising from the way their products are used are considered in the Chemical Safety Assessment and that specific risk management measures are specified. Collaboration with the European Chemicals Agency (ECHA) and national authorities is essential in this process.
Registration under REACH – Tonnage, Data Requirements, Dossier
Registration forms the foundation of this regulation. Companies, particularly importers and manufacturers, must submit comprehensive data on the identity, properties, and potential risks of chemicals. The higher the quantity, the more extensive the requirements for toxicological, ecotoxicological, and analytical evidence.
Registration Obligations & Tonnage Bands (from 1 Tonne/Year)
A registration obligation applies as soon as a company manufactures or imports substances at quantities of 1 tonne or more per year. For importers, this obligation applies regardless of whether the manufacturer is located outside the EU. The tonnage bands under REACH determine the scope of required data and are based on the annual quantities of a substance manufactured or imported. In this way, the EU provides a uniform framework for assessing chemical risks and potential exposures.
Registration Dossiers, Data, Substance Identity, and Substance Properties
A complete registration dossier contains extensive data on substance identity, physicochemical properties, exposure patterns, and safe use. Registrants are encouraged to cooperate and share data in order to prepare consistent registration dossiers and to meet the requirements of the regulation and authorities.
Chemical Safety Report (CSR) and Exposure Scenarios
For substances manufactured or imported at 10 tonnes or more per year, a Chemical Safety Report (CSR) is required. This report documents the risk assessment, describes exposure scenarios, and defines protective measures. The information is intended for both suppliers and downstream users to ensure the safe handling of the substance.
Obligations for Economic Operators: Authorization, Restriction, and Information Duties
As a European regulation, REACH provides two central instruments to regulate particularly hazardous chemicals: authorization and restriction. Both measures protect consumers, the environment, and workers from critical properties and uses.
Authorization Requirement for Substances of Very High Concern (SVHCs)
SVHCs (Substances of Very High Concern) are characterized by particularly concerning properties, such as carcinogenic, reprotoxic, or bioaccumulative effects. If these substances are included in Annex XIV of the REACH Regulation, they may only be used with authorization for the specific use. Companies must assess risks comprehensively and consider alternatives. SVHCs are listed in a Candidate List for possible inclusion in the annexes of the REACH Regulation. This Candidate List is updated biannually by the European Chemicals Agency (ECHA).
Restrictions in Annex XVII – Use and Application Limitations
Restrictions apply to substances or mixtures whose use poses significant risks to human health or the environment. Annex XVII defines clear limits and prohibitions on the placing on the market of certain products. These measures apply directly across the entire EU and are part of the European Chemicals Regulation.
Information Obligations in the Supply Chain (Art. 33) for Articles Containing ≥ 0.1% SVHC
If an article contains ≥ 1% by mass of a Candidate Substance (SVHC), suppliers must comply with their information obligations under Article 33, provide information on safe use, and register the article with the relevant substance in the SCIP database. This obligation ensures transparency toward professional customers and end users and supports the safe handling of specific articles. Mere ignorance of the presence of reportable substances (SVHCs, POPs, etc.) does not relieve companies of their due diligence obligations. Ignoring the matter can result in significant financial damage for the involved actors.
Assessing Risks: Risk Evaluation and Risk Management Measures
Companies must carry out systematic risk assessments to identify health, safety, and environmental risks at an early stage. Based on this risk assessment, appropriate risk management measures are defined to ensure the safe handling, use, and distribution of chemicals.
Roles & Responsibilities of Economic Operators
Each actor in the chemical supply chain has specific responsibilities that are crucial for the safe handling and distribution of substances within the EU. REACH defines clear requirements for manufacturers, importers, registrants, and downstream users to ensure the safety of chemical products and the chemicals they contain.
Manufacturers, Importers, Registrants, and Only Representatives
Manufacturers and importers are primarily responsible for registration and must compile the necessary data. Registrants of substances and mixtures often form consortia to jointly gather the required data and prepare dossiers. Only Representatives act on behalf of non-EU companies as the point of contact with ECHA and national authorities.
Downstream Users: Use, Compliance, and Documentation
All downstream users must ensure that their use of a substance is covered by risk-assessed exposure scenarios. This includes internal documentation, implementation of protective measures, and evaluation of potential risks throughout the process chain.
Distributors / Importers: Compliance, Labeling, and Placing on the Market
Distributors, importers, and traders may only make available on the market and place on the market products that are legally compliant. Their obligations include, among others, correct labelling, the communication of safety information, and the monitoring of REACH compliance by suppliers.
Verification and Documentation Reference (Our services for REACH compliance)
Our services support companies in ensuring full REACH compliance – ranging from necessary laboratory analyses to documentation reviews.
SVHC screening for safe articles and products
We support manufacturers by sampling raw materials and work materials for the presence of hazardous substances. This includes spot checks and batch controls of material flows as well as the analysis of articles, mixtures, and finished products. Through tailored SVHC screening for relevant candidate substances, our partners gain maximum certainty and reliability in fulfilling their due diligence obligations.
Conformity assessments, risk assessment, documentation checks
Our experts assess products for conformity, provide analytical support for risk assessments, and help partners evaluate safety-relevant supply chain documents through targeted analyses to verify their validity. This allows non-compliances to be identified at an early stage and prevents sanctions or enforcement actions by authorities.
Support for manufacturers, importers, and suppliers regarding registration & use
We guide companies in fulfilling their REACH obligations – from the registration of substances and mixtures and the analysis of SVHCs to supply chain communication and the notification of substances to authorities. Under REACH, the registration of substances and mixtures is carried out by submitting a registration dossier. This strictly requires a scientifically robust, analytical description of the substances or mixtures concerned, which goes far beyond simply providing a Certificate of Analysis (CoA). We support registrants in generating the required ‘analytical information’ that is accepted by ECHA.
