I. Regulatory Framework
What to look for in the regulatory framework. Based on EU chemical legislation practices, the framework is understood through five key aspects: Definition—REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals (Regulation 1907/2006; approved Dec 18, 2006; effective June 1, 2007);
Purpose—Aims to improve the protection of human health and the environment from risks posed by chemicals (European Commission); Registration—Chemical substances exceeding 1 tonne per company per year must be registered with ECHA (enterprises must identify risks and management methods; applies to substances and mixtures); Evaluation—ECHA and Member States evaluate information submitted by enterprises (reviewing testing proposals, checking registration dossier compliance, assessing risks to human health or the environment); Authorisation—Substances of Very High Concern (SVHC) enter the authorisation process (substances meeting regulatory criteria are added to the SVHC Candidate List); Restriction—Annex XVII restriction clauses (certain products may trigger restrictions—e.g., specific phthalates in children’s products, specific azo dyes in textiles—requiring control during design and procurement stages; WTO/FTA guidelines). In summary, the framework comprises five elements: Registration, Evaluation, Authorisation, Restriction, and the 1-tonne registration threshold.
II.
Registration Determination
What to consider for registration determination.
Based on REACH registration practices, the assessment involves the following steps: Step 1—Determine whether the product is a substance, a mixture, or an article (or a combination of an article and a substance/mixture; refer to WTO/FTA registration guidelines); Step 2—Break down the chemical composition (for mixtures, list all constituent substances and their proportions, and calculate the annual export volume of each substance to the EU; for articles, identify any substances intended to be released and estimate their annual volume exported to the EU); Step 3—Check against tonnage thresholds (if the annual volume of a substance exported to the EU is 1 tonne or more, REACH registration is generally required; for substances intended to be released from articles, registration requirements are determined based on the tonnage of the released substance); Illegality—Manufacturing or supplying unregistered substances in the EU is illegal (Guangdong WTO/TBT Notification and Enquiry Research Center); Articles—REACH applies to chemical substances whether they exist on their own, in mixtures, or in articles (manufactured, imported, or used in the EU; EEN OUEST); Non-registration—Not registering does not mean the product is exempt from REACH obligations (articles containing SVHCs at concentrations above 0.1% w/w require the provision of relevant information to downstream customers and consumers; if the total annual volume of SVHCs in the articles exported to the EU reaches 1 tonne, an SVHC notification must also be submitted to ECHA)—The assessment covers six key aspects: classification (substance, mixture, or article), chemical composition breakdown, the 1-tonne threshold, substances intended for release, the illegality of non-registration, and SVHC compliance requirements even without full registration;
these six criteria provide a clear basis for assessment.
III. Registration Process
What to consider regarding the registration process.
Based on REACH registration practices, the process can be viewed through six key aspects: Responsibility—manufacturers or importers are responsible for gathering information on substance properties and uses (including assessing relevant hazards and potential risks as well as control measures, and transmitting this information to ECHA via a registration dossier); Dossier—the registration dossier consists of two main components (the technical dossier and the Chemical Safety Report [CSR]; the CSR is required only for tonnage bands of 10 tonnes or more per year); Information—the technical dossier must compile all existing relevant information (checked against the information requirements outlined in REACH Annexes VI–X, which specify the data needed for different tonnage bands); Joint Submission—registration is based on the “one substance, one registration” principle (manufacturers and importers of the same substance must submit a joint registration to avoid unnecessary animal testing and control costs); Assessment—registrants manufacturing or importing 10 tonnes or more per year must conduct a chemical safety assessment (determining conditions of use under which risks can be controlled, per Article 14 of REACH); Threshold—manufacturers or importers must register with ECHA if they manufacture or import 1 tonne or more of a substance per year, or import articles containing 1 tonne or more of a substance intended for release (submitting a technical dossier detailing the physicochemical and toxicological properties of the chemical and necessary safety measures for handling). These six aspects—manufacturer/importer responsibility, technical dossier plus CSR, Annex VI–X information requirements, “one substance, one registration,” 10-tonne chemical safety assessment, and the 1-tonne registration threshold—form a complete process loop.
IV.
SVHC Obligations
What to consider regarding SVHC obligations.
Regarding REACH practices for Substances of Very High Concern (SVHC), obligations are understood as follows: **Definition**—SVHCs originate from the EU REACH regulation (substances meeting regulatory criteria are compiled into the Candidate List of SVHCs); **Candidate List**—Potential SVHCs are identified by national REACH authorities or by ECHA at the request of the European Commission (Step 1: preparing a dossier explaining why the substance meets the criteria; the proposal is published on the ECHA website, inviting stakeholders to submit comments within a set timeframe; if no objections are raised, the substance is automatically added to the Candidate List); **Obligations**—Inclusion in the Candidate List imposes immediate obligations on substance suppliers (providing Safety Data Sheets; communicating safe use instructions; responding to consumer inquiries within 45 days; notifying ECHA if manufactured articles contain SVHCs in quantities exceeding 1 tonne per producer/year and the concentration exceeds 0.1% w/w); **Notification**—Notification is required if the SVHC concentration in an article exceeds 0.1% (w/w), the total quantity exceeds 1 tonne per manufacturer/importer per year, and the substance has not yet been registered for that specific use; **SCIP**—Products placed on the EU market containing SVHC Candidate List substances above 0.1% must be notified in the SCIP database (notification must identify the specific article within a complex product that contains SVHCs above 0.1% and specify its location within that complex product); **Information**—Under Article 33(2) of REACH, distributors, manufacturers, and importers must provide information free of charge within 45 days (this applies regardless of whether a purchase is likely to occur; the obligation is triggered once the substance concentration in the article exceeds 0.1% w/w and applies to most everyday articles); **List**—The REACH SVHC Candidate List currently comprises 253 substances. In summary, SVHC compliance involves six key aspects: the Candidate List, the 0.1% notification threshold, the 1-tonne volume threshold, the SCIP database, the 45-day information response requirement, and the current list of 253 substances—clarifying the obligations involved.
V.
Corporate Implementation
What should enterprises focus on regarding implementation?
Regarding REACH compliance practices, the operational approach involves the following: OR (Only Representative)—Companies without an EU/EEA address cannot register themselves (EU importers bringing in over 1 tonne/year must register unless they appoint an OR to assume all rights and obligations; EU/EEA importers become downstream users; the OR must have substance-handling experience per Article 8(2) and Swiss Anmeldestelle requirements); Declarations—Useful supplier REACH declarations should identify specific details (supplier name, product or part number, declaration date, Candidate List version or date, SVHC content >0.1% w/w, substance name and identifiers, articles or components containing the substance, concentration or concentration range, sufficient safe-use information, authorized representative or signatory, Enviropass); Testing—REACH compliance testing (for substances identified as SVHCs and added to the Candidate List; testing services provided by TÜV SÜD); Restrictions—16 new items added to the REACH restriction list, effective September 1, 2025 (Shanghai Fair Trade Service Network); UK—The first step for UK REACH registration is submitting an Article 26 inquiry (UK REACH has no pre-registration provision; pre-registrations previously submitted to ECHA are no longer valid in Great Britain; inquiry dossiers are prepared using free IUCLID software; HSE UK); Fees—Registration fees (Annex I for individual or joint submissions; Annex II for on-site isolated and transported isolated intermediates; Annex III for registration updates due to tonnage band increases, changes in registrant legal personality, or changes in access rights to registration information; Luxembourg REACH Helpdesk)—Operational implementation covers six key areas: appointing an Only Representative, supplier declaration elements, compliance testing, updates on the 16 restrictions, UK REACH inquiry, and tiered registration fees.
Conclusion
How is REACH certification for automation components handled?
The conclusion lies in a five-dimensional framework: regulatory framework, determination, process, SVHC management, and operational execution.
Framework—REACH Regulation 1907/2006 (effective June 1, 2007; four processes: registration, evaluation, authorization, and restriction; 1-tonne registration threshold; prohibition of unregistered substances; Annex XVII restrictions); Determination—Three-step method (identify substance/mixture/article, break down chemical composition, check against 1-tonne threshold), identify substances intended for release from articles, SVHC compliance required even without registration (provide info if >0.1%, notify if total annual volume >1 tonne); Process—Manufacturer/importer responsibility to gather data, technical dossier plus chemical safety report (for >10 tonnes), Annex VI–X information requirements, “one substance, one registration” (joint submission), chemical safety assessment (for >10 tonnes), 1-tonne registration threshold; SVHC—Candidate List (253 items), inclusion triggers obligations (SDS, 45-day response, >0.1% notification, >1-tonne total volume notification), SCIP database notification (locating individual articles within complex products), Article 33 free information provision;
Operations—Non-EU companies appoint Only Representative (OR), supplier REACH declaration elements (name, part number, Candidate List version, concentration, safe use info), compliance testing, updates on 16 restriction entries, UK REACH inquiry, tiered registration fees.
In industry terms, REACH compliance boils down to this: 1-tonne registration, SVHC notification (if >0.1%), non-EU OR appointment, and declarations plus testing—clear these four hurdles, and REACH compliance is assured.
