The following set of concepts groups the field's terms into six thematic groups. Each concept should correspond to a data field, a rule, or a document object in a mature system.
3.1 Roles and Basic Concepts
An Economic Operator is a party in the supply chain responsible for a product: manufacturer, authorized agent, importer, distributor, and order fulfillment service provider.
Placing on the Market: The first supply of a product in the relevant market. The legal moment when obligations begin.
Manufacturer: The party that produces the product or markets it under its own name or brand. Responsible for design, risk assessment, and technical documentation.
The importer is the party that brings the product from another country and places it on the market. They are responsible for verifying that the manufacturer has fulfilled its obligations.
Authorized Representative / Responsible Person: The party acting on behalf of a manufacturer located abroad, assuming obligations in the target market. A prerequisite for selling the product in many markets.
The distributor is the party that makes the product available on the market, but is not the manufacturer or importer. They are responsible for verifying that the product bears the necessary markings and documentation.
A safe product is a product that carries an acceptable level of risk under normal or foreseeable conditions of use. The criterion is "acceptable risk," not "zero risk."
Foreseeable Misuse: Misuse that the user could reasonably afford to do. This must be considered in the risk assessment.
Technical Regulations: Binding legislation that defines the characteristics a product must possess.
A harmonized standard is an accepted way of meeting the requirements of a technical regulation. Its application generally provides a presumption of conformity.
3.2 Conformity Assessment and Documents
Conformity Assessment is the process of demonstrating a product's compliance with relevant requirements. It is carried out as an internal control or third-party review, depending on the module.
Notified Body: An organization authorized to perform third-party conformity assessments for specific product groups.
A technical file is a document containing information about a product's design, manufacturing, risk assessment, test reports, and applied standards. It is mandatory to keep it for a specified period.
A Declaration of Conformity is a legal document in which the manufacturer unilaterally declares that the product conforms to the relevant legislation.
Conformity Mark: A mark indicating that the product conforms to the relevant requirements; for example, the CE mark for the European market.
Test Report: A document from an accredited laboratory showing the results of testing a product according to specific standards. Its validity period and scope must be monitored.
Presumption of Conformity: The assumption that a product conforming to a harmonized standard meets the relevant essential requirement.
Certificate Validity: Documents must be up-to-date in terms of duration, scope, and version. An expired certificate indicates an unsuitable product.
3.3 Chemical and Substance Compatibility
A restricted substance is a substance whose use is prohibited or limited in certain products or above certain concentrations.
Substances of Very High Concern (SVHC) are substances included in the candidate list due to their carcinogenic, mutagenic, reproductive toxic, persistent, bioaccumulative, or endocrine disrupting properties. Exceeding certain thresholds necessitates notification obligations for these products.
Substance in Article: A substance contained within a non-chemical article (electronic circuit board, textile, furniture). Compliance obligations also cover non-chemical products.
Persistent Organic Pollutants (POPs) are a group of substances whose production or use is prohibited or restricted under international conventions.
The Restriction of Hazardous Substances (RoHS) regulation limits the use of certain hazardous substances in electrical and electronic equipment; it applies a threshold at the level of homogeneous materials.
Homogeneous material: A uniform material that cannot be mechanically broken down into smaller parts. The level at which restrictive material thresholds are applied.
A Full Material Declaration (FMD) is a complete declaration of the product's contents, including ingredient numbers and concentration levels. It eliminates the need to contact the supplier again when a new restriction is introduced.
Declaration Classes Levels of depth for material declarations: simple conformity response, material class declaration, substance-level declaration, and full material declaration.
Product Compliance Statement: A written statement from the supplier that the product conforms to a specific regulation. Its evidentiary value depends on the supporting data.
Conflict Minerals : The duty of care and reporting regarding the source of certain minerals such as tin, tantalum, tungsten, and gold.
Perfluorinated compounds (PFAS) are a broad group of substances that persist in the environment for extended periods. A comprehensive restriction process is underway.
3.4 Hazard Communication and GHS
GHS stands for the United Nations' Globally Harmonized System for the Classification and Labelling of Chemicals. It is the universal language of hazard communication.
Hazard Class and Category: Type and severity of damage. Defined in three main groups: physical, health, and environmental.
Hazard Statement (H): A standard textual description of the harm. The code is universal, but the text varies according to market terminology.
Precautionary Statement (P) Instructions for prevention, intervention, storage and disposal.
Pictogram and Signal Word Label: Warning symbol on the label along with the word "Danger" or "Caution".
A Safety Data Sheet (SDS) is a standard document containing 16 entries about the hazards and safe use of a substance or mixture.
Extended Safety Data Sheet. Expanded version with added exposure scenarios.
The Unique Formula Identifier (UFI) is a code linked to the composition of the mixture in the poison information notification; it appears on the label.
Poison Control Notification: Reporting the composition information of hazardous mixtures to the relevant authority for emergency medical intervention.
Harmonized Classification: A classification made legally binding for specific substances. It cannot be changed by your own assessment.
3.5 Transportation, Packaging and Waste
Dangerous Goods are products that pose risks during transport and are subject to special regulations. This is a different framework from hazard classification.
UN Number: A four-digit international code used to identify a dangerous good during transport.
Packaging Group: The hazard level of the hazardous material during transport determines the packaging durability requirements.
Limited and Exceptional Quantities: Mitigated transport regulations apply to small packages.
Differences in Transportation Modes: Land, sea, and air transportation have different sets of regulations. The same product may require different documents and labeling in each mode.
Extended Producer Responsibility (EPR) means that the manufacturer is held responsible for the costs of collecting and recycling their product at the waste stage.
Packaging Declaration: Reporting the quantity of packaging placed on the market according to material type and meeting recycling targets.
Electronic Waste (WEEE) : Obligations regarding the collection and recycling of electrical and electronic equipment waste.
The Waste Code is a code that indicates which waste category the product falls into at the end of its life; it is part of the safety data sheet.
3.6 Sustainability, Traceability and Post-Market
A Digital Product Passport (DPP) is a digital record that contains information about a product's identity, materials, repairability, and end-of-life in a machine-readable format.
Ecodesign Regulation (ESPR) is a framework that regulates the design of products in terms of durability, repairability, and recyclability.
Product Carbon Footprint (PCF) is the greenhouse gas emission per product. It is becoming increasingly common due to customer demand and legislation.
Border Carbon Adjustment (CBAM) is a mechanism for applying carbon pricing to the embodied emissions of certain imported products.
Deforestation Regulation (EUDR): The duty of care must be used to prove that certain commodities and products do not cause deforestation.
Traceability refers to having a record of who the product was purchased from and who it was sold to; the ability to reach the source and buyer of a problematic product.
Batch/Serial Tracking: Tracking the product at the production batch or serial number level. This is the only mechanism that narrows the scope of recalls.
Market Surveillance and Inspection: The process by which an authorized authority inspects the conformity of products on the market.
Non-compliance Notification: The manufacturer's obligation to notify the authority when they determine that their product poses a risk.
Recall: The process of collecting products that have already reached the customer. Requires a standard notification template and direct consumer communication.
Withdrawal from the market refers to the removal of a product from the supply chain; this does not include products that have already reached the consumer.
Corrective action is a structured effort undertaken to resolve a nonconformity and prevent its recurrence.