GLOSSARY.

The BAuA (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin) is a German federal authority under the Ministry of Labour. It researches, advises on and monitors occupational safety and the safe use of chemicals. As the central market surveillance authority it plays a decisive role in enforcing product safety regulations in Germany, especially for non-food products.

The Biocidal Products Regulation governs the placing on the market and use of biocidal products in the EU. Biocides are active substances or mixtures intended to control harmful organisms — for example disinfectants, insecticides, or wood preservatives. Products must undergo a demanding authorisation procedure at ECHA that examines efficacy, environmental compatibility, and safety for humans and animals before they can be sold.

The CE marking is a legally binding conformity marking for products placed on the European Economic Area (EEA) market. By affixing it, manufacturers self-declare that their products meet all applicable EU requirements for safety, health, and environmental protection. Key legal bases include the Machinery Directive (2006/42/EC), the Low Voltage Directive (2014/35/EU), and the Medical Devices Regulation (MDR). The conformity process includes identifying applicable directives, verifying requirements, conformity assessment, technical documentation, and affixing the CE mark. Non-compliance can lead to sales bans, recalls, and fines.

The CLP Regulation (EC) No 1272/2008 governs the classification, labelling, and packaging of substances and mixtures in the EU. It implements the United Nations' Globally Harmonized System (GHS) and ensures chemical hazards are clearly communicated through hazard pictograms, signal words, and hazard and precautionary statements. Manufacturers and importers must self-classify their substances and notify ECHA.

Compliance management is the systematic organisation of all measures that ensure a company meets its regulatory obligations. In the field of product compliance, this includes identifying relevant regulations, risk assessments, documentation, training, and internal audits. An effective compliance management system (CMS) minimises liability risks, protects against fines, and strengthens trust among trade partners and consumers.

The Digital Product Passport (DPP) is an EU initiative under the Ecodesign Regulation that aims to make product-related information digitally accessible throughout the entire lifecycle. Via a QR code or RFID chip, consumers, authorities, and recycling companies can access data on material composition, origin, repairability, and recyclability. The DPP will become mandatory for various product categories starting from 2027.

ECHA (European Chemicals Agency), based in Helsinki, is the central EU authority for implementing chemicals legislation. It manages the REACH and CLP Regulations, the Biocidal Products Regulation, and the PIC Regulation. Companies must register chemical substances with ECHA and submit safety data. The agency conducts evaluations, maintains the SVHC Candidate List, and supports national authorities with market surveillance.

EPR obliges manufacturers and importers to take responsibility for the full lifecycle of their products — including take-back, recycling, and disposal. In the EU this applies to packaging (Packaging Act), electrical equipment (WEEE), and batteries, among others. For Amazon sellers, EPR means registering with national schemes (e.g. LUCID in Germany), reporting quantities, and paying licence fees. Without a valid EPR registration, marketplace listings can be blocked.

The EU Declaration of Conformity (DoC) is a legally binding document in which a manufacturer confirms that a product meets all applicable EU harmonisation legislation. It must contain product identification, the applied directives and standards, the responsible person, and a signature. The document must be kept for at least 10 years and be available to market surveillance authorities on request.

The EU Deforestation Regulation (EUDR, EU 2023/1115) prohibits placing certain commodities and products linked to deforestation or forest degradation on the EU market. Affected commodities include soy, beef, palm oil, wood, cocoa, coffee, and rubber, as well as products derived from them. Companies must submit due-diligence statements and be able to trace their supply chains end to end.

The Radio Equipment Directive (RED) regulates the placing on the market of radio equipment in the EU. It applies to any device that uses or receives radio frequencies — from Wi-Fi routers and Bluetooth headphones to smartphones. Manufacturers must demonstrate health protection, electromagnetic compatibility, and efficient spectrum use. From 2025, additional cybersecurity requirements apply to connected devices.

The GPSR (EU 2023/988) is the new EU regulation for general consumer product safety. Since 13 December 2024 it replaces the former General Product Safety Directive (GPSD). It covers virtually all physical consumer products — new, used, or refurbished. Manufacturers, importers, distributors, fulfilment service providers, and online marketplaces are all held responsible. Key obligations include risk assessment before market entry, technical documentation (10-year retention), an EU responsible person with contact details, incident reporting, and recall measures.

Harmonised standards are European standards (EN) developed by recognised standardisation organisations (CEN, CENELEC, ETSI) on behalf of the European Commission. Applying them creates a presumption of conformity: a manufacturer who follows a harmonised standard can assume it meets the essential requirements of the relevant EU directive. They are not mandatory, but they offer the most reliable path to demonstrating compliance.

Under EU product law, the manufacturer is the natural or legal person who manufactures, designs, or has a product manufactured and markets it under their own name or brand. The manufacturer bears primary responsibility for product safety and conformity — regardless of whether production is carried out in-house or by third parties. Private-label sellers on Amazon are legally considered manufacturers.

An importer is any person or company established in the EU that places a product from a third country on the EU market. Importers must ensure the manufacturer has carried out the conformity assessment, that technical documentation is available, and that the product is correctly labelled. On Amazon, sellers who import goods directly from China or other non-EU countries are classified as importers with the full set of obligations.

Labelling requirements encompass all legally mandated information that must appear on a product, its packaging, or in accompanying documentation. This includes the CE marking, manufacturer details, importer details, warnings, material markings, and product-specific mandatory information (e.g. textile labelling, energy labels). Missing or incorrect labelling is one of the most common reasons for Amazon listing suspensions.

The Declaration of Conformity (DoC) is the central document in which a manufacturer declares that a product complies with all applicable EU legislation. It must identify the manufacturer, the product, all relevant directives and the applied standards, and be signed by the responsible person. A product may not be marketed in the EU without a valid Declaration of Conformity.

Conformity assessment is the systematic process of demonstrating that a product meets the applicable requirements. Depending on the risk class, this may involve self-assessment by the manufacturer, a type-examination, or the involvement of a Notified Body. The result is recorded in the technical documentation and forms the basis for the Declaration of Conformity.

Market surveillance authorities are government bodies that check whether products on the market comply with applicable regulations. In Germany, these are various state-level authorities as well as the BAuA at federal level. They conduct random inspections, respond to complaints, can order product recalls, and impose fines. The EU-wide Safety Gate system (formerly RAPEX) links national authorities.

Standards are documented agreements containing technical specifications that serve as guidelines, rules, or definitions. In a compliance context, EN standards (European), ISO standards (international), and IEC standards (electrical engineering) are particularly relevant. Harmonised standards enjoy a special status because applying them creates a presumption of conformity with EU directives.

Product liability obliges manufacturers, importers, and in some cases distributors to pay damages when a defective product causes personal injury or property damage — regardless of fault. The EU Product Liability Directive (85/374/EEC), currently modernised by the new Directive (EU) 2024/2853, now also covers digital products and AI systems. For Amazon sellers this means that without proper compliance documentation, existentially threatening liability claims can arise.

The Product Safety Act (Produktsicherheitsgesetz, ProdSG) is Germany's central legal basis for the safety of non-food consumer products. It transposes various EU directives into national law and defines requirements for placing on the market, the GS mark, and official market surveillance. Violations can result in fines of up to EUR 100,000.

Product safety encompasses all measures and requirements designed to ensure a product does not endanger consumers under intended or foreseeable use. It begins with product development (Safety by Design), extends through conformity assessment and labelling, and includes market surveillance and potential recall actions.

RAPEX (Rapid Exchange of Information System), renamed Safety Gate in 2023, is the EU rapid alert system for dangerous non-food products. National authorities report products that pose a risk to health and safety. Weekly published reports lead to recalls, sales bans, and listing removals on online marketplaces. For Amazon sellers, Safety Gate is one of the most frequent sources of enforcement actions.

The REACH Regulation (EC) No 1907/2006 is the EU's central chemicals safety framework. It requires manufacturers and importers to demonstrate that their substances can be used safely — following the principle "No Data, No Market". The four pillars: Registration (with ECHA for substances > 1 tonne/year), Evaluation (risk assessment by ECHA), Authorisation (for substances of very high concern / SVHC), and Restriction (bans where risks are unacceptable). Obligations extend throughout the entire supply chain.

The RoHS Directive (2011/65/EU) restricts the use of certain hazardous substances in electrical and electronic equipment. Banned or strictly limited are lead, mercury, cadmium, hexavalent chromium, PBB, and PBDE. Manufacturers must demonstrate compliance through technical documentation and an EU Declaration of Conformity. The directive applies to virtually all electrical equipment, including cables, spare parts, and accessories.

Risk management in a compliance context is the structured process of identifying, analysing, and evaluating potential risks posed by a product. Under the GPSR, manufacturers must carry out and document a risk assessment before placing a product on the market. Methods such as FMEA (Failure Mode and Effects Analysis) or risk matrices help to systematically capture hazards and prioritise countermeasures.

SVHCs are substances classified under REACH as being of very high concern — for example because they are carcinogenic, mutagenic, toxic to reproduction, or persistent and bioaccumulative. ECHA maintains a continuously updated Candidate List. Suppliers must inform downstream users if an article contains more than 0.1% by weight of an SVHC. The list currently contains over 230 substances.

Technical documentation (Technical File) is the complete set of records that proves a product meets the applicable requirements. It typically includes a product description, design drawings, risk analyses, test reports, applied standards, and the Declaration of Conformity. The documentation must be kept for at least 10 years and be available to market surveillance authorities on request.

The German Packaging Act (Verpackungsgesetz, VerpackG) obliges anyone who first places packaging on the German market to register with the LUCID register of the Central Agency Packaging Register (ZSVR) and to participate in a dual system (e.g. Grüner Punkt / Green Dot). This applies to sales, secondary, and shipping packaging. For Amazon sellers using FBA, registration is mandatory — without a LUCID number, a distribution ban may be imposed.

The WEEE Directive (2012/19/EU) governs the collection, treatment, and recovery of waste electrical and electronic equipment in the EU. In Germany, implemented through the ElektroG, it obliges manufacturers and importers to register with stiftung ear and finance disposal. Products must bear the crossed-out wheelie bin symbol. For Amazon sellers, WEEE registration is mandatory in every country of sale.

Certification is the confirmation by an independent, accredited body (Notified Body) that a product, process, or system meets specified requirements. Not all products require external certification — for many product categories self-assessment by the manufacturer is sufficient. For higher risk classes (e.g. medical devices, certain machinery) the involvement of a Notified Body is mandatory.