Frequently Asked Questions (FAQ)
Precise answers on product safety, extended producer responsibility (EPR), and EU compliance for smooth distribution.
Since the entry into force of the Market Surveillance Regulation (EU) 2019/1020 and the General Product Safety Regulation (GPSR - EU 2023/988), it is mandatory for manufacturers outside the EU to appoint an economic operator established within the European Economic Area. Without this anchor point, products (both with CE marking and non-CE goods under the GPSR as well as packaging within the meaning of the PPWR) may not be offered on the European market. At the same time, new regulatory requirements such as Extended Producer Responsibility (EPR) and future mandates from the Ecodesign Regulation (ESPR) and the Digital Product Passport (DPP) extend these obligations to environmental and data-related aspects.
Systemic Standards assumes this role as the legally required point of contact for customs authorities, market surveillance bodies, environmental agencies, and end customers.
Apply to specific product groups (e.g., electronics, machinery, or toys) which must comply with harmonized European standards.
Acts as a regulatory safety net for almost all non-food consumer products and requires safety, traceability, and a responsible person in the EU.
Regulates requirements for packaging regarding recyclability, material composition, labeling, and technical documentation.
Obligates companies to take responsibility for the collection, recycling, and disposal of their products and packaging, including registration and volume reporting in the respective EU countries.
Extends the focus to sustainability, durability, repairability, and material efficiency of products and is being introduced step-by-step as a mandatory requirement.
Creates a digital database containing information on materials, origin, environmental metrics, and the entire product lifecycle, and will become an integral part of EU product regulation in the future.
EPR is already mandatory today and affects almost all companies introducing products or packaging into the EU market. ESPR and DPP are in the phased implementation stage and will significantly expand regulatory requirements. While EPR regulates physical product responsibility, ESPR and DPP introduce structural transparency regarding sustainability and product lifecycle data. Companies must therefore not only operate in a compliant manner but also maintain structured, readily available datasets. Systemic Standards supports you in integrating these requirements early on and executing them strategically.
Our scope of services covers a wide spectrum: consumer goods and lifestyle products, consumer electronics, smart technologies, as well as mechanical engineering and industrial plants. Additionally, we support companies with EPR obligations, sustainable product requirements under ESPR, and the structured development of data for the Digital Product Passport (DPP).
In external relations with European authorities, we serve as the primary point of contact. However, civil product liability remains entirely with the manufacturer. Our role encompasses preventive conformity evaluation, legally secure representation, and ensuring the absolute completeness of your documentation and—increasingly—consistent product and environmental data (EPR/DPP).
To ensure maximum transparency and structure, every project follows a defined workflow:
Initial Onboarding & Preliminary Review: You submit your master data along with existing laboratory test reports and certificates for technical assessment.
Invoicing: Upon successful completion of the preliminary review, you receive the formal invoice. The official project launch and mandate activation take place immediately upon receipt of payment.
Gap Analysis (Compliance Check): We intensively analyze your technical files for statutory conformity and uncover potential areas of non-compliance.
Mandate Activation & Labeling: Following a successful audit evaluation, you receive our official registered address details for statutory placement on the product, packaging, and accompanying documents.
10-Year Archiving: Your files are securely transferred to our long-term, audit-proof technical archive.
We immediately analyze the root cause (e.g., missing documentation, lacking EPR registration, incorrect marking, or data discrepancies). Utilizing our Express workflow, we handle direct technical communications with market surveillance authorities or platforms, close compliance gaps, and guide the rapid release of your products.
We identify missing documents, laboratory test reports, or specific data points and guide your organization in a structured manner toward full conformity—encompassing criteria from GPSR, CE, EPR, and prospectively ESPR and DPP frameworks.
We perform risk assessments in accordance with ISO 12100 and validate safety-related control systems according to ISO 13849-1 (SISTEMA). Additionally, we dynamic map incoming requirements for sustainability and digital product data within the industrial sector.
Yes. We guide your organization through implementation for ISO 9001 and ISO 14001, linking traditional management systems with modern regulatory updates from EPR, ESPR, and DPP—ensuring a holistic process compliance strategy.
The legislator prescribes a mandatory retention period of 10 years. Concurrently, technical criteria require structured and digitally accessible product records under ESPR and DPP frameworks. Systemic Standards ensures that your files and data sets remain long-term accessible, audit-proof, and resilient.
We are not a mere "mailbox company." Our in-depth technical audit protects your operations from authority interventions, EPR non-compliance fines, and impending data gaps. Through our systemic methodology, we connect product safety, environmental mandates, and digital data compliance into a unified protection framework for your secure EU market access.
