Harmonised standard
The applicable hEN, or a European Assessment Document where no hEN exists, is identified before CE scope is set.
COMPLIANCE READINESS
Build compliance readiness into project delivery.
A practical, evidence-led framework for assessing product, construction and operational requirements before delivery into EU, UK or North American markets.
ELMSFLOW supports evidence preparation, qualification coordination and pathways toward relevant certificates. ELMSFLOW does not issue official certificates, make regulatory decisions or guarantee market access. Requirements and routes are subject to assessment and confirmation by qualified parties and competent authorities.
Eight checks before goods are shipped
For construction products and packaging equipment, these are the items confirmed with the manufacturer and the assessment body before a shipment leaves.
Factory Production Control
The manufacturer runs an auditable FPC system covering production, testing and the records behind them.
Notified Body
Notified Body involvement is confirmed where required. UK bodies no longer hold EU Notified Body status.
Declaration of Performance
DoP, or DoPC where required, is prepared and traceable to initial type testing evidence.
EU Authorised Representative
An authorised representative is appointed where required, established in the EU rather than merely in the EEA.
Product-specific assessment
Where no hEN covers the product, an Agrément-type assessment route is considered.
Cross-testing and fire class
British and Irish standard cross-testing and EN 13501-1 fire classification are matched to the specification.
Pre-shipment inspection
Pre-Shipment Inspection is accepted against AQL criteria agreed for the product and the order.
Three compliance layers
01
Product compliance
Confirm the product, intended use, material composition, destination market and customer specifications before selecting standards or tests.
- For food-contact materials, assess Regulation (EC) No 1935/2004 and the applicable material-specific requirements, intended use, declarations and testing evidence.
- Good Manufacturing Practice requirements under Commission Regulation (EC) No 2023/2006 apply to relevant food-contact materials and manufacturing processes.
- Assess BRCGS, ISO 22000, ISO 9001 and ISO 14001 against the product, factory scope, supply chain and customer requirements; none is a blanket substitute for legal compliance.
- Medical and pharmaceutical packaging is a separate Phase 2 workstream. MDR, ISO 13485 and ISO 15378 applicability depends on product classification, intended use and activity scope.
02
Construction and equipment compliance
Establish the product-specific regulatory route and assessment scope; avoid generalised CE or certification claims.
- Assess CPR (EU) 2024/3110 and the applicable product-specific harmonised European standard (hEN) or European Assessment Document (EAD) before determining CE scope.
- Factory Production Control (FPC) is the manufacturer’s own production-control system and is subject to the relevant assessment; Initial Type Testing (ITT) and EU-27 Notified Body coordination may be required. UK bodies no longer hold EU Notified Body status.
- Prepare the applicable Declaration of Performance (DoP) or Declaration of Performance and Conformity (DoPC). Where an EU Authorised Representative is required, it must be established in the EU, not merely in the EEA.
- NSAI Agrément may offer a product-specific assessment route where applicable. BS/IS cross-testing and EN 13501-1 fire-classification evidence depend on product scope and specification.
- Use Pre-Shipment Inspection (PSI) and Acceptable Quality Limit (AQL) criteria where specified, with acceptance levels agreed for the product and order.
- For packaging machinery and line equipment, assess applicable CE marking, machinery safety, EMC and LVD requirements; define the boundary between equipment and any food-contact parts.
03
Operations, permits and records
Check that the proposed site, operating model and evidence controls are ready to support compliant production and project delivery.
- Confirm planning, building and fire requirements for the site and proposed works with the relevant qualified advisers and authorities.
- Assess environmental permissions, wastewater, emissions and utilities capacity against the site activity, scale and location.
- Define hygiene zoning and operational controls appropriate to the product and process.
- Maintain quality and traceability records, alongside production, inspection, maintenance and other records required by the applicable scope.
Supplier readiness package
- Material-to-standard mapping for each product, intended use and target market.
- Factory Production Control procedures and supporting evidence.
- EU-27 Notified Body and Initial Type Testing coordination, where required by the product route.
- Applicable DoP/DoPC and evidence that an EU Authorised Representative is established in the EU, where required.
- NSAI Agrément assessment route and supporting material, where applicable.
- BS/IS cross-testing and fire or structural testing evidence, as required by specification.
- Review of the supplier technical dossier, including relevant reports, declarations and product information.
- Factory-floor verification and PSI/AQL inspection against the agreed specification and acceptance criteria.
- Consistency checks across batch information, product marking, invoices and technical documents.