REACH, IUCLID & GLP glossary

The tiered information requirements under EU Regulation (EC) No 1907/2006. The annex that applies depends on the annual tonnage a registrant manufactures or imports: Annex VII from 1 tonne, VIII from 10, IX from 100 and X from 1,000 tonnes per year. Each higher tier adds physicochemical, toxicological and ecotoxicological endpoints, so the dataset a substance needs scales with its registered volume.

The structured technical file a registrant submits to ECHA to register a substance under REACH. It compiles substance identity, manufacture and use information, classification, study summaries and, above a tonnage threshold, a chemical safety report. The dossier is assembled in IUCLID and validated before submission to demonstrate that the applicable annex data requirements are met.

Under REACH, all registrants of the same substance must register jointly. One company acts as lead registrant and submits the shared classification, study summaries and safety information on behalf of the group; the others submit member dossiers referencing it. This "one substance, one registration" principle reduces duplicate testing and shares the cost of data across the consortium.

A systematic comparison of the data available for a substance against the endpoints required at its tonnage band. It identifies which physicochemical, toxicological and ecotoxicological studies are missing, inadequate or unreliable, and informs whether each gap is filled by new testing, existing data, read-across or another adaptation. It is usually the first step in scoping a registration.

A data-gap-filling approach that uses information from one or more source substances to predict an endpoint for a structurally or mechanistically similar target substance, avoiding new testing. It must be justified scientifically — typically through structural analogy and a documented hypothesis — and is one of the adaptations permitted under REACH Annex XI when standard testing is not warranted.

A substance identified under REACH as causing serious effects — carcinogenic, mutagenic or toxic for reproduction (CMR), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or of equivalent concern such as an endocrine disruptor. SVHCs are placed on the Candidate List, which triggers notification and communication duties, and may later be moved to the Authorisation List (Annex XIV), after which their use requires specific authorisation.

The document required under REACH for substances registered at 10 tonnes per year or more. It records the chemical safety assessment: hazard assessment for human health and the environment, PBT/vPvB assessment and, where the substance is classified as hazardous, exposure scenarios and risk characterisation showing that risks are adequately controlled across identified uses.

Two reference values derived in a chemical safety assessment. The DNEL (Derived No-Effect Level) is the exposure to a substance above which humans should not be exposed, set per route, duration and population. The PNEC (Predicted No-Effect Concentration) is the environmental concentration below which adverse effects are not expected. Risk characterisation compares estimated exposure against these thresholds.

IUCLID (International Uniform Chemical Information Database) is the software used to record and exchange data on chemical substances under REACH, the Biocidal Products Regulation and OECD harmonised templates. A completed dossier is exported as an .i6z file — a compressed package of the substance dataset — which is the format submitted to ECHA and other regulatory authorities.

A detailed summary of a study, sufficient to allow an independent assessment of the study and to judge its reliability without consulting the full report. Required under REACH for key studies, it captures the test material, method and guideline, results and the author’s interpretation, typically following the OECD harmonised template structure within the dossier.

The act of sending a completed dossier to the European Chemicals Agency through REACH-IT, the official submission portal. Before acceptance, the dossier passes business-rule and technical-completeness checks; failures are returned for correction. Submission applies to REACH registrations, biocidal applications and other regulatory processes the agency administers.

A quality system, defined by the OECD Principles of GLP, covering the organisational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. Regulatory authorities require GLP compliance for many of the safety studies submitted in registration dossiers, and laboratories are inspected by national monitoring authorities to verify it.

A collection of internationally agreed methods for testing chemicals, published by the OECD across physical-chemical properties, environmental fate, ecotoxicity and health effects. Studies run to these guidelines under GLP benefit from Mutual Acceptance of Data, meaning results are accepted across member countries without duplicate testing. Each guideline carries a number, for example TG 471 for bacterial reverse mutation.

The document that defines the objectives and experimental design of a GLP study before work begins. It specifies the test and reference items, methods and guideline, timelines and responsibilities, and is approved and dated by the study director. Any subsequent change is recorded as a dated, justified amendment, and deviations from the plan during conduct are documented.

The final record of a completed GLP study, presenting the methods actually used, the results and the study director’s interpretation and conclusions. It includes a signed GLP compliance statement and a Quality Assurance statement listing the phases inspected. Together with the study plan it forms the auditable basis for the robust study summary entered into a dossier.

The single point of study control in a GLP study, responsible for the overall conduct and for the final report. The study director approves the study plan, ensures procedures are followed, that data are recorded and that deviations are documented and assessed, and signs the GLP compliance statement. The role is defined by the OECD Principles of GLP.

An inspection carried out by a laboratory’s Quality Assurance function, which is independent of study conduct, to verify that a study complies with GLP, its study plan and standard operating procedures. QA audits cover study phases, facilities and the final report; findings are recorded and the report carries a QA statement listing the dates and phases inspected.

An organisation that performs studies or testing services on behalf of a sponsor — for example, the toxicological, ecotoxicological or analytical work needed for a registration. In a regulatory context CROs typically operate under GLP and to OECD test guidelines, delivering study reports the sponsor uses to build dossiers and safety assessments.

A collective shorthand for the family of "good practice" quality frameworks — among them Good Laboratory Practice, Good Manufacturing Practice and Good Clinical Practice. The "x" stands for the discipline. Each defines documented, inspectable standards for how regulated work is planned, performed and recorded so that data and products are reliable and traceable.