Understand what the classification means
Commission Delegated Regulation (EU) 2023/707 introduced specific endocrine-disruption hazard classes into CLP. For human health, it distinguishes known or presumed endocrine disruptors from suspected endocrine disruptors, according to the available evidence.
Environmental classification is different. Interaction with the endocrine system alone is also insufficient: the criteria consider an adverse effect and a biologically plausible relationship. Classification must be checked for the specific substance or mixture.
Look beyond the trade name
INSST recommends reviewing safety data sheets and regulatory sources. Identify substances and components, request updated information from the supplier, and cross-check classification and relevant lists.
Endocrine-disruption information may appear in specific sections of the data sheet. Its absence does not establish that the hazard has been ruled out. The new CLP framework also includes different application schedules and transitional arrangements for substances and mixtures.
Identify tasks and exposure routes
The inventory must cover raw materials, products used and substances present or generated during work. Analyse dosing, maintenance, cleaning and waste management alongside the main activity.
Assessment determines who may be exposed, by which route, for how long and with which controls. Membership of a broad commercial family, such as plastics or pesticides, does not, by itself, establish the same hazard for every component.
Prioritise alternatives and effective controls
Royal Decree 374/2001 establishes Spain’s framework for preventing risks from chemical agents. Assessment must lead to eliminating or reducing risk, considering substitution, process, containment and technical measures before relying solely on personal protection.
An alternative is compared using sufficient information about its own hazards and actual use. A commercial claim that a substance is absent does not guarantee that the substitute has a lower overall risk.
Do not confuse endocrine disruptors with all CMR agents
An endocrine disruptor is not automatically covered by the carcinogen, mutagen and reprotoxic-agent regime solely for that reason. Check whether it meets the conditions of Royal Decree 665/1997; the same substance may have several classifications.
The presence or absence of an exposure limit does not resolve the entire assessment either. Justify the criteria and controls used without inventing a universal safe threshold for this heterogeneous group of substances.
Protect everyone exposed
Assessment must consider particular sensitivity and, where appropriate, pregnancy and breastfeeding under the Occupational Risk Prevention Act. This does not make prevention the individual responsibility of female workers or limit potential risk to pregnancy.
Health surveillance is organised according to exposure and evidence, with confidentiality. Changes in composition or classification require preventive decisions to be reviewed; retaining the initial data sheet is not enough when relevant new information appears.
Hypothetical example: a formulation change
A company receives an alternative formulation for a familiar product. Before accepting it, it requests composition and hazard information and compares expected exposure with that of the previous product.
If uncertainties remain, it documents them and requests technical clarification. The decision is not based solely on a commercial claim: it includes conditions of use, controls and review of the assessment.
