Every regime ยท United Kingdom
Toys (Safety) Regulations 2011
The UK toy safety regime, aligned with the EU Directive it came from: safety assessment, testing, technical documentation, a declaration of conformity, the UKCA or CE mark and warnings.
named This regime is named, not quoted: what it covers and the documents it expects are described in our own words, and no requirement text is reproduced. On the sheet its chip is outlined; a product whose regimes are all named stands as reference.
What it expects in the file
- Technical file
The technical documentation: design, drawings, bill of materials, the standards applied, the conformity assessment route, and the evidence that the requirements are met. Kept for the retention period the regime sets, typically ten years from the last unit placed on the market. - Declaration of conformity
The EU or UK declaration of conformity (or the food-contact declaration of compliance), signed by the manufacturer, naming the product, the legislation and the standards, and the notified or approved body where one was involved. - Risk assessment
The documented hazard identification and risk assessment for the product across its lifecycle, updated when the design, the use or the field data changes. - Test reports
Test reports from an accredited or accepted laboratory against the standards the technical file names, tied to the exact model and revision tested. - Labelling and instructions
Markings on the product and packaging (conformity mark, identification, warnings, manufacturer and importer details) and the instructions and safety information in the language of the market. - Traceability records
Batch, lot or serial identification on the product, the records that tie a unit to its production and supply chain, and UDI where the device rules require it.
Duties that continue after sale
- Incident reporting
Notify the authority when a product has caused, or could cause, an accident, injury or serious incident, through the channel the regime names (the Safety Business Gateway, the MHRA, the FDA, SaferProducts.gov) and within its clock. - Recall readiness
Be able to identify affected units, reach the customers who hold them, issue a notice in the required form, offer the remedy the rules require, and show the authority the effectiveness of the action. - Traceability records
Keep the records that identify which batch went to which customer, and the identification on the product that lets a unit be traced back, for the retention period the regime sets.
Product categories that engage it
See which of your products engage it
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